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Researchers studied whether dapagliflozin for diabetes treatment could also have beneficial effects on heart disease outcomes.
Diabetes affects more than 415 million adults worldwide and continues to increase in prevalence. People with diabetes are at a higher risk of other negative outcomes from cardiovascular disease, kidney disease, and heart disease. Therefore, it is important that drugs for diabetes treatment are also safe and effective in decreasing cardiovascular risks.
Dapagliflozin is an SGLT2 inhibitor used for diabetes treatment. Other SGLT2 inhibitors have demonstrated positive effects on cardiovascular outcomes, however, dapagliflozin has not yet been studied. Researchers evaluated the cardiovascular safety and efficacy of dapagliflozin in diabetes treatment and published their results in The New England Journal of Medicine.
The DECLARE-TIMI 58 trial was conducted at multiple sites in 33 different countries and included over 17,000 patients. The trial included patients 40 years of age or older with type 2 diabetes and cardiovascular disease, or multiple risk factors for cardiovascular disease. Trial participants were randomized to receive either 10 mg of dapagliflozin daily or a matched placebo. Clinical and safety parameters were assessed at in-person visits every six months for a total median follow up of 4.2 years. The study’s main safety outcomes were major adverse cardiovascular events (MACE) and cardiovascular death or hospitalization due to heart failure
Dapagliflozin had beneficial effects on cardiovascular risk factors
The study found that dapagliflozin had beneficial effects on several cardiovascular risk factors compared to placebo. Reductions in blood sugar, weight, and blood pressure were all greater in the dapagliflozin group. Dapagliflozin did not decrease the incidence of cardiovascular events, such as heart attack or stroke, in patients with heart disease or with risk factors for heart disease. However, hospitalization rates due to heart failure were lower with dapagliflozin. This decreased hospitalization due to heart failure was seen across a broad range of patients.
Since most trial participants did not have a history of heart failure, the authors noted the benefit dapagliflozin had on preventing new cases of heart failure. Death due to any cause and death due to cardiovascular disease were not different between both groups.
The participants in the dapagliflozin group saw a higher rate of diabetic ketoacidosis, although this is considered a rare event. The rate of genital infections was also higher with dapagliflozin versus placebo. Other SGLT2 inhibitor drugs have conflicting reports on the possibility of increased risk of stroke, amputations or fractures, however, this study did not observe any evidence suggesting these risks are increased with dapagliflozin.
Dapagliflozin for diabetes treatment may be safe for risks of major cardiovascular events
The DECLARE-TIMI 58 trial concludes that dapagliflozin for diabetes treatment is as safe as placebo when comparing the risk of major adverse cardiovascular events and cardiovascular death. Further, dapagliflozin demonstrated a significantly lower hospitalization rate due to heart failure in a wide range of patients with type 2 diabetes.
Written by Maggie Leung, PharmD
- Wiviott, S. D., Raz, I., Bonaca, M. P., Mosenzon, O., Kato, E. T., Cahn, A., . . . Sabatine, M. S. (2018). Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. New England Journal of Medicine. doi:10.1056/nejmoa1812389
- Murphy, M. (2018, November 10). Diabetes drug prevents heart failure. Retrieved from https://www.eurekalert.org/pub_releases/2018-11/bawh-ddp111018.php