Medtronic has updated a previous recall of its MiniMed 600 series insulin pumps to include all with a potentially problematic clear retainer ring, not just those that appear damaged.

The U.S. Food and Drug Administration announced on Oct. 5 that Medtronic will now replace any MiniMed 600 series pump that has a clear retainer ring with an updated pump that includes a black retainer ring at no extra charge, regardless of warranty status.

In November 2019, Medtronic first advised patients to examine their pumps for potential damage to the ring, and to contact the company if it appeared to be loose, damaged, or missing. In February 2020, the FDA designated the recall as class 1, “the most serious type of recall,” for which use of the devices “may cause serious injuries or death.”

In this case, one potential risk is hyperglycemia. This can occur if the reservoir isn’t properly locked into place by the retainer ring, and insulin isn’t infused into the body. That, in turn, can lead to diabetic ketoacidosis. Another risk is hypoglycemia, which could result from over-delivery of insulin if the retainer ring breaks or detaches and the user inserts the reservoir back into the pump with the infusion set still connected to the body.

While serious injuries and deaths have been reported with the use of Minimed series 600 insulin pumps, “those adverse events may not have been directly related to the damaged clear retainer rings that are the basis for this recall,” according to the FDA notice. Nonetheless, lawsuits have reportedly been filed.

The new update is not a result of any new issues, Medtronic spokesperson Pamela Reese told this news organization. “Medtronic will proactively replace all MiniMed 600 series insulin pumps with the clear retainer ring design with an equivalent pump that has an updated black retainer ring design, which is designed to better withstand damage sustained by an accidental drop or bump on a hard surface.”

She added, “As we analyze the information that we continuously collect on the safety and performance of our insulin pumps, we recognize that patients who are still using the clear retainer ring could potentially encounter future problems. Therefore, we are currently accelerating our replacement as inventory allows over the coming months to eliminate any potential performance concerns and optimize patient safety and experience.”

The company has replaced nearly half of the clear retainer ring pumps that were in use since November 2019, she said.

The specific insulin pump products are the model 630G, distributed between September 2016 and February 2020; and the 670G, distributed between May 2015 and December 2020. The 630G is approved for people aged 16 years and older, and the 670G – which works with a continuous glucose monitor in a “hybrid closed-loop system – is available for people with type 1 diabetes as young as 7 years of age.

Medtronic has updated a previous recall of its MiniMed 600 series insulin pumps to include all with a potentially problematic clear retainer ring, not just those that appear damaged.

The U.S. Food and Drug Administration announced on Oct. 5 that Medtronic will now replace any MiniMed 600 series pump that has a clear retainer ring with an updated pump that includes a black retainer ring at no extra charge, regardless of warranty status.

In November 2019, Medtronic first advised patients to examine their pumps for potential damage to the ring, and to contact the company if it appeared to be loose, damaged, or missing. In February 2020, the FDA designated the recall as class 1, “the most serious type of recall,” for which use of the devices “may cause serious injuries or death.”

In this case, one potential risk is hyperglycemia. This can occur if the reservoir isn’t properly locked into place by the retainer ring, and insulin isn’t infused into the body. That, in turn, can lead to diabetic ketoacidosis. Another risk is hypoglycemia, which could result from over-delivery of insulin if the retainer ring breaks or detaches and the user inserts the reservoir back into the pump with the infusion set still connected to the body.

While serious injuries and deaths have been reported with the use of Minimed series 600 insulin pumps, “those adverse events may not have been directly related to the damaged clear retainer rings that are the basis for this recall,” according to the FDA notice. Nonetheless, lawsuits have reportedly been filed.

The new update is not a result of any new issues, Medtronic spokesperson Pamela Reese told this news organization. “Medtronic will proactively replace all MiniMed 600 series insulin pumps with the clear retainer ring design with an equivalent pump that has an updated black retainer ring design, which is designed to better withstand damage sustained by an accidental drop or bump on a hard surface.”

She added, “As we analyze the information that we continuously collect on the safety and performance of our insulin pumps, we recognize that patients who are still using the clear retainer ring could potentially encounter future problems. Therefore, we are currently accelerating our replacement as inventory allows over the coming months to eliminate any potential performance concerns and optimize patient safety and experience.”

The company has replaced nearly half of the clear retainer ring pumps that were in use since November 2019, she said.

The specific insulin pump products are the model 630G, distributed between September 2016 and February 2020; and the 670G, distributed between May 2015 and December 2020. The 630G is approved for people aged 16 years and older, and the 670G – which works with a continuous glucose monitor in a “hybrid closed-loop system – is available for people with type 1 diabetes as young as 7 years of age.

Medtronic has updated a previous recall of its MiniMed 600 series insulin pumps to include all with a potentially problematic clear retainer ring, not just those that appear damaged.

The U.S. Food and Drug Administration announced on Oct. 5 that Medtronic will now replace any MiniMed 600 series pump that has a clear retainer ring with an updated pump that includes a black retainer ring at no extra charge, regardless of warranty status.

In November 2019, Medtronic first advised patients to examine their pumps for potential damage to the ring, and to contact the company if it appeared to be loose, damaged, or missing. In February 2020, the FDA designated the recall as class 1, “the most serious type of recall,” for which use of the devices “may cause serious injuries or death.”

In this case, one potential risk is hyperglycemia. This can occur if the reservoir isn’t properly locked into place by the retainer ring, and insulin isn’t infused into the body. That, in turn, can lead to diabetic ketoacidosis. Another risk is hypoglycemia, which could result from over-delivery of insulin if the retainer ring breaks or detaches and the user inserts the reservoir back into the pump with the infusion set still connected to the body.

While serious injuries and deaths have been reported with the use of Minimed series 600 insulin pumps, “those adverse events may not have been directly related to the damaged clear retainer rings that are the basis for this recall,” according to the FDA notice. Nonetheless, lawsuits have reportedly been filed.

The new update is not a result of any new issues, Medtronic spokesperson Pamela Reese told this news organization. “Medtronic will proactively replace all MiniMed 600 series insulin pumps with the clear retainer ring design with an equivalent pump that has an updated black retainer ring design, which is designed to better withstand damage sustained by an accidental drop or bump on a hard surface.”

She added, “As we analyze the information that we continuously collect on the safety and performance of our insulin pumps, we recognize that patients who are still using the clear retainer ring could potentially encounter future problems. Therefore, we are currently accelerating our replacement as inventory allows over the coming months to eliminate any potential performance concerns and optimize patient safety and experience.”

The company has replaced nearly half of the clear retainer ring pumps that were in use since November 2019, she said.

The specific insulin pump products are the model 630G, distributed between September 2016 and February 2020; and the 670G, distributed between May 2015 and December 2020. The 630G is approved for people aged 16 years and older, and the 670G – which works with a continuous glucose monitor in a “hybrid closed-loop system – is available for people with type 1 diabetes as young as 7 years of age.

Methylphenidate is safe and effective for treating apathy in patients with Alzheimer’s disease (AD), new research suggests.

Dundanim/shutterstock.com

Results from a phase 3 randomized trial showed that, after 6 months of treatment, mean score on the Neuropsychiatric Inventory (NPI) apathy subscale decreased by 4.5 points for patients who received methylphenidate vs. a decrease of 3.1 points for those who received placebo.

In addition, the safety profile showed no significant between-group differences.

“Methylphenidate offers a treatment approach providing a modest but potentially clinically significant benefit for patients and caregivers,” said the investigators, led by Jacobo E. Mintzer, MD, MBA, professor of health studies at the Medical University of South Carolina in Charleston.

The findings were published online Sept. 27 in JAMA Neurology.
 

Common problem

Apathy, which is common among patients with AD, is associated with increased risk for mortality, financial burden, and caregiver burden. No treatment has proved effective for apathy in this population.

Two trials of methylphenidate, a catecholaminergic agent, have provided preliminary evidence of efficacy. Findings from the Apathy in Dementia Methylphenidate trial (ADMET) suggested the drug was associated with improved cognition and few adverse events. However, both trials had small patient populations and short durations.

The current investigators conducted ADMET 2, a 6-month, phase 3 trial, to investigate methylphenidate further. They recruited 200 patients (mean age, 76 years; 66% men; 90% White) at nine clinical centers that specialized in dementia care in the United States and one in Canada.

Eligible patients had a diagnosis of possible or probable AD and a Mini-Mental State Examination (MMSE) score between 10 and 28. They also had clinically significant apathy for at least 4 weeks and an available caregiver who spent more than 10 hours a week with the patient.

The researchers randomly assigned patients to receive methylphenidate (n = 99) or placebo (n = 101). For 3 days, participants in the active group received 10 mg/day of methylphenidate. After that point, they received 20 mg/day of methylphenidate for the rest of the study.

Patients in both treatment groups were given the same number of identical-appearing capsules each day.

In-person follow-up visits took place monthly for 6 months. Participants also were contacted by telephone at days 15, 45, and 75 after treatment assignment.

Participants underwent cognitive testing at baseline and at 2, 4, and 6 months. The battery of tests included the MMSE, Hopkins Verbal Learning Test, and Wechsler Adult Intelligence Scale – Revised Digit Span.

The trial’s two primary outcomes were mean change in NPI apathy score from baseline to 6 months and the odds of an improved rating on the Alzheimer’s Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) between baseline and 6 months.

Significant change on either outcome was to be considered a signal of effective treatment.
 

Treatment-specific benefit

Ten patients in the methylphenidate group and seven in the placebo group withdrew during the study.

Mean MMSE score at baseline was 19.2 in the methylphenidate group vs. 18.5 in the placebo group, indicating moderately severe dementia. Mean baseline score on the NPI apathy subscale was 8.0 vs. 7.6, respectively.

In an adjusted, longitudinal model, mean between-group difference in change in NPI apathy score at 6 months was –1.25 (P = .002). The mean NPI apathy score decreased by 4.5 points in the methylphenidate group vs. 3.1 points in the placebo group.

The largest change in apathy score occurred during the first 2 months of treatment. At 6 months, 27% of the methylphenidate group vs. 14% of the placebo group had an NPI apathy score of 0.

In addition, 43.8% of the methylphenidate group had improvement on the ADCS-CGIC compared with 35.2% of the placebo group. The odds ratio (OR) for improvement on ADCS-CGIC for methylphenidate vs. placebo was 1.90 (P = .07).

There was also a strong association between score improvement on the NPI apathy subscale and improvement on the ADCS-CGIC subscale (OR, 2.95; P = .002).

“It is important to note that there were no group differences in any of the cognitive measures, suggesting that the effect of the treatment is specific to the treatment of apathy and not a secondary effect of improvement in cognition,” the researchers wrote.

In all, 17 serious adverse events occurred in the methylphenidate group and 10 occurred in the placebo group. However, all events were found to be hospitalizations for events not related to treatment.
 

‘Enduring effect’

Commenting on the findings, Jeffrey L. Cummings, MD, ScD, professor of brain sciences at the University of Nevada, Las Vegas, noted that the reduction in NPI apathy subscale score of more than 50% was clinically meaningful.

A more robust outcome on the ADCS-CGIC would have been desirable, he added, although that instrument is not designed specifically for apathy.

Methylphenidate’s effect on apathy observed at 2 months and remaining stable throughout the study makes it appear to be “an enduring effect, and not something that the patient accommodates to,” said Dr. Cummings, who was not involved with the research. Such a change may manifest itself in a patient’s greater willingness to help voluntarily with housework or to suggest going for a walk, he noted.

“These are not dramatic changes in cognition, of course, but they are changes in initiative and that is very important,” Dr. Cummings said. Decreased apathy also may improve quality of life for the patient’s caregiver, he added.

Overall, the findings raise the question of whether the Food and Drug Administration should recognize apathy as an indication for which drugs can be approved, said Dr. Cummings.

“For me, that would be the next major step in this line of investigation,” he concluded.

The study was funded by the National Institute on Aging. Dr. Mintzer has served as an adviser to Praxis Bioresearch and Cerevel Therapeutics on matters unrelated to this study. Dr. Cummings is the author of the Neuropsychiatric Inventory but does not receive payments for it from academic trials such as ADMET 2.
 

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

Methylphenidate is safe and effective for treating apathy in patients with Alzheimer’s disease (AD), new research suggests.

Dundanim/shutterstock.com

Results from a phase 3 randomized trial showed that, after 6 months of treatment, mean score on the Neuropsychiatric Inventory (NPI) apathy subscale decreased by 4.5 points for patients who received methylphenidate vs. a decrease of 3.1 points for those who received placebo.

In addition, the safety profile showed no significant between-group differences.

“Methylphenidate offers a treatment approach providing a modest but potentially clinically significant benefit for patients and caregivers,” said the investigators, led by Jacobo E. Mintzer, MD, MBA, professor of health studies at the Medical University of South Carolina in Charleston.

The findings were published online Sept. 27 in JAMA Neurology.
 

Common problem

Apathy, which is common among patients with AD, is associated with increased risk for mortality, financial burden, and caregiver burden. No treatment has proved effective for apathy in this population.

Two trials of methylphenidate, a catecholaminergic agent, have provided preliminary evidence of efficacy. Findings from the Apathy in Dementia Methylphenidate trial (ADMET) suggested the drug was associated with improved cognition and few adverse events. However, both trials had small patient populations and short durations.

The current investigators conducted ADMET 2, a 6-month, phase 3 trial, to investigate methylphenidate further. They recruited 200 patients (mean age, 76 years; 66% men; 90% White) at nine clinical centers that specialized in dementia care in the United States and one in Canada.

Eligible patients had a diagnosis of possible or probable AD and a Mini-Mental State Examination (MMSE) score between 10 and 28. They also had clinically significant apathy for at least 4 weeks and an available caregiver who spent more than 10 hours a week with the patient.

The researchers randomly assigned patients to receive methylphenidate (n = 99) or placebo (n = 101). For 3 days, participants in the active group received 10 mg/day of methylphenidate. After that point, they received 20 mg/day of methylphenidate for the rest of the study.

Patients in both treatment groups were given the same number of identical-appearing capsules each day.

In-person follow-up visits took place monthly for 6 months. Participants also were contacted by telephone at days 15, 45, and 75 after treatment assignment.

Participants underwent cognitive testing at baseline and at 2, 4, and 6 months. The battery of tests included the MMSE, Hopkins Verbal Learning Test, and Wechsler Adult Intelligence Scale – Revised Digit Span.

The trial’s two primary outcomes were mean change in NPI apathy score from baseline to 6 months and the odds of an improved rating on the Alzheimer’s Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) between baseline and 6 months.

Significant change on either outcome was to be considered a signal of effective treatment.
 

Treatment-specific benefit

Ten patients in the methylphenidate group and seven in the placebo group withdrew during the study.

Mean MMSE score at baseline was 19.2 in the methylphenidate group vs. 18.5 in the placebo group, indicating moderately severe dementia. Mean baseline score on the NPI apathy subscale was 8.0 vs. 7.6, respectively.

In an adjusted, longitudinal model, mean between-group difference in change in NPI apathy score at 6 months was –1.25 (P = .002). The mean NPI apathy score decreased by 4.5 points in the methylphenidate group vs. 3.1 points in the placebo group.

The largest change in apathy score occurred during the first 2 months of treatment. At 6 months, 27% of the methylphenidate group vs. 14% of the placebo group had an NPI apathy score of 0.

In addition, 43.8% of the methylphenidate group had improvement on the ADCS-CGIC compared with 35.2% of the placebo group. The odds ratio (OR) for improvement on ADCS-CGIC for methylphenidate vs. placebo was 1.90 (P = .07).

There was also a strong association between score improvement on the NPI apathy subscale and improvement on the ADCS-CGIC subscale (OR, 2.95; P = .002).

“It is important to note that there were no group differences in any of the cognitive measures, suggesting that the effect of the treatment is specific to the treatment of apathy and not a secondary effect of improvement in cognition,” the researchers wrote.

In all, 17 serious adverse events occurred in the methylphenidate group and 10 occurred in the placebo group. However, all events were found to be hospitalizations for events not related to treatment.
 

‘Enduring effect’

Commenting on the findings, Jeffrey L. Cummings, MD, ScD, professor of brain sciences at the University of Nevada, Las Vegas, noted that the reduction in NPI apathy subscale score of more than 50% was clinically meaningful.

A more robust outcome on the ADCS-CGIC would have been desirable, he added, although that instrument is not designed specifically for apathy.

Methylphenidate’s effect on apathy observed at 2 months and remaining stable throughout the study makes it appear to be “an enduring effect, and not something that the patient accommodates to,” said Dr. Cummings, who was not involved with the research. Such a change may manifest itself in a patient’s greater willingness to help voluntarily with housework or to suggest going for a walk, he noted.

“These are not dramatic changes in cognition, of course, but they are changes in initiative and that is very important,” Dr. Cummings said. Decreased apathy also may improve quality of life for the patient’s caregiver, he added.

Overall, the findings raise the question of whether the Food and Drug Administration should recognize apathy as an indication for which drugs can be approved, said Dr. Cummings.

“For me, that would be the next major step in this line of investigation,” he concluded.

The study was funded by the National Institute on Aging. Dr. Mintzer has served as an adviser to Praxis Bioresearch and Cerevel Therapeutics on matters unrelated to this study. Dr. Cummings is the author of the Neuropsychiatric Inventory but does not receive payments for it from academic trials such as ADMET 2.
 

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

Methylphenidate is safe and effective for treating apathy in patients with Alzheimer’s disease (AD), new research suggests.

Dundanim/shutterstock.com

Results from a phase 3 randomized trial showed that, after 6 months of treatment, mean score on the Neuropsychiatric Inventory (NPI) apathy subscale decreased by 4.5 points for patients who received methylphenidate vs. a decrease of 3.1 points for those who received placebo.

In addition, the safety profile showed no significant between-group differences.

“Methylphenidate offers a treatment approach providing a modest but potentially clinically significant benefit for patients and caregivers,” said the investigators, led by Jacobo E. Mintzer, MD, MBA, professor of health studies at the Medical University of South Carolina in Charleston.

The findings were published online Sept. 27 in JAMA Neurology.
 

Common problem

Apathy, which is common among patients with AD, is associated with increased risk for mortality, financial burden, and caregiver burden. No treatment has proved effective for apathy in this population.

Two trials of methylphenidate, a catecholaminergic agent, have provided preliminary evidence of efficacy. Findings from the Apathy in Dementia Methylphenidate trial (ADMET) suggested the drug was associated with improved cognition and few adverse events. However, both trials had small patient populations and short durations.

The current investigators conducted ADMET 2, a 6-month, phase 3 trial, to investigate methylphenidate further. They recruited 200 patients (mean age, 76 years; 66% men; 90% White) at nine clinical centers that specialized in dementia care in the United States and one in Canada.

Eligible patients had a diagnosis of possible or probable AD and a Mini-Mental State Examination (MMSE) score between 10 and 28. They also had clinically significant apathy for at least 4 weeks and an available caregiver who spent more than 10 hours a week with the patient.

The researchers randomly assigned patients to receive methylphenidate (n = 99) or placebo (n = 101). For 3 days, participants in the active group received 10 mg/day of methylphenidate. After that point, they received 20 mg/day of methylphenidate for the rest of the study.

Patients in both treatment groups were given the same number of identical-appearing capsules each day.

In-person follow-up visits took place monthly for 6 months. Participants also were contacted by telephone at days 15, 45, and 75 after treatment assignment.

Participants underwent cognitive testing at baseline and at 2, 4, and 6 months. The battery of tests included the MMSE, Hopkins Verbal Learning Test, and Wechsler Adult Intelligence Scale – Revised Digit Span.

The trial’s two primary outcomes were mean change in NPI apathy score from baseline to 6 months and the odds of an improved rating on the Alzheimer’s Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC) between baseline and 6 months.

Significant change on either outcome was to be considered a signal of effective treatment.
 

Treatment-specific benefit

Ten patients in the methylphenidate group and seven in the placebo group withdrew during the study.

Mean MMSE score at baseline was 19.2 in the methylphenidate group vs. 18.5 in the placebo group, indicating moderately severe dementia. Mean baseline score on the NPI apathy subscale was 8.0 vs. 7.6, respectively.

In an adjusted, longitudinal model, mean between-group difference in change in NPI apathy score at 6 months was –1.25 (P = .002). The mean NPI apathy score decreased by 4.5 points in the methylphenidate group vs. 3.1 points in the placebo group.

The largest change in apathy score occurred during the first 2 months of treatment. At 6 months, 27% of the methylphenidate group vs. 14% of the placebo group had an NPI apathy score of 0.

In addition, 43.8% of the methylphenidate group had improvement on the ADCS-CGIC compared with 35.2% of the placebo group. The odds ratio (OR) for improvement on ADCS-CGIC for methylphenidate vs. placebo was 1.90 (P = .07).

There was also a strong association between score improvement on the NPI apathy subscale and improvement on the ADCS-CGIC subscale (OR, 2.95; P = .002).

“It is important to note that there were no group differences in any of the cognitive measures, suggesting that the effect of the treatment is specific to the treatment of apathy and not a secondary effect of improvement in cognition,” the researchers wrote.

In all, 17 serious adverse events occurred in the methylphenidate group and 10 occurred in the placebo group. However, all events were found to be hospitalizations for events not related to treatment.
 

‘Enduring effect’

Commenting on the findings, Jeffrey L. Cummings, MD, ScD, professor of brain sciences at the University of Nevada, Las Vegas, noted that the reduction in NPI apathy subscale score of more than 50% was clinically meaningful.

A more robust outcome on the ADCS-CGIC would have been desirable, he added, although that instrument is not designed specifically for apathy.

Methylphenidate’s effect on apathy observed at 2 months and remaining stable throughout the study makes it appear to be “an enduring effect, and not something that the patient accommodates to,” said Dr. Cummings, who was not involved with the research. Such a change may manifest itself in a patient’s greater willingness to help voluntarily with housework or to suggest going for a walk, he noted.

“These are not dramatic changes in cognition, of course, but they are changes in initiative and that is very important,” Dr. Cummings said. Decreased apathy also may improve quality of life for the patient’s caregiver, he added.

Overall, the findings raise the question of whether the Food and Drug Administration should recognize apathy as an indication for which drugs can be approved, said Dr. Cummings.

“For me, that would be the next major step in this line of investigation,” he concluded.

The study was funded by the National Institute on Aging. Dr. Mintzer has served as an adviser to Praxis Bioresearch and Cerevel Therapeutics on matters unrelated to this study. Dr. Cummings is the author of the Neuropsychiatric Inventory but does not receive payments for it from academic trials such as ADMET 2.
 

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

The continuing decline in COVID-19 incidence suggests the latest surge has peaked as new cases in children dropped for the 4th consecutive week, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

Preliminary data from the Centers for Disease Control and Prevention, however, show an uptick in new cases in late September, largely among younger children, that may indicate otherwise. Those data have a potential 2-week reporting delay, the CDC said on its COVID Data Tracker, so the most recent points on the graph (see above) could still go up.

The AAP and the CHA said that 173,000 new cases were reported for the week of Sept. 24-30, down 16% from the week before and 31% from the peak in early September. Those new cases made up almost 27% of all cases for the week, and the nearly 5.9 million child cases that have been reported since the start of the pandemic represent 16.2% of cases among Americans of all ages, the two groups said in their weekly COVID-19 report.

The CDC data on new cases by age group suggest that younger children have borne a heavier burden in the summer surge of COVID than they did last winter. The rate of new cases was not as high for 16- and 17-year-olds in the summer, but the other age groups all reached higher peaks than in the winter, including the 12- to 15-year-olds, who have been getting vaccinated since May, according to the COVID Data Tracker.

With vaccination approval getting closer for children under age 12 years, initiation in those already eligible continues to slide. Those aged 12-15 made up just 6.9% of new vaccinations during the 2 weeks from Sept. 21 to Oct. 4, and that figure has been dropping since July 13-26, when it was 14.1%. Vaccine initiation among 16- and 17-year-olds over that time has dropped by almost half, from 5.4% to 2.9%, the CDC data show.

All the vaccinations so far add up to this: Almost 55% of those aged 12-15 have gotten at least one dose of COVID vaccine, as have over 62% of those aged 16-17, and 52% of the older group is fully vaccinated, as is 44% of the younger group. Altogether, 10.8 million children were fully vaccinated as of Oct. 4, including those under 12 who may be participating in clinical trials or had a birth date entered incorrectly, the CDC said.

[email protected]

The continuing decline in COVID-19 incidence suggests the latest surge has peaked as new cases in children dropped for the 4th consecutive week, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

Preliminary data from the Centers for Disease Control and Prevention, however, show an uptick in new cases in late September, largely among younger children, that may indicate otherwise. Those data have a potential 2-week reporting delay, the CDC said on its COVID Data Tracker, so the most recent points on the graph (see above) could still go up.

The AAP and the CHA said that 173,000 new cases were reported for the week of Sept. 24-30, down 16% from the week before and 31% from the peak in early September. Those new cases made up almost 27% of all cases for the week, and the nearly 5.9 million child cases that have been reported since the start of the pandemic represent 16.2% of cases among Americans of all ages, the two groups said in their weekly COVID-19 report.

The CDC data on new cases by age group suggest that younger children have borne a heavier burden in the summer surge of COVID than they did last winter. The rate of new cases was not as high for 16- and 17-year-olds in the summer, but the other age groups all reached higher peaks than in the winter, including the 12- to 15-year-olds, who have been getting vaccinated since May, according to the COVID Data Tracker.

With vaccination approval getting closer for children under age 12 years, initiation in those already eligible continues to slide. Those aged 12-15 made up just 6.9% of new vaccinations during the 2 weeks from Sept. 21 to Oct. 4, and that figure has been dropping since July 13-26, when it was 14.1%. Vaccine initiation among 16- and 17-year-olds over that time has dropped by almost half, from 5.4% to 2.9%, the CDC data show.

All the vaccinations so far add up to this: Almost 55% of those aged 12-15 have gotten at least one dose of COVID vaccine, as have over 62% of those aged 16-17, and 52% of the older group is fully vaccinated, as is 44% of the younger group. Altogether, 10.8 million children were fully vaccinated as of Oct. 4, including those under 12 who may be participating in clinical trials or had a birth date entered incorrectly, the CDC said.

[email protected]

The continuing decline in COVID-19 incidence suggests the latest surge has peaked as new cases in children dropped for the 4th consecutive week, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

Preliminary data from the Centers for Disease Control and Prevention, however, show an uptick in new cases in late September, largely among younger children, that may indicate otherwise. Those data have a potential 2-week reporting delay, the CDC said on its COVID Data Tracker, so the most recent points on the graph (see above) could still go up.

The AAP and the CHA said that 173,000 new cases were reported for the week of Sept. 24-30, down 16% from the week before and 31% from the peak in early September. Those new cases made up almost 27% of all cases for the week, and the nearly 5.9 million child cases that have been reported since the start of the pandemic represent 16.2% of cases among Americans of all ages, the two groups said in their weekly COVID-19 report.

The CDC data on new cases by age group suggest that younger children have borne a heavier burden in the summer surge of COVID than they did last winter. The rate of new cases was not as high for 16- and 17-year-olds in the summer, but the other age groups all reached higher peaks than in the winter, including the 12- to 15-year-olds, who have been getting vaccinated since May, according to the COVID Data Tracker.

With vaccination approval getting closer for children under age 12 years, initiation in those already eligible continues to slide. Those aged 12-15 made up just 6.9% of new vaccinations during the 2 weeks from Sept. 21 to Oct. 4, and that figure has been dropping since July 13-26, when it was 14.1%. Vaccine initiation among 16- and 17-year-olds over that time has dropped by almost half, from 5.4% to 2.9%, the CDC data show.

All the vaccinations so far add up to this: Almost 55% of those aged 12-15 have gotten at least one dose of COVID vaccine, as have over 62% of those aged 16-17, and 52% of the older group is fully vaccinated, as is 44% of the younger group. Altogether, 10.8 million children were fully vaccinated as of Oct. 4, including those under 12 who may be participating in clinical trials or had a birth date entered incorrectly, the CDC said.

[email protected]

Third-year medical student Liz Groesbeck was like other excited Las Vegas Raiders fans recently headed to the first full-capacity game in the new Allegiant Stadium since the team moved to “Sin City.” She was in an Uber on a first date just blocks from the game that would pit her Raiders against the Seattle Seahawks when she saw a man on the ground and people gathered around him.

Abandoning her keys, cellphone, and date in the Uber, Ms. Groesbeck popped out to see if she could help. The Uber had been stuck in traffic, so Ms. Groesbeck thought she’d still be able to jump back in the car if she wasn’t needed. 

Then she heard screams. “That didn’t concern me. People scream whenever anything unexpected happens,” said the 28-year-old student from the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas (UNLV). But the screams were only a small indication of what she would discover on closer inspection. The arm of the middle-aged man lying on the ground was detached. An abandoned gold SUV remained on the curb nearby. It would turn out to be a hit-and-run of pedestrians by a driver later charged by police with DUI. 

“I was one of the first people there,” Ms. Groesbeck recounted for this news organization. “I knew this guy did not just fall. I told someone to call EMS and I got someone to take his wife somewhere else [away from the bloody scene]. She was obviously very distraught. …At a couple of points she was hysterical.” 

Next, Ms. Groesbeck, who, ironically, had finished her emergency general surgery rotation the day before, focused on the patient. Kneeling beside him, she determined that the immediate priorities were to stop the bleeding and clear his airway. “He was barely breathing,” she recounted. Another student who Ms. Groesbeck believes was pursuing a medical degree — there wasn’t time for formal introductions — offered to help, along with bystanders headed to the game. 

“The crowd was very energetic. It was a beautiful thing.” Ms. Groesbeck cited the spirit of saving lives that developed from the October 1, 2017, Las Vegas country music festival shooting. “People are very willing to try to help others in any way they can.” 

MS. Groesbeck, leading the effort, asked for belts, “and bystanders immediately provided that,” and the other student followed Ms. Groesbeck’s directions to apply tourniquets with the help of those around her. With the blood loss being stemmed, Ms. Groesbeck’s next priority was making sure the patient could breathe. 

Appealing for clothing to clear the man’s airway, “five shirts were handed in a circle to me.” She only needed one jersey to scoop the blood out of his mouth manually to free his airway. 

She overruled well-meaning suggestions to lay the man on his side — which she was concerned could paralyze him — or use a straw to help him breathe. “I did not want to stick anything down his throat.” Meanwhile, there was so much traffic that night around Allegiant Stadium that when the ambulance couldn’t get any closer the firefighters and paramedics exited the vehicle and ran to the scene. 
 

From training to practice

The decisions Ms. Groesbeck made until they could arrive called upon her years of training to be a doctor, and specifically an EMT certification course she had to pass before beginning medical school, she said.

She credits the life-saving methods she learned in that course to Douglas Fraser, MD, FACS, associate professor of surgery at UNLV and University Medical Center (UMC) trauma medical director. He happened to be the attending physician when the accident victim was admitted to the hospital that night in critical condition. The man’s wife also was injured, but not to the extent of her husband.

Dr. Fraser said he didn’t know at the time that his student had been involved in saving the man’s life until Ms. Groesbeck reached out to say thanks for teaching her what to do in an emergency. “I [first] was overly impressed that she did that. Students are so busy; they move after they graduate or finish their rotations. You don’t get to see them time and time again; your short time with them could have a lasting impact and that is my goal,” Dr. Fraser told this news organization.

“They rarely thank you or reflect back. It renewed my sense that I want to teach more, to see the positive impact it had on Elizabeth” and other students, he said.

In terms of the emergency situation she navigated, Dr. Fraser said he was very proud of his student, but was also concerned she could have gotten hurt herself in the middle of a busy intersection. “She was selfless and put herself in harm’s way to help someone.” He also noted it was the first time he knew of a student putting her skills to the test so soon after learning them. “It was a good outcome and she truly provided lifesaving care to this victim.”

He attributed her training to the Stop the Bleed program, which began after the Sandy Hook tragedy in 2012. UNLV requires new med students to complete the American College of Surgeons’ first aid program to learn how to stop the bleeding of a severely injured person by applying tourniquets and pressure. “You have to stop the bleeding right away…and look to see whether their airway is open and if it’s not, open their airway or you won’t have a patient very long. I know she did that. These are the two most important lifesaving skills that she did.” 

Medical students are often called upon as doctors by their family and friends, Dr. Fraser continued. “Everyone looks to you. It can happen on an airplane; you can be anywhere. She heard a person was in need and jumped to action and was able to use the training her school provided and was able to put it to good use.” 
 

Not her first call to action

Just the week before the incident, Ms. Groesbeck was on clinical rotations at UMC helping in the emergency and operating rooms. “She was always very engaged and mature beyond her years,” Dr. Fraser said. “She definitely had that ‘it’ factor. She was sincere with patients and their families and performed well in the operating room. …She was very comfortable around the patients; very comfortable in stressful situations.” 

He added, “I look forward to her participating in trauma surgery rotations in the near future.”

In the meantime, Ms. Groesbeck was pleased to learn that the man she saved survived and thrilled to be part of that effort. As of press time, he had not contacted her. Nor has the other student who helped save his life. 

“A lot of people stepped up and donated their time to help. He got lucky on a very unlucky day,” Ms. Groesbeck said.

She recalled a previous accident victim years ago who wasn’t as lucky. On the way to pick up her white coat for the ceremony before her first year of medical school, she came upon a car that had flipped upside down. “It sheared the roof away. I checked on the restrained passenger. He was partially scalped. The windows were broken and I climbed in next to him.” This time, she used her own shirt to hold pressure on the wound. “He, unfortunately did not make it.” There was nothing she could have done, she was told. 

“That one got me mentally. Very graphic imaging was stuck in my head,” Ms. Groesbeck said. With a masters in neuroscience, she was accustomed to seeing the brain, “but not like this. I felt sad he passed in such a violent way.” So the more recent life-saving experience was redemptive, she said. “I’ve been through hell and back.”

And she’s still on track to become the doctor she envisioned as a child, mummifying her cats with gauze wraps and covering her little sister with adhesive bandages. “It felt good knowing what I could do,” Ms. Groesbeck said. “I’m glad this [man] made it. He got lucky and he could go home to his family. I was not positive when he left in the ambulance. It was a huge relief.” 

Of her role in the episode and her future career ambitions, Ms. Groesbeck noted: “We are studying all the time. It’s not very rewarding. But this, not thinking but having sprung into action, doing the right thing and he could go home to his family a week later. It’s things like this that make the endless hours of studying worth it. I feel like I accomplished something.”

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

Third-year medical student Liz Groesbeck was like other excited Las Vegas Raiders fans recently headed to the first full-capacity game in the new Allegiant Stadium since the team moved to “Sin City.” She was in an Uber on a first date just blocks from the game that would pit her Raiders against the Seattle Seahawks when she saw a man on the ground and people gathered around him.

Abandoning her keys, cellphone, and date in the Uber, Ms. Groesbeck popped out to see if she could help. The Uber had been stuck in traffic, so Ms. Groesbeck thought she’d still be able to jump back in the car if she wasn’t needed. 

Then she heard screams. “That didn’t concern me. People scream whenever anything unexpected happens,” said the 28-year-old student from the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas (UNLV). But the screams were only a small indication of what she would discover on closer inspection. The arm of the middle-aged man lying on the ground was detached. An abandoned gold SUV remained on the curb nearby. It would turn out to be a hit-and-run of pedestrians by a driver later charged by police with DUI. 

“I was one of the first people there,” Ms. Groesbeck recounted for this news organization. “I knew this guy did not just fall. I told someone to call EMS and I got someone to take his wife somewhere else [away from the bloody scene]. She was obviously very distraught. …At a couple of points she was hysterical.” 

Next, Ms. Groesbeck, who, ironically, had finished her emergency general surgery rotation the day before, focused on the patient. Kneeling beside him, she determined that the immediate priorities were to stop the bleeding and clear his airway. “He was barely breathing,” she recounted. Another student who Ms. Groesbeck believes was pursuing a medical degree — there wasn’t time for formal introductions — offered to help, along with bystanders headed to the game. 

“The crowd was very energetic. It was a beautiful thing.” Ms. Groesbeck cited the spirit of saving lives that developed from the October 1, 2017, Las Vegas country music festival shooting. “People are very willing to try to help others in any way they can.” 

MS. Groesbeck, leading the effort, asked for belts, “and bystanders immediately provided that,” and the other student followed Ms. Groesbeck’s directions to apply tourniquets with the help of those around her. With the blood loss being stemmed, Ms. Groesbeck’s next priority was making sure the patient could breathe. 

Appealing for clothing to clear the man’s airway, “five shirts were handed in a circle to me.” She only needed one jersey to scoop the blood out of his mouth manually to free his airway. 

She overruled well-meaning suggestions to lay the man on his side — which she was concerned could paralyze him — or use a straw to help him breathe. “I did not want to stick anything down his throat.” Meanwhile, there was so much traffic that night around Allegiant Stadium that when the ambulance couldn’t get any closer the firefighters and paramedics exited the vehicle and ran to the scene. 
 

From training to practice

The decisions Ms. Groesbeck made until they could arrive called upon her years of training to be a doctor, and specifically an EMT certification course she had to pass before beginning medical school, she said.

She credits the life-saving methods she learned in that course to Douglas Fraser, MD, FACS, associate professor of surgery at UNLV and University Medical Center (UMC) trauma medical director. He happened to be the attending physician when the accident victim was admitted to the hospital that night in critical condition. The man’s wife also was injured, but not to the extent of her husband.

Dr. Fraser said he didn’t know at the time that his student had been involved in saving the man’s life until Ms. Groesbeck reached out to say thanks for teaching her what to do in an emergency. “I [first] was overly impressed that she did that. Students are so busy; they move after they graduate or finish their rotations. You don’t get to see them time and time again; your short time with them could have a lasting impact and that is my goal,” Dr. Fraser told this news organization.

“They rarely thank you or reflect back. It renewed my sense that I want to teach more, to see the positive impact it had on Elizabeth” and other students, he said.

In terms of the emergency situation she navigated, Dr. Fraser said he was very proud of his student, but was also concerned she could have gotten hurt herself in the middle of a busy intersection. “She was selfless and put herself in harm’s way to help someone.” He also noted it was the first time he knew of a student putting her skills to the test so soon after learning them. “It was a good outcome and she truly provided lifesaving care to this victim.”

He attributed her training to the Stop the Bleed program, which began after the Sandy Hook tragedy in 2012. UNLV requires new med students to complete the American College of Surgeons’ first aid program to learn how to stop the bleeding of a severely injured person by applying tourniquets and pressure. “You have to stop the bleeding right away…and look to see whether their airway is open and if it’s not, open their airway or you won’t have a patient very long. I know she did that. These are the two most important lifesaving skills that she did.” 

Medical students are often called upon as doctors by their family and friends, Dr. Fraser continued. “Everyone looks to you. It can happen on an airplane; you can be anywhere. She heard a person was in need and jumped to action and was able to use the training her school provided and was able to put it to good use.” 
 

Not her first call to action

Just the week before the incident, Ms. Groesbeck was on clinical rotations at UMC helping in the emergency and operating rooms. “She was always very engaged and mature beyond her years,” Dr. Fraser said. “She definitely had that ‘it’ factor. She was sincere with patients and their families and performed well in the operating room. …She was very comfortable around the patients; very comfortable in stressful situations.” 

He added, “I look forward to her participating in trauma surgery rotations in the near future.”

In the meantime, Ms. Groesbeck was pleased to learn that the man she saved survived and thrilled to be part of that effort. As of press time, he had not contacted her. Nor has the other student who helped save his life. 

“A lot of people stepped up and donated their time to help. He got lucky on a very unlucky day,” Ms. Groesbeck said.

She recalled a previous accident victim years ago who wasn’t as lucky. On the way to pick up her white coat for the ceremony before her first year of medical school, she came upon a car that had flipped upside down. “It sheared the roof away. I checked on the restrained passenger. He was partially scalped. The windows were broken and I climbed in next to him.” This time, she used her own shirt to hold pressure on the wound. “He, unfortunately did not make it.” There was nothing she could have done, she was told. 

“That one got me mentally. Very graphic imaging was stuck in my head,” Ms. Groesbeck said. With a masters in neuroscience, she was accustomed to seeing the brain, “but not like this. I felt sad he passed in such a violent way.” So the more recent life-saving experience was redemptive, she said. “I’ve been through hell and back.”

And she’s still on track to become the doctor she envisioned as a child, mummifying her cats with gauze wraps and covering her little sister with adhesive bandages. “It felt good knowing what I could do,” Ms. Groesbeck said. “I’m glad this [man] made it. He got lucky and he could go home to his family. I was not positive when he left in the ambulance. It was a huge relief.” 

Of her role in the episode and her future career ambitions, Ms. Groesbeck noted: “We are studying all the time. It’s not very rewarding. But this, not thinking but having sprung into action, doing the right thing and he could go home to his family a week later. It’s things like this that make the endless hours of studying worth it. I feel like I accomplished something.”

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

Third-year medical student Liz Groesbeck was like other excited Las Vegas Raiders fans recently headed to the first full-capacity game in the new Allegiant Stadium since the team moved to “Sin City.” She was in an Uber on a first date just blocks from the game that would pit her Raiders against the Seattle Seahawks when she saw a man on the ground and people gathered around him.

Abandoning her keys, cellphone, and date in the Uber, Ms. Groesbeck popped out to see if she could help. The Uber had been stuck in traffic, so Ms. Groesbeck thought she’d still be able to jump back in the car if she wasn’t needed. 

Then she heard screams. “That didn’t concern me. People scream whenever anything unexpected happens,” said the 28-year-old student from the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas (UNLV). But the screams were only a small indication of what she would discover on closer inspection. The arm of the middle-aged man lying on the ground was detached. An abandoned gold SUV remained on the curb nearby. It would turn out to be a hit-and-run of pedestrians by a driver later charged by police with DUI. 

“I was one of the first people there,” Ms. Groesbeck recounted for this news organization. “I knew this guy did not just fall. I told someone to call EMS and I got someone to take his wife somewhere else [away from the bloody scene]. She was obviously very distraught. …At a couple of points she was hysterical.” 

Next, Ms. Groesbeck, who, ironically, had finished her emergency general surgery rotation the day before, focused on the patient. Kneeling beside him, she determined that the immediate priorities were to stop the bleeding and clear his airway. “He was barely breathing,” she recounted. Another student who Ms. Groesbeck believes was pursuing a medical degree — there wasn’t time for formal introductions — offered to help, along with bystanders headed to the game. 

“The crowd was very energetic. It was a beautiful thing.” Ms. Groesbeck cited the spirit of saving lives that developed from the October 1, 2017, Las Vegas country music festival shooting. “People are very willing to try to help others in any way they can.” 

MS. Groesbeck, leading the effort, asked for belts, “and bystanders immediately provided that,” and the other student followed Ms. Groesbeck’s directions to apply tourniquets with the help of those around her. With the blood loss being stemmed, Ms. Groesbeck’s next priority was making sure the patient could breathe. 

Appealing for clothing to clear the man’s airway, “five shirts were handed in a circle to me.” She only needed one jersey to scoop the blood out of his mouth manually to free his airway. 

She overruled well-meaning suggestions to lay the man on his side — which she was concerned could paralyze him — or use a straw to help him breathe. “I did not want to stick anything down his throat.” Meanwhile, there was so much traffic that night around Allegiant Stadium that when the ambulance couldn’t get any closer the firefighters and paramedics exited the vehicle and ran to the scene. 
 

From training to practice

The decisions Ms. Groesbeck made until they could arrive called upon her years of training to be a doctor, and specifically an EMT certification course she had to pass before beginning medical school, she said.

She credits the life-saving methods she learned in that course to Douglas Fraser, MD, FACS, associate professor of surgery at UNLV and University Medical Center (UMC) trauma medical director. He happened to be the attending physician when the accident victim was admitted to the hospital that night in critical condition. The man’s wife also was injured, but not to the extent of her husband.

Dr. Fraser said he didn’t know at the time that his student had been involved in saving the man’s life until Ms. Groesbeck reached out to say thanks for teaching her what to do in an emergency. “I [first] was overly impressed that she did that. Students are so busy; they move after they graduate or finish their rotations. You don’t get to see them time and time again; your short time with them could have a lasting impact and that is my goal,” Dr. Fraser told this news organization.

“They rarely thank you or reflect back. It renewed my sense that I want to teach more, to see the positive impact it had on Elizabeth” and other students, he said.

In terms of the emergency situation she navigated, Dr. Fraser said he was very proud of his student, but was also concerned she could have gotten hurt herself in the middle of a busy intersection. “She was selfless and put herself in harm’s way to help someone.” He also noted it was the first time he knew of a student putting her skills to the test so soon after learning them. “It was a good outcome and she truly provided lifesaving care to this victim.”

He attributed her training to the Stop the Bleed program, which began after the Sandy Hook tragedy in 2012. UNLV requires new med students to complete the American College of Surgeons’ first aid program to learn how to stop the bleeding of a severely injured person by applying tourniquets and pressure. “You have to stop the bleeding right away…and look to see whether their airway is open and if it’s not, open their airway or you won’t have a patient very long. I know she did that. These are the two most important lifesaving skills that she did.” 

Medical students are often called upon as doctors by their family and friends, Dr. Fraser continued. “Everyone looks to you. It can happen on an airplane; you can be anywhere. She heard a person was in need and jumped to action and was able to use the training her school provided and was able to put it to good use.” 
 

Not her first call to action

Just the week before the incident, Ms. Groesbeck was on clinical rotations at UMC helping in the emergency and operating rooms. “She was always very engaged and mature beyond her years,” Dr. Fraser said. “She definitely had that ‘it’ factor. She was sincere with patients and their families and performed well in the operating room. …She was very comfortable around the patients; very comfortable in stressful situations.” 

He added, “I look forward to her participating in trauma surgery rotations in the near future.”

In the meantime, Ms. Groesbeck was pleased to learn that the man she saved survived and thrilled to be part of that effort. As of press time, he had not contacted her. Nor has the other student who helped save his life. 

“A lot of people stepped up and donated their time to help. He got lucky on a very unlucky day,” Ms. Groesbeck said.

She recalled a previous accident victim years ago who wasn’t as lucky. On the way to pick up her white coat for the ceremony before her first year of medical school, she came upon a car that had flipped upside down. “It sheared the roof away. I checked on the restrained passenger. He was partially scalped. The windows were broken and I climbed in next to him.” This time, she used her own shirt to hold pressure on the wound. “He, unfortunately did not make it.” There was nothing she could have done, she was told. 

“That one got me mentally. Very graphic imaging was stuck in my head,” Ms. Groesbeck said. With a masters in neuroscience, she was accustomed to seeing the brain, “but not like this. I felt sad he passed in such a violent way.” So the more recent life-saving experience was redemptive, she said. “I’ve been through hell and back.”

And she’s still on track to become the doctor she envisioned as a child, mummifying her cats with gauze wraps and covering her little sister with adhesive bandages. “It felt good knowing what I could do,” Ms. Groesbeck said. “I’m glad this [man] made it. He got lucky and he could go home to his family. I was not positive when he left in the ambulance. It was a huge relief.” 

Of her role in the episode and her future career ambitions, Ms. Groesbeck noted: “We are studying all the time. It’s not very rewarding. But this, not thinking but having sprung into action, doing the right thing and he could go home to his family a week later. It’s things like this that make the endless hours of studying worth it. I feel like I accomplished something.”

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

People with insulin-treated type 1 diabetes who had problems avoiding hypoglycemic episodes despite optimal care were helped significantly by a new psychoeducational program called HARPdoc, it was reported at the annual meeting of the European Association for the Study of Diabetes.

In a randomized controlled trial (RCT), both HARPdoc and the more established Blood Glucose Awareness Training (BGAT) were effective at reducing the number of severe hypoglycemia episodes seen, from five episodes at baseline to one at 1 year in both groups, and one and none at 2-years’ follow-up, respectively.

“HARPdoc is not superior to BGAT in its ability to restore hypoglycemia awareness and reduce severe hypoglycemia,” said Stephanie Amiel, MD, FRCP, the chief investigator for the trial. However, “it does reduce cognitive barriers to hypoglycemia avoidance, so it achieves what it set out to do.”

Dr. Amiel, professor of diabetes research at Kings College London, added that it was important to note that HARPdoc was better than BGAT at improving participants’ mental health, “producing a clinically important and sustainable reduction in diabetes distress, anxiety, and depression.”
 

What’s HARPdoc?

The Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia persisting despite optimised self-care (HARPdoc) was designed to specifically address why some people with type 1 diabetes find it difficult to avoid recurrent hypoglycemia.

“It’s a psychoeducational program with clinical knowledge about hypoglycemia and group learning, but also explicit topics on mindset and behavior change,” explained Nicole de Zoysa, DClinPsych, one of the clinical psychologists involved in the trial.

Over the course of the 6-week program, there are four group sessions (weeks 1-3, and week 6) and two individual sessions (weeks 4 and 5) ­that address important “cognitive barriers” or “thinking traps” to avoiding hypoglycemia that were identified during prior qualitative research.

HARPdoc is thus “an attempt to make sense of people’s reluctance or seeming reluctance to take action around hypoglycemia, Dr. de Zoysa said. The intervention draws on both cognitive behavioral theory “to work with the beliefs” and motivational interviewing “to work with the resistance.”
 

The HARPdoc RCT

Starting in 2017 and ending earlier this year, the HARPdoc RCT was a parallel group study conducted at three specialist diabetes centers in the United Kingdom and one in the United States.

A total of 99 adults with insulin-treated type 1 diabetes and impaired hypoglycemia awareness were enrolled – with 49 randomized to the HARPdoc arm and 50 to the BGAT arm. All had been offered technologies to help them potentially bring their hypoglycemia under better control, such as continuous glucose monitoring, insulin pumps, or closed loop systems, and received structured education on flexible insulin dosing.

The aim was to show superiority of the HARPdoc program over BGAT, in helping people avoid episodes of severe hypoglycemia, defined as episodes that needed other people’s intervention to help resolve.

BGAT is also a psychoeducation program that has been around since the 1980s but barely used in the United Kingdom, Dr. Amiel noted.

Baseline demographic characteristics were similar for the HARPdoc and BGAT arms: The mean age was 57 versus 52 years, there was a long (30+ years) duration of diabetes, over half of the participants were male, and almost all were White.
 

Primary endpoint not met, but still ‘impressive’

Although the primary endpoint of the trial was not met, the reductions in severe hypoglycemia seen are still “impressive,” said Ramzi Ajjan, MD, FRCP, of Leeds (England) University and Leeds Teaching Hospitals Trust.

“I was really blown away,” by the improvement in both study arms, said Dr. Ajjan, who was not involved in the trial. “These people have had proper clinical input,” he stressed, noting that both interventions worked, with no difference between them in terms of severe hypoglycemia.

Dr. Ajjan was not surprised by the better cognition scores measured using the A2A questionnaire seen with HARPdoc versus BGAT, as “this is what the intervention was designed to address.”

In terms of the mental health benefits seen, HARPdoc significantly reduced the level of diabetes distress as measured using the Problem Areas In Diabetes (PAID) questionnaire versus the BGAT intervention.

The PAID score was around 30 in both groups at baseline, this fell to about 26 at 1 year, and around 20 at 2 years in the HARPdoc group, which was significantly lower than the score seen in the BGAT group which rose slightly then fell back to baseline levels.

A similar pattern was seen in the levels of depression and anxiety, which were measured by the HADS-D and HADS-A instruments. So HARPdoc was more effective at improving psychological and mental health outcomes than BGAT, Dr. Ajjan observed.

The HARPdoc project is funded by the Juvenile Diabetes Research Foundation with additional support from the UK’s National Institute of Health Research. The HARPdoc RCT was jointly sponsored by King’s College London and King’s College Hospital NHS Foundation Trust. Dr. Amiel has served on advisory panels for Roche, Medtronic, and Novo Nordisk. Dr. de Zoysa did not state having any conflicts of interest. Dr. Ajjan disclosed that he has financial relationships with multiple pharmaceutical companies.

People with insulin-treated type 1 diabetes who had problems avoiding hypoglycemic episodes despite optimal care were helped significantly by a new psychoeducational program called HARPdoc, it was reported at the annual meeting of the European Association for the Study of Diabetes.

In a randomized controlled trial (RCT), both HARPdoc and the more established Blood Glucose Awareness Training (BGAT) were effective at reducing the number of severe hypoglycemia episodes seen, from five episodes at baseline to one at 1 year in both groups, and one and none at 2-years’ follow-up, respectively.

“HARPdoc is not superior to BGAT in its ability to restore hypoglycemia awareness and reduce severe hypoglycemia,” said Stephanie Amiel, MD, FRCP, the chief investigator for the trial. However, “it does reduce cognitive barriers to hypoglycemia avoidance, so it achieves what it set out to do.”

Dr. Amiel, professor of diabetes research at Kings College London, added that it was important to note that HARPdoc was better than BGAT at improving participants’ mental health, “producing a clinically important and sustainable reduction in diabetes distress, anxiety, and depression.”
 

What’s HARPdoc?

The Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia persisting despite optimised self-care (HARPdoc) was designed to specifically address why some people with type 1 diabetes find it difficult to avoid recurrent hypoglycemia.

“It’s a psychoeducational program with clinical knowledge about hypoglycemia and group learning, but also explicit topics on mindset and behavior change,” explained Nicole de Zoysa, DClinPsych, one of the clinical psychologists involved in the trial.

Over the course of the 6-week program, there are four group sessions (weeks 1-3, and week 6) and two individual sessions (weeks 4 and 5) ­that address important “cognitive barriers” or “thinking traps” to avoiding hypoglycemia that were identified during prior qualitative research.

HARPdoc is thus “an attempt to make sense of people’s reluctance or seeming reluctance to take action around hypoglycemia, Dr. de Zoysa said. The intervention draws on both cognitive behavioral theory “to work with the beliefs” and motivational interviewing “to work with the resistance.”
 

The HARPdoc RCT

Starting in 2017 and ending earlier this year, the HARPdoc RCT was a parallel group study conducted at three specialist diabetes centers in the United Kingdom and one in the United States.

A total of 99 adults with insulin-treated type 1 diabetes and impaired hypoglycemia awareness were enrolled – with 49 randomized to the HARPdoc arm and 50 to the BGAT arm. All had been offered technologies to help them potentially bring their hypoglycemia under better control, such as continuous glucose monitoring, insulin pumps, or closed loop systems, and received structured education on flexible insulin dosing.

The aim was to show superiority of the HARPdoc program over BGAT, in helping people avoid episodes of severe hypoglycemia, defined as episodes that needed other people’s intervention to help resolve.

BGAT is also a psychoeducation program that has been around since the 1980s but barely used in the United Kingdom, Dr. Amiel noted.

Baseline demographic characteristics were similar for the HARPdoc and BGAT arms: The mean age was 57 versus 52 years, there was a long (30+ years) duration of diabetes, over half of the participants were male, and almost all were White.
 

Primary endpoint not met, but still ‘impressive’

Although the primary endpoint of the trial was not met, the reductions in severe hypoglycemia seen are still “impressive,” said Ramzi Ajjan, MD, FRCP, of Leeds (England) University and Leeds Teaching Hospitals Trust.

“I was really blown away,” by the improvement in both study arms, said Dr. Ajjan, who was not involved in the trial. “These people have had proper clinical input,” he stressed, noting that both interventions worked, with no difference between them in terms of severe hypoglycemia.

Dr. Ajjan was not surprised by the better cognition scores measured using the A2A questionnaire seen with HARPdoc versus BGAT, as “this is what the intervention was designed to address.”

In terms of the mental health benefits seen, HARPdoc significantly reduced the level of diabetes distress as measured using the Problem Areas In Diabetes (PAID) questionnaire versus the BGAT intervention.

The PAID score was around 30 in both groups at baseline, this fell to about 26 at 1 year, and around 20 at 2 years in the HARPdoc group, which was significantly lower than the score seen in the BGAT group which rose slightly then fell back to baseline levels.

A similar pattern was seen in the levels of depression and anxiety, which were measured by the HADS-D and HADS-A instruments. So HARPdoc was more effective at improving psychological and mental health outcomes than BGAT, Dr. Ajjan observed.

The HARPdoc project is funded by the Juvenile Diabetes Research Foundation with additional support from the UK’s National Institute of Health Research. The HARPdoc RCT was jointly sponsored by King’s College London and King’s College Hospital NHS Foundation Trust. Dr. Amiel has served on advisory panels for Roche, Medtronic, and Novo Nordisk. Dr. de Zoysa did not state having any conflicts of interest. Dr. Ajjan disclosed that he has financial relationships with multiple pharmaceutical companies.

People with insulin-treated type 1 diabetes who had problems avoiding hypoglycemic episodes despite optimal care were helped significantly by a new psychoeducational program called HARPdoc, it was reported at the annual meeting of the European Association for the Study of Diabetes.

In a randomized controlled trial (RCT), both HARPdoc and the more established Blood Glucose Awareness Training (BGAT) were effective at reducing the number of severe hypoglycemia episodes seen, from five episodes at baseline to one at 1 year in both groups, and one and none at 2-years’ follow-up, respectively.

“HARPdoc is not superior to BGAT in its ability to restore hypoglycemia awareness and reduce severe hypoglycemia,” said Stephanie Amiel, MD, FRCP, the chief investigator for the trial. However, “it does reduce cognitive barriers to hypoglycemia avoidance, so it achieves what it set out to do.”

Dr. Amiel, professor of diabetes research at Kings College London, added that it was important to note that HARPdoc was better than BGAT at improving participants’ mental health, “producing a clinically important and sustainable reduction in diabetes distress, anxiety, and depression.”
 

What’s HARPdoc?

The Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia persisting despite optimised self-care (HARPdoc) was designed to specifically address why some people with type 1 diabetes find it difficult to avoid recurrent hypoglycemia.

“It’s a psychoeducational program with clinical knowledge about hypoglycemia and group learning, but also explicit topics on mindset and behavior change,” explained Nicole de Zoysa, DClinPsych, one of the clinical psychologists involved in the trial.

Over the course of the 6-week program, there are four group sessions (weeks 1-3, and week 6) and two individual sessions (weeks 4 and 5) ­that address important “cognitive barriers” or “thinking traps” to avoiding hypoglycemia that were identified during prior qualitative research.

HARPdoc is thus “an attempt to make sense of people’s reluctance or seeming reluctance to take action around hypoglycemia, Dr. de Zoysa said. The intervention draws on both cognitive behavioral theory “to work with the beliefs” and motivational interviewing “to work with the resistance.”
 

The HARPdoc RCT

Starting in 2017 and ending earlier this year, the HARPdoc RCT was a parallel group study conducted at three specialist diabetes centers in the United Kingdom and one in the United States.

A total of 99 adults with insulin-treated type 1 diabetes and impaired hypoglycemia awareness were enrolled – with 49 randomized to the HARPdoc arm and 50 to the BGAT arm. All had been offered technologies to help them potentially bring their hypoglycemia under better control, such as continuous glucose monitoring, insulin pumps, or closed loop systems, and received structured education on flexible insulin dosing.

The aim was to show superiority of the HARPdoc program over BGAT, in helping people avoid episodes of severe hypoglycemia, defined as episodes that needed other people’s intervention to help resolve.

BGAT is also a psychoeducation program that has been around since the 1980s but barely used in the United Kingdom, Dr. Amiel noted.

Baseline demographic characteristics were similar for the HARPdoc and BGAT arms: The mean age was 57 versus 52 years, there was a long (30+ years) duration of diabetes, over half of the participants were male, and almost all were White.
 

Primary endpoint not met, but still ‘impressive’

Although the primary endpoint of the trial was not met, the reductions in severe hypoglycemia seen are still “impressive,” said Ramzi Ajjan, MD, FRCP, of Leeds (England) University and Leeds Teaching Hospitals Trust.

“I was really blown away,” by the improvement in both study arms, said Dr. Ajjan, who was not involved in the trial. “These people have had proper clinical input,” he stressed, noting that both interventions worked, with no difference between them in terms of severe hypoglycemia.

Dr. Ajjan was not surprised by the better cognition scores measured using the A2A questionnaire seen with HARPdoc versus BGAT, as “this is what the intervention was designed to address.”

In terms of the mental health benefits seen, HARPdoc significantly reduced the level of diabetes distress as measured using the Problem Areas In Diabetes (PAID) questionnaire versus the BGAT intervention.

The PAID score was around 30 in both groups at baseline, this fell to about 26 at 1 year, and around 20 at 2 years in the HARPdoc group, which was significantly lower than the score seen in the BGAT group which rose slightly then fell back to baseline levels.

A similar pattern was seen in the levels of depression and anxiety, which were measured by the HADS-D and HADS-A instruments. So HARPdoc was more effective at improving psychological and mental health outcomes than BGAT, Dr. Ajjan observed.

The HARPdoc project is funded by the Juvenile Diabetes Research Foundation with additional support from the UK’s National Institute of Health Research. The HARPdoc RCT was jointly sponsored by King’s College London and King’s College Hospital NHS Foundation Trust. Dr. Amiel has served on advisory panels for Roche, Medtronic, and Novo Nordisk. Dr. de Zoysa did not state having any conflicts of interest. Dr. Ajjan disclosed that he has financial relationships with multiple pharmaceutical companies.

In the fall of 1980, my parents made me take a high school class that I was REALLY angry over. It was a waste of time. It was beneath my dignity. It was something I never was going to use. It was embarrassing.

It was ... typing.

And I was completely wrong.

Looking back from 2021, I have to say that, of all the things I learned in high school, it’s probably the skill I depend on the most every day. It’s probably been at least 25 years since I had a day when I didn’t type something.

Some of it is the rise of the Internet and computers, but a lot of it is also the way I run my practice. My schedule isn’t as busy as those of my colleagues in general practice, and I don’t use one of those new-fangled EMRs (my charts are on computer, but not in a specialized program per se).

I’ve always been my own transcriptionist. I type roughly 40 words a minute; certainly not blazing speed, but enough to get the job done. For a few years I used voice dictation, but the only speech program I really liked folded up years ago (yes, ViaVoice, I still miss you).

So now I just type, and proofread, all my own notes. Old-school maybe, certainly not efficient as far as time goes, but it works for me. My thoughts go through my fingers directly into the chart, occasionally pausing to think something through before I put it in or hitting backspace if I think of a better way to phrase it. Typing my own notes lets me turn the case over as I’m hitting the keys, working my way through the differential and what needs to be done.

Writing the notes myself allows me to tell the patient’s story, and think about it in the process. It allows me to work through it again the next time I open the chart, months, or even years, later. Hopefully it shows my thought process and why I did things the way I did for myself, the colleague I’m sending the note to, and any physicians down the line.

I could probably save time with a system that lets me just check boxes or circle pertinent positives and negatives in a template, but that’s not how my thought process works. I feel like I’d be missing something if I did.

And, 41 years later, it’s still a reminder of how much of my parents’ advice was correct. Because at the time, I was pretty sure they were wrong.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

In the fall of 1980, my parents made me take a high school class that I was REALLY angry over. It was a waste of time. It was beneath my dignity. It was something I never was going to use. It was embarrassing.

It was ... typing.

And I was completely wrong.

Looking back from 2021, I have to say that, of all the things I learned in high school, it’s probably the skill I depend on the most every day. It’s probably been at least 25 years since I had a day when I didn’t type something.

Some of it is the rise of the Internet and computers, but a lot of it is also the way I run my practice. My schedule isn’t as busy as those of my colleagues in general practice, and I don’t use one of those new-fangled EMRs (my charts are on computer, but not in a specialized program per se).

I’ve always been my own transcriptionist. I type roughly 40 words a minute; certainly not blazing speed, but enough to get the job done. For a few years I used voice dictation, but the only speech program I really liked folded up years ago (yes, ViaVoice, I still miss you).

So now I just type, and proofread, all my own notes. Old-school maybe, certainly not efficient as far as time goes, but it works for me. My thoughts go through my fingers directly into the chart, occasionally pausing to think something through before I put it in or hitting backspace if I think of a better way to phrase it. Typing my own notes lets me turn the case over as I’m hitting the keys, working my way through the differential and what needs to be done.

Writing the notes myself allows me to tell the patient’s story, and think about it in the process. It allows me to work through it again the next time I open the chart, months, or even years, later. Hopefully it shows my thought process and why I did things the way I did for myself, the colleague I’m sending the note to, and any physicians down the line.

I could probably save time with a system that lets me just check boxes or circle pertinent positives and negatives in a template, but that’s not how my thought process works. I feel like I’d be missing something if I did.

And, 41 years later, it’s still a reminder of how much of my parents’ advice was correct. Because at the time, I was pretty sure they were wrong.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

In the fall of 1980, my parents made me take a high school class that I was REALLY angry over. It was a waste of time. It was beneath my dignity. It was something I never was going to use. It was embarrassing.

It was ... typing.

And I was completely wrong.

Looking back from 2021, I have to say that, of all the things I learned in high school, it’s probably the skill I depend on the most every day. It’s probably been at least 25 years since I had a day when I didn’t type something.

Some of it is the rise of the Internet and computers, but a lot of it is also the way I run my practice. My schedule isn’t as busy as those of my colleagues in general practice, and I don’t use one of those new-fangled EMRs (my charts are on computer, but not in a specialized program per se).

I’ve always been my own transcriptionist. I type roughly 40 words a minute; certainly not blazing speed, but enough to get the job done. For a few years I used voice dictation, but the only speech program I really liked folded up years ago (yes, ViaVoice, I still miss you).

So now I just type, and proofread, all my own notes. Old-school maybe, certainly not efficient as far as time goes, but it works for me. My thoughts go through my fingers directly into the chart, occasionally pausing to think something through before I put it in or hitting backspace if I think of a better way to phrase it. Typing my own notes lets me turn the case over as I’m hitting the keys, working my way through the differential and what needs to be done.

Writing the notes myself allows me to tell the patient’s story, and think about it in the process. It allows me to work through it again the next time I open the chart, months, or even years, later. Hopefully it shows my thought process and why I did things the way I did for myself, the colleague I’m sending the note to, and any physicians down the line.

I could probably save time with a system that lets me just check boxes or circle pertinent positives and negatives in a template, but that’s not how my thought process works. I feel like I’d be missing something if I did.

And, 41 years later, it’s still a reminder of how much of my parents’ advice was correct. Because at the time, I was pretty sure they were wrong.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

A second study also evaluated the growth uterine fibroids during a different time during a woman’s lifespan - pregnancy. While it’s commonly thought that fibroids grow during pregnancy, a prospective cross-sectional study in the International Journal of Gynecology & Obstetrics (Tian et al) evaluated 394 women with uterine fibroids and found that growth depended on gestational age. In this group, ultrasound examinations were conducted to measure the size of uterine fibroids during weeks 6–7, 11–14, 22–24 and 28–34 of pregnancy and before delivery. The study team found that uterine fibroid size commonly increased before 22–24 weeks of pregnancy with the fastest growth occurring before 11–14 weeks gestation. Later in pregnancy, from 22–24 weeks to the date of delivery, uterine fibroid size remained unchanged.

Lin et al published a large-scale nationwide cohort study in PLoS One that evaluated whether women with uterine fibroids were at increased risk of developing endometriosis. Overall, 31,239 women with uterine fibroids were matched to 124, 956 control participants and followed for 14 years. Compared to controls, patients with uterine fibroids were at a higher risk of developing endometriosis (adjusted hazard ratio [aHR] 6.44, P < 0.05). Other conditions associated with a higher risk of endometriosis included history of tubo-ovarian infection (aHR 2.86, P = 0.01), endometritis (aHR 1.14, P < 0.001), infertility (aHR 1.26, P < 0.001) and allergic diseases (aHR, 1.11, P < .001). Similarly, having both uterine fibroids and infertility significantly increased the risk of endometriosis (aHR 6.95; P < 0.001).

A second study also evaluated the growth uterine fibroids during a different time during a woman’s lifespan - pregnancy. While it’s commonly thought that fibroids grow during pregnancy, a prospective cross-sectional study in the International Journal of Gynecology & Obstetrics (Tian et al) evaluated 394 women with uterine fibroids and found that growth depended on gestational age. In this group, ultrasound examinations were conducted to measure the size of uterine fibroids during weeks 6–7, 11–14, 22–24 and 28–34 of pregnancy and before delivery. The study team found that uterine fibroid size commonly increased before 22–24 weeks of pregnancy with the fastest growth occurring before 11–14 weeks gestation. Later in pregnancy, from 22–24 weeks to the date of delivery, uterine fibroid size remained unchanged.

Lin et al published a large-scale nationwide cohort study in PLoS One that evaluated whether women with uterine fibroids were at increased risk of developing endometriosis. Overall, 31,239 women with uterine fibroids were matched to 124, 956 control participants and followed for 14 years. Compared to controls, patients with uterine fibroids were at a higher risk of developing endometriosis (adjusted hazard ratio [aHR] 6.44, P < 0.05). Other conditions associated with a higher risk of endometriosis included history of tubo-ovarian infection (aHR 2.86, P = 0.01), endometritis (aHR 1.14, P < 0.001), infertility (aHR 1.26, P < 0.001) and allergic diseases (aHR, 1.11, P < .001). Similarly, having both uterine fibroids and infertility significantly increased the risk of endometriosis (aHR 6.95; P < 0.001).

A second study also evaluated the growth uterine fibroids during a different time during a woman’s lifespan - pregnancy. While it’s commonly thought that fibroids grow during pregnancy, a prospective cross-sectional study in the International Journal of Gynecology & Obstetrics (Tian et al) evaluated 394 women with uterine fibroids and found that growth depended on gestational age. In this group, ultrasound examinations were conducted to measure the size of uterine fibroids during weeks 6–7, 11–14, 22–24 and 28–34 of pregnancy and before delivery. The study team found that uterine fibroid size commonly increased before 22–24 weeks of pregnancy with the fastest growth occurring before 11–14 weeks gestation. Later in pregnancy, from 22–24 weeks to the date of delivery, uterine fibroid size remained unchanged.

Lin et al published a large-scale nationwide cohort study in PLoS One that evaluated whether women with uterine fibroids were at increased risk of developing endometriosis. Overall, 31,239 women with uterine fibroids were matched to 124, 956 control participants and followed for 14 years. Compared to controls, patients with uterine fibroids were at a higher risk of developing endometriosis (adjusted hazard ratio [aHR] 6.44, P < 0.05). Other conditions associated with a higher risk of endometriosis included history of tubo-ovarian infection (aHR 2.86, P = 0.01), endometritis (aHR 1.14, P < 0.001), infertility (aHR 1.26, P < 0.001) and allergic diseases (aHR, 1.11, P < .001). Similarly, having both uterine fibroids and infertility significantly increased the risk of endometriosis (aHR 6.95; P < 0.001).

Research has shown that hepatitis C virus infections in patients with hemophilia lead to the development of hepatocellular carcinoma (HCC) at a relatively younger age than that in patients without hemophilia. However, hemophilia was not a significant risk factor for hepatocarcinogenesis after sustained virologic response (SVR) against HCV, according to Yosuke Inukai of Nagoya (Japan) University and colleagues.

The researchers assessed 699 patients who achieved SVR after HCV antiviral treatment: 78 patients with hemophilia (H group) and 621 patients without hemophilia (NH group). They examined patient characteristics, clinical outcomes, and the cumulative incidence of HCC after SVR, according to a report published online in Annals of Hepatology.
 

No added risk

Patients in the H-group were significantly younger and had a lower hepatic fibrosis score, compared with the NH group. Over a follow-up period of 7 years, there were no differences seen in the incidence of liver-related disease or overall death between the two groups. HCC was diagnosed in 4 patients in the H group and 36 patients in the NH group after SVR.

Multivariate analysis showed that male sex, patient age, and the presence of cirrhosis were significant risk factors for HCC incidence. However, after propensity-score matching that adjusted for the risk factors of HCC between the two groups, there was no significant difference seen in the cumulative incidence of HCC between the two groups.
 

Need for vigilance

The lack of a significant difference in the cumulative incidence of HCC after SVR or the long-term prognosis in patients with and without hemophilia, suggests that SVR could reduce the rates of liver carcinogenesis and liver disease–related mortality in both groups of patients, the researchers stated.

However: “Although there were no differences in overall survival, deaths from liver failure and bleeding events were observed in patients with hemophilia during the study period. Since the age in the H group at the time of starting antiviral treatment was 16 years younger than that in the NH group, careful observation is needed in patients with hemophilia even after eradication of HCV,” the researchers concluded.

The authors reported that they had no conflicts of interest.

[email protected]

Research has shown that hepatitis C virus infections in patients with hemophilia lead to the development of hepatocellular carcinoma (HCC) at a relatively younger age than that in patients without hemophilia. However, hemophilia was not a significant risk factor for hepatocarcinogenesis after sustained virologic response (SVR) against HCV, according to Yosuke Inukai of Nagoya (Japan) University and colleagues.

The researchers assessed 699 patients who achieved SVR after HCV antiviral treatment: 78 patients with hemophilia (H group) and 621 patients without hemophilia (NH group). They examined patient characteristics, clinical outcomes, and the cumulative incidence of HCC after SVR, according to a report published online in Annals of Hepatology.
 

No added risk

Patients in the H-group were significantly younger and had a lower hepatic fibrosis score, compared with the NH group. Over a follow-up period of 7 years, there were no differences seen in the incidence of liver-related disease or overall death between the two groups. HCC was diagnosed in 4 patients in the H group and 36 patients in the NH group after SVR.

Multivariate analysis showed that male sex, patient age, and the presence of cirrhosis were significant risk factors for HCC incidence. However, after propensity-score matching that adjusted for the risk factors of HCC between the two groups, there was no significant difference seen in the cumulative incidence of HCC between the two groups.
 

Need for vigilance

The lack of a significant difference in the cumulative incidence of HCC after SVR or the long-term prognosis in patients with and without hemophilia, suggests that SVR could reduce the rates of liver carcinogenesis and liver disease–related mortality in both groups of patients, the researchers stated.

However: “Although there were no differences in overall survival, deaths from liver failure and bleeding events were observed in patients with hemophilia during the study period. Since the age in the H group at the time of starting antiviral treatment was 16 years younger than that in the NH group, careful observation is needed in patients with hemophilia even after eradication of HCV,” the researchers concluded.

The authors reported that they had no conflicts of interest.

[email protected]

Research has shown that hepatitis C virus infections in patients with hemophilia lead to the development of hepatocellular carcinoma (HCC) at a relatively younger age than that in patients without hemophilia. However, hemophilia was not a significant risk factor for hepatocarcinogenesis after sustained virologic response (SVR) against HCV, according to Yosuke Inukai of Nagoya (Japan) University and colleagues.

The researchers assessed 699 patients who achieved SVR after HCV antiviral treatment: 78 patients with hemophilia (H group) and 621 patients without hemophilia (NH group). They examined patient characteristics, clinical outcomes, and the cumulative incidence of HCC after SVR, according to a report published online in Annals of Hepatology.
 

No added risk

Patients in the H-group were significantly younger and had a lower hepatic fibrosis score, compared with the NH group. Over a follow-up period of 7 years, there were no differences seen in the incidence of liver-related disease or overall death between the two groups. HCC was diagnosed in 4 patients in the H group and 36 patients in the NH group after SVR.

Multivariate analysis showed that male sex, patient age, and the presence of cirrhosis were significant risk factors for HCC incidence. However, after propensity-score matching that adjusted for the risk factors of HCC between the two groups, there was no significant difference seen in the cumulative incidence of HCC between the two groups.
 

Need for vigilance

The lack of a significant difference in the cumulative incidence of HCC after SVR or the long-term prognosis in patients with and without hemophilia, suggests that SVR could reduce the rates of liver carcinogenesis and liver disease–related mortality in both groups of patients, the researchers stated.

However: “Although there were no differences in overall survival, deaths from liver failure and bleeding events were observed in patients with hemophilia during the study period. Since the age in the H group at the time of starting antiviral treatment was 16 years younger than that in the NH group, careful observation is needed in patients with hemophilia even after eradication of HCV,” the researchers concluded.

The authors reported that they had no conflicts of interest.

[email protected]

Johnson & Johnson asked the Food and Drug Administration (FDA) on Tuesday to authorize an extra dose of its COVID-19 vaccine as a booster shot.

The company said it filed a request for people ages 18 and older who have received the one-shot vaccine. Johnson & Johnson submitted data for several different booster intervals -- ranging from 2 months to 6 months -- but didn’t formally recommend one to the FDA, The Associated Press reported.

“We’re describing the data to them,” Mathai Mammen, MD, head of global research and development for Janssen, the company’s vaccine division, told CNN.

“The process is not that we asked for a very specific interval -- we’re providing them data and we’re going to be presenting to the committee,” he said. “They’ll take all that into consideration when they ultimately decide on an appropriate interval.”

The FDA’s independent vaccine advisory committee meets next week to review data on booster shots from both Johnson & Johnson and Moderna. It’s the first step in the review process, which then requires approval from leaders at the FDA and Centers for Disease Control and Prevention. If both agencies authorize the extra shots, Americans could receive boosters from Johnson & Johnson and Moderna later this month, the AP reported.

Johnson & Johnson previously released data that showed the vaccine remains highly effective against COVID-19 at least 5 months after vaccination, with 81% efficacy against hospitalizations in the United States.

Two weeks ago, the company reported that a booster dose at 2 months or 6 months further lifted immunity, with a booster at 2 months providing 94% protection against moderate and severe COVID-19. The company said the 6-month booster raised antibodies by 12 times but didn’t release additional data at that time.

In September, the FDA authorized booster shots of the Pfizer vaccine for ages 65 and older, those who live in long-term care facilities, and those with higher risks for contracting COVID-19. The Biden administration is supporting a booster campaign to address potential waning vaccine immunity and remaining surges of the more contagious Delta variant, the AP reported.

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

Johnson & Johnson asked the Food and Drug Administration (FDA) on Tuesday to authorize an extra dose of its COVID-19 vaccine as a booster shot.

The company said it filed a request for people ages 18 and older who have received the one-shot vaccine. Johnson & Johnson submitted data for several different booster intervals -- ranging from 2 months to 6 months -- but didn’t formally recommend one to the FDA, The Associated Press reported.

“We’re describing the data to them,” Mathai Mammen, MD, head of global research and development for Janssen, the company’s vaccine division, told CNN.

“The process is not that we asked for a very specific interval -- we’re providing them data and we’re going to be presenting to the committee,” he said. “They’ll take all that into consideration when they ultimately decide on an appropriate interval.”

The FDA’s independent vaccine advisory committee meets next week to review data on booster shots from both Johnson & Johnson and Moderna. It’s the first step in the review process, which then requires approval from leaders at the FDA and Centers for Disease Control and Prevention. If both agencies authorize the extra shots, Americans could receive boosters from Johnson & Johnson and Moderna later this month, the AP reported.

Johnson & Johnson previously released data that showed the vaccine remains highly effective against COVID-19 at least 5 months after vaccination, with 81% efficacy against hospitalizations in the United States.

Two weeks ago, the company reported that a booster dose at 2 months or 6 months further lifted immunity, with a booster at 2 months providing 94% protection against moderate and severe COVID-19. The company said the 6-month booster raised antibodies by 12 times but didn’t release additional data at that time.

In September, the FDA authorized booster shots of the Pfizer vaccine for ages 65 and older, those who live in long-term care facilities, and those with higher risks for contracting COVID-19. The Biden administration is supporting a booster campaign to address potential waning vaccine immunity and remaining surges of the more contagious Delta variant, the AP reported.

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

Johnson & Johnson asked the Food and Drug Administration (FDA) on Tuesday to authorize an extra dose of its COVID-19 vaccine as a booster shot.

The company said it filed a request for people ages 18 and older who have received the one-shot vaccine. Johnson & Johnson submitted data for several different booster intervals -- ranging from 2 months to 6 months -- but didn’t formally recommend one to the FDA, The Associated Press reported.

“We’re describing the data to them,” Mathai Mammen, MD, head of global research and development for Janssen, the company’s vaccine division, told CNN.

“The process is not that we asked for a very specific interval -- we’re providing them data and we’re going to be presenting to the committee,” he said. “They’ll take all that into consideration when they ultimately decide on an appropriate interval.”

The FDA’s independent vaccine advisory committee meets next week to review data on booster shots from both Johnson & Johnson and Moderna. It’s the first step in the review process, which then requires approval from leaders at the FDA and Centers for Disease Control and Prevention. If both agencies authorize the extra shots, Americans could receive boosters from Johnson & Johnson and Moderna later this month, the AP reported.

Johnson & Johnson previously released data that showed the vaccine remains highly effective against COVID-19 at least 5 months after vaccination, with 81% efficacy against hospitalizations in the United States.

Two weeks ago, the company reported that a booster dose at 2 months or 6 months further lifted immunity, with a booster at 2 months providing 94% protection against moderate and severe COVID-19. The company said the 6-month booster raised antibodies by 12 times but didn’t release additional data at that time.

In September, the FDA authorized booster shots of the Pfizer vaccine for ages 65 and older, those who live in long-term care facilities, and those with higher risks for contracting COVID-19. The Biden administration is supporting a booster campaign to address potential waning vaccine immunity and remaining surges of the more contagious Delta variant, the AP reported.

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

Baricitinib, an oral inhibitor of Janus kinase (JAK) types 1 and 2, produced substantial rates of hair growth with acceptable tolerability for patients with alopecia areata, according to the results of two phase 3 trials presented at the European Academy of Dermatology and Venereology (EADV) 2021 Annual Meeting.

In both trials, severe alopecia areata, defined as a SALT (Severity of Alopecia Tool) score of greater than or equal to 50, was an enrollment requirement. The primary endpoint was a SALT score of less than or equal to 20, signifying 80% scalp coverage.

“The mean SALT score at entry was 85,” reported Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn. He explained that the SALT scale extends from 0 (no hair loss) to 100 (complete hair loss). About 45% of patients in the phase 3 trials had alopecia universalis.

In both trials, called BRAVE-AA1 and BRAVE-AA2, a response was seen with baricitinib after about 4 weeks. Response increased steadily through the entire 36 weeks of treatment. At the end of 36 weeks, when response curves still had an upward trajectory, the proportion of those treated with the 4-mg dose of baricitinib who had achieved a SALT score of less than or equal to 20 had reached 35.2% in BRAVE-AA1 and 32.5% in BRAVE-AA2.

The nearly identical BRAVE-AA1 and BRAVE-AA2 trials enrolled 654 and 546 patients, respectively. The patients were randomly assigned in a 3:2:2 ratio to receive baricitinib 4 mg, baricitinib 2 mg, or placebo. All treatments were taken once daily. Regrowth of eyebrow and eyelash hair were secondary outcomes.

There was a clear dose effect; hair growth increased more quickly with the 4-mg dose of baricitinib than with the 2-mg dose. The difference between the active therapy and placebo was significant by 16 weeks with the 4-mg dose. By 24 weeks, the advantage of the 2-mg dose over placebo also reached significance. The response rate with the 4-mg dose was nearly twice as great.

At the end of the 36-week trials, the proportion of patients treated with baricitinib 2 mg who achieved the primary endpoint was 21.7% and 17.3% in the BRAVE-AA1 and BRAVE-AA2 trials, respectively. Among patients taking placebo, the primary endpoint was met by 5.3% and 2.6%, respectively, at the end of the two trials.

The differences in responses with the 4-mg and the 2-mg doses were significantly higher compared with placebo (P ≤ .001 for both doses vs. placebo).

Using a scoring system for eyebrow and eyelash hair loss, the proportion of patients who achieved a score of 0 (full coverage) or 1 (minimal gaps) was again superior in both trials for patients taking the higher dose of baricitinib. This level of response was reached by about 31% to 35% of those taking the 4-mg dose in BRAVE-AA1 and BRAVE-AA2 (P ≤ .001 vs. placebo). With the lower dose, the rates were 19.1% and 13.5%, respectively. This endpoint was reached in only about 3% of patients who took placebo.

Rates of adverse events were modestly higher in the two active treatment groups in comparison with the group taking placebo. The most commonly occurring adverse events with baricitinib included upper respiratory tract infections, nasopharyngitis, urinary tract infections, and headache, according to Dr. King.

“Most of the adverse events were mild to moderate,” he said. He also reported that none of these adverse events occurred in more than 10% of patients, and there were no cases of other opportunistic infections, thromboembolic events, or gastrointestinal perforations. The discontinuation rates because of adverse events with active therapy were less than 3% in both trials.

JAK inhibitors are currently employed in the treatment of a variety of inflammatory diseases. Baricitinib is currently approved for the treatment of rheumatoid arthritis. Because specificity differs markedly for their inhibition of JAK kinases (JAK1, JAK2, JAK3, and Tyk2), these drugs do not appear to be interchangeable with regard to clinical effect.

Several case reports of hair regrowth with baricitinib led to a phase 2 trial, which was recently published in the Journal of the American Academy of Dermatology. In this trial, the therapy also yielded substantial benefit for patients with alopecia areata. The benefit of baricitinib is attributed to inhibition of JAK1 and JAK2 signaling, which has been implicated in cytokine-mediated immune dysfunction leading to damage of hair follicles.

Alopecia areata is a common disorder that can have a large adverse impact on quality of life, Dr. King noted. There is no approved therapy for this condition, so there is a large unmet need. Although longer follow-up is needed to gauge sustained efficacy and safety, he considers these results promising for a therapy with clinically meaningful benefit.

This point was reiterated by Yolanda Gilaberte Calzada, MD, PhD, head of the Dermatology Service, University Hospital Miguel Servet, Zaragoza, Spain, who was moderator of the session in which Dr. King presented these data. She expressed excitement about the promise of baricitinib, particularly with regard to the substantial proportion of patients who achieved meaningful degrees of hair regrowth.

“All of us will be happy to have options for alopecia areata,” said Dr. Calzada, who predicted that the higher dose of baricitinib will be selected for clinical development, given its greater efficacy with little increase in safety concerns.

Eli Lilly provided funding for the BRAVE-AA1 and -AA2 trials. Dr. King has financial relationships with Arena, Aclaris, Bristol-Myers Squibb, Concert, Pfizer, Regeneron, Sanofi Genzyme, and Eli Lilly. Dr. Calzada has disclosed no relevant financial relationships.

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

Baricitinib, an oral inhibitor of Janus kinase (JAK) types 1 and 2, produced substantial rates of hair growth with acceptable tolerability for patients with alopecia areata, according to the results of two phase 3 trials presented at the European Academy of Dermatology and Venereology (EADV) 2021 Annual Meeting.

In both trials, severe alopecia areata, defined as a SALT (Severity of Alopecia Tool) score of greater than or equal to 50, was an enrollment requirement. The primary endpoint was a SALT score of less than or equal to 20, signifying 80% scalp coverage.

“The mean SALT score at entry was 85,” reported Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn. He explained that the SALT scale extends from 0 (no hair loss) to 100 (complete hair loss). About 45% of patients in the phase 3 trials had alopecia universalis.

In both trials, called BRAVE-AA1 and BRAVE-AA2, a response was seen with baricitinib after about 4 weeks. Response increased steadily through the entire 36 weeks of treatment. At the end of 36 weeks, when response curves still had an upward trajectory, the proportion of those treated with the 4-mg dose of baricitinib who had achieved a SALT score of less than or equal to 20 had reached 35.2% in BRAVE-AA1 and 32.5% in BRAVE-AA2.

The nearly identical BRAVE-AA1 and BRAVE-AA2 trials enrolled 654 and 546 patients, respectively. The patients were randomly assigned in a 3:2:2 ratio to receive baricitinib 4 mg, baricitinib 2 mg, or placebo. All treatments were taken once daily. Regrowth of eyebrow and eyelash hair were secondary outcomes.

There was a clear dose effect; hair growth increased more quickly with the 4-mg dose of baricitinib than with the 2-mg dose. The difference between the active therapy and placebo was significant by 16 weeks with the 4-mg dose. By 24 weeks, the advantage of the 2-mg dose over placebo also reached significance. The response rate with the 4-mg dose was nearly twice as great.

At the end of the 36-week trials, the proportion of patients treated with baricitinib 2 mg who achieved the primary endpoint was 21.7% and 17.3% in the BRAVE-AA1 and BRAVE-AA2 trials, respectively. Among patients taking placebo, the primary endpoint was met by 5.3% and 2.6%, respectively, at the end of the two trials.

The differences in responses with the 4-mg and the 2-mg doses were significantly higher compared with placebo (P ≤ .001 for both doses vs. placebo).

Using a scoring system for eyebrow and eyelash hair loss, the proportion of patients who achieved a score of 0 (full coverage) or 1 (minimal gaps) was again superior in both trials for patients taking the higher dose of baricitinib. This level of response was reached by about 31% to 35% of those taking the 4-mg dose in BRAVE-AA1 and BRAVE-AA2 (P ≤ .001 vs. placebo). With the lower dose, the rates were 19.1% and 13.5%, respectively. This endpoint was reached in only about 3% of patients who took placebo.

Rates of adverse events were modestly higher in the two active treatment groups in comparison with the group taking placebo. The most commonly occurring adverse events with baricitinib included upper respiratory tract infections, nasopharyngitis, urinary tract infections, and headache, according to Dr. King.

“Most of the adverse events were mild to moderate,” he said. He also reported that none of these adverse events occurred in more than 10% of patients, and there were no cases of other opportunistic infections, thromboembolic events, or gastrointestinal perforations. The discontinuation rates because of adverse events with active therapy were less than 3% in both trials.

JAK inhibitors are currently employed in the treatment of a variety of inflammatory diseases. Baricitinib is currently approved for the treatment of rheumatoid arthritis. Because specificity differs markedly for their inhibition of JAK kinases (JAK1, JAK2, JAK3, and Tyk2), these drugs do not appear to be interchangeable with regard to clinical effect.

Several case reports of hair regrowth with baricitinib led to a phase 2 trial, which was recently published in the Journal of the American Academy of Dermatology. In this trial, the therapy also yielded substantial benefit for patients with alopecia areata. The benefit of baricitinib is attributed to inhibition of JAK1 and JAK2 signaling, which has been implicated in cytokine-mediated immune dysfunction leading to damage of hair follicles.

Alopecia areata is a common disorder that can have a large adverse impact on quality of life, Dr. King noted. There is no approved therapy for this condition, so there is a large unmet need. Although longer follow-up is needed to gauge sustained efficacy and safety, he considers these results promising for a therapy with clinically meaningful benefit.

This point was reiterated by Yolanda Gilaberte Calzada, MD, PhD, head of the Dermatology Service, University Hospital Miguel Servet, Zaragoza, Spain, who was moderator of the session in which Dr. King presented these data. She expressed excitement about the promise of baricitinib, particularly with regard to the substantial proportion of patients who achieved meaningful degrees of hair regrowth.

“All of us will be happy to have options for alopecia areata,” said Dr. Calzada, who predicted that the higher dose of baricitinib will be selected for clinical development, given its greater efficacy with little increase in safety concerns.

Eli Lilly provided funding for the BRAVE-AA1 and -AA2 trials. Dr. King has financial relationships with Arena, Aclaris, Bristol-Myers Squibb, Concert, Pfizer, Regeneron, Sanofi Genzyme, and Eli Lilly. Dr. Calzada has disclosed no relevant financial relationships.

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

Baricitinib, an oral inhibitor of Janus kinase (JAK) types 1 and 2, produced substantial rates of hair growth with acceptable tolerability for patients with alopecia areata, according to the results of two phase 3 trials presented at the European Academy of Dermatology and Venereology (EADV) 2021 Annual Meeting.

In both trials, severe alopecia areata, defined as a SALT (Severity of Alopecia Tool) score of greater than or equal to 50, was an enrollment requirement. The primary endpoint was a SALT score of less than or equal to 20, signifying 80% scalp coverage.

“The mean SALT score at entry was 85,” reported Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn. He explained that the SALT scale extends from 0 (no hair loss) to 100 (complete hair loss). About 45% of patients in the phase 3 trials had alopecia universalis.

In both trials, called BRAVE-AA1 and BRAVE-AA2, a response was seen with baricitinib after about 4 weeks. Response increased steadily through the entire 36 weeks of treatment. At the end of 36 weeks, when response curves still had an upward trajectory, the proportion of those treated with the 4-mg dose of baricitinib who had achieved a SALT score of less than or equal to 20 had reached 35.2% in BRAVE-AA1 and 32.5% in BRAVE-AA2.

The nearly identical BRAVE-AA1 and BRAVE-AA2 trials enrolled 654 and 546 patients, respectively. The patients were randomly assigned in a 3:2:2 ratio to receive baricitinib 4 mg, baricitinib 2 mg, or placebo. All treatments were taken once daily. Regrowth of eyebrow and eyelash hair were secondary outcomes.

There was a clear dose effect; hair growth increased more quickly with the 4-mg dose of baricitinib than with the 2-mg dose. The difference between the active therapy and placebo was significant by 16 weeks with the 4-mg dose. By 24 weeks, the advantage of the 2-mg dose over placebo also reached significance. The response rate with the 4-mg dose was nearly twice as great.

At the end of the 36-week trials, the proportion of patients treated with baricitinib 2 mg who achieved the primary endpoint was 21.7% and 17.3% in the BRAVE-AA1 and BRAVE-AA2 trials, respectively. Among patients taking placebo, the primary endpoint was met by 5.3% and 2.6%, respectively, at the end of the two trials.

The differences in responses with the 4-mg and the 2-mg doses were significantly higher compared with placebo (P ≤ .001 for both doses vs. placebo).

Using a scoring system for eyebrow and eyelash hair loss, the proportion of patients who achieved a score of 0 (full coverage) or 1 (minimal gaps) was again superior in both trials for patients taking the higher dose of baricitinib. This level of response was reached by about 31% to 35% of those taking the 4-mg dose in BRAVE-AA1 and BRAVE-AA2 (P ≤ .001 vs. placebo). With the lower dose, the rates were 19.1% and 13.5%, respectively. This endpoint was reached in only about 3% of patients who took placebo.

Rates of adverse events were modestly higher in the two active treatment groups in comparison with the group taking placebo. The most commonly occurring adverse events with baricitinib included upper respiratory tract infections, nasopharyngitis, urinary tract infections, and headache, according to Dr. King.

“Most of the adverse events were mild to moderate,” he said. He also reported that none of these adverse events occurred in more than 10% of patients, and there were no cases of other opportunistic infections, thromboembolic events, or gastrointestinal perforations. The discontinuation rates because of adverse events with active therapy were less than 3% in both trials.

JAK inhibitors are currently employed in the treatment of a variety of inflammatory diseases. Baricitinib is currently approved for the treatment of rheumatoid arthritis. Because specificity differs markedly for their inhibition of JAK kinases (JAK1, JAK2, JAK3, and Tyk2), these drugs do not appear to be interchangeable with regard to clinical effect.

Several case reports of hair regrowth with baricitinib led to a phase 2 trial, which was recently published in the Journal of the American Academy of Dermatology. In this trial, the therapy also yielded substantial benefit for patients with alopecia areata. The benefit of baricitinib is attributed to inhibition of JAK1 and JAK2 signaling, which has been implicated in cytokine-mediated immune dysfunction leading to damage of hair follicles.

Alopecia areata is a common disorder that can have a large adverse impact on quality of life, Dr. King noted. There is no approved therapy for this condition, so there is a large unmet need. Although longer follow-up is needed to gauge sustained efficacy and safety, he considers these results promising for a therapy with clinically meaningful benefit.

This point was reiterated by Yolanda Gilaberte Calzada, MD, PhD, head of the Dermatology Service, University Hospital Miguel Servet, Zaragoza, Spain, who was moderator of the session in which Dr. King presented these data. She expressed excitement about the promise of baricitinib, particularly with regard to the substantial proportion of patients who achieved meaningful degrees of hair regrowth.

“All of us will be happy to have options for alopecia areata,” said Dr. Calzada, who predicted that the higher dose of baricitinib will be selected for clinical development, given its greater efficacy with little increase in safety concerns.

Eli Lilly provided funding for the BRAVE-AA1 and -AA2 trials. Dr. King has financial relationships with Arena, Aclaris, Bristol-Myers Squibb, Concert, Pfizer, Regeneron, Sanofi Genzyme, and Eli Lilly. Dr. Calzada has disclosed no relevant financial relationships.

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