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oai:repisalud.isciii.es:20.500.12105/173152024-01-23T20:12:50Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16927
Repisalud author Hanefeld, Markolf author Arteaga, Juan M author Leiter, Lawrence A author Marchesini, Giulio author Nikonova, Elena author Shestakova, Marina author Stager, William author Gómez-Huelgas, Ricardo 2024-01-23T20:12:50Z 2024-01-23T20:12:50Z 2017-06-07 http://hdl.handle.net/10668/11141 http://hdl.handle.net/20.500.12105/17315 28449324 10.1111/dom.12986 1463-1326 Diabetes, obesity & metabolism This post hoc assessment evaluated the efficacy and safety of once-daily, prandial glucagon-like peptide-1 receptor agonist lixisenatide in patients with type 2 diabetes (T2D) and normal renal function (estimated glomerular filtration rate ≥90 mL/min), or mild (60-89 mL/min) or moderate (30-59 mL/min) renal impairment. Patients from 9 lixisenatide trials in the GetGoal clinical trial programme were categorized by baseline creatinine clearance: normal renal function (lixisenatide n = 2094, placebo n = 1150); renal impairment (mild: lixisenatide n = 637, placebo n = 414; moderate: lixisenatide n = 122, placebo n = 68). Meta-analyses of placebo-adjusted mean differences between baseline renal categories were performed for efficacy and safety outcomes. HbA1c, 2-hour postprandial plasma glucose and fasting plasma glucose were comparably reduced in lixisenatide-treated patients with normal renal function, and mild and moderate renal impairment. The most common adverse events (AEs) in all renal function categories were gastrointestinal (GI), predominantly nausea and vomiting. A 14% higher incidence of GI AEs and a 10% higher incidence of nausea and vomiting were seen with mild impairment vs normal function (P = .003 for both), but no significant differences were observed between the mild and moderate impairment categories (P = .99 and P = .57, respectively), or between the moderate impairment and normal categories (P = .16 and P = .65, respectively). Additionally, the incidence of hypoglycaemia was similar in all categories. This study demonstrates that baseline renal status does not affect efficacy outcomes in lixisenatide- vs placebo-treated patients, and that no lixisenatide dose adjustment is required for patients with T2D with mild or moderate renal impairment. eng GLP-1 incretin therapy meta-analysis type 2 diabetes Efficacy and safety of lixisenatide in patients with type 2 diabetes and renal impairment. research article