Durability of response to dapagliflozin: a review of long-term efficacy and safety.

BACKGROUND

Due to the chronic nature of type 2 diabetes (T2D), it is essential for an anti-diabetic drug to have durable efficacy and a good long-term safety profile. Dapagliflozin is a member of a unique class of anti-diabetic drugs that inhibit the sodium-glucose cotransporter 2 (SGLT-2) in the renal tubules and have an insulin-independent mechanism of action. In short-term studies (≤ 24 weeks), dapagliflozin reduced glycated hemoglobin (A1c), weight, and systolic blood pressure, and had a good safety profile.

METHODS

This review summarizes the findings of long-term studies that evaluated the efficacy and safety of dapagliflozin.

RESULTS

These findings indicate that dapagliflozin is effective as monotherapy and in combination with other anti-hyperglycemic agents, including insulin and oral anti-diabetic therapies, in improving glycemic control and reducing blood pressure and weight for up to 4 years. The findings were fairly consistent across various patient populations with T2D, including those with cardiovascular disease (CVD) and mild renal impairment. Extended use of dapagliflozin was not associated with an increase in safety signals over time. Frequently observed adverse events (AEs) were consistent with the drug's mechanism of action and were generally mild in intensity. No substantial impact of dapagliflozin on renal function was observed, and findings show that the drug is safe in T2D patients with CVD or mild renal impairment, as well as elderly patients.

CONCLUSIONS

The findings across the studies support the use of dapagliflozin for the long-term treatment of T2D across a broad spectrum of patients.