PMID- 34304912
OWN - NLM
STAT- MEDLINE
DCOM- 20211124
LR  - 20221207
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 43
IP  - 8
DP  - 2021 Aug
TI  - Efficacy and Tolerability of Evogliptin in Patients with Type 2 Diabetes 
      Mellitus: A Systematic Review and Meta-analysis with Bayesian Inference Through a 
      Quality-management System.
PG  - 1336-1355
LID - S0149-2918(21)00231-9 [pii]
LID - 10.1016/j.clinthera.2021.06.001 [doi]
AB  - PURPOSE: Evogliptin is one of the latest dipeptidyl peptidase-4 (DPP-4) 
      inhibitor, and a number of clinical trials have been performed following its 
      development, including several randomized controlled trials (RCTs) performed to 
      evaluate its efficacy and tolerability. In our study, we performed a systematic 
      review and meta-analysis of its efficacy and tolerability by collecting RCTs and 
      confirmed the results with Bayesian inference. Moreover, an updated 
      quality-management system was integrated into the study process of systematic 
      review. METHODS: PubMed, EMBASE, the Cochrane Central Register of Controlled 
      Trials, and ClinicalTrials.gov were searched for literature published between May 
      1990 and November 2020. We selected 6 homogeneous RCTs in 1017 subjects for 
      efficacy and 1070 subjects for tolerability analysis. Regarding the efficacy 
      profile, the mean differences from baseline (95% CIs) in hemoglobin (Hb) A(1c) 
      and fasting plasma glucose (FPG) were generated as end points and derived from 
      each study. Regarding the tolerability profile, risk ratios of adverse events 
      (AEs), serious AEs, adverse drug reactions, and hypoglycemia were generated from 
      baseline to outcome measurements as derived from each study. A subsequent 
      meta-analysis was performed with Bayesian inference. FINDINGS: For HbA(1c) and 
      FPG, the results suggested a statistically significant improvement with 
      evogliptin versus placebo (HbA(1c), -0.44 [95% CI, -0.54 to -0.34; P < 0.00001] 
      and posterior median, -0.38 [95% CI, -0.51 to -0.24]; FPG, -0.61 [95% CI, -0.90 
      to -0.31; P < 0.0001] and posterior median, -0.48 [95% CI, -0.90 to -0.16]), but 
      no statistically significant difference with evogliptin versus other DPP-4 
      inhibitors (HbA(1c,) -0.01 [95% CI, -0.14 to 0.12] and posterior median, -0.06 
      [95% CI, -0.25 to 0.12]; FPG, 0.17 [95% CI, -0.10 to 0.44] and posterior median, 
      0.27 [95% CI, -0.12 to 0.65]). In terms of tolerability, the overall prevalence 
      of adverse events, including hypoglycemia, was similar between evogliptin and 
      other DPP-4 inhibitors and placebo. IMPLICATIONS: Evogliptin appears more 
      efficacious in terms of changes in HbA(1c) and FPG compared with placebo, with an 
      efficacy comparable to those of other DPP-4 inhibitors, although with the limited 
      data studied and the minuscule sample sizes, the predictions of posterior 
      medians, mean differences, and risk ratios of HbA(1c), FPG, and AEs by Bayesian 
      inference were consistent with our findings through our quality-management 
      system.
CI  - Copyright (c) 2021 The Author(s). Published by Elsevier Inc. All rights reserved.
FAU - Oh, Hojin
AU  - Oh H
AD  - College of Pharmacy and Research Institute of Life and Pharmaceutical Sciences, 
      Sunchon National University, Suncheon, Republic of Korea. Electronic address: 
      navytoto@hanmail.net.
FAU - Nguyen, Hai Duc
AU  - Nguyen HD
AD  - College of Pharmacy and Research Institute of Life and Pharmaceutical Sciences, 
      Sunchon National University, Suncheon, Republic of Korea.
FAU - Yoon, In Mo
AU  - Yoon IM
AD  - Unimedi Plastic Surgery Clinic, Seoul, Republic of Korea.
FAU - Kim, Min-Sun
AU  - Kim MS
AD  - College of Pharmacy and Research Institute of Life and Pharmaceutical Sciences, 
      Sunchon National University, Suncheon, Republic of Korea.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PT  - Systematic Review
DEP - 20210722
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 
      (4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Piperazines)
SB  - IM
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - *Dipeptidyl-Peptidase IV Inhibitors/adverse effects
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects
MH  - Piperazines
OTO - NOTNLM
OT  - DPP-4 inhibitors
OT  - Evogliptin
OT  - Fasting plasma glucose
OT  - HbA(1c)
OT  - Meta-analysis
OT  - RCTs
EDAT- 2021/07/27 06:00
MHDA- 2021/11/25 06:00
CRDT- 2021/07/26 05:34
PHST- 2021/04/08 00:00 [received]
PHST- 2021/05/28 00:00 [revised]
PHST- 2021/06/07 00:00 [accepted]
PHST- 2021/07/27 06:00 [pubmed]
PHST- 2021/11/25 06:00 [medline]
PHST- 2021/07/26 05:34 [entrez]
AID - S0149-2918(21)00231-9 [pii]
AID - 10.1016/j.clinthera.2021.06.001 [doi]
PST - ppublish
SO  - Clin Ther. 2021 Aug;43(8):1336-1355. doi: 10.1016/j.clinthera.2021.06.001. Epub 
      2021 Jul 22.