0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
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.
Text Size: A A A
Published online

Extract

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.

Topics

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

First Page Preview

View Large
First page PDF preview

Figures

Tables

References

Correspondence

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.
CME
Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

Multimedia

Some tools below are only available to our subscribers or users with an online account.

143 Views
0 Citations
×

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

See Also...
Jobs
brightcove.createExperiences();