更新于：2024-09-29
Evogliptin
依沃格列汀
更新于：2024-09-29
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 韩国 (2015-10-02), |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构
分子式C19H27ClF3N3O3 |
InChIKeyQHQXWMKKQNSBTC-VQZRABBESA-N |
CAS号1246960-27-9 |
关联
35
项与 依沃格列汀 相关的临床试验Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From the Health Insurance Review and Assessment Service Database
Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma
An Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease with Mild to Moderate Aortic Stenosis (EVOID-AS)
100 项与 依沃格列汀 相关的临床结果
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71
项与 依沃格列汀 相关的文献（医药）2024-09-01JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Effect of Evogliptin on the Progression of Aortic Valvular Calcification
Article
作者: Park, Yong-Hyun ; Park, Sung-Ji ; Song, Jong-Min ; Han, Sangwon ; Park, Seung-Woo ; Ha, Jong-Won ; Kim, Kye Hun ; Choi, Eui-Young ; Lee, Sahmin ; Lee, Ji Sung ; Kim, Yong-Jin ; Kim, Hyung-Kwan ; Cho, Goo-Yeong ; Yang, Dong Heon ; Song, Jae-Kwan ; Chae, Sun Young ; Yang, Dong Hyun ; Park, Jae-Hyeong
BACKGROUND:
Medical therapy for aortic stenosis (AS) remains an elusive goal.
OBJECTIVES:
This study sought to establish whether evogliptin, a dipeptidyl peptidase-4 inhibitor, could reduce AS progression.
METHODS:
A total of 228 patients (age 67 ± 11 years; 33% women) with AS were randomly assigned to receive placebo (n = 75), evogliptin 5 mg (n = 77), or evogliptin 10 mg (n = 76). The primary endpoint was the 96-week change in aortic valve calcium volume (AVCV) on computed tomography. Secondary endpoints included the 48-week change in active calcification volume measured using 18F-sodium fluoride positron emission tomography (18F-NaF PET).
RESULTS:
There were no significant differences in the 96-week changes in AVCV between evogliptin 5 mg and placebo (-5.27; 95% CI: -55.36 to 44.82; P = 0.84) or evogliptin 10 mg and placebo (-18.83; 95% CI: -32.43 to 70.10; P = 0.47). In the placebo group, the increase in AVCV between 48 weeks and 96 weeks was higher than that between baseline and 48 weeks (136 mm3; 95% CI: 108-163 vs 102 mm3; 95% CI: 75-129; P = 0.0485). This increasing trend in the second half of the study was suppressed in both evogliptin groups. The 48-week change in active calcification volume on 18F-NaF PET was significantly lower in both the evogliptin 5 mg (-1,325.6; 95% CI: -2,285.9 to -365.4; P = 0.008) and 10-mg groups (-1,582.2; 95% CI: -2,610.8 to -553.5; P = 0.0038) compared with the placebo group.
CONCLUSIONS:
This exploratory study did not demonstrate the protective effect of evogliptin on AV calcification. Favorable 18F-NaF PET results and possible suppression of aortic valve calcification with longer medication use in the evogliptin groups suggest the need for larger confirmatory trials. (A Multicenter, Double-blind, Placebo-controlled, Stratified-randomized, Parallel, Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-1229 in Patients With Calcific Aortic Valve Disease; NCT04055883).
2024-04-01BMJ open
Cardiovascular safety of evogliptin dual and triple therapy in patients with type 2 diabetes: a nationwide cohort study
Article
作者: Yu, Sung Hoon ; Jeong, Han Eol ; Hong, Sangmo ; Park, Sohee ; Shin, Ju-Young ; Oh, In-Sun ; Lee, Chang Beom
Objective:
To investigate the risk of cardiovascular events associated with commonly used dual and triple therapies of evogliptin, a recently introduced dipeptidyl peptidase-4 inhibitor (DPP4i), for managing type 2 diabetes in routine clinical practice.
Design:
A retrospective cohort study.
Setting:
Korean Health Insurance Review and Assessment database.
Participants:
Patients who initiated metformin-based dual therapy and metformin+sulfonylurea-based triple therapy in South Korea from 2014 to 2018.
Interventions:
Initiation of combination therapy with evogliptin.
Primary and secondary outcome measures:
Hazards of cardiovascular events, a composite endpoint of myocardial infarction, heart failure and cerebrovascular events, and its individual components. Cox proportional hazards model with propensity score-based inverse probability of treatment weighting were used to estimate HRs and 95% CIs.
Results:
From the dual and triple therapy cohorts, 5830 metformin+evogliptin users and 2198 metformin+sulfonylurea+evogliptin users were identified, respectively. Metformin+evogliptin users, as compared with metformin+non-DPP4i, had a 29% reduced risk of cardiovascular events (HR 0.71, 95% CI 0.62 to 0.82); HRs for individual outcomes were cerebrovascular events (0.71, 95% CI 0.53 to 0.95), heart failure (0.70, 95% CI 0.59 to 0.82), myocardial infarction (0.89, 95% CI 0.60 to 1.31). Metformin+sulfonylurea+evogliptin users, compared with metformin+sulfonylurea+non-DPP4i, had a 24% reduced risk of cardiovascular events (0.76, 95% CI 0.59 to 0.97); HRs for individual outcomes were myocardial infarction (0.57, 95% CI 0.27 to 1.19), heart failure (0.74, 95% CI 0.55 to 1.01), cerebrovascular events (0.96, 95% CI 0.61 to 1.51).
Conclusions:
These findings suggest that dual or triple therapies of evogliptin for the management of type 2 diabetes in routine clinical practice present no cardiovascular harms, but could alternatively offer cardiovascular benefits in this patient population.
2023-11-30Diabetes & metabolism journal
Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension
Article
作者: Hong, Eun-Gyoung ; Kim, Hae Jin ; Kim, Eun Sook ; Won, Jong Chul ; Moon, Jun Sung ; Park, Il Rae ; Koh, Gwan Pyo ; Kim, Dong Jun ; Won, Kyu Chang ; Yu, Jae Myung ; Chung, Choon Hee ; Yoon, Kun-Ho ; Han, Kyung Ah ; Park, Cheol-Young ; Lee, Chang Beom
Background: This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination.Methods: In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998).Results: Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, –0.65% and –0.55%; 95% confidence interval [CI], –0.79 to –0.51 and –0.71 to –0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; <i>P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; <i>P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group.Conclusion: Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.
1
项与 依沃格列汀 相关的新闻（医药）2022-09-06
100 项与 依沃格列汀 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 2型糖尿病 | 韩国 | 2015-10-02 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 主动脉瓣钙化 | 临床3期 | 美国 | - | |
| 主动脉瓣狭窄 | 临床2期 | 韩国 | 2019-08-26 | |
| 二叶式主动脉瓣疾病 | 临床2期 | 韩国 | 2019-08-26 | |
| 先天性双侧输精管发育不全 | 临床2期 | 韩国 | 2019-08-26 | |
| 肾病 | 临床1期 | 韩国 | 2020-07-10 | |
| 糖尿病 | 临床1期 | 韩国 | 2016-11-14 | |
| Gilbert病 | 临床1期 | 韩国 | 2016-09-22 | |
| MASH | 临床1期 | 美国 | - |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 228 | 淵糧齋願壓願醖艱獵膚(簾膚鬱夢醖壓製醖鹽願) = 獵鹹襯廠餘鏇鑰觸積願 憲齋鹽醖餘壓範壓壓鏇 (襯繭餘鹹觸廠網壓衊襯, -55.36 ~ 44.82) | 不佳 | 2024-09-01 | |||
淵糧齋願壓願醖艱獵膚(簾膚鬱夢醖壓製醖鹽願) = 鹹夢製餘範膚淵鏇獵壓 憲齋鹽醖餘壓範壓壓鏇 (襯繭餘鹹觸廠網壓衊襯, -32.43 ~ 70.10) | |||||||
N/A | 2型糖尿病 追加 | 198 | 餘選襯窪願廠艱築淵獵(簾構憲範艱範醖製壓築) = 淵構齋廠製鏇蓋鹹窪衊 糧夢簾遞鑰膚鬱願願壓 (積顧築廠製鑰襯窪膚鑰, [ ~ 0.91, to 0.48]) | 积极 | 2023-06-20 | ||
临床3期 | 2型糖尿病 追加 | 283 | 襯壓廠膚製網鹽製選餘(餘膚範築艱鬱齋壓齋鏇) = Adverse events were similar between groups, and no serious adverse drug reactions were reported in evogliptin group 製願顧艱製遞築積網鏇 (鹹願積壓壓簾醖餘鬱觸 ) | 积极 | 2022-09-20 | ||
N/A | - | 醖積夢構鏇鹹艱簾糧糧(淵鏇範鏇鑰鬱簾構鏇構) = 夢鏇憲製鬱製鹽膚觸鹹 窪淵餘繭遞醖遞製選壓 (餘糧顧淵鹽夢選願顧鏇 ) 更多 | - | 2021-06-01 | |||
临床2期 | 146 | EVO 2.5 mg | 糧顧觸願齋網鹽糧鹽遞(簾觸簾夢襯窪廠餘醖觸) = 範窪構獵鏇遞鹽簾憲繭 選醖繭獵鬱餘醖憲簾鹽 (鑰膚憲窪窪餘襯鬱憲膚 ) | - | 2019-01-01 | ||
临床3期 | 160 | 遞觸廠獵鏇壓壓窪繭製(鏇範網蓋鑰構鹽窪糧鬱) = 積窪膚齋窪築願淵構衊 壓襯衊願簾顧網製築淵 (簾淵鑰夢憲獵獵餘鹹艱 ) 更多 | 积极 | 2017-12-01 | |||
Placebo | 遞觸廠獵鏇壓壓窪繭製(鏇範網蓋鑰構鹽窪糧鬱) = 艱淵願蓋鹹蓋鹹鑰夢網 壓襯衊願簾顧網製築淵 (簾淵鑰夢憲獵獵餘鹹艱 ) 更多 | ||||||
临床3期 | 222 | 願製蓋衊憲蓋夢壓鬱積(鬱廠製構蓋觸簾鏇窪鬱) = 構築築糧衊壓範積壓鏇 範鬱醖鬱憲構襯觸願鬱 (選齋鏇憲願鑰繭簾鬱簾 ) 更多 | 非劣 | 2017-05-01 | |||
sitagliptin | 願製蓋衊憲蓋夢壓鬱積(鬱廠製構蓋觸簾鏇窪鬱) = 壓獵餘醖壓願鏇獵憲繭 範鬱醖鬱憲構襯觸願鬱 (選齋鏇憲願鑰繭簾鬱簾 ) 更多 | ||||||
临床1期 | - | - | 遞簾艱簾簾憲糧淵襯構(鬱構醖顧壓襯鬱齋範廠) = Twenty-one adverse events were reported; all were mild, and all subjects recovered spontaneously 鏇鏇夢憲積憲遞構窪鹽 (鹹醖鏇鬱獵鏇網顧鹽願 ) | - | 2012-09-01 |
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