PMID- 34711126
OWN - NLM
STAT- MEDLINE
DCOM- 20220308
LR  - 20221207
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 21
IP  - 3
DP  - 2022 Mar
TI  - Safety and tolerability of linagliptin in Asians with type 2 diabetes: a pooled 
      analysis of 4457 patients from 21 randomized, double-blind, placebo-controlled 
      clinical trials.
PG  - 425-434
LID - 10.1080/14740338.2022.1999409 [doi]
AB  - BACKGROUND: Safety and tolerability of glucose-lowering drugs is a key 
      consideration for use in type 2 diabetes (T2D). We evaluated the safety and 
      tolerability of the dipeptidyl peptidase-4 inhibitor linagliptin in Asian 
      patients with T2D. RESEARCH DESIGN AND METHODS: This was a post-hoc, descriptive 
      pooled analysis of 21 randomized, double-blind, placebo-controlled clinical 
      trials of linagliptin in T2D patients lasting </=52 weeks. We evaluated adverse 
      events (AEs) and laboratory parameters in Asian participants living in Asia, both 
      overall and in the East Asian subgroup. RESULTS: This analysis included 4457 
      Asian patients overall (2712 receiving linagliptin; 1745 receiving placebo) and 
      3057 (68.6%) East Asians. AEs were reported in 1510 (55.7%) Asian patients 
      receiving linagliptin and 1032 (59.1%) receiving placebo but were considered 
      drug-related in only 13.0% of each group. Serious AEs occurred in 109 (4.0%) 
      linagliptin patients and 90 (5.2%) placebo patients. The most common AEs were 
      nasopharyngitis (6.4% linagliptin, 7.3% placebo), upper respiratory tract 
      infection (5.7% linagliptin, 6.5% placebo), and hypoglycemia (7.3% linagliptin, 
      6.3% placebo). One linagliptin patient had pancreatitis; none had bullous 
      pemphigoid. No clinically relevant mean changes in laboratory parameters 
      occurred. These findings were consistent in East Asians. CONCLUSIONS: Linagliptin 
      is well tolerated in Asian T2D patients, including East Asians, with low risk for 
      AEs.
FAU - Kanasaki, Keizo
AU  - Kanasaki K
AD  - Department of Internal Medicine 1, Faculty of Medicine, Shimane University, 
      Izumo, Japan.
FAU - Qu, Shen
AU  - Qu S
AD  - Department of Endocrinology and Metabolism, Shanghai Tenth People's Hospital, 
      Tongji University School of Medicine, Shanghai, China.
FAU - Yamamoto, Fumiko
AU  - Yamamoto F
AD  - Medicine Division, Nippon Boehringer Ingelheim Co., Ltd, Tokyo, Japan.
FAU - Schepers, Cornelia
AU  - Schepers C
AD  - Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, 
      Ingelheim, Germany.
FAU - Sani Simoes, Rafael
AU  - Sani Simoes R
AD  - Global Patient Safety & Pharmacovigilance, Boehringer Ingelheim International 
      GmbH, Ingelheim, Germany.
FAU - Yabe, Daisuke
AU  - Yabe D
AUID- ORCID: 0000-0002-5334-7687
AD  - Department of Diabetes, Endocrinology and Metabolism and Department of 
      Rheumatology and Clinical Immunology, Gifu University Graduate School of 
      Medicine, Gifu, Japan.
AD  - Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power 
      Medical Research Institute, Kobe, Japan.
AD  - Division of Molecular and Metabolic Medicine, Department of Physiology and Cell 
      Biology, Kobe University Graduate School of Medicine, Kobe, Japan.
AD  - Center for Healthcare Information Technology (C-HIT), Tokai National Higher 
      Education and Research System, Nagoya, Japan.
FAU - Ji, Linong
AU  - Ji L
AD  - Department of Endocrinology and Metabolism, Peking University People's Hospital, 
      Beijing, China.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20211110
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 3X29ZEJ4R2 (Linagliptin)
SB  - IM
MH  - Asian People
MH  - Blood Glucose
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - *Dipeptidyl-Peptidase IV Inhibitors/therapeutic use
MH  - Double-Blind Method
MH  - Glycated Hemoglobin
MH  - Humans
MH  - Hypoglycemic Agents/therapeutic use
MH  - Linagliptin/adverse effects
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Asia
OT  - Asian continental ancestry group
OT  - diabetes mellitus
OT  - dipeptidyl-peptidase iv inhibitors
OT  - drug-related side effects and adverse reactions
OT  - linagliptin
OT  - type 2
EDAT- 2021/10/30 06:00
MHDA- 2022/03/09 06:00
CRDT- 2021/10/29 05:28
PHST- 2021/10/30 06:00 [pubmed]
PHST- 2022/03/09 06:00 [medline]
PHST- 2021/10/29 05:28 [entrez]
AID - 10.1080/14740338.2022.1999409 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2022 Mar;21(3):425-434. doi: 10.1080/14740338.2022.1999409. 
      Epub 2021 Nov 10.