Dapagliflozin for the Treatment of Type 2 Diabetes Mellitus

Abstract

Objective: To review the pharmacology, pharmacokinetics, clinical trials, and adverse effects of dapagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor. Data Sources: Data were gathered from articles indexed in PubMed, International Pharmaceutical from (2006 to April 2014) was performed using the following terms “dapagliflozin,” “SGLT-2 inhibitor,” and “Farxiga.” Abstracts and manufacturer’s package insert were also used as an additional reference. Study Selection and Data Extraction: All English language prospective randomized, double-blinded trials evaluating the efficacy of dapagliflozin for the treatment of type 2 diabetes were identified. Data Synthesis: We evaluated 9 clinical trials with dapagliflozin as monotherapy or add-on therapy. Results from these studies demonstrated that dapagliflozin to be noninferior to metformin in treatment naïve patients for reduction in A1C. Additionally, dapagliflozin was noninferior to glimepiride when added on to metformin. As an add-on therapy to insulin, insulin sensitizers or sitagliptin, dapagliflozin was found to be clinically effective compared to placebo. Finally, in all of the clinical trials increased risk of urinary infection was common in dapagliflozin group. Conclusion: As the second SGLT-2 inhibitor approved in the United States, dapagliflozin is safe and effective for treatment of type 2 diabetes mellitus. It appears to have no increased cardiovascular risk and provides a moderate benefit for patients with high blood pressure or those who are overweight. However, dapagliflozin was found to be associated with nasopharyngitis, mycotic infections, and genital or urinary tract infections. This medication may be best used as adjunctive therapy for patients not well-controlled on other antidiabetic agents. However, caution should be taken when used in patients at risk of urinary tract infections and dehydration.