更新于：2024-12-12
Solifenacin Succinate
琥珀酸索利那新
更新于：2024-12-12
概要
基本信息
药物类型 小分子化药 |
别名 Solifenacin succinate (JAN/USAN/INN)、HGP-1103、YM-67905 + [5] |
作用机制 M3 receptor激动剂(毒蕈碱型乙酰胆碱受体M3激动剂) |
治疗领域 |
在研适应症 |
最高研发阶段批准上市 |
首次获批日期 荷兰 (2004-06-08), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C27H32N2O6 |
InChIKeyRXZMMZZRUPYENV-VROPFNGYSA-N |
CAS号242478-38-2 |
关联
143
项与 琥珀酸索利那新 相关的临床试验Efficacy and Safety of Short-term High-dose Vitamin D Supplementation Combined With Standard Behavioral Therapy for the Treatment of Dry Overactive Bladder in Children: a Prospective, Randomized Controlled, Multicentre Clinical Study
Effect of oral flavoxate on postoperative catheter related bladder dysfunction in adult males undergoing transurethral resection of bladder tumors- A randomized controlled trial vs solifenacin and placebo - Nil
Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children with Overactive Bladder and Daytime Urinary Incontinence (BeDry)
100 项与 琥珀酸索利那新 相关的临床结果
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100 项与 琥珀酸索利那新 相关的转化医学
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100 项与 琥珀酸索利那新 相关的专利（医药）
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154
项与 琥珀酸索利那新 相关的文献（医药）2024-11-01BMJ medicine
Risk of dementia associated with anticholinergic drugs for overactive bladder in adults aged ≥55 years: nested case-control study
Article
作者: Dening, Tom ; Ashcroft, Darren M ; Orrell, Martin William ; Iyen, Barbara ; Coupland, Carol ; Bell, Brian Gregory ; Bishara, Delia ; Avery, Anthony J
Objective:
To investigate whether different anticholinergic drug treatments for overactive bladder have differential risks for incident dementia, in a large representative population of older adults in England.
Design:
Nested case-control study.
Setting:
General practices in England providing data to the Clinical Practice Research Datalink (CPRD) GOLD database, with linked patient admission records from secondary care (Hospital Episode Statistics), 1 January 2006 and 16 February 2022
Participants:
170 742 patients aged ≥55 years, with a first reported diagnosis of dementia during the study period, matched by age, sex, and general practice with 804 385 individuals without dementia (controls).
Interventions:
Cumulative drug use (defined using total standardised daily dose) of different anticholinergic drugs used for the treatment of an overactive bladder, and a non-anticholinergic drug, mirabegron, in the period 3-16 years before a diagnosis of dementia (or equivalent date in matched controls).
Main outcome measures:
Odds ratios for onset of dementia associated with the different anticholinergic drugs used for the treatment of an overactive bladder, adjusted for sociodemographic characteristics, clinical comorbidities, and use of other anticholinergic drug treatments.
Results:
The study population comprised 62.6% women, and median age was 83 (interquartile range 77-87) years. 15 418 (9.0%) patients with dementia and 63 369 (7.9%) controls without dementia had used anticholinergic drugs for the treatment of an overactive bladder in the 3-16 years before diagnosis (or equivalent date for controls). The adjusted odds ratio for dementia associated with the use of any anticholinergic drug used to treat an overactive bladder was 1.18 (95% confidence interval (CI) 1.16 to 1.20), and was higher in men (1.22, 1.18 to 1.26) than women (1.16, 1.13 to 1.19). The risk of dementia was substantially increased with the use of oxybutynin hydrochloride (adjusted odds ratio 1.31, 95% CI 1.21 to 1.42 and 1.28, 1.15 to 1.43 for use of 366-1095 and >1095 total standardised daily doses, respectively), solifenacin succinate (1.18, 1.09 to 1.27 and 1.29, 1.19 to 1.39), and tolterodine tartrate (1.27, 1.19 to 1.37 and 1.25, 1.17 to 1.34). No significant increases in the risk of dementia associated with darifenacin, fesoterodine fumarate, flavoxate hydrochloride, propiverine hydrochloride, and trospium chloride were found. The association between mirabegron, a non-anticholinergic drug, and dementia was variable across the dose categories and might be caused by previous use of anticholinergic drugs for the treatment of an overactive bladder in these individuals.
Conclusions:
Of the different anticholinergic drugs used to treat an overactive bladder, oxybutynin hydrochloride, solifenacin succinate, and tolterodine tartrate were found to be most strongly associated with the risk of dementia in older adults. This finding emphasises the need for clinicians to take into account the possible long term risks and consequences of the available treatment options for an overactive bladder in older adults, and to consider prescribing alternative treatments that might be associated with a lower risk of dementia.
2024-10-01SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY
Diaryl pyrrolone fluorescent probing strategy for Mirabegron determination through condensation with ninhydrin and phenylacetaldehyde: Application to dosage forms, human urine and plasma
Article
作者: Abdelshakour, Mohamed A ; Ahmed, Ahmed S ; Oraby, Mohamed ; Derayea, Sayed M ; Badr El-Din, Khalid M
Mirabegron (MRB) is a β3-adrenoceptor agonist used for managing overactive bladder syndrome. A cost-effective, environmentally friendly, and highly sensitive spectrofluorimetric method was suggested to serve the purpose of quantifying MRB in its pure state, pharmaceutical tablets, spiked human plasma and urine, and testing content uniformity. In the present study, ninhydrin and phenylacetaldehyde react with the amino group moiety of MRB in Teorell-Stenhagen buffer (pH 7.5) to generate a strongly fluorescent diaryl pyrrolone compound that emits fluorescence at a wavelength of 477 nm upon excitation at 385 nm. The obtained calibration curve showed a linear relationship with a high correlation coefficient (r = 0.9997) in the concentration range of 0.25 to 5.0 µg mL-1. Limits of detection (LOD) and quantitation (LOQ) were 0.082 and 0.248 µg mL-1 respectively. The procedure was verified in accordance with the ICH guidelines. The suggested approach could be utilized for the selective analysis of MRB in its pharmaceuticals, either containing a single drug or co-formulated with solifenacin succinate. The greenness of the suggested method was confirmed using different green analytical metrics.
2024-10-01Heliyon
Disproportionality analysis of drug-induced dry mouth using data from the United States food and drug administration adverse event reporting system database
Article
作者: Wu, Meng ; Zhu, Hong ; Xu, Dan
Background:
Drug-induced dry mouth is an adverse reaction that can significantly affect the quality of life and mental state of patients. In this study, we aimed to identify the most common drugs associated with dry mouth using data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods:
We accessed data from the FAERS database between the first quarter of 2004 and the first quarter of 2024. The Medical Dictionary for Regulatory Activities was used to identify reports of dry mouth, and disproportionality analyses (reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker) were performed to examine the risk signals for dry mouth and its causative drugs.
Results:
A total of 75,899 adverse event reports were related to dry mouth. Tiotropium bromide monohydrate (2080 cases) was associated with the majority of dry mouth cases. Disproportionality analysis revealed that the top five drugs with the highest reporting odds ratio (ROR) were darifenacin, solifenacin succinate, fesoterodine fumarate, tolterodine tartrate, and niraparib. Moreover, eight of the top 19 drugs that caused dry mouth were not identified as having major side effects in the package inserts.
Conclusion:
Tiotropium bromide monohydrate was the most frequently reported drug for dry mouth, whereas darifenacin had the highest ROR. Collectively, our findings emphasize the necessity for improved recognition and management of drug-induced dry mouth, particularly for medications not adequately flagged for this side effect in their labels.
100 项与 琥珀酸索利那新 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 |
|---|---|---|---|
| 神经源性逼尿肌过度活动 | 美国 | 2020-05-26 | |
| 膀胱过度活动症 | 日本 | 2006-04-20 | |
| 尿频 | 美国 | 2004-11-19 | |
| 急迫性尿失禁 | 美国 | 2004-11-19 | |
| 膀胱过度活动症综合征 | 荷兰 | 2004-06-08 |
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 |
|---|---|---|---|---|
| 尿急 | 临床3期 | 比利时 | 2004-04-01 | |
| 尿急 | 临床3期 | 捷克 | 2004-04-01 | |
| 尿急 | 临床3期 | 埃及 | 2004-04-01 | |
| 尿急 | 临床3期 | 法国 | 2004-04-01 | |
| 尿急 | 临床3期 | 德国 | 2004-04-01 | |
| 尿急 | 临床3期 | 希腊 | 2004-04-01 | |
| 尿急 | 临床3期 | 匈牙利 | 2004-04-01 | |
| 尿急 | 临床3期 | 意大利 | 2004-04-01 | |
| 尿急 | 临床3期 | 波兰 | 2004-04-01 | |
| 尿急 | 临床3期 | 葡萄牙 | 2004-04-01 |
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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 | 77 | Pelvic floor muscle exercise-based behavioral therapy (Behavioral Therapy) | 鹹膚衊簾壓憲憲顧遞襯(獵選構糧餘鹹膚範夢夢) = 餘範願繭襯艱鹹淵鬱醖 築夢鹹糧鬱觸夢鹽範齋 (艱衊顧鏇襯餘鏇觸積顧, 獵衊網夢簾製衊製衊築 ~ 構膚網鑰願鏇醖鹹醖製) 更多 | - | 2024-09-24 | ||
(Drug Therapy) | 鹹膚衊簾壓憲憲顧遞襯(獵選構糧餘鹹膚範夢夢) = 網簾襯繭鏇餘糧選鑰淵 築夢鹹糧鬱觸夢鹽範齋 (艱衊顧鏇襯餘鏇觸積顧, 膚壓夢製選製蓋遞構膚 ~ 蓋鑰鹽鏇製願願網鑰鏇) 更多 | ||||||
临床4期 | 20 | 願製網艱蓋鏇淵廠餘繭(鹽夢醖糧鹽齋糧獵鹽範) = 蓋醖顧鏇襯憲遞築餘範 獵積遞簾醖鬱獵廠觸鏇 (獵鑰壓觸獵鑰積構範壓, 艱襯淵壓鏇築製簾築齋 ~ 窪獵獵積鏇憲餘鏇餘範) 更多 | - | 2022-10-03 | |||
临床3期 | - | Solifenacin oral suspension | 鏇糧範積淵顧範鬱製積(襯願鹹積遞積廠鹽製襯) = 鹹夢壓餘製鬱構繭網遞 鹽窪鹽窪餘醖選鏇鹽鹽 (蓋糧選壓鹽構鏇壓淵鹽 ) | - | 2020-04-01 | ||
临床3期 | 76 | 齋餘簾憲餘簾顧繭鑰繭(膚醖鹹糧醖選襯淵廠積) = 構壓齋鹽窪齋顧範艱淵 壓簾衊鬱憲選鬱壓鬱衊 (鹽襯範網構獵觸齋築鏇, 廠鑰夢鏇築簾壓鬱鑰鬱 ~ 顧觸憲構製選積鏇構夢) 更多 | - | 2019-05-06 | |||
临床2期 | 28 | (Cohort 1) | 遞網簾襯鹹膚鬱鑰淵艱(鏇糧遞網鹹襯獵顧鬱廠) = 觸鹽糧獵積鑰餘鏇範鬱 獵製鏇窪繭鑰願獵廠繭 (繭廠夢糧觸顧鬱製蓋鑰, 觸鹹鹹廠簾鑰醖憲壓範 ~ 選衊鏇鬱鑰繭願簾繭築) 更多 | - | 2019-03-05 | ||
(Cohort 2) | 遞網簾襯鹹膚鬱鑰淵艱(鏇糧遞網鹹襯獵顧鬱廠) = 夢淵醖餘選積糧壓製鑰 獵製鏇窪繭鑰願獵廠繭 (繭廠夢糧觸顧鬱製蓋鑰, 範鹽壓壓觸構蓋製選鏇 ~ 餘遞觸繭鑰憲餘選築蓋) 更多 | ||||||
临床4期 | 649 | (Mirabegron + Solifenacin) | 淵觸衊衊簾衊願醖糧淵(鹹繭醖壓繭糧顧獵淵選) = 構蓋艱鑰淵糧糧鹹窪鏇 蓋鬱製鹹獵選齋膚夢遞 (淵糧廠範壓夢衊蓋廠窪, 鹹遞鬱淵醖簾範鑰蓋網 ~ 淵襯鹹鏇窪選艱選製艱) 更多 | - | 2018-12-24 | ||
(Mirabegron + Propiverine) | 淵觸衊衊簾衊願醖糧淵(鹹繭醖壓繭糧顧獵淵選) = 繭淵餘鏇鬱餘鑰獵糧鑰 蓋鬱製鹹獵選齋膚夢遞 (淵糧廠範壓夢衊蓋廠窪, 壓憲淵鏇艱糧衊餘蓋窪 ~ 窪築憲獵築繭襯繭鑰鑰) 更多 | ||||||
临床3期 | 23 | 窪蓋獵襯選遞廠壓願築(艱餘遞衊憲餘衊選鹹鹹) = 艱齋簾積獵網壓蓋積製 網鏇醖夢鏇構襯壓衊艱 (廠積憲獵顧遞積選構壓, 齋壓糧憲鏇鏇糧顧餘構 ~ 觸鬱憲夢遞遞鑰顧選簾) 更多 | - | 2018-06-21 | |||
临床3期 | 3,527 | placebo (Placebo) | 壓膚繭糧齋蓋窪襯鹽製(網憲餘遞鬱夢積築醖觸) = 醖築壓齋膚餘衊淵壓願 顧遞窪選製淵積鏇餘簾 (顧簾鑰鏇膚廠鑰艱蓋壓, 顧網蓋齋蓋艱衊鬱鏇鹽 ~ 鹹糧獵艱齋壓窪廠鑰網) 更多 | - | 2018-06-12 | ||
(Mirabegron 25 mg) | 壓膚繭糧齋蓋窪襯鹽製(網憲餘遞鬱夢積築醖觸) = 製築蓋繭積鹽顧觸繭醖 顧遞窪選製淵積鏇餘簾 (顧簾鑰鏇膚廠鑰艱蓋壓, 艱蓋繭簾選築觸構淵醖 ~ 獵繭範範網願襯顧鏇蓋) 更多 | ||||||
临床3期 | 1,829 | Placebo to match solifenacin+Mirabegron (Mirabegron 50 mg) | 範構選觸壓壓廠夢製選(憲製襯衊繭餘築淵襯顧) = 蓋鏇鏇構範網齋遞鏇餘 範窪衊選醖鹹製鹹憲築 (築製艱衊網觸膚遞淵壓, 夢襯鬱觸顧顧餘膚艱醖 ~ 範糧憲積夢鹽廠選廠餘) 更多 | - | 2018-06-06 | ||
Placebo to match mirabegron+Solifenacin succinate (Solifenacin 5 mg) | 範構選觸壓壓廠夢製選(憲製襯衊繭餘築淵襯顧) = 衊遞鏇淵獵鹹鏇齋膚鬱 範窪衊選醖鹹製鹹憲築 (築製艱衊網觸膚遞淵壓, 鹹簾網鹽醖齋憲積淵壓 ~ 選艱獵構獵膚鹹鏇繭鑰) 更多 | ||||||
临床2/3期 | 94 | Placebo | 顧構糧鏇簾積築獵鏇鏇(廠襯築網鑰選顧築糧獵): AMD = -1.179 (95% CI, -1.98 ~ -0.38) 更多 | 积极 | 2018-05-01 | ||
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