Table 2.
Changes in LDL-C levels in phase 3 CLEAR trials
Study | Duration | Population | Results at 12 weeks |
---|---|---|---|
CLEAR Wisdom | 52 weeks | Patients with ASCVD and/or HeFH and LDL-C > 70 mg/dL while receiving maximally tolerated statin (with or without other LLT) | Bempedoic acid added to maximally tolerated statin (with or without other LLT) reduced LDL-C by 17.4% (95% CI, − 21.0, − 13.9) more than placebo (P < .001) |
CLEAR Harmony | 52 weeks | Bempedoic acid added to different intensities of background statin treatment (low, moderate or high) with or without additional LLT reduced LDL-C from baseline (difference vs placebo. − 18.1% (95% CI, − 20.0%, − 16.1%): P < .001 | |
CLEAR Tranquility | 12 weeks | Patients with hypercholesterolemia and a history of statin intolerance who required additional LDL-C lowering | Bempedoic acid added to stable LLT, including ezetimibe, reduces LDL-C up to 28.5% (95% CI, − 34.4, − 22.5) more than placebo (P < .001) |
CLEAR Serenity | 24 weeks | Treatment with bempedoic acid reduced LDL-C 21.4% (95% CI, − 25.1, − 17.7) more than placebo (P < .001) |
CLEAR Wisdom, Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk; CLEAR Harmony, Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk; CLEAR Tranquility, Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C; CLEAR Serenity, Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant. (Reproduced with permission of JAMA Network [14].)
ASCVD atherosclerotic cardiovascular disease, HeFH heterozygous familial hypercholesterolemia, LDL-C low-density lipoprotein cholesterol, LLT lipid lowering therapy