PMID- 22268497
OWN - NLM
STAT- MEDLINE
DCOM- 20120709
LR  - 20220419
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 14
IP  - 5
DP  - 2012 May
TI  - Safety and tolerability of linagliptin: a pooled analysis of data from randomized 
      controlled trials in 3572 patients with type 2 diabetes mellitus.
PG  - 470-8
LID - 10.1111/j.1463-1326.2012.01565.x [doi]
AB  - AIMS: To assess the safety and tolerability of the dipeptidyl peptidase-4 
      inhibitor linagliptin in patients with type 2 diabetes. METHODS: Data were pooled 
      from eight randomized, double-blind, placebo-controlled Phase III clinical trials 
      lasting </=24 weeks. Incidences were calculated with descriptive statistics for the 
      overall population and for subgroups of elderly and renally impaired patients. 
      RESULTS: A total of 2523 patients received linagliptin 5 mg once daily and 1049 
      patients received placebo. The overall incidence of adverse events (AEs) or 
      serious AEs with linagliptin was similar to placebo (AEs 55.8% vs. 55.0%; serious 
      AEs 2.8% vs. 2.7%). Overall aggregated infection incidence was 19.5% for 
      linagliptin and 21.4% for placebo. Similar or reduced incidence of AEs versus 
      placebo were seen with linagliptin for upper respiratory tract infection (3.3% 
      vs. 4.9%), headache (2.9% vs. 3.1%), urinary tract infection (2.2% vs. 2.7%), 
      blood and lymphatic disorders (1.0% vs. 1.2%), hypersensitivity (0.1% vs. 0.1%), 
      hepatic enzyme increase (0.1% and 0.1%) and serum creatinine increase (0.0% and 
      0.1%). There was a slight increased frequency of nasopharyngitis (5.9% vs. 5.1%) 
      and cough (1.7% vs. 1.0%) with linagliptin. Hypoglycaemia incidence was 8.2% for 
      linagliptin and 5.1% for placebo; incidence was higher in patients with a 
      background of sulphonylurea therapy (20.7% and 13.3%, respectively). In patients 
      not receiving concomitant sulphonylurea, the hypoglycaemic incidence with 
      linagliptin was very low in both the total population (<1%), and elderly and 
      renally impaired patients (both <1%). CONCLUSIONS: This pooled analysis shows 
      that linagliptin is well tolerated, with a low risk of hypoglycaemia.
CI  - (c) 2012 Blackwell Publishing Ltd.
FAU - Schernthaner, G
AU  - Schernthaner G
AD  - Department of Medicine I, Rudolfstiftung Hospital, Vienna, Austria. 
      guntram@schernthaner.eu
FAU - Barnett, A H
AU  - Barnett AH
FAU - Emser, A
AU  - Emser A
FAU - Patel, S
AU  - Patel S
FAU - Troost, J
AU  - Troost J
FAU - Woerle, H-J
AU  - Woerle HJ
FAU - von Eynatten, M
AU  - von Eynatten M
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20120216
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Purines)
RN  - 0 (Quinazolines)
RN  - 0 (Sulfonylurea Compounds)
RN  - 3X29ZEJ4R2 (Linagliptin)
SB  - IM
MH  - Blood Glucose/*drug effects
MH  - Clinical Trials, Phase III as Topic
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Linagliptin
MH  - Male
MH  - Middle Aged
MH  - Purines/*therapeutic use
MH  - Quinazolines/*therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Sulfonylurea Compounds/therapeutic use
EDAT- 2012/01/25 06:00
MHDA- 2012/07/10 06:00
CRDT- 2012/01/25 06:00
PHST- 2012/01/25 06:00 [entrez]
PHST- 2012/01/25 06:00 [pubmed]
PHST- 2012/07/10 06:00 [medline]
AID - 10.1111/j.1463-1326.2012.01565.x [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2012 May;14(5):470-8. doi: 10.1111/j.1463-1326.2012.01565.x. 
      Epub 2012 Feb 16.