PMID- 27396241
OWN - NLM
STAT- MEDLINE
DCOM- 20180328
LR  - 20221207
IS  - 1873-460X (Electronic)
IS  - 1056-8727 (Linking)
VI  - 30
IP  - 7
DP  - 2016 Sep-Oct
TI  - Safety and efficacy of linagliptin in patients with type 2 diabetes mellitus and 
      coronary artery disease: Analysis of pooled events from 19 clinical trials.
PG  - 1378-84
LID - S1056-8727(16)30216-1 [pii]
LID - 10.1016/j.jdiacomp.2016.06.015 [doi]
AB  - AIMS: To examine the safety and efficacy of linagliptin in patients with type 2 
      diabetes mellitus (T2DM) and coronary artery disease (CAD) using pooled data from 
      the global clinical trials program. METHODS: Patient-level data were pooled from 
      randomized, placebo-controlled clinical trials of linagliptin (5mg, monotherapy 
      or combination therapy). Safety/efficacy analyses were conducted for patients 
      with CAD and >/=12 and >/=24weeks of treatment, respectively. RESULTS: The safety 
      analysis included 19 trials (linagliptin, n=451; placebo, n=272) and the efficacy 
      analysis, 12 trials (linagliptin, n=328; placebo, n=198); mean (+/- standard 
      deviation) exposure to study treatment was 212 (144) days linagliptin and 245 
      (171) days placebo. Occurrence of cardiac adverse events (AEs) was similar for 
      linagliptin- and placebo-treated patients (9.1% and 9.2%, respectively); 
      exposure-adjusted incidence rates (per 100 patient-years) were 16.6 and 14.0, 
      respectively. Overall incidence of AEs was numerically lower with linagliptin 
      than placebo. After 24weeks, mean adjusted change (standard error) from baseline 
      glycosylated hemoglobin was -0.64% (0.04) with linagliptin vs. -0.08% (0.05) with 
      placebo (P<.001). CONCLUSIONS: This comprehensive pooled analysis showed that 
      addition of linagliptin to treatment regimens of patients with T2DM and CAD was 
      not associated with an increased incidence of cardiac AEs, was well tolerated, 
      and was effective.
CI  - Copyright (c) 2016 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Lehrke, Michael
AU  - Lehrke M
AD  - University Hospital Aachen, Aachen, Germany.
FAU - Leiter, Lawrence A
AU  - Leiter LA
AD  - Keenan Research Centre in the Li Ka Shing Research Institute, St. Michael's 
      Hospital, University of Toronto, Toronto, Canada.
FAU - Hehnke, Uwe
AU  - Hehnke U
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
FAU - Thiemann, Sandra
AU  - Thiemann S
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
FAU - Bhandari, Amit
AU  - Bhandari A
AD  - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
FAU - Meinicke, Thomas
AU  - Meinicke T
AD  - Boehringer Ingelheim Corporation, Biberach, Germany.
FAU - Johansen, Odd Erik
AU  - Johansen OE
AD  - Boehringer Ingelheim Norway KS, Asker, Norway. Electronic address: 
      odd_erik.johansen@boehringer-ingelheim.com.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160616
PL  - United States
TA  - J Diabetes Complications
JT  - Journal of diabetes and its complications
JID - 9204583
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 3X29ZEJ4R2 (Linagliptin)
SB  - IM
MH  - Aged
MH  - Coronary Artery Disease/*complications
MH  - Diabetes Mellitus, Type 2/complications/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/*therapeutic use
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Linagliptin/*therapeutic use
MH  - Male
MH  - Middle Aged
OTO - NOTNLM
OT  - Coronary artery disease
OT  - Dipeptidyl peptidase-4 inhibitor
OT  - Drug safety
OT  - Heart failure
OT  - Linagliptin
OT  - Type 2 diabetes mellitus
EDAT- 2016/07/12 06:00
MHDA- 2018/03/29 06:00
CRDT- 2016/07/12 06:00
PHST- 2016/04/28 00:00 [received]
PHST- 2016/06/13 00:00 [revised]
PHST- 2016/06/15 00:00 [accepted]
PHST- 2016/07/12 06:00 [entrez]
PHST- 2016/07/12 06:00 [pubmed]
PHST- 2018/03/29 06:00 [medline]
AID - S1056-8727(16)30216-1 [pii]
AID - 10.1016/j.jdiacomp.2016.06.015 [doi]
PST - ppublish
SO  - J Diabetes Complications. 2016 Sep-Oct;30(7):1378-84. doi: 
      10.1016/j.jdiacomp.2016.06.015. Epub 2016 Jun 16.