American Diabetes Association (ADA) 75th Scientific Sessions 2015:

Dapagliflozin Did Not Raise Cardiovascular Risk in Elderly Diabetic Patients Over a 4-Year Period

Ingrid Gause-Nilsson, MD, PhD, Senior Medical Lead, AstraZeneca R&D, Mölndal, Sweden, presented results of a post hoc pooled analysis of elderly patients with type 2 diabetes treated with dapagliflozin at the American Diabetes Association’s 75th Scientific Sessions, from June 5–9 in Boston.

Many Patients with Type 2 Diabetes Are at Risk of Cardiovascular Disease
”Cardiovascular disease and hypertension are common comorbidities in patients with type 2 diabetes, especially in older patients,” said Dr. Gause-Nilsson. “It is important to ensure that medications to treat type 2 diabetes do not negatively affect cardiovascular risk in these patients, as they are at increased risk of suffering new cardiovascular events.”

Dapagliflozin reduces plasma glucose in patients with type 2 diabetes by inhibiting renal glucose reabsorption, leading to increased glucosuria. Dapagliflozin is also associated with blood pressure and weight reduction.

Prior Meta-Analysis Showed No Increased Cardiovascular Risk with Dapagliflozin
In a previous pooled analysis of 21 phase 2b/3 trials in type 2 diabetes (≤4 years), the hazard ratio for the prespecified primary endpoint of major adverse cardiac events (MACE: cardiovascular death, myocardial infarction, and stroke) plus unstable angina for dapagliflozin (all doses [2.5, 5, 10, 20, and 50 mg]; n=5936) vs comparator (n=3403) was 0.79 (0.58, 1.07). The hazard ratio for MACE was 0.77 (0.54, 1.10).

“The results of the meta-analysis above indicated no increased risk of cardiovascular events overall, nor in patients with some specific risk factors for cardiovascular disease,” reiterated Dr. Gause-Nilsson.

Post Hoc Analysis Assessed Safety in High-Risk Elderly Patients
Dr. Gause-Nilsson and colleagues performed a post hoc pooled analysis of the data to assess cardiovascular safety in a high-risk subgroup of elderly (≥65 years of age) patients with a history of cardiovascular disease and hypertension (n=707 for dapagliflozin; n=556 for comparator).

Incidence of MACE and Adverse Events Was Similar in Both Groups
For MACE, the hazard ratio was 0.92 (0.51, 1.64). For MACE plus unstable angina, the hazard ratio was 0.82 (0.50, 1.37). The overall adverse event profile was similar between treatment groups.

Conclusion
The analyses suggest that dapagliflozin is not associated with increased cardiovascular risk in elderly patients with type 2 diabetes, comorbid cardiovascular disease, and hypertension.

The impact of dapagliflozin on cardiovascular events is being prospectively tested in the ongoing Dapagliflozin Effect on CardiovascuLAR Events (DECLARE)-Thrombolysis in Myocardial Infarction (TIMI) 58 study.

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