Abstract
This study compared dapagliflozin, a sodium-glucose co-transporter 2 inhibitor, and dipeptidyl peptidase-4 inhibitors (DPP-4i) with regard to cardiovascular (CV) event incidence and direct medical costs during type 2 diabetes treatment. A retrospective cohort study was conducted using national health insurance claims data from September 1, 2014, to June 30, 2018, of patients in Korea. Patients who were prescribed dapagliflozin and DPP-4i for the first time were included. The primary outcome was the incidence of a composite of major adverse CV events (MACEs)—nonfatal myocardial infarction, nonfatal stroke, or in-hospital CV death. Proportional hazard models after propensity score weighting were used to determine hazard ratios (HRs) and 95% confidence intervals (CIs) for MACE in the dapagliflozin and DPP-4i groups. A decision analytic model was used to compare direct medical costs between the two treatment groups from a healthcare provider’s perspective. Of the 260,336 patients in the cohort, 23,147 and 237,189 received dapagliflozin and DPP-4i, respectively. During the follow-up, 184 patients receiving dapagliflozin and 3,674 receiving DPP-4i (incidence, 6.47 and 11.33 events/1,000 person-years, respectively) had MACE. The adjusted HR of MACE for dapagliflozin compared with that for DPP-4i was 0.69 (95% CI 0.57–0.83). The corresponding HRs were consistent among patients with and without underlying CV disease. The estimated direct medical cost appeared to be lower by $68,452 in the dapagliflozin group than that in the DPP-4i group for 3 years, in 1,000 hypothetical patients. In this population-based cohort study, the use of dapagliflozin instead of DPP-4i was associated with a reduced risk of MACE, which subsequently reduced direct medical costs. These data provide valuable information to patients, practitioners, and authorities regarding the risk of CV events associated with dapagliflozin versus DPP-4i use in clinical practice.
Highlights
Patients with diabetes have an increased risk of developing cardiovascular disease (CVD), the leading cause of mortality in patients with diabetes (Fox et al, 2004; Fox et al, 2007; Franco et al, 2007)
The results of the Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction (DECLARE-TIMI) 58 trial, which compared the effect of dapagliflozin plus an existing glucoselowering drug (GLD) treatment with a placebo in patients with type 2 diabetes (T2D) and high cardiovascular (CV) risk, showed that dapagliflozin yielded a primary safety outcome of major adverse CV events [MACEs; nonfatal myocardial infarction (MI), nonfatal stroke, or CV mortality] that was noninferior to the placebo (Wiviott et al, 2019)
CVD-REAL Nordic and CVD-REAL 2—a part of the Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT2 Inhibitors (CVD-REAL) study program that analyzed the effects of sodium-glucose co-transporter 2 inhibitor (SGLT2i) treatment on CV in a real-world setting—suggested that SGLT2i was associated with a lower risk of CV events than other GLDs, including dipeptidyl peptidase-4 inhibitors (DPP-4i), metformin, and sulfonylurea (Birkeland et al, 2017; Kosiborod et al, 2017; Kosiborod et al, 2018)
Summary
Patients with diabetes have an increased risk of developing cardiovascular disease (CVD), the leading cause of mortality in patients with diabetes (Fox et al, 2004; Fox et al, 2007; Franco et al, 2007). The results of the Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction (DECLARE-TIMI) 58 trial, which compared the effect of dapagliflozin plus an existing glucoselowering drug (GLD) treatment with a placebo in patients with type 2 diabetes (T2D) and high cardiovascular (CV) risk, showed that dapagliflozin yielded a primary safety outcome of major adverse CV events [MACEs; nonfatal myocardial infarction (MI), nonfatal stroke, or CV mortality] that was noninferior to the placebo (Wiviott et al, 2019). CVD-REAL Nordic and CVD-REAL 2—a part of the Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT2 Inhibitors (CVD-REAL) study program that analyzed the effects of SGLT2i treatment on CV in a real-world setting—suggested that SGLT2i was associated with a lower risk of CV events than other GLDs, including dipeptidyl peptidase-4 inhibitors (DPP-4i), metformin, and sulfonylurea (Birkeland et al, 2017; Kosiborod et al, 2017; Kosiborod et al, 2018). We studied the risk of MACE dapagliflozin, with DPP-4i as an active comparator, as it showed no significant effect on the risk of MACE in many clinical trials among patients with T2D and is considered to be neutral with regard to CV risk (Lamos et al, 2019)
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