Efficacy and safety of lixisenatide in patients with type 2 diabetes and renal impairment
| Autor: | Hanefeld, Markolf, Arteaga, Juan M., Leiter, Lawrence A., Marchesini, Giulio, Nikonova, Elena, Shestakova, Marina, Stager, William, Gómez‐Huelgas, Ricardo |
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| Přispěvatelé: | Hanefeld, Markolf, Arteaga, Juan M., Leiter, Lawrence A., Marchesini, Giulio, Nikonova, Elena, Shestakova, Marina, Stager, William, Gómez-Huelgas, Ricardo |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male Endocrinology Diabetes and Metabolism Severity of Illness Index meta-analysi Endocrinology Internal Medicine Humans Diabetic Nephropathies Renal Insufficiency Aged Aged 80 and over type 2 diabete Clinical Trials as Topic Original Articles Middle Aged meta-analysis Treatment Outcome Diabetes Mellitus Type 2 meta‐analysis Original Article incretin therapy Female type 2 diabetes GLP-1 Peptides GLP‐1 Glomerular Filtration Rate |
| Zdroj: | Diabetes, Obesity & Metabolism |
| ISSN: | 1463-1326 1462-8902 |
| Popis: | Aims: 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 â¥90 mL/min), or mild (60-89 mL/min) or moderate (30-59 mL/min) renal impairment. Methods: 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. Results: 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. Conclusions: 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. |
| Databáze: | OpenAIRE |
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