Dapagliflozin associated with lower risk for all-cause mortality in type 2 diabetes regardless of CVD risk, study finds

The population-based retrospective cohort study included 22,124 type 2 diabetes patients from a British national primary care database, 4,444 of whom had taken dapagliflozin.

Patients with type 2 diabetes who took dapagliflozin appeared to be at lower risk for death from any cause, regardless of cardiovascular disease (CVD) status at baseline, according to a recent study.

Researchers in the United Kingdom performed a population-based retrospective cohort study of patients included in a national primary care database to determine whether dapagliflozin use led to decreased mortality. Patients treated from Jan. 1, 2013, to Sept. 1, 2015, were eligible for the study and were followed from the index date until they died; left their physician's practice; had a last data collection from their physician's practice; or were diagnosed with myocardial infarction or ischemic heart disease, stroke or transient ischemic attack, heart failure, or left ventricular dysfunction. The study's primary outcome was all-cause mortality in all study patients. All-cause mortality and incident CVD were also analyzed in patients at low CVD risk. The study results were published online Feb. 20 by the Journal of Clinical Endocrinology & Metabolism.

Overall, 22,124 patients were included in the study, 4,444 who had taken dapagliflozin and 17,680 matched controls who had taken another standard antidiabetic medication. Patients were matched for age, sex, body mass index, duration of type 2 diabetes, and smoking. Mean age was 58.4 years, and duration of diabetes was approximately nine years. A total of 4,350 patients in the study population had a previous CVD event, defined as ischemic heart disease, stroke, and/or heart failure. Death from any cause was significantly less likely in all patients with type 2 diabetes who had taken dapagliflozin (adjusted incidence rate ratio, 0.50; 95% CI, 0.33 to 0.75; P=0.001) and in those at low risk for CVD who had taken dapagliflozin (adjusted incidence rate ratio, 0.44; 95% CI, 0.25 to 0.78; P=0.002). No statistically significant difference in risk for incident CVD was seen in low-risk patients who had taken dapagliflozin and those who had not.

The authors noted that their trial was retrospective, that the number of events was low, that follow-up was relatively short, and that they could not completely rule out prescription by indication bias, among other limitations. However, they concluded that patients with type 2 diabetes who take dapagliflozin were at lower risk for death from any cause compared with patients who take other antidiabetic drugs, regardless of CVD risk at baseline, indicating potential benefit of the drug in the general diabetes population. They called for future studies to confirm their results. “In case an incremental mortality benefit is confirmed in subsequent studies, then treatment with dapagliflozin might then be considered a reasonable option to a broad range of patients with type 2 diabetes,” they wrote.