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 ......
Invited Commentary |

The Gap Between Clinical Trials and the Real World:  Extrapolating Treatment Effects From Younger to Older Adults

Mary E. Tinetti, MD1,2
[+] Author Affiliations
1Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
2Yale School of Public Health, New Haven, Connecticut
JAMA Intern Med. 2014;174(3):397-398. doi:10.1001/jamainternmed.2013.13283.
Text Size: A A A
Published online

Extract

The exclusion of older adults, particularly those with complex and multiple chronic conditions, from randomized clinical trials (RCTs) has been well chronicled.1,2 Less well studied is how the preventive benefits seen in participants in RCTs translate to older individuals with multiple chronic health problems.

Helping to fill this gap, O’Hare and coauthors3 investigate whether the benefits of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) in preventing progression to end-stage renal disease (ESRD) that are seen in younger populations would be similar for older adults. Using a simulation design, the authors provide evidence that the same relative benefit of ACEIs and ARBs seen in participants in RCTs do not provide the same absolute benefit in terms of less ESRD in older adults; this finding is important because the results from the participants in the RCTs inform current guidelines. For most of the older veterans in their study, more than 100 persons would need to be treated to prevent 1 case of ESRD. For many subgroups, the number needed to treat was greater than 1000, a sharp contrast to the range of 9 to 25 reported in the 4 trials highlighted in the article. These findings leave one wondering whether the poor translation of the effectiveness of ACEIs and ARBs from younger to older individuals is an isolated situation or whether we are unwittingly subjecting older adults to a wide array of preventive treatments that have no or marginal benefit or even impart unintended harm. The study by O’Hare et al supports the need to look at this question more systematically and calls into question the prevailing practice of assuming that results extrapolate from young to old and from healthier to sicker populations.

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

First Page Preview

View Large
First page PDF preview

Figures

Tables

References

Correspondence

CME
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.
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.
Submit a Comment

Multimedia

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

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

Related Content

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

See Also...
Articles Related By Topic
Related Collections
PubMed Articles
Jobs
JAMAevidence.com
brightcove.createExperiences();