PMID- 24865132
OWN - NLM
STAT- MEDLINE
DCOM- 20150707
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 16
IP  - 11
DP  - 2014 Nov
TI  - Safety and efficacy of the dipeptidyl peptidase-4 inhibitor linagliptin in 
      elderly patients with type 2 diabetes: a comprehensive analysis of data from 1331 
      individuals aged >/= 65 years.
PG  - 1078-86
LID - 10.1111/dom.12321 [doi]
AB  - AIMS: To investigate individual patient data from a comprehensive trials 
      programme to evaluate the safety and efficacy of the dipeptidyl peptidase-4 
      (DPP-4) inhibitor linagliptin across a range of glucose-lowering regimens in a 
      large elderly population with type 2 diabetes mellitus (T2DM). METHODS: Data were 
      pooled from individuals aged >/= 65 years, who participated in seven phase III, 
      placebo-controlled clinical trials of linagliptin (24-52 weeks). Safety was 
      assessed by incidence and severity of adverse events (AEs) with a focus on 
      hypoglycaemia. The primary efficacy endpoint was change in glycated haemoglobin 
      (HbA1c). RESULTS: In total, 841 subjects received linagliptin 5 mg once a day and 
      490 received placebo. At baseline, the population had a mean +/- s.d. age of 71.0 +/- 
      4.6 years and a mean HbA1c concentration of 8.0 +/- 0.8%; 63.5% of subjects 
      received >/= 2 antidiabetes drugs. Overall AEs and drug-related AEs were 
      experienced by similar proportions of patients (linagliptin 71.3, placebo 73.3; 
      linagliptin 18.1, placebo 19.8%, respectively). The incidence of 
      investigator-reported hypoglycaemia was 21.4% with linagliptin and 25.7% with 
      placebo. Severe hypoglycaemic events were rare and there were fewer in the 
      linagliptin group (1.0 vs. 1.8%). At week 24, the placebo-corrected adjusted mean 
      +/- s.e. reduction in HbA1c with linagliptin was -0.62 +/- 0.06% (95% CI: -0.73, 
      -0.51). CONCLUSIONS: Data from this large cohort show that linagliptin is a 
      well-tolerated and efficacious therapy for elderly patients with T2DM. Treatment 
      with linagliptin may support individualized treatment goals, while effectively 
      managing the risk of hypoglycaemia or drug-related side effects.
CI  - (c) 2014 John Wiley & Sons Ltd.
FAU - Schernthaner, G
AU  - Schernthaner G
AD  - Rudolfstiftung Hospital, Vienna, Austria.
FAU - Barnett, A H
AU  - Barnett AH
FAU - Patel, S
AU  - Patel S
FAU - Hehnke, U
AU  - Hehnke U
FAU - von Eynatten, M
AU  - von Eynatten M
FAU - Woerle, H-J
AU  - Woerle HJ
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140703
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Purines)
RN  - 0 (Quinazolines)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 3X29ZEJ4R2 (Linagliptin)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Glucose/*drug effects
MH  - Comorbidity
MH  - Diabetes Mellitus, Type 2/*drug therapy/epidemiology
MH  - Dipeptidyl-Peptidase IV Inhibitors/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Glycated Hemoglobin/*drug effects
MH  - Humans
MH  - Hypoglycemia/*chemically induced/epidemiology
MH  - Incidence
MH  - Linagliptin
MH  - Male
MH  - Purines/*administration & dosage/adverse effects
MH  - Quinazolines/*administration & dosage/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - DPP-IV inhibitor
OT  - diabetes mellitus
EDAT- 2014/05/29 06:00
MHDA- 2015/07/08 06:00
CRDT- 2014/05/29 06:00
PHST- 2014/02/14 00:00 [received]
PHST- 2014/05/06 00:00 [revised]
PHST- 2014/05/20 00:00 [accepted]
PHST- 2014/05/29 06:00 [entrez]
PHST- 2014/05/29 06:00 [pubmed]
PHST- 2015/07/08 06:00 [medline]
AID - 10.1111/dom.12321 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2014 Nov;16(11):1078-86. doi: 10.1111/dom.12321. Epub 2014 
      Jul 3.