User login
FDA grants accelerated approval to copanlisib for relapsed follicular lymphoma
The Food and Drug Administration has granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments.
Approval of the kinase inhibitor was based on an overall response rate of 59% in a single-arm trial of 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments. These patients had a complete or partial response for a median 12.2 months.
“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said in the press release. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them,” he said.
The Food and Drug Administration has granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments.
Approval of the kinase inhibitor was based on an overall response rate of 59% in a single-arm trial of 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments. These patients had a complete or partial response for a median 12.2 months.
“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said in the press release. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them,” he said.
The Food and Drug Administration has granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments.
Approval of the kinase inhibitor was based on an overall response rate of 59% in a single-arm trial of 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments. These patients had a complete or partial response for a median 12.2 months.
“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said in the press release. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them,” he said.
Briviact gets monotherapy approval for partial-onset seizures
A supplemental new drug application for Briviact (brivaracetam) CV as a monotherapy treatment for partial-onset seizures in patients aged 16 years and older with epilepsy received approval from the Food and Drug Administration on Sept. 15, according to an announcement from its manufacturer, UCB.
Brivaracetam is already approved in the United States as an adjunctive treatment for partial-onset seizures in patients in this age group. As a result, adults and adolescents aged 16 years and older with partial-onset seizures in the United States can now be initiated on brivaracetam as monotherapy or adjunctive therapy.
Brivaracetam is the newest antiepileptic drug (AED) in the ‘racetam’ class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment with brivaracetam for monotherapy or adjunctive therapy. According to the prescribing information, it is available in three formulations: film-coated tablets (10-mg, 25-mg, 50-mg, 75-mg, and 100-mg strengths), oral solution (10 mg/mL), and injection (50 mg in a 5-mL single-dose vial).
Common adverse reactions reported in at least 5% of brivaracetam users and at least 2% more frequently than placebo are somnolence and sedation, dizziness, fatigue, and nausea and vomiting.
“This new monotherapy indication builds on an already strong and compelling clinical profile for Briviact, providing doctors the flexibility to tailor their choice of AED to match individual patient needs and circumstances,” explained Pavel Klein, MD, director of the Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Md., in the UCB announcement. “In helping to progress their journey towards seizure freedom by providing a choice of treatment which can be initiated as monotherapy, at a therapeutic dose, from day 1, Briviact provides an additional treatment choice for neurologists and their patients.”
A supplemental new drug application for Briviact (brivaracetam) CV as a monotherapy treatment for partial-onset seizures in patients aged 16 years and older with epilepsy received approval from the Food and Drug Administration on Sept. 15, according to an announcement from its manufacturer, UCB.
Brivaracetam is already approved in the United States as an adjunctive treatment for partial-onset seizures in patients in this age group. As a result, adults and adolescents aged 16 years and older with partial-onset seizures in the United States can now be initiated on brivaracetam as monotherapy or adjunctive therapy.
Brivaracetam is the newest antiepileptic drug (AED) in the ‘racetam’ class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment with brivaracetam for monotherapy or adjunctive therapy. According to the prescribing information, it is available in three formulations: film-coated tablets (10-mg, 25-mg, 50-mg, 75-mg, and 100-mg strengths), oral solution (10 mg/mL), and injection (50 mg in a 5-mL single-dose vial).
Common adverse reactions reported in at least 5% of brivaracetam users and at least 2% more frequently than placebo are somnolence and sedation, dizziness, fatigue, and nausea and vomiting.
“This new monotherapy indication builds on an already strong and compelling clinical profile for Briviact, providing doctors the flexibility to tailor their choice of AED to match individual patient needs and circumstances,” explained Pavel Klein, MD, director of the Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Md., in the UCB announcement. “In helping to progress their journey towards seizure freedom by providing a choice of treatment which can be initiated as monotherapy, at a therapeutic dose, from day 1, Briviact provides an additional treatment choice for neurologists and their patients.”
A supplemental new drug application for Briviact (brivaracetam) CV as a monotherapy treatment for partial-onset seizures in patients aged 16 years and older with epilepsy received approval from the Food and Drug Administration on Sept. 15, according to an announcement from its manufacturer, UCB.
Brivaracetam is already approved in the United States as an adjunctive treatment for partial-onset seizures in patients in this age group. As a result, adults and adolescents aged 16 years and older with partial-onset seizures in the United States can now be initiated on brivaracetam as monotherapy or adjunctive therapy.
Brivaracetam is the newest antiepileptic drug (AED) in the ‘racetam’ class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment with brivaracetam for monotherapy or adjunctive therapy. According to the prescribing information, it is available in three formulations: film-coated tablets (10-mg, 25-mg, 50-mg, 75-mg, and 100-mg strengths), oral solution (10 mg/mL), and injection (50 mg in a 5-mL single-dose vial).
Common adverse reactions reported in at least 5% of brivaracetam users and at least 2% more frequently than placebo are somnolence and sedation, dizziness, fatigue, and nausea and vomiting.
“This new monotherapy indication builds on an already strong and compelling clinical profile for Briviact, providing doctors the flexibility to tailor their choice of AED to match individual patient needs and circumstances,” explained Pavel Klein, MD, director of the Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Md., in the UCB announcement. “In helping to progress their journey towards seizure freedom by providing a choice of treatment which can be initiated as monotherapy, at a therapeutic dose, from day 1, Briviact provides an additional treatment choice for neurologists and their patients.”
Diabetes infusion sets under voluntary recall
Medtronic announced Sept. 11 that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps.
The recall is for a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. According to recent reports from patients and root-cause analysis, the vent membrane in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This can lead to potential over-delivery of insulin shortly after an infusion set change and may cause hypoglycemia.
Current manufactured infusion sets include a design update of this component that Medtronic believes reduces the risk of insulin over-delivery after an infusion set change. Medtronic said they are working with patients on recalled infusion sets with the discontinued component to replace the recalled sets with new infusion sets containing the updated component at no cost.
“Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients,” said Francine Kaufman, MD, chief medical officer of the Diabetes Group at Medtronic in a press release. “Our Medtronic Diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support our customers throughout this process.”
Read the full press release on the Food and Drug Administration’s website.
Medtronic announced Sept. 11 that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps.
The recall is for a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. According to recent reports from patients and root-cause analysis, the vent membrane in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This can lead to potential over-delivery of insulin shortly after an infusion set change and may cause hypoglycemia.
Current manufactured infusion sets include a design update of this component that Medtronic believes reduces the risk of insulin over-delivery after an infusion set change. Medtronic said they are working with patients on recalled infusion sets with the discontinued component to replace the recalled sets with new infusion sets containing the updated component at no cost.
“Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients,” said Francine Kaufman, MD, chief medical officer of the Diabetes Group at Medtronic in a press release. “Our Medtronic Diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support our customers throughout this process.”
Read the full press release on the Food and Drug Administration’s website.
Medtronic announced Sept. 11 that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps.
The recall is for a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. According to recent reports from patients and root-cause analysis, the vent membrane in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This can lead to potential over-delivery of insulin shortly after an infusion set change and may cause hypoglycemia.
Current manufactured infusion sets include a design update of this component that Medtronic believes reduces the risk of insulin over-delivery after an infusion set change. Medtronic said they are working with patients on recalled infusion sets with the discontinued component to replace the recalled sets with new infusion sets containing the updated component at no cost.
“Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients,” said Francine Kaufman, MD, chief medical officer of the Diabetes Group at Medtronic in a press release. “Our Medtronic Diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support our customers throughout this process.”
Read the full press release on the Food and Drug Administration’s website.
PBC linked to increased risk of bone fracture
Patients with primary biliary cholangitis (PBC) may have an increase in the risk of developing bone fracture, according to Jian Zhao, MD, and associates.
In four cross-sectional studies, 515 patients were examined to assess the prevalence of fracture in a PBC population. Of those patients, the estimated prevalence of fracture was 15.2%. In four additional studies, 1,002 patients and 8,805 controls were examined to assess the relative risk of fracture among PBC patients. Those results found a significantly increased risk of fracture in PBC patients with the pooled odds ratio of 1.93.
It is noted that multiple factors underlie the osteopenic bone disease in PBC. In addition to cholestasis, risk factors include female sex, low body mass index, advanced age, and history of fragility fracture. Steroid use may also contribute to bone loss in PBC, especially in autoimmune hepatitis–primary biliary cholangitis overlap syndrome.
“The prevalence of bone fracture among PBC patients is relatively high and PBC increases the risk of fracture,” the researchers concluded. “Calcium and vitamin D supplementation or even bisphosphonate therapy should be recommended for PBC patients with bone loss to decrease the risk of fracture.”
Read the study in Clinics and Research in Hepatology and Gastroenterology (doi: 10.1016/j.clinre.2017.05.008).
Patients with primary biliary cholangitis (PBC) may have an increase in the risk of developing bone fracture, according to Jian Zhao, MD, and associates.
In four cross-sectional studies, 515 patients were examined to assess the prevalence of fracture in a PBC population. Of those patients, the estimated prevalence of fracture was 15.2%. In four additional studies, 1,002 patients and 8,805 controls were examined to assess the relative risk of fracture among PBC patients. Those results found a significantly increased risk of fracture in PBC patients with the pooled odds ratio of 1.93.
It is noted that multiple factors underlie the osteopenic bone disease in PBC. In addition to cholestasis, risk factors include female sex, low body mass index, advanced age, and history of fragility fracture. Steroid use may also contribute to bone loss in PBC, especially in autoimmune hepatitis–primary biliary cholangitis overlap syndrome.
“The prevalence of bone fracture among PBC patients is relatively high and PBC increases the risk of fracture,” the researchers concluded. “Calcium and vitamin D supplementation or even bisphosphonate therapy should be recommended for PBC patients with bone loss to decrease the risk of fracture.”
Read the study in Clinics and Research in Hepatology and Gastroenterology (doi: 10.1016/j.clinre.2017.05.008).
Patients with primary biliary cholangitis (PBC) may have an increase in the risk of developing bone fracture, according to Jian Zhao, MD, and associates.
In four cross-sectional studies, 515 patients were examined to assess the prevalence of fracture in a PBC population. Of those patients, the estimated prevalence of fracture was 15.2%. In four additional studies, 1,002 patients and 8,805 controls were examined to assess the relative risk of fracture among PBC patients. Those results found a significantly increased risk of fracture in PBC patients with the pooled odds ratio of 1.93.
It is noted that multiple factors underlie the osteopenic bone disease in PBC. In addition to cholestasis, risk factors include female sex, low body mass index, advanced age, and history of fragility fracture. Steroid use may also contribute to bone loss in PBC, especially in autoimmune hepatitis–primary biliary cholangitis overlap syndrome.
“The prevalence of bone fracture among PBC patients is relatively high and PBC increases the risk of fracture,” the researchers concluded. “Calcium and vitamin D supplementation or even bisphosphonate therapy should be recommended for PBC patients with bone loss to decrease the risk of fracture.”
Read the study in Clinics and Research in Hepatology and Gastroenterology (doi: 10.1016/j.clinre.2017.05.008).
FROM CLINICS AND RESEARCH IN HEPATOLOGY AND GASTROENTEROLOGY
FDA clears first 2D mammography device with patient-controlled compression
The Food and Drug Administration has granted premarket clearance to the first 2D digital mammography system that allows patients to control the amount of compression applied to their own breasts before the mammogram x-ray is taken.
Senographe Pristina with Self-Compression uses a handheld wireless remote control that allows women to adjust the compression force after breast positioning and during a mammography exam. The technologist positions the patient and initiates compression, then guides the patient to gradually increase compression using the remote control until adequate compression is reached. The technologist checks the applied compression and breast positioning and makes the final decision on whether the compression is adequate or needs to be adjusted, according to the FDA’s Sept. 1 announcement.
“Regular mammograms are an important tool in detecting breast cancer,” Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement. “However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam.”
Read more details of the clearance on the FDA’s website.
The Food and Drug Administration has granted premarket clearance to the first 2D digital mammography system that allows patients to control the amount of compression applied to their own breasts before the mammogram x-ray is taken.
Senographe Pristina with Self-Compression uses a handheld wireless remote control that allows women to adjust the compression force after breast positioning and during a mammography exam. The technologist positions the patient and initiates compression, then guides the patient to gradually increase compression using the remote control until adequate compression is reached. The technologist checks the applied compression and breast positioning and makes the final decision on whether the compression is adequate or needs to be adjusted, according to the FDA’s Sept. 1 announcement.
“Regular mammograms are an important tool in detecting breast cancer,” Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement. “However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam.”
Read more details of the clearance on the FDA’s website.
The Food and Drug Administration has granted premarket clearance to the first 2D digital mammography system that allows patients to control the amount of compression applied to their own breasts before the mammogram x-ray is taken.
Senographe Pristina with Self-Compression uses a handheld wireless remote control that allows women to adjust the compression force after breast positioning and during a mammography exam. The technologist positions the patient and initiates compression, then guides the patient to gradually increase compression using the remote control until adequate compression is reached. The technologist checks the applied compression and breast positioning and makes the final decision on whether the compression is adequate or needs to be adjusted, according to the FDA’s Sept. 1 announcement.
“Regular mammograms are an important tool in detecting breast cancer,” Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement. “However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam.”
Read more details of the clearance on the FDA’s website.
Respiratory infections in early years of life linked to celiac disease
in those with a family history of CD, according to Renata Auricchio, MD, University of Naples (Italy) Federico II, and her associates.
In a prospective cohort study, 373 newborns from families with at least one relative with CD were recruited. The cumulative incidence of new cases of CD was 6% at 3 years and 13.5% at 5 years of age, the researchers noted. In the first year when no child produced anti-tissue transglutaminase (anti-tTG) antibodies, respiratory infections (upper and lower tract) were more common among the case patients than among the controls (58% vs. 40%). During the second year, respiratory infections were again more frequent among the case patients than among controls (52% vs. 32%). And in the third year of life when most of the case patients were diagnosed with CD, no clinical event was more frequent in the case patients than in the control group.
“In this study, we report that early infections significantly contribute to the risk of developing CD,” Dr. Auricchio and her associates concluded. “It is possible that the exposure to early infection stimulates a genetically predisposed immune profile, which contributes to the switch from tolerance to intolerance to gluten, which is a common food antigen.”
Read the full study in Pediatrics (doi: 10.1542/peds.2016-4102).
in those with a family history of CD, according to Renata Auricchio, MD, University of Naples (Italy) Federico II, and her associates.
In a prospective cohort study, 373 newborns from families with at least one relative with CD were recruited. The cumulative incidence of new cases of CD was 6% at 3 years and 13.5% at 5 years of age, the researchers noted. In the first year when no child produced anti-tissue transglutaminase (anti-tTG) antibodies, respiratory infections (upper and lower tract) were more common among the case patients than among the controls (58% vs. 40%). During the second year, respiratory infections were again more frequent among the case patients than among controls (52% vs. 32%). And in the third year of life when most of the case patients were diagnosed with CD, no clinical event was more frequent in the case patients than in the control group.
“In this study, we report that early infections significantly contribute to the risk of developing CD,” Dr. Auricchio and her associates concluded. “It is possible that the exposure to early infection stimulates a genetically predisposed immune profile, which contributes to the switch from tolerance to intolerance to gluten, which is a common food antigen.”
Read the full study in Pediatrics (doi: 10.1542/peds.2016-4102).
in those with a family history of CD, according to Renata Auricchio, MD, University of Naples (Italy) Federico II, and her associates.
In a prospective cohort study, 373 newborns from families with at least one relative with CD were recruited. The cumulative incidence of new cases of CD was 6% at 3 years and 13.5% at 5 years of age, the researchers noted. In the first year when no child produced anti-tissue transglutaminase (anti-tTG) antibodies, respiratory infections (upper and lower tract) were more common among the case patients than among the controls (58% vs. 40%). During the second year, respiratory infections were again more frequent among the case patients than among controls (52% vs. 32%). And in the third year of life when most of the case patients were diagnosed with CD, no clinical event was more frequent in the case patients than in the control group.
“In this study, we report that early infections significantly contribute to the risk of developing CD,” Dr. Auricchio and her associates concluded. “It is possible that the exposure to early infection stimulates a genetically predisposed immune profile, which contributes to the switch from tolerance to intolerance to gluten, which is a common food antigen.”
Read the full study in Pediatrics (doi: 10.1542/peds.2016-4102).
FROM PEDIATRICS
FDA grants accelerated approval for treatment of Chagas disease in children
The Food and Drug Administration announced Aug. 29 the accelerated approval of benznidazole for use in children aged 2-12 years who have Chagas disease.
In two placebo-controlled clinical trials, researchers examined pediatric patients aged 6-12 with Chagas disease. In the first trial, about 60% of children treated with benznidazole had an antibody test change from positive to negative, compared with about 14% children who received a placebo. Similar findings were found in the second trial. In that one, about 55% of children treated with benznidazole had an antibody test change from positive to negative, compared with 5% who received a placebo. Also, a different study of the safety and pharmacokinetics of benznidazole in pediatric patients aged 2-12 provided information for dosing recommendations down to 2 years of age.
“The FDA is committed to making available safe and effective therapeutic options to treat tropical diseases,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
This is the first treatment approved in the United States for Chagas disease. According to the agency, additional study is needed to “verify and describe the anticipated clinical benefit of benznidazole.”
Read the full press release on the FDA’s website.
The Food and Drug Administration announced Aug. 29 the accelerated approval of benznidazole for use in children aged 2-12 years who have Chagas disease.
In two placebo-controlled clinical trials, researchers examined pediatric patients aged 6-12 with Chagas disease. In the first trial, about 60% of children treated with benznidazole had an antibody test change from positive to negative, compared with about 14% children who received a placebo. Similar findings were found in the second trial. In that one, about 55% of children treated with benznidazole had an antibody test change from positive to negative, compared with 5% who received a placebo. Also, a different study of the safety and pharmacokinetics of benznidazole in pediatric patients aged 2-12 provided information for dosing recommendations down to 2 years of age.
“The FDA is committed to making available safe and effective therapeutic options to treat tropical diseases,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
This is the first treatment approved in the United States for Chagas disease. According to the agency, additional study is needed to “verify and describe the anticipated clinical benefit of benznidazole.”
Read the full press release on the FDA’s website.
The Food and Drug Administration announced Aug. 29 the accelerated approval of benznidazole for use in children aged 2-12 years who have Chagas disease.
In two placebo-controlled clinical trials, researchers examined pediatric patients aged 6-12 with Chagas disease. In the first trial, about 60% of children treated with benznidazole had an antibody test change from positive to negative, compared with about 14% children who received a placebo. Similar findings were found in the second trial. In that one, about 55% of children treated with benznidazole had an antibody test change from positive to negative, compared with 5% who received a placebo. Also, a different study of the safety and pharmacokinetics of benznidazole in pediatric patients aged 2-12 provided information for dosing recommendations down to 2 years of age.
“The FDA is committed to making available safe and effective therapeutic options to treat tropical diseases,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
This is the first treatment approved in the United States for Chagas disease. According to the agency, additional study is needed to “verify and describe the anticipated clinical benefit of benznidazole.”
Read the full press release on the FDA’s website.
Initiation of ART beneficial in reducing all-cause mortality in AIDS-free patients
Immediate initiation of combined antiretroviral therapy (ART) shows benefits in reducing all-cause mortality in non-AIDS HIV-positive patients aged 50 years or older, according to Sara Lodi, PhD, and her associates.
In a study of 9,596 eligible patients, 2,672 (28%) were U.S. veterans. Results found the 5-year risk of all-cause mortality under immediate ART initiation was 5.3% in the general HIV population and 14.4% in the veterans. The 5-year risk of all-cause mortality was 0.40% lower for the general HIV population and 1.61% lower for veterans compared with immediate initiation versus initiation at CD4 below 350 cells/mm3.
Results also showed rates of all-cause mortality and non-AIDS mortality per 1,000 person-years were 12.3 and 6.3 for the general HIV population and 42.4 and 9.7 for the veterans. In both populations, the observed rates of all-cause and non-AIDS mortality were higher for males and for individuals with lower CD4 count and older age at baseline.
“Immediate initiation of ART appears to be beneficial in reducing all-cause mortality in AIDS-free patients aged 50 years or older, despite their low baseline CD4 count,” the researchers concluded. “More effort should be made into diagnosing HIV earlier, particularly in older patients in order to ensure timely initiation of treatment and follow-up for concomitant comorbidities, thereby maximizing the benefit of early treatment for HIV.”
The study was funded by grants from the NIH and the UK Medical Research Council. Several of the investigators disclosed receiving grants from a number of drug companies.
Read the study in JAIDS (doi: 10.1097/QAI.0000000000001498).
Immediate initiation of combined antiretroviral therapy (ART) shows benefits in reducing all-cause mortality in non-AIDS HIV-positive patients aged 50 years or older, according to Sara Lodi, PhD, and her associates.
In a study of 9,596 eligible patients, 2,672 (28%) were U.S. veterans. Results found the 5-year risk of all-cause mortality under immediate ART initiation was 5.3% in the general HIV population and 14.4% in the veterans. The 5-year risk of all-cause mortality was 0.40% lower for the general HIV population and 1.61% lower for veterans compared with immediate initiation versus initiation at CD4 below 350 cells/mm3.
Results also showed rates of all-cause mortality and non-AIDS mortality per 1,000 person-years were 12.3 and 6.3 for the general HIV population and 42.4 and 9.7 for the veterans. In both populations, the observed rates of all-cause and non-AIDS mortality were higher for males and for individuals with lower CD4 count and older age at baseline.
“Immediate initiation of ART appears to be beneficial in reducing all-cause mortality in AIDS-free patients aged 50 years or older, despite their low baseline CD4 count,” the researchers concluded. “More effort should be made into diagnosing HIV earlier, particularly in older patients in order to ensure timely initiation of treatment and follow-up for concomitant comorbidities, thereby maximizing the benefit of early treatment for HIV.”
The study was funded by grants from the NIH and the UK Medical Research Council. Several of the investigators disclosed receiving grants from a number of drug companies.
Read the study in JAIDS (doi: 10.1097/QAI.0000000000001498).
Immediate initiation of combined antiretroviral therapy (ART) shows benefits in reducing all-cause mortality in non-AIDS HIV-positive patients aged 50 years or older, according to Sara Lodi, PhD, and her associates.
In a study of 9,596 eligible patients, 2,672 (28%) were U.S. veterans. Results found the 5-year risk of all-cause mortality under immediate ART initiation was 5.3% in the general HIV population and 14.4% in the veterans. The 5-year risk of all-cause mortality was 0.40% lower for the general HIV population and 1.61% lower for veterans compared with immediate initiation versus initiation at CD4 below 350 cells/mm3.
Results also showed rates of all-cause mortality and non-AIDS mortality per 1,000 person-years were 12.3 and 6.3 for the general HIV population and 42.4 and 9.7 for the veterans. In both populations, the observed rates of all-cause and non-AIDS mortality were higher for males and for individuals with lower CD4 count and older age at baseline.
“Immediate initiation of ART appears to be beneficial in reducing all-cause mortality in AIDS-free patients aged 50 years or older, despite their low baseline CD4 count,” the researchers concluded. “More effort should be made into diagnosing HIV earlier, particularly in older patients in order to ensure timely initiation of treatment and follow-up for concomitant comorbidities, thereby maximizing the benefit of early treatment for HIV.”
The study was funded by grants from the NIH and the UK Medical Research Council. Several of the investigators disclosed receiving grants from a number of drug companies.
Read the study in JAIDS (doi: 10.1097/QAI.0000000000001498).
FROM THE JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
FDA approves once-daily treatment for hyperuricemia in gout
The Food and Drug Administration announced Aug. 21 the approval of Duzallo, a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone.
Duzallo is a fixed-dose combination of lesinurad 200 mg and allopurinol 300 mg that will be marketed by Ironwood Pharmaceuticals. It will also be available in a lesinurad 200 mg plus allopurinol 200 mg dosage.
“With Duzallo, nearly twice as many patients with uncontrolled gout may be able to achieve target serum uric acid levels compared to those patients taking allopurinol alone, which is important, considering the significant unmet need among uncontrolled gout patients to get to goal of under 6 mg/dL,” said Tom McCourt, senior vice president of marketing and sales and chief commercial officer at Ironwood in an announcement from the company.
Duzallo is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout, allopurinol, with the most recent FDA-approved treatment for gout, lesinurad (Zurampic). Allopurinol is an xanthine oxidase inhibitor whose action differs from that of uricosuric agents such as lesinurad. Allopurinol reduces the production of uric acid, whereas lesinurad increases renal excretion of uric acid by selectively inhibiting the action of URAT1, the uric acid transporter responsible for the majority of renal uric acid reabsorption.
Duzallo is not recommended for the treatment of asymptomatic hyperuricemia. It has a boxed warning regarding the risk of acute renal failure.
Duzallo is expected to be commercially available early in the fourth quarter of 2017.
The Food and Drug Administration announced Aug. 21 the approval of Duzallo, a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone.
Duzallo is a fixed-dose combination of lesinurad 200 mg and allopurinol 300 mg that will be marketed by Ironwood Pharmaceuticals. It will also be available in a lesinurad 200 mg plus allopurinol 200 mg dosage.
“With Duzallo, nearly twice as many patients with uncontrolled gout may be able to achieve target serum uric acid levels compared to those patients taking allopurinol alone, which is important, considering the significant unmet need among uncontrolled gout patients to get to goal of under 6 mg/dL,” said Tom McCourt, senior vice president of marketing and sales and chief commercial officer at Ironwood in an announcement from the company.
Duzallo is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout, allopurinol, with the most recent FDA-approved treatment for gout, lesinurad (Zurampic). Allopurinol is an xanthine oxidase inhibitor whose action differs from that of uricosuric agents such as lesinurad. Allopurinol reduces the production of uric acid, whereas lesinurad increases renal excretion of uric acid by selectively inhibiting the action of URAT1, the uric acid transporter responsible for the majority of renal uric acid reabsorption.
Duzallo is not recommended for the treatment of asymptomatic hyperuricemia. It has a boxed warning regarding the risk of acute renal failure.
Duzallo is expected to be commercially available early in the fourth quarter of 2017.
The Food and Drug Administration announced Aug. 21 the approval of Duzallo, a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone.
Duzallo is a fixed-dose combination of lesinurad 200 mg and allopurinol 300 mg that will be marketed by Ironwood Pharmaceuticals. It will also be available in a lesinurad 200 mg plus allopurinol 200 mg dosage.
“With Duzallo, nearly twice as many patients with uncontrolled gout may be able to achieve target serum uric acid levels compared to those patients taking allopurinol alone, which is important, considering the significant unmet need among uncontrolled gout patients to get to goal of under 6 mg/dL,” said Tom McCourt, senior vice president of marketing and sales and chief commercial officer at Ironwood in an announcement from the company.
Duzallo is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout, allopurinol, with the most recent FDA-approved treatment for gout, lesinurad (Zurampic). Allopurinol is an xanthine oxidase inhibitor whose action differs from that of uricosuric agents such as lesinurad. Allopurinol reduces the production of uric acid, whereas lesinurad increases renal excretion of uric acid by selectively inhibiting the action of URAT1, the uric acid transporter responsible for the majority of renal uric acid reabsorption.
Duzallo is not recommended for the treatment of asymptomatic hyperuricemia. It has a boxed warning regarding the risk of acute renal failure.
Duzallo is expected to be commercially available early in the fourth quarter of 2017.
Safety alert for intragastric balloon systems
The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.
The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.
The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be reported through MedWatch. The FDA will keep the public informed as new information becomes available.
Read the full safety alert on the FDA’s website.
As past chair of the AGA Center for GI Innovation and Technology, I have been closely following balloon-based obesity devices as they’ve entered the marketplace. The center has welcomed the introduction of these noninvasive devices that can be managed by GIs, and we’ve worked closely with device companies and the FDA for the past several years to ensure these devices were introduced to the market in a safe and efficient manner.
We do not have enough information now to connect these recent patient deaths to these devices. That said, the FDA’s letter reinforces a few important points. Foremost, the fact that complications and adverse events can occur with any procedure. For physicians using intragastric balloons, each patient must be appropriately evaluated prior to the decision to place the balloon, especially for the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment, and following the procedure, in order to detect the development of possible complications, and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms.
Michael Kochman MD, AGAF, is the Wilmott Family Professor of Medicine, professor of medicine in surgery, gastroenterology division, University of Pennsylvania, Philadelphia.
As past chair of the AGA Center for GI Innovation and Technology, I have been closely following balloon-based obesity devices as they’ve entered the marketplace. The center has welcomed the introduction of these noninvasive devices that can be managed by GIs, and we’ve worked closely with device companies and the FDA for the past several years to ensure these devices were introduced to the market in a safe and efficient manner.
We do not have enough information now to connect these recent patient deaths to these devices. That said, the FDA’s letter reinforces a few important points. Foremost, the fact that complications and adverse events can occur with any procedure. For physicians using intragastric balloons, each patient must be appropriately evaluated prior to the decision to place the balloon, especially for the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment, and following the procedure, in order to detect the development of possible complications, and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms.
Michael Kochman MD, AGAF, is the Wilmott Family Professor of Medicine, professor of medicine in surgery, gastroenterology division, University of Pennsylvania, Philadelphia.
As past chair of the AGA Center for GI Innovation and Technology, I have been closely following balloon-based obesity devices as they’ve entered the marketplace. The center has welcomed the introduction of these noninvasive devices that can be managed by GIs, and we’ve worked closely with device companies and the FDA for the past several years to ensure these devices were introduced to the market in a safe and efficient manner.
We do not have enough information now to connect these recent patient deaths to these devices. That said, the FDA’s letter reinforces a few important points. Foremost, the fact that complications and adverse events can occur with any procedure. For physicians using intragastric balloons, each patient must be appropriately evaluated prior to the decision to place the balloon, especially for the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment, and following the procedure, in order to detect the development of possible complications, and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms.
Michael Kochman MD, AGAF, is the Wilmott Family Professor of Medicine, professor of medicine in surgery, gastroenterology division, University of Pennsylvania, Philadelphia.
The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.
The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.
The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be reported through MedWatch. The FDA will keep the public informed as new information becomes available.
Read the full safety alert on the FDA’s website.
The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.
The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.
The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be reported through MedWatch. The FDA will keep the public informed as new information becomes available.
Read the full safety alert on the FDA’s website.