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 ......
Viewpoint |

Valsartan/Sacubitril for Heart Failure Reconciling Disparities Between Preclinical and Clinical Investigations

Arthur M. Feldman, MD, PhD1; Julia A. Haller, MD2,3; Steven T. DeKosky, MD4
[+] Author Affiliations
1Departments of Medicine and Physiology, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania
2Wills Eye Institute, Philadelphia, Pennsylvania
3Thomas Jefferson University, Philadelphia, Pennsylvania
4Department of Neurology, McKnight Brain Institute, University of Florida College of Medicine, Gainesville
JAMA. 2016;315(1):25-26. doi:10.1001/jama.2015.17632.
Text Size: A A A
Published online

Extract

This Viewpoint discusses the importantance of developing effective mechanisms for reconciling differences that emerge when information accrual from genetic animal models outpace the data collection from patients enrolled in clinical trials.

Valsartan/sacubitril (Entresto, Novartis) is a combination of the neprilysin inhibitor sacubitril and the angiotensin receptor antagonist valsartan. In July 2015, the US Food and Drug Administration (FDA) approved valsartan/sacubitril through the fast-track pathway for the treatment of patients with New York Heart Association class II through IV heart failure symptoms and a reduced ejection fraction. The approval was based on the results of a single phase 3 clinical trial (PARADIGM-HF)1 that included 8400 patients. In this trial, valsartan/sacubitril was associated with a 20% (hazard ratio, 0.80) decrease in the primary end point of death from cardiovascular cause or first hospitalization for heart failure (from 26.5% to 21.8%), when compared with the angiotensin-converting inhibitor enalapril, and a 16% (hazard ratio, 0.84) reduction in all-cause mortality (from 19.8% to 17.0%). However, recent translational science studies involving the central nervous system and the eye suggest that other effects of valsartan/sacubitril might influence its use in some patients.

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

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.

12,442 Views
3 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.

Jobs
brightcove.createExperiences();