SGLT-2-Inhibtiors – Miraculous Novel Treatment of Type 2 Diabetes?german translation / full article
QuestionIn the past years, a large number of randomized controlled studies evaluating the efficacy of SGLT-2-Inhibitors (SGLT-2-I, Gliflozines) have been published. Only few studies evaluate cardiovascular outcomes for a longer period of time. Is it recommendable to use SGLT-2-I routinely in the treatment of diabetes mellitus type 2 if satisfactory metabolic control cannot be achieved with life style interventions and metformin alone?AnswerTo date only two large randomized controlled trials with cardiovascular endpoints have been published. These reveal a slight superiority compared to placebo regarding the primary cardiovascular composite outcome. Only one of the two trials also shows superiority regarding all-cause and cardiovascular mortality. The positive effects are hampered by a large rate of adverse drug events, especially genital infections. FDA and EMA are warning because of the risk of ketoacidosis as a serious adverse event. A positive group effect cannot be derived from the sparse evidence of the two randomized trials. In sight of the high rate of discontinuation (> 25 %) of the study drug it appears to be questionable whether the positive effects in the studies can be reproduced in every day practice. In practice, SGLT-2-I may serve as a treatment possibility in exceptional cases. A general positive recommendation cannot be made from the data currently available.