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Aliskiren failed to improve CAD in prehypertensive patients
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AMSTERDAM — Patients with prehypertension and evidence of CAD who were assigned aliskiren did not show significant improvement in CAD compared with similar patients assigned placebo.
The results were presented by Stephen Nicholls, MBBS, PhD, deputy director of the South Australian Health and Medical Research Institute, Adelaide, Australia, at ESC Congress 2013.
In the AQUARIUS study — a prospective, randomized, multicenter, double blind, placebo-controlled trial — Nicholls and colleagues investigated whether aliskiren (Tekturna, Novartis), a renin inhibitor approved as an antihypertensive agent, could provide value in lowering BP beyond prehypertensive goals.
Stephen Nicholls
The researchers enrolled 613 participants aged at least 35 years with angiographic evidence of CAD, systolic BP between 125 mm Hg and 139 mm Hg and diastolic BP less than 90 mm Hg, and two additional CV risk factors. One group (n=305) was assigned aliskiren 300 mg daily. The other group (n=308) was assigned placebo daily. Participants with diabetes were discontinued from the study after results of the ALTITUDE trial showed an increased risk for several adverse events in those with diabetes assigned aliskiren, Nicholls said at the presentation. There were 458 participants remaining in the study after 72 weeks.
The primary outcome was change in percent atheroma volume. The secondary outcome was change in total atheroma volume. These were assessed by IVUS at baseline and at the end of the study.
In those who remained in the study after 72 weeks, percent atheroma volume decreased by 0.33% in the group assigned aliskiren and increased by 0.11% in the group assigned placebo (P=.08). Total atheroma volume decreased by 4 mm3 in the group assigned aliskiren and by 2.1 mm3 in the group assigned placebo (P=.18). Regression of percent atheroma volume occurred in 56.9% of those assigned aliskiren vs. 48.9% of those assigned placebo (P=.09). Regression of total atheroma volume occurred in 64.4% of those assigned aliskiren vs. 57.5% of those assigned placebo (P=.13).
Those assigned aliskiren had a lower rate of major CV events (8.5% vs. 16.2%; P=.004) and of nonfatal MI (0.3% vs. 2.6%; P=.02) than those assigned placebo.
“These are small numbers, but we certainly find that these are quite intriguing and provocative findings in the context of a small imaging study,” Nicholls said at the presentation. “This tells us that … there may be benefits from continuing to be more aggressive with BP lowering in patients with coronary disease. We need to do a large, definitive outcome study to tell us what the ideal BP is for patients with coronary disease.”
For more information:
Nicholls S. Hot Line IV: Late breaking trials on heart failure and acute coronary syndrome. Presented at: the European Society of Cardiology Congress; Aug. 31-Sept. 4, 2013; Amsterdam.
Disclosure: The study was funded by Novartis. Nicholls reports financial ties with Amgen, Anthera, AstraZeneca, Boehringer Ingelheim, CSL Behring, Eli Lilly, Esperion, InfraReDx, LipoScience, Merck, Novartis, Omthera, Resverlogix, Roche, Sanofi-Aventis and Takeda.