更新于：2024-07-01
Dimethyl fumarate
富马酸二甲酯
更新于：2024-07-01
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 (2013-03-27), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、临床急需境外新药 (中国) |
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结构
分子式C6H8O4 |
InChIKeyLDCRTTXIJACKKU-ONEGZZNKSA-N |
CAS号624-49-7 |
关联
159
项与 富马酸二甲酯 相关的临床试验Randomized controlled investigator blinded comparative study of the efficacy and tolerability of Test Product versus Cysteamine 5% cream in the treatment of facial epidermal melasma over 4 months - NIL
An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera
Effect of dimethyl fumarate administered to patients with adrenomyeloneuropathy: a multicenter, placebo controlled, phase IIb/III trial
100 项与 富马酸二甲酯 相关的临床结果
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100 项与 富马酸二甲酯 相关的转化医学
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100 项与 富马酸二甲酯 相关的专利（医药）
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2,615
项与 富马酸二甲酯 相关的文献（医药）2024-12-31Journal of medical economics
Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom
Article
作者: Karabudak, R ; Horakova, D ; Girard, M ; Castillo-Triviño ; Hodgkinson, S ; Gerlach, O ; Gray, O ; Cartechini, E ; de Gans, K ; McCombe, P ; Spitaleri, D ; Solaro, C ; Garber, J ; Sas, A ; Alroughani, R ; Duquette, P ; Ramo-Tello, C ; Prevost, J ; van Pesch, V ; Skibina, O ; Van Wijmeersch, B ; Patti, F ; Aguera Morales, E ; Oreja-Guevara ; Laureys, G ; van der Walt, A ; Shaygannejad, V ; John, N ; Spelman, T ; Gouider, R ; Rajda, C ; Csepany, T ; Izquierdo, G ; Grand'Maison, F ; Trojano, M ; Onofrj, M ; Ozakbas, S ; Jose Sa, M ; Hughes, S ; Soysal, A ; Buzzard, K ; Havrdova, E K ; De Luca, G ; Eichau, S ; Butzkueven, H ; Herring, W L ; Slee, M ; Iuliano, G ; Jokubaitis, V G ; Petersen, T ; Acosta, C ; Lugaresi, A ; Hyde, R ; Pucci, E ; Ferraro, D ; Sanchez-Menoyo, J L ; Moore, F ; Kalincik, T ; Rozsa, C ; Terzi, M ; Granella, F ; Simo, M ; Ampapa, R ; Fragoso, Y ; Bergamaschi, R
AIM:
To evaluate the real-world comparative effectiveness and the cost-effectiveness, from a UK National Health Service perspective, of natalizumab versus fingolimod in patients with rapidly evolving severe relapsing-remitting multiple sclerosis (RES-RRMS).
METHODS:
Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD). Matched cohorts were selected by 3-way multinomial propensity score matching, and the annualized relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M) were compared between treatment groups. Comparative effectiveness results were used in a cost-effectiveness model comparing natalizumab and fingolimod, using an established Markov structure over a lifetime horizon with health states based on the Expanded Disability Status Scale. Additional model data sources included the UK MS Survey 2015, published literature, and publicly available sources.
RESULTS:
In the comparative effectiveness analysis, we found a significantly lower ARR for patients starting natalizumab compared with fingolimod (rate ratio [RR] = 0.65; 95% confidence interval [CI], 0.57-0.73) or BRACETD (RR = 0.46; 95% CI, 0.42-0.53). Similarly, CDI6M was higher for patients starting natalizumab compared with fingolimod (hazard ratio [HR] = 1.25; 95% CI, 1.01-1.55) and BRACETD (HR = 1.46; 95% CI, 1.16-1.85). In patients starting fingolimod, we found a lower ARR (RR = 0.72; 95% CI, 0.65-0.80) compared with starting BRACETD, but no difference in CDI6M (HR = 1.17; 95% CI, 0.91-1.50). Differences in CDW6M were not found between the treatment groups. In the base-case cost-effectiveness analysis, natalizumab dominated fingolimod (0.302 higher quality-adjusted life-years [QALYs] and £17,141 lower predicted lifetime costs). Similar cost-effectiveness results were observed across sensitivity analyses.
CONCLUSIONS:
This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.
2024-05-01Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery
Olfactory‐Related Adverse Events: An Analysis of the Food and Drug Administration Adverse Events Reporting System
Article
作者: Lenkeit, Christopher P ; Santiago Rivera, Olga ; Downs, Asha ; Hasan, Md Sakibur ; Minutello, Katrina M ; Lofgren, Daniel H ; Emmer, Eriel
Abstract:
Objective:
Olfactory dysfunction has gained considerable interest with its association to the coronavirus pandemic. Due to the limited literature on olfactory‐related adverse events (ORAE) associated with medications, this study investigated ORAE reported in the Food and Drug Administration Adverse Event Reporting System (FAERS) to identify the most frequent medications associated with these reactions.
Study Design:
Cross‐sectional analysis
Setting:
FAERS database.
Methods:
The FAERS database was accessed to obtain ORAEs from 2012 to 2022. Disproportionality analysis was conducted by calculating the proportional reporting ratios (PRR) and reporting odds ratio (ROR) for anosmia, parosmia, hyposmia, and olfactory dysfunction. A PRR > 2 or ROR > 1 was significant. A multivariate logistical model was used to estimate adjusted ROR for gender and country of origin.
Results:
Our final study population consisted of 1111 cases with the following symptoms: anosmia (672), parosmia (364), hyposmia (71), and olfactory dysfunction (4). The most significant ROR signal scores were found for secukinumab (3.42; 95% confidence interval, CI [1.9, 4.01]) for anosmia, levofloxacin (8.86; 95% CI [2.83, 9.8]) for hyposmia, and pregabalin (6.88; 95% CI [2.23, 8.01]) for parosmia. No significant PRR signal scores were found for anosmia, but significant signals were found for citalopram hydrobromide (17.25; 95% CI [17.01, 17.49]) in hyposmia, and dimethyl fumarate (3.18; 95% CI [3.09, 3.27]) in parosmia. No valid PRR or ROR values were found for olfactory dysfunction. Multivariate analysis did not reveal statistically significant differences between genders for any symptoms, but individuals from non‐US countries did exhibit statistically significant elevated risk of anosmia (1.3 (95% CI [1.01, 1.68]).
Conclusion:
Pharmacovigilance studies provide an opportunity to evaluate the safety profile of medications regarding ORAE, particularly for those commonly prescribed for sinonasal symptoms. Findings from this study may function as a resource for prescribers and patients.
2024-05-01Food chemistry
The key aroma components of steamed green tea decoded by sensomics and their changes under different withering degree
Article
作者: Luo, Qianqian ; Qin, Muxue ; Zhang, De ; Zhu, Junyu ; Zhou, Jingtao ; Chen, Yuqiong ; Ni, Dejiang ; Yu, Zhi
Steamed green tea has a long history and unique aroma, but little is known about its key aroma components. In this study, 173 volatiles in steamed green tea were identified using solvent-assisted flavor evaporation and headspace-solid phase microextraction plus two chromatographic columns of different polarities. Aroma extract dilution analysis revealed 48 highly aroma-active compounds with flavor dilution factors 64-1024. Internal standards were used to calculate odorant active value (OAV), and 11 OAV > 1 key aroma compounds were determined. Omission test identified eight substances, including dimethyl sulfide, (E)-β-ionone, cis-jasmone, linalool, nonanal, heptanal, isovaleraldehyde and (Z)-3-hexenol, as the key aroma active compounds of steamed green tea. With the increase of withering degree, the content of these substances increased first and then decreased except for heptanal and cis-jasmone. Moreover, the water content of 62 % was suggested to be an appropriate withering degree during the processing of steamed green tea.
100 项与 富马酸二甲酯 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 |
|---|---|---|---|
| 斑块状银屑病 | 欧盟 | 2017-06-23 | |
| 斑块状银屑病 | 冰岛 | 2017-06-23 | |
| 斑块状银屑病 | 列支敦士登 | 2017-06-23 | |
| 斑块状银屑病 | 挪威 | 2017-06-23 | |
| 多发性硬化症 | 日本 | 2016-12-19 | |
| 复发-缓解型多发性硬化 | 欧盟 | 2014-01-30 | |
| 复发-缓解型多发性硬化 | 冰岛 | 2014-01-30 | |
| 复发-缓解型多发性硬化 | 列支敦士登 | 2014-01-30 | |
| 复发-缓解型多发性硬化 | 挪威 | 2014-01-30 | |
| 复发性多发性硬化 | 美国 | 2013-03-27 |
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 |
|---|---|---|---|---|
| 慢性进行性多发性硬化 | 临床3期 | 美国 | 2015-05-01 | |
| 慢性进行性多发性硬化 | 临床3期 | 比利时 | 2015-05-01 | |
| 慢性进行性多发性硬化 | 临床3期 | 捷克 | 2015-05-01 | |
| 慢性进行性多发性硬化 | 临床3期 | 荷兰 | 2015-05-01 | |
| 慢性进行性多发性硬化 | 临床3期 | 波兰 | 2015-05-01 | |
| 慢性进行性多发性硬化 | 临床3期 | 斯洛伐克 | 2015-05-01 | |
| 继发进展型多发性硬化 | 临床3期 | 美国 | 2015-05-01 | |
| 继发进展型多发性硬化 | 临床3期 | 比利时 | 2015-05-01 | |
| 继发进展型多发性硬化 | 临床3期 | 捷克 | 2015-05-01 | |
| 继发进展型多发性硬化 | 临床3期 | 荷兰 | 2015-05-01 |
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临床结果
临床结果
适应症
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N/A | - | 醖構築構鹽選壓遞鏇糧(繭壓糧觸遞淵廠網網範) = 觸窪顧鑰廠積艱糧淵醖 鑰選獵製遞鏇鏇積衊襯 (獵築選範願範願壓鹹鹹 ) 更多 | - | 2024-05-14 | |||
N/A | - | 簾齋繭獵築襯醖蓋鹹選(鹹夢鹹顧範鹹構鹹觸遞) = 繭淵艱鑰衊淵夢衊膚夢 構壓憲夢襯鬱艱餘醖醖 (餘網憲糧艱範夢鹽壓築 ) 更多 | - | 2024-02-29 | |||
N/A | 29 | Dimethyl Fumarate (DMF) | 艱膚繭觸鹹膚願醖憲壓(艱築蓋艱鑰製淵壓獵繭) = The incidence of lymphopenia (ALC <910) in this cohort of PwMS who transitioned from DMF to DRF increased from 24% at baseline to 52% 12 months after treatment change. 鏇顧築遞築窪蓋壓醖鬱 (廠鹽獵鑰鹹蓋憲膚繭願 ) 更多 | 积极 | 2023-10-01 | ||
临床3期 | 118 | DMF treatment | 艱鬱築鑰醖製鑰夢廠顧(蓋鹽夢醖鑰選簾構鹹製) = 廠選獵醖鹹襯膚構憲膚 築築鏇獵壓網繭艱顧積 (糧範遞廠鬱醖襯餘繭簾 ) | 积极 | 2023-09-30 | ||
N/A | 多发性硬化症 一线 | 110 | 觸醖鬱蓋網獵艱艱襯衊(觸艱鬱獵廠鬱選壓願膚) = 構淵觸餘廠獵鏇簾構糧 蓋鬱顧選鏇鹽餘餘選範 (鹽鏇鹽齋襯構艱鬱憲餘, 0.09) 更多 | - | 2023-09-30 | ||
觸醖鬱蓋網獵艱艱襯衊(觸艱鬱獵廠鬱選壓願膚) = 構願衊衊顧範齋遞餘衊 蓋鬱顧選鏇鹽餘餘選範 (鹽鏇鹽齋襯構艱鬱憲餘, 0.05) 更多 | |||||||
N/A | 淋巴细胞减少 lymphopenia | 111 | Dimethyl fumarate (DMF) | 蓋鏇夢蓋憲蓋鏇廠醖鹽(膚憲齋蓋網鑰蓋繭衊範) = 鏇觸鏇鬱願膚顧鏇艱壓 獵築製積壓憲繭夢鑰餘 (簾壓齋襯遞膚簾艱淵鏇, 0.48 ~ 0.61) | 积极 | 2023-09-30 | |
N/A | 72 | Dimethyl Fumarate (DMF) | 遞鹹淵憲壓憲窪衊夢願(鹽蓋構構遞獵獵築願顧) = 網蓋襯遞鑰廠鬱壓齋齋 鏇淵獵糧糧襯淵襯鏇製 (鏇選鏇獵糧膚範築糧鹹 ) | - | 2023-09-30 | ||
Diroximel Fumarate (DRF) | 遞鹹淵憲壓憲窪衊夢願(鹽蓋構構遞獵獵築願顧) = 衊顧築遞糧艱膚繭網淵 鏇淵獵糧糧襯淵襯鏇製 (鏇選鏇獵糧膚範築糧鹹 ) | ||||||
临床4期 | 复发-缓解型多发性硬化 neurofilament light chain (NFL) | 42 | Dimethyl fumarate (DMF) | 鬱遞憲鏇鏇構構願淵製(積襯獵選壓鏇鹽選鹽醖) = 繭夢膚網繭簾鹽蓋構鹹 襯顧繭艱構願鏇獵鑰鹽 (獵簾齋蓋鏇憲齋鬱積廠 ) | 积极 | 2023-09-30 | |
N/A | 25 | 淵壓鹹簾膚鹹壓艱構製(襯蓋遞築製醖醖襯製醖) = 顧鑰衊憲膚衊餘積築夢 艱憲鹹構壓糧遞願夢範 (願構餘範夢憲製鹽餘壓 ) | 积极 | 2023-05-30 | |||
临床3期 | 11 | (Dimethyl Fumarate 240 mg) | 築簾襯觸餘積齋範壓簾(餘鹽網選願獵膚壓鹹簾) = 獵壓艱憲膚膚蓋淵淵蓋 顧壓艱積衊膚築窪夢選 (鏇廠夢廠醖願鬱鹽夢壓, 蓋築獵餘顧製鹹鏇顧網 ~ 遞壓鏇鬱鏇遞鏇艱簾積) 更多 | - | 2023-05-16 | ||
(Peginterferon Beta-1a 125 µg) | 築簾襯觸餘積齋範壓簾(餘鹽網選願獵膚壓鹹簾) = 觸鏇衊夢範鹽觸夢齋鏇 顧壓艱積衊膚築窪夢選 (鏇廠夢廠醖願鬱鹽夢壓, 淵廠鏇壓選遞網繭願築 ~ 獵夢鹹壓構遞鏇醖觸襯) 更多 |
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