The addition of bempedoic acid to maximally tolerated statins in patients with hypercholesterolemia significantly and durably reduces LDL-C levels compared with the addition of placebo, according to results of the CLEAR Wisdom trial presented at ACC.19 in New Orleans.

Anne C. Goldberg, MD, et al., hypothesized that bempedoic acid might promote further LDL-C reductions in patients who must limit their statin dose or who cannot tolerate statins. They randomized 779 patients to treatment with bempedoic acid 180 mg or placebo once daily for one year in addition to maximally tolerated statins. A subset of 77 patients was not able to tolerate any statin dose. The primary endpoint was the percent change in LDL-C from baseline to week 12.

A total of 740 patients completed the study (490 on bempedoic acid and 250 on placebo). LDL-C levels in the bempedoic acid group declined from 119.4 mg/dL at baseline to 97.6 mg/dL at 12 weeks compared with no change from baseline in the placebo group (122.4 mg/dL vs 122.8 mg/dL). The mean percent change in LDL-C was 15.1 percent with bempedoic acid vs. 2.4 percent with placebo (p<0.001). Among the patients not taking statins the mean percent change was –24.6 percent with bempedoic acid vs. –2.6 percent with placebo.

"These findings indicate that this agent may add to the armamentarium of treatment options for high-risk patients with atherosclerotic cardiovascular disease whose LDL cholesterol remains uncontrolled despite taking a maximally tolerated statin," Goldberg said.

At one year, the LDL-C level was 99.6 mg/dL in the bempedoic acid group vs. 116.9 mg/dL in the placebo group. "The effect of bempedoic acid was durable at one year and we observed no increase in adverse effects from the addition of bempedoic acid to statin therapy," Goldberg said.

"The key next step is a randomized trial to see whether this drug lowers events compared with currently available agents added to statins, such as exetimide," noted ACC.org Editor-in-Chief Kim A. Eagle, MD, MACC.

Keywords: ACC19, ACC Annual Scientific Session, Hypercholesterolemia, Cardiovascular Diseases, Dicarboxylic Acids, Dyslipidemias, Secondary Prevention, Acute Coronary Syndrome

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