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更新于：2025-04-14
Dronedarone Hydrochloride
盐酸决奈达隆
更新于：2025-04-14
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C31H45ClN2O5S |
InChIKeyDWKVCQXJYURSIQ-UHFFFAOYSA-N |
CAS号141625-93-6 |
关联
50
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100 项与 盐酸决奈达隆 相关的临床结果
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100 项与 盐酸决奈达隆 相关的转化医学
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100 项与 盐酸决奈达隆 相关的专利（医药）
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996
项与 盐酸决奈达隆 相关的文献（医药）2025-12-31JOURNAL OF MEDICAL ECONOMICS
Economic impact associated with dronedarone use in patients with atrial fibrillation
Article
作者: Dotiwala, Zenobia ; Lebovics, Gary ; Casciano, Julian ; Preblick, Ron
OBJECTIVE/AIM:
In 2009, dronedarone was approved by the United States Food and Drug Administration based on results from the ATHENA trial (NCT00174785), which showed significant reduction of cardiovascular (CV) hospitalization and death in patients with atrial fibrillation (AF) randomized to dronedarone versus placebo. In 2020, a retrospective study by Goehring et al. showed CV hospitalizations and deaths were lower in clinical practice following initiation of dronedarone compared to other antiarrhythmic drugs (AADs) in patients with AF and atrial flutter. However, the economic impact associated with dronedarone use has not been fully assessed. The objective of this study was to estimate the cost associated with CV outcomes reported by Goehring et al. (2020).
METHODS:
National average Medicare payments in the Centers for Medicare and Medicaid Services (CMS) database (www.data.CMS.gov) were used to assign cost estimates to CV outcomes evaluated in Goehring et al. (2020) by diagnosis-related grouping. When costs were unavailable in the CMS database, a literature search was performed to identify publications reporting hospitalization costs.
RESULTS:
The weighted average cost for CV hospitalization was calculated to be $20,508. When multiplied by the event rate reported in Goehring et al. (2020), cost per person year for CV hospitalization was 14% lower with dronedarone versus other AADs ($3,679 vs $4,272, respectively). For hospitalizations due to heart failure, cost was 31% lower with dronedarone compared with other AADs ($324 vs $472, respectively).
LIMITATIONS:
Costs have been calculated based on national averages reported by CMS (Medicare perspective) and are estimates. Regional differences may be present.
CONCLUSIONS:
Patients with AF taking dronedarone had lower costs associated with CV hospitalization compared with patients taking other AADs.
2025-12-31SCANDINAVIAN CARDIOVASCULAR JOURNAL
The use of antiarrhythmic drugs for atrial fibrillation in Finland 2007–2018
Article
作者: Siponen, Rasmus ; Marjamaa, Annukka ; Lehto, Mika ; Hartikainen, Juha ; Putaala, Jukka ; Teppo, Konsta ; Aro, Aapo ; Airaksinen, Juhani ; Mustonen, Pirjo ; Salmela, Birgitta ; Haukka, Jari ; Virrankorpi, Janne ; Linna, Miika ; Lappalainen, Antti ; Halminen, Olli
BACKGROUND:
Patients with atrial fibrillation (AF) are often treated with antiarrhythmic drugs (AADs) to maintain sinus rhythm and with heart rate-lowering drugs to achieve the optimal rate control. In this study, we investigated trends in the use of AADs and rate control drugs in Finnish patients with AF.
METHODS AND RESULTS:
The Finnish AntiCoagulation in Atrial Fibrillation (FinACAF) study is a nationwide study including all patients with AF in Finland from 2007 to 2018. The number of AAD purchases and the proportions of all prevalent AF patients in a certain year of interest were calculated. In total, 391030 AF patients were identified between 2007 and 2018, and 39,816 (10.2%) of them had purchased either class I or III AADs. The proportion of patients using classes I and III AADs decreased from 8.6% to 6.3%. Flecainide and amiodarone were the most often used AADs. The use of flecainide and amiodarone decreased from 4.9% to 3.9% and 1.9% to 1.5%, respectively. The proportion of patients on beta-blockers remained stable at 75%. Dronedarone became available in 2011 when it also was the most used (0.8% of patients), but the use decreased thereafter. The use of sotalol and digoxin decreased from 1.5% to 0.6% and 24.6% to 11.0% over the study period.
CONCLUSION:
The number of AAD purchases increased alongside with the increasing prevalence of AF, whereas the proportion of AF patients on classes I and III AADs and digoxin decreased between 2007 and 2018. Flecainide remained the most used AAD followed by amiodarone.
2025-05-01AMERICAN JOURNAL OF MEDICINE
The Safety Profile of Amiodarone Among Older Adults (Age ≥75 Years): A Pharmacovigilance Study from the FDA Data
Article
作者: Eisen, Alon ; Fishman, Tamar ; Greenberg, Noam ; Erez, Aharon ; Scandrett, Karen ; Goldman, Adam ; Lerman, Tsahi T ; Fishman, Boris ; Nace, David A ; Rahat, Ori ; Kruchin, Boris ; Levi, Amos ; Kornowski, Ran ; Golovchiner, Gregory ; Orvin, Katia ; Seluk, Lior ; Buturlin, Kirill ; Forman, Daniel E ; Barsheshet, Alon ; Gadot, Chen ; Goldenberg, Gustavo
BACKGROUND:
Amiodarone is a widely used antiarrhythmic agent with significant toxicities and drug interactions more likely to affect older adults. Nevertheless, data regarding amiodarone safety in this population are limited.
METHODS:
We conducted a retrospective analysis of FDA [Food and Drug Administration] Adverse Event Reporting System (FAERS) data from 2003 to 2024. Reports with amiodarone as the primary suspect were compared with other antiarrhythmics (sotalol, dronedarone, flecainide, propafenone, dofetilide). Disproportionality analysis assessed reporting odds ratios (RORs) for predefined adverse events in adults (<75 years) and older adults (≥75 years). Interaction analysis evaluated differences between age groups.
RESULTS:
Among 9196 amiodarone FAERS reports, 4129 (44.9%) involved older adults. Hyperthyroidism (ROR 39.1; 95% confidence interval [CI], 25-61 and ROR 23.4; 95% CI, 11-49.8) and hypothyroidism (ROR 36.9; 95% CI, 15.2-89.8 and ROR 24.5; 95% CI, 11.5-52.1) were substantially over-reported in amiodarone users among both adults and older adults, respectively. Drug-induced liver injury and peripheral neuropathy were also over-reported without a significant age interaction. Interstitial lung disease was reported more frequently in amiodarone users overall, with significantly higher reporting in older adults (ROR 11.4; 95% CI, 6.9-18.6 vs 4.9; 95% CI, 3.4-7.0; Pinteraction = .007). Bradycardia was also over-reported in older adults compared with adults (ROR 1.6; 95% CI, 1.3-2 vs 1.0; 95% CI, 0.8-1.3; Pinteraction = .003). Torsades de pointes/QT prolongation were less frequently reported in both age groups.
CONCLUSIONS:
In this global postmarketing study, interstitial lung disease and bradycardia were more frequently reported in older adults treated with amiodarone. These findings support vigilant monitoring for these adverse events, particularly in older patients.
100 项与 盐酸决奈达隆 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 |
|---|---|---|---|
| 心房颤动 | 美国 | 2009-07-01 | |
| 心房扑动 | 美国 | 2009-07-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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临床结果
临床结果
适应症
分期
评价
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NEWS 人工标引  | N/A | 108 | 觸繭遞範膚鏇齋齋窪壓(觸壓鏇夢齋憲鏇壓壓範) = 蓋齋簾網範積壓積憲簾 簾衊獵糧積憲鬱艱夢範 (窪襯簾壓蓋築觸鏇構壓 ) 更多 | 积极 | 2024-08-23 | ||
觸繭遞範膚鏇齋齋窪壓(觸壓鏇夢齋憲鏇壓壓範) = 鑰襯選觸獵糧構憲簾鹽 簾衊獵糧積憲鬱艱夢範 (窪襯簾壓蓋築觸鏇構壓 ) 更多 | |||||||
N/A | 心房颤动 维持 | 37 | 餘觸觸選製鏇範鏇獵構(遞鹹廠獵鏇積觸膚遞構) = AF recurrence and cardiovascular death results were not significantly different between dronedarone and sotalol in all-studies and sensitivity analyses 鬱鏇繭獵願醖夢構獵廠 (顧構觸繭簾醖夢醖構壓 ) 更多 | 积极 | 2023-06-01 | ||
N/A | - | 醖餘艱簾遞網襯選築鹽(鏇膚網遞齋顧廠選壓糧): HR = 0.38 (95% CI, 0.19 ~ 0.74) | - | 2022-08-29 | |||
临床3期 | 4,628 | 蓋壓鏇製夢糧鹹簾淵襯(網製獵襯顧簾醖襯遞鑰) = 廠網膚鹹廠壓製膚窪遞 觸淵壓壓網繭獵構願鏇 (廠齋鑰築製觸糧衊醖簾 ) 更多 | - | 2022-08-29 | |||
Placebo | 蓋壓鏇製夢糧鹹簾淵襯(網製獵襯顧簾醖襯遞鑰) = 遞膚鹹鬱願襯積遞憲遞 觸淵壓壓網繭獵構願鏇 (廠齋鑰築製觸糧衊醖簾 ) 更多 | ||||||
临床3期 | 4,628 | 鏇膚醖糧製顧鹽鹹遞蓋(鬱選壓齋鏇窪築膚齋窪) = 範鑰製衊遞鹹簾顧築觸 衊醖獵醖壓獵夢製鹽蓋 (鹹獵鑰繭蓋範築壓製繭 ) 更多 | - | 2022-08-29 | |||
Placebo | 鏇膚醖糧製顧鹽鹹遞蓋(鬱選壓齋鏇窪築膚齋窪) = 鹽艱遞構鹹製夢築顧醖 衊醖獵醖壓獵夢製鹽蓋 (鹹獵鑰繭蓋範築壓製繭 ) 更多 | ||||||
N/A | - | 蓋鏇築鹽夢齋願衊艱鹹(鬱鏇鹹選壓遞繭齋餘顧) = 鬱遞壓顧鏇衊鹹鏇餘齋 鬱遞蓋艱醖醖鹽艱壓廠 (鑰鬱構鬱廠選淵顧製鏇 ) 更多 | - | 2022-06-08 | |||
Placebo | 蓋鏇築鹽夢齋願衊艱鹹(鬱鏇鹹選壓遞繭齋餘顧) = 淵憲繭顧醖鑰鬱獵醖艱 鬱遞蓋艱醖醖鹽艱壓廠 (鑰鬱構鬱廠選淵顧製鏇 ) 更多 | ||||||
临床3期 | - | Dronedarone 400 mg BID | 願製壓夢醖繭淵餘鬱壓(網鑰簾餘襯淵獵鹹鹽衊) = 築蓋網鹹積窪鏇顧醖積 餘夢製繭糧願糧壓範鹹 (鹹醖鑰鏇獵鑰製蓋糧築 ) | 积极 | 2021-08-27 | ||
Placebo | 願製壓夢醖繭淵餘鬱壓(網鑰簾餘襯淵獵鹹鹽衊) = 獵餘築築廠簾憲繭廠鹹 餘夢製繭糧願糧壓範鹹 (鹹醖鑰鏇獵鑰製蓋糧築 ) | ||||||
N/A | - | 1,062 | Dronedarone + Antiplatelet drugs | 遞築簾壓簾醖齋壓壓遞(襯襯鹹艱範選願獵選壓) = There was no difference in MACE between four groups 願構積蓋窪範鹽鑰顧淵 (餘簾簾鏇製鏇衊膚獵觸 ) 更多 | - | 2018-08-28 | |
临床3期 | 33 | Placebo (Placebo) | 網醖選餘製鹹窪膚壓鹹(鬱廠鑰醖願壓願窪觸網) = 製鹹鬱糧蓋選窪窪製餘 鏇艱憲蓋範醖獵憲網鏇 (構積鬱憲淵憲網製觸窪, .07) 更多 | - | 2016-02-19 | ||
(Multaq® (Dronedarone)) | 網醖選餘製鹹窪膚壓鹹(鬱廠鑰醖願壓願窪觸網) = 範願膚襯製鹹構憲膚簾 鏇艱憲蓋範醖獵憲網鏇 (構積鬱憲淵憲網製觸窪, .05) 更多 | ||||||
临床4期 | 112 | (Placebo) | 遞製夢鑰遞窪襯膚獵窪(鹽顧網獵壓顧鹽糧淵顧) = 鹽艱餘蓋範壓窪願餘鹹 鹹膚鑰淵壓獵鏇齋觸餘 (網積夢網鑰廠範鑰壓餘, 淵築窪鹽醖齋蓋積壓窪 ~ 選製鹹膚構獵艱糧艱夢) 更多 | - | 2013-04-01 | ||
(Dronedarone) | 遞製夢鑰遞窪襯膚獵窪(鹽顧網獵壓顧鹽糧淵顧) = 獵鏇窪願觸顧鹽窪醖窪 鹹膚鑰淵壓獵鏇齋觸餘 (網積夢網鑰廠範鑰壓餘, 願顧鏇積簾願窪鹽膚積 ~ 網構觸廠鏇夢憲鏇獵餘) 更多 |
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