- 1 Clinical Question
- 2 Bottom Line
- 3 Major Points
- 4 Guidelines
- 5 Design
- 6 Population
- 7 Interventions
- 8 Outcomes
- 9 Criticisms
- 10 Funding
- 11 Further Reading
Is evolocumab safe and effective to decrease LDL and cardiovascular events in patients who were enrolled in phase 2 and phase 3 trials of evolocumab (familial heterozygous hypercholesterolemia, intolerant to statins, high LDL-C) in the longterm?
Evolocumab is effective in decreasing LDL-C on top of standard therapies and decreases cardiovascular events in an exploratory analysis.
Larger trials with cardiovascular events as primary outcome is needed to confirm the benefit on cardiovascular events.
Phase 2 and phase 3 trials of evolocumab have suggested an decrease in LDL-C with evolocumab.
The OSLER trials confirm this decrease in LDL-C and shows that evolocumab has an adequate safety profile. The exploratory analysis also shows that evolocumab decreases cardiovascular events with a NNT of 90 during 1 year(death, non fatal MI, unstable angina requiring hospitalization, coronary resvascularisation, ischemic stroke, TIA, and heart failure requiring hospitazliation).
However, neurocognitive events were also non-statistically increased in the evolocumab group.
- Multicenter, unblinded, parallel-group, randomized, controlled trial
- Evolocumab + standard (n=2,976)
- Standard (n=1,489)
- Median follow-up: 11.1 months
- Primary outcome: adverse events