CLEAR Outcomes
Trial question
What is the role of bempedoic acid in patients with statin-intolerant patients?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 13970
13970 patients (6740 female, 7230 male)
Inclusion criteria: patients who were unable or unwilling to take statins owing to unacceptable adverse effects and had or were at high risk for CVD
Key exclusion criteria: fasting blood triglycerides > 500 mg/dL; recent history of major cardiovascular events, TIA, or unstable or symptomatic cardiac arrhythmia; history of severe HF; uncontrolled hypertension or uncontrolled diabetes
Interventions
N=6992 bempedoic acid (an oral dose of 180 mg daily)
N=6978 placebo (matching placebo)
Primary outcome
Major adverse cardiovascular events
11.7
13.3
13.3 %
10.0 %
6.7 %
3.3 %
0.0 %
Bempedoic
acid
Placebo
Significant
decrease ▼
NNT = 62
Significant decrease in major adverse cardiovascular events (11.7% vs. 13.3%; HR 0.87, 95% CI 0.79 to 0.96)
Secondary outcomes
Significant decrease in composite of death from cardiovascular causes, nonfatal stroke, or nonfatal myocardial infarction (8.2% vs. 9.5%; HR 0.85, 95% CI 0.76 to 0.96)
Significant decrease in fatal or nonfatal myocardial infarction (3.7% vs. 4.8%; HR 0.77, 95% CI 0.66 to 0.91)
Significant decrease in coronary revascularization (6.2% vs. 7.6%; HR 0.81, 95% CI 0.72 to 0.92)
Safety outcomes
No significant difference in adverse and serious adverse events.
Significant difference in hyperuricemia (10.9% vs. 5.6%).
Conclusion
In patients who were unable or unwilling to take statins owing to unacceptable adverse effects and had or were at high risk for CVD, bempedoic acid was superior to placebo with respect to major adverse cardiovascular events.
Reference
Steven E Nissen, A Michael Lincoff, Danielle Brennan et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med. 2023 Apr 13;388(15):1353-1364.
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