PMID- 28789492
OWN - NLM
STAT- MEDLINE
DCOM- 20181127
LR  - 20221207
IS  - 0578-1426 (Print)
IS  - 0578-1426 (Linking)
VI  - 56
IP  - 8
DP  - 2017 Aug 1
TI  - [The efficacy and safety of linagliptin in elderly patients with type 2 diabetes: 
      a pooled analysis of eight placebo-controlled clinical trials].
PG  - 588-594
LID - 10.3760/cma.j.issn.0578-1426.2017.08.007 [doi]
AB  - Objective: To evaluate the efficacy and safety of dipeptidyl peptidase-4 
      inhibitor, linagliptin, in subjects aged 60 years or older with type 2 diabetes 
      mellitus (T2DM). Methods: Data from eight 24-week, multinational, multicenter, 
      randomized, double-blind, placebo-controlled, parallel-group studies were 
      analyzed. Patients aged 60 years or older with T2DM were received oral 
      linagliptin (5 mg/d) or placebo in combination with metformin, or metformin plus 
      sulfonylurea. Efficacy was assessed by the changes in glycosylated hemoglobin A1c 
      (HbA1c) and fasting plasma glucose (FPG) from baseline to 24 weeks of treatment. 
      Safety endpoint included the frequency and intensity of adverse events. Results: 
      A total of 1 421 patients (placebo 429, linagliptin 992) were included in the 
      full analysis set (FAS). Mean ages of the subjects were (67.4+/-5.6) years in the 
      linagliptin group and (66.7+/-5.6) years in the placebo group. Baseline HbA1c was 
      (8.0+/-0.8) % in the linagliptin group and (8.1+/-0.9) % in the placebo group. At the 
      end of 24-week, placebo-adjusted reduction in HbA1c in subjects with linagliptin 
      was (0.7+/-0.1)% (95%CI 0.6-0.8, P<0.000 1), and placebo-adjusted reduction in FPG 
      in subjects with linagliptin was (0.88+/-0.12) mmol/L(95%CI 0.65-1.11, P<0.000 1). 
      Overall safety and tolerability in the two groups were similar. Adverse events 
      occurred in 57.1% of patients in the placebo group and 61.1% of patients in the 
      linagliptin group, and the incidence of adverse events leading to discontinuation 
      was 3.2% in the placebo group and 3.8% in the linagliptin group. Serious adverse 
      events occurred in 1.6% of patients in the placebo group and 2.8% of patients in 
      the linagliptin group. Investigator-defined hypoglycaemia occurred in 7.3% of 
      patients in the placebo group and 11.9% of patients in the linagliptin group. 
      Among them, most were mild or moderate hypoglycaemia, and severe hypoglycaemia 
      only occurred in 0.2% of patients in the placebo and 0.5% in the linagliptin 
      groups. Overall incidence of hypoglycaemia in linagliptin group was slightly 
      higher than that in placebo group, which might be due to the fact that more 
      patients were taking sulfonylureas in linagliptin group than in placebo group 
      (26.8% linagliptin; 18.4% placebo). No difference could be viewed in 
      hypoglycaemia between the two groups in patients without sulfonylureas (1.2% 
      linagliptin, 1.1% placebo). Moreover, no severe hypoglycaemia was reported in 
      subjects without sulfonylureas. The incidences of other adverse events were 
      similar in both groups. Conclusion: Linagliptin was efficacious in lowering 
      glucose with a safety profile similar to placebo in type 2 diabetic patients aged 
      60 years or older.
FAU - Guo, X H
AU  - Guo XH
AD  - Department of Endocrinology, Peking University First Hospital, Beijing100034, 
      China.
FAU - Feng, Z K
AU  - Feng ZK
FAU - Xu, L H
AU  - Xu LH
LA  - chi
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - China
TA  - Zhonghua Nei Ke Za Zhi
JT  - Zhonghua nei ke za zhi
JID - 16210490R
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sulfonylurea Compounds)
RN  - 3X29ZEJ4R2 (Linagliptin)
RN  - 9100L32L2N (Metformin)
RN  - IY9XDZ35W2 (Glucose)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Glucose/metabolism
MH  - China/epidemiology
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Glucose
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemia/*chemically induced/epidemiology
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Incidence
MH  - Linagliptin/adverse effects/*therapeutic use
MH  - Metformin/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Sulfonylurea Compounds/adverse effects/*therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Aged
OT  - Diabetes mellitus, type 2
OT  - Linagliptin
EDAT- 2017/08/10 06:00
MHDA- 2018/11/28 06:00
CRDT- 2017/08/10 06:00
PHST- 2017/08/10 06:00 [entrez]
PHST- 2017/08/10 06:00 [pubmed]
PHST- 2018/11/28 06:00 [medline]
AID - 10.3760/cma.j.issn.0578-1426.2017.08.007 [doi]
PST - ppublish
SO  - Zhonghua Nei Ke Za Zhi. 2017 Aug 1;56(8):588-594. doi: 
      10.3760/cma.j.issn.0578-1426.2017.08.007.