Annals of internal medicine
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Randomized Controlled Trial
In symptomatic knee OA, adding oral methotrexate to usual analgesia reduced pain at 6 mo.
Kingsbury SR, Tharmanathan P, Keding A, et al. Pain reduction with oral methotrexate in knee osteoarthritis: a randomized, placebo-controlled clinical trial. Ann Intern Med. 2024;177:1145-1156. 39074374.
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Meta Analysis
In T2D, SGLT-2 inhibitor effects on CV and kidney outcomes were consistent regardless of GLP-1 receptor agonist use.
Apperloo EM, Neuen BL, Fletcher RA, et al. Efficacy and safety of SGLT2 inhibitors with and without glucagon-like peptide 1 receptor agonists: a SMART-C collaborative meta-analysis of randomised controlled trials. Lancet Diabetes Endocrinol. 2024;12:545-557. 38991584.
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Nearly all medical devices reviewed by the U. S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. ⋯ Advocates of the 510(k) clearance process tout its support for device innovation and rapid market access, and critics of the 510(k) clearance process express that it may inadequately protect patient safety. In September 2023, the FDA issued 3 guidance documents that, if finalized, would significantly change medical device regulation. This article provides clinical and regulatory context for the proposed guidance documents, which focus on predicate selection, clinical testing requirements, and implantable devices, and identifies opportunities for further reforms that promote transparency and patient safety.