PMID- 24687427 OWN - NLM STAT- MEDLINE DCOM- 20150713 LR - 20221207 IS - 1520-7560 (Electronic) IS - 1520-7552 (Linking) VI - 30 IP - 8 DP - 2014 Nov TI - Lixisenatide as add-on to oral anti-diabetic therapy: an effective treatment for glycaemic control with body weight benefits in type 2 diabetes. PG - 742-8 LID - 10.1002/dmrr.2548 [doi] AB - BACKGROUND: Achieving recommended glycated haemoglobin (HbA1c ) targets in patients with type 2 diabetes mellitus (T2DM) requires effective control of fasting and post-prandial plasma glucose. As T2DM progresses, oral anti-diabetics are no longer sufficient to maintain glycaemic control. Five phase III studies in the GetGoal clinical trial programme assessed the efficacy of lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist, in combination with oral anti-diabetics in patients with T2DM insufficiently controlled using oral anti-diabetics. METHODS: A meta-analysis was performed of the results of five 24-week clinical trials (comprising 2760 patients) concerning lixisenatide or placebo plus oral anti-diabetic therapy. The primary endpoint of these studies was change in HbA1c at week 24. Changes in fasting and post-prandial plasma glucose, and weight were also established as were the odds ratios for hypoglycaemia and composite safety and efficacy endpoints. Meta-analysis outcomes were assessed using a random effects model. All meta-analyses were performed using RevMan, version 5.1. RESULTS: Lixisenatide was significantly better than placebo in terms of achieving all endpoints in this meta-analysis, including the primary endpoint change in HbA1c at week 24, with p < 0.0001 for all endpoints. The mean number of symptomatic hypoglycaemic events per patient year was increased for patients in the lixisenatide versus placebo groups (p = 0.04). However, compared with patients in the placebo group, patients treated with lixisenatide were more likely to achieve composite efficacy and safety endpoints. CONCLUSIONS: This meta-analysis demonstrates that lixisenatide in combination with oral anti-diabetic therapy significantly improves outcomes combining efficacy and safety parameters in patients with T2DM. CI - (c) 2014 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons, Ltd. FAU - Raccah, Denis AU - Raccah D AD - Department of Diabetology, University Hospital Sainte-Marguerite, Marseille, France. FAU - Gourdy, Pierre AU - Gourdy P FAU - Sagnard, Luc AU - Sagnard L FAU - Ceriello, Antonio AU - Ceriello A LA - eng PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PL - England TA - Diabetes Metab Res Rev JT - Diabetes/metabolism research and reviews JID - 100883450 RN - 0 (GLP1R protein, human) RN - 0 (Glucagon-Like Peptide-1 Receptor) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Peptides) RN - 0 (Receptors, Glucagon) RN - 0 (Sulfonylurea Compounds) RN - 0 (Thiazolidinediones) RN - 0 (hemoglobin A1c protein, human) RN - 74O62BB01U (lixisenatide) RN - 9100L32L2N (Metformin) RN - X4OV71U42S (Pioglitazone) SB - IM MH - Administration, Oral MH - Clinical Trials, Phase III as Topic MH - Combined Modality Therapy/adverse effects MH - Diabetes Mellitus, Type 2/blood/complications/*drug therapy/metabolism MH - Drug Administration Schedule MH - *Drug Resistance, Multiple MH - Drug Therapy, Combination/adverse effects MH - Glucagon-Like Peptide-1 Receptor MH - Glycated Hemoglobin/analysis MH - Humans MH - Hyperglycemia/*prevention & control MH - Hypoglycemia/chemically induced MH - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use MH - Metformin/administration & dosage/adverse effects/therapeutic use MH - Multicenter Studies as Topic MH - Overweight/chemically induced/complications/*prevention & control MH - Peptides/administration & dosage/adverse effects/*therapeutic use MH - Pioglitazone MH - Randomized Controlled Trials as Topic MH - Receptors, Glucagon/*agonists/metabolism MH - Sulfonylurea Compounds/administration & dosage/adverse effects/therapeutic use MH - Thiazolidinediones/administration & dosage/adverse effects/therapeutic use OTO - NOTNLM OT - glycaemic control OT - lixisenatide OT - oral anti-diabetics OT - prandial OT - type 2 diabetes mellitus EDAT- 2014/04/02 06:00 MHDA- 2015/07/15 06:00 CRDT- 2014/04/02 06:00 PHST- 2013/12/27 00:00 [received] PHST- 2014/02/18 00:00 [revised] PHST- 2014/03/19 00:00 [accepted] PHST- 2014/04/02 06:00 [entrez] PHST- 2014/04/02 06:00 [pubmed] PHST- 2015/07/15 06:00 [medline] AID - 10.1002/dmrr.2548 [doi] PST - ppublish SO - Diabetes Metab Res Rev. 2014 Nov;30(8):742-8. doi: 10.1002/dmrr.2548.