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Randomized Clinical Trial of Aspirin and Simvastatin for Pulmonary Arterial Hypertension
Circulation, 05/24/2011
Clinical Article
Kawut SM et al. – 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.
Methods- A randomized, double–blind, placebo–controlled
- 2x2 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
- 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
- The primary outcome was 6–minute walk distance at 6 months
- 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).