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 Multicenter Study
In uncontrolled T2DM treated with a basal-bolus insulin regimen, weekly icodec was noninferior to daily glargine for HbA1c at 26 wk.
Mathieu C, Ásbjörnsdóttir B, Bajaj HS, et al. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. Lancet. 2023;401:1929-1940. 37156252.
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Comment Randomized Controlled Trial
In adults with hypertension, effects of BP-lowering drug monotherapy varied by patient.
Sundström J, Lind L, Nowrouzi S, et al. Heterogeneity in blood pressure response to 4 antihypertensive drugs: a randomized clinical trial. JAMA. 2023;329:1160-1169. 37039792.
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Comment Randomized Controlled Trial
In relapsing AAV with rituximab-induced remission, maintenance rituximab vs. azathioprine reduced relapse at ≥32 mo.
Smith RM, Jones RB, Specks U, et al; RITAZAREM co-investigators. Rituximab versus azathioprine for maintenance of remission for patients with ANCA-associated vasculitis and relapsing disease: an international randomised controlled trial. Ann Rheum Dis. 2023;82:937-944. 36958796.
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Randomized Controlled Trial
Time-Restricted Eating Without Calorie Counting for Weight Loss in a Racially Diverse Population : A Randomized Controlled Trial.
Time-restricted eating (TRE), without calorie counting, has become a popular weight loss strategy, yet long-term randomized trials evaluating its efficacy are limited. ⋯ National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases.