All-Cause Mortality in Patients With Diabetes Under Treatment With Dapagliflozin: A Population-Based, Open-Cohort Study in The Health Improvement Network Database

J Clin Endocrinol Metab. 2017 May 1;102(5):1719-1725. doi: 10.1210/jc.2016-3446.

Abstract

Context: Empagliflozin was found to decrease mortality in patients with type 2 diabetes mellitus (T2DM) and a prior cardiovascular disease (CVD) event.

Objectives: To establish whether these benefits can be replicated in a real-world setting, should be expected with the use of dapagliflozin, and apply to T2DM patients at low risk of CVD.

Design: General practice, population-based, retrospective cohort study (January 2013 to September 2015).

Setting: The Health Improvement Network database.

Participants: A total of 22,124 T2DM patients (4444 exposed to dapagliflozin; 17,680 unexposed T2DM patients) matched for age, sex, body mass index, T2DM duration, and smoking.

Main outcome measures: The primary outcome was all-cause mortality (high and low risk for CVD) in the total study population, expressed as the adjusted incidence rate ratio (aIRR) with 95% confidence intervals (CIs). As a secondary analysis in the low-risk population, all-cause mortality and incident CVD were considered.

Results: Patients with T2DM exposed to dapagliflozin were significantly less likely to die of any cause (aIRR: 0.50; 95% CI: 0.33 to 0.75; P = 0.001). Similarly, in low-risk patients, death from any cause was significantly lower in the cohort exposed to dapagliflozin (aIRR: 0.44; 95% CI: 0.25 to 0.78; P = 0.002). The difference in the risk of incident CVD did not reach statistical significance between groups in low-risk patients (aIRR: 0.89; 95% CI: 0.61 to 1.31; P = 0.546).

Conclusions: Patients with T2DM who were exposed to dapagliflozin had a lower risk of death from any cause irrespective of baseline CVD status.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Benzhydryl Compounds / therapeutic use*
  • Cardiovascular Diseases / epidemiology
  • Case-Control Studies
  • Cause of Death
  • Cohort Studies
  • Databases, Factual
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Female
  • Glucosides / therapeutic use*
  • Heart Failure / epidemiology
  • Humans
  • Hypoglycemic Agents / therapeutic use*
  • Ischemic Attack, Transient / epidemiology
  • Male
  • Middle Aged
  • Mortality*
  • Myocardial Infarction / epidemiology
  • Myocardial Ischemia / epidemiology
  • Retrospective Studies
  • Stroke / epidemiology
  • Ventricular Dysfunction, Left / epidemiology

Substances

  • 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
  • Benzhydryl Compounds
  • Glucosides
  • Hypoglycemic Agents