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. 2020 Oct 29;15(10):e0240166. doi: 10.1371/journal.pone.0240166

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