title: Randomized clinical trial of aspirin and simvastatin for pulmonary arterial hypertension: ASA-STAT.
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.
  
  
  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.
authors: Penn Cardiovascular Institute, Department of Medicine and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, 423 Guardian Drive, Philadelphia, PA 19104, USA. kawut@upenn.edu
authors: Steven M
authors: SM
authors: Kawut
authors: Emilia
authors: E
authors: Bagiella
authors: David J
authors: DJ
authors: Lederer
authors: Daichi
authors: D
authors: Shimbo
authors: Evelyn M
authors: EM
authors: Horn
authors: Kari E
authors: KE
authors: Roberts
authors: Nicholas S
authors: NS
authors: Hill
authors: R Graham
authors: RG
authors: Barr
authors: Erika B
authors: EB
authors: Rosenzweig
authors: Wendy
authors: W
authors: Post
authors: Russell P
authors: RP
authors: Tracy
authors: Harold I
authors: HI
authors: Palevsky
authors: Paul M
authors: PM
authors: Hassoun
authors: Reda E
authors: RE
authors: Girgis
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