Randomised controlled trial
Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients
- Randomised controlled trial
- double-blind
- placebo-controlled
Authors' conclusion
Among statin-intolerant patients, treatment with bempedoic acid was associated with a lower risk of major adverse cardiovascular events (death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization).
Study context
- Population
- Statin-intolerant patients with, or at high risk for, CVD
- Participants
- 13,970 participants
- Comparison
- Bempedoic acid vs placebo
- Bempedoic acidn = 6,992
- Placebon = 6,978reference
- Primary endpoint
- MACE: death from CV causes, nonfatal MI, nonfatal stroke or coronary revascularization
Primary result
As reported in the abstract
Hazard ratio
0.87
95% CI 0.79–0.96
P = 0.004
Events by treatment group
Bempedoic acid vs Placebo
HR 0.87 (95% CI 0.79–0.96); P = 0.004
Further findings
| Outcome | Bempedoic acid | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Death from CV causes, nonfatal stroke or nonfatal MI | 8.2% | 9.5% | 0.85 (0.76–0.96) | P = 0.006 | |
| Fatal or nonfatal MI | 3.7% | 4.8% | 0.77 (0.66–0.91) | P = 0.002 | |
| Coronary revascularization | 6.2% | 7.6% | 0.81 (0.72–0.92) | P = 0.001 | |
| 0.512Hazard ratio (log scale) |
| Outcome | difference (mg per deciliter) | P value |
|---|---|---|
| LDL-C reduction vs placebo · 6 months | 29.2 |
- LDL-C reduction vs placebo: difference in percent reductions 21.1 percentage points; baseline mean 139.0 mg per deciliter in both groups
Fatal or nonfatal stroke, death from CV causes, death from any cause
- No significant effects
Safety
Gout
Cholelithiasis
Small increases in serum creatinine, uric acid and hepatic-enzyme levels
- Higher incidence with bempedoic acid than placebo
Original publication
Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med. Published 4 March 2023. doi:10.1056/nejmoa2215024
Summarised from the published abstract; every number is checked against it