• Am. J. Respir. Crit. Care Med. · Oct 2022

    Randomized Controlled Trial Multicenter Study

    Clinical Trial of Losartan for Pulmonary Emphysema: Pulmonary Trials Cooperative LEEP Trial.

    • Robert A Wise, Janet T Holbrook, Robert H Brown, Gerard J Criner, Mark T Dransfield, Jiaxian He, Robert J Henderson, David A Kaminsky, Robert J Kaner, Stephen C Lazarus, Barry J Make, Meredith C McCormack, Enid R Neptune, and Loretta G Que.
    • Johns Hopkins University School of Medicine, Baltimore, Maryland.
    • Am. J. Respir. Crit. Care Med. 2022 Oct 1; 206 (7): 838845838-845.

    AbstractRationale: There are no pharmacologic agents that modify emphysema progression in patients with chronic obstructive pulmonary disease (COPD). Objectives: To evaluate the efficacy of losartan, an angiotensin receptor blocker, to reduce emphysema progression. Methods: The trial was a multicenter, randomized, placebo-controlled trial conducted between May 2017 and January 2021. Eligible participants were aged ⩾40 years, had moderate to severe airflow obstruction, ⩾10 pack-years of smoking, mild-moderate emphysema on high-resolution computed tomography, and no medical indication for or intolerance of angiotensin receptor blockers. Treatment with losartan 100 mg daily or matching placebo (1:1) was randomly assigned. The primary outcome was emphysema progression on high-resolution computed tomography over 48 weeks. Secondary outcomes included the St George's Respiratory Questionnaire, the modified Medical Research Council dyspnea scale, the COPD Assessment Test, and the Physical Function-Short Form 20a. Measurements and Main Results: A total of 220 participants were enrolled; 58% were men, 19% were African American, and 24% were current smokers. The medians (interquartile ranges) for age were 65 (61-73) years and 48 (36-59) for percent predicted FEV1 after bronchodilator use. The mean (95% confidence interval) percentage emphysema progression was 1.35% (0.67-2.03) in the losartan group versus 0.66% (0.09-1.23) in the placebo group (P = NS). Conclusions: Losartan did not prevent emphysema progression in people with COPD with mild-moderate emphysema. Clinical trial registered with www.clinicaltrials.gov (NCT02696564).

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