Two previously marketed obesity drugs—fenfluramine and sibutramine—were withdrawn after evidence of cardiovascular harm emerged. Nissen and colleagues assessed whether obesity treatment with naltrexone-bupropion increases major adverse cardiovascular events (MACE) in a randomized, placebo-controlled noninferiority trial that enrolled 8910 overweight or obese patients. The authors report results of interim analyses performed after accrual of 25% and 50% of expected MACE, which found that the risk estimate for MACE did not exceed the prespecified noninferiority boundary; however, because of unanticipated early termination of the trial, the cardiovascular safety of the treatment remains uncertain. In an Editorial, Sharfstein and Psaty discuss the evaluation of the cardiovascular safety of naltrexone-bupropion treatment of obesity.
Editorial and Related Article
Continuing Medical Education
Observational studies suggest vitamin D supplementation is associated with beneficial effects on knee osteoarthritis (OA). In a randomized, double-blind trial that enrolled 413 patients with symptomatic knee OA and low serum 25-hydroxyvitamin D levels, Jin and colleagues found that compared with placebo, vitamin D supplementation did not result in significant differences in the change in tibial cartilage volume or knee pain score over 2 years.
Persistent postconcussion symptoms (PPCS) occur in approximately one-third of children who experience a concussion. In an analysis of data from 3063 children aged 5 up to 18 years who presented to an emergency department with acute concussion, Zemek and colleagues derived and validated a clinical risk score for PPCS. The authors report the risk score had modest discrimination to stratify patients at risk of PPCS 28 days after head injury. In an Editorial, Babcock and Kurowski discuss identification of childre at risk fro PPCS.
Hypertensive disorders of pregnancy, particularly preeclampsia, are associated with an increased risk of cardiomyopathy during the peripartum period—from the last month of pregnancy through 5 months after delivery. In a cohort study involving more than 1 million Danish women, Behrens and colleagues found that women with a history of hypertensive disorders of pregnancy, compared with women without such a history, have a small increased risk of cardiomyopathy, which persists beyond the peripartum period.
Few older adults with type 2 diabetes are enrolled in randomized trials of glucose-lowering medications, leading to substantial uncertainty about optimal glycemic control for this patient population. Lipska and colleagues reviewed the existing evidence on the benefits and harms of intensive vs standard glycemic control targets for older patients. The authors present an approach to help patients and clinicians reach individualized treatment goals.
Author Audio Interview and Continuing Medical Education
In many clinical studies, an outcome of interest is the time interval between the initiation of treatment and the occurrence of an adverse event. This JAMA Guide to Statistics and Methods article by Tolles and Lewis discusses the use of time-to-event analysis in clinical trials, statistical methods for analyses, and considerations for interpreting results.
Postthrombotic syndrome (PTS) may occur in 20% to 50% of patients with a deep venous thrombosis. This JAMA Clinical Guidelines Synopsis by Jain and Cifu summarizes an American Heart Association scientific statement: The Postthrombotic Syndrome: Evidence-Based Prevention, Diagnosis, and Treatment Strategies. Prevention and treatment strategies considered in the evidence review include elastic compression stockings, low-molecular-weight heparin, new oral anticoagulants, and compression dressings and pentoxifylline for treatment of venous ulcers.
Highlights. JAMA. 2016;315(10):957-959. doi:10.1001/jama.2015.14149