1. Effects of SGLT-2 inhibitors on diabetic ketoacidosis: A meta-analysis of randomised controlled trials.
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Monami, Matteo, Nreu, Besmir, Zannoni, Stefania, Lualdi, Carlotta, and Mannucci, Edoardo
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DIABETIC acidosis , *SODIUM-glucose cotransporters , *RANDOMIZED controlled trials , *ADVERSE health care events , *KIDNEY tubules , *CLINICAL trials , *COMPARATIVE studies , *HYPOGLYCEMIC agents , *RESEARCH methodology , *MEDICAL cooperation , *META-analysis , *TYPE 2 diabetes , *RESEARCH , *SYSTEMATIC reviews , *EVALUATION research , *TREATMENT effectiveness , *PHARMACODYNAMICS - Abstract
Aims: Diabetic ketoacidosis (DKA) associated with SGLT-2 inhibitors (SGLT-2i) is a possible adverse event. In fact, SGLT-2i are capable of stimulating the release of glucagon and ketone re-absorption in the renal tubuli, thus increasing the concentration of ketone bodies.Methods: A Medline search for SGLT2i (dapagliflozin, empagliflozin, canagliflozin, ipragliflozin, ertugliflozin, luseogliflozin) was performed, collecting all randomized trials with a duration of treatment≥12weeks, enrolling patients with type 2 diabetes, and comparing a SGLT2i with placebo or other comparators. The principal outcome was the effect of SGLT2i on ketoacidosis as serious adverse event.Results: Out of 72 trials reporting information on DKA, 9 reported at least one event of ketoacidosis; those eight trials enrolled 10,157 and 5396 in SGLT-2 inhibitors and comparator groups, respectively. No signal of increased risk for ketoacidosis was observed for SGLT2 inhibitors as a class (MH-OR [95% CI] 1.14 [0.45-2.88], p=0.78) or as individual molecule. The sensitivity analysis with continuity correction (inputing one event each in drug and comparator arms of each trial with zero events) suggested a reduced incidence of ketoacidosis in patients treated with SGLT-2 inhibitors (MH-OR 0.65 [0.47-0.90]; p=0.01).Conclusions: The results of clinical trials summarized in the present meta-analysis reassure us that, when the drug is properly prescribed, the risk of DKA is negligible. [ABSTRACT FROM AUTHOR]- Published
- 2017
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