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Randomized Clinical Trial of Aspirin and Simvastatin for Pulmonary Arterial Hypertension

Steven M. Kawut; Emilia Bagiella; David J. Lederer; Daichi Shimbo; Evelyn M. Horn; Kari E. Roberts; Nicholas S. Hill; R. Graham Barr; Erika S. Berman Rosenzweig; Wendy Post; Russell P. Tracy; Harold I. Palevsky; Paul M. Hassoun; Reda E. Girgis; ASA-STAT Study Group

Title:
Randomized Clinical Trial of Aspirin and Simvastatin for Pulmonary Arterial Hypertension
Author(s):
Kawut, Steven M.
Bagiella, Emilia
Lederer, David J.
Shimbo, Daichi
Horn, Evelyn M.
Roberts, Kari E.
Hill, Nicholas S.
Barr, R. Graham
Berman Rosenzweig, Erika S.
Post, Wendy
Tracy, Russell P.
Palevsky, Harold I.
Hassoun, Paul M.
Girgis, Reda E.
ASA-STAT Study Group
Date:
Type:
Articles
Department(s):
Medicine
Center for Behavioral Cardiovascular Health
Pediatrics
Biostatistics
Volume:
123
Persistent URL:
Book/Journal Title:
Circulation
Publisher:
American Heart Association, Inc.
Abstract:
Background—Pulmonary arterial hypertension (PAH) is a progressive disease that causes exercise limitation, heart failure, and death. We aimed to determine the safety and efficacy of aspirin and simvastatin in PAH. Methods and Results—We performed a randomized, double-blind, placebo-controlled 2×2 factorial clinical trial of aspirin and simvastatin in patients with PAH receiving background therapy at 4 centers. A total of 92 patients with PAH were to be randomized to aspirin 81 mg or matching placebo and simvastatin 40 mg or matching placebo. The primary outcome was 6-minute walk distance at 6 months. Sixty-five subjects had been randomized when the trial was terminated by the Data Safety and Monitoring Board after an interim analysis showed futility in reaching the primary end point for simvastatin. After adjustment for baseline 6-minute walk distance, there was no significant difference in the 6-minute walk distance at 6 months between aspirin (n=32) and placebo (n=33; placebo-corrected difference −0.5 m, 95% confidence interval −28.4 to 27.4 m; P=0.97) or between simvastatin (n=32) and placebo (n=33; placebo-corrected difference −27.6 m, 95% confidence interval −59.6 to 4.3 m; P=0.09). There tended to be more major bleeding episodes with aspirin than with placebo (4 events versus 1 event, respectively; P=0.17). Conclusions—Neither aspirin nor simvastatin had a significant effect on the 6-minute walk distance, although patients randomized to simvastatin tended to have a lower 6-minute walk distance at 6 months. These results do not support the routine treatment of patients with PAH with these medications.
Subject(s):
Aspirin--Therapeutic use
Pulmonary hypertension
Statins (Cardiovascular agents)
Medical sciences
Epidemiology
Medicine
Publisher DOI:
https://doi.org/10.1161/CIRCULATIONAHA.110.015693
Item views
218
Metadata:
text | xml
Suggested Citation:
Steven M. Kawut, Emilia Bagiella, David J. Lederer, Daichi Shimbo, Evelyn M. Horn, Kari E. Roberts, Nicholas S. Hill, R. Graham Barr, Erika S. Berman Rosenzweig, Wendy Post, Russell P. Tracy, Harold I. Palevsky, Paul M. Hassoun, Reda E. Girgis, ASA-STAT Study Group, , Randomized Clinical Trial of Aspirin and Simvastatin for Pulmonary Arterial Hypertension, Columbia University Academic Commons, .

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