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Table 1 Key inclusion and exclusion criteria*

From: Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials

Inclusion criteria
COMBO I COMBO II
Patients with hypercholesterolemia and established CHD or CHD risk equivalents# with LDL-C poorly controlled with a maximally tolerated daily dose of statin with or without other LLT, both at stable dose for at least 4 weeks (6 weeks for fenofibrate) prior to the screening visit (week −2) Patients with hypercholesterolemia and established CHD or CHD risk equivalents# with LDL-C poorly controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (week −3)
Baseline entry criteria: LDL-C levels depending on history of documented CVD: Baseline entry criteria: LDL-C levels depending on history of documented CVD:
• LDL-C ≥70 mg/dL (≥1.81 mmol/L) at the screening visit with a history of documented CVD • LDL-C ≥70 mg/dL (≥1.81 mmol/L) at the screening visit with a history of documented CVD
• LDL-C ≥100 mg/dL (≥2.59 mmol/L) at the screening visit in patients without history of documented CVD • LDL-C ≥100 mg/dL (≥2.59 mmol/L) at the screening visit in patients without history of documented CVD
Exclusion criteria
COMBO I COMBO II
Age <18 years Age <18 years
Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) during the screening period Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) during the screening period
Currently taking a statin that is not simvastatin, atorvastatin, or rosuvastatin taken daily at a registered dose Currently taking a statin that is not simvastatin, atorvastatin, or rosuvastatin taken daily at a registered dose
Use of fibrates, other than fenofibrate, within 6 weeks prior to the screening visit (week −2) Use of concomitant meds
 Ezetimibe, omega-3 fatty acid (at doses ≥1,000 mg daily), nicotinic acid, bile acid-binding sequestrant, or red yeast rice products in the past 4 weeks prior to screening visit (week −3)
 Use of fibrates in the past 6 weeks prior to screening visit (week −3)
  1. CHD, coronary heart disease; CVD, cardiovascular disease (defined as CHD, ischemic stroke or peripheral arterial disease – see Additional file 1 for additional details); LDL-C, low-density lipoprotein cholesterol; LLT, lipid-lowering therapy.
  2. *Further information on the inclusion and exclusion criteria can be found in Additional file 1.
  3. Differences between COMBO I and COMBO II are shown in bold font.
  4. #See Additional file 1 for definition of CHD risk equivalents.