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Table 1 Inclusion and exclusion criteria

From: Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk

Inclusion criteria

 Aged ≥18 years or legal age of majority at screening visit, whichever is greater

 ASCVD (including CHDa, documented PAD or previous ischaemic stroke) and/or ≥1 additional cardiovascular risk factorb

 Stable anti-hyperglycaemic treatment (including insulin)

 Stable, maximally tolerated dose/regimen of statin for at least 4 weeks prior to screening without other lipid-lowering therapy

 Non-HDL-C ≥100 mg/dl (2.59 mmol/l)

 TG ≥150 and <500 mg/dl (≥1.70 and <5.65 mmol/l)

 No weight variation >5 kg within 3 months

Exclusion criteria

 HbA1c ≥9%

 Use of any lipid-lowering therapy (other than statin) or over-the-counter product/nutraceuticals known to impact lipids within 4 weeks prior to screening

 BMI >45 kg/m2

 Alcohol consumption >two standard alcoholic drinks/day

  1. ASCVD atherosclerotic cardiovascular disease, BMI body mass index, CHD coronary heart disease, CKD chronic kidney disease, HbA 1c glycated haemoglobin, MI myocardial infarction, non-HDL-C non-high-density lipoprotein cholesterol, PAD peripheral arterial disease, TG triglyceride, UA unstable angina
  2. aHistory of CHD: acute MI, silent MI, UA, coronary revascularisation procedure or clinically significant CHD diagnosed by invasive or non-invasive testing
  3. bCardiovascular risk factors: hypertension, current smoker, aged ≥45 years (men) and ≥55 years (women), history of micro/macroalbuminuria or diabetic retinopathy, family history of premature CHD, low HDL-C, documented CKD
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Cardiovascular Diabetology

ISSN: 1475-2840