Table 1. Main trial and subgroup characteristics.
Trial | Trial population | Median/mean trial duration | Randomization groups | N | Mean/median on-treatment LDL-C | Subgroup-defining baseline characteristics |
---|---|---|---|---|---|---|
IDEAL | History of MI | 4.8 years | Simvastatin 20 mg | 4449 | 104 mg/dl | Age <65 years/Age 65–80 years CKD/No CKD PVD present/absent Smoking status current, former, never |
Atorvastatin 80 mg | 4439 | 81 mg/dl | ||||
TNT | Chronic CHD | 4.9 years | Atorvastatin 10 mg | 5006 | 101 mg/dl | Age <65/Age 65–75 years CABG present/absent CKD present/absent DM present absent DM+CKD DM+ No CKD Metabolic syndrome present/absent Resistant HTN present/absent Smoking status current, former, never |
Atorvastatin 80 mg | 4995 | 77 mg/dl | ||||
IMPROVE-IT | Recent acute coronary syndrome on simvastatin | 6 years | Placebo | 9077 | 70 mg/dl | High risk (≥3 risk enhancers)* Intermediate risk (2 risk enhancers)* Low risk (0–1 risk enhancer)* Diabetes present/absent Age <65, 65–75, ≥75 years |
Ezetimibe 10 mg | 9067 | 54 mg/dl | ||||
FOURIER | Chronic atherosclerotic cardiovascular disease on maximal statin | 2.2 years | Placebo | 13,780 | 92 mg/dl | Baseline LDL-C <70, ≥70 mg/dl DM present/absent hsCRP levels <1mg/dL, 1 to 3 mg/DL, > 3mg/dL Lp(a) <37 nM, ≥37 nM MI history present/absent MI <2 years ago, ≥2 years ago ≥2 prior MI, 0–1 prior MI Multi-vessel coronary artery disease present/absent PVD present/absent Statin therapy maximal/submaximal |
Evolocumab | 13,784 | 30 mg/dl | ||||
ODYSSEY OUTCOMES | Acute coronary syndrome <1 year on maximal statin | 2.8 years | Placebo | 9462 | 96 mg/dl | Prior CABG, CABG at index event, no CABG CHD only CHD+PVD CHD+CeVD CHD+ PVD+ CeVD DM, preDM, no DM Genetic risk score low/high 2018 AHA/ACC guideline very high risk with multiple events, very high risk with single event, not very high risk |
Alirocumab | 9462 | 48 mg/dl |
* Risk enhancers: Heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke, prior coronary artery bypass grafting, peripheral arterial disease, estimated glomerular filtration rate <60 ml/min/1.73 m2, current smoking
AHA/ACC American Heart Association/American College of Cardiology
CABG Coronary artery bypass grafting
CeVD Cerebrovascular disease
CHD Coronary heart disease
CKD Chronic kidney disease
DM Diabetes mellitus
FOURIER Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk
HTN Hypertension
IDEAL Incremental Decrease in End Points Through Aggressive Lipid Lowering
IMPROVE-IT Improved Reduction of Outcomes: Vytorin Efficacy International Trial
MI Myocardial infarction
PVD Peripheral vascular disease
TNT Treating to New Targets