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Fig. 1 | Lipids in Health and Disease

Fig. 1

From: Efficacy and safety of alirocumab in patients with hypercholesterolemia not adequately controlled with non-statin lipid-lowering therapy or the lowest strength of statin: ODYSSEY NIPPON study design and rationale

Fig. 1

Study design. JAS, Japan Atherosclerosis Society [2]; LDL-C, low-density lipoprotein cholesterol; LLT: lipid-lowering therapy; PCV, phone-call visit; Q2W: every 2 weeks; Q4W: every 4 weeks; R, randomization; W, week. a As a general rule, patients start the run-in period to reach a stable daily dose of atorvastatin 5 mg or non-statin LLT. b When patients have received atorvastatin 5 mg/day or non-statin LLT at a stable daily dose for at least 4 weeks, they can skip the run-in period and start the study from the screening period. c To maintain the double blind, injections of placebo will be conducted at W2, W6, and W10. d Uptitration to alirocumab 150 mg Q2W at W24 is done only if LDL-C is ≥100 mg/dL or ≥120 mg/dL at W20, depending on risk category. e Last administration of up-titrated alirocumab 150 mg Q2W at W62. f The permitted atorvastatin at a dose of 5 mg daily, non-statin LLT, or diet therapy should remain stable (including dose) throughout the study barring exceptional circumstances

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Lipids in Health and Disease

ISSN: 1476-511X