A Randomized Controlled Trial Is Conducted to Evaluate the Safety

question 84

Multiple Choice

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%

---

Definitions:

Creativity And Consumer Focus

A business approach that emphasizes innovative thinking and prioritizes understanding and meeting consumer needs.