Efficacy for LDL-C-lowering and safety of pemafibrate extended-release formulation in patients with statin-intolerant hypercholesterolemia: A phase 3 multicenter, randomized, double-blind, placebo-con
6 hours ago
- #Pemafibrate
- #Hypercholesterolemia
- #Statin intolerance
- Pemafibrate extended-release formulation evaluated for LDL-C lowering in statin-intolerant hypercholesterolemia patients.
- Phase 3 trial: multicenter, randomized, double-blind, placebo-controlled, parallel-group design.
- Primary endpoint: percentage change in LDL-C from baseline to week 12.
- Significant LDL-C reduction with pemafibrate (-20.0% for 0.2 mg/d, -24.8% for 0.4 mg/d) vs. placebo (-0.4%).
- Apolipoprotein B reductions also greater with pemafibrate (-18.2% for 0.2 mg/d, -20.6% for 0.4 mg/d).
- Safety profile similar across groups, with slightly higher adverse events in pemafibrate groups (47.8%-54.2%) vs. placebo (37.5%).
- Conclusion: Pemafibrate is effective and safe for LDL-C reduction in statin-intolerant patients with normal triglycerides.