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Atorvastatin at 80 mg/d reduced cerebrovascular events more than did atorvastatin at 10 mg/d in stable coronary heart disease

P. O'Malley

ACP Journal Club, 2007

5,006 participants

Abstract

M e t h o d s Design: Randomized controlled trial. Allocation: {Concealed}†.* Blinding: Blinded (clinicians, patients, and endpoints adjudication committee).* Follow-up period: Median 4.9 years. Setting: 256 sites in 14 countries across 4 continents. Patients: 10 001 patients 35 to 75 years of age (mean age 61 y, 81% men) who had clinically evident CHD (defined as previous myocardial infarction or coronary revascularization, or previous or current angina with objective evidence of CHD), low-density lipoprotein cholesterol (LDL-C) level 130 to 250 mg/dL (3.4 to 6.5 mmol/L), and triglyceride level ≤ 600 mg/dL (6.8 mmol/L). LDL-C level was required to be < 130 mg/dL (3.4 mmol/L) during an 8-week run-in period with atorvastatin, 10 mg/d. Intervention: Atorvastatin, 80 mg/d (n = 4995), or atorvastatin, 10 mg/d (n = 5006), with target mean LDL-C levels at 75 mg/dL (1.9 mmol/L) and 100 mg/dL (2.6 mmol/L), respectively. Outcomes: Cerebrovascular events, including fatal or nonfatal stroke and transient ischemic attack (TIA) (predefined secondary outcome). Patient follow-up: 99% (intention-to-treat analysis).

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 5,006 participants or records.

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