Trial-level surrogacy of non-high-density and low-density lipoprotein cholesterol reduction on the clinical efficacy of statins
Authors' conclusion
Neither LDL - c nor non-HDL-c demonstrated trial-level surrogacy for predicting treatment effects on mortality and cardiovascular events in statin trials. Although they are relevant biomarkers for the follow-up of patients treated with statins, their reduction does not reliably predict a similar reduction in cardiovascular risk. As such, they should not be used as pivotal evidence in drug trials.
Study context
- Population
- Statin trials versus placebo or usual care on all-cause mortality and cardiovascular events, published between 1987 and August 2023participants in Twenty randomized controlled trials (RCTs), median follow-up of 4.85 years
- Participants
- 194,686 participants
- Comparison
- Statin efficacy versus placebo or usual care; weighted linear regressions between log RR or ARD, and absolute difference in non-HDL-c or LDL - c
- Outcome
- All clinical outcomes
Methodological detailsRCTs
- RCTs
Pooled result
As reported in the abstract
- Statin treatment showed significant efficacy in improving all clinical outcomes
Further pooled results
Trial-level surrogacy (R²trial) of LDL - c and non-HDL-c
- R²trial for LDL - c
- 0 to 0.1
- R²trial for non-HDL-c
- 0 to 0.04
- Association between treatment effects on LDL - c or non-HDL-c reduction and clinical outcomes was weak
Surrogate threshold effect (STE) for major adverse cardiovascular event
mmol/L
- STE for LDL - c
- 0.76 (0.36-1.69)
- STE for non-HDL-c
- 0.87 (0.49-2.19)
Original publication
Trial-level surrogacy of non-high-density and low-density lipoprotein cholesterol reduction on the clinical efficacy of statins. Eur Heart J Cardiovasc Pharmacother. Published 25 February 2025. doi:10.
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