Abstract
BackgroundStatins are generally well-tolerated and serious side effects are infrequent, but some patients experience adverse events and reduce their statin dose or discontinue treatment altogether. Alirocumab is a highly specific, fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), which can produce substantial and sustained reductions of low-density lipoprotein cholesterol (LDL-C).MethodsThe randomized, double-blind, placebo-controlled, parallel-group, phase 3 ODYSSEY NIPPON study will explore alirocumab 150 mg every 4 weeks (Q4W) in 163 Japanese patients with hypercholesterolemia who are on the lowest-strength dose of atorvastatin (5 mg/day) or are receiving a non-statin lipid-lowering therapy (LLT) (fenofibrate, bezafibrate, ezetimibe, or diet therapy alone). Hypercholesterolemia is defined as LDL-C ≥ 100 mg/dL (2.6 mmol/L) in patients with heterozygous familial hypercholesterolemia or non-familial hypercholesterolemia with a history of documented coronary heart disease, or ≥120 mg/dL (3.1 mmol/L) in patients with non-familial hypercholesterolemia classified as primary prevention category III (i.e. high-risk patients). During the 12-week double-blind treatment period, patients will be randomized (1:1:1) to receive alirocumab subcutaneously (SC) 150 mg Q4W alternating with placebo for alirocumab Q4W, or alirocumab 150 mg SC every 2 weeks (Q2W), or SC placebo Q2W. The primary efficacy endpoint is the percentage change in calculated LDL-C from baseline to week 12. The long-term safety and tolerability of alirocumab will also be investigated.DiscussionThe ODYSSEY NIPPON study will provide insights into the efficacy and safety of alirocumab 150 mg Q4W or 150 mg Q2W among Japanese patients with hypercholesterolemia who are on the lowest-strength dose of atorvastatin, or are receiving a non-statin LLT (including diet therapy alone).Trial registrationClinicalTrials.gov number: NCT02584504
Highlights
Statins are generally well-tolerated and serious side effects are infrequent, but some patients experience adverse events and reduce their statin dose or discontinue treatment altogether
The Japan Atherosclerosis Society (JAS) guidelines recommend lowering low-density lipoprotein cholesterol (LDL-C) to
Patients Patients are eligible to participate if they are aged ≥20 years, have heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH), are on the lowest-strength dose of atorvastatin (i.e. 5 mg/day) or are receiving a non-statin therapy, and have elevated LDL-C values according to the JAS guidelines [2]
Summary
Statins are generally well-tolerated and serious side effects are infrequent, but some patients experience adverse events and reduce their statin dose or discontinue treatment altogether. Statins substantially reduce the risk of cardiovascular morbidity and mortality [3] and are the preferred treatment option for lowering LDL-C [2, 4, 5]. They are generally well-tolerated and serious side effects are infrequent [6, 7], but some patients experience statinassociated effects [6, 8,9,10,11,12,13,14] that result in dose reductions or discontinuation of treatment [15]
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