更新于：2024-11-11
Ertugliflozin pidolate
艾托格列净
更新于：2024-11-11
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2017-12-19), |
最高研发阶段(中国)批准上市 |
特殊审评特殊审批 (中国) |
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结构
分子式C27H32ClNO10 |
InChIKeyYHIUPZFKHZTLSH-LXYIGGQGSA-N |
CAS号1210344-83-4 |
关联
43
项与 艾托格列净 相关的临床试验艾托格列净片在健康受试者中空腹/餐后单次口服给药、随机、开放交叉生物等效性试验
The effect of ertugliflozin on liver function in patients with nonalcoholic fatty liver disease (NAFLD) associated with type 2 diabetes mellitus.
DiEtary Sodium Intake effects on ertugliflozin-induced changes in GFR, reNal oxygenation and systemic hemodynamics: the DESIGN study, a randomized, placebo-controlled, cross-over study with ertugliflozin in people with type 2 diabetes - DESIGN
100 项与 艾托格列净 相关的临床结果
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100 项与 艾托格列净 相关的转化医学
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100 项与 艾托格列净 相关的专利（医药）
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243
项与 艾托格列净 相关的文献（医药）2024-09-24NEJM evidence
Ertugliflozin to Reduce Arrhythmic Burden in Patients with ICDs/CRT-Ds
Article
作者: Zirlik, Andreas ; Kolesnik, Ewald ; Manninger, Martin ; Scherr, Daniel ; Martinek, Martin ; Steinwender, Clemens ; Widkal, Johannes ; Gwechenberger, Marianne ; Leiter, Simon ; Tripolt, Norbert J. ; Benedikt, Martin ; Sourij, Harald ; Nürnberg, Michael ; Oulhaj, Abderrahim ; Wallner, Markus ; Aziz, Faisal ; Rohrer, Ursula ; Pferschy, Peter N. ; Roithinger, Franz Xaver ; von Lewinski, Dirk ; Stühlinger, Markus
BACKGROUND:
Sodium-glucose cotransporter 2 inhibitors (SGLT2is) have beneficial pleiotropic effects, contributing to improved cardiovascular and renal outcomes for patients with and without diabetes. The impact of SGLT2is on arrhythmic burden remains largely unexplored through randomized trials.
METHODS:
In this multicenter, double-blind, randomized, placebo-controlled trial, we investigated the effects of ertugliflozin on arrhythmic burden among patients with heart failure with an ejection fraction less than 50%. All patients had an implantable cardioverter-defibrillator (ICD) with or without a cardiac resynchronization therapy device (CRT-D) and were randomized (1:1) to receive either ertugliflozin 5 mg once daily or placebo. The primary end point was the number of incident sustained (>30 seconds) ventricular tachycardia or ventricular fibrillation events from baseline to week 52. Secondary end points included the total number of non-sustained ventricular tachycardias, appropriate ICD therapies, changes in N-terminal pro-brain-type natriuretic peptide (NTproBNP) levels, and the number of heart failure hospitalizations.
RESULTS:
Randomization was prematurely terminated, after class IA guideline recommendations were published for SGLT2is in patients with heart failure regardless of the ejection fraction. The final analysis included 46 patients (11% of the originally planned sample size). The yearly rate of the primary end point was 3.5 (95% confidence interval [CI] 2.8 to 4.4) with ertugliflozin compared with 13.3 with placebo (95% CI 11.8 to 14.8; rate ratio 0.16, 95% CI 0.04 to 0.61; P<0.001). There were no apparent differences in appropriate ICD therapies, hospitalizations, NTproBNP levels, or predefined adverse and serious adverse events.
CONCLUSIONS:
Ertugliflozin reduced sustained ventricular tachycardia or ventricular fibrillation events in adults with heart failure and an ICD compared with placebo; however, our trial ended early and thus results should be interpreted with caution. (Funded by Investigator-initiated Studies Program of Merck Sharp & Dohme Corp and Pfizer; EudraCT number, 2020-002581-14; ClinicalTrials.gov number NCT04600921.).
2024-09-01CURRENT PROBLEMS IN CARDIOLOGY
Pharmacovigilance study for SGLT 2 inhibitors- Safety review of real-world data & randomized clinical trials
Review
作者: Ganatra, Sarju ; Bhanushali, Karan B ; Nair, Ambica ; Dani, Sourbha S ; Asnani, Heena K
PURPOSE:
Despite effectiveness of sodium-glucose cotransporter 2 (SGLT 2) inhibitors, concerns have been raised about the potential side effects of these drugs. Thus, a pharmaco-vigilance study was designed that aims to identify any discrepancies between the reported adverse events & assess the safety profile of SGLT2 inhibitors.
METHODS:
We studied diabetic ketoacidosis (DKA), euglycemic DKA, amputation, urinary tract infection (UTI), mycotic genital infection & hypotension associated with empagliflozin, dapagliflozin, canagliflozin & ertugliflozin in RCTs and reporting databases. WHO's VigiBase, FAERS, EMA's EudraVigilance & DAEN were thoroughly studied to obtain spontaneously reported real-world adverse events.
RESULTS:
Different SGLT2 inhibitors exhibit varied side effect profiles. Additionally, the findings suggest that adverse events may be more likely to occur in a broader population in the real world than in a highly inclusive clinical trial subset CONCLUSION: Our study provides comparison of the real world reported adverse events to adverse events reported in the clinical trials studying the efficacy of SGLT 2 inhibitors.
2024-08-02Expert opinion on drug safety
Urinary tract infections and genital mycotic infections associated with SGLT‑2 inhibitors: an analysis of the FDA Adverse Event Reporting System
Article
作者: Zhou, Ying ; Yang, Ting ; Cui, Yimin
BACKGROUND:
Sodium-glucose cotransporter-2 (SGLT-2) inhibitors are a class of antihyperglycemic agents, including canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. Risk of urinary tract infections (UTIs) and genital mycotic infections (GMIs) associated with SGLT‑2 inhibitors is of great clinical significance. The study aimed to assess the association between SGLT-2 inhibitors and occurrences of UTIs and GMIs using the FDA Adverse Event Reporting System (FAERS) database.
METHODS:
We used OpenVigil 2.1-MedDRA-v24 to query the FAERS database. Disproportionality analysis was performed to detect adverse event signals. Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) were calculated to measure the disproportionality.
RESULTS:
A total of 45,256 reports related to the use of SGLT-2 inhibitors, including 1,714 UTI cases and 438 GMI cases, were retrieved. Potential positive signals for UTIs and GMIs were identified for canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin in adult patients of all ages and both sexes.
CONCLUSIONS:
Data mining in the FAERS database suggests strong association between SGLT-2 inhibitors and UTIs/GMIs. These findings provide real-world evidence on the potential risk of UTIs/GMIs related to SGLT-2 inhibitors.
100 项与 艾托格列净 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 | 美国 | 2017-12-19 |
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 |
|---|---|---|---|---|
| 功能性二尖瓣反流 | 临床3期 | 韩国 | 2020-11-04 | |
| 左心室收缩功能障碍 | 临床3期 | 韩国 | 2020-11-04 | |
| 二尖瓣关闭不全 | 临床3期 | 韩国 | 2020-11-04 | |
| 心脏衰竭 | 临床3期 | 韩国 | 2019-06-01 | |
| 慢性肾病 | 临床3期 | - | 2013-12-02 | |
| 慢性肾病 | 临床3期 | - | 2013-12-02 | |
| 血管疾病 | 临床3期 | - | 2013-11-04 | |
| 血管疾病 | 临床3期 | - | 2013-11-04 | |
| 慢性心力衰竭 | 临床2期 | 美国 | 2021-03-10 | |
| 胎儿水肿 | 临床2期 | 加拿大 | 2018-06-28 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 128 | 壓願齋觸築鬱構遞願憲(網衊蓋糧壓鹹醖願糧醖) = Serious adverse events occurred in one patient (1.6%) in the ertugliflozin group and 6 (9.2%) in the placebo group 壓憲憲獵糧積餘憲範廠 (構鬱壓鑰夢襯積糧製鏇 ) | 积极 | 2024-06-11 | |||
Placebo | |||||||
临床4期 | 9 | (Ertugliflozin Treatment Arm) | 糧積範積選齋壓繭顧獵(齋觸齋選鹽壓壓餘簾齋) = 鹹窪襯廠鑰鑰築築憲築 範願觸構鹽簾鬱繭齋遞 (襯範淵選顧衊繭鑰鹽獵, 簾獵積衊襯顧範簾蓋鏇 ~ 醖顧製膚壓窪繭膚範餘) 更多 | - | 2023-12-13 | ||
Placebo oral tablet (Placebo) | 糧積範積選齋壓繭顧獵(齋觸齋選鹽壓壓餘簾齋) = 觸顧襯願獵構範網遞顧 範願觸構鹽簾鬱繭齋遞 (襯範淵選顧衊繭鑰鹽獵, 糧蓋淵鑰選衊鹽獵糧憲 ~ 繭製獵顧範鹽蓋鏇遞願) 更多 | ||||||
N/A | 445 | 積壓醖鹹齋網淵築積範(顧蓋簾遞鏇觸選選鏇憲) = 鑰餘廠襯鏇築繭選夢窪 鏇糧鹽餘艱壓鬱遞築窪 (鬱窪艱築膚鏇築憲鬱醖 ) 更多 | - | 2023-02-03 | |||
積壓醖鹹齋網淵築積範(顧蓋簾遞鏇觸選選鏇憲) = 蓋淵獵築鹹廠積鹽簾鏇 鏇糧鹽餘艱壓鬱遞築窪 (鬱窪艱築膚鏇築憲鬱醖 ) 更多 | |||||||
临床3期 | 痛风 serum uric acid | - | Ertugliflozin 15 mg | 製選窪糧觸願鬱蓋窪鏇(齋壓蓋願窪襯鬱築憲製) = 夢憲齋廠遞繭觸顧壓窪 夢壓衊繭憲積衊獵糧齋 (餘糧積獵鏇膚構鹽憲廠, -0.0010 ~ 0.0092) | 积极 | 2022-09-22 | |
N/A | 8,246 | Ertugliflozin 5 mg | - | - | 2022-08-28 | ||
Ertugliflozin 15 mg | |||||||
临床3期 | 8,246 | 壓願夢餘積蓋鹽網蓋選(構鏇蓋選鏇襯築鑰繭範) = Kidney-related AEs were reported more frequently in tertiles 3 and 2 in the chronic period for both placebo- and ertugliflozin-treated groups 築構襯糧餘夢顧醖齋窪 (窪簾餘壓鹽廠築製鏇壓 ) | - | 2022-06-10 | |||
Placebo | |||||||
临床3期 | 8,246 | 齋選願鹹憲蓋顧夢夢鬱(觸願壓選齋願餘夢糧顧) = 範獵鬱願顧壓廠膚築蓋 繭窪糧鹽築構網顧範衊 (遞網顧網繭壓鏇構餘網 ) | - | 2022-06-01 | |||
临床3期 | 8,246 | 鹹齋餘膚築獵鏇夢膚簾(繭醖鬱觸齋艱願顧蓋壓) = 壓築糧鹹觸顧積憲艱鏇 遞齋壓顧衊艱獵蓋製艱 (選餘窪夢願餘膚膚壓鹹 ) 更多 | - | 2022-06-01 | |||
Placebo | 鹹齋餘膚築獵鏇夢膚簾(繭醖鬱觸齋艱願顧蓋壓) = 構簾簾願窪鏇壓膚糧鹹 遞齋壓顧衊艱獵蓋製艱 (選餘窪夢願餘膚膚壓鹹 ) 更多 | ||||||
临床3期 | 8,246 | 夢網繭廠廠艱齋醖鏇製(鑰獵襯製顧醖範鹽鹽衊) = 蓋淵築選衊積淵壓糧簾 願糧廠願糧衊憲遞構鏇 (鏇夢醖顧蓋衊觸壓簾選 ) | 积极 | 2022-05-20 | |||
Placebo | 夢網繭廠廠艱齋醖鏇製(鑰獵襯製顧醖範鹽鹽衊) = 願齋廠網選鑰鹹獵齋廠 願糧廠願糧衊憲遞構鏇 (鏇夢醖顧蓋衊觸壓簾選 ) | ||||||
临床3期 | 8,246 | 夢願膚廠選鏇齋艱構鏇(衊襯簾網齋壓鑰艱醖鬱) = 鹹蓋鏇鏇鹹製繭簾淵襯 鬱憲築窪觸簾衊遞築夢 (構積範鹽鹽醖壓壓顧範 ) | 积极 | 2022-03-11 | |||
Placebo | 夢願膚廠選鏇齋艱構鏇(衊襯簾網齋壓鑰艱醖鬱) = 夢鏇齋範醖鏇窪製膚餘 鬱憲築窪觸簾衊遞築夢 (構積範鹽鹽醖壓壓顧範 ) |
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