Currently Viewing:
ACC 2017
Marijuana Use Linked to High Risk of Heart Failure, Stroke
March 09, 2017
Ceramides Can Predict Who Will Develop Heart Disease, Study Finds
March 10, 2017
Erectile Dysfunction Drugs Are Safe After Heart Attacks
March 11, 2017
When High Blood Pressure Means Lower Death Risk, but More Hospitalization
March 13, 2017
Repatha Found to Cut CV Death, Heart Attack, Stroke 25% After a Year
March 17, 2017
Bringing MACRA to Cardiologists, Ready or Not
March 17, 2017
Low-Dose Xarelto Beats Aspirin for Long-Term Prevention of Life-Threatening Blood Clots
March 18, 2017
Dr Robert P. Giugliano on the Results of the EBBINGHAUS Evolocumab Cognitive Study
March 18, 2017
Data Show It's Hard to Fill PCSK9 Prescriptions, Confirming Cardiologists' Complaints
March 19, 2017
Currently Reading
Can SGLT2 Inhibitors Prevent Heart Failure in a Broad Population?
March 19, 2017
Dr William Borden: Advice for Cardiologists on Adjusting to MACRA
March 19, 2017
Dr Janet Wright Outlines Goals and Roadblocks of Million Hearts Initiative
March 20, 2017
Charting the Path to Health Equity: Steps for Providers
March 20, 2017
Dr Jim McDermott Discusses Objectives and Outcomes of CVD-REAL Trial
March 20, 2017
Dr Seth J. Baum on the Patient's Role in Getting PCSK9 Inhibitors Approved by Payers
March 20, 2017
Dr Robert P. Giugliano Discusses the Significance of the FOURIER and EBBINGHAUS Trials
April 06, 2017
Dr Janet Wright Discusses How Million Hearts Will Leverage Partnerships for Success
April 06, 2017
Dr Seth J. Baum Discusses Payers' Reluctance to Approve Coverage of PCSK9 Inhibitors
April 07, 2017
Dr Rob Nolan on the Future Directions of eCounseling Research
April 14, 2017
Dr Janet Wright on Cardiologists' Role in Public Health and Prevention Efforts
April 15, 2017
Dr William Borden Discusses MACRA Requirements From a Cardiologist's Perspective
May 08, 2017
Dr Seth J. Baum on the Patient's Role in Getting PCSK9 Inhibitors Approved by Payers
May 10, 2017
Dr Rob Nolan Explains Behavioral Principles Behind eCounseling Hypertension Program
May 15, 2017
Dr Rob Nolan Discusses Behavioral Foundations of eCounseling Programs
June 10, 2017

Can SGLT2 Inhibitors Prevent Heart Failure in a Broad Population?

Mary Caffrey
Results from the CVD-REAL study seek to answer questions raised by the EMPA-REG OUTCOME study: do the effects of SGLT2 inhibitors on heart failure apply to a broad population?
A study of nearly 365,000 patients taking medication for type 2 diabetes (T2D) shows that sodium glucose co-transporter-2 (SGLT2) inhibitors outperform other treatments for the disease in key ways—and may help prevent heart failure in patients not yet diagnosed.

Results from the study, called CVD-REAL, were presented Sunday at the 66th Scientific Session of the American College of Cardiology (ACC). The study, which covered patients from the United States and 5 European countries, examined some questions left unanswered by the EMPA-REG OUTCOME study, which was the first cardiovascular outcomes trial (CVOT) that did not merely find that a T2D therapy was safe, but that it could offer cardioprotective benefits and reduce deaths.

But because EMPA-REG OUTCOME was a safety trial required by the FDA, it studied high-risk patients, and it only examined 1 drug, empagliflozin (Jardiance). In an interview with The American Journal of Managed Care, AstraZeneca's Jim McDermott, vice president for Medical Affairs, Diabetes, said CVD-REAL is designed to ask whether the effects on heart failure are a class effect for all SGLT2 inhibitors, if these effects could be applied to a broad population, and “if they can be demonstrated in a real-world environment. AstraZeneca funded the study.

Researchers gathered data from patients taking all 3 approved therapies: dapagliflozin (Farxiga) from AstraZeneca; canagliflozin (Invokana) from Janssen; and empagliflozin from Boehringer-Ingelheim and Eli Lilly. They also matched data from patients taking other glucose-lowering therapies. Compared with other T2D drugs, the SGLT2 inhibitor class:
  • Reduced the rate of hospitalization for heart failure by 39%
  • Reduced the rate of death from any cause by 51%

Researchers also computed a composite endpoint of hospitalization for heart failure and death from any cause, and found that SGLT2s inhibitors reduced this by 46%, compared with other T2D therapies.

SGLT2 inhibitors work through a unique mechanism of action, which causes excess blood glucose to be expelled through urine. McDermott said this mechanism has been shown to have a diuretic effect that positively affects blood pressure (and has been shown to help patients lose weight), although this is not well-understood.

EMPA-REG OUTCOME raised the curtain on potential new benefits that CVD-REAL sought to explore. Could SGLT2 inhibitors not only treat diabetes, but also prevent heart failure in these patients?

Mikhail Kosiborod, MD, the study's lead author and a cardiologist at St. Luke's Health System in Kansas City, Missouri, said in his presentation that the results suggest a a “heart failure prevention signal,” because so few of the study participants had been diagnosed with cardiovascular disease at baseline.

McDermott agreed. “Eighty-seven percent of the patients did not have predefined cardiovascular disease,” he said. “This tells me we can apply the results to a much broader population.” The study did not include results by individual drug. Of the data reviewed for the HF analysis, 41.8% of patients were on dapagliflozin, 52.7% on canagliflozin, and 5.5% on empagliflozin. The US population was more heavily weighted with canagliflozin users, where it was approved first, while the European data had more dapagliflozin users. Because the results were so consistent across different countries, McDermott said, they point to a class effect.

CVD-REAL will continue with more countries participating, McDermott said. Besides the United States, the first study included Denmark, Norway, Sweden, the United Kingdom and Germany; future studies may include data from Canada, Mexico, and Japan.

The expense of CVOTs has raised the question whether data-driven studies, such as CVD-REAL, could be the wave of the future. But both McDermott, in the interview, and Kosiborod, in his presentation, said CVOTs remain extremely important. “We need more and more data from various sources,” Kosiborod said.

Copyright AJMC 2006-2020 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
Welcome the the new and improved, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up