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Comment & Response |

Selecting the Optimal Design for Drug Discontinuation Trials in a Setting of Advanced, Life-Limiting Illness

Purav Mody, MD1; Oanh Kieu Nguyen, MD, MAS1,2
[+] Author Affiliations
1Department of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas
2Department of Clinical Sciences, UT Southwestern Medical Center, Dallas, Texas
JAMA Intern Med. 2015;175(10):1725. doi:10.1001/jamainternmed.2015.4000.
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To the Editor We read with great interest the recent study on discontinuing statin therapy in individuals with advanced illness by Kutner and colleagues.1 Though we appreciate the spirit of the study and the difficulty of conducting a randomized clinical trial in this challenging population, we disagree with the authors’ interpretation that the results suggest that stopping statin medication therapy is safe according to the prespecified criteria for noninferiority. As is stated in the results, the noninferiority end point for the primary outcome of death within 60 days was not met. The statin discontinuation group had 23.5% mortality at 60 days vs 20.5% in the continuation group, an absolute risk difference of 3.5% (90% CI, −3.5% to 10.5%). The possible excess mortality of up to 10.5%, indicated by the upper limit of the 90% CI, is over twice the value of the noninferiority margin of 5% selected by the authors. Consequently, claiming that stopping statin therapy is safe appears to overstate the findings for the primary outcome of the study.


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October 1, 2015
Eric C. T. Geijteman, MD; Henning Tiemeier, MD, PhD; Teun van Gelder, MD, PhD
1Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam2Department of Public Health, Erasmus University Medical Center, Rotterdam
3Department of Epidemiology, Erasmus University Medical Center, Rotterdam
4Department of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam
JAMA Intern Med. 2015;175(10):1724-1725. doi:10.1001/jamainternmed.2015.3997.
October 1, 2015
Jean S. Kutner, MD, MSPH; Christine S. Ritchie, MD, MSPH; Amy P. Abernethy, MD, PhD
1Department of Medicine, University of Colorado School of Medicine, Aurora
2San Francisco Veterans Affairs Medical Center, Center for Research on Aging at the Jewish Home of San Francisco, San Francisco, California3Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco
4Center for Learning Health Care, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
JAMA Intern Med. 2015;175(10):1725. doi:10.1001/jamainternmed.2015.4003.
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