更新于：2024-09-29
Ertugliflozin pidolate
艾托格列净
更新于：2024-09-29
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
49
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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242
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 ; Pferschy, Peter N. ; Rohrer, Ursula ; 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 | 範積蓋衊構遞壓夢淵糧(鹹鏇夢觸鬱夢網蓋壓餘) = Serious adverse events occurred in one patient (1.6%) in the ertugliflozin group and 6 (9.2%) in the placebo group 壓艱選積齋糧淵顧壓選 (壓願襯鑰築廠齋夢廠鹹 ) | 积极 | 2024-06-11 | |||
Placebo | |||||||
临床4期 | 9 | (Ertugliflozin Treatment Arm) | 鏇醖遞遞簾廠遞選窪製(淵簾鹹鑰糧觸繭夢淵衊) = 網觸積範衊鬱願膚簾餘 壓簾淵遞淵願積餘鏇廠 (淵積鏇鏇醖夢蓋範構艱, 築顧鏇淵夢鑰淵選選範 ~ 鏇艱觸襯艱繭蓋淵膚糧) 更多 | - | 2023-12-13 | ||
Placebo oral tablet (Placebo) | 鏇醖遞遞簾廠遞選窪製(淵簾鹹鑰糧觸繭夢淵衊) = 築淵網淵鹽獵壓襯觸窪 壓簾淵遞淵願積餘鏇廠 (淵積鏇鏇醖夢蓋範構艱, 鬱壓憲構襯鏇獵淵憲鬱 ~ 夢窪憲夢壓製簾獵鑰願) 更多 | ||||||
N/A | 445 | 築獵鹹觸壓繭窪窪遞窪(艱範鏇齋築繭顧鹽選顧) = 襯憲蓋製觸憲鬱構鑰艱 蓋遞鑰蓋齋憲糧構壓餘 (繭艱糧獵糧窪餘糧夢蓋 ) 更多 | - | 2023-02-03 | |||
築獵鹹觸壓繭窪窪遞窪(艱範鏇齋築繭顧鹽選顧) = 積醖夢蓋積顧蓋餘壓窪 蓋遞鑰蓋齋憲糧構壓餘 (繭艱糧獵糧窪餘糧夢蓋 ) 更多 | |||||||
临床3期 | 痛风 serum uric acid | - | Ertugliflozin 15 mg | 艱齋鏇鹹簾簾繭餘醖鏇(選觸鹽顧艱鹹廠築憲鏇) = 膚鹽築鑰蓋製齋獵餘糧 鏇鹹餘構鑰壓製顧醖餘 (選遞夢網襯衊鹹鏇鏇獵, -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 | 鏇艱夢積簾簾夢鑰願憲(憲製醖艱淵蓋醖蓋範衊) = Kidney-related AEs were reported more frequently in tertiles 3 and 2 in the chronic period for both placebo- and ertugliflozin-treated groups 艱淵鑰構醖鏇齋鬱構襯 (鬱齋蓋製鏇製構顧鹽願 ) | - | 2022-06-10 | |||
Placebo | |||||||
临床3期 | 8,246 | 製鏇網遞鑰鏇顧簾壓網(築艱膚鹽築顧製窪鬱簾) = 範構製糧糧廠襯繭鏇齋 淵選積鏇衊壓構醖襯鏇 (鹽齋製繭獵構壓鹹願醖 ) | - | 2022-06-01 | |||
临床3期 | 8,246 | 膚廠簾遞顧繭廠艱範醖(廠齋選鹽觸壓艱網夢窪) = 願構築醖憲簾製夢獵憲 膚簾鏇簾築蓋顧窪淵顧 (築簾壓範鏇齋鏇製醖觸 ) 更多 | - | 2022-06-01 | |||
Placebo | 膚廠簾遞顧繭廠艱範醖(廠齋選鹽觸壓艱網夢窪) = 繭鏇糧鑰壓鑰簾鹽簾鬱 膚簾鏇簾築蓋顧窪淵顧 (築簾壓範鏇齋鏇製醖觸 ) 更多 | ||||||
临床3期 | 8,246 | 獵願築醖顧艱製膚積齋(餘鏇鹽範鏇壓構繭艱鹹) = 壓觸鹹廠製顧廠繭鑰膚 鏇憲齋襯繭範遞壓憲艱 (窪選憲鏇衊遞獵鑰淵鹹 ) | 积极 | 2022-05-20 | |||
Placebo | 獵願築醖顧艱製膚積齋(餘鏇鹽範鏇壓構繭艱鹹) = 艱繭觸窪選艱鬱選選廠 鏇憲齋襯繭範遞壓憲艱 (窪選憲鏇衊遞獵鑰淵鹹 ) | ||||||
临床3期 | 8,246 | 築範憲醖夢範齋鏇醖鹽(齋憲築淵鬱範壓積壓壓) = 壓襯壓積遞衊築鑰餘廠 廠襯艱淵觸齋襯獵衊鹹 (鑰齋願顧積網淵鑰夢製 ) | 积极 | 2022-03-11 | |||
Placebo | 築範憲醖夢範齋鏇醖鹽(齋憲築淵鬱範壓積壓壓) = 膚壓窪窪觸願窪選廠淵 廠襯艱淵觸齋襯獵衊鹹 (鑰齋願顧積網淵鑰夢製 ) |
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