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Comment & Response
October 2015

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

Author Affiliations
  • 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, California
  • 3Division 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

In Reply We appreciate the opportunity to respond to the letters submitted by Geijteman et al and Mody and Nguyen. This is an important discourse.

Geijteman and colleagues provided important insights that can inform the design of deprescribing trials in the future. Furthermore, they raise concerns related to contamination among patients in the control group and of potential adverse effects (depression and abandonment) that may be precipitated by raising the issue of discontinuing a drug among people with limited life expectancy. Indeed, we had similar concerns and collected data on each of these items in this study.1 Among the 189 participants randomized to the statin discontinuation arm, 25 (13%) either never discontinued or restarted a statin at some time during the study period. Among the 192 participants randomized to the statin continuation arm, 62 (32%) discontinued a statin at some time during the study period. Prior to randomization, study participants were asked 9 questions regarding possible negative perceptions about discontinuing statins, including the implications for personal longevity. There were no statistically significant differences between the study groups in responses to these items (unpublished data). Study participants were monitored for potential negative psychological sequelae (ie, anxiety or depressive symptoms) after having their medications discontinued or continued, and no statistically significant differences were observed (unpublished data).