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Comment & Response
January 2, 2020

Interpreting the Benefit of Simvastatin-Ezetimibe in Patients 75 Years or Older

Author Affiliations
  • 1Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts
  • 2Google, Mountain View, California
JAMA Cardiol. 2020;5(2):235. doi:10.1001/jamacardio.2019.5200

To the Editor Bach et al1 conducted an important study to assess the treatment effect from simvastatin-ezetimibe therapy vs simvastatin monotherapy among patients 75 years or older with stabilized acute coronary syndrome. The primary end point consisted of death due to cardiovascular disease (CVD), myocardial infarction, stroke, unstable angina requiring hospitalization, and coronary revascularization after 30 days. One secondary end point consisted of only death due to CVD, myocardial infarction, and stroke. For the primary end point, the 7-year absolute risk reduction from adding ezetimibe was 8.7%.1 However, no confidence interval for the risk difference was reported. Instead, the conclusion of a significant reduction in risk was based on a hazard ratio (HR) of 0.80 (95% CI, 0.70-0.90) in favor of adding ezetimibe. For the secondary end point, the absolute risk reduction was 6.7% with an HR of 0.79 (95% CI, 0.69-0.91).1 Even if the HR provides a valid summary of the treatment effect, it is difficult to interpret clinically since the actual hazards of the treatment groups were not provided.2

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