PMID- 25215428
OWN - NLM
STAT- MEDLINE
DCOM- 20150702
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 31
IP  - 1
DP  - 2015 Jan
TI  - Efficacy and safety of linagliptin as monotherapy or add-on treatment in Asian 
      patients with suboptimal glycemic control: a pooled analysis.
PG  - 99-106
LID - 10.1185/03007995.2014.964856 [doi]
AB  - AIMS: To evaluate the efficacy and safety of the dipeptidyl peptidase (DPP)-4 
      inhibitor linagliptin in Asian patients with type 2 diabetes mellitus (T2DM), a 
      rapidly increasing population. METHODS: Data were pooled for Asian patients 
      receiving linagliptin orally once daily, as monotherapy or added to existing oral 
      antidiabetes therapies, in multinational randomized placebo-controlled clinical 
      trials. Efficacy data were taken from four pivotal trials with 24-week durations 
      to allow for robust efficacy assessment. Safety data were pooled from a wider 
      group of 10 trials with varying durations to capture the largest possible 
      incidence of adverse events (AEs). The primary efficacy endpoint was change from 
      baseline to week 24 in HbA1c. AEs were analyzed descriptively. RESULTS: Mean 
      baseline HbA1c (+/-SD) in this population was 8.2 +/- 0.9%. Placebo-corrected mean 
      change in HbA1c after 24 weeks was -0.79% (95% confidence interval [CI]: -0.92 to 
      -0.67; p < 0.0001). Placebo-corrected mean change in fasting plasma glucose was 
      -17.8 +/- 2.4 mg/dL (95% CI: -22.6, -13.0; p < 0.0001). In a small subgroup, mean 
      post-prandial glucose was reduced by a placebo-corrected -56.9 +/- 14.0 mg/dL (95% 
      CI: -85.2, -28.5). AEs occurred in 58.0% of linagliptin patients (serious AEs in 
      2.4%) and 58.2% of placebo patients (serious AEs in 3.0%). CONCLUSIONS: This 
      study was limited by the post hoc nature of the analysis, and because the pooling 
      did not differentiate between geographically distant Asian regions. Nonetheless, 
      this analysis provides evidence that linagliptin was efficacious and well 
      tolerated as monotherapy or added to other oral antidiabetes therapies in Asian 
      patients with T2DM.
FAU - Zeng, Zhengpei
AU  - Zeng Z
AD  - Peking Union Medical College Hospital , Beijing , China.
FAU - Choi, Dong Seop
AU  - Choi DS
FAU - Mohan, Viswanathan
AU  - Mohan V
FAU - Emser, Angela
AU  - Emser A
FAU - Siddiqui, Kamran
AU  - Siddiqui K
FAU - Gong, Yan
AU  - Gong Y
FAU - Patel, Sanjay
AU  - Patel S
FAU - Woerle, Hans-Juergen
AU  - Woerle HJ
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20141008
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Purines)
RN  - 0 (Quinazolines)
RN  - 3X29ZEJ4R2 (Linagliptin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - *Asian People
MH  - Blood Glucose/metabolism
MH  - Diabetes Mellitus, Type 2/*drug therapy/*ethnology
MH  - Dipeptidyl-Peptidase IV Inhibitors/*administration & dosage
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Linagliptin
MH  - Male
MH  - Middle Aged
MH  - Purines/*administration & dosage
MH  - Quinazolines/*administration & dosage
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Asian patients
OT  - DPP-4 inhibitor
OT  - Linagliptin
OT  - Type 2 diabetes
EDAT- 2014/09/13 06:00
MHDA- 2015/07/03 06:00
CRDT- 2014/09/13 06:00
PHST- 2014/09/13 06:00 [entrez]
PHST- 2014/09/13 06:00 [pubmed]
PHST- 2015/07/03 06:00 [medline]
AID - 10.1185/03007995.2014.964856 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2015 Jan;31(1):99-106. doi: 10.1185/03007995.2014.964856. Epub 
      2014 Oct 8.