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Published on: September 15, 2018
Efficacy and Safety of Alirocumab in Japanese Patients With Heterozygous Familial Hypercholesterolemia or at High
Tamio Teramoto1, Masahiko Kobayashi, Hiromi Tasaki
1Teikyo Academic Research Center, Teikyo University.
Insights
Alirocumab significantly reduced low-density lipoprotein cholesterol (LDL-C) in Japanese patients with hypercholesterolemia. This treatment was well-tolerated over 52 weeks when added to statin therapy.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Research
Background:
- The ODYSSEY Japan study investigated alirocumab's efficacy in Japanese patients with heterozygous familial hypercholesterolemia (heFH) or high cardiovascular risk non-FH.
- Patients required additional lipid-lowering therapy to meet LDL-C goals (<2.6 or <3.1 mmol/L).
Purpose of the Study:
- To demonstrate LDL-C reduction by alirocumab as an add-on therapy.
- To assess the efficacy and safety of alirocumab in a Japanese high-risk population.
Main Methods:
- A 52-week, randomized, double-blind, placebo-controlled study in 216 Japanese patients.
- Patients received alirocumab (75 mg Q2W, escalating if needed) or placebo, plus stable statin therapy.
- Stratification for heFH was used, with LDL-C measured at baseline, week 8, 24, and 52.
Main Results:
- Alirocumab achieved a mean LDL-C reduction of -62.5% at week 24, sustained to week 52, versus 1.6% (week 24) and -3.6% (week 52) for placebo (P<0.0001).
- The difference in LDL-C reduction between groups was -64.1% at week 24 (P<0.0001).
- No significant differences in adverse event patterns were observed between treatment groups over 52 weeks.
Conclusions:
- Alirocumab significantly reduced LDL-C compared to placebo in high-risk Japanese patients on statins.
- The treatment demonstrated good tolerability over the 52-week study period.
Background:
The ODYSSEY Japan study was designed to demonstrate the reduction in low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on to existing lipid-lowering therapy in Japanese patients with heterozygous familial hypercholesterolemia (heFH) or non-FH at high cardiovascular risk who require additional pharmacological management to achieve their LDL-C treatment goal (<2.6 or <3.1 mmol/L, depending on risk category).
Methods And Results:
This randomized, double-blind, parallel-group, 52-week study was conducted in Japan. Patients (n=216) with heFH, non-FH at high cardiovascular risk with coronary disease, or classified as category III were enrolled. The prespecified safety analysis was done after the last patient completed 52 weeks. Patients were randomized (2:1, alirocumab:placebo) with stratification for heFH to s.c. alirocumab (75 mg every 2 weeks [Q2 W] with increase to 150 mg if week 8 LDL-C ≥2.6/3.1 mmol/L) or placebo for 52 weeks plus stable statin therapy. At week 24, mean±SE change in LDL-C from baseline was -62.5±1.3% in the alirocumab group and 1.6±1.8% in the placebo group (difference, -64.1±2.2%; P<0.0001); the reduction was sustained to week 52 (alirocumab, -62.5±1.4%; placebo, -3.6±1.9%). No patterns were evident between treatment groups for adverse events at 52 weeks.
Conclusions:
In high-risk Japanese patients with hypercholesterolemia on stable statin therapy, alirocumab markedly reduced LDL-C vs. placebo and was well tolerated over 52 weeks. (Circ J 2016; 80: 1980-1987).
