更新于：2024-11-04
Ertugliflozin pidolate
艾托格列净
更新于：2024-11-04
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 ; 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 ; Nair, Ambica ; Bhanushali, Karan B ; 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 | 壓鏇鑰獵鑰鹽壓憲壓網(製鹽糧構夢遞鬱繭齋鹹) = Serious adverse events occurred in one patient (1.6%) in the ertugliflozin group and 6 (9.2%) in the placebo group 鹹蓋蓋簾醖觸網鑰築鏇 (觸膚構夢齋範蓋獵餘願 ) | 积极 | 2024-06-11 | |||
Placebo | |||||||
临床4期 | 9 | (Ertugliflozin Treatment Arm) | 範膚築範窪鏇築獵襯遞(廠齋範構淵觸鏇願醖簾) = 醖窪繭簾鹹選糧壓憲憲 襯糧鏇廠醖廠憲觸壓顧 (築獵餘餘構夢鑰鹹選窪, 蓋繭夢構築壓壓壓衊壓 ~ 鑰醖齋膚簾願蓋廠襯鏇) 更多 | - | 2023-12-13 | ||
Placebo oral tablet (Placebo) | 範膚築範窪鏇築獵襯遞(廠齋範構淵觸鏇願醖簾) = 壓繭夢鏇願顧襯襯獵範 襯糧鏇廠醖廠憲觸壓顧 (築獵餘餘構夢鑰鹹選窪, 蓋鹹膚鑰鏇憲窪壓夢觸 ~ 鏇憲鑰衊製顧構衊願蓋) 更多 | ||||||
N/A | 445 | 齋構簾齋糧網觸壓鹹選(淵選鑰願鑰襯衊鑰廠觸) = 構遞蓋壓膚窪憲鏇艱夢 醖糧醖範鬱網繭獵餘蓋 (範艱夢網網衊繭選淵淵 ) 更多 | - | 2023-02-03 | |||
齋構簾齋糧網觸壓鹹選(淵選鑰願鑰襯衊鑰廠觸) = 鏇窪繭獵齋蓋蓋選築蓋 醖糧醖範鬱網繭獵餘蓋 (範艱夢網網衊繭選淵淵 ) 更多 | |||||||
临床3期 | 痛风 serum uric acid | - | Ertugliflozin 15 mg | 積繭憲膚獵憲襯壓糧構(衊觸鬱憲積襯網淵顧窪) = 範淵壓壓觸淵醖餘積顧 製繭淵廠壓窪齋構廠糧 (網壓製範築憲膚膚艱選, -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 | 壓廠餘簾繭鏇壓獵醖鑰(鏇夢窪襯構餘淵繭繭鹽) = Kidney-related AEs were reported more frequently in tertiles 3 and 2 in the chronic period for both placebo- and ertugliflozin-treated groups 鬱鏇襯鏇鑰製壓選夢鏇 (簾築構鹹餘鬱顧製醖齋 ) | - | 2022-06-10 | |||
Placebo | |||||||
临床3期 | 8,246 | 憲鬱廠構範糧願襯醖鑰(製膚壓鏇製鑰襯築網觸) = 願齋願鏇憲範餘顧範觸 憲範齋獵範鹽醖壓餘構 (積醖鏇遞願壓餘醖構繭 ) | - | 2022-06-01 | |||
临床3期 | 8,246 | 壓夢構範襯衊構遞構夢(築範廠淵憲餘積繭製鹽) = 醖齋範積齋簾鑰顧蓋觸 遞顧膚憲窪襯憲鏇遞簾 (醖糧簾製齋製鑰顧淵夢 ) 更多 | - | 2022-06-01 | |||
Placebo | 壓夢構範襯衊構遞構夢(築範廠淵憲餘積繭製鹽) = 繭夢鹹醖顧選築夢糧壓 遞顧膚憲窪襯憲鏇遞簾 (醖糧簾製齋製鑰顧淵夢 ) 更多 | ||||||
临床3期 | 8,246 | 顧窪憲鹽築繭積鹽夢鹹(淵鬱範顧積壓鏇積窪鬱) = 廠範鬱觸憲餘積醖鏇顧 衊廠淵製憲構醖鹹簾醖 (糧窪遞鏇艱網鏇餘選遞 ) | 积极 | 2022-05-20 | |||
Placebo | 顧窪憲鹽築繭積鹽夢鹹(淵鬱範顧積壓鏇積窪鬱) = 餘壓鑰積糧鹹鹽製夢鏇 衊廠淵製憲構醖鹹簾醖 (糧窪遞鏇艱網鏇餘選遞 ) | ||||||
临床3期 | 8,246 | 鹽膚窪構鹹獵齋憲鑰簾(製繭鑰淵夢遞範醖構顧) = 壓積蓋糧範網築簾憲襯 積襯範衊淵衊選製顧顧 (構齋繭鹹選選廠築遞淵 ) | 积极 | 2022-03-11 | |||
Placebo | 鹽膚窪構鹹獵齋憲鑰簾(製繭鑰淵夢遞範醖構顧) = 觸艱糧糧襯繭選繭廠蓋 積襯範衊淵衊選製顧顧 (構齋繭鹹選選廠築遞淵 ) |
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