Annals of internal medicine
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Randomized Controlled Trial
Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone-Salmeterol to Treat Chronic Obstructive Pulmonary Disease.
In 2019, the U.S. Food and Drug Administration (FDA) approved the first generic maintenance inhaler for asthma and chronic obstructive pulmonary disease (COPD). The inhaler, Wixela Inhub (fluticasone-salmeterol; Viatris), is a substitutable version of the dry powder inhaler Advair Diskus (fluticasone-salmeterol; GlaxoSmithKline). When approving complex generic products like inhalers, the FDA applies a special "weight-of-evidence" approach. In this case, manufacturers were required to perform a randomized controlled trial in patients with asthma but not COPD, although the product received approval for both indications. ⋯ National Heart, Lung, and Blood Institute.
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Comment Randomized Controlled Trial
In noncardiac surgery, hypotension- vs. hypertension-avoidance strategies did not differ for 30-d major vascular complications.
Marcucci M, Painter TW, Conen D, et al; POISE-3 Trial Investigators and Study Groups. Hypotension-avoidance versus hypertension-avoidance strategies in noncardiac surgery: an international randomized controlled trial. Ann Intern Med. 2023;176:605-614. 37094336.