Long-term safety and efficacy of anacetrapib in patients with atherosclerotic vascular disease.
HPS3/TIMI55-REVEAL Collaborative Group None., Writing Committee None., Sammons E., Hopewell JC., Chen F., Stevens W., Wallendszus K., Valdes-Marquez E., Dayanandan R., Knott C., Murphy K., Wincott E., Baxter A., Goodenough R., Lay M., Hill M., Macdonnell S., Fabbri G., Lucci D., Fajardo-Moser M., Brenner S., Hao D., Zhang H., Liu J., Wuhan B., Mosegaard S., Herrington W., Wanner C., Angermann C., Ertl G., Maggioni A., Barter P., Mihaylova B., Mitchel Y., Blaustein R., Goto S., Tobert J., DeLucca P., Chen Y., Chen Z., Gray A., Haynes R., Armitage J., Baigent C., Wiviott S., Cannon C., Braunwald E., Collins R., Bowman L., Landray M., REVEAL Collaborative Group None.
AIMS: REVEAL was the first randomized controlled trial to demonstrate that adding cholesteryl ester transfer protein inhibitor therapy to intensive statin therapy reduced the risk of major coronary events. We now report results from extended follow-up beyond the scheduled study treatment period. METHODS AND RESULTS: A total of 30 449 adults with prior atherosclerotic vascular disease were randomly allocated to anacetrapib 100 mg daily or matching placebo, in addition to open-label atorvastatin therapy. After stopping the randomly allocated treatment, 26 129 survivors entered a post-trial follow-up period, blind to their original treatment allocation. The primary outcome was first post-randomization major coronary event (i.e. coronary death, myocardial infarction, or coronary revascularization) during the in-trial and post-trial treatment periods, with analysis by intention-to-treat. Allocation to anacetrapib conferred a 9% [95% confidence interval (CI) 3-15%; P = 0.004] proportional reduction in the incidence of major coronary events during the study treatment period (median 4.1 years). During extended follow-up (median 2.2 years), there was a further 20% (95% CI 10-29%; P