Finding the optimal fluid strategies for sepsis

Article Type
Changed

A new review offers evidence-based strategies for improving sepsis outcomes with appropriate doses of intravenous fluid therapy at each stage of treatment.

The document offers guidance on the four forms of fluid use; assessing whether intravenous fluid administration is indicated; and fluid therapy goals, timing, type, and other clinical parameters. The recommendations are based on a literature search that included 28 randomized clinical trials, 7 secondary analyses of RCTs, 20 observational studies, 5 systematic reviews or meta-analyses, 1 scoping review, 1 practice guideline, and 14 references from a reference review.

“Our review highlights that crystalloids should remain the standard of care for most critically ill patients, especially during early resuscitation,” Fernando G. Zampieri, MD, PhD, assistant adjunct professor of critical care medicine at the University of Alberta and Alberta Health Services, both in Edmonton, said in an interview. “In particular, starches should not be used in critically ill patients. Balanced solutions might be better for most patients, except for patients with traumatic brain injury, where 0.9% saline is recommended.”

The review was published online in JAMA.
 

Four therapeutic phases

Approximately 20%-30% of patients admitted to an intensive care unit have sepsis, and fluid therapy is a key component of their treatment. Although intravenous fluid can increase cardiac output and blood pressure, maintain or increase intravascular fluid volume, and deliver medications, too much fluid or the wrong type of fluid may cause harm.

“Deciding which type of fluid is the best for a patient [with sepsis] can be challenging,” said Dr. Zampieri.

Fluid therapy can be conceptualized as encompassing four overlapping phases from early illness through resolution of sepsis, according to the review. These phases include resuscitation (rapidly administering fluid to restore perfusion), optimization (assessing risks and benefits of additional fluids to treat shock and ensure organ perfusion), stabilization (using fluid therapy only when there is a signal of fluid responsiveness), and evacuation (eliminating excess fluid accumulated during treatment).

The review described the studies that underpin its key recommendations for management in these phases. Three RCTs included 3,723 patients with sepsis who received 1-2 L of fluid. They found that goal-directed therapy with administration of fluid boluses to attain a central venous pressure of 8-12 mm Hg, vasopressors to attain a mean arterial blood pressure of 65-90 mm Hg, and red blood cell transfusions or inotropes to attain a central venous oxygen saturation of at least 70% did not decrease mortality, compared with unstructured clinical care (24.9% vs. 25.4%, P = .68).

One RCT with 1,563 patients with sepsis and hypotension who received 1 L of fluid found that favoring vasopressor treatment did not improve mortality, compared with further fluid administration (14.0% vs. 14.9%, P = .61).

In another RCT, among 1,554 patients with septic shock who were treated in the ICU with at least 1 L of fluid, restricting fluid administration in the absence of severe hypoperfusion did not reduce mortality, compared with more liberal fluid administration (42.3% vs. 42.1%, P = .96).

An RCT of 1,000 patients with acute respiratory distress during the evacuation phase found that limiting fluid administration and giving diuretics improved the number of days alive without mechanical ventilation, compared with fluid treatment to attain higher intracardiac pressure (14.6 vs. 12.1 days, P < .001).

This study also found that hydroxyethyl starch significantly increased the incidence of kidney replacement therapy, compared with saline (7.0% vs. 5.8%, P = .04), Ringer lactate, or Ringer acetate.
 

 

 

Ultrasonography lacks validation

The authors summarized the key concerns about fluid therapy. Fluid therapy should be initiated for patients with evidence of sepsis-induced hypoperfusion who are likely to have increased cardiac output with fluid administration. Fluid administration should be discontinued when evidence of hypoperfusion resolves, the patient no longer responds to fluid, or the patient shows evidence of fluid overload.

Balanced solutions should be selected over 0.9% saline for fluid therapy, according to the review. Hydroxyethyl starches should not be used.

Fluid removal should be considered after the resuscitation and optimization phases and when a patient has stabilized, the authors wrote. Diuretics are first-line therapy to facilitate fluid elimination.

Kidney replacement therapy may be considered for patients with severe acute kidney injury who have complications from fluid overload and are unresponsive to diuretic therapy.

“The use of ultrasonography as a bedside tool to guide fluid resuscitation is promising but lacks validation in robust randomized controlled trials,” said Dr. Zampieri. “Point-of-care ultrasound may be useful to assess causes of shock and [helping to exclude] a life-threatening diagnosis at presentation, such as cardiac tamponade.”

Pending the emergence of further evidence, the authors suggest that clinicians prescribe fluids judiciously, preferably at aliquots followed by frequent reassessment. “Defining a resuscitation target (such as capillary refill time or lactate, among others) and performing fluid challenges to correct them while no overt signs of fluid overload (such as pulmonary edema) occur is a common practice that is also sustained by clinical research,” said Dr. Zampieri.

He added that the review’s recommendations are based on research conducted mainly in high-income settings, and that generalizability will depend on factors such as local standards of care and resource availability.

“Our review provides an overall guidance, but caution is warranted before extrapolating the suggestion to every possible clinical scenario,” he concluded.
 

Fluids as drugs

Commenting on the review, Hernando Gomez, MD, MPH, an associate professor of critical care medicine at the University of Pittsburgh, said: “I agree with the conclusions and commend the authors for this very practical revision of the literature.” Dr. Gomez was not involved in the review.

“I would like to stress the point, however, that although fluids can be harmful, particularly when not indicated and when used in excess, fluid resuscitation in patients with sepsis who have evidence of hypoperfusion is paramount,” he said.

“The association between fluid accumulation and poor outcomes is truly a Goldilocks problem, often described in the literature as a ‘U’ shape, where too little fluid (i.e., a very restrictive strategy) or too much fluid (i.e., use in excess and in discordance with the patient’s needs) can be harmful,” said Dr. Gomez.

Furthermore, every strategy to assess fluid responsiveness has limitations. “It is key that clinicians resist the temptation to dismiss these limitations, because decisions made on flawed data are as dangerous as not assessing fluid responsiveness in the first place,” he said.

Based on the evidence, clinicians should “think of fluids as a drug and carefully assess risks and benefits before deciding to administer fluids to their patients,” Dr. Gomez added. It is also important to separate the question “Does my patient need fluids?” from the question “Is my patient fluid responsive?”

“These are two different questions that often get conflated,” Dr. Gomez said. “If a bolus of fluid given to a patient who needs fluids and is fluid-responsive does not improve tissue perfusion, then fluids should not be given.”

No funding was reported for the review. Dr. Zampieri reported receiving fluids and logistics from Baxter Hospitalar during the conduct of the BaSICS trial, personal fees from Bactiguard for statistical consulting and from Baxter for participating in an advisory board, grants from Ionis Pharmaceuticals outside the submitted work, and serving as lead investigator of the BaSICS trial. Dr. Gomez reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

A new review offers evidence-based strategies for improving sepsis outcomes with appropriate doses of intravenous fluid therapy at each stage of treatment.

The document offers guidance on the four forms of fluid use; assessing whether intravenous fluid administration is indicated; and fluid therapy goals, timing, type, and other clinical parameters. The recommendations are based on a literature search that included 28 randomized clinical trials, 7 secondary analyses of RCTs, 20 observational studies, 5 systematic reviews or meta-analyses, 1 scoping review, 1 practice guideline, and 14 references from a reference review.

“Our review highlights that crystalloids should remain the standard of care for most critically ill patients, especially during early resuscitation,” Fernando G. Zampieri, MD, PhD, assistant adjunct professor of critical care medicine at the University of Alberta and Alberta Health Services, both in Edmonton, said in an interview. “In particular, starches should not be used in critically ill patients. Balanced solutions might be better for most patients, except for patients with traumatic brain injury, where 0.9% saline is recommended.”

The review was published online in JAMA.
 

Four therapeutic phases

Approximately 20%-30% of patients admitted to an intensive care unit have sepsis, and fluid therapy is a key component of their treatment. Although intravenous fluid can increase cardiac output and blood pressure, maintain or increase intravascular fluid volume, and deliver medications, too much fluid or the wrong type of fluid may cause harm.

“Deciding which type of fluid is the best for a patient [with sepsis] can be challenging,” said Dr. Zampieri.

Fluid therapy can be conceptualized as encompassing four overlapping phases from early illness through resolution of sepsis, according to the review. These phases include resuscitation (rapidly administering fluid to restore perfusion), optimization (assessing risks and benefits of additional fluids to treat shock and ensure organ perfusion), stabilization (using fluid therapy only when there is a signal of fluid responsiveness), and evacuation (eliminating excess fluid accumulated during treatment).

The review described the studies that underpin its key recommendations for management in these phases. Three RCTs included 3,723 patients with sepsis who received 1-2 L of fluid. They found that goal-directed therapy with administration of fluid boluses to attain a central venous pressure of 8-12 mm Hg, vasopressors to attain a mean arterial blood pressure of 65-90 mm Hg, and red blood cell transfusions or inotropes to attain a central venous oxygen saturation of at least 70% did not decrease mortality, compared with unstructured clinical care (24.9% vs. 25.4%, P = .68).

One RCT with 1,563 patients with sepsis and hypotension who received 1 L of fluid found that favoring vasopressor treatment did not improve mortality, compared with further fluid administration (14.0% vs. 14.9%, P = .61).

In another RCT, among 1,554 patients with septic shock who were treated in the ICU with at least 1 L of fluid, restricting fluid administration in the absence of severe hypoperfusion did not reduce mortality, compared with more liberal fluid administration (42.3% vs. 42.1%, P = .96).

An RCT of 1,000 patients with acute respiratory distress during the evacuation phase found that limiting fluid administration and giving diuretics improved the number of days alive without mechanical ventilation, compared with fluid treatment to attain higher intracardiac pressure (14.6 vs. 12.1 days, P < .001).

This study also found that hydroxyethyl starch significantly increased the incidence of kidney replacement therapy, compared with saline (7.0% vs. 5.8%, P = .04), Ringer lactate, or Ringer acetate.
 

 

 

Ultrasonography lacks validation

The authors summarized the key concerns about fluid therapy. Fluid therapy should be initiated for patients with evidence of sepsis-induced hypoperfusion who are likely to have increased cardiac output with fluid administration. Fluid administration should be discontinued when evidence of hypoperfusion resolves, the patient no longer responds to fluid, or the patient shows evidence of fluid overload.

Balanced solutions should be selected over 0.9% saline for fluid therapy, according to the review. Hydroxyethyl starches should not be used.

Fluid removal should be considered after the resuscitation and optimization phases and when a patient has stabilized, the authors wrote. Diuretics are first-line therapy to facilitate fluid elimination.

Kidney replacement therapy may be considered for patients with severe acute kidney injury who have complications from fluid overload and are unresponsive to diuretic therapy.

“The use of ultrasonography as a bedside tool to guide fluid resuscitation is promising but lacks validation in robust randomized controlled trials,” said Dr. Zampieri. “Point-of-care ultrasound may be useful to assess causes of shock and [helping to exclude] a life-threatening diagnosis at presentation, such as cardiac tamponade.”

Pending the emergence of further evidence, the authors suggest that clinicians prescribe fluids judiciously, preferably at aliquots followed by frequent reassessment. “Defining a resuscitation target (such as capillary refill time or lactate, among others) and performing fluid challenges to correct them while no overt signs of fluid overload (such as pulmonary edema) occur is a common practice that is also sustained by clinical research,” said Dr. Zampieri.

He added that the review’s recommendations are based on research conducted mainly in high-income settings, and that generalizability will depend on factors such as local standards of care and resource availability.

“Our review provides an overall guidance, but caution is warranted before extrapolating the suggestion to every possible clinical scenario,” he concluded.
 

Fluids as drugs

Commenting on the review, Hernando Gomez, MD, MPH, an associate professor of critical care medicine at the University of Pittsburgh, said: “I agree with the conclusions and commend the authors for this very practical revision of the literature.” Dr. Gomez was not involved in the review.

“I would like to stress the point, however, that although fluids can be harmful, particularly when not indicated and when used in excess, fluid resuscitation in patients with sepsis who have evidence of hypoperfusion is paramount,” he said.

“The association between fluid accumulation and poor outcomes is truly a Goldilocks problem, often described in the literature as a ‘U’ shape, where too little fluid (i.e., a very restrictive strategy) or too much fluid (i.e., use in excess and in discordance with the patient’s needs) can be harmful,” said Dr. Gomez.

Furthermore, every strategy to assess fluid responsiveness has limitations. “It is key that clinicians resist the temptation to dismiss these limitations, because decisions made on flawed data are as dangerous as not assessing fluid responsiveness in the first place,” he said.

Based on the evidence, clinicians should “think of fluids as a drug and carefully assess risks and benefits before deciding to administer fluids to their patients,” Dr. Gomez added. It is also important to separate the question “Does my patient need fluids?” from the question “Is my patient fluid responsive?”

“These are two different questions that often get conflated,” Dr. Gomez said. “If a bolus of fluid given to a patient who needs fluids and is fluid-responsive does not improve tissue perfusion, then fluids should not be given.”

No funding was reported for the review. Dr. Zampieri reported receiving fluids and logistics from Baxter Hospitalar during the conduct of the BaSICS trial, personal fees from Bactiguard for statistical consulting and from Baxter for participating in an advisory board, grants from Ionis Pharmaceuticals outside the submitted work, and serving as lead investigator of the BaSICS trial. Dr. Gomez reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new review offers evidence-based strategies for improving sepsis outcomes with appropriate doses of intravenous fluid therapy at each stage of treatment.

The document offers guidance on the four forms of fluid use; assessing whether intravenous fluid administration is indicated; and fluid therapy goals, timing, type, and other clinical parameters. The recommendations are based on a literature search that included 28 randomized clinical trials, 7 secondary analyses of RCTs, 20 observational studies, 5 systematic reviews or meta-analyses, 1 scoping review, 1 practice guideline, and 14 references from a reference review.

“Our review highlights that crystalloids should remain the standard of care for most critically ill patients, especially during early resuscitation,” Fernando G. Zampieri, MD, PhD, assistant adjunct professor of critical care medicine at the University of Alberta and Alberta Health Services, both in Edmonton, said in an interview. “In particular, starches should not be used in critically ill patients. Balanced solutions might be better for most patients, except for patients with traumatic brain injury, where 0.9% saline is recommended.”

The review was published online in JAMA.
 

Four therapeutic phases

Approximately 20%-30% of patients admitted to an intensive care unit have sepsis, and fluid therapy is a key component of their treatment. Although intravenous fluid can increase cardiac output and blood pressure, maintain or increase intravascular fluid volume, and deliver medications, too much fluid or the wrong type of fluid may cause harm.

“Deciding which type of fluid is the best for a patient [with sepsis] can be challenging,” said Dr. Zampieri.

Fluid therapy can be conceptualized as encompassing four overlapping phases from early illness through resolution of sepsis, according to the review. These phases include resuscitation (rapidly administering fluid to restore perfusion), optimization (assessing risks and benefits of additional fluids to treat shock and ensure organ perfusion), stabilization (using fluid therapy only when there is a signal of fluid responsiveness), and evacuation (eliminating excess fluid accumulated during treatment).

The review described the studies that underpin its key recommendations for management in these phases. Three RCTs included 3,723 patients with sepsis who received 1-2 L of fluid. They found that goal-directed therapy with administration of fluid boluses to attain a central venous pressure of 8-12 mm Hg, vasopressors to attain a mean arterial blood pressure of 65-90 mm Hg, and red blood cell transfusions or inotropes to attain a central venous oxygen saturation of at least 70% did not decrease mortality, compared with unstructured clinical care (24.9% vs. 25.4%, P = .68).

One RCT with 1,563 patients with sepsis and hypotension who received 1 L of fluid found that favoring vasopressor treatment did not improve mortality, compared with further fluid administration (14.0% vs. 14.9%, P = .61).

In another RCT, among 1,554 patients with septic shock who were treated in the ICU with at least 1 L of fluid, restricting fluid administration in the absence of severe hypoperfusion did not reduce mortality, compared with more liberal fluid administration (42.3% vs. 42.1%, P = .96).

An RCT of 1,000 patients with acute respiratory distress during the evacuation phase found that limiting fluid administration and giving diuretics improved the number of days alive without mechanical ventilation, compared with fluid treatment to attain higher intracardiac pressure (14.6 vs. 12.1 days, P < .001).

This study also found that hydroxyethyl starch significantly increased the incidence of kidney replacement therapy, compared with saline (7.0% vs. 5.8%, P = .04), Ringer lactate, or Ringer acetate.
 

 

 

Ultrasonography lacks validation

The authors summarized the key concerns about fluid therapy. Fluid therapy should be initiated for patients with evidence of sepsis-induced hypoperfusion who are likely to have increased cardiac output with fluid administration. Fluid administration should be discontinued when evidence of hypoperfusion resolves, the patient no longer responds to fluid, or the patient shows evidence of fluid overload.

Balanced solutions should be selected over 0.9% saline for fluid therapy, according to the review. Hydroxyethyl starches should not be used.

Fluid removal should be considered after the resuscitation and optimization phases and when a patient has stabilized, the authors wrote. Diuretics are first-line therapy to facilitate fluid elimination.

Kidney replacement therapy may be considered for patients with severe acute kidney injury who have complications from fluid overload and are unresponsive to diuretic therapy.

“The use of ultrasonography as a bedside tool to guide fluid resuscitation is promising but lacks validation in robust randomized controlled trials,” said Dr. Zampieri. “Point-of-care ultrasound may be useful to assess causes of shock and [helping to exclude] a life-threatening diagnosis at presentation, such as cardiac tamponade.”

Pending the emergence of further evidence, the authors suggest that clinicians prescribe fluids judiciously, preferably at aliquots followed by frequent reassessment. “Defining a resuscitation target (such as capillary refill time or lactate, among others) and performing fluid challenges to correct them while no overt signs of fluid overload (such as pulmonary edema) occur is a common practice that is also sustained by clinical research,” said Dr. Zampieri.

He added that the review’s recommendations are based on research conducted mainly in high-income settings, and that generalizability will depend on factors such as local standards of care and resource availability.

“Our review provides an overall guidance, but caution is warranted before extrapolating the suggestion to every possible clinical scenario,” he concluded.
 

Fluids as drugs

Commenting on the review, Hernando Gomez, MD, MPH, an associate professor of critical care medicine at the University of Pittsburgh, said: “I agree with the conclusions and commend the authors for this very practical revision of the literature.” Dr. Gomez was not involved in the review.

“I would like to stress the point, however, that although fluids can be harmful, particularly when not indicated and when used in excess, fluid resuscitation in patients with sepsis who have evidence of hypoperfusion is paramount,” he said.

“The association between fluid accumulation and poor outcomes is truly a Goldilocks problem, often described in the literature as a ‘U’ shape, where too little fluid (i.e., a very restrictive strategy) or too much fluid (i.e., use in excess and in discordance with the patient’s needs) can be harmful,” said Dr. Gomez.

Furthermore, every strategy to assess fluid responsiveness has limitations. “It is key that clinicians resist the temptation to dismiss these limitations, because decisions made on flawed data are as dangerous as not assessing fluid responsiveness in the first place,” he said.

Based on the evidence, clinicians should “think of fluids as a drug and carefully assess risks and benefits before deciding to administer fluids to their patients,” Dr. Gomez added. It is also important to separate the question “Does my patient need fluids?” from the question “Is my patient fluid responsive?”

“These are two different questions that often get conflated,” Dr. Gomez said. “If a bolus of fluid given to a patient who needs fluids and is fluid-responsive does not improve tissue perfusion, then fluids should not be given.”

No funding was reported for the review. Dr. Zampieri reported receiving fluids and logistics from Baxter Hospitalar during the conduct of the BaSICS trial, personal fees from Bactiguard for statistical consulting and from Baxter for participating in an advisory board, grants from Ionis Pharmaceuticals outside the submitted work, and serving as lead investigator of the BaSICS trial. Dr. Gomez reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Ticks use static electricity to latch onto hosts: Study

Article Type
Changed

It turns out that some people really are tick magnets.

Researchers have discovered that ticks can defy gravity in their quest to latch onto people and animals. The key is static electricity, just like when someone rubs a balloon and things stick to it.

The study was published in the journal Current Biology. In the first phase of the research, scientists exposed ticks to furry rabbit feet and to acrylic surfaces that each had electrostatic charges.

“Ticks were readily attracted across air gaps of up to several millimeters or centimeters onto these statically charged surfaces,” the authors wrote. “This establishes that electrostatic attraction of ticks onto hosts can take place over large air gaps of many body lengths of a tick.”

In a second part of the study, the researchers created computer models simulating the electrostatic charges that exist in environments where both ticks and mammals are found. In one simulation, the researchers observed that the body parts of a cow with the most electric charge were the nose, tail, and legs, which are the body parts most likely to be encountered by a tick. They also found that the vegetation near the animal had a strong electric field that is just a few millimeters wide.

In a final phase of the study, the researchers conducted laboratory experiments in which they re-created the electric field conditions from the computer model and successfully lifted some ticks across an air gap, although some ticks did not make the full leap if they were observed to be resisting.

The authors noted that their findings could be applied to developing new tick prevention strategies, such as designing clothing that resists electrostatic charges or spraying livestock.

The study authors reported that they had no conflicts of interest.

A version of this article first appeared on WebMD.com.

Publications
Topics
Sections

It turns out that some people really are tick magnets.

Researchers have discovered that ticks can defy gravity in their quest to latch onto people and animals. The key is static electricity, just like when someone rubs a balloon and things stick to it.

The study was published in the journal Current Biology. In the first phase of the research, scientists exposed ticks to furry rabbit feet and to acrylic surfaces that each had electrostatic charges.

“Ticks were readily attracted across air gaps of up to several millimeters or centimeters onto these statically charged surfaces,” the authors wrote. “This establishes that electrostatic attraction of ticks onto hosts can take place over large air gaps of many body lengths of a tick.”

In a second part of the study, the researchers created computer models simulating the electrostatic charges that exist in environments where both ticks and mammals are found. In one simulation, the researchers observed that the body parts of a cow with the most electric charge were the nose, tail, and legs, which are the body parts most likely to be encountered by a tick. They also found that the vegetation near the animal had a strong electric field that is just a few millimeters wide.

In a final phase of the study, the researchers conducted laboratory experiments in which they re-created the electric field conditions from the computer model and successfully lifted some ticks across an air gap, although some ticks did not make the full leap if they were observed to be resisting.

The authors noted that their findings could be applied to developing new tick prevention strategies, such as designing clothing that resists electrostatic charges or spraying livestock.

The study authors reported that they had no conflicts of interest.

A version of this article first appeared on WebMD.com.

It turns out that some people really are tick magnets.

Researchers have discovered that ticks can defy gravity in their quest to latch onto people and animals. The key is static electricity, just like when someone rubs a balloon and things stick to it.

The study was published in the journal Current Biology. In the first phase of the research, scientists exposed ticks to furry rabbit feet and to acrylic surfaces that each had electrostatic charges.

“Ticks were readily attracted across air gaps of up to several millimeters or centimeters onto these statically charged surfaces,” the authors wrote. “This establishes that electrostatic attraction of ticks onto hosts can take place over large air gaps of many body lengths of a tick.”

In a second part of the study, the researchers created computer models simulating the electrostatic charges that exist in environments where both ticks and mammals are found. In one simulation, the researchers observed that the body parts of a cow with the most electric charge were the nose, tail, and legs, which are the body parts most likely to be encountered by a tick. They also found that the vegetation near the animal had a strong electric field that is just a few millimeters wide.

In a final phase of the study, the researchers conducted laboratory experiments in which they re-created the electric field conditions from the computer model and successfully lifted some ticks across an air gap, although some ticks did not make the full leap if they were observed to be resisting.

The authors noted that their findings could be applied to developing new tick prevention strategies, such as designing clothing that resists electrostatic charges or spraying livestock.

The study authors reported that they had no conflicts of interest.

A version of this article first appeared on WebMD.com.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM CURRENT BIOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Malaria is spreading in the U.S. for the first time in 20 years

Article Type
Changed

The first cases since at least 2003 of people getting malaria from a mosquito bite within the U.S. have occurred in Florida and Texas, the Centers for Disease Control and Prevention says. 

The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.

All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.

Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The Texas Department of State Health Services said the last time malaria was locally acquired in the state was 1994.

The Florida Department of Health said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.

The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.

More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.

A version of this article first appeared on WebMD.com.

Publications
Topics
Sections

The first cases since at least 2003 of people getting malaria from a mosquito bite within the U.S. have occurred in Florida and Texas, the Centers for Disease Control and Prevention says. 

The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.

All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.

Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The Texas Department of State Health Services said the last time malaria was locally acquired in the state was 1994.

The Florida Department of Health said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.

The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.

More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.

A version of this article first appeared on WebMD.com.

The first cases since at least 2003 of people getting malaria from a mosquito bite within the U.S. have occurred in Florida and Texas, the Centers for Disease Control and Prevention says. 

The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.

All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.

Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The Texas Department of State Health Services said the last time malaria was locally acquired in the state was 1994.

The Florida Department of Health said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.

The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.

More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.

A version of this article first appeared on WebMD.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Nebulized amphotericin B does not affect aspergillosis exacerbation-free status at 1 year

Article Type
Changed

 

Topline

Nebulized amphotericin B does not improve exacerbation-free status at 1 year for patients with bronchopulmonary aspergillosis, though it may delay onset and incidence.

Methodology

Investigators searched PubMed and Embase databases for studies that included at least five patients with allergic bronchopulmonary aspergillosis who were managed with nebulized amphotericin B.

They included five studies, two of which were randomized controlled trials (RCTs), and three were observational studies; there was a total of 188 patients.

The primary objective of this systematic review and meta-analysis was to determine the frequency of patients remaining exacerbation free 1 year after initiating treatment with nebulized amphotericin B.
 

Takeaway

From the studies (one observational, two RCTs; n = 84) with exacerbation data at 1 or 2 years, the pooled proportion of patients who remained exacerbation free with nebulized amphotericin B at 1 year was 76% (I2 = 64.6%).

The pooled difference in risk with the two RCTs that assessed exacerbation-free status at 1 year was 0.33 and was not significantly different between the nebulized amphotericin B and control arms, which received nebulized saline.

Two RCTs provided the time to first exacerbation, which was significantly longer with nebulized amphotericin B than with nebulized saline (337 vs. 177 days; P = .004; I2 = 82%).

The proportion of patients who experienced two or more exacerbations was significantly lower with nebulized amphotericin B than with nebulized saline (9/33 [27.3%] vs 20/38 [52.6%]; P = .03).
 

In practice

“The time to first exacerbation was prolonged with [nebulized amphotericin B] therapy and is an important indicator of effectiveness. Also, the proportion of subjects experiencing ≥ 2 exacerbations was also lesser with NAB than in the control,” concluded Valliappan Muthu, MD, and colleagues. However, “the ideal duration and optimal dose of LAMB for nebulization are unclear.”

Study details

“Nebulized amphotericin B for preventing exacerbations in allergic bronchopulmonary aspergillosis: A systematic review and meta-analysis” was published online in Pulmonary Pharmacology and Therapeutics.

Limitations

The current review is limited by the small number of included trials and may have a high risk of bias. Therefore, more evidence is required for the use of nebulized amphotericin B in routine care. The authors have disclosed no conflicts of interest.

A version of this article originally appeared on Medscape.com.

Publications
Topics
Sections

 

Topline

Nebulized amphotericin B does not improve exacerbation-free status at 1 year for patients with bronchopulmonary aspergillosis, though it may delay onset and incidence.

Methodology

Investigators searched PubMed and Embase databases for studies that included at least five patients with allergic bronchopulmonary aspergillosis who were managed with nebulized amphotericin B.

They included five studies, two of which were randomized controlled trials (RCTs), and three were observational studies; there was a total of 188 patients.

The primary objective of this systematic review and meta-analysis was to determine the frequency of patients remaining exacerbation free 1 year after initiating treatment with nebulized amphotericin B.
 

Takeaway

From the studies (one observational, two RCTs; n = 84) with exacerbation data at 1 or 2 years, the pooled proportion of patients who remained exacerbation free with nebulized amphotericin B at 1 year was 76% (I2 = 64.6%).

The pooled difference in risk with the two RCTs that assessed exacerbation-free status at 1 year was 0.33 and was not significantly different between the nebulized amphotericin B and control arms, which received nebulized saline.

Two RCTs provided the time to first exacerbation, which was significantly longer with nebulized amphotericin B than with nebulized saline (337 vs. 177 days; P = .004; I2 = 82%).

The proportion of patients who experienced two or more exacerbations was significantly lower with nebulized amphotericin B than with nebulized saline (9/33 [27.3%] vs 20/38 [52.6%]; P = .03).
 

In practice

“The time to first exacerbation was prolonged with [nebulized amphotericin B] therapy and is an important indicator of effectiveness. Also, the proportion of subjects experiencing ≥ 2 exacerbations was also lesser with NAB than in the control,” concluded Valliappan Muthu, MD, and colleagues. However, “the ideal duration and optimal dose of LAMB for nebulization are unclear.”

Study details

“Nebulized amphotericin B for preventing exacerbations in allergic bronchopulmonary aspergillosis: A systematic review and meta-analysis” was published online in Pulmonary Pharmacology and Therapeutics.

Limitations

The current review is limited by the small number of included trials and may have a high risk of bias. Therefore, more evidence is required for the use of nebulized amphotericin B in routine care. The authors have disclosed no conflicts of interest.

A version of this article originally appeared on Medscape.com.

 

Topline

Nebulized amphotericin B does not improve exacerbation-free status at 1 year for patients with bronchopulmonary aspergillosis, though it may delay onset and incidence.

Methodology

Investigators searched PubMed and Embase databases for studies that included at least five patients with allergic bronchopulmonary aspergillosis who were managed with nebulized amphotericin B.

They included five studies, two of which were randomized controlled trials (RCTs), and three were observational studies; there was a total of 188 patients.

The primary objective of this systematic review and meta-analysis was to determine the frequency of patients remaining exacerbation free 1 year after initiating treatment with nebulized amphotericin B.
 

Takeaway

From the studies (one observational, two RCTs; n = 84) with exacerbation data at 1 or 2 years, the pooled proportion of patients who remained exacerbation free with nebulized amphotericin B at 1 year was 76% (I2 = 64.6%).

The pooled difference in risk with the two RCTs that assessed exacerbation-free status at 1 year was 0.33 and was not significantly different between the nebulized amphotericin B and control arms, which received nebulized saline.

Two RCTs provided the time to first exacerbation, which was significantly longer with nebulized amphotericin B than with nebulized saline (337 vs. 177 days; P = .004; I2 = 82%).

The proportion of patients who experienced two or more exacerbations was significantly lower with nebulized amphotericin B than with nebulized saline (9/33 [27.3%] vs 20/38 [52.6%]; P = .03).
 

In practice

“The time to first exacerbation was prolonged with [nebulized amphotericin B] therapy and is an important indicator of effectiveness. Also, the proportion of subjects experiencing ≥ 2 exacerbations was also lesser with NAB than in the control,” concluded Valliappan Muthu, MD, and colleagues. However, “the ideal duration and optimal dose of LAMB for nebulization are unclear.”

Study details

“Nebulized amphotericin B for preventing exacerbations in allergic bronchopulmonary aspergillosis: A systematic review and meta-analysis” was published online in Pulmonary Pharmacology and Therapeutics.

Limitations

The current review is limited by the small number of included trials and may have a high risk of bias. Therefore, more evidence is required for the use of nebulized amphotericin B in routine care. The authors have disclosed no conflicts of interest.

A version of this article originally appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Palliative Care: Utilization Patterns in Inpatient Dermatology

Article Type
Changed
Display Headline
Palliative Care: Utilization Patterns in Inpatient Dermatology
IN PARTNERSHIP WITH THE SOCIETY OF DERMATOLOGY HOSPITALISTS

Palliative care (PC) is a field of medicine that focuses on improving quality of life by managing physical symptoms as well as mental and spiritual well-being in patients with severe illnesses.1,2 Despite cases of severe dermatologic disease, the use of PC in the field of dermatology is limited, often leaving patients with a range of unmet needs.2,3 In one study that explored PC in patients with melanoma, only one-third of patients with advanced melanoma had a PC consultation.4 Reasons behind the lack of utilization of PC in dermatology include time constraints and limited training in addressing the complex psychosocial needs of patients with severe dermatologic illnesses.1 We conducted a retrospective, cross-sectional, single-institution study of specific inpatient dermatology consultations over a 5-year period to describe PC utilization among patients who were hospitalized with select severe dermatologic diseases.

Methods

A retrospective, cross-sectional study of inpatient dermatology consultations over a 5-year period (October 2016 to October 2021) was performed at Atrium Health Wake Forest Baptist Medical Center (Winston-Salem, North Carolina). Patients’ medical records were reviewed if they had one of the following diseases: bullous pemphigoid, calciphylaxis, cutaneous T-cell lymphoma (CTCL), drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, erythrodermic psoriasis, graft-vs-host disease, pemphigus vulgaris (PV), purpura fulminans, pyoderma gangrenosum, and Stevens-Johnson syndrome/toxic epidermal necrolysis. These diseases were selected for inclusion because they have been associated with a documented increase in inpatient mortality and have been described in the published literature on PC in dermatology.2 This study was reviewed and approved by the Wake Forest University institutional review board.

Use of PC consultative services along with other associated consultative care (ie, recreation therapy [RT], acute pain management, pastoral care) was assessed for each patient. Recreation therapy included specific interventions such as music therapy, arts/craft therapy, pet therapy, and other services with the goal of improving patient cognitive, emotional, and social function. For patients with a completed PC consultation, goals for PC intervention were recorded.

Results

The total study sample included 193 inpatient dermatology consultations. The mean age of the patients was 58.9 years (range, 2–100 years); 66.8% (129/193) were White and 28.5% (55/193) were Black (Table). Palliative care was consulted in 5.7% of cases, with consultations being requested by the primary care team. Reasons for PC consultation included assessment of the patient’s goals of care (4.1% [8/193]), pain management (3.6% [7/193]), non–pain symptom management (2.6% [5/193]), psychosocial support (1.6% [3/193]), and transitions of care (1.0% [2/193]). The average length of patients’ hospital stay prior to PC consultation was 11.5 days(range, 1–32 days). Acute pain management was the reason for consultation in 15.0% of cases (29/193), RT in 21.8% (42/193), and pastoral care in 13.5% (26/193) of cases. Patients with calciphylaxis received the most PC and pain consultations, but fewer than half received these services. Patients with calciphylaxis, PV, purpura fulminans, and CTCL received a higher percentage of PC consultations than the overall cohort, while patients with calciphylaxis, DRESS syndrome, PV, and pyoderma gangrenosum received relatively more pain consultations than the overall cohort (Figure).

Patient Demographics and Dermatologic Diagnosis

Comment

Clinical practice guidelines for quality PC stress the importance of specialists being familiar with these services and the ability to involve PC as part of the treatment plan to achieve better care for patients with serious illnesses.5 Our results demonstrated low rates of PC consultation services for dermatology patients, which supports the existing literature and suggests that PC may be highly underutilized in inpatient settings for patients with serious skin diseases. Use of PC was infrequent and was initiated relatively late in the course of hospital admission, which can negatively impact a patient’s well-being and care experience and can increase the care burden on their caregivers and families.2

Percentage of patients within each disease entity who received palliative care (PC), acute pain management, recreation therapy (RT), or pastoral care consultations during hospitalization.
Percentage of patients within each disease entity who received palliative care (PC), acute pain management, recreation therapy (RT), or pastoral care consultations during hospitalization. BP indicates bullous pemphigoid; CTCL, cutaneous T-cell lymphoma; DRESS, drug reaction with eosinophilia and systemic symptoms; GVHD, graft-vs-host disease; PG, pyoderma gangrenosum; PV, pemphigus vulgaris; SJS/TEN, StevensJohnson syndrome/toxic epidermal necrolysis.

Our results suggest a discrepancy in the frequency of formal PC and other palliative consultative services used for dermatologic diseases, with non-PC services including RT, acute pain management, and pastoral care more likely to be utilized. Impacting this finding may be that RT, pastoral care, and acute pain management are provided by nonphysician providers at our institution, not attending faculty staffing PC services. Patients with calciphylaxis were more likely to have PC consultations, potentially due to medicine providers’ familiarity with its morbidity and mortality, as it is commonly associated with end-stage renal disease. Similarly, internal medicine providers may be more familiar with pain classically associated with PG and PV and may be more likely to engage pain experts. Some diseases with notable morbidity and potential mortality were underrepresented including SJS/TEN, erythrodermic psoriasis, CTCL, and GVHD.

Limitations of our study included examination of data from a single institution, as well as the small sample sizes in specific subgroups, which prevented us from making comparisons between diseases. The cross-sectional design also limited our ability to control for confounding variables.

Conclusion

We urge dermatology consultation services to advocate for patients with serious skin diseases andinclude PC consultation as part of their recommendations to primary care teams. Further research should characterize the specific needs of patients that may be addressed by PC services and explore ways dermatologists and others can identify and provide specialty care to hospitalized patients.

References
  1. Kelley AS, Morrison RS. Palliative care for the seriously ill. N Engl J Med. 2015;373:747-755.
  2. Thompson LL, Chen ST, Lawton A, et al. Palliative care in dermatology: a clinical primer, review of the literature, and needs assessment. J Am Acad Dermatol. 2021;85:708-717. doi:10.1016/j.jaad.2020.08.029
  3. Yang CS, Quan VL, Charrow A. The power of a palliative perspective in dermatology. JAMA Dermatol. 2022;158:609-610. doi:10.1001/jamadermatol.2022.1298
  4. Osagiede O, Colibaseanu DT, Spaulding AC, et al. Palliative care use among patients with solid cancer tumors. J Palliat Care. 2018;33:149-158.
  5. Clinical Practice Guidelines for Quality Palliative Care. 4th ed. National Coalition for Hospice and Palliative Care; 2018. Accessed June 21, 2023. https://www.nationalcoalitionhpc.org/wp-content/uploads/2018/10/NCHPC-NCPGuidelines_4thED_web_FINAL.pdf
Article PDF
Author and Disclosure Information

From the Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, North Carolina.

The authors no conflict of interest.

Correspondence: Lindsay C. Strowd, MD, Wake Forest University School of Medicine, Department of Dermatology, Medical Center Blvd, Winston-Salem, NC 27157 (lchaney@wakehealth.edu).

Issue
Cutis - 112(1)
Publications
Topics
Page Number
23-25
Sections
Author and Disclosure Information

From the Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, North Carolina.

The authors no conflict of interest.

Correspondence: Lindsay C. Strowd, MD, Wake Forest University School of Medicine, Department of Dermatology, Medical Center Blvd, Winston-Salem, NC 27157 (lchaney@wakehealth.edu).

Author and Disclosure Information

From the Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, North Carolina.

The authors no conflict of interest.

Correspondence: Lindsay C. Strowd, MD, Wake Forest University School of Medicine, Department of Dermatology, Medical Center Blvd, Winston-Salem, NC 27157 (lchaney@wakehealth.edu).

Article PDF
Article PDF
IN PARTNERSHIP WITH THE SOCIETY OF DERMATOLOGY HOSPITALISTS
IN PARTNERSHIP WITH THE SOCIETY OF DERMATOLOGY HOSPITALISTS

Palliative care (PC) is a field of medicine that focuses on improving quality of life by managing physical symptoms as well as mental and spiritual well-being in patients with severe illnesses.1,2 Despite cases of severe dermatologic disease, the use of PC in the field of dermatology is limited, often leaving patients with a range of unmet needs.2,3 In one study that explored PC in patients with melanoma, only one-third of patients with advanced melanoma had a PC consultation.4 Reasons behind the lack of utilization of PC in dermatology include time constraints and limited training in addressing the complex psychosocial needs of patients with severe dermatologic illnesses.1 We conducted a retrospective, cross-sectional, single-institution study of specific inpatient dermatology consultations over a 5-year period to describe PC utilization among patients who were hospitalized with select severe dermatologic diseases.

Methods

A retrospective, cross-sectional study of inpatient dermatology consultations over a 5-year period (October 2016 to October 2021) was performed at Atrium Health Wake Forest Baptist Medical Center (Winston-Salem, North Carolina). Patients’ medical records were reviewed if they had one of the following diseases: bullous pemphigoid, calciphylaxis, cutaneous T-cell lymphoma (CTCL), drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, erythrodermic psoriasis, graft-vs-host disease, pemphigus vulgaris (PV), purpura fulminans, pyoderma gangrenosum, and Stevens-Johnson syndrome/toxic epidermal necrolysis. These diseases were selected for inclusion because they have been associated with a documented increase in inpatient mortality and have been described in the published literature on PC in dermatology.2 This study was reviewed and approved by the Wake Forest University institutional review board.

Use of PC consultative services along with other associated consultative care (ie, recreation therapy [RT], acute pain management, pastoral care) was assessed for each patient. Recreation therapy included specific interventions such as music therapy, arts/craft therapy, pet therapy, and other services with the goal of improving patient cognitive, emotional, and social function. For patients with a completed PC consultation, goals for PC intervention were recorded.

Results

The total study sample included 193 inpatient dermatology consultations. The mean age of the patients was 58.9 years (range, 2–100 years); 66.8% (129/193) were White and 28.5% (55/193) were Black (Table). Palliative care was consulted in 5.7% of cases, with consultations being requested by the primary care team. Reasons for PC consultation included assessment of the patient’s goals of care (4.1% [8/193]), pain management (3.6% [7/193]), non–pain symptom management (2.6% [5/193]), psychosocial support (1.6% [3/193]), and transitions of care (1.0% [2/193]). The average length of patients’ hospital stay prior to PC consultation was 11.5 days(range, 1–32 days). Acute pain management was the reason for consultation in 15.0% of cases (29/193), RT in 21.8% (42/193), and pastoral care in 13.5% (26/193) of cases. Patients with calciphylaxis received the most PC and pain consultations, but fewer than half received these services. Patients with calciphylaxis, PV, purpura fulminans, and CTCL received a higher percentage of PC consultations than the overall cohort, while patients with calciphylaxis, DRESS syndrome, PV, and pyoderma gangrenosum received relatively more pain consultations than the overall cohort (Figure).

Patient Demographics and Dermatologic Diagnosis

Comment

Clinical practice guidelines for quality PC stress the importance of specialists being familiar with these services and the ability to involve PC as part of the treatment plan to achieve better care for patients with serious illnesses.5 Our results demonstrated low rates of PC consultation services for dermatology patients, which supports the existing literature and suggests that PC may be highly underutilized in inpatient settings for patients with serious skin diseases. Use of PC was infrequent and was initiated relatively late in the course of hospital admission, which can negatively impact a patient’s well-being and care experience and can increase the care burden on their caregivers and families.2

Percentage of patients within each disease entity who received palliative care (PC), acute pain management, recreation therapy (RT), or pastoral care consultations during hospitalization.
Percentage of patients within each disease entity who received palliative care (PC), acute pain management, recreation therapy (RT), or pastoral care consultations during hospitalization. BP indicates bullous pemphigoid; CTCL, cutaneous T-cell lymphoma; DRESS, drug reaction with eosinophilia and systemic symptoms; GVHD, graft-vs-host disease; PG, pyoderma gangrenosum; PV, pemphigus vulgaris; SJS/TEN, StevensJohnson syndrome/toxic epidermal necrolysis.

Our results suggest a discrepancy in the frequency of formal PC and other palliative consultative services used for dermatologic diseases, with non-PC services including RT, acute pain management, and pastoral care more likely to be utilized. Impacting this finding may be that RT, pastoral care, and acute pain management are provided by nonphysician providers at our institution, not attending faculty staffing PC services. Patients with calciphylaxis were more likely to have PC consultations, potentially due to medicine providers’ familiarity with its morbidity and mortality, as it is commonly associated with end-stage renal disease. Similarly, internal medicine providers may be more familiar with pain classically associated with PG and PV and may be more likely to engage pain experts. Some diseases with notable morbidity and potential mortality were underrepresented including SJS/TEN, erythrodermic psoriasis, CTCL, and GVHD.

Limitations of our study included examination of data from a single institution, as well as the small sample sizes in specific subgroups, which prevented us from making comparisons between diseases. The cross-sectional design also limited our ability to control for confounding variables.

Conclusion

We urge dermatology consultation services to advocate for patients with serious skin diseases andinclude PC consultation as part of their recommendations to primary care teams. Further research should characterize the specific needs of patients that may be addressed by PC services and explore ways dermatologists and others can identify and provide specialty care to hospitalized patients.

Palliative care (PC) is a field of medicine that focuses on improving quality of life by managing physical symptoms as well as mental and spiritual well-being in patients with severe illnesses.1,2 Despite cases of severe dermatologic disease, the use of PC in the field of dermatology is limited, often leaving patients with a range of unmet needs.2,3 In one study that explored PC in patients with melanoma, only one-third of patients with advanced melanoma had a PC consultation.4 Reasons behind the lack of utilization of PC in dermatology include time constraints and limited training in addressing the complex psychosocial needs of patients with severe dermatologic illnesses.1 We conducted a retrospective, cross-sectional, single-institution study of specific inpatient dermatology consultations over a 5-year period to describe PC utilization among patients who were hospitalized with select severe dermatologic diseases.

Methods

A retrospective, cross-sectional study of inpatient dermatology consultations over a 5-year period (October 2016 to October 2021) was performed at Atrium Health Wake Forest Baptist Medical Center (Winston-Salem, North Carolina). Patients’ medical records were reviewed if they had one of the following diseases: bullous pemphigoid, calciphylaxis, cutaneous T-cell lymphoma (CTCL), drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, erythrodermic psoriasis, graft-vs-host disease, pemphigus vulgaris (PV), purpura fulminans, pyoderma gangrenosum, and Stevens-Johnson syndrome/toxic epidermal necrolysis. These diseases were selected for inclusion because they have been associated with a documented increase in inpatient mortality and have been described in the published literature on PC in dermatology.2 This study was reviewed and approved by the Wake Forest University institutional review board.

Use of PC consultative services along with other associated consultative care (ie, recreation therapy [RT], acute pain management, pastoral care) was assessed for each patient. Recreation therapy included specific interventions such as music therapy, arts/craft therapy, pet therapy, and other services with the goal of improving patient cognitive, emotional, and social function. For patients with a completed PC consultation, goals for PC intervention were recorded.

Results

The total study sample included 193 inpatient dermatology consultations. The mean age of the patients was 58.9 years (range, 2–100 years); 66.8% (129/193) were White and 28.5% (55/193) were Black (Table). Palliative care was consulted in 5.7% of cases, with consultations being requested by the primary care team. Reasons for PC consultation included assessment of the patient’s goals of care (4.1% [8/193]), pain management (3.6% [7/193]), non–pain symptom management (2.6% [5/193]), psychosocial support (1.6% [3/193]), and transitions of care (1.0% [2/193]). The average length of patients’ hospital stay prior to PC consultation was 11.5 days(range, 1–32 days). Acute pain management was the reason for consultation in 15.0% of cases (29/193), RT in 21.8% (42/193), and pastoral care in 13.5% (26/193) of cases. Patients with calciphylaxis received the most PC and pain consultations, but fewer than half received these services. Patients with calciphylaxis, PV, purpura fulminans, and CTCL received a higher percentage of PC consultations than the overall cohort, while patients with calciphylaxis, DRESS syndrome, PV, and pyoderma gangrenosum received relatively more pain consultations than the overall cohort (Figure).

Patient Demographics and Dermatologic Diagnosis

Comment

Clinical practice guidelines for quality PC stress the importance of specialists being familiar with these services and the ability to involve PC as part of the treatment plan to achieve better care for patients with serious illnesses.5 Our results demonstrated low rates of PC consultation services for dermatology patients, which supports the existing literature and suggests that PC may be highly underutilized in inpatient settings for patients with serious skin diseases. Use of PC was infrequent and was initiated relatively late in the course of hospital admission, which can negatively impact a patient’s well-being and care experience and can increase the care burden on their caregivers and families.2

Percentage of patients within each disease entity who received palliative care (PC), acute pain management, recreation therapy (RT), or pastoral care consultations during hospitalization.
Percentage of patients within each disease entity who received palliative care (PC), acute pain management, recreation therapy (RT), or pastoral care consultations during hospitalization. BP indicates bullous pemphigoid; CTCL, cutaneous T-cell lymphoma; DRESS, drug reaction with eosinophilia and systemic symptoms; GVHD, graft-vs-host disease; PG, pyoderma gangrenosum; PV, pemphigus vulgaris; SJS/TEN, StevensJohnson syndrome/toxic epidermal necrolysis.

Our results suggest a discrepancy in the frequency of formal PC and other palliative consultative services used for dermatologic diseases, with non-PC services including RT, acute pain management, and pastoral care more likely to be utilized. Impacting this finding may be that RT, pastoral care, and acute pain management are provided by nonphysician providers at our institution, not attending faculty staffing PC services. Patients with calciphylaxis were more likely to have PC consultations, potentially due to medicine providers’ familiarity with its morbidity and mortality, as it is commonly associated with end-stage renal disease. Similarly, internal medicine providers may be more familiar with pain classically associated with PG and PV and may be more likely to engage pain experts. Some diseases with notable morbidity and potential mortality were underrepresented including SJS/TEN, erythrodermic psoriasis, CTCL, and GVHD.

Limitations of our study included examination of data from a single institution, as well as the small sample sizes in specific subgroups, which prevented us from making comparisons between diseases. The cross-sectional design also limited our ability to control for confounding variables.

Conclusion

We urge dermatology consultation services to advocate for patients with serious skin diseases andinclude PC consultation as part of their recommendations to primary care teams. Further research should characterize the specific needs of patients that may be addressed by PC services and explore ways dermatologists and others can identify and provide specialty care to hospitalized patients.

References
  1. Kelley AS, Morrison RS. Palliative care for the seriously ill. N Engl J Med. 2015;373:747-755.
  2. Thompson LL, Chen ST, Lawton A, et al. Palliative care in dermatology: a clinical primer, review of the literature, and needs assessment. J Am Acad Dermatol. 2021;85:708-717. doi:10.1016/j.jaad.2020.08.029
  3. Yang CS, Quan VL, Charrow A. The power of a palliative perspective in dermatology. JAMA Dermatol. 2022;158:609-610. doi:10.1001/jamadermatol.2022.1298
  4. Osagiede O, Colibaseanu DT, Spaulding AC, et al. Palliative care use among patients with solid cancer tumors. J Palliat Care. 2018;33:149-158.
  5. Clinical Practice Guidelines for Quality Palliative Care. 4th ed. National Coalition for Hospice and Palliative Care; 2018. Accessed June 21, 2023. https://www.nationalcoalitionhpc.org/wp-content/uploads/2018/10/NCHPC-NCPGuidelines_4thED_web_FINAL.pdf
References
  1. Kelley AS, Morrison RS. Palliative care for the seriously ill. N Engl J Med. 2015;373:747-755.
  2. Thompson LL, Chen ST, Lawton A, et al. Palliative care in dermatology: a clinical primer, review of the literature, and needs assessment. J Am Acad Dermatol. 2021;85:708-717. doi:10.1016/j.jaad.2020.08.029
  3. Yang CS, Quan VL, Charrow A. The power of a palliative perspective in dermatology. JAMA Dermatol. 2022;158:609-610. doi:10.1001/jamadermatol.2022.1298
  4. Osagiede O, Colibaseanu DT, Spaulding AC, et al. Palliative care use among patients with solid cancer tumors. J Palliat Care. 2018;33:149-158.
  5. Clinical Practice Guidelines for Quality Palliative Care. 4th ed. National Coalition for Hospice and Palliative Care; 2018. Accessed June 21, 2023. https://www.nationalcoalitionhpc.org/wp-content/uploads/2018/10/NCHPC-NCPGuidelines_4thED_web_FINAL.pdf
Issue
Cutis - 112(1)
Issue
Cutis - 112(1)
Page Number
23-25
Page Number
23-25
Publications
Publications
Topics
Article Type
Display Headline
Palliative Care: Utilization Patterns in Inpatient Dermatology
Display Headline
Palliative Care: Utilization Patterns in Inpatient Dermatology
Sections
Inside the Article

Practice Points

  • Although severe dermatologic disease negatively impacts patients’ quality of life, palliative care may be underutilized in this population.
  • Palliative care should be an integral part of caring for patients who are admitted to the hospital with serious dermatologic illnesses.
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media

Placebo effect can be found in a cup of coffee

Article Type
Changed

 

The best part of waking up is placebo in your cup

Coffee makes the world go round. It’s impossible to picture any workplace without a cast of forlorn characters huddled around the office coffee maker on a Monday morning, imbibing their beverage du jour until they’ve been lifted out of their semi-zombified stupor.

PxHere

Millions upon millions of people swear by their morning coffee. And if they don’t get that sweet, sweet caffeine boost, they’ll make Garfield and the Boomtown Rats’ opinions of Mondays look tame. And it only makes sense that they’d believe that. After all, caffeine is a stimulant. It helps your brain focus and kicks it into overdrive. Of course drinking a beverage full of caffeine wakes you up. Right?

Not so fast, a group of Portuguese researchers say. That morning cup of coffee? It may actually be a placebo. Cue the dramatic sound effect.

Here’s the scoop: After recruiting a group of coffee drinkers (at least one cup a day), the researchers kept their test subjects off of coffee for at least 3 hours, then performed a brief functional MRI scan on all test subjects. Half an hour later, study participants received either a standard cup of coffee or pure caffeine. Half an hour after consuming their respective study product, the subjects underwent a second MRI.

As expected, both people who consumed coffee and those who consumed pure caffeine showed decreased connectivity in the default mode network after consumption, indicating preparation in the brain to move from resting to working on tasks. However, those who had pure caffeine did not show increased connectivity in the visual and executive control networks, while those who had coffee did. Simply put, caffeine may wake you up, but it doesn’t make you any sharper. Only coffee gets you in shape for that oh-so-important Monday meeting.

This doesn’t make a lot of sense. How can the drug part of coffee not be responsible for every effect the drink gives you? That’s where the placebo comes in, according to the scientists. It’s possible the effect they saw was caused by withdrawal – after just 3 hours? Yikes, hope not – but it’s more likely it comes down to psychology. We expect coffee to wake us up and make us ready for the day, so that’s exactly what it does. Hey, if that’s all it takes, time to convince ourselves that eating an entire pizza is actually an incredibly effective weight loss tool. Don’t let us down now, placebo effect.
 

Bread, milk, toilet paper, AFib diagnosis

Now consider the shopping cart. It does its job of carrying stuff around the store well enough, but can it lift you out of a semi-zombified stupor in the morning? No. Can it identify undiagnosed atrial fibrillation? Again, no.

Gustavo Fring

Not so fast, say the investigators conducting the SHOPS-AF (Supermarket/Hypermarket Opportunistic Screening for Atrial Fibrillation) study. They built a better shopping cart. Except they call it a trolley, not a cart, since the study was conducted in England, where they sometimes have funny names for things.

Their improved shopping trolley – we’re just going to call it a cart from here on – has an electrocardiogram sensor embedded into the handlebar, so it can effectively detect AFib in shoppers who held it for at least 60 seconds. The sensor lights up red if it detects an irregular heartbeat and green if it does not. Let’s see a cup of coffee do that.

They put 10 of these modified carts in four supermarkets in Liverpool to see what would happen. Would shoppers be able to tell that we secretly replaced the fine coffee they usually serve with Folger’s crystals? Oops. Sorry about that. Coffee on the brain, apparently. Back to the carts.

A total of 2,155 adult shoppers used one of the carts over 2 months, and electrocardiogram data were available for 220 participants who either had a red light on the sensor and/or an irregular pulse that suggested atrial fibrillation. After further review by the SHOPS-AF cardiologist, AFib was diagnosed in 59 shoppers, of whom 39 were previously undiagnosed.

They’re already working to cut the scan time to 30 seconds for SHOPS-AF II, but we’re wondering about a possible flaw in the whole health-care-delivery-through-shopping-cart scenario. When we go to the local super/hyper/megamart, it seems like half of the people trundling up and down the aisles are store employees filling orders for customers who won’t even set foot inside. Is the shopping cart on its way out? Maybe. Who wants to tell the SHOPS-AF II team? Not us.
 

 

 

Put pneumonia where your mouth is

Getting dentures does not mean the end of dental care. If anything, new research reveals a huge reason for staying on top of one’s denture care: pneumonia.

Pxfuel

It all started with swabs. Scientists in the United Kingdom took mouth, tongue, and denture specimens from frail elderly hospital patients who had pneumonia and wore dentures and from similar patients in care homes who wore dentures and did not have pneumonia. When they compared the microbial populations of the two groups, the investigators found about 20 times the number of respiratory pathogens on the dentures of those with pneumonia.

The research team suggested that dentures may play a role in causing pneumonia, but lead author Josh Twigg, BDS, PhD, also noted that “you certainly couldn’t say that people got pneumonia because they were wearing dentures. It’s just showing that there is an association there.” Improper cleaning, though, could lead to microbial colonization of the dentures, and patients could be inhaling those microbes into their lungs, thereby turning a dental issue into a respiratory issue.

More research needs to be done on the association between dentures and pneumonia, but Dr. Twigg hoped that the results of this study could be presented to the public. The message? “It is important to clean dentures thoroughly” and visit the dentist regularly, he said, but the best way to prevent denture-related infections is to avoid needing to wear dentures entirely.

Publications
Topics
Sections

 

The best part of waking up is placebo in your cup

Coffee makes the world go round. It’s impossible to picture any workplace without a cast of forlorn characters huddled around the office coffee maker on a Monday morning, imbibing their beverage du jour until they’ve been lifted out of their semi-zombified stupor.

PxHere

Millions upon millions of people swear by their morning coffee. And if they don’t get that sweet, sweet caffeine boost, they’ll make Garfield and the Boomtown Rats’ opinions of Mondays look tame. And it only makes sense that they’d believe that. After all, caffeine is a stimulant. It helps your brain focus and kicks it into overdrive. Of course drinking a beverage full of caffeine wakes you up. Right?

Not so fast, a group of Portuguese researchers say. That morning cup of coffee? It may actually be a placebo. Cue the dramatic sound effect.

Here’s the scoop: After recruiting a group of coffee drinkers (at least one cup a day), the researchers kept their test subjects off of coffee for at least 3 hours, then performed a brief functional MRI scan on all test subjects. Half an hour later, study participants received either a standard cup of coffee or pure caffeine. Half an hour after consuming their respective study product, the subjects underwent a second MRI.

As expected, both people who consumed coffee and those who consumed pure caffeine showed decreased connectivity in the default mode network after consumption, indicating preparation in the brain to move from resting to working on tasks. However, those who had pure caffeine did not show increased connectivity in the visual and executive control networks, while those who had coffee did. Simply put, caffeine may wake you up, but it doesn’t make you any sharper. Only coffee gets you in shape for that oh-so-important Monday meeting.

This doesn’t make a lot of sense. How can the drug part of coffee not be responsible for every effect the drink gives you? That’s where the placebo comes in, according to the scientists. It’s possible the effect they saw was caused by withdrawal – after just 3 hours? Yikes, hope not – but it’s more likely it comes down to psychology. We expect coffee to wake us up and make us ready for the day, so that’s exactly what it does. Hey, if that’s all it takes, time to convince ourselves that eating an entire pizza is actually an incredibly effective weight loss tool. Don’t let us down now, placebo effect.
 

Bread, milk, toilet paper, AFib diagnosis

Now consider the shopping cart. It does its job of carrying stuff around the store well enough, but can it lift you out of a semi-zombified stupor in the morning? No. Can it identify undiagnosed atrial fibrillation? Again, no.

Gustavo Fring

Not so fast, say the investigators conducting the SHOPS-AF (Supermarket/Hypermarket Opportunistic Screening for Atrial Fibrillation) study. They built a better shopping cart. Except they call it a trolley, not a cart, since the study was conducted in England, where they sometimes have funny names for things.

Their improved shopping trolley – we’re just going to call it a cart from here on – has an electrocardiogram sensor embedded into the handlebar, so it can effectively detect AFib in shoppers who held it for at least 60 seconds. The sensor lights up red if it detects an irregular heartbeat and green if it does not. Let’s see a cup of coffee do that.

They put 10 of these modified carts in four supermarkets in Liverpool to see what would happen. Would shoppers be able to tell that we secretly replaced the fine coffee they usually serve with Folger’s crystals? Oops. Sorry about that. Coffee on the brain, apparently. Back to the carts.

A total of 2,155 adult shoppers used one of the carts over 2 months, and electrocardiogram data were available for 220 participants who either had a red light on the sensor and/or an irregular pulse that suggested atrial fibrillation. After further review by the SHOPS-AF cardiologist, AFib was diagnosed in 59 shoppers, of whom 39 were previously undiagnosed.

They’re already working to cut the scan time to 30 seconds for SHOPS-AF II, but we’re wondering about a possible flaw in the whole health-care-delivery-through-shopping-cart scenario. When we go to the local super/hyper/megamart, it seems like half of the people trundling up and down the aisles are store employees filling orders for customers who won’t even set foot inside. Is the shopping cart on its way out? Maybe. Who wants to tell the SHOPS-AF II team? Not us.
 

 

 

Put pneumonia where your mouth is

Getting dentures does not mean the end of dental care. If anything, new research reveals a huge reason for staying on top of one’s denture care: pneumonia.

Pxfuel

It all started with swabs. Scientists in the United Kingdom took mouth, tongue, and denture specimens from frail elderly hospital patients who had pneumonia and wore dentures and from similar patients in care homes who wore dentures and did not have pneumonia. When they compared the microbial populations of the two groups, the investigators found about 20 times the number of respiratory pathogens on the dentures of those with pneumonia.

The research team suggested that dentures may play a role in causing pneumonia, but lead author Josh Twigg, BDS, PhD, also noted that “you certainly couldn’t say that people got pneumonia because they were wearing dentures. It’s just showing that there is an association there.” Improper cleaning, though, could lead to microbial colonization of the dentures, and patients could be inhaling those microbes into their lungs, thereby turning a dental issue into a respiratory issue.

More research needs to be done on the association between dentures and pneumonia, but Dr. Twigg hoped that the results of this study could be presented to the public. The message? “It is important to clean dentures thoroughly” and visit the dentist regularly, he said, but the best way to prevent denture-related infections is to avoid needing to wear dentures entirely.

 

The best part of waking up is placebo in your cup

Coffee makes the world go round. It’s impossible to picture any workplace without a cast of forlorn characters huddled around the office coffee maker on a Monday morning, imbibing their beverage du jour until they’ve been lifted out of their semi-zombified stupor.

PxHere

Millions upon millions of people swear by their morning coffee. And if they don’t get that sweet, sweet caffeine boost, they’ll make Garfield and the Boomtown Rats’ opinions of Mondays look tame. And it only makes sense that they’d believe that. After all, caffeine is a stimulant. It helps your brain focus and kicks it into overdrive. Of course drinking a beverage full of caffeine wakes you up. Right?

Not so fast, a group of Portuguese researchers say. That morning cup of coffee? It may actually be a placebo. Cue the dramatic sound effect.

Here’s the scoop: After recruiting a group of coffee drinkers (at least one cup a day), the researchers kept their test subjects off of coffee for at least 3 hours, then performed a brief functional MRI scan on all test subjects. Half an hour later, study participants received either a standard cup of coffee or pure caffeine. Half an hour after consuming their respective study product, the subjects underwent a second MRI.

As expected, both people who consumed coffee and those who consumed pure caffeine showed decreased connectivity in the default mode network after consumption, indicating preparation in the brain to move from resting to working on tasks. However, those who had pure caffeine did not show increased connectivity in the visual and executive control networks, while those who had coffee did. Simply put, caffeine may wake you up, but it doesn’t make you any sharper. Only coffee gets you in shape for that oh-so-important Monday meeting.

This doesn’t make a lot of sense. How can the drug part of coffee not be responsible for every effect the drink gives you? That’s where the placebo comes in, according to the scientists. It’s possible the effect they saw was caused by withdrawal – after just 3 hours? Yikes, hope not – but it’s more likely it comes down to psychology. We expect coffee to wake us up and make us ready for the day, so that’s exactly what it does. Hey, if that’s all it takes, time to convince ourselves that eating an entire pizza is actually an incredibly effective weight loss tool. Don’t let us down now, placebo effect.
 

Bread, milk, toilet paper, AFib diagnosis

Now consider the shopping cart. It does its job of carrying stuff around the store well enough, but can it lift you out of a semi-zombified stupor in the morning? No. Can it identify undiagnosed atrial fibrillation? Again, no.

Gustavo Fring

Not so fast, say the investigators conducting the SHOPS-AF (Supermarket/Hypermarket Opportunistic Screening for Atrial Fibrillation) study. They built a better shopping cart. Except they call it a trolley, not a cart, since the study was conducted in England, where they sometimes have funny names for things.

Their improved shopping trolley – we’re just going to call it a cart from here on – has an electrocardiogram sensor embedded into the handlebar, so it can effectively detect AFib in shoppers who held it for at least 60 seconds. The sensor lights up red if it detects an irregular heartbeat and green if it does not. Let’s see a cup of coffee do that.

They put 10 of these modified carts in four supermarkets in Liverpool to see what would happen. Would shoppers be able to tell that we secretly replaced the fine coffee they usually serve with Folger’s crystals? Oops. Sorry about that. Coffee on the brain, apparently. Back to the carts.

A total of 2,155 adult shoppers used one of the carts over 2 months, and electrocardiogram data were available for 220 participants who either had a red light on the sensor and/or an irregular pulse that suggested atrial fibrillation. After further review by the SHOPS-AF cardiologist, AFib was diagnosed in 59 shoppers, of whom 39 were previously undiagnosed.

They’re already working to cut the scan time to 30 seconds for SHOPS-AF II, but we’re wondering about a possible flaw in the whole health-care-delivery-through-shopping-cart scenario. When we go to the local super/hyper/megamart, it seems like half of the people trundling up and down the aisles are store employees filling orders for customers who won’t even set foot inside. Is the shopping cart on its way out? Maybe. Who wants to tell the SHOPS-AF II team? Not us.
 

 

 

Put pneumonia where your mouth is

Getting dentures does not mean the end of dental care. If anything, new research reveals a huge reason for staying on top of one’s denture care: pneumonia.

Pxfuel

It all started with swabs. Scientists in the United Kingdom took mouth, tongue, and denture specimens from frail elderly hospital patients who had pneumonia and wore dentures and from similar patients in care homes who wore dentures and did not have pneumonia. When they compared the microbial populations of the two groups, the investigators found about 20 times the number of respiratory pathogens on the dentures of those with pneumonia.

The research team suggested that dentures may play a role in causing pneumonia, but lead author Josh Twigg, BDS, PhD, also noted that “you certainly couldn’t say that people got pneumonia because they were wearing dentures. It’s just showing that there is an association there.” Improper cleaning, though, could lead to microbial colonization of the dentures, and patients could be inhaling those microbes into their lungs, thereby turning a dental issue into a respiratory issue.

More research needs to be done on the association between dentures and pneumonia, but Dr. Twigg hoped that the results of this study could be presented to the public. The message? “It is important to clean dentures thoroughly” and visit the dentist regularly, he said, but the best way to prevent denture-related infections is to avoid needing to wear dentures entirely.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Comorbid respiratory disease key predictor of NTM-PD

Article Type
Changed

Patients with comorbid respiratory disease were significantly more likely to develop nontuberculosis mycobacterial pulmonary disease (NTM-PD), data from a systematic review of 99 studies indicate.

NTM-PD is frequently underdiagnosed, and data on specific risk factors are lacking, especially for high-risk individuals with preexisting respiratory diseases, wrote Michael R. Loebinger, PhD, of Imperial College London, and colleagues.

“NTM-PD can be a substantial burden for patients, contributing to lung function decline and reduced health-related quality of life, and is associated with significant morbidity and mortality,” they said.

In a study published in the journal Chest, the researchers identified 99 studies published between 2011 and 2021. Of these, 24 reported an association between risk factors and NTM-PD among patients with respiratory disease compared with patients without NTM-PD and with healthy control persons without NTM-PD; these studies were included in the meta-analysis.

Overall, comorbid respiratory disease was significantly associated with an increased risk of NTM-PD, with odds ratios ranging from 4.15 for asthma to 21.43 for bronchiectasis. Other conditions significantly associated with NTM-PD risk included history of tuberculosis (odds ratio, 12.69), interstitial lung disease (OR, 6.39), and chronic obstructive pulmonary disease (COPD) (OR, 6.63).

Other factors associated with increased NTM-PD risk included inhaled corticosteroids (OR, 4.46), oral corticosteroids (OR, 3.37), and other immunosuppressants (OR, 2.60). Additional risk factors were use of anti–tumor necrosis factor-alpha for rheumatoid arthritis (OR, 2.13), solid tumors (OR, 4.66), current pneumonia (OR, 5.54), cardiovascular disease (OR, 1.73), and low body mass index (OR, 3.04).

Additional marginal or nonsignificant associations with NTM-PD risk were found for lung function, diabetes, renal disease, cancer, healthy weight, and infection with either Pseudomonas aeruginosa or Staphylococcus aureus.

Possible protective factors, though not significant, included increasing or high BMI and long-term macrolide use.

Bronchiectasis, which is associated with the highest risk of NTM-PD, was assessed in four studies. It was evaluated less frequently because it was often considered a reason for study exclusion, the researchers wrote in their discussion.

“However, many studies report high numbers of patients with nodular bronchiectatic NTM-PD and is suggested to be almost universal in patients with noncavitary NTM-PD,” they said.

The most common risk factors for NTM-PD in the included studies were the use of immunosuppressants, female sex, COPD comorbidity, and history of suspected tuberculosis.

The findings were limited by several factors, including the high level of heterogeneity among the included studies, the lack of data on attributable risk, and inconsistent definitions of NTM-PD, the researchers noted. However, the results may be useful for highlighting risk factors that could be used to identify high-risk patients and to promote early diagnosis and treatment, they said. In addition, long-term studies are needed regarding the impact of multiple potential risk factors on individual risk for NTM-PD among patients with respiratory disease, they concluded.

The study was supported by Insmed BV. Dr. Loebinger has relationships with Insmed, AstraZeneca, Chiesi, Savara, Parion, Zambon, 30T, Electromed, Recode, AN2 Therapeutics, and Armata.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

Patients with comorbid respiratory disease were significantly more likely to develop nontuberculosis mycobacterial pulmonary disease (NTM-PD), data from a systematic review of 99 studies indicate.

NTM-PD is frequently underdiagnosed, and data on specific risk factors are lacking, especially for high-risk individuals with preexisting respiratory diseases, wrote Michael R. Loebinger, PhD, of Imperial College London, and colleagues.

“NTM-PD can be a substantial burden for patients, contributing to lung function decline and reduced health-related quality of life, and is associated with significant morbidity and mortality,” they said.

In a study published in the journal Chest, the researchers identified 99 studies published between 2011 and 2021. Of these, 24 reported an association between risk factors and NTM-PD among patients with respiratory disease compared with patients without NTM-PD and with healthy control persons without NTM-PD; these studies were included in the meta-analysis.

Overall, comorbid respiratory disease was significantly associated with an increased risk of NTM-PD, with odds ratios ranging from 4.15 for asthma to 21.43 for bronchiectasis. Other conditions significantly associated with NTM-PD risk included history of tuberculosis (odds ratio, 12.69), interstitial lung disease (OR, 6.39), and chronic obstructive pulmonary disease (COPD) (OR, 6.63).

Other factors associated with increased NTM-PD risk included inhaled corticosteroids (OR, 4.46), oral corticosteroids (OR, 3.37), and other immunosuppressants (OR, 2.60). Additional risk factors were use of anti–tumor necrosis factor-alpha for rheumatoid arthritis (OR, 2.13), solid tumors (OR, 4.66), current pneumonia (OR, 5.54), cardiovascular disease (OR, 1.73), and low body mass index (OR, 3.04).

Additional marginal or nonsignificant associations with NTM-PD risk were found for lung function, diabetes, renal disease, cancer, healthy weight, and infection with either Pseudomonas aeruginosa or Staphylococcus aureus.

Possible protective factors, though not significant, included increasing or high BMI and long-term macrolide use.

Bronchiectasis, which is associated with the highest risk of NTM-PD, was assessed in four studies. It was evaluated less frequently because it was often considered a reason for study exclusion, the researchers wrote in their discussion.

“However, many studies report high numbers of patients with nodular bronchiectatic NTM-PD and is suggested to be almost universal in patients with noncavitary NTM-PD,” they said.

The most common risk factors for NTM-PD in the included studies were the use of immunosuppressants, female sex, COPD comorbidity, and history of suspected tuberculosis.

The findings were limited by several factors, including the high level of heterogeneity among the included studies, the lack of data on attributable risk, and inconsistent definitions of NTM-PD, the researchers noted. However, the results may be useful for highlighting risk factors that could be used to identify high-risk patients and to promote early diagnosis and treatment, they said. In addition, long-term studies are needed regarding the impact of multiple potential risk factors on individual risk for NTM-PD among patients with respiratory disease, they concluded.

The study was supported by Insmed BV. Dr. Loebinger has relationships with Insmed, AstraZeneca, Chiesi, Savara, Parion, Zambon, 30T, Electromed, Recode, AN2 Therapeutics, and Armata.

A version of this article first appeared on Medscape.com.

Patients with comorbid respiratory disease were significantly more likely to develop nontuberculosis mycobacterial pulmonary disease (NTM-PD), data from a systematic review of 99 studies indicate.

NTM-PD is frequently underdiagnosed, and data on specific risk factors are lacking, especially for high-risk individuals with preexisting respiratory diseases, wrote Michael R. Loebinger, PhD, of Imperial College London, and colleagues.

“NTM-PD can be a substantial burden for patients, contributing to lung function decline and reduced health-related quality of life, and is associated with significant morbidity and mortality,” they said.

In a study published in the journal Chest, the researchers identified 99 studies published between 2011 and 2021. Of these, 24 reported an association between risk factors and NTM-PD among patients with respiratory disease compared with patients without NTM-PD and with healthy control persons without NTM-PD; these studies were included in the meta-analysis.

Overall, comorbid respiratory disease was significantly associated with an increased risk of NTM-PD, with odds ratios ranging from 4.15 for asthma to 21.43 for bronchiectasis. Other conditions significantly associated with NTM-PD risk included history of tuberculosis (odds ratio, 12.69), interstitial lung disease (OR, 6.39), and chronic obstructive pulmonary disease (COPD) (OR, 6.63).

Other factors associated with increased NTM-PD risk included inhaled corticosteroids (OR, 4.46), oral corticosteroids (OR, 3.37), and other immunosuppressants (OR, 2.60). Additional risk factors were use of anti–tumor necrosis factor-alpha for rheumatoid arthritis (OR, 2.13), solid tumors (OR, 4.66), current pneumonia (OR, 5.54), cardiovascular disease (OR, 1.73), and low body mass index (OR, 3.04).

Additional marginal or nonsignificant associations with NTM-PD risk were found for lung function, diabetes, renal disease, cancer, healthy weight, and infection with either Pseudomonas aeruginosa or Staphylococcus aureus.

Possible protective factors, though not significant, included increasing or high BMI and long-term macrolide use.

Bronchiectasis, which is associated with the highest risk of NTM-PD, was assessed in four studies. It was evaluated less frequently because it was often considered a reason for study exclusion, the researchers wrote in their discussion.

“However, many studies report high numbers of patients with nodular bronchiectatic NTM-PD and is suggested to be almost universal in patients with noncavitary NTM-PD,” they said.

The most common risk factors for NTM-PD in the included studies were the use of immunosuppressants, female sex, COPD comorbidity, and history of suspected tuberculosis.

The findings were limited by several factors, including the high level of heterogeneity among the included studies, the lack of data on attributable risk, and inconsistent definitions of NTM-PD, the researchers noted. However, the results may be useful for highlighting risk factors that could be used to identify high-risk patients and to promote early diagnosis and treatment, they said. In addition, long-term studies are needed regarding the impact of multiple potential risk factors on individual risk for NTM-PD among patients with respiratory disease, they concluded.

The study was supported by Insmed BV. Dr. Loebinger has relationships with Insmed, AstraZeneca, Chiesi, Savara, Parion, Zambon, 30T, Electromed, Recode, AN2 Therapeutics, and Armata.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

CDC signs off on RSV vaccine for older adults

Article Type
Changed

The Centers for Disease Control and Prevention has given a green light to two new vaccines to protect against respiratory syncytial virus, or RSV, in older adults.

CDC Director Rochelle P. Walensky, MD, MPH, agreed with and endorsed the recommendations made earlier by CDC advisors that people age 60 and over may get one of two new vaccines for RSV. Decisions should be made based on discussions with one’s health care provider about whether the vaccine is right for them, the federal health agency said.

The new vaccines, the first licensed in the United States to protect against the respiratory illness, are expected to be available this fall.

On June 21, the CDC’s Advisory Committee on Immunization Practices (ACIP), an independent panel, stopped short of recommending the vaccines for everyone age 65 and above, which was the original question the committee was to consider. The experts amended that question, changing it to whether the panel should recommend the vaccine for those 65 and above if the person and their doctor agreed. The committee voted 9 to 5 in favor.
 

RSV vaccines

RSV leads to 6,000 to 10,000 deaths a year in the United States among those age 65 and older and 60,000 to 160,000 hospitalizations in that group. Seniors and infants are among the most vulnerable to the lower respiratory infection, marked by runny nose, wheezing, sneezing, decreased appetite, and fever.

The FDA in May approved two vaccines — GSK’s Arexvy and Pfizer’s Abrysvo — for adults age 60 and above.

The vote recommending shared decision-making about the vaccine, instead of a routine vaccination recommended for all, “is a weaker recommendation,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center in Nashville and medical director of the National Foundation for Infectious Diseases. Dr. Schaffner is a non-voting member of ACIP. He attended the meeting.

He said the experts voiced concern about a number of issues, including what some saw as a lack of sufficient data from trials on the most vulnerable groups, such as nursing home residents.

Experts also wanted more information about the duration of protection and exactly when a second dose might be needed. At the meeting, a GSK official said its vaccine was 84.6% effective after one and a half seasons, down from 94.1% after one season. A Pfizer official said its vaccine decreased the risk of RSV with three or more symptoms by 78.6% after a season and a half, down from 88.9% after one season.

The panel also wanted more data on whether the RSV vaccines could be administered at the same time as other vaccines recommended for adults.

Both companies gave a range of cost estimates. Pfizer expects its vaccine to cost $180 to $270 but said it could not guarantee that range. GSK said it expects a price of $200 to $295. Under the Inflation Reduction Act, recommended vaccines are covered under Medicare for those with Part D plans, which 51 million of 65 million Medicare patients have. Commercial insurance is likely to cover the vaccines if the CDC recommends them.

A version of this article first appeared on WebMD.com.

This article was updated 7/5/23.

Publications
Topics
Sections

The Centers for Disease Control and Prevention has given a green light to two new vaccines to protect against respiratory syncytial virus, or RSV, in older adults.

CDC Director Rochelle P. Walensky, MD, MPH, agreed with and endorsed the recommendations made earlier by CDC advisors that people age 60 and over may get one of two new vaccines for RSV. Decisions should be made based on discussions with one’s health care provider about whether the vaccine is right for them, the federal health agency said.

The new vaccines, the first licensed in the United States to protect against the respiratory illness, are expected to be available this fall.

On June 21, the CDC’s Advisory Committee on Immunization Practices (ACIP), an independent panel, stopped short of recommending the vaccines for everyone age 65 and above, which was the original question the committee was to consider. The experts amended that question, changing it to whether the panel should recommend the vaccine for those 65 and above if the person and their doctor agreed. The committee voted 9 to 5 in favor.
 

RSV vaccines

RSV leads to 6,000 to 10,000 deaths a year in the United States among those age 65 and older and 60,000 to 160,000 hospitalizations in that group. Seniors and infants are among the most vulnerable to the lower respiratory infection, marked by runny nose, wheezing, sneezing, decreased appetite, and fever.

The FDA in May approved two vaccines — GSK’s Arexvy and Pfizer’s Abrysvo — for adults age 60 and above.

The vote recommending shared decision-making about the vaccine, instead of a routine vaccination recommended for all, “is a weaker recommendation,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center in Nashville and medical director of the National Foundation for Infectious Diseases. Dr. Schaffner is a non-voting member of ACIP. He attended the meeting.

He said the experts voiced concern about a number of issues, including what some saw as a lack of sufficient data from trials on the most vulnerable groups, such as nursing home residents.

Experts also wanted more information about the duration of protection and exactly when a second dose might be needed. At the meeting, a GSK official said its vaccine was 84.6% effective after one and a half seasons, down from 94.1% after one season. A Pfizer official said its vaccine decreased the risk of RSV with three or more symptoms by 78.6% after a season and a half, down from 88.9% after one season.

The panel also wanted more data on whether the RSV vaccines could be administered at the same time as other vaccines recommended for adults.

Both companies gave a range of cost estimates. Pfizer expects its vaccine to cost $180 to $270 but said it could not guarantee that range. GSK said it expects a price of $200 to $295. Under the Inflation Reduction Act, recommended vaccines are covered under Medicare for those with Part D plans, which 51 million of 65 million Medicare patients have. Commercial insurance is likely to cover the vaccines if the CDC recommends them.

A version of this article first appeared on WebMD.com.

This article was updated 7/5/23.

The Centers for Disease Control and Prevention has given a green light to two new vaccines to protect against respiratory syncytial virus, or RSV, in older adults.

CDC Director Rochelle P. Walensky, MD, MPH, agreed with and endorsed the recommendations made earlier by CDC advisors that people age 60 and over may get one of two new vaccines for RSV. Decisions should be made based on discussions with one’s health care provider about whether the vaccine is right for them, the federal health agency said.

The new vaccines, the first licensed in the United States to protect against the respiratory illness, are expected to be available this fall.

On June 21, the CDC’s Advisory Committee on Immunization Practices (ACIP), an independent panel, stopped short of recommending the vaccines for everyone age 65 and above, which was the original question the committee was to consider. The experts amended that question, changing it to whether the panel should recommend the vaccine for those 65 and above if the person and their doctor agreed. The committee voted 9 to 5 in favor.
 

RSV vaccines

RSV leads to 6,000 to 10,000 deaths a year in the United States among those age 65 and older and 60,000 to 160,000 hospitalizations in that group. Seniors and infants are among the most vulnerable to the lower respiratory infection, marked by runny nose, wheezing, sneezing, decreased appetite, and fever.

The FDA in May approved two vaccines — GSK’s Arexvy and Pfizer’s Abrysvo — for adults age 60 and above.

The vote recommending shared decision-making about the vaccine, instead of a routine vaccination recommended for all, “is a weaker recommendation,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center in Nashville and medical director of the National Foundation for Infectious Diseases. Dr. Schaffner is a non-voting member of ACIP. He attended the meeting.

He said the experts voiced concern about a number of issues, including what some saw as a lack of sufficient data from trials on the most vulnerable groups, such as nursing home residents.

Experts also wanted more information about the duration of protection and exactly when a second dose might be needed. At the meeting, a GSK official said its vaccine was 84.6% effective after one and a half seasons, down from 94.1% after one season. A Pfizer official said its vaccine decreased the risk of RSV with three or more symptoms by 78.6% after a season and a half, down from 88.9% after one season.

The panel also wanted more data on whether the RSV vaccines could be administered at the same time as other vaccines recommended for adults.

Both companies gave a range of cost estimates. Pfizer expects its vaccine to cost $180 to $270 but said it could not guarantee that range. GSK said it expects a price of $200 to $295. Under the Inflation Reduction Act, recommended vaccines are covered under Medicare for those with Part D plans, which 51 million of 65 million Medicare patients have. Commercial insurance is likely to cover the vaccines if the CDC recommends them.

A version of this article first appeared on WebMD.com.

This article was updated 7/5/23.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Severe strep infections rebound after pandemic lull

Article Type
Changed

Severe infections caused by group A streptococcus bacteria are on the rise in countries around the world, including the United States, according to new data from the Centers for Disease Control and Prevention.
 

Group A strep bacteria usually cause mild illnesses like strep throat and scarlet fever. But they can also cause more severe diseases, like the flesh-eating disease necrotizing fasciitis and streptococcal toxic shock syndrome, known as invasive group A strep infections. 

These infections fell by 25% during the COVID-19 pandemic and were especially low in children. The number of milder infections also dropped. But in 2022, severe infections came roaring back, particularly in children.

Infections increased earlier in the winter/spring season – from September to November – than in a typical year and rose to higher than prepandemic levels in many parts of the country, such as Colorado and Minnesota.

Now in 2023, invasive infections are high in children in some parts of the country, even after respiratory viruses like the flu and respiratory syncytial virus (RSV) decreased in those areas. Some parts of the country also saw high rates of invasive infections in older adults. 

Less severe strep A infections in children have returned to levels similar to or higher than those seen in prepandemic years.

A similar postpandemic resurgence in invasive infections has also been seen in other countries, including Canada, the United Kingdom, France, and Denmark.

Strep A is a very common bacteria that causes only mild or no symptoms in most people, and severe infections are usually quite rare. They tend to affect the most vulnerable people: those who have another virus, multiple chronic conditions, or an open wound.

People should watch for fever, headaches, or confusion during a strep infection, which all might signal a more severe illness.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

Severe infections caused by group A streptococcus bacteria are on the rise in countries around the world, including the United States, according to new data from the Centers for Disease Control and Prevention.
 

Group A strep bacteria usually cause mild illnesses like strep throat and scarlet fever. But they can also cause more severe diseases, like the flesh-eating disease necrotizing fasciitis and streptococcal toxic shock syndrome, known as invasive group A strep infections. 

These infections fell by 25% during the COVID-19 pandemic and were especially low in children. The number of milder infections also dropped. But in 2022, severe infections came roaring back, particularly in children.

Infections increased earlier in the winter/spring season – from September to November – than in a typical year and rose to higher than prepandemic levels in many parts of the country, such as Colorado and Minnesota.

Now in 2023, invasive infections are high in children in some parts of the country, even after respiratory viruses like the flu and respiratory syncytial virus (RSV) decreased in those areas. Some parts of the country also saw high rates of invasive infections in older adults. 

Less severe strep A infections in children have returned to levels similar to or higher than those seen in prepandemic years.

A similar postpandemic resurgence in invasive infections has also been seen in other countries, including Canada, the United Kingdom, France, and Denmark.

Strep A is a very common bacteria that causes only mild or no symptoms in most people, and severe infections are usually quite rare. They tend to affect the most vulnerable people: those who have another virus, multiple chronic conditions, or an open wound.

People should watch for fever, headaches, or confusion during a strep infection, which all might signal a more severe illness.

A version of this article first appeared on Medscape.com.

Severe infections caused by group A streptococcus bacteria are on the rise in countries around the world, including the United States, according to new data from the Centers for Disease Control and Prevention.
 

Group A strep bacteria usually cause mild illnesses like strep throat and scarlet fever. But they can also cause more severe diseases, like the flesh-eating disease necrotizing fasciitis and streptococcal toxic shock syndrome, known as invasive group A strep infections. 

These infections fell by 25% during the COVID-19 pandemic and were especially low in children. The number of milder infections also dropped. But in 2022, severe infections came roaring back, particularly in children.

Infections increased earlier in the winter/spring season – from September to November – than in a typical year and rose to higher than prepandemic levels in many parts of the country, such as Colorado and Minnesota.

Now in 2023, invasive infections are high in children in some parts of the country, even after respiratory viruses like the flu and respiratory syncytial virus (RSV) decreased in those areas. Some parts of the country also saw high rates of invasive infections in older adults. 

Less severe strep A infections in children have returned to levels similar to or higher than those seen in prepandemic years.

A similar postpandemic resurgence in invasive infections has also been seen in other countries, including Canada, the United Kingdom, France, and Denmark.

Strep A is a very common bacteria that causes only mild or no symptoms in most people, and severe infections are usually quite rare. They tend to affect the most vulnerable people: those who have another virus, multiple chronic conditions, or an open wound.

People should watch for fever, headaches, or confusion during a strep infection, which all might signal a more severe illness.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

FDA passes on olorofim despite critical need for antifungals

Article Type
Changed

The U.S. Food and Drug Administration is declining to approve the investigational antifungal olorofim and is asking for more data, according to a news release from the manufacturer, F2G.

Olorofim, (formerly known as F901318) is the first in the orotomide class of antifungals to be evaluated clinically for the treatment of invasive mold infections. Its maker, F2G, is a biotech company based in Manchester, England, that focuses on developing drugs for rare fungal diseases.

The company says it remains optimistic and will address the FDA’s requirements and continue to seek approval.

The FDA’s denial comes as fungal infections are becoming increasingly common and resistant to treatment. There are only four antifungal classes currently available, and there are few new candidates in the pipeline. No new classes of antifungals have been developed in 2 decades.

David Andes, MD, chief of the division of infectious diseases at the University of Wisconsin–Madison, told this news organization he shares the hope that the company can meet the requirements to gain approval.

“Some of the early results were really exciting,” he said. “People are enthusiastic about the compound because it has a novel mechanism of action, and it is active against a group of fungi that we have limited to no options for.”
 

Early results ‘exciting’

Dr. Andes said several physicians have been able to prescribe olorofim under the compassionate use program “and have witnessed success.”

Olorofim is the first antifungal agent to be granted breakthrough therapy designation, which the FDA granted in November 2019 for the treatment of invasive mold infections for patients with limited or no treatment options, including patients with refractory aspergillosis or those who are intolerant of currently available therapy. It is also indicated for infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species.

Olorofim received a second breakthrough therapy designation in October 2020. The second designation was granted for treatment of central nervous system coccidioidomycosis that is refractory or for cases that cannot be treated with standard-of-care therapy.

It is very difficult for patients to be approved to receive compassionate use medicines, Dr. Andes pointed out. “I’d like to have access sooner rather than later,” he added.

Dr. Andes says the drugs are expensive and are time consuming to produce. And with antifungals, it is difficult to demonstrate safety in comparison with other antimicrobial agents because “it’s hard to hurt a fungus without having toxicity with human cells.”
 

Complete response letter issued

F2G received a complete response letter from the FDA regarding its new drug application for olorofim, according to the news release issued by the company. “While F2G is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives,” Francesco Maria Lavino, chief executive officer, said in the release. “We are assessing the details of the Complete Response Letter, and we plan to meet with the FDA to discuss it further.”

Dr. Andes says few other antifungals have made it as far as olorofim in clinical trials.

Lance B. Price, PhD, codirector of the Antibiotic Resistance Action Center at George Washington University in Washington, told this news organization that despite the lack of antifungals in the pipeline, “We can’t allow our desperation to override the checkpoints that ensure that antifungals are safe to use in people.”

In the meantime, he said, it is important to preserve the utility of current antifungals by avoiding overusing them in medicine and agriculture.

“Sadly,” he said, “a drug called ipflufenoquin, which works by a similar mode of action as olorofim, has already been approved by the U.S. Environmental Protection Agency for use in plant agriculture. This could weaken the effectiveness of olorofim for treating things like Aspergillus infections even before the drug has been approved for use in humans.”
 

 

 

Plant drug undermining olorofim efficacy in humans

“While I’m sure this makes financial sense for the makers of ipflufenoquin, it borders on insanity from a public health perspective,” Dr. Price said.

Meanwhile, the global threat of fungal infections grows. The World Health Organization has launched its first-ever list of health-threatening fungi. Authors of a WHO report that contains the list write, “The invasive forms of these fungal infections often affect severely ill patients and those with significant underlying immune system–related conditions.”

F2G will continue to expand olorofim’s clinical trial program, according to the company’s statement. Along with its partner, Shionogi, it is enrolling patients with proven or probable invasive aspergillosis in a global phase 3 trial (OASIS), which will compare outcomes after treatment with olorofim in comparison with amphotericin B liposome (AmBisome) followed by standard of care.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

The U.S. Food and Drug Administration is declining to approve the investigational antifungal olorofim and is asking for more data, according to a news release from the manufacturer, F2G.

Olorofim, (formerly known as F901318) is the first in the orotomide class of antifungals to be evaluated clinically for the treatment of invasive mold infections. Its maker, F2G, is a biotech company based in Manchester, England, that focuses on developing drugs for rare fungal diseases.

The company says it remains optimistic and will address the FDA’s requirements and continue to seek approval.

The FDA’s denial comes as fungal infections are becoming increasingly common and resistant to treatment. There are only four antifungal classes currently available, and there are few new candidates in the pipeline. No new classes of antifungals have been developed in 2 decades.

David Andes, MD, chief of the division of infectious diseases at the University of Wisconsin–Madison, told this news organization he shares the hope that the company can meet the requirements to gain approval.

“Some of the early results were really exciting,” he said. “People are enthusiastic about the compound because it has a novel mechanism of action, and it is active against a group of fungi that we have limited to no options for.”
 

Early results ‘exciting’

Dr. Andes said several physicians have been able to prescribe olorofim under the compassionate use program “and have witnessed success.”

Olorofim is the first antifungal agent to be granted breakthrough therapy designation, which the FDA granted in November 2019 for the treatment of invasive mold infections for patients with limited or no treatment options, including patients with refractory aspergillosis or those who are intolerant of currently available therapy. It is also indicated for infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species.

Olorofim received a second breakthrough therapy designation in October 2020. The second designation was granted for treatment of central nervous system coccidioidomycosis that is refractory or for cases that cannot be treated with standard-of-care therapy.

It is very difficult for patients to be approved to receive compassionate use medicines, Dr. Andes pointed out. “I’d like to have access sooner rather than later,” he added.

Dr. Andes says the drugs are expensive and are time consuming to produce. And with antifungals, it is difficult to demonstrate safety in comparison with other antimicrobial agents because “it’s hard to hurt a fungus without having toxicity with human cells.”
 

Complete response letter issued

F2G received a complete response letter from the FDA regarding its new drug application for olorofim, according to the news release issued by the company. “While F2G is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives,” Francesco Maria Lavino, chief executive officer, said in the release. “We are assessing the details of the Complete Response Letter, and we plan to meet with the FDA to discuss it further.”

Dr. Andes says few other antifungals have made it as far as olorofim in clinical trials.

Lance B. Price, PhD, codirector of the Antibiotic Resistance Action Center at George Washington University in Washington, told this news organization that despite the lack of antifungals in the pipeline, “We can’t allow our desperation to override the checkpoints that ensure that antifungals are safe to use in people.”

In the meantime, he said, it is important to preserve the utility of current antifungals by avoiding overusing them in medicine and agriculture.

“Sadly,” he said, “a drug called ipflufenoquin, which works by a similar mode of action as olorofim, has already been approved by the U.S. Environmental Protection Agency for use in plant agriculture. This could weaken the effectiveness of olorofim for treating things like Aspergillus infections even before the drug has been approved for use in humans.”
 

 

 

Plant drug undermining olorofim efficacy in humans

“While I’m sure this makes financial sense for the makers of ipflufenoquin, it borders on insanity from a public health perspective,” Dr. Price said.

Meanwhile, the global threat of fungal infections grows. The World Health Organization has launched its first-ever list of health-threatening fungi. Authors of a WHO report that contains the list write, “The invasive forms of these fungal infections often affect severely ill patients and those with significant underlying immune system–related conditions.”

F2G will continue to expand olorofim’s clinical trial program, according to the company’s statement. Along with its partner, Shionogi, it is enrolling patients with proven or probable invasive aspergillosis in a global phase 3 trial (OASIS), which will compare outcomes after treatment with olorofim in comparison with amphotericin B liposome (AmBisome) followed by standard of care.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration is declining to approve the investigational antifungal olorofim and is asking for more data, according to a news release from the manufacturer, F2G.

Olorofim, (formerly known as F901318) is the first in the orotomide class of antifungals to be evaluated clinically for the treatment of invasive mold infections. Its maker, F2G, is a biotech company based in Manchester, England, that focuses on developing drugs for rare fungal diseases.

The company says it remains optimistic and will address the FDA’s requirements and continue to seek approval.

The FDA’s denial comes as fungal infections are becoming increasingly common and resistant to treatment. There are only four antifungal classes currently available, and there are few new candidates in the pipeline. No new classes of antifungals have been developed in 2 decades.

David Andes, MD, chief of the division of infectious diseases at the University of Wisconsin–Madison, told this news organization he shares the hope that the company can meet the requirements to gain approval.

“Some of the early results were really exciting,” he said. “People are enthusiastic about the compound because it has a novel mechanism of action, and it is active against a group of fungi that we have limited to no options for.”
 

Early results ‘exciting’

Dr. Andes said several physicians have been able to prescribe olorofim under the compassionate use program “and have witnessed success.”

Olorofim is the first antifungal agent to be granted breakthrough therapy designation, which the FDA granted in November 2019 for the treatment of invasive mold infections for patients with limited or no treatment options, including patients with refractory aspergillosis or those who are intolerant of currently available therapy. It is also indicated for infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species.

Olorofim received a second breakthrough therapy designation in October 2020. The second designation was granted for treatment of central nervous system coccidioidomycosis that is refractory or for cases that cannot be treated with standard-of-care therapy.

It is very difficult for patients to be approved to receive compassionate use medicines, Dr. Andes pointed out. “I’d like to have access sooner rather than later,” he added.

Dr. Andes says the drugs are expensive and are time consuming to produce. And with antifungals, it is difficult to demonstrate safety in comparison with other antimicrobial agents because “it’s hard to hurt a fungus without having toxicity with human cells.”
 

Complete response letter issued

F2G received a complete response letter from the FDA regarding its new drug application for olorofim, according to the news release issued by the company. “While F2G is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives,” Francesco Maria Lavino, chief executive officer, said in the release. “We are assessing the details of the Complete Response Letter, and we plan to meet with the FDA to discuss it further.”

Dr. Andes says few other antifungals have made it as far as olorofim in clinical trials.

Lance B. Price, PhD, codirector of the Antibiotic Resistance Action Center at George Washington University in Washington, told this news organization that despite the lack of antifungals in the pipeline, “We can’t allow our desperation to override the checkpoints that ensure that antifungals are safe to use in people.”

In the meantime, he said, it is important to preserve the utility of current antifungals by avoiding overusing them in medicine and agriculture.

“Sadly,” he said, “a drug called ipflufenoquin, which works by a similar mode of action as olorofim, has already been approved by the U.S. Environmental Protection Agency for use in plant agriculture. This could weaken the effectiveness of olorofim for treating things like Aspergillus infections even before the drug has been approved for use in humans.”
 

 

 

Plant drug undermining olorofim efficacy in humans

“While I’m sure this makes financial sense for the makers of ipflufenoquin, it borders on insanity from a public health perspective,” Dr. Price said.

Meanwhile, the global threat of fungal infections grows. The World Health Organization has launched its first-ever list of health-threatening fungi. Authors of a WHO report that contains the list write, “The invasive forms of these fungal infections often affect severely ill patients and those with significant underlying immune system–related conditions.”

F2G will continue to expand olorofim’s clinical trial program, according to the company’s statement. Along with its partner, Shionogi, it is enrolling patients with proven or probable invasive aspergillosis in a global phase 3 trial (OASIS), which will compare outcomes after treatment with olorofim in comparison with amphotericin B liposome (AmBisome) followed by standard of care.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article