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JAMA Guide to Statistics and Methods |

Time-to-Event Analysis

Juliana Tolles, MD, MHS1,2,3; Roger J. Lewis, MD, PhD1,2,3,4
[+] Author Affiliations
1Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California
2Los Angeles Biomedical Research Institute, Torrance, California
3David Geffen School of Medicine at UCLA, Los Angeles, California
4Berry Consultants LLC, Austin, Texas
JAMA. 2016;315(10):1046-1047. doi:10.1001/jama.2016.1825.
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This Guide to Statistics and Methods discusses the use of time-to-event analysis to evaluate the risk of an adverse outcome from a medical treatment.

Time-to-event analysis, also called survival analysis, was used in the study by Nissen et al1 published in this issue of JAMA to compare the risk of major adverse cardiovascular events (MACE) in a noninferiority trial of a combination of naltrexone and bupropion vs placebo for overweight or obese patients with cardiovascular risk factors. The authors used a type of time-to-event analysis called Cox proportional hazards modeling to compare the risk of MACE in the 2 groups, concluding that the use of naltrexone-bupropion increased the risk of MACE per unit time by no more than a factor of 2.

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Figure.
Time to MACE in the Final End-of-Study Analysis

The survival curves cross in this figure from Nissen et al,1 suggesting that the proportionality assumption may have been violated. MACE indicates major adverse cardiovascular events.

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