A Randomized Controlled Trial Is Conducted to Evaluate the Safety

A randomized controlled trial is conducted to evaluate the safety and efficacy of high-dose protovastatin compared with low-dose protovastatin in patients with stable coronary artery disease (CAD) in the prevention of CAD-related complications.  A total of 12,780 patients with stable CAD who achieved low-density lipoprotein cholesterol (LDL-C) <120 mg/dL during a run-in period (protovastatin 1 mg/d) are randomized (1:1) to high-dose (protovastatin 4 mg/d; n = 6,392) or low-dose (protovastatin 1 mg/d; n = 6,388) statin therapy.  The primary endpoint is a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or unstable angina requiring emergency hospitalization.  With a median follow-up of 4 years, the risk of the primary endpoint is 4.3% in the high-dose group and 5.4% in the low-dose group.  The difference in the risk of the primary endpoint is statistically significant.  Which of the following is the most accurate interpretation of these results?

A) Number needed to treat with high-dose protovastatin is 9
B) Number needed to treat with high-dose protovastatin is 91
C) Relative risk reduction for high-dose protovastatin is 1%
D) Relative risk reduction for high-dose protovastatin is 80%

Correct Answer:

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