Hanefeld, MarkolfArteaga, Juan MLeiter, Lawrence AMarchesini, GiulioNikonova, ElenaShestakova, MarinaStager, WilliamGómez-Huelgas, Ricardo2023-01-252023-01-252017-06-07Hanefeld M, Arteaga JM, Leiter LA, Marchesini G, Nikonova E, Shestakova et al. Efficacy and safety of lixisenatide in patients with type 2 diabetes and renal impairment. Diabetes Obes Metab. 2017 Nov;19(11):1594-1601.Hanefeld M, Arteaga JM, Leiter LA, Marchesini G, Nikonova E, Shestakova M, et al. Efficacy and safety of lixisenatide in patients with type 2 diabetes and renal impairment. Diabetes Obes Metab. 2017 Nov;19(11):1594-1601http://hdl.handle.net/10668/11141This 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.enAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/GLP-1Incretin therapyMeta-analysisType 2 diabetesAdultAgedAged, 80 and overClinical Trials as TopicDiabetes Mellitus, Type 2Diabetic NephropathiesFemaleGlomerular Filtration RateHumansMaleMiddle AgedPeptidesRenal InsufficiencySeverity of Illness IndexTreatment Outcomeresearch article28449324open accessAdaptación psicológicaAyunoCreatininaDiabetes Mellitus Tipo 2Ensayo clínicoGlucosa10.1111/dom.129861463-1326PMC5655920https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/dom.12986https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5655920/pdf