SGLT2 Inhibitors are Associated with Reduced Cardiovascular Disease for Patients with Type 2 Diabetes

SAN DIEGO, June 13, 2017 /PRNewswire-USNewswire/ -- A new class of medication, known as sodium-glucose transporter-2 (SGLT2) inhibitors, is associated with lower rates of death and hospitalization for heart failure when used to treat patients with type 2 diabetes, both with or without existing cardiovascular disease, and regardless of the specific SGLT2 inhibitor used, according to a study, "Hospitalization for Heart Failure and Death in New Users of SGLT2 Inhibitors in Patients With and Without Cardiovascular Disease—CVD-REAL Study," presented today at the American Diabetes Association's 77th Scientific Sessions^® at the San Diego Convention Center.

The CVD-REAL study analyzed the outcomes of 306,156 patients with type 2 diabetes (T2D) from five different countries—the United States, United Kingdom, Norway, Sweden and Denmark—who were treated with SGLT2-inhibitors. SGLT2 is a protein responsible for glucose regulation in the body. SGLT2 inhibitors reduce renal glucose reabsorption by causing excess blood glucose to be expelled through urine.

Using data from clinical practice, researchers compared rates of heart failure (HF) and death in patients with and without prior cardiovascular disease (CVD) to HF rates in new users of SGLT2-inhibitors and other glucose lowering drugs (oGLD). Data on HF and subsequent death rates were collected using medical records, medical claims, electronic health records and national registers.

Propensity scores were used to match patients treated with SGLT2 inhibitors and oGLD. After matching, baseline characteristics were balanced between groups, and 306,156 patients, >150,000 person years (PY) (100,947 PY for SGLT2i; 89,208 PY for oGLD) and 950 new HF events were analyzed. The hazard ratios (HR) for HF, death and the composite of death or heart failure were estimated by country and pooled as a weighted average.

An association between SGLT2-inhibitors and lower rates of death due to heart failure and hospitalization for heart failure was seen in all of the five participating countries. Furthermore, the benefits of SGLT2-inhibitor treatments were consistent regardless of the type of SGLT2-inhibitor used, which varied from country to country. SGLT2-inhibitors, when compared to oGLD, were associated with 31 percent lower rates of HF in patients with CVD and 45percent without CVD (HR 0.69; 95% CI 0.59-0.80; HR 0.55 95% CI 0.34-0.88). Similar results were seen for death and death due to HF regardless of whether the patients had a history of cardiovascular disease or not. All patients treated with SGLT2-inhibitors were less likely to have heart failure or subsequent death, compared to the oGLD patients.

"This study offers further evidence regarding the potential of SGLT2-inhibitors to improve outcomes in patients with diabetes," said Dr. Matthew A. Cavender, MD, MPH, assistant professor of medicine, at the University of North Carolina School of Medicine. "While our results are striking in their similarity to a prior randomized study evaluating the benefit of SGLT-2 inhibitors in patients with diabetes and known cardiovascular disease, these results go one step further to show that SGLT2-inhibition may benefit all patients with diabetes, regardless of whether they have known cardiovascular disease. It's also important to note that there was a significant difference in the particular SGLT2-inhibitor used in each country, suggesting that the benefits seen with SGLT2-inhibitors are likely to be a class effect. Previous research has shown that patients with diabetes have a 30 percent higher risk for heart failure when compared to patients without diabetes. These findings suggest that use of SGLT-2 inhibitors may provide the opportunity to reduce the incidence of heart failure among patients with diabetes."

Ongoing randomized clinical trials with SGLT2-inhibitors are likely to provide a considerable amount of additional information regarding its clinical effectiveness. In follow-up to this study, there are plans to further evaluate the effectiveness of SGLT2-inhibitors on other important clinical events and to broaden the study's focus to evaluate the association between other drugs designed for use in patients with diabetes and history of cardiovascular events.

To speak with Dr. Cavender, please contact the Association's media relations team on-site at the San Diego Convention Center on June 9-13, by phone at 619-525-6250 or by email at [email protected].

The American Diabetes Association's 77th Scientific Sessions, to be held June 9-13, 2017, at the San Diego Convention Center, is the world's largest scientific meeting focused on diabetes research, prevention and care. During the five-day meeting, health care professionals have exclusive access to more than 2,500 original research presentations, participate in provocative and engaging exchanges with leading diabetes experts, and can earn Continuing Medical Education (CME) or Continuing Education (CE) credits for educational sessions. The program is grouped into eight interest areas: Acute and Chronic Complications; Behavioral Medicine, Clinical Nutrition, Education and Exercise; Clinical Diabetes/Therapeutics; Epidemiology/Genetics; Immunology/Transplantation; Insulin Action/Molecular Metabolism; Integrated Physiology/Obesity; and Islet Biology/Insulin Secretion. Brenda Montgomery, RN, MSHS, CDE, President of Health Care and Education^[1], will deliver her address on Saturday, June 10, and Alvin C. Powers, MD, President of Medicine and Science, will present his address on Sunday, June 11. Eight abstracts were selected by the Scientific Sessions Meeting Planning Committee to be presented on Tuesday, June 13, in the President's Oral Session. These abstracts represent important research being conducted in the field of diabetes today. In total, the 2017 Scientific Sessions includes 378 abstracts in 49 oral sessions; 2,152 poster presentations including 50 moderated poster discussions; and 360 published-only abstracts. Join the Scientific Sessions conversation on Twitter, #2017ADA. 

About the American Diabetes Association
More than 29 million Americans have diabetes, and every 23 seconds another person is diagnosed with diabetes. The American Diabetes Association (Association) is the global authority on diabetes and since 1940 has been committed to its mission to prevent and cure diabetes and to improve the lives of all people affected by diabetes. To tackle this global public health crisis, the Association drives discovery in research to treat, manage and prevent all types of diabetes, as well as to search for cures; raises voice to the urgency of the diabetes epidemic; and provides support and advocacy for people living with diabetes, those at risk of developing diabetes and the health care professionals who serve them. For more information, please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit diabetes.org. Information from both of these sources is available in English and Spanish. Find us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn). 

377-OR Hospitalization for Heart Failure and Death in New Users of SGLT2 Inhibitors in Patients With and Without Cardiovascular Disease—CVD-REAL Study

77th Scientific Sessions
News Briefing: Cardiovascular Disease and Diabetes, Monday, June 12, 12:00 p.m. PT

Oral Presentation: ADA Presidents Oral Session
Location: Ballroom 20D
Session Time: Tuesday, June 13, 2017, 9:45 - 11:45 a.m.

Authors: MATTHEW A. CAVENDER, ANNA NORHAMMAR, KÅRE I. BIRKELAND, MARIT EIKA JØRGENSEN, JOHN P.H. WILDING, KAMLESH KHUNTI, ALEX Z. FU, JOHAN BODEGARD, BETINA T. BLAK, ERIC T. WITTBRODT, MARCUS THURESSON, PETER FENICI, NIKLAS HAMMAR, MIKHAIL N. KOSIBOROD, THE CVD-REAL INVESTIGATORS AND STUDY GROUP, Chapel Hill, NC, Stockholm, Sweden, Oslo, Norway, Gentofte, Denmark, Liverpool, United Kingdom, Leicester, United Kingdom, Washington, DC, Luton, United Kingdom, Wilmington, DE, Uppsala, Sweden, Cambridge, United Kingdom, Mölndal, Sweden, Kansas City, MO

A reduction in CV death and heart failure (HF) is reported with a SGLT2i in patients with T2D and established CV disease (CVD). Using observational data from clinical practice, we compared HF and death in patients with and without prior CVD or HF in new users of SGLT2i and other glucose lowering drugs (oGLD) in the U.S., UK, Sweden, Norway and Denmark. 1:1 propensity score matching was applied. HF and death were collected via medical records (UK), medical claims, electronic health and death records (U.S.), and national registers (Nordics). Hazard ratios (HR) for HF, death, and the composite were estimated by country and pooled as a weighted average. After matching, baseline characteristics were balanced between groups. 306,156 patients, >150,000 person years (PY) (100,947 PY for SGLT2i; 89,208 PY for oGLD) and 950 new HF events were analyzed. SGLT2i, when compared to oGLD, was associated with lower rates of HF in patients with and without CVD (HR 0.69; 95% CI 0.59-0.80; HR 0.55 95% CI 0.34-0.88). Similar results were seen for death and death/HF irrespective of CVD or HF history. Findings were consistent across countries with varying SGLT2i class composition. In this large cohort of patients with and without CVD, SGLT2i was associated with a significant reduction in HF and death vs. oGLD. This suggests that the benefit of SGLT2i applies to a broad population of patients with T2D.

Author Disclosures: M.A. Cavender: Advisory Panel; Author; Merck. Consultant; Author; AstraZeneca. Research Support; Author; The Medicines Company, GlaxoSmithKline, Novartis, Takeda, Abbott, AstraZeneca. A. Norhammar: Advisory Panel; Author; AstraZeneca, Boehringer Ingelheim GmbH, MSD Sweden, Merck, Novo Nordisk, Boehringer Ingelheim GmbH, Lilly. Consultant; Author; AstraZeneca, Boehringer Ingelheim GmbH, MSD Sweden. Research Support; Author; Swedish Heart and Lung foundation. K.I. Birkeland: Research Support; Author; AstraZeneca. M. Jørgensen: Research Support; Author; AstraZeneca. Stock/Shareholder; Author; Novo Nordisk. J.P.H. Wilding: Advisory Panel; Author; AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, NovoNordisk, Orexigen, Sanofi (fees to institution), Astellas. Consultant; Author; AstraZeneca, Boehringer Ingelheim GmbH, Janssen, Lilly, Orexigen. Research Support; Author; AstraZeneca, Novo Nordisk, Takeda. K. Khunti: Advisory Panel; Author; AstraZeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Janssen, Boehringer Ingelheim. Consultant; Author; AstraZeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Janssen, Boehringer Ingelheim. Research Support; Author; AstraZeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Merck Sharp & Dohme, Roche. A.Z. Fu: Consultant; Author; Asclepius Analytics, Complete HEOR Services. Research Support; Author; AstraZeneca, Merck. J. Bodegard: Employee; Author; AstraZeneca. B.T. Blak: Employee; Author; AstraZeneca. Stock/Shareholder; Author; AstraZeneca. E.T. Wittbrodt: Employee; Author; AstraZeneca. Stock/Shareholder; Author; AstraZeneca. M. Thuresson: Consultant; Author; AstraZeneca. P. Fenici: Employee; Author; AstraZeneca. Stock/Shareholder; Author; AstraZeneca. N. Hammar: Employee; Author; AstraZeneca. Stock/Shareholder; Author; AstraZeneca. M.N. Kosiborod: Advisory Panel; Author; AstraZeneca, Boehringer Ingelheim GmbH, Gillead, Sanofi, Lilly, Glytec, Novo Nordisk, ZS Pharma, Takeda, Merck. Consultant; Author; AstraZeneca, Sanofi, ZS Pharma. Research Support; Author; AstraZeneca, Boehringer Ingelheim GmbH, Gillead, Sanofi.

^[1] Disclosures for Brenda Montgomery. Employer: AstraZeneca Pharmaceuticals. Montgomery's role as President, Health Care & Education of the American Diabetes Association (Association) is a voluntary position to which she was elected by the members of the Association in 2015. She continues to recuse herself from any and all discussions, decisions or votes that have or could be perceived as having a conflict of interest with her employer. 

SOURCE American Diabetes Association

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