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Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease
, Louise Bowman1, Jemma C Hopewell1
1Clinical Trial Service Unit, University of Oxford, Oxford, United Kingdom
Insights
Anacetinib significantly reduced major coronary events in patients with atherosclerotic vascular disease on statin therapy. This cholesteryl ester transfer protein inhibitor offers a new therapeutic option for cardiovascular risk reduction.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Trials
Background:
- Atherosclerotic vascular disease patients face ongoing cardiovascular event risk despite statin therapy.
- Cholesteryl ester transfer protein (CETP) inhibitors like anacetinib alter lipid profiles, but previous CETP inhibitors had mixed cardiovascular outcome results.
- Anacetinib targets CETP to reduce LDL and increase HDL cholesterol.
Purpose of the Study:
- To evaluate the efficacy and safety of anacetinib in reducing cardiovascular events in patients with atherosclerotic vascular disease receiving intensive statin therapy.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease.
- Participants received intensive atorvastatin therapy plus either 100 mg anacetinib daily or placebo.
- The primary outcome was the first major coronary event (composite of coronary death, myocardial infarction, or revascularization).
Main Results:
- Anacetinib significantly reduced the primary outcome compared to placebo (10.8% vs. 11.8%, rate ratio 0.91, P=0.004).
- Anacetinib increased HDL cholesterol by 104% and decreased non-HDL cholesterol by 18% at the trial midpoint.
- No significant differences in death, cancer, or serious adverse events were observed between groups.
Conclusions:
- Anacetinib use led to a lower incidence of major coronary events in patients with atherosclerotic vascular disease on intensive statin therapy.
- The study supports anacetinib as a potential therapeutic agent for cardiovascular risk reduction in this patient population.
- Anacetinib demonstrated a favorable safety profile with no increased risk of death or cancer.
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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