PMID- 28449324
OWN - NLM
STAT- MEDLINE
DCOM- 20180612
LR  - 20220408
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 19
IP  - 11
DP  - 2017 Nov
TI  - Efficacy and safety of lixisenatide in patients with type 2 diabetes and renal 
      impairment.
PG  - 1594-1601
LID - 10.1111/dom.12986 [doi]
AB  - 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 >/=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.
CI  - (c) 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - Hanefeld, Markolf
AU  - Hanefeld M
AUID- ORCID: 0000-0001-7323-1203
AD  - Centre for Clinical Studies, GWT-Technical University Dresden, Dresden, Germany.
FAU - Arteaga, Juan M
AU  - Arteaga JM
AD  - National University of Colombia School of Medicine, Bogota D.C., Colombia.
FAU - Leiter, Lawrence A
AU  - Leiter LA
AUID- ORCID: 0000-0002-1040-6229
AD  - Keenan Research Centre in the Li Ka Shing Knowledge Institute of St Michael's 
      Hospital, University of Toronto, Toronto, Canada.
FAU - Marchesini, Giulio
AU  - Marchesini G
AD  - Department of Medical and Surgical Sciences, University of Bologna, Bologna, 
      Italy.
FAU - Nikonova, Elena
AU  - Nikonova E
AD  - Artech Information Systems, LLC, Morristown, New Jersey.
FAU - Shestakova, Marina
AU  - Shestakova M
AD  - Endocrinology Research Center, Moscow, Russian Federation.
AD  - I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.
FAU - Stager, William
AU  - Stager W
AD  - Sanofi, Bridgewater, New Jersey.
FAU - Gomez-Huelgas, Ricardo
AU  - Gomez-Huelgas R
AD  - Internal Medicine Department, University Regional Hospital, Malaga, Spain.
AD  - Malaga Institute of Biomedicine (IBIMA), Malaga, Spain.
AD  - CIBER Fisiopatologia Obesidad y Nutricion, Instituto de Salud Carlos III, Madrid, 
      Spain.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20170607
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Peptides)
RN  - 74O62BB01U (lixisenatide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Clinical Trials as Topic/statistics & numerical data
MH  - Diabetes Mellitus, Type 2/complications/*drug therapy/epidemiology
MH  - Diabetic Nephropathies/drug therapy/epidemiology/pathology
MH  - Female
MH  - Glomerular Filtration Rate
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Peptides/*therapeutic use
MH  - Renal Insufficiency/complications/*drug therapy/epidemiology/pathology
MH  - Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC5655920
OTO - NOTNLM
OT  - GLP-1
OT  - incretin therapy
OT  - meta-analysis
OT  - type 2 diabetes
COIS- M. H. has served on an advisory panel and as an author for Bristol-Myers Squibb, 
      GlaxoSmithKline, Sanofi and Takeda; and has served on a speakers' bureau and as 
      an author for Bayer Health Care, Eli Lilly, GlaxoSmithKline, Roche, Sanofi and 
      Takeda. J. M. A. has served on an advisory panel and as an author for 
      AstraZeneca, Bristol-Myers Squibb, Novo Nordisk and Sanofi; and as a speaker for 
      Sanofi. L. A. L. has received research funding from, has provided CME on behalf 
      of, and/or has served as an adviser to AstraZeneca, Boehringer Ingelheim, Eli 
      Lilly, GlaxoSmithKline, Janssen, Merck, Novo Nordisk, Pfizer, Sanofi, Servier and 
      Takeda. G. M. has received research support from and served as an author for MSD; 
      has served on a speakers' bureau and as an author for Boehringer Ingelheim, Eli 
      Lilly, MSD, Novartis, Novo Nordisk and Sanofi; and has served on an advisory 
      panel for Boehringer Ingelheim, Eli Lilly and Sanofi. E. N. is an employee of 
      Artech Information Systems, under contract with Sanofi as a clinical data 
      associate. M. S. has served on an advisory panel and as an author for Novo 
      Nordisk; has received research support from and served as an author for Novartis; 
      and has served on speakers' bureau and as an author for AstraZeneca, Boehringer 
      Ingelheim, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Novo Nordisk and 
      Servier. W. S. is an employee of Sanofi. R. G.-H. has served on an advisory panel 
      and as an author for Boehringer Ingelheim, Eli Lilly, Janssen, Novo Nordisk and 
      Sanofi.
EDAT- 2017/04/28 06:00
MHDA- 2018/06/13 06:00
PMCR- 2017/10/25
CRDT- 2017/04/28 06:00
PHST- 2016/12/28 00:00 [received]
PHST- 2017/04/13 00:00 [revised]
PHST- 2017/04/22 00:00 [accepted]
PHST- 2017/04/28 06:00 [pubmed]
PHST- 2018/06/13 06:00 [medline]
PHST- 2017/04/28 06:00 [entrez]
PHST- 2017/10/25 00:00 [pmc-release]
AID - DOM12986 [pii]
AID - 10.1111/dom.12986 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2017 Nov;19(11):1594-1601. doi: 10.1111/dom.12986. Epub 2017 
      Jun 7.