Efficacy and safety of add-on bempedoic acid on maximal dose of rosuvastatin and ezetimibe in patients with established coronary artery disease (ADDBEMPERE study).

BACKGROUND: Bempedoic acid (BA) has emerged as an add-on therapy to statin and ezetimibe combination to achieve low-density lipoprotein cholesterol (LDL-C) targets. Data are limited regarding the efficacy and safety of adding BA in patients who are receiving the maximal dose of rosuvastatin in combination with ezetimibe. OBJECTIVE: This study evaluated the efficacy and safety of adding bempedoic acid on the maximal dose of rosuvastatin with ezetimibe to achieve LDL cholesterol target in patients with established CAD. METHODS: Postcoronary angioplasty patients having LDL >70 mg/dL despite being on a stable dose of ezetimibe and rosuvastatin (40 mg) combination were initiated on BA. Follow-up was done at 12, 24, and 48 weeks. Efficacy of BA was assessed by changes in lipid parameters. Safety assessments included clinical adverse events and changes in laboratory parameters. Adverse events of special interest included musculoskeletal safety, uric acid levels, hepatic and renal safety, and new-onset diabetes. RESULTS: The study involved 322 patients. Baseline LDL-C was 82.1 ± 15.6 mg/dL (mean ± SD) and was reduced to 57.6 ± 32.0 (-29.8%) at 12 weeks (P < .001) without any further significant reduction. LDL-C levels of <70 and <55 mg/dL were achieved in 84.8% and 69.6% patients, respectively, at 48 weeks. However, LDL-C levels of <30 mg/dL were achieved only in 14.6% patients. A significant reduction in high-sensitivity C-reactive protein was observed. A significant increase in uric acid was noted. However, clinical gout occurred in only 3 patients. None of our patients developed myopathy, new-onset diabetes, hepatic or renal impairment. CONCLUSION: Addition of BA to the full dose of rosuvastatin and ezetimibe leads to a significant reduction in LDL-C. Benefits start early and are sustained. Therapy is well tolerated.