Key result
In a real-world clinical setting in Japan, alirocumab was well tolerated with a 3.4% incidence of adverse drug reactions and effectively reduced LDL-C by an average of 45.6% from baseline.
Why the study?
The safety and effectiveness of alirocumab in Japanese patients with familial or non-familial hypercholesterolemia required evaluation in a real-world clinical setting.
Does alirocumab reduce LDL-C and maintain safety in Japanese patients with hypercholesterolemia at high cardiovascular risk?
Observational (n=1,177)
Yes
Does alirocumab reduce LDL-C and maintain safety in Japanese patients with hypercholesterolemia at high cardiovascular risk?
Alirocumab is safe and effective for significantly lowering LDL-C in Japanese patients with hypercholesterolemia in a real-world setting.
Supports alirocumab tolerability and LDL-C reduction in high-risk Japanese patients; extends RCT data to real-world settings but leaves practice implications open.
BACKGROUND: This study evaluated the safety and effectiveness of alirocumab in Japanese patients with familial hypercholesterolemia (FH) or non-FH in a real-world clinical setting. METHODS AND RESULTS: This post-marketing surveillance study had a 2-year standard observation period. The study included Japanese patients with hypercholesterolemia who were treatment naïve to alirocumab, had a high risk of developing cardiovascular events, and had an insufficient response to, or were unsuitable for, treatment with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors. Alirocumab was administered at a dose of 75 or 150 mg via subcutaneous injection every 2 or 4 weeks. Overall, 1,177 and 1,038 patients were included in the safety and effectiveness analysis populations, respectively. The incidence of adverse drug reactions (ADRs) was 3.4% (40/1,177). The time to ADR occurrence was within 4 weeks in half the patients experiencing ADRs (n=20). There were no meaningful differences in the ADRs experienced in the FH and non-FH groups. The mean (±SE) percentage changes in low-density lipoprotein cholesterol from baseline to last observation carried forward were -46.9±2.1% and -42.7±2.0% in the non-FH and FH groups, respectively. Total cholesterol, triglycerides, apolipoprotein B/E, and lipoprotein(a) concentrations were decreased at Week 4 and maintained until Week 104 in the overall population. CONCLUSIONS: Alirocumab was well tolerated and showed effectiveness in Japanese patients with hypercholesterolemia in a real-world clinical setting.
No takes yet. Share an insight, caveat, or question.
Kiyosue et al. (2023) conducted an observational in Hypercholesterolemia (Familial and Non-Familial) (n=1,177). Alirocumab was evaluated on Percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline to last observation carried forward (LOCF) (Mean change -45.6%, p=<0.001). In a real-world clinical setting in Japan, alirocumab was well tolerated with a 3.4% incidence of adverse drug reactions and effectively reduced LDL-C by an average of 45.6% from baseline.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: