[Dapagliflozin, a novel oral antidiabetic with an uncertain future]

Diabetes mellitus type 2 (DM2) is one of the main sociosanitary problems; there are many treatments for it. Recently, it has been approved the first drug of a new family of oral hypoglycemic agents (OHA): dapagliflozin. We aimed to review the available scientific evidence on dapagliflozin, in order to analyze its effectiveness, safety and cost and to estimate its role in the current pharmacotherapy of DM2.

Effectiveness and safety of dapagliflozin were analyzed by an evaluation of the scientific evidence. The cost of different OHA was calculated based on the defined daily dose (DDD) and their ex-factory prices.

Seven randomized clinical trials were identified: 2 monotherapy (840 patients) and 5 in combination with other hypoglycemic agents (3184 patients). In the seven trials, dapagliflozin reduced HbA1c; all were compared with placebo, unless in a trial of combination therapy in which was compared with an active drug (glipizide). The most common side effects were genitourinary infections and hypotension, although it should be taken into consideration the increase of the bladder cancer. Besides the DPP-4 inhibitors, dapagliflozin is one of the OHA more expensive (annual cost of DDD= 729.3 euros).

Dapagliflozin does not provide advantages over pharmacotherapy for DM2. Its lack of experience of use, the absence of significant clinical benefits and its high cost make it necessary to restrict its use.