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Christopher Palmer has been an associate editor at MDedge News since 2017. When he's not tidying grammar, he writes short pieces about breaking FDA announcements and approvals, as well as journal articles. He proudly holds a BA in English and philosophy. Follow him on Twitter @cmacmpalm.
FDA gives green light to freeze-dried plasma in combat
The Department of Defense has received emergency use authorization from the Food and Drug Administration to use pathogen-reduced, leukocyte-depleted, freeze-dried plasma for the emergency treatment of hemorrhage and coagulopathy in combat situations.
Hemorrhage and coagulopathy are the leading causes of preventable deaths among combat trauma casualties. While plasma contains proteins that help clot blood and thus can treat these conditions, it isn’t feasible to keep it on hand for combat emergencies in the field because of logistical and operational requirements, such as refrigeration or thawing periods. This freeze-dried plasma product, on the other hand, can be easily reconstituted in situations in which refrigeration isn’t possible.
The FDA authorization allows for the use of a French-made, powdered, freeze-dried product. This emergency use authorization came about in part because of a joint program established between the FDA and the Department of Defense in January 2018.
“Earlier this year, we reaffirmed our commitment to the Department of Defense and to the dedicated men and women protecting our country, by expediting the development and availability of safe and effective, priority medical products that are essential to the health of our military service members,” said FDA commissioner Scott Gottlieb, MD. “This is especially true when it comes to products used to treat injuries in a potential battlefield setting.”
More information about this emergency use authorization can be found in the FDA’s full press announcement.
The Department of Defense has received emergency use authorization from the Food and Drug Administration to use pathogen-reduced, leukocyte-depleted, freeze-dried plasma for the emergency treatment of hemorrhage and coagulopathy in combat situations.
Hemorrhage and coagulopathy are the leading causes of preventable deaths among combat trauma casualties. While plasma contains proteins that help clot blood and thus can treat these conditions, it isn’t feasible to keep it on hand for combat emergencies in the field because of logistical and operational requirements, such as refrigeration or thawing periods. This freeze-dried plasma product, on the other hand, can be easily reconstituted in situations in which refrigeration isn’t possible.
The FDA authorization allows for the use of a French-made, powdered, freeze-dried product. This emergency use authorization came about in part because of a joint program established between the FDA and the Department of Defense in January 2018.
“Earlier this year, we reaffirmed our commitment to the Department of Defense and to the dedicated men and women protecting our country, by expediting the development and availability of safe and effective, priority medical products that are essential to the health of our military service members,” said FDA commissioner Scott Gottlieb, MD. “This is especially true when it comes to products used to treat injuries in a potential battlefield setting.”
More information about this emergency use authorization can be found in the FDA’s full press announcement.
The Department of Defense has received emergency use authorization from the Food and Drug Administration to use pathogen-reduced, leukocyte-depleted, freeze-dried plasma for the emergency treatment of hemorrhage and coagulopathy in combat situations.
Hemorrhage and coagulopathy are the leading causes of preventable deaths among combat trauma casualties. While plasma contains proteins that help clot blood and thus can treat these conditions, it isn’t feasible to keep it on hand for combat emergencies in the field because of logistical and operational requirements, such as refrigeration or thawing periods. This freeze-dried plasma product, on the other hand, can be easily reconstituted in situations in which refrigeration isn’t possible.
The FDA authorization allows for the use of a French-made, powdered, freeze-dried product. This emergency use authorization came about in part because of a joint program established between the FDA and the Department of Defense in January 2018.
“Earlier this year, we reaffirmed our commitment to the Department of Defense and to the dedicated men and women protecting our country, by expediting the development and availability of safe and effective, priority medical products that are essential to the health of our military service members,” said FDA commissioner Scott Gottlieb, MD. “This is especially true when it comes to products used to treat injuries in a potential battlefield setting.”
More information about this emergency use authorization can be found in the FDA’s full press announcement.
FDA recommends pooled Zika testing of blood donations
The moving away from individual testing of donations and toward pooled testing.
“This [practice of pooled testing] is usually more cost effective and less burdensome for blood establishments,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement. “However, the FDA will continue to monitor the situation closely and, as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”
The new testing recommendations reflect the decreasing number of cases of Zika virus infection in the U.S. and its territories, as well as advice from the agency’s Blood Products Advisory Committee.
The guidance makes an exception to its pooled testing recommendations: Donations from areas where a positive donation has been detected or in which the risk of mosquito-borne transmission of Zika virus is high should be tested individually. The guidance also allows the use of an FDA-approved pathogen-reduction device for plasma and certain platelet products.
The moving away from individual testing of donations and toward pooled testing.
“This [practice of pooled testing] is usually more cost effective and less burdensome for blood establishments,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement. “However, the FDA will continue to monitor the situation closely and, as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”
The new testing recommendations reflect the decreasing number of cases of Zika virus infection in the U.S. and its territories, as well as advice from the agency’s Blood Products Advisory Committee.
The guidance makes an exception to its pooled testing recommendations: Donations from areas where a positive donation has been detected or in which the risk of mosquito-borne transmission of Zika virus is high should be tested individually. The guidance also allows the use of an FDA-approved pathogen-reduction device for plasma and certain platelet products.
The moving away from individual testing of donations and toward pooled testing.
“This [practice of pooled testing] is usually more cost effective and less burdensome for blood establishments,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement. “However, the FDA will continue to monitor the situation closely and, as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”
The new testing recommendations reflect the decreasing number of cases of Zika virus infection in the U.S. and its territories, as well as advice from the agency’s Blood Products Advisory Committee.
The guidance makes an exception to its pooled testing recommendations: Donations from areas where a positive donation has been detected or in which the risk of mosquito-borne transmission of Zika virus is high should be tested individually. The guidance also allows the use of an FDA-approved pathogen-reduction device for plasma and certain platelet products.
Refusal number fuels sexual hostility in men
The more sexual refusals men received in a virtual dating simulation, the more hostile the verbal comments men made to the women – regardless of the amount of alcohol the men had consumed, according to a study published in Aggressive Behavior.
“Contrary to our predictions [the relationship between sexual refusals and hostile comments] was not moderated by alcohol condition,” reported Jacqueline Woerner, PhD, and her colleagues. “Because participants had multiple opportunities to escalate their aggression or desist, this paradigm provides new insights into the mechanisms through which intoxication enhances the likelihood of sexual aggression in dating situations.”Dr. Woerner and her colleagues used a virtual dating simulation to compare the sexual aggression of 31 intoxicated men with that of an equal number sober controls. The men, aged 21-29 years and largely white, received either a mixed alcoholic drink adjusted to achieve a blood alcohol concentration of 0.08% or an alcohol-free beverage.
The men went on four computer-mediated dates with a virtual woman; the simulated dates covered a span of a couple of months during the session. The woman was programmed to always consent to some lower-level sexual activities (such as kissing), to consent to some medium-level activities (such as touching breasts) only during later dates, but to always refuse higher-level sexual activities (such as vaginal or oral sex).
As hypothesized, the number of consensual sexual activities correlated with the number of refusals, which suggested that, per expectancy confirmation theory, these men tended to focus on earlier cues that confirmed mutual sexual desire and to ignore those that suggested that the woman was no longer interested, according to the researchers. This correlation and the behaviors it suggests were significantly stronger among intoxicated men than they were among sober controls, reported Dr. Woerner, now affiliated with Yale University, New Haven, Conn., and her colleagues.
However, when the researchers examined the impact of alcohol on the relationship between sexual refusals and the number of hostile verbal comments, they got surprising results. The connection between sexual refusals and alcohol condition was not significant. Among the possible explanations for this unexpected finding were the “extremely high levels of hostility” of some men toward women and the sense of entitlement of some men toward women – whether the men are intoxicated or sober. Dr. Woerner and her colleagues wrote.
Dr. Woerner and her colleagues also recorded audio of participants as they interacted with the simulation. The intensity of the commentary – with comments like “You prude, we’ve been hanging out for months now” – suggested the participants took the simulation seriously, the researchers noted.
The study was funded by the National Institute on Alcohol Abuse and Alcoholism.
SOURCE: Woerner J et al. Aggress Behav. 2018. doi: 10.1002/ab.21773.
The more sexual refusals men received in a virtual dating simulation, the more hostile the verbal comments men made to the women – regardless of the amount of alcohol the men had consumed, according to a study published in Aggressive Behavior.
“Contrary to our predictions [the relationship between sexual refusals and hostile comments] was not moderated by alcohol condition,” reported Jacqueline Woerner, PhD, and her colleagues. “Because participants had multiple opportunities to escalate their aggression or desist, this paradigm provides new insights into the mechanisms through which intoxication enhances the likelihood of sexual aggression in dating situations.”Dr. Woerner and her colleagues used a virtual dating simulation to compare the sexual aggression of 31 intoxicated men with that of an equal number sober controls. The men, aged 21-29 years and largely white, received either a mixed alcoholic drink adjusted to achieve a blood alcohol concentration of 0.08% or an alcohol-free beverage.
The men went on four computer-mediated dates with a virtual woman; the simulated dates covered a span of a couple of months during the session. The woman was programmed to always consent to some lower-level sexual activities (such as kissing), to consent to some medium-level activities (such as touching breasts) only during later dates, but to always refuse higher-level sexual activities (such as vaginal or oral sex).
As hypothesized, the number of consensual sexual activities correlated with the number of refusals, which suggested that, per expectancy confirmation theory, these men tended to focus on earlier cues that confirmed mutual sexual desire and to ignore those that suggested that the woman was no longer interested, according to the researchers. This correlation and the behaviors it suggests were significantly stronger among intoxicated men than they were among sober controls, reported Dr. Woerner, now affiliated with Yale University, New Haven, Conn., and her colleagues.
However, when the researchers examined the impact of alcohol on the relationship between sexual refusals and the number of hostile verbal comments, they got surprising results. The connection between sexual refusals and alcohol condition was not significant. Among the possible explanations for this unexpected finding were the “extremely high levels of hostility” of some men toward women and the sense of entitlement of some men toward women – whether the men are intoxicated or sober. Dr. Woerner and her colleagues wrote.
Dr. Woerner and her colleagues also recorded audio of participants as they interacted with the simulation. The intensity of the commentary – with comments like “You prude, we’ve been hanging out for months now” – suggested the participants took the simulation seriously, the researchers noted.
The study was funded by the National Institute on Alcohol Abuse and Alcoholism.
SOURCE: Woerner J et al. Aggress Behav. 2018. doi: 10.1002/ab.21773.
The more sexual refusals men received in a virtual dating simulation, the more hostile the verbal comments men made to the women – regardless of the amount of alcohol the men had consumed, according to a study published in Aggressive Behavior.
“Contrary to our predictions [the relationship between sexual refusals and hostile comments] was not moderated by alcohol condition,” reported Jacqueline Woerner, PhD, and her colleagues. “Because participants had multiple opportunities to escalate their aggression or desist, this paradigm provides new insights into the mechanisms through which intoxication enhances the likelihood of sexual aggression in dating situations.”Dr. Woerner and her colleagues used a virtual dating simulation to compare the sexual aggression of 31 intoxicated men with that of an equal number sober controls. The men, aged 21-29 years and largely white, received either a mixed alcoholic drink adjusted to achieve a blood alcohol concentration of 0.08% or an alcohol-free beverage.
The men went on four computer-mediated dates with a virtual woman; the simulated dates covered a span of a couple of months during the session. The woman was programmed to always consent to some lower-level sexual activities (such as kissing), to consent to some medium-level activities (such as touching breasts) only during later dates, but to always refuse higher-level sexual activities (such as vaginal or oral sex).
As hypothesized, the number of consensual sexual activities correlated with the number of refusals, which suggested that, per expectancy confirmation theory, these men tended to focus on earlier cues that confirmed mutual sexual desire and to ignore those that suggested that the woman was no longer interested, according to the researchers. This correlation and the behaviors it suggests were significantly stronger among intoxicated men than they were among sober controls, reported Dr. Woerner, now affiliated with Yale University, New Haven, Conn., and her colleagues.
However, when the researchers examined the impact of alcohol on the relationship between sexual refusals and the number of hostile verbal comments, they got surprising results. The connection between sexual refusals and alcohol condition was not significant. Among the possible explanations for this unexpected finding were the “extremely high levels of hostility” of some men toward women and the sense of entitlement of some men toward women – whether the men are intoxicated or sober. Dr. Woerner and her colleagues wrote.
Dr. Woerner and her colleagues also recorded audio of participants as they interacted with the simulation. The intensity of the commentary – with comments like “You prude, we’ve been hanging out for months now” – suggested the participants took the simulation seriously, the researchers noted.
The study was funded by the National Institute on Alcohol Abuse and Alcoholism.
SOURCE: Woerner J et al. Aggress Behav. 2018. doi: 10.1002/ab.21773.
FROM AGGRESSIVE BEHAVIOR
FDA approves Aristada Initio for schizophrenia
The Food and Drug Administration has approved aripiprazole lauroxil (Aristada Initio) for the initiation of aripiprazole lauroxil (Aristada) for treating schizophrenia in adults, the drug’s developer, Alkermes, announced July 2 in a press release.
“,” Craig Hopkinson, MD, chief medical officer at Alkermes, said in the press release.
The standard initiation regimen for aripiprazole lauroxil previously was 21 consecutive days of oral aripiprazole starting with the first dose of Aristada. The alternative initiation regimen allows patients to achieve “relevant levels of aripiprazole within 4 days of initiation,” according to Alkermes. The result gives health care providers “an additional tool to support patients.”
One important advantage of Aristada Initio is that, in addition to monthly and 6-week dosing options, it offers a 2-month option.
Aristada and Aristada Initio both contain aripiprazole lauroxil, but the drugs are not interchangeable because they have different pharmacokinetic profiles, the company said. In addition, Aristada Initio is to be administered a single time only.
Aristada Initio has exhibited some of the same adverse events as other atypical antipsychotics, including neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes. Injection-site reactions also have been observed.
Aristada Initio is expected to become available by mid-July.
Full prescribing information and boxed warnings can be found on the Alkermes website.
The Food and Drug Administration has approved aripiprazole lauroxil (Aristada Initio) for the initiation of aripiprazole lauroxil (Aristada) for treating schizophrenia in adults, the drug’s developer, Alkermes, announced July 2 in a press release.
“,” Craig Hopkinson, MD, chief medical officer at Alkermes, said in the press release.
The standard initiation regimen for aripiprazole lauroxil previously was 21 consecutive days of oral aripiprazole starting with the first dose of Aristada. The alternative initiation regimen allows patients to achieve “relevant levels of aripiprazole within 4 days of initiation,” according to Alkermes. The result gives health care providers “an additional tool to support patients.”
One important advantage of Aristada Initio is that, in addition to monthly and 6-week dosing options, it offers a 2-month option.
Aristada and Aristada Initio both contain aripiprazole lauroxil, but the drugs are not interchangeable because they have different pharmacokinetic profiles, the company said. In addition, Aristada Initio is to be administered a single time only.
Aristada Initio has exhibited some of the same adverse events as other atypical antipsychotics, including neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes. Injection-site reactions also have been observed.
Aristada Initio is expected to become available by mid-July.
Full prescribing information and boxed warnings can be found on the Alkermes website.
The Food and Drug Administration has approved aripiprazole lauroxil (Aristada Initio) for the initiation of aripiprazole lauroxil (Aristada) for treating schizophrenia in adults, the drug’s developer, Alkermes, announced July 2 in a press release.
“,” Craig Hopkinson, MD, chief medical officer at Alkermes, said in the press release.
The standard initiation regimen for aripiprazole lauroxil previously was 21 consecutive days of oral aripiprazole starting with the first dose of Aristada. The alternative initiation regimen allows patients to achieve “relevant levels of aripiprazole within 4 days of initiation,” according to Alkermes. The result gives health care providers “an additional tool to support patients.”
One important advantage of Aristada Initio is that, in addition to monthly and 6-week dosing options, it offers a 2-month option.
Aristada and Aristada Initio both contain aripiprazole lauroxil, but the drugs are not interchangeable because they have different pharmacokinetic profiles, the company said. In addition, Aristada Initio is to be administered a single time only.
Aristada Initio has exhibited some of the same adverse events as other atypical antipsychotics, including neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes. Injection-site reactions also have been observed.
Aristada Initio is expected to become available by mid-July.
Full prescribing information and boxed warnings can be found on the Alkermes website.
FDA approves Zephyr endobronchial valve to treat severe emphysema
The valve is the first minimally invasive device approved in the United States for treating such patients, according to Pulmonx, the device manufacturer.
The FDA previously granted the novel device expedited review, as patients who did not respond to drug treatment had only limited alternative options, including lung volume reduction and lung transplant, Tina Kiang, PhD, of the FDA’s Center for Devices and Radiological Health, said in a press release. “This novel device is a less invasive treatment that expands the options available to patients,” said Dr. Kiang, acting director of the center’s Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices.
The approval is based on a multicenter study of 190 patients with severe emphysema. A total of 128 received Zephyr valves and medical management, while 62 received medical management only. The primary measure was the number of patients who achieved at least a 15% improvement in their pulmonary function score: At 1 year, 47.7% of the Zephyr valve patients had achieved such improvement versus 16.8% of the control group, according to the FDA.
Adverse events included death, pneumothorax, pneumonia, worsening of emphysema, coughing up blood, shortness of breath, and chest pain. The valve is contraindicated in patients with active lung infections; those allergic to nitinol, nickel, titanium, or silicone; and active smokers.
Read more about this approval in the full FDA press announcement.
The valve is the first minimally invasive device approved in the United States for treating such patients, according to Pulmonx, the device manufacturer.
The FDA previously granted the novel device expedited review, as patients who did not respond to drug treatment had only limited alternative options, including lung volume reduction and lung transplant, Tina Kiang, PhD, of the FDA’s Center for Devices and Radiological Health, said in a press release. “This novel device is a less invasive treatment that expands the options available to patients,” said Dr. Kiang, acting director of the center’s Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices.
The approval is based on a multicenter study of 190 patients with severe emphysema. A total of 128 received Zephyr valves and medical management, while 62 received medical management only. The primary measure was the number of patients who achieved at least a 15% improvement in their pulmonary function score: At 1 year, 47.7% of the Zephyr valve patients had achieved such improvement versus 16.8% of the control group, according to the FDA.
Adverse events included death, pneumothorax, pneumonia, worsening of emphysema, coughing up blood, shortness of breath, and chest pain. The valve is contraindicated in patients with active lung infections; those allergic to nitinol, nickel, titanium, or silicone; and active smokers.
Read more about this approval in the full FDA press announcement.
The valve is the first minimally invasive device approved in the United States for treating such patients, according to Pulmonx, the device manufacturer.
The FDA previously granted the novel device expedited review, as patients who did not respond to drug treatment had only limited alternative options, including lung volume reduction and lung transplant, Tina Kiang, PhD, of the FDA’s Center for Devices and Radiological Health, said in a press release. “This novel device is a less invasive treatment that expands the options available to patients,” said Dr. Kiang, acting director of the center’s Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices.
The approval is based on a multicenter study of 190 patients with severe emphysema. A total of 128 received Zephyr valves and medical management, while 62 received medical management only. The primary measure was the number of patients who achieved at least a 15% improvement in their pulmonary function score: At 1 year, 47.7% of the Zephyr valve patients had achieved such improvement versus 16.8% of the control group, according to the FDA.
Adverse events included death, pneumothorax, pneumonia, worsening of emphysema, coughing up blood, shortness of breath, and chest pain. The valve is contraindicated in patients with active lung infections; those allergic to nitinol, nickel, titanium, or silicone; and active smokers.
Read more about this approval in the full FDA press announcement.
FDA approves encorafenib/binimetinib for advanced melanoma with BRAF mutations
The Food and Drug Administration has approved combination therapy of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K mutations; the FDA also has approved the THxID BRAF Kit as a companion diagnostic for this combination therapy.
The approval was based on results from the randomized, active-controlled, open-label, multicenter COLUMBUS trial, which included 517 patients. Progression-free survival, according to RECIST 1.1 criteria, was the major efficacy measure; the median progression-free survival was 14.9 months in the encorafenib/binimetinib combination arm versus 7.3 months in the vemurafenib (Zelboraf) monotherapy arm (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P less than .0001).
Fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia were the most common adverse reactions. Discontinuation of therapy from adverse reactions occurred in 5% of patients receiving the combination, the FDA said in a press statement.
The full prescribing information for encorafenib and binimetinib can be found on the FDA website.
The Food and Drug Administration has approved combination therapy of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K mutations; the FDA also has approved the THxID BRAF Kit as a companion diagnostic for this combination therapy.
The approval was based on results from the randomized, active-controlled, open-label, multicenter COLUMBUS trial, which included 517 patients. Progression-free survival, according to RECIST 1.1 criteria, was the major efficacy measure; the median progression-free survival was 14.9 months in the encorafenib/binimetinib combination arm versus 7.3 months in the vemurafenib (Zelboraf) monotherapy arm (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P less than .0001).
Fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia were the most common adverse reactions. Discontinuation of therapy from adverse reactions occurred in 5% of patients receiving the combination, the FDA said in a press statement.
The full prescribing information for encorafenib and binimetinib can be found on the FDA website.
The Food and Drug Administration has approved combination therapy of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K mutations; the FDA also has approved the THxID BRAF Kit as a companion diagnostic for this combination therapy.
The approval was based on results from the randomized, active-controlled, open-label, multicenter COLUMBUS trial, which included 517 patients. Progression-free survival, according to RECIST 1.1 criteria, was the major efficacy measure; the median progression-free survival was 14.9 months in the encorafenib/binimetinib combination arm versus 7.3 months in the vemurafenib (Zelboraf) monotherapy arm (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P less than .0001).
Fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia were the most common adverse reactions. Discontinuation of therapy from adverse reactions occurred in 5% of patients receiving the combination, the FDA said in a press statement.
The full prescribing information for encorafenib and binimetinib can be found on the FDA website.
Midlife fitness tied to lower later-life CVD mortality, depression risk
Higher cardiorespiratory fitness at midlife appears linked to a lower risk of depression in later life. In addition, higher midlife fitness is associated with a lower risk of cardiovascular mortality when depression preceded CVD death, according to a retrospective study published in JAMA Psychiatry.
“These findings ... should encourage physicians to consider fitness and physical activity in promoting healthy aging,” wrote Benjamin L. Willis, MD, MPH, of the Cooper Institute in Dallas, and his associates.
The study included 17,989 participants from the Cooper Center Longitudinal Study and linked data from those participants with a depression diagnosis based on Medicare claims and cardiovascular disease (CVD) mortality rates based on the National Death Index.
The participants were mostly men (80.2%), and their mean age at midlife assessment was 50 years. The participants’ treadmill time at midlife was used to categorize them into age- and sex-specific quintiles, with quintile 1 representing low fitness, quintiles 2 and 3 representing moderate fitness, and quintiles 4 and 5 representing high fitness.
After 117,218 person-years of follow-up, the investigators observed 2,701 depression diagnoses, 610 deaths tied to cardiovascular disease without prior depression, and 231 deaths associated with CVD after depression.
In addition, Dr. Willis and his associates found that (hazard ratio, 0.84; 95% confidence interval, 0.74-0.95), compared with participants with a low level of fitness. Participants with a high level of fitness also had a 61% lower risk of death from CVD without depression (HR, 0.39; 95% CI, 0.31-0.48), compared with those who had low fitness levels. Participants with a high fitness level who received a depression diagnosis had a 56% lower risk of death from CVD (HR, 0.44; 95% CI, 0.31-0.64), compared with those who had a low level of fitness.
The researchers pointed out that cardiovascular disease mortality is higher following depression but that cardiorespiratory fitness at midlife is a modifiable risk factor for both depression and CVD mortality.
Dr. Willis and his associates cited several limitations. Among them was the unavailability of information about participants’ use of medication that could influence either the presence or absence of a depression diagnosis.
Nevertheless, they said, the results provide lessons for clinicians and patients.
“This study shows that being fit at midlife is associated with a lower risk of later-life depression and subsequent CVD mortality, even in the presence of depression,” they wrote. “These findings suggest the importance of fitness in primary prevention of heart disease and associated CVD mortality in older aging adults.”
The investigators reported no conflicts of interest.
SOURCE: Willis BL et al. JAMA Psychiatry. 2018 Jun 27. doi: 10.1001/jamapsychiatry.2018.1467.
Higher cardiorespiratory fitness at midlife appears linked to a lower risk of depression in later life. In addition, higher midlife fitness is associated with a lower risk of cardiovascular mortality when depression preceded CVD death, according to a retrospective study published in JAMA Psychiatry.
“These findings ... should encourage physicians to consider fitness and physical activity in promoting healthy aging,” wrote Benjamin L. Willis, MD, MPH, of the Cooper Institute in Dallas, and his associates.
The study included 17,989 participants from the Cooper Center Longitudinal Study and linked data from those participants with a depression diagnosis based on Medicare claims and cardiovascular disease (CVD) mortality rates based on the National Death Index.
The participants were mostly men (80.2%), and their mean age at midlife assessment was 50 years. The participants’ treadmill time at midlife was used to categorize them into age- and sex-specific quintiles, with quintile 1 representing low fitness, quintiles 2 and 3 representing moderate fitness, and quintiles 4 and 5 representing high fitness.
After 117,218 person-years of follow-up, the investigators observed 2,701 depression diagnoses, 610 deaths tied to cardiovascular disease without prior depression, and 231 deaths associated with CVD after depression.
In addition, Dr. Willis and his associates found that (hazard ratio, 0.84; 95% confidence interval, 0.74-0.95), compared with participants with a low level of fitness. Participants with a high level of fitness also had a 61% lower risk of death from CVD without depression (HR, 0.39; 95% CI, 0.31-0.48), compared with those who had low fitness levels. Participants with a high fitness level who received a depression diagnosis had a 56% lower risk of death from CVD (HR, 0.44; 95% CI, 0.31-0.64), compared with those who had a low level of fitness.
The researchers pointed out that cardiovascular disease mortality is higher following depression but that cardiorespiratory fitness at midlife is a modifiable risk factor for both depression and CVD mortality.
Dr. Willis and his associates cited several limitations. Among them was the unavailability of information about participants’ use of medication that could influence either the presence or absence of a depression diagnosis.
Nevertheless, they said, the results provide lessons for clinicians and patients.
“This study shows that being fit at midlife is associated with a lower risk of later-life depression and subsequent CVD mortality, even in the presence of depression,” they wrote. “These findings suggest the importance of fitness in primary prevention of heart disease and associated CVD mortality in older aging adults.”
The investigators reported no conflicts of interest.
SOURCE: Willis BL et al. JAMA Psychiatry. 2018 Jun 27. doi: 10.1001/jamapsychiatry.2018.1467.
Higher cardiorespiratory fitness at midlife appears linked to a lower risk of depression in later life. In addition, higher midlife fitness is associated with a lower risk of cardiovascular mortality when depression preceded CVD death, according to a retrospective study published in JAMA Psychiatry.
“These findings ... should encourage physicians to consider fitness and physical activity in promoting healthy aging,” wrote Benjamin L. Willis, MD, MPH, of the Cooper Institute in Dallas, and his associates.
The study included 17,989 participants from the Cooper Center Longitudinal Study and linked data from those participants with a depression diagnosis based on Medicare claims and cardiovascular disease (CVD) mortality rates based on the National Death Index.
The participants were mostly men (80.2%), and their mean age at midlife assessment was 50 years. The participants’ treadmill time at midlife was used to categorize them into age- and sex-specific quintiles, with quintile 1 representing low fitness, quintiles 2 and 3 representing moderate fitness, and quintiles 4 and 5 representing high fitness.
After 117,218 person-years of follow-up, the investigators observed 2,701 depression diagnoses, 610 deaths tied to cardiovascular disease without prior depression, and 231 deaths associated with CVD after depression.
In addition, Dr. Willis and his associates found that (hazard ratio, 0.84; 95% confidence interval, 0.74-0.95), compared with participants with a low level of fitness. Participants with a high level of fitness also had a 61% lower risk of death from CVD without depression (HR, 0.39; 95% CI, 0.31-0.48), compared with those who had low fitness levels. Participants with a high fitness level who received a depression diagnosis had a 56% lower risk of death from CVD (HR, 0.44; 95% CI, 0.31-0.64), compared with those who had a low level of fitness.
The researchers pointed out that cardiovascular disease mortality is higher following depression but that cardiorespiratory fitness at midlife is a modifiable risk factor for both depression and CVD mortality.
Dr. Willis and his associates cited several limitations. Among them was the unavailability of information about participants’ use of medication that could influence either the presence or absence of a depression diagnosis.
Nevertheless, they said, the results provide lessons for clinicians and patients.
“This study shows that being fit at midlife is associated with a lower risk of later-life depression and subsequent CVD mortality, even in the presence of depression,” they wrote. “These findings suggest the importance of fitness in primary prevention of heart disease and associated CVD mortality in older aging adults.”
The investigators reported no conflicts of interest.
SOURCE: Willis BL et al. JAMA Psychiatry. 2018 Jun 27. doi: 10.1001/jamapsychiatry.2018.1467.
REPORTING FROM JAMA PSYCHIATRY
FDA: MiniMed 670G now available for younger diabetes patients
The MiniMed 670G hybrid closed loop system has been approved to help manage basal insulin levels in patients aged 7-13 years who have type 1 diabetes, according to a Food and Drug Administration announcement.
The system, manufactured by Medtronic, automatically measures insulin levels every 5 minutes using an included sensor and then delivers insulin as needed through its insulin pump and attached infusion patch.
As part of this approval for children aged 7-13 years, the FDA is requiring the product developer to perform a postmarket study to evaluate how the device performs in this age group in real-world settings.
“Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people’s lives,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The device was approved in September 2017 for use in patients aged 14 years and older.
Read more about this approval in the full FDA announcement.
The MiniMed 670G hybrid closed loop system has been approved to help manage basal insulin levels in patients aged 7-13 years who have type 1 diabetes, according to a Food and Drug Administration announcement.
The system, manufactured by Medtronic, automatically measures insulin levels every 5 minutes using an included sensor and then delivers insulin as needed through its insulin pump and attached infusion patch.
As part of this approval for children aged 7-13 years, the FDA is requiring the product developer to perform a postmarket study to evaluate how the device performs in this age group in real-world settings.
“Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people’s lives,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The device was approved in September 2017 for use in patients aged 14 years and older.
Read more about this approval in the full FDA announcement.
The MiniMed 670G hybrid closed loop system has been approved to help manage basal insulin levels in patients aged 7-13 years who have type 1 diabetes, according to a Food and Drug Administration announcement.
The system, manufactured by Medtronic, automatically measures insulin levels every 5 minutes using an included sensor and then delivers insulin as needed through its insulin pump and attached infusion patch.
As part of this approval for children aged 7-13 years, the FDA is requiring the product developer to perform a postmarket study to evaluate how the device performs in this age group in real-world settings.
“Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people’s lives,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The device was approved in September 2017 for use in patients aged 14 years and older.
Read more about this approval in the full FDA announcement.
Tralokinumab appears safe and effective for atopic dermatitis, in phase 2b study
Treatment with symptoms in patients with moderate to severe atopic dermatitis (AD), in a recent phase 2b study published in the Journal of Allergy and Clinical Immunology.
The randomized, double-blind, placebo-controlled, dose-ranging study assigned 204 patients to receive placebo or 45 mg, 150 mg, or 300 mg of tralokinumab administered subcutaneously every second week for 12 weeks. The groups had similar demographics and disease characteristics. The patients were aged 15-75 years and had Eczema Area and Severity Index (EASI) scores of 12 or more and an Investigator Global Assessment (IGA) score of 3 or higher. The coprimary endpoints were change in EASI from baseline to week 12 and the percentage of patients with either 0 (clear) or 1 (almost clear) on the IGA scale.
The higher dosages of tralokinumab showed the greatest adjusted mean differences in EASI scores: reductions of 4.36 for the 150-mg group (P = .03) and 4.94 for the 300-mg group (P = .01), compared with placebo. The changes in the 300-mg group were apparent as early as 4 weeks into treatment and were maintained beyond the 12-week mark. The greatest differences, compared with placebo, in IGA were seen in the 300-mg group as well.
Furthermore, patients who had high levels of biomarkers associated with IL-13 showed greater improvements than those seen in the intention-to-treat population at large. By week 12, patient-reported pruritus was also improved, and there were improvements in Dermatology Quality of Life Index (which did not persist past 12 weeks).
Most treatment-emergent adverse events were considered only mild or moderate, and the few more serious events were deemed unrelated to the study drug. The most common adverse events were upper respiratory infections and headaches.
“Participants entering the study had not achieved an adequate response to stable topical glucocorticoids during the 2-week run-in period and, therefore, represent a population with moderate to severe AD and major unmet treatment needs,” the investigators wrote. “The clinically meaningful benefits observed by combining tralokinumab treatment with topical glucocorticoids suggests that tralokinumab could demonstrate improvements in participants whose symptoms cannot be effectively controlled by topical glucocorticoids alone.”
The study was funded by MedImmune, a member of the AstraZeneca Group. Five authors were or are employees of the company; the three remaining authors had disclosures related to numerous pharmaceutical companies, including two with disclosures that included MedImmune.
SOURCE: Wollenberg A et al. J Allergy Clin Immunol. 2018 Jun 12. doi: 10.1016/j.jaci.2018.05.029.
Treatment with symptoms in patients with moderate to severe atopic dermatitis (AD), in a recent phase 2b study published in the Journal of Allergy and Clinical Immunology.
The randomized, double-blind, placebo-controlled, dose-ranging study assigned 204 patients to receive placebo or 45 mg, 150 mg, or 300 mg of tralokinumab administered subcutaneously every second week for 12 weeks. The groups had similar demographics and disease characteristics. The patients were aged 15-75 years and had Eczema Area and Severity Index (EASI) scores of 12 or more and an Investigator Global Assessment (IGA) score of 3 or higher. The coprimary endpoints were change in EASI from baseline to week 12 and the percentage of patients with either 0 (clear) or 1 (almost clear) on the IGA scale.
The higher dosages of tralokinumab showed the greatest adjusted mean differences in EASI scores: reductions of 4.36 for the 150-mg group (P = .03) and 4.94 for the 300-mg group (P = .01), compared with placebo. The changes in the 300-mg group were apparent as early as 4 weeks into treatment and were maintained beyond the 12-week mark. The greatest differences, compared with placebo, in IGA were seen in the 300-mg group as well.
Furthermore, patients who had high levels of biomarkers associated with IL-13 showed greater improvements than those seen in the intention-to-treat population at large. By week 12, patient-reported pruritus was also improved, and there were improvements in Dermatology Quality of Life Index (which did not persist past 12 weeks).
Most treatment-emergent adverse events were considered only mild or moderate, and the few more serious events were deemed unrelated to the study drug. The most common adverse events were upper respiratory infections and headaches.
“Participants entering the study had not achieved an adequate response to stable topical glucocorticoids during the 2-week run-in period and, therefore, represent a population with moderate to severe AD and major unmet treatment needs,” the investigators wrote. “The clinically meaningful benefits observed by combining tralokinumab treatment with topical glucocorticoids suggests that tralokinumab could demonstrate improvements in participants whose symptoms cannot be effectively controlled by topical glucocorticoids alone.”
The study was funded by MedImmune, a member of the AstraZeneca Group. Five authors were or are employees of the company; the three remaining authors had disclosures related to numerous pharmaceutical companies, including two with disclosures that included MedImmune.
SOURCE: Wollenberg A et al. J Allergy Clin Immunol. 2018 Jun 12. doi: 10.1016/j.jaci.2018.05.029.
Treatment with symptoms in patients with moderate to severe atopic dermatitis (AD), in a recent phase 2b study published in the Journal of Allergy and Clinical Immunology.
The randomized, double-blind, placebo-controlled, dose-ranging study assigned 204 patients to receive placebo or 45 mg, 150 mg, or 300 mg of tralokinumab administered subcutaneously every second week for 12 weeks. The groups had similar demographics and disease characteristics. The patients were aged 15-75 years and had Eczema Area and Severity Index (EASI) scores of 12 or more and an Investigator Global Assessment (IGA) score of 3 or higher. The coprimary endpoints were change in EASI from baseline to week 12 and the percentage of patients with either 0 (clear) or 1 (almost clear) on the IGA scale.
The higher dosages of tralokinumab showed the greatest adjusted mean differences in EASI scores: reductions of 4.36 for the 150-mg group (P = .03) and 4.94 for the 300-mg group (P = .01), compared with placebo. The changes in the 300-mg group were apparent as early as 4 weeks into treatment and were maintained beyond the 12-week mark. The greatest differences, compared with placebo, in IGA were seen in the 300-mg group as well.
Furthermore, patients who had high levels of biomarkers associated with IL-13 showed greater improvements than those seen in the intention-to-treat population at large. By week 12, patient-reported pruritus was also improved, and there were improvements in Dermatology Quality of Life Index (which did not persist past 12 weeks).
Most treatment-emergent adverse events were considered only mild or moderate, and the few more serious events were deemed unrelated to the study drug. The most common adverse events were upper respiratory infections and headaches.
“Participants entering the study had not achieved an adequate response to stable topical glucocorticoids during the 2-week run-in period and, therefore, represent a population with moderate to severe AD and major unmet treatment needs,” the investigators wrote. “The clinically meaningful benefits observed by combining tralokinumab treatment with topical glucocorticoids suggests that tralokinumab could demonstrate improvements in participants whose symptoms cannot be effectively controlled by topical glucocorticoids alone.”
The study was funded by MedImmune, a member of the AstraZeneca Group. Five authors were or are employees of the company; the three remaining authors had disclosures related to numerous pharmaceutical companies, including two with disclosures that included MedImmune.
SOURCE: Wollenberg A et al. J Allergy Clin Immunol. 2018 Jun 12. doi: 10.1016/j.jaci.2018.05.029.
FROM THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
FDA approves bevacizumab for advanced ovarian cancer
The Food and Drug Administration has approved bevacizumab (Avastin) for treating stage III or IV ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, first in combination with chemotherapy (carboplatin and paclitaxel), then as monotherapy.
The approval was based on an improvement in progression-free survival (PFS) in the phase 3, three-arm GOG-0218 trial, evaluating the addition of bevacizumab to carboplatin and paclitaxel for patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, the FDA said in a press statement.
The most serious adverse events of bevacizumab included gastrointestinal perforation, wounds that don’t heal, and serious bleeding. Other possible adverse events included kidney problems, fistula, severe high blood pressure, severe stroke or heart problems, and problems of the nervous system and vision. Less serious events included headache, nosebleeds, rectal bleeding, and dry skin.
The recommended bevacizumab dose for stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection is 15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles, the FDA said.
The Food and Drug Administration has approved bevacizumab (Avastin) for treating stage III or IV ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, first in combination with chemotherapy (carboplatin and paclitaxel), then as monotherapy.
The approval was based on an improvement in progression-free survival (PFS) in the phase 3, three-arm GOG-0218 trial, evaluating the addition of bevacizumab to carboplatin and paclitaxel for patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, the FDA said in a press statement.
The most serious adverse events of bevacizumab included gastrointestinal perforation, wounds that don’t heal, and serious bleeding. Other possible adverse events included kidney problems, fistula, severe high blood pressure, severe stroke or heart problems, and problems of the nervous system and vision. Less serious events included headache, nosebleeds, rectal bleeding, and dry skin.
The recommended bevacizumab dose for stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection is 15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles, the FDA said.
The Food and Drug Administration has approved bevacizumab (Avastin) for treating stage III or IV ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, first in combination with chemotherapy (carboplatin and paclitaxel), then as monotherapy.
The approval was based on an improvement in progression-free survival (PFS) in the phase 3, three-arm GOG-0218 trial, evaluating the addition of bevacizumab to carboplatin and paclitaxel for patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, the FDA said in a press statement.
The most serious adverse events of bevacizumab included gastrointestinal perforation, wounds that don’t heal, and serious bleeding. Other possible adverse events included kidney problems, fistula, severe high blood pressure, severe stroke or heart problems, and problems of the nervous system and vision. Less serious events included headache, nosebleeds, rectal bleeding, and dry skin.
The recommended bevacizumab dose for stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection is 15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles, the FDA said.