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EVALI update warns of chemicals in vaping products
A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).
Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.
“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.
In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.
Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.
The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.
The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.
Nicotine-only vaping products
In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.
A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.
In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).
Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.
The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.
In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.
The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.
SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.
A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).
Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.
“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.
In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.
Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.
The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.
The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.
Nicotine-only vaping products
In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.
A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.
In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).
Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.
The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.
In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.
The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.
SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.
A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).
Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.
“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.
In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.
Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.
The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.
The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.
Nicotine-only vaping products
In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.
A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.
In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).
Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.
The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.
In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.
The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.
SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.
FROM MMWR
FDA supports sunscreen safety studies
Six active in a randomized trial including four product types. The results were published in JAMA.
The testing was done as part of a proposed rule on sunscreen, published in February 2019, which requested additional information on sunscreen ingredients. Murali K. Matta, PhD, of the Food and Drug Administration and coauthors wrote that these plasma concentrations “surpassed the FDA threshold for potentially waiving additional safety studies for sunscreens.” But, they added, the findings “do not indicate that individuals should refrain from the use of sunscreen.”
This was a follow-up study to a smaller study of 24 health volunteers published last year that determined that the sunscreen active ingredients tested were absorbed systemically (JAMA. 2019;321[21]:2082-91). “This follow-up study expanded the sample size, tested additional sunscreen active ingredients and formulations, and confirmed the finding that sunscreen active ingredients are systemically absorbed,” the authors wrote.
To gather information on the absorption of active ingredients in sunscreens, the investigators randomized 48 adults to one of four sunscreen products (lotion, aerosol spray, nonaerosol spray, or pump spray) with one of six active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate). Not all products contained each of the ingredients.
The participants applied the products in amounts of 2 mg/cm2 to 75% of body surface area at baseline, no use on day 1 and four times a day at 2-hour intervals on days 2 through 4. The researchers collected blood samples over 21 days and measured the maximum plasma concentrations. The average age of the participants was 37 years, and half were women. The study was conducted in a clinical pharmacology unit.
The geometric mean maximum plasma concentrations for the primary endpoint of avobenzone in lotion, aerosol spray, nonaerosol spray, and pump spray were 7.1 ng/mL, 3.5 ng/mL, 3.5 ng/mL, and 3.3 ng/mL, respectively.
For oxybenzone, the concentrations were 258.1 ng/mL and 180.1 ng/mL, respectively, for lotion and aerosol spray. The concentrations for octocrylene were 7.8 ng/mL, 6.6 ng/mL, and 6.6 ng/mL, respectively, for lotion, aerosol spray, and nonaerosol spray.
For homosalate, the geometric mean plasma concentrations were 23.1 ng/mL for aerosol spray, 17.9 for nonaerosol spray, and 13.9 for pump spray. For octisalate, the concentrations were 5.1 ng/mL, 5.8 ng/mL, and 4.6 ng/mL, respectively, for aerosol spray, nonaerosol spray, and pump spray. For octinoxate, the concentrations were 7.9 ng/mL for nonaerosol spray and 5.2 ng/mL for pump spray.
“The systemic exposures, as measured by geometric mean maximum plasma concentrations, of all the tested active ingredients were higher than 0.5 ng/mL after a single application,” the researchers noted.
Overall, the most common event was rash, which was reported in 14 participants.
The study findings were limited by several factors including the use of an indoor clinical setting, rather than outdoor exposure; the inability to assess absorption differences by formulation and Fitzpatrick skin type; and the variation in amounts of ingredients among products, the researchers noted. However, the results can be used to design additional studies needed to research the effects of systemic exposure to sunscreen ingredients, they said.
In an accompanying editorial (JAMA. 2020;323:223-4), Adewole S. Adamson, MD, of the University of Texas at Austin, and Kanade Shinkai, MD, of the University of California, San Francisco, wrote that “the study did not address key questions about sunscreen safety,” including the length of time it takes “for plasma concentrations of sunscreen ingredients to fall below the FDA threshold for safety testing.” Dr. Shinkai is also editor in chief of JAMA Dermatology.
“In making an informed decision, clinicians must determine whether the magnitude of the benefit exceeds the risk of potential harm for a specific individual,” they said. “Importantly, this balance may be different, depending on characteristics of the sunscreen user (e.g., for individuals with darker skin types and for children) and may depend on the frequency and duration of application (e.g., daily vs. intermittent use; starting in infancy or later in life),” they noted.
“In the absence of clear data demonstrating harm, the use of chemical sunscreen may still be considered appropriate; the use of mineral-based sunscreen is a well-established safe alternative,” although the potential harms remain uncertain until the sunscreen industry conducts the safety studies recommended by the FDA, Dr. Adamson and Dr. Shinkai concluded.
In a statement released by the FDA on Jan 21, the day the study was published, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said that, considering the “recognized public health benefits” of using sunscreen, the FDA “urges Americans to use sunscreens in conjunction with other sun protective measures (such as protective clothing).”
Commenting on the study, she said, “results from our study released today show there is evidence that some sunscreen active ingredients may be absorbed. However, the fact that an ingredient is absorbed through the skin and into the body does not mean that the ingredient is unsafe, nor does the FDA seeking further information indicate such. Rather, this finding calls for further industry testing to determine the safety and effect of systemic exposure of sunscreen ingredients, especially with chronic use.”
The study was supported by the FDA. The researchers and editorial authors had no financial conflicts to disclose.
SOURCES: Matta MK et al. JAMA. 2020;323:256-267.
Six active in a randomized trial including four product types. The results were published in JAMA.
The testing was done as part of a proposed rule on sunscreen, published in February 2019, which requested additional information on sunscreen ingredients. Murali K. Matta, PhD, of the Food and Drug Administration and coauthors wrote that these plasma concentrations “surpassed the FDA threshold for potentially waiving additional safety studies for sunscreens.” But, they added, the findings “do not indicate that individuals should refrain from the use of sunscreen.”
This was a follow-up study to a smaller study of 24 health volunteers published last year that determined that the sunscreen active ingredients tested were absorbed systemically (JAMA. 2019;321[21]:2082-91). “This follow-up study expanded the sample size, tested additional sunscreen active ingredients and formulations, and confirmed the finding that sunscreen active ingredients are systemically absorbed,” the authors wrote.
To gather information on the absorption of active ingredients in sunscreens, the investigators randomized 48 adults to one of four sunscreen products (lotion, aerosol spray, nonaerosol spray, or pump spray) with one of six active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate). Not all products contained each of the ingredients.
The participants applied the products in amounts of 2 mg/cm2 to 75% of body surface area at baseline, no use on day 1 and four times a day at 2-hour intervals on days 2 through 4. The researchers collected blood samples over 21 days and measured the maximum plasma concentrations. The average age of the participants was 37 years, and half were women. The study was conducted in a clinical pharmacology unit.
The geometric mean maximum plasma concentrations for the primary endpoint of avobenzone in lotion, aerosol spray, nonaerosol spray, and pump spray were 7.1 ng/mL, 3.5 ng/mL, 3.5 ng/mL, and 3.3 ng/mL, respectively.
For oxybenzone, the concentrations were 258.1 ng/mL and 180.1 ng/mL, respectively, for lotion and aerosol spray. The concentrations for octocrylene were 7.8 ng/mL, 6.6 ng/mL, and 6.6 ng/mL, respectively, for lotion, aerosol spray, and nonaerosol spray.
For homosalate, the geometric mean plasma concentrations were 23.1 ng/mL for aerosol spray, 17.9 for nonaerosol spray, and 13.9 for pump spray. For octisalate, the concentrations were 5.1 ng/mL, 5.8 ng/mL, and 4.6 ng/mL, respectively, for aerosol spray, nonaerosol spray, and pump spray. For octinoxate, the concentrations were 7.9 ng/mL for nonaerosol spray and 5.2 ng/mL for pump spray.
“The systemic exposures, as measured by geometric mean maximum plasma concentrations, of all the tested active ingredients were higher than 0.5 ng/mL after a single application,” the researchers noted.
Overall, the most common event was rash, which was reported in 14 participants.
The study findings were limited by several factors including the use of an indoor clinical setting, rather than outdoor exposure; the inability to assess absorption differences by formulation and Fitzpatrick skin type; and the variation in amounts of ingredients among products, the researchers noted. However, the results can be used to design additional studies needed to research the effects of systemic exposure to sunscreen ingredients, they said.
In an accompanying editorial (JAMA. 2020;323:223-4), Adewole S. Adamson, MD, of the University of Texas at Austin, and Kanade Shinkai, MD, of the University of California, San Francisco, wrote that “the study did not address key questions about sunscreen safety,” including the length of time it takes “for plasma concentrations of sunscreen ingredients to fall below the FDA threshold for safety testing.” Dr. Shinkai is also editor in chief of JAMA Dermatology.
“In making an informed decision, clinicians must determine whether the magnitude of the benefit exceeds the risk of potential harm for a specific individual,” they said. “Importantly, this balance may be different, depending on characteristics of the sunscreen user (e.g., for individuals with darker skin types and for children) and may depend on the frequency and duration of application (e.g., daily vs. intermittent use; starting in infancy or later in life),” they noted.
“In the absence of clear data demonstrating harm, the use of chemical sunscreen may still be considered appropriate; the use of mineral-based sunscreen is a well-established safe alternative,” although the potential harms remain uncertain until the sunscreen industry conducts the safety studies recommended by the FDA, Dr. Adamson and Dr. Shinkai concluded.
In a statement released by the FDA on Jan 21, the day the study was published, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said that, considering the “recognized public health benefits” of using sunscreen, the FDA “urges Americans to use sunscreens in conjunction with other sun protective measures (such as protective clothing).”
Commenting on the study, she said, “results from our study released today show there is evidence that some sunscreen active ingredients may be absorbed. However, the fact that an ingredient is absorbed through the skin and into the body does not mean that the ingredient is unsafe, nor does the FDA seeking further information indicate such. Rather, this finding calls for further industry testing to determine the safety and effect of systemic exposure of sunscreen ingredients, especially with chronic use.”
The study was supported by the FDA. The researchers and editorial authors had no financial conflicts to disclose.
SOURCES: Matta MK et al. JAMA. 2020;323:256-267.
Six active in a randomized trial including four product types. The results were published in JAMA.
The testing was done as part of a proposed rule on sunscreen, published in February 2019, which requested additional information on sunscreen ingredients. Murali K. Matta, PhD, of the Food and Drug Administration and coauthors wrote that these plasma concentrations “surpassed the FDA threshold for potentially waiving additional safety studies for sunscreens.” But, they added, the findings “do not indicate that individuals should refrain from the use of sunscreen.”
This was a follow-up study to a smaller study of 24 health volunteers published last year that determined that the sunscreen active ingredients tested were absorbed systemically (JAMA. 2019;321[21]:2082-91). “This follow-up study expanded the sample size, tested additional sunscreen active ingredients and formulations, and confirmed the finding that sunscreen active ingredients are systemically absorbed,” the authors wrote.
To gather information on the absorption of active ingredients in sunscreens, the investigators randomized 48 adults to one of four sunscreen products (lotion, aerosol spray, nonaerosol spray, or pump spray) with one of six active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate). Not all products contained each of the ingredients.
The participants applied the products in amounts of 2 mg/cm2 to 75% of body surface area at baseline, no use on day 1 and four times a day at 2-hour intervals on days 2 through 4. The researchers collected blood samples over 21 days and measured the maximum plasma concentrations. The average age of the participants was 37 years, and half were women. The study was conducted in a clinical pharmacology unit.
The geometric mean maximum plasma concentrations for the primary endpoint of avobenzone in lotion, aerosol spray, nonaerosol spray, and pump spray were 7.1 ng/mL, 3.5 ng/mL, 3.5 ng/mL, and 3.3 ng/mL, respectively.
For oxybenzone, the concentrations were 258.1 ng/mL and 180.1 ng/mL, respectively, for lotion and aerosol spray. The concentrations for octocrylene were 7.8 ng/mL, 6.6 ng/mL, and 6.6 ng/mL, respectively, for lotion, aerosol spray, and nonaerosol spray.
For homosalate, the geometric mean plasma concentrations were 23.1 ng/mL for aerosol spray, 17.9 for nonaerosol spray, and 13.9 for pump spray. For octisalate, the concentrations were 5.1 ng/mL, 5.8 ng/mL, and 4.6 ng/mL, respectively, for aerosol spray, nonaerosol spray, and pump spray. For octinoxate, the concentrations were 7.9 ng/mL for nonaerosol spray and 5.2 ng/mL for pump spray.
“The systemic exposures, as measured by geometric mean maximum plasma concentrations, of all the tested active ingredients were higher than 0.5 ng/mL after a single application,” the researchers noted.
Overall, the most common event was rash, which was reported in 14 participants.
The study findings were limited by several factors including the use of an indoor clinical setting, rather than outdoor exposure; the inability to assess absorption differences by formulation and Fitzpatrick skin type; and the variation in amounts of ingredients among products, the researchers noted. However, the results can be used to design additional studies needed to research the effects of systemic exposure to sunscreen ingredients, they said.
In an accompanying editorial (JAMA. 2020;323:223-4), Adewole S. Adamson, MD, of the University of Texas at Austin, and Kanade Shinkai, MD, of the University of California, San Francisco, wrote that “the study did not address key questions about sunscreen safety,” including the length of time it takes “for plasma concentrations of sunscreen ingredients to fall below the FDA threshold for safety testing.” Dr. Shinkai is also editor in chief of JAMA Dermatology.
“In making an informed decision, clinicians must determine whether the magnitude of the benefit exceeds the risk of potential harm for a specific individual,” they said. “Importantly, this balance may be different, depending on characteristics of the sunscreen user (e.g., for individuals with darker skin types and for children) and may depend on the frequency and duration of application (e.g., daily vs. intermittent use; starting in infancy or later in life),” they noted.
“In the absence of clear data demonstrating harm, the use of chemical sunscreen may still be considered appropriate; the use of mineral-based sunscreen is a well-established safe alternative,” although the potential harms remain uncertain until the sunscreen industry conducts the safety studies recommended by the FDA, Dr. Adamson and Dr. Shinkai concluded.
In a statement released by the FDA on Jan 21, the day the study was published, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said that, considering the “recognized public health benefits” of using sunscreen, the FDA “urges Americans to use sunscreens in conjunction with other sun protective measures (such as protective clothing).”
Commenting on the study, she said, “results from our study released today show there is evidence that some sunscreen active ingredients may be absorbed. However, the fact that an ingredient is absorbed through the skin and into the body does not mean that the ingredient is unsafe, nor does the FDA seeking further information indicate such. Rather, this finding calls for further industry testing to determine the safety and effect of systemic exposure of sunscreen ingredients, especially with chronic use.”
The study was supported by the FDA. The researchers and editorial authors had no financial conflicts to disclose.
SOURCES: Matta MK et al. JAMA. 2020;323:256-267.
FROM JAMA
Cannabis users struggle to quit cigarettes
a large national survey has found.
“Over the past decade, there has been an increase in the use of cannabis among cigarette smokers and prevalence of cigarettes and cannabis co-use, suggesting that the negative consequences of cigarette–cannabis co-use may also become more prevalent over time,” wrote Andrea H. Weinberger, PhD, of Yeshiva University, New York, and colleagues. They noted that the prevalence of cigarette smoking is nearly three times higher among persons who use cannabis and have cannabis use disorders relative to those who do not.
The 2019 National Survey of Drug Use and Health estimated that 15.9% of Americans aged 12 years or older used cannabis in the past year. This number has been rising throughout the 2000s.
In that same report, cannabis use disorder (or marijuana use disorder) was defined as when an individual experiences clinically significant impairment caused by the recurrent use of marijuana, including health problems, persistent or increasing use, and failure to meet major responsibilities at work, school, or home. The report stated that approximately 1.6% of Americans aged 12 or older in 2018 had marijuana use disorder.
In the study published in Tobacco Control, the researchers used the National Survey on Drug Use and Health data to analyze cigarette smoking quit ratios among U.S. adults with and without cannabis use and cannabis use disorders. “Quit ratio was calculated as the proportion of former smokers among lifetime smokers and is considered a measure of total cessation in a population,” the researchers said.
In 2016, the quit ratios for adults with a history of cannabis use or cannabis use disorders were 23% and 15%, respectively, compared with 51% and 48%, respectively, in those with no cannabis use or cannabis use disorders.
Overall, quit ratios did not change significantly from 2002 to 2016 for individuals with cannabis use disorders after controlling for multiple demographic factors and other substance use disorders. However, during the same time period, quit ratios showed a nonlinear increase in cannabis users, nonusers, and individuals without cannabis use disorders.
The study findings were limited by several factors including the inability to generalize results to youth or individuals living outside the United States, the use of DSM-IV criteria to identify cannabis use disorder, the use of self-reports, and the inability to examine the timing of cannabis use as related to attempts to quit smoking, the researchers noted. However, the results highlight the need to consider offering smoking cessation treatment to individuals being treated for cannabis use disorders, and to include cannabis users in smoking cessation programs, the researchers noted.
“Based on our results, both public health and clinical efforts to improve cigarette quit outcomes may benefit from including those with any cannabis use,” they said. More research is needed to determine whether trends in the quit ratio change over time for cannabis users or those with cannabis use disorder, they added.
The study was funded by the National Institute on Drug Abuse. The researchers had no financial conflicts to disclose.
SOURCE: Weinberger AH et al. Tob Control. 2020;29(1):74-80. doi: 10.1136/tobaccocontrol-2018-054590.
a large national survey has found.
“Over the past decade, there has been an increase in the use of cannabis among cigarette smokers and prevalence of cigarettes and cannabis co-use, suggesting that the negative consequences of cigarette–cannabis co-use may also become more prevalent over time,” wrote Andrea H. Weinberger, PhD, of Yeshiva University, New York, and colleagues. They noted that the prevalence of cigarette smoking is nearly three times higher among persons who use cannabis and have cannabis use disorders relative to those who do not.
The 2019 National Survey of Drug Use and Health estimated that 15.9% of Americans aged 12 years or older used cannabis in the past year. This number has been rising throughout the 2000s.
In that same report, cannabis use disorder (or marijuana use disorder) was defined as when an individual experiences clinically significant impairment caused by the recurrent use of marijuana, including health problems, persistent or increasing use, and failure to meet major responsibilities at work, school, or home. The report stated that approximately 1.6% of Americans aged 12 or older in 2018 had marijuana use disorder.
In the study published in Tobacco Control, the researchers used the National Survey on Drug Use and Health data to analyze cigarette smoking quit ratios among U.S. adults with and without cannabis use and cannabis use disorders. “Quit ratio was calculated as the proportion of former smokers among lifetime smokers and is considered a measure of total cessation in a population,” the researchers said.
In 2016, the quit ratios for adults with a history of cannabis use or cannabis use disorders were 23% and 15%, respectively, compared with 51% and 48%, respectively, in those with no cannabis use or cannabis use disorders.
Overall, quit ratios did not change significantly from 2002 to 2016 for individuals with cannabis use disorders after controlling for multiple demographic factors and other substance use disorders. However, during the same time period, quit ratios showed a nonlinear increase in cannabis users, nonusers, and individuals without cannabis use disorders.
The study findings were limited by several factors including the inability to generalize results to youth or individuals living outside the United States, the use of DSM-IV criteria to identify cannabis use disorder, the use of self-reports, and the inability to examine the timing of cannabis use as related to attempts to quit smoking, the researchers noted. However, the results highlight the need to consider offering smoking cessation treatment to individuals being treated for cannabis use disorders, and to include cannabis users in smoking cessation programs, the researchers noted.
“Based on our results, both public health and clinical efforts to improve cigarette quit outcomes may benefit from including those with any cannabis use,” they said. More research is needed to determine whether trends in the quit ratio change over time for cannabis users or those with cannabis use disorder, they added.
The study was funded by the National Institute on Drug Abuse. The researchers had no financial conflicts to disclose.
SOURCE: Weinberger AH et al. Tob Control. 2020;29(1):74-80. doi: 10.1136/tobaccocontrol-2018-054590.
a large national survey has found.
“Over the past decade, there has been an increase in the use of cannabis among cigarette smokers and prevalence of cigarettes and cannabis co-use, suggesting that the negative consequences of cigarette–cannabis co-use may also become more prevalent over time,” wrote Andrea H. Weinberger, PhD, of Yeshiva University, New York, and colleagues. They noted that the prevalence of cigarette smoking is nearly three times higher among persons who use cannabis and have cannabis use disorders relative to those who do not.
The 2019 National Survey of Drug Use and Health estimated that 15.9% of Americans aged 12 years or older used cannabis in the past year. This number has been rising throughout the 2000s.
In that same report, cannabis use disorder (or marijuana use disorder) was defined as when an individual experiences clinically significant impairment caused by the recurrent use of marijuana, including health problems, persistent or increasing use, and failure to meet major responsibilities at work, school, or home. The report stated that approximately 1.6% of Americans aged 12 or older in 2018 had marijuana use disorder.
In the study published in Tobacco Control, the researchers used the National Survey on Drug Use and Health data to analyze cigarette smoking quit ratios among U.S. adults with and without cannabis use and cannabis use disorders. “Quit ratio was calculated as the proportion of former smokers among lifetime smokers and is considered a measure of total cessation in a population,” the researchers said.
In 2016, the quit ratios for adults with a history of cannabis use or cannabis use disorders were 23% and 15%, respectively, compared with 51% and 48%, respectively, in those with no cannabis use or cannabis use disorders.
Overall, quit ratios did not change significantly from 2002 to 2016 for individuals with cannabis use disorders after controlling for multiple demographic factors and other substance use disorders. However, during the same time period, quit ratios showed a nonlinear increase in cannabis users, nonusers, and individuals without cannabis use disorders.
The study findings were limited by several factors including the inability to generalize results to youth or individuals living outside the United States, the use of DSM-IV criteria to identify cannabis use disorder, the use of self-reports, and the inability to examine the timing of cannabis use as related to attempts to quit smoking, the researchers noted. However, the results highlight the need to consider offering smoking cessation treatment to individuals being treated for cannabis use disorders, and to include cannabis users in smoking cessation programs, the researchers noted.
“Based on our results, both public health and clinical efforts to improve cigarette quit outcomes may benefit from including those with any cannabis use,” they said. More research is needed to determine whether trends in the quit ratio change over time for cannabis users or those with cannabis use disorder, they added.
The study was funded by the National Institute on Drug Abuse. The researchers had no financial conflicts to disclose.
SOURCE: Weinberger AH et al. Tob Control. 2020;29(1):74-80. doi: 10.1136/tobaccocontrol-2018-054590.
FROM TOBACCO CONTROL
Cherry concentrate fails for gout flares
Tart cherry concentrate had no impact on gout flares over a 28-day period, based on data from 50 adult patients.
Urate-lowering therapy is part of gout management, and previous studies have suggested that tart cherry concentrate lowers sodium urate within hours in healthy volunteers and to a nonsignificant extent over 120 days in patients with gout, but “the optimal dose of tart cherry concentrate for either a serum urate effect on or flare prevention is unknown,” wrote Lisa K. Stamp, MD, of the University of Otago, Christchurch, New Zealand, and colleagues.
In a study published in Rheumatology, the researchers randomized 50 adults with gout and baseline serum urate levels greater than 0.36 mmol/L (6 mg/dL) to receive one of four doses of tart cherry juice concentrate (7.5 mL, 15 mL, 22.5 mL, or 30 mL) or a placebo twice daily for 28 days. Half of the participants were taking allopurinol and half were not taking any urate-lowering therapy.
After 28 days, patients who received cherry juice showed no significant changes in serum urate regardless of whether they were also taking allopurinol. In addition, cherry juice at any dose had no significant effect on reducing the serum urate area under the curve and no apparent impact on measures including urine urate excretion, change in urinary anthocyanins, and frequency of gout flares, compared with placebo. However, the cherry juice was well tolerated, and 84% of the study participants said they would recommend it to a friend as a method of gout prevention.
The researchers collected blood samples at baseline, and at 1, 3, and 5 hours after consuming cherry juice, and on days 1, 3, 7, 14, 21, and 28. “If there is an effect of cherry concentrate on gout flares over a longer time period, it is not likely to be mediated by reduction in serum urate,” the researchers said.
Of 24 adverse events reported during the study, 18 occurred in patients taking cherry juice at all dosage levels, and one case of hyperglycemia was potentially related to cherry concentrate. No serious adverse events associated with tart cherry concentrate occurred during the study period.
The study findings were limited by several factors including the inability to blind the study because participants prepared their doses at home, and the lack of data on the exact contents of the cherry juice concentrate used in the study, the researchers noted. However, the results suggest that tart cherry concentrate has no effect on serum urate concentration or urinary urate excretion, which make it unlikely to be useful in reducing gout flares, they concluded.
The study was supported by the Health Research Council of New Zealand. The researchers had no financial conflicts to disclose.
SOURCE: Stamp LK et al. Rheumatology. 2019 Dec 31. doi: 10.1093/rheumatology/kez606.
Tart cherry concentrate had no impact on gout flares over a 28-day period, based on data from 50 adult patients.
Urate-lowering therapy is part of gout management, and previous studies have suggested that tart cherry concentrate lowers sodium urate within hours in healthy volunteers and to a nonsignificant extent over 120 days in patients with gout, but “the optimal dose of tart cherry concentrate for either a serum urate effect on or flare prevention is unknown,” wrote Lisa K. Stamp, MD, of the University of Otago, Christchurch, New Zealand, and colleagues.
In a study published in Rheumatology, the researchers randomized 50 adults with gout and baseline serum urate levels greater than 0.36 mmol/L (6 mg/dL) to receive one of four doses of tart cherry juice concentrate (7.5 mL, 15 mL, 22.5 mL, or 30 mL) or a placebo twice daily for 28 days. Half of the participants were taking allopurinol and half were not taking any urate-lowering therapy.
After 28 days, patients who received cherry juice showed no significant changes in serum urate regardless of whether they were also taking allopurinol. In addition, cherry juice at any dose had no significant effect on reducing the serum urate area under the curve and no apparent impact on measures including urine urate excretion, change in urinary anthocyanins, and frequency of gout flares, compared with placebo. However, the cherry juice was well tolerated, and 84% of the study participants said they would recommend it to a friend as a method of gout prevention.
The researchers collected blood samples at baseline, and at 1, 3, and 5 hours after consuming cherry juice, and on days 1, 3, 7, 14, 21, and 28. “If there is an effect of cherry concentrate on gout flares over a longer time period, it is not likely to be mediated by reduction in serum urate,” the researchers said.
Of 24 adverse events reported during the study, 18 occurred in patients taking cherry juice at all dosage levels, and one case of hyperglycemia was potentially related to cherry concentrate. No serious adverse events associated with tart cherry concentrate occurred during the study period.
The study findings were limited by several factors including the inability to blind the study because participants prepared their doses at home, and the lack of data on the exact contents of the cherry juice concentrate used in the study, the researchers noted. However, the results suggest that tart cherry concentrate has no effect on serum urate concentration or urinary urate excretion, which make it unlikely to be useful in reducing gout flares, they concluded.
The study was supported by the Health Research Council of New Zealand. The researchers had no financial conflicts to disclose.
SOURCE: Stamp LK et al. Rheumatology. 2019 Dec 31. doi: 10.1093/rheumatology/kez606.
Tart cherry concentrate had no impact on gout flares over a 28-day period, based on data from 50 adult patients.
Urate-lowering therapy is part of gout management, and previous studies have suggested that tart cherry concentrate lowers sodium urate within hours in healthy volunteers and to a nonsignificant extent over 120 days in patients with gout, but “the optimal dose of tart cherry concentrate for either a serum urate effect on or flare prevention is unknown,” wrote Lisa K. Stamp, MD, of the University of Otago, Christchurch, New Zealand, and colleagues.
In a study published in Rheumatology, the researchers randomized 50 adults with gout and baseline serum urate levels greater than 0.36 mmol/L (6 mg/dL) to receive one of four doses of tart cherry juice concentrate (7.5 mL, 15 mL, 22.5 mL, or 30 mL) or a placebo twice daily for 28 days. Half of the participants were taking allopurinol and half were not taking any urate-lowering therapy.
After 28 days, patients who received cherry juice showed no significant changes in serum urate regardless of whether they were also taking allopurinol. In addition, cherry juice at any dose had no significant effect on reducing the serum urate area under the curve and no apparent impact on measures including urine urate excretion, change in urinary anthocyanins, and frequency of gout flares, compared with placebo. However, the cherry juice was well tolerated, and 84% of the study participants said they would recommend it to a friend as a method of gout prevention.
The researchers collected blood samples at baseline, and at 1, 3, and 5 hours after consuming cherry juice, and on days 1, 3, 7, 14, 21, and 28. “If there is an effect of cherry concentrate on gout flares over a longer time period, it is not likely to be mediated by reduction in serum urate,” the researchers said.
Of 24 adverse events reported during the study, 18 occurred in patients taking cherry juice at all dosage levels, and one case of hyperglycemia was potentially related to cherry concentrate. No serious adverse events associated with tart cherry concentrate occurred during the study period.
The study findings were limited by several factors including the inability to blind the study because participants prepared their doses at home, and the lack of data on the exact contents of the cherry juice concentrate used in the study, the researchers noted. However, the results suggest that tart cherry concentrate has no effect on serum urate concentration or urinary urate excretion, which make it unlikely to be useful in reducing gout flares, they concluded.
The study was supported by the Health Research Council of New Zealand. The researchers had no financial conflicts to disclose.
SOURCE: Stamp LK et al. Rheumatology. 2019 Dec 31. doi: 10.1093/rheumatology/kez606.
FROM RHEUMATOLOGY
Gout rates reduced with SGLT2 inhibitors
The incidence of gout was approximately 40% lower in diabetes patients who were prescribed sodium-glucose cotransporter 2 inhibitors (SGLT2) than it was in those who were prescribed glucagonlike peptide–1 receptor (GLP-1) agonists in a population-based new-user cohort study.
Hyperuricemia is a known cause of gout and common in type 2 diabetes patients. SGLT2 inhibitors may reduce the risk of gout by preventing the reabsorption of glucose and lowering serum uric acid levels; however, the impact on gout risk remains uncertain, wrote Michael Fralick, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
In a study published in the Annals of Internal Medicine, the researchers compared SGLT2 inhibitors and GLP-1 agonists in patients with type 2 diabetes to assess protection against gout.
The study population included adults with type 2 diabetes mellitus who had a new prescription for an SGTL2 inhibitor or GLP-1 agonist. The average age of the patients was 54 years; approximately half were women. Baseline characteristics were similar between the groups.
Overall, the researchers found a relative risk reduction of approximately 40% and an absolute risk reduction of approximately three fewer cases per 1,000 person-years in patients who received SGLT2 inhibitors, compared with those who received GLP-1 agonists. The incidence rate for gout in the SGLT2 and GLP-1 groups were 4.9 per 1,000 person-years and 7.8 per 1,000 person-years, respectively.
The study findings were limited by the investigators’ inability to measure potential confounding variables such as body mass index, alcohol use, and high purine diet; incomplete lab data on creatinine and hemoglobin A; and a low baseline risk for gout in the study population, the researchers noted. However, the results persisted across sensitivity analysis and, if replicated, suggest that “SGLT2 inhibitors might be an effective class of medication for the prevention of gout for patients with diabetes or metabolic disorders,” they wrote.
The study was supported in part by Brigham and Women’s Hospital; lead author Dr. Fralick disclosed funding from the Eliot Phillipson Clinician-Scientist Training Program at the University of Toronto and the Canadian Institutes of Health Research.
SOURCE: Fralick M et al. Ann Intern Med. 2020 Jan 14. doi: 10.7326/M19-2610.
The incidence of gout was approximately 40% lower in diabetes patients who were prescribed sodium-glucose cotransporter 2 inhibitors (SGLT2) than it was in those who were prescribed glucagonlike peptide–1 receptor (GLP-1) agonists in a population-based new-user cohort study.
Hyperuricemia is a known cause of gout and common in type 2 diabetes patients. SGLT2 inhibitors may reduce the risk of gout by preventing the reabsorption of glucose and lowering serum uric acid levels; however, the impact on gout risk remains uncertain, wrote Michael Fralick, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
In a study published in the Annals of Internal Medicine, the researchers compared SGLT2 inhibitors and GLP-1 agonists in patients with type 2 diabetes to assess protection against gout.
The study population included adults with type 2 diabetes mellitus who had a new prescription for an SGTL2 inhibitor or GLP-1 agonist. The average age of the patients was 54 years; approximately half were women. Baseline characteristics were similar between the groups.
Overall, the researchers found a relative risk reduction of approximately 40% and an absolute risk reduction of approximately three fewer cases per 1,000 person-years in patients who received SGLT2 inhibitors, compared with those who received GLP-1 agonists. The incidence rate for gout in the SGLT2 and GLP-1 groups were 4.9 per 1,000 person-years and 7.8 per 1,000 person-years, respectively.
The study findings were limited by the investigators’ inability to measure potential confounding variables such as body mass index, alcohol use, and high purine diet; incomplete lab data on creatinine and hemoglobin A; and a low baseline risk for gout in the study population, the researchers noted. However, the results persisted across sensitivity analysis and, if replicated, suggest that “SGLT2 inhibitors might be an effective class of medication for the prevention of gout for patients with diabetes or metabolic disorders,” they wrote.
The study was supported in part by Brigham and Women’s Hospital; lead author Dr. Fralick disclosed funding from the Eliot Phillipson Clinician-Scientist Training Program at the University of Toronto and the Canadian Institutes of Health Research.
SOURCE: Fralick M et al. Ann Intern Med. 2020 Jan 14. doi: 10.7326/M19-2610.
The incidence of gout was approximately 40% lower in diabetes patients who were prescribed sodium-glucose cotransporter 2 inhibitors (SGLT2) than it was in those who were prescribed glucagonlike peptide–1 receptor (GLP-1) agonists in a population-based new-user cohort study.
Hyperuricemia is a known cause of gout and common in type 2 diabetes patients. SGLT2 inhibitors may reduce the risk of gout by preventing the reabsorption of glucose and lowering serum uric acid levels; however, the impact on gout risk remains uncertain, wrote Michael Fralick, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
In a study published in the Annals of Internal Medicine, the researchers compared SGLT2 inhibitors and GLP-1 agonists in patients with type 2 diabetes to assess protection against gout.
The study population included adults with type 2 diabetes mellitus who had a new prescription for an SGTL2 inhibitor or GLP-1 agonist. The average age of the patients was 54 years; approximately half were women. Baseline characteristics were similar between the groups.
Overall, the researchers found a relative risk reduction of approximately 40% and an absolute risk reduction of approximately three fewer cases per 1,000 person-years in patients who received SGLT2 inhibitors, compared with those who received GLP-1 agonists. The incidence rate for gout in the SGLT2 and GLP-1 groups were 4.9 per 1,000 person-years and 7.8 per 1,000 person-years, respectively.
The study findings were limited by the investigators’ inability to measure potential confounding variables such as body mass index, alcohol use, and high purine diet; incomplete lab data on creatinine and hemoglobin A; and a low baseline risk for gout in the study population, the researchers noted. However, the results persisted across sensitivity analysis and, if replicated, suggest that “SGLT2 inhibitors might be an effective class of medication for the prevention of gout for patients with diabetes or metabolic disorders,” they wrote.
The study was supported in part by Brigham and Women’s Hospital; lead author Dr. Fralick disclosed funding from the Eliot Phillipson Clinician-Scientist Training Program at the University of Toronto and the Canadian Institutes of Health Research.
SOURCE: Fralick M et al. Ann Intern Med. 2020 Jan 14. doi: 10.7326/M19-2610.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: Sodium-glucose cotransporter 2 (SGLT2) inhibitor use was associated with lower rates of gout in type 2 diabetes patients compared with glucagonlike peptide–1 (GLP-1) agonist use.
Major finding: The incidence of gout was 4.9 per 1,000 person-years in patients on SGLT2 inhibitors and 7.8 per 1,000 person-years in patients on GLP1 agonists.
Study details: The data come from a population-based cohort study of 295,907 adults with type 2 diabetes.
Disclosures: The study was supported in part by Brigham and Women’s Hospital; lead author Dr. Fralick disclosed funding from the Eliot Phillipson Clinician-Scientist Training Program at the University of Toronto and the Canadian Institutes of Health Research.
Source: Fralick M et al. Ann Intern Med. 2020 Jan 14. doi: 10.7326/M19-2610.
Meta-analysis provides safety data on IL-17, IL-23 inhibitors
according to the results of a meta-analysis of 44 studies.
While associated with more adverse events than with placebo, IL-17 and IL-23 inhibitors are “generally well-tolerated and considered safe,” but the extent of adverse events and the existence of a possible drug class effect “have not been fully investigated,” wrote Nikolai D. Loft, MD, of the department of dermatology and allergy at Herlev and Gentofte Hospital in Hellerup, Denmark, and colleagues.
In a study published in the Journal of the European Academy of Dermatology and Venereology, the researchers identified phase 3 studies with data on adverse event reports in patients with psoriasis and psoriatic arthritis who were treated with either IL-17 inhibitors (brodalumab, ixekizumab, or secukinumab) or IL-23 inhibitors (guselkumab, risankizumab, or tildrakizumab).
Overall, across all treatments, the proportion of patients with reports of any adverse events ranged from 0.49 to 0.57 in short-term studies (12-16 weeks) and from 0.83 to 0.93 with long-term treatment (52 weeks). In a pooled analysis, the proportion of patients with any adverse events was 0.57, 0.52, 0.72, and 0.81, at 12, 16, 24, and 52 weeks, respectively.
The most common adverse events across all treatments were infections, nasopharyngitis, and headaches. Among those on ixekizumab, injection-site reactions was one of the most common adverse events reported, in nearly 16% of patients after 52 weeks of treatment, the authors noted.
Fewer adverse events were reported in patients on IL-23 inhibitors, compared with those on IL-17 inhibitors. The proportion of patients reporting serious adverse events was “low,” the researchers wrote. Patients on tildrakizumab had the lowest proportion of any adverse events overall, based on short-term data over 12-16 weeks.
No significant differences emerged in reported adverse events across IL-17 inhibitors after 52 weeks.
Other findings included a higher prevalence of Candida infections among those treated with IL-17 inhibitors after 12-16 weeks and 24 weeks, compared with those on placebo, but the infections, described as mild to moderate, did not result in drug discontinuation, the authors noted. The potential risk of inflammatory bowel disease (IBD) associated with IL-17 inhibitors has been raised as a concern, but in their analysis, “IBD was very rare and after 12 weeks no difference between active treatments and placebo was seen.”
The study findings were limited by several factors, including incomplete data for interdrug comparison, varying time points for safety measures, differences in dosing in clinical trials than the approved dosing, and lack of longer-term follow-up data for most of the treatments, the researchers noted. However, the analysis was strengthened by the inclusion of phase 3 studies with both short-and long-term data, and “overall, IL-17 and IL-23 inhibitors appear to be well-tolerated with good safety profiles.”
Dr. Loft disclosed serving as an honorary speaker for Eli Lilly; other coauthors disclosed relationships with multiple companies; two authors reported no conflicts of interest. There were no funding sources for the study listed.
SOURCE: Loft ND et al. J Eur Acad Dermatol Venereol 2019 Nov 13. doi: 10.1111/jdv.16073.
according to the results of a meta-analysis of 44 studies.
While associated with more adverse events than with placebo, IL-17 and IL-23 inhibitors are “generally well-tolerated and considered safe,” but the extent of adverse events and the existence of a possible drug class effect “have not been fully investigated,” wrote Nikolai D. Loft, MD, of the department of dermatology and allergy at Herlev and Gentofte Hospital in Hellerup, Denmark, and colleagues.
In a study published in the Journal of the European Academy of Dermatology and Venereology, the researchers identified phase 3 studies with data on adverse event reports in patients with psoriasis and psoriatic arthritis who were treated with either IL-17 inhibitors (brodalumab, ixekizumab, or secukinumab) or IL-23 inhibitors (guselkumab, risankizumab, or tildrakizumab).
Overall, across all treatments, the proportion of patients with reports of any adverse events ranged from 0.49 to 0.57 in short-term studies (12-16 weeks) and from 0.83 to 0.93 with long-term treatment (52 weeks). In a pooled analysis, the proportion of patients with any adverse events was 0.57, 0.52, 0.72, and 0.81, at 12, 16, 24, and 52 weeks, respectively.
The most common adverse events across all treatments were infections, nasopharyngitis, and headaches. Among those on ixekizumab, injection-site reactions was one of the most common adverse events reported, in nearly 16% of patients after 52 weeks of treatment, the authors noted.
Fewer adverse events were reported in patients on IL-23 inhibitors, compared with those on IL-17 inhibitors. The proportion of patients reporting serious adverse events was “low,” the researchers wrote. Patients on tildrakizumab had the lowest proportion of any adverse events overall, based on short-term data over 12-16 weeks.
No significant differences emerged in reported adverse events across IL-17 inhibitors after 52 weeks.
Other findings included a higher prevalence of Candida infections among those treated with IL-17 inhibitors after 12-16 weeks and 24 weeks, compared with those on placebo, but the infections, described as mild to moderate, did not result in drug discontinuation, the authors noted. The potential risk of inflammatory bowel disease (IBD) associated with IL-17 inhibitors has been raised as a concern, but in their analysis, “IBD was very rare and after 12 weeks no difference between active treatments and placebo was seen.”
The study findings were limited by several factors, including incomplete data for interdrug comparison, varying time points for safety measures, differences in dosing in clinical trials than the approved dosing, and lack of longer-term follow-up data for most of the treatments, the researchers noted. However, the analysis was strengthened by the inclusion of phase 3 studies with both short-and long-term data, and “overall, IL-17 and IL-23 inhibitors appear to be well-tolerated with good safety profiles.”
Dr. Loft disclosed serving as an honorary speaker for Eli Lilly; other coauthors disclosed relationships with multiple companies; two authors reported no conflicts of interest. There were no funding sources for the study listed.
SOURCE: Loft ND et al. J Eur Acad Dermatol Venereol 2019 Nov 13. doi: 10.1111/jdv.16073.
according to the results of a meta-analysis of 44 studies.
While associated with more adverse events than with placebo, IL-17 and IL-23 inhibitors are “generally well-tolerated and considered safe,” but the extent of adverse events and the existence of a possible drug class effect “have not been fully investigated,” wrote Nikolai D. Loft, MD, of the department of dermatology and allergy at Herlev and Gentofte Hospital in Hellerup, Denmark, and colleagues.
In a study published in the Journal of the European Academy of Dermatology and Venereology, the researchers identified phase 3 studies with data on adverse event reports in patients with psoriasis and psoriatic arthritis who were treated with either IL-17 inhibitors (brodalumab, ixekizumab, or secukinumab) or IL-23 inhibitors (guselkumab, risankizumab, or tildrakizumab).
Overall, across all treatments, the proportion of patients with reports of any adverse events ranged from 0.49 to 0.57 in short-term studies (12-16 weeks) and from 0.83 to 0.93 with long-term treatment (52 weeks). In a pooled analysis, the proportion of patients with any adverse events was 0.57, 0.52, 0.72, and 0.81, at 12, 16, 24, and 52 weeks, respectively.
The most common adverse events across all treatments were infections, nasopharyngitis, and headaches. Among those on ixekizumab, injection-site reactions was one of the most common adverse events reported, in nearly 16% of patients after 52 weeks of treatment, the authors noted.
Fewer adverse events were reported in patients on IL-23 inhibitors, compared with those on IL-17 inhibitors. The proportion of patients reporting serious adverse events was “low,” the researchers wrote. Patients on tildrakizumab had the lowest proportion of any adverse events overall, based on short-term data over 12-16 weeks.
No significant differences emerged in reported adverse events across IL-17 inhibitors after 52 weeks.
Other findings included a higher prevalence of Candida infections among those treated with IL-17 inhibitors after 12-16 weeks and 24 weeks, compared with those on placebo, but the infections, described as mild to moderate, did not result in drug discontinuation, the authors noted. The potential risk of inflammatory bowel disease (IBD) associated with IL-17 inhibitors has been raised as a concern, but in their analysis, “IBD was very rare and after 12 weeks no difference between active treatments and placebo was seen.”
The study findings were limited by several factors, including incomplete data for interdrug comparison, varying time points for safety measures, differences in dosing in clinical trials than the approved dosing, and lack of longer-term follow-up data for most of the treatments, the researchers noted. However, the analysis was strengthened by the inclusion of phase 3 studies with both short-and long-term data, and “overall, IL-17 and IL-23 inhibitors appear to be well-tolerated with good safety profiles.”
Dr. Loft disclosed serving as an honorary speaker for Eli Lilly; other coauthors disclosed relationships with multiple companies; two authors reported no conflicts of interest. There were no funding sources for the study listed.
SOURCE: Loft ND et al. J Eur Acad Dermatol Venereol 2019 Nov 13. doi: 10.1111/jdv.16073.
FROM THE JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
Vitamin E acetate confirmed as likely source of EVALI
Vitamin E acetate was found in fluid from the lungs of 94% of patients with electronic cigarette, or vaping, product use–associated lung injury, data from a convenience sample of 51 patients indicate. The findings were published in the New England Journal of Medicine.
Cases of electronic cigarette, or vaping, product use–associated lung injury (EVALI) were reported to the Centers for Disease Control and Prevention starting in early 2019, and numbers rose throughout the year, “which suggests new or increased exposure to one or more toxicants from the use of e-cigarette products,” wrote Benjamin C. Blount, PhD, of the National Center for Environmental Health at the CDC, and colleagues.
To further investigate potential toxins in patients with EVALI, the researchers examined bronchoalveolar-lavage (BAL) fluid from 51 EVALI patients and 99 healthy controls.
After the researchers used isotope dilution mass spectrometry on the samples, 48 of the 51 patients (94%) showed vitamin E acetate in their BAL samples. No other potential toxins – including plant oils, medium-chain triglyceride oil, petroleum distillates, and diluent terpenes – were identified. The samples of one patient each showed coconut oil and limonene.
A total of 47 of 51 patients for whom complete laboratory data were available either reported vaping tetrahydrocannabinol products within 90 days of becoming ill, or showed tetrahydrocannabinol or its metabolites in their BAL fluid. In addition, 30 of 47 patients showed nicotine or nicotine metabolites in their BAL fluid.
The average age of the patients was 23 years, 69% were male. Overall, 25 were confirmed EVALI cases and 26 were probable cases, and probable cases included the three patients who showed no vitamin E acetate.
The safety of inhaling vitamin E acetate, which is a common ingredient in dietary supplements and skin care creams, has not been well studied. It could contribute to lung injury when heated in e-cigarette products by splitting the acetate to create the reactive compound and potential lung irritant ketene, the researchers said.
The study findings were limited by several factors including the possibility that vitamin E acetate is a marker for exposure to other toxicants, a lack of data on the impact of heating vitamin e acetate, and the inability to assess the timing of the vitamin E acetate exposure compared to BAL sample collection, the researchers noted.
However, the results suggest that vitamin E acetate may play a role in EVALI because of the high detection rate in patients from across the United States, the biologically possible potential for lung injury from vitamin e acetate, and the timing of the rise of EVALI and the use of vitamin E acetate in vaping products, they concluded.
The research was supported by the National Cancer Institute, the FDA Center for Tobacco Products, and The Ohio State University Pelotonia intramural research program. The authors had no financial conflicts to disclose.
SOURCE: Blount BC et al. N Engl J Med. 2019 Dec 20. doi: 10.1056/NEJMoa1916433.
Vitamin E acetate was found in fluid from the lungs of 94% of patients with electronic cigarette, or vaping, product use–associated lung injury, data from a convenience sample of 51 patients indicate. The findings were published in the New England Journal of Medicine.
Cases of electronic cigarette, or vaping, product use–associated lung injury (EVALI) were reported to the Centers for Disease Control and Prevention starting in early 2019, and numbers rose throughout the year, “which suggests new or increased exposure to one or more toxicants from the use of e-cigarette products,” wrote Benjamin C. Blount, PhD, of the National Center for Environmental Health at the CDC, and colleagues.
To further investigate potential toxins in patients with EVALI, the researchers examined bronchoalveolar-lavage (BAL) fluid from 51 EVALI patients and 99 healthy controls.
After the researchers used isotope dilution mass spectrometry on the samples, 48 of the 51 patients (94%) showed vitamin E acetate in their BAL samples. No other potential toxins – including plant oils, medium-chain triglyceride oil, petroleum distillates, and diluent terpenes – were identified. The samples of one patient each showed coconut oil and limonene.
A total of 47 of 51 patients for whom complete laboratory data were available either reported vaping tetrahydrocannabinol products within 90 days of becoming ill, or showed tetrahydrocannabinol or its metabolites in their BAL fluid. In addition, 30 of 47 patients showed nicotine or nicotine metabolites in their BAL fluid.
The average age of the patients was 23 years, 69% were male. Overall, 25 were confirmed EVALI cases and 26 were probable cases, and probable cases included the three patients who showed no vitamin E acetate.
The safety of inhaling vitamin E acetate, which is a common ingredient in dietary supplements and skin care creams, has not been well studied. It could contribute to lung injury when heated in e-cigarette products by splitting the acetate to create the reactive compound and potential lung irritant ketene, the researchers said.
The study findings were limited by several factors including the possibility that vitamin E acetate is a marker for exposure to other toxicants, a lack of data on the impact of heating vitamin e acetate, and the inability to assess the timing of the vitamin E acetate exposure compared to BAL sample collection, the researchers noted.
However, the results suggest that vitamin E acetate may play a role in EVALI because of the high detection rate in patients from across the United States, the biologically possible potential for lung injury from vitamin e acetate, and the timing of the rise of EVALI and the use of vitamin E acetate in vaping products, they concluded.
The research was supported by the National Cancer Institute, the FDA Center for Tobacco Products, and The Ohio State University Pelotonia intramural research program. The authors had no financial conflicts to disclose.
SOURCE: Blount BC et al. N Engl J Med. 2019 Dec 20. doi: 10.1056/NEJMoa1916433.
Vitamin E acetate was found in fluid from the lungs of 94% of patients with electronic cigarette, or vaping, product use–associated lung injury, data from a convenience sample of 51 patients indicate. The findings were published in the New England Journal of Medicine.
Cases of electronic cigarette, or vaping, product use–associated lung injury (EVALI) were reported to the Centers for Disease Control and Prevention starting in early 2019, and numbers rose throughout the year, “which suggests new or increased exposure to one or more toxicants from the use of e-cigarette products,” wrote Benjamin C. Blount, PhD, of the National Center for Environmental Health at the CDC, and colleagues.
To further investigate potential toxins in patients with EVALI, the researchers examined bronchoalveolar-lavage (BAL) fluid from 51 EVALI patients and 99 healthy controls.
After the researchers used isotope dilution mass spectrometry on the samples, 48 of the 51 patients (94%) showed vitamin E acetate in their BAL samples. No other potential toxins – including plant oils, medium-chain triglyceride oil, petroleum distillates, and diluent terpenes – were identified. The samples of one patient each showed coconut oil and limonene.
A total of 47 of 51 patients for whom complete laboratory data were available either reported vaping tetrahydrocannabinol products within 90 days of becoming ill, or showed tetrahydrocannabinol or its metabolites in their BAL fluid. In addition, 30 of 47 patients showed nicotine or nicotine metabolites in their BAL fluid.
The average age of the patients was 23 years, 69% were male. Overall, 25 were confirmed EVALI cases and 26 were probable cases, and probable cases included the three patients who showed no vitamin E acetate.
The safety of inhaling vitamin E acetate, which is a common ingredient in dietary supplements and skin care creams, has not been well studied. It could contribute to lung injury when heated in e-cigarette products by splitting the acetate to create the reactive compound and potential lung irritant ketene, the researchers said.
The study findings were limited by several factors including the possibility that vitamin E acetate is a marker for exposure to other toxicants, a lack of data on the impact of heating vitamin e acetate, and the inability to assess the timing of the vitamin E acetate exposure compared to BAL sample collection, the researchers noted.
However, the results suggest that vitamin E acetate may play a role in EVALI because of the high detection rate in patients from across the United States, the biologically possible potential for lung injury from vitamin e acetate, and the timing of the rise of EVALI and the use of vitamin E acetate in vaping products, they concluded.
The research was supported by the National Cancer Institute, the FDA Center for Tobacco Products, and The Ohio State University Pelotonia intramural research program. The authors had no financial conflicts to disclose.
SOURCE: Blount BC et al. N Engl J Med. 2019 Dec 20. doi: 10.1056/NEJMoa1916433.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Vaping marijuana gaining traction among U.S. teens
Monitoring the Future survey asked about daily vaping this year for first time
Vaping has expanded as a popular method of drug delivery for U.S. teenagers, and one in five students in grades 10 and 12 reported vaping marijuana in the past year, according to results of the 2019 Monitoring the Future survey conducted by the National Institute on Drug Abuse (NIDA).
This year’s findings, announced Dec. 18, continue to illustrate “a clear shift in the pattern of drug taking among teenagers,” said NIDA Director Nora D. Volkow, MD, in a teleconference held to review the results.
Use of alcohol and drugs – including opioids and stimulants – continues to decline among teens, but vaping continues its significant rise, with a surge in marijuana vaping this year.
The increase in past-month marijuana vaping among 12th graders, from 7.5% in 2018 to 14% in 2019, represents the second-largest 1-year jump tracked for any substance in the survey’s history, Dr. Volkow said. The largest jump was the increase in past-month nicotine vaping among 12th-graders from 2017-2018.
“It is very unfortunate that we are seeing the steep rise in the use of vaping devices” because the devices deliver drugs in very high concentration, Dr. Volkow said. The growing popularity of vaping “threatens to undo years of progress protecting the health of adolescents in the U.S.,” Dr. Volkow said in a statement. The Monitoring the Future survey began including vaping questions in 2017.
Monitoring the Future is a national tool to assess drug and alcohol use and related attitudes among adolescent students across the United States. This year’s self-reported survey included 42,531 in grades 8, 10, and 12 from 396 public and private schools.
Nicotine vaping increased from 2018 to 2019 across all three grades; past-month nicotine use equated to 1 in 4, 1 in 5, and 1 in 10 (26%, 20%, and 10%) among 12th, 10th, and 8th graders, respectively, according to the survey. Daily nicotine vaping, measured for the first time this year because of public health concerns, was approximately 12% for 12th graders, 7% for 10th graders, and 2% for 8th graders. Daily marijuana vaping, also measured for the first time this year, was approximately 4%, 3%, and 1% among 12th, 10th, and 8th graders, respectively. Additional findings on the rise of vaping by U.S. teenagers were released Dec. 17 in a research letter published online in JAMA (doi: 10.1001/jama.2019.20185).
Meanwhile, positive trends in this year’s survey included a reduction in the misuse of prescription drugs, including OxyContin, Vicodin, and Adderall, and in the use of traditional cigarettes and other tobacco products, as well as alcohol, noted Richard A. Miech, PhD, MPH, of the University of Michigan, Ann Arbor, principal investigator for Monitoring the Future. However, the challenge of preventing and reducing vaping in teens remains “a whole new uncharted territory,” in part because the design of the vaping devices facilitates discreet use at home and at school, he said.
Physicians and parents have important roles to play in screening for vaping among teens, Dr. Volkow said in a question and answer session. Health care clinicians, including pediatricians and family physicians, “are in a unique position to communicate with their young patients” by educating them about the dangers of vaping, encouraging them to stop if they have started using these devices, and referring them for further treatment if they are showing signs of addiction, she said.
Monitoring the Future was funded by NIDA. The researchers had no disclosures.
Monitoring the Future survey asked about daily vaping this year for first time
Monitoring the Future survey asked about daily vaping this year for first time
Vaping has expanded as a popular method of drug delivery for U.S. teenagers, and one in five students in grades 10 and 12 reported vaping marijuana in the past year, according to results of the 2019 Monitoring the Future survey conducted by the National Institute on Drug Abuse (NIDA).
This year’s findings, announced Dec. 18, continue to illustrate “a clear shift in the pattern of drug taking among teenagers,” said NIDA Director Nora D. Volkow, MD, in a teleconference held to review the results.
Use of alcohol and drugs – including opioids and stimulants – continues to decline among teens, but vaping continues its significant rise, with a surge in marijuana vaping this year.
The increase in past-month marijuana vaping among 12th graders, from 7.5% in 2018 to 14% in 2019, represents the second-largest 1-year jump tracked for any substance in the survey’s history, Dr. Volkow said. The largest jump was the increase in past-month nicotine vaping among 12th-graders from 2017-2018.
“It is very unfortunate that we are seeing the steep rise in the use of vaping devices” because the devices deliver drugs in very high concentration, Dr. Volkow said. The growing popularity of vaping “threatens to undo years of progress protecting the health of adolescents in the U.S.,” Dr. Volkow said in a statement. The Monitoring the Future survey began including vaping questions in 2017.
Monitoring the Future is a national tool to assess drug and alcohol use and related attitudes among adolescent students across the United States. This year’s self-reported survey included 42,531 in grades 8, 10, and 12 from 396 public and private schools.
Nicotine vaping increased from 2018 to 2019 across all three grades; past-month nicotine use equated to 1 in 4, 1 in 5, and 1 in 10 (26%, 20%, and 10%) among 12th, 10th, and 8th graders, respectively, according to the survey. Daily nicotine vaping, measured for the first time this year because of public health concerns, was approximately 12% for 12th graders, 7% for 10th graders, and 2% for 8th graders. Daily marijuana vaping, also measured for the first time this year, was approximately 4%, 3%, and 1% among 12th, 10th, and 8th graders, respectively. Additional findings on the rise of vaping by U.S. teenagers were released Dec. 17 in a research letter published online in JAMA (doi: 10.1001/jama.2019.20185).
Meanwhile, positive trends in this year’s survey included a reduction in the misuse of prescription drugs, including OxyContin, Vicodin, and Adderall, and in the use of traditional cigarettes and other tobacco products, as well as alcohol, noted Richard A. Miech, PhD, MPH, of the University of Michigan, Ann Arbor, principal investigator for Monitoring the Future. However, the challenge of preventing and reducing vaping in teens remains “a whole new uncharted territory,” in part because the design of the vaping devices facilitates discreet use at home and at school, he said.
Physicians and parents have important roles to play in screening for vaping among teens, Dr. Volkow said in a question and answer session. Health care clinicians, including pediatricians and family physicians, “are in a unique position to communicate with their young patients” by educating them about the dangers of vaping, encouraging them to stop if they have started using these devices, and referring them for further treatment if they are showing signs of addiction, she said.
Monitoring the Future was funded by NIDA. The researchers had no disclosures.
Vaping has expanded as a popular method of drug delivery for U.S. teenagers, and one in five students in grades 10 and 12 reported vaping marijuana in the past year, according to results of the 2019 Monitoring the Future survey conducted by the National Institute on Drug Abuse (NIDA).
This year’s findings, announced Dec. 18, continue to illustrate “a clear shift in the pattern of drug taking among teenagers,” said NIDA Director Nora D. Volkow, MD, in a teleconference held to review the results.
Use of alcohol and drugs – including opioids and stimulants – continues to decline among teens, but vaping continues its significant rise, with a surge in marijuana vaping this year.
The increase in past-month marijuana vaping among 12th graders, from 7.5% in 2018 to 14% in 2019, represents the second-largest 1-year jump tracked for any substance in the survey’s history, Dr. Volkow said. The largest jump was the increase in past-month nicotine vaping among 12th-graders from 2017-2018.
“It is very unfortunate that we are seeing the steep rise in the use of vaping devices” because the devices deliver drugs in very high concentration, Dr. Volkow said. The growing popularity of vaping “threatens to undo years of progress protecting the health of adolescents in the U.S.,” Dr. Volkow said in a statement. The Monitoring the Future survey began including vaping questions in 2017.
Monitoring the Future is a national tool to assess drug and alcohol use and related attitudes among adolescent students across the United States. This year’s self-reported survey included 42,531 in grades 8, 10, and 12 from 396 public and private schools.
Nicotine vaping increased from 2018 to 2019 across all three grades; past-month nicotine use equated to 1 in 4, 1 in 5, and 1 in 10 (26%, 20%, and 10%) among 12th, 10th, and 8th graders, respectively, according to the survey. Daily nicotine vaping, measured for the first time this year because of public health concerns, was approximately 12% for 12th graders, 7% for 10th graders, and 2% for 8th graders. Daily marijuana vaping, also measured for the first time this year, was approximately 4%, 3%, and 1% among 12th, 10th, and 8th graders, respectively. Additional findings on the rise of vaping by U.S. teenagers were released Dec. 17 in a research letter published online in JAMA (doi: 10.1001/jama.2019.20185).
Meanwhile, positive trends in this year’s survey included a reduction in the misuse of prescription drugs, including OxyContin, Vicodin, and Adderall, and in the use of traditional cigarettes and other tobacco products, as well as alcohol, noted Richard A. Miech, PhD, MPH, of the University of Michigan, Ann Arbor, principal investigator for Monitoring the Future. However, the challenge of preventing and reducing vaping in teens remains “a whole new uncharted territory,” in part because the design of the vaping devices facilitates discreet use at home and at school, he said.
Physicians and parents have important roles to play in screening for vaping among teens, Dr. Volkow said in a question and answer session. Health care clinicians, including pediatricians and family physicians, “are in a unique position to communicate with their young patients” by educating them about the dangers of vaping, encouraging them to stop if they have started using these devices, and referring them for further treatment if they are showing signs of addiction, she said.
Monitoring the Future was funded by NIDA. The researchers had no disclosures.
Osteoporotic fracture risk is undermanaged in older adults
Treatment of osteoporosis in older adults at increased risk for fractures declined from 2010 to 2014, based on a study of nearly 900,000 individuals.
Osteoporotic fractures are associated with morbidity and mortality, functional decline, increased nursing home admissions, and a significant economic burden, Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, said in a presentation at the annual meeting of the American College of Rheumatology.
“The number of Americans at risk for fractures on the basis of having osteoporosis is expected to increase by 32% based on the graying of the population,” he said. “Underdiagnosis and undertreatment may be contributing to the increased burden that we are starting to see,” he added.
To assess the impact of osteoporosis management on patients at increased risk for fractures, Dr. Curtis and his colleagues examined temporal trends over 5 years from 885,676 Medicare fee-for-service members with a closed fragility (or osteoporosis-related) fracture between Jan. 1, 2010, and Dec. 31, 2014. The average age of the patients was 81 years; 91% were white, and 94% were women.
The researchers used diagnosis and procedure codes to create an algorithm with a positive predictive value of more than 90%. Individuals with Paget’s disease or a malignancy other than nonmelanoma skin cancer at baseline were excluded.
Overall, use of dual x-ray absorptiometry (DXA) screening in this high-risk population decreased over the study period, with rates during 2010-2014 of 25%, 24%, 23%, 22%, and 16%, respectively. The presence of an osteoporosis diagnosis in the study population decreased over the same period, with rates of 7%, 6%, 6%, 5%, and 4%, respectively. In addition, the percentage of high-risk patients undergoing osteoporosis treatment at the time of fracture during 2010-2014 was 29%, 24%, 20%, 16%, and 11%, respectively.
Despite their history of fracture, more than half of individuals in each year’s database had a comorbidity or were taking a medication that increased fall risk. The most common comorbidity was impaired mobility (about 20% of each yearly cohort), followed by history of falls, history of stroke, impaired vision, muscle atrophy or weakness, and Parkinson’s disease. Approximately half of the patients in each year’s group were taking opioids, and approximately 20% were taking oral corticosteroids.
The findings were limited by several factors, including those common to studies involving administrative claims databases, such as a lack of complete medical and treatment history, lack of diagnostic validation for osteoporosis-related fractures, and lack of information on why use of DXA decreased over time, Dr. Curtis said. However, the results show the need to improve management of individuals at increased risk for falls and fractures to reduce not only the risk of morbidity and mortality, but also the economic impact.
Dr. Curtis disclosed serving as a consultant for Radius Health and Amgen, and the University of Alabama at Birmingham Medical Center received grants from these companies.
SOURCE: Curtis et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 1872.
Treatment of osteoporosis in older adults at increased risk for fractures declined from 2010 to 2014, based on a study of nearly 900,000 individuals.
Osteoporotic fractures are associated with morbidity and mortality, functional decline, increased nursing home admissions, and a significant economic burden, Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, said in a presentation at the annual meeting of the American College of Rheumatology.
“The number of Americans at risk for fractures on the basis of having osteoporosis is expected to increase by 32% based on the graying of the population,” he said. “Underdiagnosis and undertreatment may be contributing to the increased burden that we are starting to see,” he added.
To assess the impact of osteoporosis management on patients at increased risk for fractures, Dr. Curtis and his colleagues examined temporal trends over 5 years from 885,676 Medicare fee-for-service members with a closed fragility (or osteoporosis-related) fracture between Jan. 1, 2010, and Dec. 31, 2014. The average age of the patients was 81 years; 91% were white, and 94% were women.
The researchers used diagnosis and procedure codes to create an algorithm with a positive predictive value of more than 90%. Individuals with Paget’s disease or a malignancy other than nonmelanoma skin cancer at baseline were excluded.
Overall, use of dual x-ray absorptiometry (DXA) screening in this high-risk population decreased over the study period, with rates during 2010-2014 of 25%, 24%, 23%, 22%, and 16%, respectively. The presence of an osteoporosis diagnosis in the study population decreased over the same period, with rates of 7%, 6%, 6%, 5%, and 4%, respectively. In addition, the percentage of high-risk patients undergoing osteoporosis treatment at the time of fracture during 2010-2014 was 29%, 24%, 20%, 16%, and 11%, respectively.
Despite their history of fracture, more than half of individuals in each year’s database had a comorbidity or were taking a medication that increased fall risk. The most common comorbidity was impaired mobility (about 20% of each yearly cohort), followed by history of falls, history of stroke, impaired vision, muscle atrophy or weakness, and Parkinson’s disease. Approximately half of the patients in each year’s group were taking opioids, and approximately 20% were taking oral corticosteroids.
The findings were limited by several factors, including those common to studies involving administrative claims databases, such as a lack of complete medical and treatment history, lack of diagnostic validation for osteoporosis-related fractures, and lack of information on why use of DXA decreased over time, Dr. Curtis said. However, the results show the need to improve management of individuals at increased risk for falls and fractures to reduce not only the risk of morbidity and mortality, but also the economic impact.
Dr. Curtis disclosed serving as a consultant for Radius Health and Amgen, and the University of Alabama at Birmingham Medical Center received grants from these companies.
SOURCE: Curtis et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 1872.
Treatment of osteoporosis in older adults at increased risk for fractures declined from 2010 to 2014, based on a study of nearly 900,000 individuals.
Osteoporotic fractures are associated with morbidity and mortality, functional decline, increased nursing home admissions, and a significant economic burden, Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, said in a presentation at the annual meeting of the American College of Rheumatology.
“The number of Americans at risk for fractures on the basis of having osteoporosis is expected to increase by 32% based on the graying of the population,” he said. “Underdiagnosis and undertreatment may be contributing to the increased burden that we are starting to see,” he added.
To assess the impact of osteoporosis management on patients at increased risk for fractures, Dr. Curtis and his colleagues examined temporal trends over 5 years from 885,676 Medicare fee-for-service members with a closed fragility (or osteoporosis-related) fracture between Jan. 1, 2010, and Dec. 31, 2014. The average age of the patients was 81 years; 91% were white, and 94% were women.
The researchers used diagnosis and procedure codes to create an algorithm with a positive predictive value of more than 90%. Individuals with Paget’s disease or a malignancy other than nonmelanoma skin cancer at baseline were excluded.
Overall, use of dual x-ray absorptiometry (DXA) screening in this high-risk population decreased over the study period, with rates during 2010-2014 of 25%, 24%, 23%, 22%, and 16%, respectively. The presence of an osteoporosis diagnosis in the study population decreased over the same period, with rates of 7%, 6%, 6%, 5%, and 4%, respectively. In addition, the percentage of high-risk patients undergoing osteoporosis treatment at the time of fracture during 2010-2014 was 29%, 24%, 20%, 16%, and 11%, respectively.
Despite their history of fracture, more than half of individuals in each year’s database had a comorbidity or were taking a medication that increased fall risk. The most common comorbidity was impaired mobility (about 20% of each yearly cohort), followed by history of falls, history of stroke, impaired vision, muscle atrophy or weakness, and Parkinson’s disease. Approximately half of the patients in each year’s group were taking opioids, and approximately 20% were taking oral corticosteroids.
The findings were limited by several factors, including those common to studies involving administrative claims databases, such as a lack of complete medical and treatment history, lack of diagnostic validation for osteoporosis-related fractures, and lack of information on why use of DXA decreased over time, Dr. Curtis said. However, the results show the need to improve management of individuals at increased risk for falls and fractures to reduce not only the risk of morbidity and mortality, but also the economic impact.
Dr. Curtis disclosed serving as a consultant for Radius Health and Amgen, and the University of Alabama at Birmingham Medical Center received grants from these companies.
SOURCE: Curtis et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract 1872.
REPORTING FROM ACR 2019
Novel analysis links insomnia to first-onset major depressive disorder
a prospective study of 768 adults with a history of depression suggests.
Insomnia has been identified as a risk factor for depression, but the impact of lifetime depression history and the role of insomnia in major depressive disorder (MDD) remains unclear, wrote Tessa Blanken, MSc, of the Netherlands Institute for Neuroscience, Amsterdam, and colleagues. Studies of this relationship have been hampered by the difficulty of isolating the impact of insomnia as an independent predictor of MDD from depression and other disorders.
In a study published in Sleep, the researchers reviewed data from 768 adults aged 18-65 years who were participants in the Netherlands Study of Depression and Anxiety, a multicenter, longitudinal study that included four assessments over 6 years. The participants had no current or prior diagnosis of MDD. The average age of the participants was 41 years, and 63% were women.
The investigators used Network Outcome Analysis to study the link between insomnia and MDD. The investigators wrote, “Network modeling techniques provide a unique framework to study the interactions among symptoms and their role in the development and maintenance of psychiatric disorders. Using network analysis we can estimate the unique association between pairs of symptoms, while controlling for the state and associations of all other symptoms.”
Over 6-years’ follow-up, 141 participants (18%) were diagnosed with first-onset MDD. Overall, insomnia severity was a significant predictor of first-onset MDD (hazard ratio 1.11, 95% confidence interval). The analysis showed that the predictive effect of insomnia on first-onset MDD was driven solely by the item “Did you have trouble falling asleep” (hazard ratio, 1.33; 95% confidence interval, 1.12-1.57; observed range, 0-4). Those individuals who had trouble falling asleep 3-4 times or more than 4 times a week were 2.3 or 3.2 times, respectively, more likely to develop first-onset MDD. None of the other sleep complaints, such as nocturnal and early morning awakening, significantly increased the risk of first-onset MDD.
The study findings were limited by several factors including the full impact of short sleep duration and lack of chronotype assessment, the researchers noted. However, “the identification of ‘difficulty initiating sleep’ as a risk factor is particularly promising because a recent meta-analysis showed that cognitive behavioural therapy, the treatment of choice for insomnia, is highly effective,” the researchers wrote. The results suggest that treating problems in sleep initiation could contribute to preventing first-onset depression and reducing the overall burden of MDD, they concluded.
The study was supported by the European Research Council. The researchers had no financial conflicts to disclose.
SOURCE: Blanken TF et al. Sleep. 2019 Dec 2. doi: 10.1093/sleep/zsz288.
a prospective study of 768 adults with a history of depression suggests.
Insomnia has been identified as a risk factor for depression, but the impact of lifetime depression history and the role of insomnia in major depressive disorder (MDD) remains unclear, wrote Tessa Blanken, MSc, of the Netherlands Institute for Neuroscience, Amsterdam, and colleagues. Studies of this relationship have been hampered by the difficulty of isolating the impact of insomnia as an independent predictor of MDD from depression and other disorders.
In a study published in Sleep, the researchers reviewed data from 768 adults aged 18-65 years who were participants in the Netherlands Study of Depression and Anxiety, a multicenter, longitudinal study that included four assessments over 6 years. The participants had no current or prior diagnosis of MDD. The average age of the participants was 41 years, and 63% were women.
The investigators used Network Outcome Analysis to study the link between insomnia and MDD. The investigators wrote, “Network modeling techniques provide a unique framework to study the interactions among symptoms and their role in the development and maintenance of psychiatric disorders. Using network analysis we can estimate the unique association between pairs of symptoms, while controlling for the state and associations of all other symptoms.”
Over 6-years’ follow-up, 141 participants (18%) were diagnosed with first-onset MDD. Overall, insomnia severity was a significant predictor of first-onset MDD (hazard ratio 1.11, 95% confidence interval). The analysis showed that the predictive effect of insomnia on first-onset MDD was driven solely by the item “Did you have trouble falling asleep” (hazard ratio, 1.33; 95% confidence interval, 1.12-1.57; observed range, 0-4). Those individuals who had trouble falling asleep 3-4 times or more than 4 times a week were 2.3 or 3.2 times, respectively, more likely to develop first-onset MDD. None of the other sleep complaints, such as nocturnal and early morning awakening, significantly increased the risk of first-onset MDD.
The study findings were limited by several factors including the full impact of short sleep duration and lack of chronotype assessment, the researchers noted. However, “the identification of ‘difficulty initiating sleep’ as a risk factor is particularly promising because a recent meta-analysis showed that cognitive behavioural therapy, the treatment of choice for insomnia, is highly effective,” the researchers wrote. The results suggest that treating problems in sleep initiation could contribute to preventing first-onset depression and reducing the overall burden of MDD, they concluded.
The study was supported by the European Research Council. The researchers had no financial conflicts to disclose.
SOURCE: Blanken TF et al. Sleep. 2019 Dec 2. doi: 10.1093/sleep/zsz288.
a prospective study of 768 adults with a history of depression suggests.
Insomnia has been identified as a risk factor for depression, but the impact of lifetime depression history and the role of insomnia in major depressive disorder (MDD) remains unclear, wrote Tessa Blanken, MSc, of the Netherlands Institute for Neuroscience, Amsterdam, and colleagues. Studies of this relationship have been hampered by the difficulty of isolating the impact of insomnia as an independent predictor of MDD from depression and other disorders.
In a study published in Sleep, the researchers reviewed data from 768 adults aged 18-65 years who were participants in the Netherlands Study of Depression and Anxiety, a multicenter, longitudinal study that included four assessments over 6 years. The participants had no current or prior diagnosis of MDD. The average age of the participants was 41 years, and 63% were women.
The investigators used Network Outcome Analysis to study the link between insomnia and MDD. The investigators wrote, “Network modeling techniques provide a unique framework to study the interactions among symptoms and their role in the development and maintenance of psychiatric disorders. Using network analysis we can estimate the unique association between pairs of symptoms, while controlling for the state and associations of all other symptoms.”
Over 6-years’ follow-up, 141 participants (18%) were diagnosed with first-onset MDD. Overall, insomnia severity was a significant predictor of first-onset MDD (hazard ratio 1.11, 95% confidence interval). The analysis showed that the predictive effect of insomnia on first-onset MDD was driven solely by the item “Did you have trouble falling asleep” (hazard ratio, 1.33; 95% confidence interval, 1.12-1.57; observed range, 0-4). Those individuals who had trouble falling asleep 3-4 times or more than 4 times a week were 2.3 or 3.2 times, respectively, more likely to develop first-onset MDD. None of the other sleep complaints, such as nocturnal and early morning awakening, significantly increased the risk of first-onset MDD.
The study findings were limited by several factors including the full impact of short sleep duration and lack of chronotype assessment, the researchers noted. However, “the identification of ‘difficulty initiating sleep’ as a risk factor is particularly promising because a recent meta-analysis showed that cognitive behavioural therapy, the treatment of choice for insomnia, is highly effective,” the researchers wrote. The results suggest that treating problems in sleep initiation could contribute to preventing first-onset depression and reducing the overall burden of MDD, they concluded.
The study was supported by the European Research Council. The researchers had no financial conflicts to disclose.
SOURCE: Blanken TF et al. Sleep. 2019 Dec 2. doi: 10.1093/sleep/zsz288.
FROM SLEEP