Real-world effectiveness of alirocumab in patients with documented statin intolerance

Background/Introduction Statin intolerance is a relevant barrier to achieving recommended low-density lipoprotein cholesterol (LDL-C) goals in patients at high cardiovascular risk. Alirocumab, a monoclonal antibody targeting PCSK9, offers an alternative for LDL-C reduction in patients unable to tolerate statin therapy. Purpose To evaluate the long-term effectiveness, tolerability, and treatment adherence of alirocumab in real-world patients with confirmed statin intolerance. Methods A retrospective observational analysis was conducted including patients with documented statin intolerance who initiated alirocumab. Eligible individuals received at least two doses and had LDL-C measurements before and after treatment initiation. Clinical characteristics, lipid profile evolution, adherence, tolerability, and cardiovascular events were assessed during follow-up. Results Twenty-six patients were included. Alirocumab dosing was 150 mg in 65.4% and 75 mg in 34.6%. LDL-C reductions were sustained throughout follow-up, with 73.1% of patients achieving <70 mg/dL and 42.3% achieving <55 mg/dL. Treatment was well tolerated, with high adherence and no significant adverse events reported. Cardiovascular event incidence was low: no myocardial infarction, stroke, or cardiovascular death occurred. Four patients presented unstable angina, with three requiring revascularisation. No sex-based differences were observed in LDL-C reduction or target achievement. Conclusions In statin-intolerant patients, alirocumab provided effective and sustained LDL-C lowering with excellent tolerability and favourable long-term adherence. The low incidence of cardiovascular events supports its role as a therapeutic alternative for lipid management in high-risk individuals unable to tolerate statin therapy.