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Lucas Franki is an associate editor for MDedge News, and has been with the company since 2014. He has a BA in English from Penn State University and is an Eagle Scout.
FDA approves daratumumab split-dosing regimen in MM
The Food and Drug Administration has approved a split-dosing regimen for daratumumab (Darzalex) in patients with multiple myeloma, allowing the first infusion to be split over 2 days.
FDA approval is based on results from the global, multi-arm, phase 1b EQUULEUS (MMY1001) trial, which evaluated daratumumab in combination with a variety of treatment regimens. Splitting the first infusion over 2 consecutive days reduced the duration of the infusion and resulted in a similar rate of infusion site reactions; concentrations were similar at the end of weekly dosing in patients who received the first infusion at once or over a 2-day period.
The adverse events reported in EQUULEUS (MMY1001) were largely similar to those seen in previous trials; the most common adverse events include infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, and upper respiratory tract infection.
The approval providers “added flexibility for how patients may receive initial treatment,” Craig Tendler, MD, vice president of clinical development and global medical affairs at Janssen Research & Development, said in a statement.
The Food and Drug Administration has approved a split-dosing regimen for daratumumab (Darzalex) in patients with multiple myeloma, allowing the first infusion to be split over 2 days.
FDA approval is based on results from the global, multi-arm, phase 1b EQUULEUS (MMY1001) trial, which evaluated daratumumab in combination with a variety of treatment regimens. Splitting the first infusion over 2 consecutive days reduced the duration of the infusion and resulted in a similar rate of infusion site reactions; concentrations were similar at the end of weekly dosing in patients who received the first infusion at once or over a 2-day period.
The adverse events reported in EQUULEUS (MMY1001) were largely similar to those seen in previous trials; the most common adverse events include infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, and upper respiratory tract infection.
The approval providers “added flexibility for how patients may receive initial treatment,” Craig Tendler, MD, vice president of clinical development and global medical affairs at Janssen Research & Development, said in a statement.
The Food and Drug Administration has approved a split-dosing regimen for daratumumab (Darzalex) in patients with multiple myeloma, allowing the first infusion to be split over 2 days.
FDA approval is based on results from the global, multi-arm, phase 1b EQUULEUS (MMY1001) trial, which evaluated daratumumab in combination with a variety of treatment regimens. Splitting the first infusion over 2 consecutive days reduced the duration of the infusion and resulted in a similar rate of infusion site reactions; concentrations were similar at the end of weekly dosing in patients who received the first infusion at once or over a 2-day period.
The adverse events reported in EQUULEUS (MMY1001) were largely similar to those seen in previous trials; the most common adverse events include infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, and upper respiratory tract infection.
The approval providers “added flexibility for how patients may receive initial treatment,” Craig Tendler, MD, vice president of clinical development and global medical affairs at Janssen Research & Development, said in a statement.
FDA issues warnings to companies selling illegal Alzheimer’s treatments
The Food and Drug Administration has issued warning letters to 12 companies and advisory letters to 5 companies illegally selling more than 58 products claiming to treat Alzheimer’s disease.
The products, many of which are marketed as dietary supplements, are being sold in a variety of forms, including tablets, capsules, and oils. These drugs are either unapproved or mislabeled and claim to prevent, treat, or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, in violation of the Federal Food, Drug, and Cosmetic Act.
“Alzheimer’s is a challenging disease that, unfortunately, has no cure. Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease, or worse, as some fraudulent treatments can cause serious or even fatal injuries,” FDA Commissioner Scott Gottlieb, MD, said in a press release.
In an additional statement, Dr. Gottlieb detailed several new strategies for improving the safety and accuracy of dietary supplements, including efforts to more rapidly communicate to the public potential safety issues with dietary supplement products and to establish a flexible regulatory framework that promotes innovation and upholds product safety.
The Food and Drug Administration has issued warning letters to 12 companies and advisory letters to 5 companies illegally selling more than 58 products claiming to treat Alzheimer’s disease.
The products, many of which are marketed as dietary supplements, are being sold in a variety of forms, including tablets, capsules, and oils. These drugs are either unapproved or mislabeled and claim to prevent, treat, or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, in violation of the Federal Food, Drug, and Cosmetic Act.
“Alzheimer’s is a challenging disease that, unfortunately, has no cure. Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease, or worse, as some fraudulent treatments can cause serious or even fatal injuries,” FDA Commissioner Scott Gottlieb, MD, said in a press release.
In an additional statement, Dr. Gottlieb detailed several new strategies for improving the safety and accuracy of dietary supplements, including efforts to more rapidly communicate to the public potential safety issues with dietary supplement products and to establish a flexible regulatory framework that promotes innovation and upholds product safety.
The Food and Drug Administration has issued warning letters to 12 companies and advisory letters to 5 companies illegally selling more than 58 products claiming to treat Alzheimer’s disease.
The products, many of which are marketed as dietary supplements, are being sold in a variety of forms, including tablets, capsules, and oils. These drugs are either unapproved or mislabeled and claim to prevent, treat, or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, in violation of the Federal Food, Drug, and Cosmetic Act.
“Alzheimer’s is a challenging disease that, unfortunately, has no cure. Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease, or worse, as some fraudulent treatments can cause serious or even fatal injuries,” FDA Commissioner Scott Gottlieb, MD, said in a press release.
In an additional statement, Dr. Gottlieb detailed several new strategies for improving the safety and accuracy of dietary supplements, including efforts to more rapidly communicate to the public potential safety issues with dietary supplement products and to establish a flexible regulatory framework that promotes innovation and upholds product safety.
Interactive parenting, life skill intervention improves self-esteem in teen mothers
than did those who received standard care, according to Joanne E. Cox, MD, director of primary care at Boston Children’s Hospital and Harvard Medical School, and her associates.
A total of 140 mothers who were aged less than 19 years when they delivered and whose child was aged less than 12 months were included in the study published in Pediatrics. Of this group, 72 received the intervention, which included a series of five 1-hour, one-on-one, interactive modules adapted from the Nurturing and Ansell-Casey Life Skills curricula, delivered over the infant’s first 15 months, in addition to standard teen-tot clinic care. The remaining 68 mothers received teen-tot care alone.
While overall maternal self-esteem decreased in both the intervention and control groups when measured at 36 months, the intervention group experienced a significantly smaller decrease from baseline (P = .011). Similarly, the intervention group had higher scores regarding preparedness for motherhood (P = .011), acceptance of infant (P = .008), and expected relationship with infant (P = .029).
Of the 52 mothers in the intervention group and 48 mothers in the control group for whom pregnancy data was available at 36 months, 42% in the intervention group had a repeat pregnancy, compared with 67% in the control group (adjusted odds ratio, 0.20; 95% confidence interval, 0.06-0.75; P = .017).
The study findings “highlight the positive impact of pairing medical services with comprehensive social services and parenting education and can inform future policy and services for teen parents. These positive effects also have potential to improve long-term outcomes for teens and their children,” Dr. Cox and her associates concluded.
The study authors reported no conflicts of interest. The study was supported in part by a grant from the Office of Adolescent Pregnancy Programs, the Edgerley Family Endowment, a Leadership Education in Adolescent Health training grant, the Maternal and Child Health Bureau, and the Health Resources and Services Administration.
lfranki@mdedge.com
SOURCE: Cox JE et al. Pediatrics. 2019 Feb 12. doi: 10.1542/peds.2018-2303.
than did those who received standard care, according to Joanne E. Cox, MD, director of primary care at Boston Children’s Hospital and Harvard Medical School, and her associates.
A total of 140 mothers who were aged less than 19 years when they delivered and whose child was aged less than 12 months were included in the study published in Pediatrics. Of this group, 72 received the intervention, which included a series of five 1-hour, one-on-one, interactive modules adapted from the Nurturing and Ansell-Casey Life Skills curricula, delivered over the infant’s first 15 months, in addition to standard teen-tot clinic care. The remaining 68 mothers received teen-tot care alone.
While overall maternal self-esteem decreased in both the intervention and control groups when measured at 36 months, the intervention group experienced a significantly smaller decrease from baseline (P = .011). Similarly, the intervention group had higher scores regarding preparedness for motherhood (P = .011), acceptance of infant (P = .008), and expected relationship with infant (P = .029).
Of the 52 mothers in the intervention group and 48 mothers in the control group for whom pregnancy data was available at 36 months, 42% in the intervention group had a repeat pregnancy, compared with 67% in the control group (adjusted odds ratio, 0.20; 95% confidence interval, 0.06-0.75; P = .017).
The study findings “highlight the positive impact of pairing medical services with comprehensive social services and parenting education and can inform future policy and services for teen parents. These positive effects also have potential to improve long-term outcomes for teens and their children,” Dr. Cox and her associates concluded.
The study authors reported no conflicts of interest. The study was supported in part by a grant from the Office of Adolescent Pregnancy Programs, the Edgerley Family Endowment, a Leadership Education in Adolescent Health training grant, the Maternal and Child Health Bureau, and the Health Resources and Services Administration.
lfranki@mdedge.com
SOURCE: Cox JE et al. Pediatrics. 2019 Feb 12. doi: 10.1542/peds.2018-2303.
than did those who received standard care, according to Joanne E. Cox, MD, director of primary care at Boston Children’s Hospital and Harvard Medical School, and her associates.
A total of 140 mothers who were aged less than 19 years when they delivered and whose child was aged less than 12 months were included in the study published in Pediatrics. Of this group, 72 received the intervention, which included a series of five 1-hour, one-on-one, interactive modules adapted from the Nurturing and Ansell-Casey Life Skills curricula, delivered over the infant’s first 15 months, in addition to standard teen-tot clinic care. The remaining 68 mothers received teen-tot care alone.
While overall maternal self-esteem decreased in both the intervention and control groups when measured at 36 months, the intervention group experienced a significantly smaller decrease from baseline (P = .011). Similarly, the intervention group had higher scores regarding preparedness for motherhood (P = .011), acceptance of infant (P = .008), and expected relationship with infant (P = .029).
Of the 52 mothers in the intervention group and 48 mothers in the control group for whom pregnancy data was available at 36 months, 42% in the intervention group had a repeat pregnancy, compared with 67% in the control group (adjusted odds ratio, 0.20; 95% confidence interval, 0.06-0.75; P = .017).
The study findings “highlight the positive impact of pairing medical services with comprehensive social services and parenting education and can inform future policy and services for teen parents. These positive effects also have potential to improve long-term outcomes for teens and their children,” Dr. Cox and her associates concluded.
The study authors reported no conflicts of interest. The study was supported in part by a grant from the Office of Adolescent Pregnancy Programs, the Edgerley Family Endowment, a Leadership Education in Adolescent Health training grant, the Maternal and Child Health Bureau, and the Health Resources and Services Administration.
lfranki@mdedge.com
SOURCE: Cox JE et al. Pediatrics. 2019 Feb 12. doi: 10.1542/peds.2018-2303.
FROM PEDIATRICS
Clown-tox, tattooed immunity, and cingulum-bundle comedy
Quit clowning around
Would you like a balloon giraffe, elephant, or hypodermic needle? A recently published study examined how the use of “medical clowns” eased the anxiety and pain of children during botulinum toxin injections. These injections are used to treat spasticity in children, and researchers hypothesized that a clown might be an effective distraction.
As anyone who has been to a circus can surmise, the clowns did not perform better than the control distractions.
Researchers concluded that the clowns were appreciated by the parents but not particularly effective on the children. Maybe that’s because the parents weren’t the ones being stuck with needles while some crazy person in clown makeup attempted to distract them. Or maybe they were all just big fans of Stephen King’s “It.”
Inked immunity
Starting to feel a bit under the weather? Head to the local tattoo artist for the cure! Research from the University of Alabama at Birmingham found evidence that the immune systems of heavily tattooed people are stronger than those without, proving once and for all that tats = toughness. Hell's Angels were on to something all along.
While your immune system can actually grow temporarily weaker after one tattoo, multiple tattoos create a stronger immunological response. Researchers tested the immunoglobulin A levels in those getting a first tattoo and those with many tattoos. They found that the latter group had higher IgA levels.
Maybe that’s why Adam Levine showed off his ink at the Super Bowl halftime show – he was just signaling his strong immune system to the rest of us.
Brain surgery is a laughing matter
This certainly came as a surprise to us, but as it turns out, undergoing brain surgery while conscious and awake can be extremely stressful and panic inducing to the patient. We’re sure most people (including us) would prefer to be asleep for their surgery, but sometimes when dealing with the brain, the surgeon needs to be able to talk to the patient to accurately assess their faculties in case they damage something important.
So the question is: How do you keep brain surgery patients from panicking? Why, with the power of laughter, of course! Specifically, a group at Emory University, Atlanta, published a case study in the Journal of Clinical Investigation about their treatment of a patient with moderate anxiety. When the patient woke up from initial anesthesia, she began to panic. However, after electrical stimulation of the cingulum bundle, the patient immediately turned her frown upside down and began laughing and joking with the surgeons.
Sadly, while the team did not report on the quality of the jokes being told, we can only assume the phrase “this isn’t brain surgery” was thrown around multiple times.
A male brain is a terrible thing to waste
In the future, comedy may mean pressing a button to stimulate your cingulum bundle, but for now we still have jokes. One old joke goes like this: Some aliens land on earth and want to learn about humans, so they go into a store to buy some brains. “Why does the male brain cost twice as much as the female brain?” one asks the store owner, who replies, “It’s hardly been used.”
There may be another explanation: Womens’ brains appear to age more slowly than mens’, investigators at Washington University, St. Louis, said in the Proceedings of the National Academy of Sciences.
They performed PET scans on 121 women and 84 men aged 20-82 years to determine the fraction of sugar committed to aerobic glycolysis in various regions of the brain, and then a machine-learning algorithm used those data to calculate metabolic ages.
The womens’ brains were younger than the mens’ brains, with various calculations producing average differences of 2.7-5.3 years, they reported.
The male brain, it seems, is used for something, and after one LOTME staffer spent 5 minutes explaining total quarterback rating (QBR) to his wife, we think we’ve figured out what it is: sports trivia.
Quit clowning around
Would you like a balloon giraffe, elephant, or hypodermic needle? A recently published study examined how the use of “medical clowns” eased the anxiety and pain of children during botulinum toxin injections. These injections are used to treat spasticity in children, and researchers hypothesized that a clown might be an effective distraction.
As anyone who has been to a circus can surmise, the clowns did not perform better than the control distractions.
Researchers concluded that the clowns were appreciated by the parents but not particularly effective on the children. Maybe that’s because the parents weren’t the ones being stuck with needles while some crazy person in clown makeup attempted to distract them. Or maybe they were all just big fans of Stephen King’s “It.”
Inked immunity
Starting to feel a bit under the weather? Head to the local tattoo artist for the cure! Research from the University of Alabama at Birmingham found evidence that the immune systems of heavily tattooed people are stronger than those without, proving once and for all that tats = toughness. Hell's Angels were on to something all along.
While your immune system can actually grow temporarily weaker after one tattoo, multiple tattoos create a stronger immunological response. Researchers tested the immunoglobulin A levels in those getting a first tattoo and those with many tattoos. They found that the latter group had higher IgA levels.
Maybe that’s why Adam Levine showed off his ink at the Super Bowl halftime show – he was just signaling his strong immune system to the rest of us.
Brain surgery is a laughing matter
This certainly came as a surprise to us, but as it turns out, undergoing brain surgery while conscious and awake can be extremely stressful and panic inducing to the patient. We’re sure most people (including us) would prefer to be asleep for their surgery, but sometimes when dealing with the brain, the surgeon needs to be able to talk to the patient to accurately assess their faculties in case they damage something important.
So the question is: How do you keep brain surgery patients from panicking? Why, with the power of laughter, of course! Specifically, a group at Emory University, Atlanta, published a case study in the Journal of Clinical Investigation about their treatment of a patient with moderate anxiety. When the patient woke up from initial anesthesia, she began to panic. However, after electrical stimulation of the cingulum bundle, the patient immediately turned her frown upside down and began laughing and joking with the surgeons.
Sadly, while the team did not report on the quality of the jokes being told, we can only assume the phrase “this isn’t brain surgery” was thrown around multiple times.
A male brain is a terrible thing to waste
In the future, comedy may mean pressing a button to stimulate your cingulum bundle, but for now we still have jokes. One old joke goes like this: Some aliens land on earth and want to learn about humans, so they go into a store to buy some brains. “Why does the male brain cost twice as much as the female brain?” one asks the store owner, who replies, “It’s hardly been used.”
There may be another explanation: Womens’ brains appear to age more slowly than mens’, investigators at Washington University, St. Louis, said in the Proceedings of the National Academy of Sciences.
They performed PET scans on 121 women and 84 men aged 20-82 years to determine the fraction of sugar committed to aerobic glycolysis in various regions of the brain, and then a machine-learning algorithm used those data to calculate metabolic ages.
The womens’ brains were younger than the mens’ brains, with various calculations producing average differences of 2.7-5.3 years, they reported.
The male brain, it seems, is used for something, and after one LOTME staffer spent 5 minutes explaining total quarterback rating (QBR) to his wife, we think we’ve figured out what it is: sports trivia.
Quit clowning around
Would you like a balloon giraffe, elephant, or hypodermic needle? A recently published study examined how the use of “medical clowns” eased the anxiety and pain of children during botulinum toxin injections. These injections are used to treat spasticity in children, and researchers hypothesized that a clown might be an effective distraction.
As anyone who has been to a circus can surmise, the clowns did not perform better than the control distractions.
Researchers concluded that the clowns were appreciated by the parents but not particularly effective on the children. Maybe that’s because the parents weren’t the ones being stuck with needles while some crazy person in clown makeup attempted to distract them. Or maybe they were all just big fans of Stephen King’s “It.”
Inked immunity
Starting to feel a bit under the weather? Head to the local tattoo artist for the cure! Research from the University of Alabama at Birmingham found evidence that the immune systems of heavily tattooed people are stronger than those without, proving once and for all that tats = toughness. Hell's Angels were on to something all along.
While your immune system can actually grow temporarily weaker after one tattoo, multiple tattoos create a stronger immunological response. Researchers tested the immunoglobulin A levels in those getting a first tattoo and those with many tattoos. They found that the latter group had higher IgA levels.
Maybe that’s why Adam Levine showed off his ink at the Super Bowl halftime show – he was just signaling his strong immune system to the rest of us.
Brain surgery is a laughing matter
This certainly came as a surprise to us, but as it turns out, undergoing brain surgery while conscious and awake can be extremely stressful and panic inducing to the patient. We’re sure most people (including us) would prefer to be asleep for their surgery, but sometimes when dealing with the brain, the surgeon needs to be able to talk to the patient to accurately assess their faculties in case they damage something important.
So the question is: How do you keep brain surgery patients from panicking? Why, with the power of laughter, of course! Specifically, a group at Emory University, Atlanta, published a case study in the Journal of Clinical Investigation about their treatment of a patient with moderate anxiety. When the patient woke up from initial anesthesia, she began to panic. However, after electrical stimulation of the cingulum bundle, the patient immediately turned her frown upside down and began laughing and joking with the surgeons.
Sadly, while the team did not report on the quality of the jokes being told, we can only assume the phrase “this isn’t brain surgery” was thrown around multiple times.
A male brain is a terrible thing to waste
In the future, comedy may mean pressing a button to stimulate your cingulum bundle, but for now we still have jokes. One old joke goes like this: Some aliens land on earth and want to learn about humans, so they go into a store to buy some brains. “Why does the male brain cost twice as much as the female brain?” one asks the store owner, who replies, “It’s hardly been used.”
There may be another explanation: Womens’ brains appear to age more slowly than mens’, investigators at Washington University, St. Louis, said in the Proceedings of the National Academy of Sciences.
They performed PET scans on 121 women and 84 men aged 20-82 years to determine the fraction of sugar committed to aerobic glycolysis in various regions of the brain, and then a machine-learning algorithm used those data to calculate metabolic ages.
The womens’ brains were younger than the mens’ brains, with various calculations producing average differences of 2.7-5.3 years, they reported.
The male brain, it seems, is used for something, and after one LOTME staffer spent 5 minutes explaining total quarterback rating (QBR) to his wife, we think we’ve figured out what it is: sports trivia.
Frailty, diabetes increase fragility fracture risk
increasing their risk of fragility fracture, according to findings from a prospective cohort study.
A total of 3,149 participants (70% women) were included in the study, 138 (60% women) of whom had type 2 diabetes. The mean age was 65 years and mean follow-up was 9.2 years. Over the study period, 611 fragility fractures were reported, of which 35 were in patients with diabetes and 576 in patients without diabetes. Overall, 25.4% of patients with diabetes experienced a fragility fracture, compared with 19.1% of control patients. Diabetes was associated with a significantly increased risk of all fragility fractures (hazard ratio, 1.54). It was also significantly associated with risk of hip fracture (HR, 2.60) but not clinical spine fracture.
In a Cox model incorporating the interaction between frailty index (FI) scores and diabetes, there was a significant association between FI and overall fracture risk per 0.01-point FI increase (HR, 1.02; 95% confidence interval, 1.01-1.03) and per 0.10-point FI increase (HR, 1.19; 95% CI, 1.10-1.33). However, no interaction between frailty and diabetes was observed for hip or clinical spine fractures.
“Frailty status may aid in the understanding of the paradox and thus enhance the quality of assessment and care for diabetes,” wrote Guowei Li, MBBS, PhD, of McMaster University, Hamilton, Ont., and his colleagues, adding that “particular attention should be paid to diabetes as a risk factor for fragility fractures in those who are frail.”
Four study authors reported conflicts of interest with some pharmaceutical companies that manufacture therapies for osteoporosis.
SOURCE: Li G et al. Diabetes Care. 2019 Jan 28. doi: 10.2337/dc18-1965.
increasing their risk of fragility fracture, according to findings from a prospective cohort study.
A total of 3,149 participants (70% women) were included in the study, 138 (60% women) of whom had type 2 diabetes. The mean age was 65 years and mean follow-up was 9.2 years. Over the study period, 611 fragility fractures were reported, of which 35 were in patients with diabetes and 576 in patients without diabetes. Overall, 25.4% of patients with diabetes experienced a fragility fracture, compared with 19.1% of control patients. Diabetes was associated with a significantly increased risk of all fragility fractures (hazard ratio, 1.54). It was also significantly associated with risk of hip fracture (HR, 2.60) but not clinical spine fracture.
In a Cox model incorporating the interaction between frailty index (FI) scores and diabetes, there was a significant association between FI and overall fracture risk per 0.01-point FI increase (HR, 1.02; 95% confidence interval, 1.01-1.03) and per 0.10-point FI increase (HR, 1.19; 95% CI, 1.10-1.33). However, no interaction between frailty and diabetes was observed for hip or clinical spine fractures.
“Frailty status may aid in the understanding of the paradox and thus enhance the quality of assessment and care for diabetes,” wrote Guowei Li, MBBS, PhD, of McMaster University, Hamilton, Ont., and his colleagues, adding that “particular attention should be paid to diabetes as a risk factor for fragility fractures in those who are frail.”
Four study authors reported conflicts of interest with some pharmaceutical companies that manufacture therapies for osteoporosis.
SOURCE: Li G et al. Diabetes Care. 2019 Jan 28. doi: 10.2337/dc18-1965.
increasing their risk of fragility fracture, according to findings from a prospective cohort study.
A total of 3,149 participants (70% women) were included in the study, 138 (60% women) of whom had type 2 diabetes. The mean age was 65 years and mean follow-up was 9.2 years. Over the study period, 611 fragility fractures were reported, of which 35 were in patients with diabetes and 576 in patients without diabetes. Overall, 25.4% of patients with diabetes experienced a fragility fracture, compared with 19.1% of control patients. Diabetes was associated with a significantly increased risk of all fragility fractures (hazard ratio, 1.54). It was also significantly associated with risk of hip fracture (HR, 2.60) but not clinical spine fracture.
In a Cox model incorporating the interaction between frailty index (FI) scores and diabetes, there was a significant association between FI and overall fracture risk per 0.01-point FI increase (HR, 1.02; 95% confidence interval, 1.01-1.03) and per 0.10-point FI increase (HR, 1.19; 95% CI, 1.10-1.33). However, no interaction between frailty and diabetes was observed for hip or clinical spine fractures.
“Frailty status may aid in the understanding of the paradox and thus enhance the quality of assessment and care for diabetes,” wrote Guowei Li, MBBS, PhD, of McMaster University, Hamilton, Ont., and his colleagues, adding that “particular attention should be paid to diabetes as a risk factor for fragility fractures in those who are frail.”
Four study authors reported conflicts of interest with some pharmaceutical companies that manufacture therapies for osteoporosis.
SOURCE: Li G et al. Diabetes Care. 2019 Jan 28. doi: 10.2337/dc18-1965.
FROM DIABETES CARE
ICYMI: MRI-based treat-to-target approach offers no benefit for RA patients
Patients with RA in clinical remission who received an MRI-based treat-to-target strategy did not achieve superior disease activity remission rates (85% vs. 88%) or reduced radiographic progression (66% vs. 62%), compared with a conventional treat-to-target strategy, according to results of the Danish, 2-year, investigator-initiated, randomized, multicenter IMAGINE-RA trial published in JAMA (2019 Feb 5. doi: 10.1001/jama.2018.21362).
We covered this study at the 2018 European Congress of Rheumatology before it was published in the journal. Read the story at the link above.
Patients with RA in clinical remission who received an MRI-based treat-to-target strategy did not achieve superior disease activity remission rates (85% vs. 88%) or reduced radiographic progression (66% vs. 62%), compared with a conventional treat-to-target strategy, according to results of the Danish, 2-year, investigator-initiated, randomized, multicenter IMAGINE-RA trial published in JAMA (2019 Feb 5. doi: 10.1001/jama.2018.21362).
We covered this study at the 2018 European Congress of Rheumatology before it was published in the journal. Read the story at the link above.
Patients with RA in clinical remission who received an MRI-based treat-to-target strategy did not achieve superior disease activity remission rates (85% vs. 88%) or reduced radiographic progression (66% vs. 62%), compared with a conventional treat-to-target strategy, according to results of the Danish, 2-year, investigator-initiated, randomized, multicenter IMAGINE-RA trial published in JAMA (2019 Feb 5. doi: 10.1001/jama.2018.21362).
We covered this study at the 2018 European Congress of Rheumatology before it was published in the journal. Read the story at the link above.
FROM JAMA
Stryker issues voluntary field action for Lifepak 15 defibrillators
Stryker has announced a voluntary field action for its Lifepak 15 monitor/defibrillators, according to a safety alert from the Food and Drug Administration.
The company is notifying certain Lifepak 15 customers of an issue causing the device to lock up after a defibrillation shock is delivered. The lockup displays as a blank monitor with the LED lights on, indicating that the power is on, but the keypad and device become nonfunctional, the FDA said. This lockup can delay delivery of therapy, which can cause injury or death.
Since the introduction of the device in 2009, 58 complaints regarding the issue have been reported, including 6 that resulted in death. In all, 13,003 devices are included in the field action.
Customers should continue to use their devices if they have been affected until a correction can be completed. If the lockup occurs, the user should press and hold the “on” button until the LED turns off, then hit the “on” button again. If this does not reset the device, the batteries should be removed and reinserted, or the device should be removed and reconnected to its power adapter, the FDA said.
Find the full press release on the FDA website.
Stryker has announced a voluntary field action for its Lifepak 15 monitor/defibrillators, according to a safety alert from the Food and Drug Administration.
The company is notifying certain Lifepak 15 customers of an issue causing the device to lock up after a defibrillation shock is delivered. The lockup displays as a blank monitor with the LED lights on, indicating that the power is on, but the keypad and device become nonfunctional, the FDA said. This lockup can delay delivery of therapy, which can cause injury or death.
Since the introduction of the device in 2009, 58 complaints regarding the issue have been reported, including 6 that resulted in death. In all, 13,003 devices are included in the field action.
Customers should continue to use their devices if they have been affected until a correction can be completed. If the lockup occurs, the user should press and hold the “on” button until the LED turns off, then hit the “on” button again. If this does not reset the device, the batteries should be removed and reinserted, or the device should be removed and reconnected to its power adapter, the FDA said.
Find the full press release on the FDA website.
Stryker has announced a voluntary field action for its Lifepak 15 monitor/defibrillators, according to a safety alert from the Food and Drug Administration.
The company is notifying certain Lifepak 15 customers of an issue causing the device to lock up after a defibrillation shock is delivered. The lockup displays as a blank monitor with the LED lights on, indicating that the power is on, but the keypad and device become nonfunctional, the FDA said. This lockup can delay delivery of therapy, which can cause injury or death.
Since the introduction of the device in 2009, 58 complaints regarding the issue have been reported, including 6 that resulted in death. In all, 13,003 devices are included in the field action.
Customers should continue to use their devices if they have been affected until a correction can be completed. If the lockup occurs, the user should press and hold the “on” button until the LED turns off, then hit the “on” button again. If this does not reset the device, the batteries should be removed and reinserted, or the device should be removed and reconnected to its power adapter, the FDA said.
Find the full press release on the FDA website.
Tantrum-taming edibles, support gators, and chemo eggs
Chill out, kid
What do you do when your child has constant tantrums? A simple edible could do the trick, according to a Hollywood physician.
The natural medicine physician is in hot (bong) water after recommending marijuana cookies as treatment for a 4-year-old child’s ADHD and bipolar disorder. The icing on the cake (or cookie) is that both diagnoses weren’t even accurate. Perhaps the doctor was sampling his own treatments before the office visit?
The progressive physician has had his license revoked for the “grossly negligent” diagnosis, which he made in 30 minutes without consulting the child’s teachers, his father, or a psychiatrist. Probably not the best way to handle it, said the state medical board. Perhaps he should have suggested some CBD-infused Coke, instead?
Gator saver
Dogs, cats, peacocks – these are the animals that many people with anxiety, depression, and other mental health issues use for emotional support. But now, enter Wally, the emotional support alligator.
Spanning 5 feet long and sporting way too many teeth, Wally is the constant companion of a 65-year-old Pennsylvania man with depression. Wally’s owner decided to forgo pharmacologic treatment for something decidedly more reptilian.
Wally, who was rescued from Florida, loves chicken wings, hugs, and his adopted gator brother, Scrappy. He also has the potential to reach 16 feet long, which is … concerning. Something tells me you can’t take Wally on a plane as a service gator.
But don’t worry, Wally has been approved by a doctor. Rumors that Wally had the doctor’s arm in his jaws before approval are unsubstantiated.
Synergy is not always a good thing
Since it is generally agreed that two heads are better than one, three heads must be even better than two, right? But what if we’re not talking about heads? Suppose, instead, that the subject is global pandemics. Would it be better if three of the greatest threats to humanity’s existence on the planet decided to join forces?
The Lancet Global Syndemic Commission, a group of more than 40 international experts, said that obesity, undernutrition, and climate change “constitute a syndemic, or synergy of epidemics, because they co-occur in time and place, interact with each other to produce complex sequelae, and share common underlying societal drivers” (Lancet. 2019 Jan. 27. doi: 10.1016/S0140-6736[18]32822-8).
It gets better: The commission suggested that the “three interconnected health pandemics [have been] effectively orchestrated by the shadowy manipulations and influence of vested commercial interests – an entity collectively defined as ‘Big Food,’ ” according to Science Alert.
This all seems like a lot to overcome, but we here at LOTME have faith in science, and in the scientists who are working to solve these problems. After all, it’s not like anyone’s out there disregarding the science and saying that this stuff isn’t really happening. … Wait, what? … Climate change deniers? … Really? … The president tweeted what? … We’re doomed.
I prefer my medication sunny side up
Here’s a hypothetical question for you: If you were to have cancer, how would you prefer to be treated? Would you rather go through the rigors of chemotherapy? Or would you rather eat an omelet?
Okay, it probably wouldn’t work quite like that, but a group of physicians from the University of Edinburgh have successfully modified chickens to lay eggs containing a pair of human proteins within the egg white.
One of these proteins has antiviral and anticancer effects, and the other can help damaged tissue repair itself. The researchers added that the protein in the egg white could be modified to make the key ingredients for other protein-based drugs such as Avastin and Herceptin, which are used for treating cancer.
We know what you’re thinking: It’ll probably take a thousand eggs to make one dose – but no, it only takes three. Over the course of a year, one chicken could produce a hundred doses, and do it for far cheaper than is currently possible. We hate jumping on the social media bandwagon here, but frankly, this is an egg worth giving millions of Instagram likes.
Chill out, kid
What do you do when your child has constant tantrums? A simple edible could do the trick, according to a Hollywood physician.
The natural medicine physician is in hot (bong) water after recommending marijuana cookies as treatment for a 4-year-old child’s ADHD and bipolar disorder. The icing on the cake (or cookie) is that both diagnoses weren’t even accurate. Perhaps the doctor was sampling his own treatments before the office visit?
The progressive physician has had his license revoked for the “grossly negligent” diagnosis, which he made in 30 minutes without consulting the child’s teachers, his father, or a psychiatrist. Probably not the best way to handle it, said the state medical board. Perhaps he should have suggested some CBD-infused Coke, instead?
Gator saver
Dogs, cats, peacocks – these are the animals that many people with anxiety, depression, and other mental health issues use for emotional support. But now, enter Wally, the emotional support alligator.
Spanning 5 feet long and sporting way too many teeth, Wally is the constant companion of a 65-year-old Pennsylvania man with depression. Wally’s owner decided to forgo pharmacologic treatment for something decidedly more reptilian.
Wally, who was rescued from Florida, loves chicken wings, hugs, and his adopted gator brother, Scrappy. He also has the potential to reach 16 feet long, which is … concerning. Something tells me you can’t take Wally on a plane as a service gator.
But don’t worry, Wally has been approved by a doctor. Rumors that Wally had the doctor’s arm in his jaws before approval are unsubstantiated.
Synergy is not always a good thing
Since it is generally agreed that two heads are better than one, three heads must be even better than two, right? But what if we’re not talking about heads? Suppose, instead, that the subject is global pandemics. Would it be better if three of the greatest threats to humanity’s existence on the planet decided to join forces?
The Lancet Global Syndemic Commission, a group of more than 40 international experts, said that obesity, undernutrition, and climate change “constitute a syndemic, or synergy of epidemics, because they co-occur in time and place, interact with each other to produce complex sequelae, and share common underlying societal drivers” (Lancet. 2019 Jan. 27. doi: 10.1016/S0140-6736[18]32822-8).
It gets better: The commission suggested that the “three interconnected health pandemics [have been] effectively orchestrated by the shadowy manipulations and influence of vested commercial interests – an entity collectively defined as ‘Big Food,’ ” according to Science Alert.
This all seems like a lot to overcome, but we here at LOTME have faith in science, and in the scientists who are working to solve these problems. After all, it’s not like anyone’s out there disregarding the science and saying that this stuff isn’t really happening. … Wait, what? … Climate change deniers? … Really? … The president tweeted what? … We’re doomed.
I prefer my medication sunny side up
Here’s a hypothetical question for you: If you were to have cancer, how would you prefer to be treated? Would you rather go through the rigors of chemotherapy? Or would you rather eat an omelet?
Okay, it probably wouldn’t work quite like that, but a group of physicians from the University of Edinburgh have successfully modified chickens to lay eggs containing a pair of human proteins within the egg white.
One of these proteins has antiviral and anticancer effects, and the other can help damaged tissue repair itself. The researchers added that the protein in the egg white could be modified to make the key ingredients for other protein-based drugs such as Avastin and Herceptin, which are used for treating cancer.
We know what you’re thinking: It’ll probably take a thousand eggs to make one dose – but no, it only takes three. Over the course of a year, one chicken could produce a hundred doses, and do it for far cheaper than is currently possible. We hate jumping on the social media bandwagon here, but frankly, this is an egg worth giving millions of Instagram likes.
Chill out, kid
What do you do when your child has constant tantrums? A simple edible could do the trick, according to a Hollywood physician.
The natural medicine physician is in hot (bong) water after recommending marijuana cookies as treatment for a 4-year-old child’s ADHD and bipolar disorder. The icing on the cake (or cookie) is that both diagnoses weren’t even accurate. Perhaps the doctor was sampling his own treatments before the office visit?
The progressive physician has had his license revoked for the “grossly negligent” diagnosis, which he made in 30 minutes without consulting the child’s teachers, his father, or a psychiatrist. Probably not the best way to handle it, said the state medical board. Perhaps he should have suggested some CBD-infused Coke, instead?
Gator saver
Dogs, cats, peacocks – these are the animals that many people with anxiety, depression, and other mental health issues use for emotional support. But now, enter Wally, the emotional support alligator.
Spanning 5 feet long and sporting way too many teeth, Wally is the constant companion of a 65-year-old Pennsylvania man with depression. Wally’s owner decided to forgo pharmacologic treatment for something decidedly more reptilian.
Wally, who was rescued from Florida, loves chicken wings, hugs, and his adopted gator brother, Scrappy. He also has the potential to reach 16 feet long, which is … concerning. Something tells me you can’t take Wally on a plane as a service gator.
But don’t worry, Wally has been approved by a doctor. Rumors that Wally had the doctor’s arm in his jaws before approval are unsubstantiated.
Synergy is not always a good thing
Since it is generally agreed that two heads are better than one, three heads must be even better than two, right? But what if we’re not talking about heads? Suppose, instead, that the subject is global pandemics. Would it be better if three of the greatest threats to humanity’s existence on the planet decided to join forces?
The Lancet Global Syndemic Commission, a group of more than 40 international experts, said that obesity, undernutrition, and climate change “constitute a syndemic, or synergy of epidemics, because they co-occur in time and place, interact with each other to produce complex sequelae, and share common underlying societal drivers” (Lancet. 2019 Jan. 27. doi: 10.1016/S0140-6736[18]32822-8).
It gets better: The commission suggested that the “three interconnected health pandemics [have been] effectively orchestrated by the shadowy manipulations and influence of vested commercial interests – an entity collectively defined as ‘Big Food,’ ” according to Science Alert.
This all seems like a lot to overcome, but we here at LOTME have faith in science, and in the scientists who are working to solve these problems. After all, it’s not like anyone’s out there disregarding the science and saying that this stuff isn’t really happening. … Wait, what? … Climate change deniers? … Really? … The president tweeted what? … We’re doomed.
I prefer my medication sunny side up
Here’s a hypothetical question for you: If you were to have cancer, how would you prefer to be treated? Would you rather go through the rigors of chemotherapy? Or would you rather eat an omelet?
Okay, it probably wouldn’t work quite like that, but a group of physicians from the University of Edinburgh have successfully modified chickens to lay eggs containing a pair of human proteins within the egg white.
One of these proteins has antiviral and anticancer effects, and the other can help damaged tissue repair itself. The researchers added that the protein in the egg white could be modified to make the key ingredients for other protein-based drugs such as Avastin and Herceptin, which are used for treating cancer.
We know what you’re thinking: It’ll probably take a thousand eggs to make one dose – but no, it only takes three. Over the course of a year, one chicken could produce a hundred doses, and do it for far cheaper than is currently possible. We hate jumping on the social media bandwagon here, but frankly, this is an egg worth giving millions of Instagram likes.
FDA permits marketing of first M. genitalium diagnostic test
the first test for the diagnoses of sexually transmitted infections (STIs) caused by the M. genitalium bacterium, the agency reported in a press release.
M. genitalium is associated with nongonococcal urethritis in men and cervicitis in women, causing 15%-30% of persistent or recurring urethritis cases and 10%-30% of cervicitis cases, according to the Centers for Disease Control and Prevention. It also can lead to pelvic inflammatory disease (PID) in women. The assay is a nucleic acid amplification test, which can detect the bacterium in urine, as well as urethral, penile meatal, endocervical, or vaginal swab samples.
In a clinical study of 11,774 samples, the Aptima assay correctly identified M. genitalium in about 90% of vaginal, male urethral, male urine, and penile samples. It also correctly identified the bacterium in female urine and endocervical samples 78% and 82% of the time, respectively. The test was even more accurate in identifying samples that did not have M. genitalium present, according to an FDA press release
“In the past, it has been hard to diagnose this organism. By being able to detect it more reliably, doctors may be able to more carefully tailor treatment and use medicines most likely to be effective,” FDA Commissioner Scott Gottlieb, MD, said in the press release. “Having accurate and reliable tests to identify the specific bacteria that’s causing an infection can assist doctors in choosing the right treatment for the right infection, which can reduce overuse of antibiotics and help in the fight against antimicrobial resistance.”
Find the full press release on the FDA website.
the first test for the diagnoses of sexually transmitted infections (STIs) caused by the M. genitalium bacterium, the agency reported in a press release.
M. genitalium is associated with nongonococcal urethritis in men and cervicitis in women, causing 15%-30% of persistent or recurring urethritis cases and 10%-30% of cervicitis cases, according to the Centers for Disease Control and Prevention. It also can lead to pelvic inflammatory disease (PID) in women. The assay is a nucleic acid amplification test, which can detect the bacterium in urine, as well as urethral, penile meatal, endocervical, or vaginal swab samples.
In a clinical study of 11,774 samples, the Aptima assay correctly identified M. genitalium in about 90% of vaginal, male urethral, male urine, and penile samples. It also correctly identified the bacterium in female urine and endocervical samples 78% and 82% of the time, respectively. The test was even more accurate in identifying samples that did not have M. genitalium present, according to an FDA press release
“In the past, it has been hard to diagnose this organism. By being able to detect it more reliably, doctors may be able to more carefully tailor treatment and use medicines most likely to be effective,” FDA Commissioner Scott Gottlieb, MD, said in the press release. “Having accurate and reliable tests to identify the specific bacteria that’s causing an infection can assist doctors in choosing the right treatment for the right infection, which can reduce overuse of antibiotics and help in the fight against antimicrobial resistance.”
Find the full press release on the FDA website.
the first test for the diagnoses of sexually transmitted infections (STIs) caused by the M. genitalium bacterium, the agency reported in a press release.
M. genitalium is associated with nongonococcal urethritis in men and cervicitis in women, causing 15%-30% of persistent or recurring urethritis cases and 10%-30% of cervicitis cases, according to the Centers for Disease Control and Prevention. It also can lead to pelvic inflammatory disease (PID) in women. The assay is a nucleic acid amplification test, which can detect the bacterium in urine, as well as urethral, penile meatal, endocervical, or vaginal swab samples.
In a clinical study of 11,774 samples, the Aptima assay correctly identified M. genitalium in about 90% of vaginal, male urethral, male urine, and penile samples. It also correctly identified the bacterium in female urine and endocervical samples 78% and 82% of the time, respectively. The test was even more accurate in identifying samples that did not have M. genitalium present, according to an FDA press release
“In the past, it has been hard to diagnose this organism. By being able to detect it more reliably, doctors may be able to more carefully tailor treatment and use medicines most likely to be effective,” FDA Commissioner Scott Gottlieb, MD, said in the press release. “Having accurate and reliable tests to identify the specific bacteria that’s causing an infection can assist doctors in choosing the right treatment for the right infection, which can reduce overuse of antibiotics and help in the fight against antimicrobial resistance.”
Find the full press release on the FDA website.
FDA approves 0.5-mL Fluzone Quadrivalent vaccine in young children
according to Sanofi Pasteur, the vaccine’s manufacturer.
FDA approval was based on results of a phase 4 safety and immunogenicity study of nearly 2,000 children. Children aged 6-35 months who received one or two doses of Fluzone at 0.50 mL had a safety profile similar to that of children who received one or two doses of Fluzone at 0.25 mL. Results from the study were presented at the Pediatric Academic Societies annual meeting in April 2018.
This flu vaccine should not be given to anyone with a severe allergic reaction (anaphylaxis) to egg or egg products, according to the press release.
In children, the most common adverse events are injection site reactions, muscle aches, fatigue, and headache; in young children, irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever are common.
“Offering pediatricians the convenience of the same 0.5-mL dose option for children may help streamline immunization efforts. The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering,” David P. Greenberg, MD, regional medical head of Sanofi Pasteur of North America, said in the press release.
Find the full press release on the Sanofi website.
according to Sanofi Pasteur, the vaccine’s manufacturer.
FDA approval was based on results of a phase 4 safety and immunogenicity study of nearly 2,000 children. Children aged 6-35 months who received one or two doses of Fluzone at 0.50 mL had a safety profile similar to that of children who received one or two doses of Fluzone at 0.25 mL. Results from the study were presented at the Pediatric Academic Societies annual meeting in April 2018.
This flu vaccine should not be given to anyone with a severe allergic reaction (anaphylaxis) to egg or egg products, according to the press release.
In children, the most common adverse events are injection site reactions, muscle aches, fatigue, and headache; in young children, irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever are common.
“Offering pediatricians the convenience of the same 0.5-mL dose option for children may help streamline immunization efforts. The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering,” David P. Greenberg, MD, regional medical head of Sanofi Pasteur of North America, said in the press release.
Find the full press release on the Sanofi website.
according to Sanofi Pasteur, the vaccine’s manufacturer.
FDA approval was based on results of a phase 4 safety and immunogenicity study of nearly 2,000 children. Children aged 6-35 months who received one or two doses of Fluzone at 0.50 mL had a safety profile similar to that of children who received one or two doses of Fluzone at 0.25 mL. Results from the study were presented at the Pediatric Academic Societies annual meeting in April 2018.
This flu vaccine should not be given to anyone with a severe allergic reaction (anaphylaxis) to egg or egg products, according to the press release.
In children, the most common adverse events are injection site reactions, muscle aches, fatigue, and headache; in young children, irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever are common.
“Offering pediatricians the convenience of the same 0.5-mL dose option for children may help streamline immunization efforts. The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering,” David P. Greenberg, MD, regional medical head of Sanofi Pasteur of North America, said in the press release.
Find the full press release on the Sanofi website.