Sotagliflozin Gets FDA’s Blessing for Heart Failure
After a rocky development and regulatory road, the FDA has approved sotagliflozin (Inpefa) for treating heart failure in patients with or without diabetes, manufacturer Lexicon Pharmaceuticals announced on Friday. The dual SGLT1 and SGLT2 inhibitor is indicated for reducing the risk of cardiovascular death and urgent visits or hospitalization for heart failure in adults with […]
FDA Approves First Oral Antiviral Drug for COVID-19
The FDA has granted full approval to nirmatrelvir-ritonavir (Paxlovid) for treating adult outpatients with mild to moderate COVID-19 who are at risk for severe disease, the agency announced on Thursday. “Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people […]
Babies Fare Better If Gestational Diabetes Is Treated Early in Second Trimester
Treating gestational diabetes early in pregnancy without waiting for confirmation of a repeat oral glucose-tolerance test (OGTT) improved neonatal outcomes, the TOBOGM randomized trial showed. For women first diagnosed before 20 weeks’ gestation, immediate treatment significantly reduced the composite incidence of adverse neonatal outcomes — preterm birth, birth trauma, high birth weight, respiratory distress, phototherapy, […]
Platelet-Rich Plasma Injections Flop for Erectile Dysfunction in U.S. Study
CHICAGO — Intracavernosal platelet-rich plasma (PRP) injections were no better than placebo for treating mild-to-moderate erectile dysfunction, a randomized, single-center trial found. At 1 month after the second round of injections, no significant difference was seen between the PRP and placebo groups for the study’s primary endpoint, the percentage of men attaining a minimum clinically […]
Trial: Functional Scoring a Better Guide to Neonatal Opioid Withdrawal Tx
A newer function-based approach to treating neonatal opioid withdrawal syndrome safely readied babies to go home sooner, the ACT NOW randomized trial showed. With the Eat, Sleep, Console care approach, time from birth to medical readiness for hospital discharge by American Academy of Pediatrics-endorsed standards was nearly a week sooner than when treating guided by […]
Sodium Thiosulphate Not Much Help for Calciphylaxis in CKD
Intravenous sodium thiosulphate flopped for treating calciphylaxis in people with chronic kidney disease (CKD), researchers reported. In a systematic review and meta-analysis, there was no significant difference in skin lesion improvement seen across 12 studies of patients treated with and without IV sodium thiosulphate (risk ratio 1.23, 95% CI 0.85-1.78), found Wen Wen, MD, MMSc, […]
Helmet CPAP Leads Noninvasive Ventilation Therapies for Acute Respiratory Failure
The available noninvasive oxygenation strategies varied in their effectiveness in treating acute hypoxemic respiratory failure (AHRF), according to a meta-analysis of randomized trials. Helmet continuous positive airway pressure (CPAP) was the only modality that had at least moderate certainty evidence backing a probable mortality reduction compared with standard oxygen therapy (SOT; 231 fewer deaths per […]
FDA Advisors Endorse Rexulti for Agitation in Alzheimer’s Dementia
FDA advisors voted in favor of brexpiprazole (Rexulti) for treating agitation associated with Alzheimer’s dementia (AAD), despite increased mortality risk. By a vote of 9-1 on Friday, members of the agency’s Psychopharmacologic Drugs Advisory Committee (PDAC) and the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) said the data presented by the drug’s sponsors, […]
FDA Panel Backs Full Approval of Paxlovid for COVID-19
An FDA panel recommended the agency grant full approval to nirmatrelvir-ritonavir (Paxlovid) for treating high-risk COVID-19. By a vote of 16-1 on Thursday, the Antimicrobial Drugs Advisory Committee said the totality of evidence supports the traditional approval of the oral antiviral, which has been widely used since late 2021 under an emergency use authorization to […]
CDC Offers Tentative Guidance for Severe Mpox Treatment
With no clinical trial data yet available for treating severe mpox, the CDC has published an interim report with guidance. There are many FDA-regulated drugs and biologics stockpiled for smallpox preparedness that can be used to treat severe mpox; however, there are many clinical considerations when using these to help manage strategic decision-making, the CDC […]