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Comment & Response
August 2017

Intensity of Statin Treatment and Mortality—Reply

Author Affiliations
  • 1Division of Cardiovascular Medicine and Cardiovascular Institute, Stanford University, Stanford, California
  • 2Veterans Affairs Health System, Palo Alto, California
JAMA Cardiol. 2017;2(8):928-929. doi:10.1001/jamacardio.2017.0549

In Reply Nunes as well as Donzelli and Schivalocchi correctly note that observational studies should be interpreted with caution, as they cannot account for all potential confounders linking treatment (statin intensity) to outcome (mortality). Randomized clinical trials are the gold standard for demonstrating a causal relationship between statin intensity and mortality; however, care in the community may differ from a trial protocol. Observational data can provide insight into whether or not results in the community are consistent with clinical trial data. Clinical trials of standard care vs use of high-intensity statins have shown varying effects,1-3 with a meta-analysis4 showing a nonsignificant mortality benefit of high-intensity statin therapy (relative risk, 0.92; 95% CI, 0.83-1.03), with an effect size comparable with our findings (hazard ratio, 0.91; 95% CI, 0.88-0.93).5 The Veterans Affairs and Department of Defense Guideline6 noted the lack of statistical significance in this mortality benefit in recommending against using high-intensity statins for most patients with cardiovascular disease. While our estimate of mortality benefit was almost identical to the meta-analysis of randomized trials, our much larger sample made the mortality benefit highly statistically significant.

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