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Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease.

Publication ,  Journal Article
HPS3/TIMI55–REVEAL Collaborative Group, ; Bowman, L; Hopewell, JC; Chen, F; Wallendszus, K; Stevens, W; Collins, R; Wiviott, SD; Cannon, CP ...
Published in: N Engl J Med
September 28, 2017

BACKGROUND: Patients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTS: During the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONS: Among patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

September 28, 2017

Volume

377

Issue

13

Start / End Page

1217 / 1227

Location

United States

Related Subject Headings

  • Oxazolidinones
  • Middle Aged
  • Medication Adherence
  • Male
  • Kaplan-Meier Estimate
  • Incidence
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
  • General & Internal Medicine
  • Female
 

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HPS3/TIMI55–REVEAL Collaborative Group, ., Bowman, L., Hopewell, J. C., Chen, F., Wallendszus, K., Stevens, W., … Landray, M. J. (2017). Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease. N Engl J Med, 377(13), 1217–1227. https://doi.org/10.1056/NEJMoa1706444
HPS3/TIMI55–REVEAL Collaborative Group, Martin J., Louise Bowman, Jemma C. Hopewell, Fang Chen, Karl Wallendszus, William Stevens, Rory Collins, et al. “Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease.N Engl J Med 377, no. 13 (September 28, 2017): 1217–27. https://doi.org/10.1056/NEJMoa1706444.
HPS3/TIMI55–REVEAL Collaborative Group, Bowman L, Hopewell JC, Chen F, Wallendszus K, Stevens W, et al. Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease. N Engl J Med. 2017 Sep 28;377(13):1217–27.
HPS3/TIMI55–REVEAL Collaborative Group, Martin J., et al. “Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease.N Engl J Med, vol. 377, no. 13, Sept. 2017, pp. 1217–27. Pubmed, doi:10.1056/NEJMoa1706444.
HPS3/TIMI55–REVEAL Collaborative Group, Bowman L, Hopewell JC, Chen F, Wallendszus K, Stevens W, Collins R, Wiviott SD, Cannon CP, Braunwald E, Sammons E, Landray MJ. Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease. N Engl J Med. 2017 Sep 28;377(13):1217–1227.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

September 28, 2017

Volume

377

Issue

13

Start / End Page

1217 / 1227

Location

United States

Related Subject Headings

  • Oxazolidinones
  • Middle Aged
  • Medication Adherence
  • Male
  • Kaplan-Meier Estimate
  • Incidence
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
  • General & Internal Medicine
  • Female