Dapagliflozin: An emerging treatment option for type 2 diabetes mellitus

Dapagliflozin is a sodium glucose co-transporter inhibitor under review for FDA approval for the treatment of type 2 diabetes mellitus. Despite the availability of many antidiabetic agents in the United States, type 2 diabetes remains inadequately controlled in many patients. Type 2 diabetes patients are at risk for complications such as retinopathy, nephropathy, neuropathy, and accelerated cardiovascular disease. Moreover, many of the currently marketed antidiabetic agents in the United States have been associated with treatment-limiting side effects. Therefore, efficacious alternative agents without these side effects are needed for the management of patients with this devastating chronic condition. Phase 3 trials have established the efficacy of dapagliflozin dosages of 5 to 10 mg once daily in treatment-naive type 2 diabetes patients. Dosages of dapagliflozin ranging from 2.5 to 10 mg once daily have been shown to be efficacious in type 2 diabetes patients already on metformin or glimepiride. Pharmacokinetic studies of dapagliflozin have shown a low propensity for drug interactions. The most common adverse effects reported in phase 3 trials were signs and symptoms suggestive of genital and urinary tract infections. Unresolved issues with dapagliflozin treatment include risks of breast cancer, bladder cancer, and liver dysfunction in type 2 diabetes mellitus patients. (Formulary. 2011; 46:412-431.)