Reference : Dapagliflozin in patients with type 2 diabetes mellitus: A pooled analysis of safety ...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
Human health sciences : Endocrinology, metabolism & nutrition
Dapagliflozin in patients with type 2 diabetes mellitus: A pooled analysis of safety data from phase IIb/III clinical trials.
Jabbour, Serge [> >]
Seufert, Jochen [> >]
Scheen, André mailto [Université de Liège - ULiège > Département des sciences cliniques > Département des sciences cliniques >]
Bailey, Clifford J. [> >]
Karup, Cathrina [> >]
Langkilde, Anna M. [> >]
Diabetes, Obesity and Metabolism
Yes (verified by ORBi)
United Kingdom
[en] SGLT2 inhibitor ; antidiabetic drug ; dapagliflozin ; type 2 diabetes
[en] AIM: To evaluate the safety and tolerability of dapagliflozin, a highly selective sodium-glucose co-transporter-2 inhibitor, in patients with type 2 diabetes mellitus (T2DM). METHODS: Data were pooled from 13 placebo-controlled trials of up to 24 weeks' duration (dapagliflozin, n = 2360; placebo, n = 2295). Larger placebo-/comparator-controlled pools of 21 (</=208 weeks; dapagliflozin, n = 5936; control, n = 3403) and 30 trials (>/=12 weeks; dapagliflozin, n = 9195; control, n = 4629) assessed the rare adverse events (AEs) of diabetic ketoacidosis (DKA) and lower limb amputation, respectively. RESULTS: Over 24 weeks, the overall incidence of AEs and serious AEs (SAEs) was similar for dapagliflozin and placebo: 60.0% vs 55.7% and 5.1% vs 5.4%, respectively. Rates of hypoglycaemia, volume depletion AEs, urinary tract infections (UTIs) and fractures were balanced between the groups. Genital infections were more frequent with dapagliflozin (5.5%) vs placebo (0.6%) and renal function AEs occurred in 3.2% vs 1.8% of patients (the most common renal AE was decreased creatinine clearance: 1.1% vs 0.7%). In the 21-study pool, 1 SAE of DKA and 3 AEs of ketonuria/metabolic acidosis occurred with dapagliflozin vs none with control; estimated combined incidence for these events was 0.03% (95% confidence interval 0.010-0.089). In the 30-study pool, lower limb amputation occurred in 8 (0.1%) and 7 (0.2%) patients receiving dapagliflozin and control, respectively. CONCLUSION: The overall incidence rates of AEs and SAEs were similar in the dapagliflozin and placebo/control groups, including the incidence of hypoglycaemia, volume depletion, fractures, UTIs, amputations and DKA. Genital infections were more frequent with dapagliflozin than placebo.
(c) 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

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