Shorter Antibiotic Course Noninferior for UTI Recurrence in Kids
Five days of oral antibiotic treatment for febrile urinary tract infections (UTIs) in kids was noninferior to the standard 10-day course, the randomized controlled STOP trial showed. The recurrence rate of all UTIs — febrile and non-febrile — within 30 days of treatment with oral amoxicillin-clavulanate acid was 2.8% in the short-term group compared with […]
JAK1 Inhibitor Shows ‘Remarkable’ Activity in T-Cell Lymphoma
Treatment with a novel, oral JAK1 tyrosine kinase inhibitor induced rapid and durable responses in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), findings from a single-arm phase II study showed. Among 88 heavily pretreated patients evaluable for efficacy, 44% (95% CI 34-55) responded to single-agent golidocitinib, with 24% (95% CI 15-34) achieving a […]
Novel Gout Drug Aces Mid-Stage Tests
SAN DIEGO — An investigational once-daily oral agent that inhibits urate transporter-1 (URAT1) as a means of forcing uric acid excretion showed good efficacy and safety in a pair of phase II trials reported here. In one of these studies, the new product, called AR882 for the time being, reduced serum urate by 40% to […]
Novel Aldosterone Synthase Inhibitor Cuts Albuminuria in Phase II Trial
PHILADELPHIA — An oral investigational aldosterone synthase inhibitor (ASI) cut albuminuria by nearly 40% in people in chronic kidney disease (CKD) in a phase II trial. The 10-mg dose of ASI BI 690517 yielded an average 37.4% (95% CI -52.2 to -18.2%) greater reduction in urine albumin-creatinine ratio (UACR) from baseline to week 14 compared […]
FDA Panel Favors Dropping OTC Decongestant
Hundreds of allergy and cold medicines on retail shelves contain oral phenylephrine, with brands including Sudafed PE and Suphedrine PE totaling over a billion dollars in sales each year. However, that oral decongestant — the only one available outside the pharmacy — doesn’t work, an FDA advisory panel said. All 16 voting members of the […]
Chronic Cough Drug Shows Some Benefit, but Taste-Related Events an Issue
MILAN — Twice-daily doses of the oral P2X3 receptor antagonist gefapixant may improve refractory or unexplained chronic cough, but at the cost of adverse events, a meta-analysis and systematic review found. Moderate-certainty evidence indicated that a 45-mg dose led to a small (17.6%, 95% CI 10.6-24.0) decrease in awake cough frequency, a small (16.0%, 95% […]
COX-2 Inhibitor Added to Levonorgestrel Improved Emergency Contraception Efficacy
Taking the oral cyclo-oxygenase (COX)-2 inhibitor piroxicam in combination with levonorgestrel improved emergency contraception efficacy versus levonorgestrel alone, with no additional adverse events, a randomized controlled trial showed. Piroxicam 40 mg combined with levonorgestrel 1.5 mg prevented 94.7% of expected pregnancies compared with 63.4% with levonorgestrel plus placebo (P<0.0001), reported Raymond Hang Wun Li, MD, […]
FDA OKs First Pill for Postpartum Depression
The FDA approved zuranolone (Zurzuvae) as the first oral treatment for postpartum depression, the agency announced late on Friday. Until now, brexanolone (Zulresso) has been the only other treatment with an indication for postpartum depression, but that drug requires a continuous IV infusion administered by a healthcare provider. “Postpartum depression is a serious and potentially […]
Novel IDH1/2 Inhibitor Shows ‘Dramatic Effect’ in Low-Grade Glioma
CHICAGO — Oral vorasidenib monotherapy significantly improved progression-free survival (PFS), and delayed the time to next therapy, in patients with mutated, low-grade glioma, according to an interim analysis of the INDIGO trial. Among 331 patients with grade 2 isocitrate dehydrogenase (IDH)-mutant glioma, who received no prior treatment other than surgery, those randomly assigned to receive […]
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, […]