PMID- 25143188 OWN - NLM STAT- MEDLINE DCOM- 20160309 LR - 20221207 IS - 1865-8652 (Electronic) IS - 0741-238X (Linking) VI - 31 IP - 8 DP - 2014 Aug TI - Lixisenatide treatment for older patients with type 2 diabetes mellitus uncontrolled on oral antidiabetics: meta-analysis of five randomized controlled trials. PG - 861-72 LID - 10.1007/s12325-014-0146-4 [doi] AB - AIM: Evaluate the efficacy and safety of lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist, in older patients with type 2 diabetes mellitus (T2DM) insufficiently controlled on oral antidiabetics (OADs). METHODS: A meta-analysis was conducted on data from older patients (>/=65 years) from five of the GetGoal trials, in which patients with T2DM were treated with lixisenatide 20 microg once daily or placebo, as an add-on to OADs. The primary endpoint in all trials was change from baseline at week 24 in glycated hemoglobin (HbA1c). Other endpoints included changes in post-prandial plasma glucose (PPG), fasting plasma glucose (FPG) and weight. Composite and safety endpoints were also analyzed. RESULTS: A total of 501 patients aged >/=65 years were included in this meta-analysis: 304 received lixisenatide plus OADs and 197 received placebo as add-on to OADs. Lixisenatide as an add-on to OADs significantly reduced HbA1c, PPG, FPG and weight, with placebo-corrected treatment effects at week 24 of -0.54% (p<0.0001), -126 mg/dL (p<0.0001), -13 mg/dL (p=0.0005) and -0.90 kg (p=0.0021), respectively. Patients receiving lixisenatide plus OADs were significantly more likely to achieve composite (HbA1c levels<7%, HbA1c levels<7% and no symptomatic hypoglycemia, and HbA1c levels<7%, no weight gain and no symptomatic hypoglycemia) and safety endpoints than those receiving placebo plus OADs. Symptomatic hypoglycemia was experienced by 8.55% and 3.55% of patients in the lixisenatide plus OADs and placebo plus OADs groups, respectively (p=0.0276), although no serious hypoglycemic episodes were reported. CONCLUSIONS: Lixisenatide plus OADs improved glycemic control in older patients inadequately controlled on OADs compared with placebo plus OADs. Lixisenatide is well tailored to the pathophysiology of T2DM in older patients. FAU - Hanefeld, Markolf AU - Hanefeld M AD - GWT-TUD, Study Centre Prof. Hanefeld, Dresden Technical University, Fiedlerstr. 34, 01307, Dresden, Germany, hanefeld@gwtonline-zks.de. FAU - Berria, Rachele AU - Berria R FAU - Lin, Jay AU - Lin J FAU - Aronson, Ronnie AU - Aronson R FAU - Darmon, Patrice AU - Darmon P FAU - Evans, Marc AU - Evans M FAU - Van Gaal, Luc AU - Van Gaal L LA - eng PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't DEP - 20140821 PL - United States TA - Adv Ther JT - Advances in therapy JID - 8611864 RN - 0 (Blood Glucose) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Peptides) RN - 74O62BB01U (lixisenatide) MH - Aged MH - Blood Glucose MH - Body Weight MH - Diabetes Mellitus, Type 2/*drug therapy MH - Double-Blind Method MH - Drug Administration Schedule MH - Drug Therapy, Combination MH - Female MH - Glycated Hemoglobin/analysis MH - Humans MH - Hypoglycemia/chemically induced MH - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use MH - Male MH - Peptides/administration & dosage/adverse effects/*therapeutic use MH - Postprandial Period MH - Randomized Controlled Trials as Topic EDAT- 2014/08/22 06:00 MHDA- 2016/03/10 06:00 CRDT- 2014/08/22 06:00 PHST- 2014/06/05 00:00 [received] PHST- 2014/08/22 06:00 [entrez] PHST- 2014/08/22 06:00 [pubmed] PHST- 2016/03/10 06:00 [medline] AID - 10.1007/s12325-014-0146-4 [doi] PST - ppublish SO - Adv Ther. 2014 Aug;31(8):861-72. doi: 10.1007/s12325-014-0146-4. Epub 2014 Aug 21.