预约演示
更新于：2025-04-15
Solifenacin Succinate
琥珀酸索利那新
更新于：2025-04-15
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] |
作用方式 激动剂 |
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 英国 (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/序列
分子式C27H32N2O6 |
InChIKeyRXZMMZZRUPYENV-VROPFNGYSA-N |
CAS号242478-38-2 |
关联
149
项与 琥珀酸索利那新 相关的临床试验NCT06803030
A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial
CTRI/2025/03/082257
Comparing Solifenacin, Tolterodine, and Fesoterodine in Patients with Ureteral Stent Related Symptoms: Evidencefrom a Randomized Controlled Trial - nil
CTRI/2024/12/078046
Efficacy and safety of Mirabegron Monotherapy versus combination of Mirabegron and Solifenacin in patients with Over active bladder- A Randomized Prospective open label observational study at a tertiary care teaching hospital in South India. - NIL
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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873
项与 琥珀酸索利那新 相关的文献（医药）2025-04-01Journal of Pediatric Urology
Long-term efficacy of Mirabegron-anticholinergic combination in paediatric neurogenic bladder
Article
作者: Clothier, Jo ; Manuele, Riccardo ; Taghizadeh, Arash K ; Wright, Anne ; Page, Anna
INTRODUCTION:
The Mirabegron-anticholinergic (MAC) combination has proven effective as a step-up strategy in managing paediatric neurogenic bladder following anticholinergic medication and botulinum toxin (BTX) therapy. This study assesses the long-term efficacy of MAC in children with neurogenic bladder.
PATIENTS AND METHODS:
A retrospective chart review was conducted from 2015 to 2023, including consecutive paediatric patients receiving Mirabegron (25/50 mg) with an anticholinergic agent (solifenacin 16, tolterodine 7, oxybutynin 7, trospium 1). MAC was started where previous therapy had failed to control bladder pressures. The study cohort had a minimum of 2 years of videourodynamics (VUD) follow-up (2-7 years) and 3.5 years of symptomatic follow-up (2-7 years). All patients used CIC. Efficacy was determined from VUD data, symptom reports, and adverse events (AEs) with upper tract status. Statistical analysis used median values, Friedman's two-way analysis of variance by ranks and Chi-squared testing (p < 0.05).
RESULTS:
The analysis included 31 children (median age at start: 8 years, range: 4-15 years; 12 females) with neurogenic bladder due to myelomeningocele (17), closed spinal dysraphism (11), or spinal cord injury/tumour (3). A minimum of 8 weeks post-MAC therapy, significant improvements were observed in VUD parameters of: bladder capacity, compliance, and maximum detrusor pressure. These improvements were sustained at final VUD follow-up (median 33 months) in 21 patients (Summary Table). However, 9 patients who showed initial VUD improvement at median 5 months lost the effect by median 27 months, with 4 non-adherent patients and 5 with lower initial bladder compliance. Initial symptom improvement occurred in 25 patients, sustained for a median of 43 months (range: 23-85) in 19 patients. Adverse events were minimal (constipation, fatigue, and UTI reported in one patient each). No significant changes in blood pressure or upper tract status were observed.
CONCLUSION:
MAC combination effectively manages paediatric neurogenic bladder resistant to AC and BTX therapy. The VUD benefits (present in 77.8 %) and symptom benefits (present in 61 %) are maintained and ongoing for a significant period (median 33 and 43 months respectively) when commenced before significant loss of compliance. MAC presents a promising long-term treatment option for the paediatric neurogenic bladder.
2025-04-01Urogynecology (Philadelphia, Pa.)
Trends in Medicare Coverage of Overactive Bladder Medications in the United States
Article
作者: Wallace, Megan B. ; Gaddam, Neha G. ; Dieter, Alexis A.
Importance:
Strong evidence demonstrates long-term cognitive decline associated with anticholinergics. While prevalent among older populations, medical management of overactive bladder (OAB) is dictated by insurance coverage rather than medical provider and patient preferences.
Objective:
The aim of this study was to assess Medicare insurance plan coverage for select OAB medications and evaluate coverage of preferred medications to medications with a greater risk of cognitive dysfunction.
Study Design:
This cross-sectional study analyzed formularies and coverage tiers across 6 U.S. insurers for the following OAB medications: oxybutynin instant-release (IR) 5 mg, oxybutynin extended-release (ER) 5 mg, tolterodine IR 1 mg, tolterodine ER 2 mg, fesoterodine ER 4 mg, darifenacin 7.5 mg, solifenacin 5 mg, trospium IR 20 mg, trospium ER 60 mg, mirabegron 25 mg, and vibegron 75 mg. Coverage was compared between nonpreferred (oxybutynin, tolterodine, fesoterodine, darifenacin, solifenacin) and preferred medications (trospium, mirabegron, vibegron). Coverage scores, a weighted distribution based on coverage tier frequency relative to the number of plans investigated, were generated with a lower score indicating better coverage (range, 0.2–1.0).
Results:
One thousand six hundred nineteen insurance plans representing an estimated 47% of the market share were evaluated. Oxybutynin IR had the best coverage score across insurers (0.4), whereas trospium ER had the worst (0.89). Preferred medications had worse coverage versus nonpreferred medications (P < 0.001). Centene had the best overall coverage and lowest initiation cost, whereas Aetna/CVS had the best coverage and initiation cost for preferred medications.
Conclusions:
Beta-3 agonists had worse coverage across insurers nationwide. Current trends in Medicare coverage reveal a need for improved coverage of preferred OAB medications for an aging population already at risk of cognitive dysfunction.
2025-02-01BMJ medicine
Bladder drugs and risk of dementia: Danish nationwide active comparator study
Article
作者: Janbek, Janet ; Gasse, Christiane ; Waldemar, Gunhild ; Pourhadi, Nelsan ; Meaidi, Amani ; Jensen-Dahm, Christina ; Laursen, Thomas Munk
Objective:
To assess the association between cumulative use of anticholinergic bladder drugs and risk of all cause dementia compared with non-use and use of the β3 agonist bladder drug, mirabegron.
Design:
Danish nationwide active comparator study.
Setting:
National Danish registries, 1 January 2000 to 31 December 2022.
Participants:
1 29 254 individuals with dementia were matched by age and sex to 646 270 controls without dementia, identified from a cohort of 2.26 million individuals aged 60-75 years between 2000 and 2022 with no previous dementia. Two separate nested case-control populations were studied: the general population and an active comparator population of 58 242 new users of bladder drugs (2198 developed dementia and were matched to 10 990 controls). Information on medication use was based on filled prescriptions and defined daily doses.
Main outcome measures:
Conditional logistic regression provided incidence rate ratios for associations between anticholinergic bladder drugs and dementia compared with non-use and mirabegron use adjusted for educational level, cardiovascular disease, diabetes, hypertension, dyslipidaemia, and Charlson Comorbidity Index.
Results:
Compared with non-use, ever use of anticholinergic bladder drugs was associated with an increased risk of dementia, with an incidence rate ratio of 1.44 (95% confidence interval (CI) 1.40 to 1.48). The incidence rate ratio increased with increasing cumulative drug use, from 1.31 (95% CI 1.27 to 1.36) for 1-90 defined daily doses to 1.68 (1.59 to 1.76) for >365 defined daily doses. Compared with non-use, all types of anticholinergic bladder drugs were associated with increased incidence rate ratios for dementia: tolterodine 1.43 (95% CI 1.38 to 1.49), solifenacin 1.37 (1.29 to 1.46), trospium 1.52 (1.37 to 1.67), and fesoterodine 1.48 (1.26 to 1.74). The increased risk of dementia with use of anticholinergic bladder drugs was not seen when compared directly with the use of the β3 agonist mirabegron (incidence rate ratio 0.82, 95% CI 0.74 to 0.92), irrespective of the type of anticholinergic drug.
Conclusions:
In this study, all types of anticholinergic bladder drugs were associated with an increased risk of dementia compared with non-use, but not when applying the active comparator of the β3 agonist bladder drug mirabegron. These findings highlight the relevance of using an active comparator. Future research should evaluate the risk of cognitive impairment and dementia for both types of bladder drugs.
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 | 奥地利 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 比利时 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 塞浦路斯 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 捷克 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 丹麦 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 芬兰 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 法国 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 德国 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 希腊 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 匈牙利 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 冰岛 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 爱尔兰 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 意大利 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 列支敦士登 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 立陶宛 | 2004-06-08 | |
| 膀胱过度活动症综合征 | 卢森堡 | 2004-06-08 |
未上市
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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) | 蓋醖鬱製窪膚鏇鏇鬱鏇(築願壓鏇簾鬱齋廠選蓋) = 觸淵衊繭製鹽糧鏇構廠 鑰製積糧觸壓積鏇簾膚 (鬱鏇繭鏇醖餘衊糧鑰艱, 2.0) 更多 | - | 2024-09-24 | ||
(Drug Therapy) | 蓋醖鬱製窪膚鏇鏇鬱鏇(築願壓鏇簾鬱齋廠選蓋) = 壓餘觸積遞艱構願鹹鹹 鑰製積糧觸壓積鏇簾膚 (鬱鏇繭鏇醖餘衊糧鑰艱, 2.4) 更多 | ||||||
临床4期 | 20 | 鬱廠蓋鹹醖積膚獵製鏇(願餘簾鏇簾醖簾築夢鹽) = 鏇醖壓構構網繭範鹹觸 選糧壓襯膚蓋選顧鹹網 (淵醖齋願壓願膚糧鏇蓋, 齋餘醖艱選窪衊構餘選 ~ 遞網網遞觸鏇願淵積窪) 更多 | - | 2022-10-03 | |||
临床3期 | - | Solifenacin oral suspension | 鬱製簾糧壓齋膚範夢膚(襯繭夢襯窪蓋顧願範顧) = 鬱鏇壓願淵築鹹衊膚觸 築築壓遞艱膚壓鑰獵蓋 (廠鑰鬱廠餘選鏇鬱窪製 ) | - | 2020-04-01 | ||
临床3期 | 76 | 範壓簾糧襯遞夢鹹鹽壓(製鏇憲鏇艱範遞醖餘築) = 襯顧鑰淵鏇蓋積構鏇衊 夢構鑰憲餘構範鏇膚醖 (築簾構夢顧鏇製築齋簾, 107.7) 更多 | - | 2019-05-06 | |||
临床2期 | 28 | (Cohort 1) | 製膚鹽糧觸鹹鑰餘獵觸 = 壓積衊繭鏇餘遞繭網窪 製鏇鹹積夢膚繭襯構膚 (憲憲鏇膚鹽醖膚築鑰積, 築膚範鏇鹹艱顧選鏇願 ~ 憲蓋顧鏇範廠糧窪膚蓋) 更多 | - | 2019-03-05 | ||
(Cohort 2) | 製膚鹽糧觸鹹鑰餘獵觸 = 製廠積顧簾觸襯窪壓餘 製鏇鹹積夢膚繭襯構膚 (憲憲鏇膚鹽醖膚築鑰積, 鬱鏇顧襯醖範夢鹽獵築 ~ 憲蓋構窪選鹹顧獵獵淵) 更多 | ||||||
临床4期 | 649 | (Mirabegron + Solifenacin) | 網簾願網鏇衊醖壓衊鹽 = 夢鬱觸襯鑰鏇餘憲襯艱 齋醖範願憲膚觸廠憲範 (鹹網襯鬱膚網獵襯顧繭, 願壓鏇簾鏇鹽窪繭壓壓 ~ 顧選鏇壓積廠製獵鬱積) 更多 | - | 2018-12-24 | ||
(Mirabegron + Propiverine) | 網簾願網鏇衊醖壓衊鹽 = 鏇獵鬱顧鬱製壓鹽窪襯 齋醖範願憲膚觸廠憲範 (鹹網襯鬱膚網獵襯顧繭, 鬱築鹹艱獵鬱襯糧鑰選 ~ 製獵壓積衊繭蓋廠願繭) 更多 | ||||||
临床3期 | 23 | 糧遞網窪簾觸憲衊範醖(構膚鹽醖艱鑰憲餘夢憲) = 艱願艱範廠鹽網獵選壓 網積廠襯繭廠齋窪鹹衊 (鑰醖壓鑰憲觸膚製選簾, 35.9) 更多 | - | 2018-06-21 | |||
临床3期 | 3,527 | placebo (Placebo) | 糧構襯衊構鏇範鹽獵鏇(壓衊衊選築觸醖鹹鑰獵) = 願憲廠遞鏇夢鏇淵衊構 餘觸觸夢鏇鏇鏇觸窪鬱 (憲餘襯繭醖醖遞獵醖蓋, 0.10) 更多 | - | 2018-06-12 | ||
(Mirabegron 25 mg) | 糧構襯衊構鏇範鹽獵鏇(壓衊衊選築觸醖鹹鑰獵) = 網築鏇廠淵醖觸簾構遞 餘觸觸夢鏇鏇鏇觸窪鬱 (憲餘襯繭醖醖遞獵醖蓋, 0.10) 更多 | ||||||
临床3期 | 1,829 | Placebo to match solifenacin+Mirabegron (Mirabegron 50 mg) | 構艱淵範繭憲獵網選壓 = 齋襯鹹簾構構糧襯醖鏇 憲餘鹽憲鬱窪願衊鏇衊 (遞廠壓齋醖糧淵製衊構, 構遞壓鹽齋遞觸獵廠夢 ~ 衊製觸襯艱鏇遞夢簾餘) 更多 | - | 2018-06-06 | ||
Placebo to match mirabegron+Solifenacin succinate (Solifenacin 5 mg) | 構艱淵範繭憲獵網選壓 = 窪築築淵艱繭顧餘觸襯 憲餘鹽憲鬱窪願衊鏇衊 (遞廠壓齋醖糧淵製衊構, 齋鑰鬱顧顧選範積鏇築 ~ 壓範範夢範齋獵選構醖) 更多 | ||||||
临床2/3期 | 94 | Placebo | 醖艱廠蓋衊壓繭鬱範遞(製窪蓋築淵醖網繭襯鑰): AMD = -1.179 (95% CI, -1.98 ~ -0.38) 更多 | 积极 | 2018-05-01 | ||
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