Efficacy and safety of bempedoic acid among patients with and without diabetes: prespecified analysis of the CLEAR Outcomes randomised trial
Primary result · MACE-4 in patients with diabetesResult — go to the resultHazard ratio 0.83 95% CI 0.72–0.95Authors' conclusion
Among patients with diabetes, bempedoic acid reduces LDL cholesterol and high-sensitivity C-reactive protein and risk of cardiovascular events. Patients without diabetes had no increase in new-onset diabetes or worsening HbA1c with bempedoic acid. The efficacy and cardiometabolic safety profile of bempedoic acid makes it a clinical option for those with and without diabetes.
Study context
- Population
- Statin-intolerant patients with or without CVD and LDL-C ≥2.59 mmol/L; 6373 (45.6%) with diabetes, 5796 (41.5%) with prediabetes, 1801 (12.9%) with normoglycaemiarandomised 1:1
- Participants
- 13,970 patients
- Comparison
- Bempedoic acid 180 mg once daily vs placebo, by baseline glycaemia status
- Primary endpoint
- Major adverse cardiovascular event (MACE-4) (CV death, nonfatal MI, nonfatal stroke or coronary revascularisation), time-to-event, ITT population stratified by baseline glycaemia; new-onset diabetes and HbA1c increase in those without diabetes
- Follow-up
- Median 3.4 years
Methodological detailsdouble-blind, placebo-controlled, multicentre (1250 sites, 32 countries)
- Double-blind
- Placebo-controlled
- Multicentre (1250 sites, 32 countries)
Primary result
MACE-4 in patients with diabetes · median 3.4 years
Hazard ratio
0.83
95% CI 0.72–0.95
interaction p=0.42
Bempedoic acidvs Placebo
HR 0.83 (95% CI 0.72–0.95); interaction p=0.42
As reported in the abstract
Further findings
| Outcome | P value |
|---|---|
| LDL-C and high-sensitivity C-reactive protein, placebo-corrected, each glycaemic stratum · 6 months | all p<0.001 |
- LDL-C and high-sensitivity C-reactive protein, placebo-corrected, each glycaemic stratum: reduced with bempedoic acid in diabetes, prediabetes and normoglycaemia
Safety
| Outcome | Bempedoic acid | Placebo | HR (95% CI) | |
|---|---|---|---|---|
| New-onset diabetes in patients without diabetes at baseline | 11.1% | 11.5% | 0.95 (0.83–1.09) | |
| 0.512Hazard ratio (log scale) |
- New-onset diabetes in patients without diabetes at baseline: 429 of 3848 vs 433 of 3749
HbA1c in prediabetes and normoglycaemia · month 12 and end of study
- HbA1c similar between randomised groups
Original publication
Efficacy and safety of bempedoic acid among patients with and without diabetes: prespecified analysis of the CLEAR Outcomes randomised trial. Lancet Diabetes Endocrinol. Published 4 December 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →