Objective: 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.
Methods: 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.
Results: 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).
Conclusions: 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.
Objetivo: La diabetes mellitus tipo 2 (DM2) es uno de los principales problemas sociosanitarios a nivel mundial, para la que existen multitud de tratamientos. Recientemente, se ha aprobado el primer farmaco de una nueva familia de antidiabeticos orales (ADO): la dapagliflozina. Nuestro objetivo es revisar la evidencia cientifica disponible sobre la dapagliflozina, con el fin de analizar su eficacia, seguridad y coste y poder estimar su papel en la farmacoterapia actual de la DM2. Métodos: La eficacia y seguridad de la dapagliflozina se analizaron mediante una evaluacion de la evidencia cientifica. El coste de los diferentes ADO se calculo en base a sus dosis diarias definidas (DDD) y al precio de venta del laboratorio. Resultados: Se identificaron 7 ensayos clinicos aleatorizados: 2 en monoterapia (840 pacientes) y 5 en terapia combinada con otros antidiabeticos (3184 pacientes). En los 7 ensayos, la dapagliflozina redujo la concentracion de HbA1c; en todos se comparo con placebo, salvo en un estudio en terapia combinada que se comparo frente a farmaco activo (glipizida). Entre los efectos adversos mas frecuentes se detectaron infecciones genitourinarias e hipotension, aunque se debe prestar especial atencion al incremento del cancer de vejiga. Junto con los inhibidores de la DPP-4, la dapagliflozina es uno de los ADO de mayor coste (coste anual de DDD=729,3 euros). Conclusiones: La dapagliflozina no aporta ventajas respecto a la farmacoterapia de la DM2 ya existente. Su falta de experiencia de uso, la ausencia de importantes beneficios clinicos y su elevado coste hacen necesario restringir su utilizacion.
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