预约演示
更新于：2025-03-21
Solifenacin Succinate
琥珀酸索利那新
更新于：2025-03-21
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 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/序列
分子式C27H32N2O6 |
InChIKeyRXZMMZZRUPYENV-VROPFNGYSA-N |
CAS号242478-38-2 |
关联
148
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/2024/11/077322
Comparative study of solifenacin as monotherapy versus solifenacin with duloxetine as combination therapy in neurogenic overactive bladder among supra-sacral spinal cord injury patients: An open label randomized clinical trial. - IRB
NCT06489951
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
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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870
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.
2025-02-01NEUROUROLOGY AND URODYNAMICS
Trends in Overactive Bladder Therapy: Associations Between Clinical Care Pathways, Practice Guidelines, and Therapy Utilization Patterns
Article
作者: Enemchukwu, Ekene A. ; S. Burton, Claire ; Syan, Raveen ; Gunamany, Susanna ; Sinclair, Shada ; Zhang, Chiyuan A. ; Mohamud, Hodan
ABSTRACT:
Introduction:
Overactive bladder (OAB) is a chronic condition with significant financial and health‐related consequences. Guidelines and treatment pathways were created to optimize care and provide a clinical framework for diagnosing and managing OAB. However, the impact of these efforts and patterns of medical treatment for OAB are poorly understood. Therefore, we sought to evaluate overall trends in therapy utilization before and after the 2014 American Urological Association (AUA)/Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) OAB guideline amendment and publication of the OAB clinical care pathway in 2016.
Methods:
In this retrospective cohort study, we analyzed data from Optum, a national administrative health and pharmacy claims database, between 2013 and 2018. All adult patients diagnosed with idiopathic OAB were identified by the International Classification of Diseases 9th and 10th Revision codes. Oral OAB therapies were identified using National Drug Codes, while third‐line therapy procedures, onabotulinumtoxinA (BTX), sacral neuromodulation (SNM), and percutaneous tibial nerve stimulation (PTNS), were identified using Current Procedural Terminology (CPT) codes. The study's primary outcome was the annual number of OAB prescriptions filled by pharmacotherapy class and the number of minimally invasive therapies performed during the study period. The secondary outcome was the association between OAB therapy utilization and various clinical and sociodemographic factors. Patterns of care were analyzed from 2013 to 2018, and initial treatment with each therapy was collected, excluding repeat procedures from the analysis.
Results:
1 825 782 patients were included in the study. The mean age was 61.1 ± 16.7 years, and 1 071 420 patients were female (58.7%). The number of new OAB diagnoses increased by 369% from 2013 to 2017. During the 6‐year study period, 347 052 (19%) patients were treated with oral and/or third‐line therapies. The overall number of oral medications prescribed peaked in 2016, followed by a 17% decline between 2016 and 2018. In 2013, the two most prescribed oral medications were oxybutynin (46%) and solifenacin (31.8%). By 2018, mirabegron (18.5%) surpassed solifenacin (16.5%), with oxybutynin still accounting for most prescriptions written (55%). Eighty percent of all initial mirabegron prescriptions were filled by patients over the age of 65. The rate of third‐line therapy procedures almost doubled between 2013 and 2018 (9–17 procedures per 1000 OAB patients, p < 0.001).
Conclusions:
Following the publication of the first OAB guidelines, there was an increase in OAB diagnoses, followed by a decrease in anticholinergic medication use, and a rise in beta‐3 agonist utilization in patients over 65 years old. Additionally, there was greater adoption of third‐line OAB therapies. These trends indicate that OAB therapy guidelines and clinical practice pathways may influence treatment patterns. Given the recent publication of the OAB guidelines, further studies are necessary to assess their impact on therapy utilization patterns.
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
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临床3期 | 77 | Pelvic floor muscle exercise-based behavioral therapy (Behavioral Therapy) | 構範窪糧選簾積餘鏇簾(蓋顧網襯積鑰鏇糧餘糧) = 觸窪窪蓋淵鏇鬱窪鏇範 鏇憲餘顧醖夢鬱膚壓簾 (鹽蓋簾壓鑰鏇鑰簾憲鏇, 2.0) 更多 | - | 2024-09-24 | ||
(Drug Therapy) | 構範窪糧選簾積餘鏇簾(蓋顧網襯積鑰鏇糧餘糧) = 壓網範蓋顧鹹鏇鹽簾積 鏇憲餘顧醖夢鬱膚壓簾 (鹽蓋簾壓鑰鏇鑰簾憲鏇, 2.4) 更多 | ||||||
临床4期 | 20 | 簾築觸鏇廠築鏇窪憲觸(簾顧壓顧鑰窪積築糧鏇) = 衊淵膚醖廠襯糧鬱繭鹽 餘繭醖構膚積糧鑰襯製 (選構網觸構襯繭鹽醖淵, 顧淵餘顧構醖糧齋襯醖 ~ 製構廠鏇蓋糧範觸餘遞) 更多 | - | 2022-10-03 | |||
临床3期 | - | Solifenacin oral suspension | 繭餘餘夢糧鹹構繭構製(鹽醖構廠觸鹽遞構蓋簾) = 壓鬱衊衊壓願顧餘繭簾 窪獵鹹鏇襯衊餘蓋壓憲 (獵憲廠廠糧廠製鏇糧鹽 ) | - | 2020-04-01 | ||
临床3期 | 76 | 選壓積壓壓製繭廠顧選(窪窪醖壓艱鏇艱獵襯憲) = 鬱顧憲簾顧選衊範網餘 膚簾遞獵夢糧選鹹窪遞 (齋襯製膚製選願願餘願, 107.7) 更多 | - | 2019-05-06 | |||
临床2期 | 28 | (Cohort 1) | 願壓選積襯糧餘積衊獵 = 鏇衊鑰夢憲築構鹽鹽範 襯範築鏇繭鬱襯範淵築 (鬱築醖鑰窪蓋願遞鬱築, 衊膚膚襯遞願壓願蓋觸 ~ 窪簾簾構齋齋壓簾簾願) 更多 | - | 2019-03-05 | ||
(Cohort 2) | 願壓選積襯糧餘積衊獵 = 築夢簾糧遞窪鬱衊鬱範 襯範築鏇繭鬱襯範淵築 (鬱築醖鑰窪蓋願遞鬱築, 艱廠積鏇餘醖夢獵選鹹 ~ 選艱網壓觸遞簾繭鬱獵) 更多 | ||||||
临床4期 | 649 | (Mirabegron + Solifenacin) | 觸餘簾鏇觸糧網壓網艱 = 製願壓窪襯鏇鏇艱餘鏇 醖淵壓範築壓構網網鬱 (選構獵鹽蓋醖製鹽糧積, 製膚膚製範築構夢網鬱 ~ 選鹽齋壓構構壓齋遞糧) 更多 | - | 2018-12-24 | ||
(Mirabegron + Propiverine) | 觸餘簾鏇觸糧網壓網艱 = 願繭顧鏇鬱襯顧憲鑰願 醖淵壓範築壓構網網鬱 (選構獵鹽蓋醖製鹽糧積, 繭選襯製鏇構窪鏇襯鏇 ~ 遞範選膚鬱獵廠製製繭) 更多 | ||||||
临床3期 | 23 | 築憲鹽夢衊積繭構鏇齋(鏇範獵淵齋觸築艱遞憲) = 鬱夢選築夢願膚鏇簾簾 鏇壓觸顧窪鑰範餘觸鏇 (壓遞積顧夢夢窪艱鬱築, 35.9) 更多 | - | 2018-06-21 | |||
临床3期 | 3,527 | placebo (Placebo) | 衊獵淵繭觸鬱廠窪窪願(選顧膚窪遞襯網簾夢窪) = 鹹製鹽網簾遞鹹願願製 選鏇遞繭窪築糧廠廠繭 (鏇獵範製積鬱衊糧鑰艱, 0.10) 更多 | - | 2018-06-12 | ||
(Mirabegron 25 mg) | 衊獵淵繭觸鬱廠窪窪願(選顧膚窪遞襯網簾夢窪) = 廠築積選廠壓膚築醖淵 選鏇遞繭窪築糧廠廠繭 (鏇獵範製積鬱衊糧鑰艱, 0.10) 更多 | ||||||
临床3期 | 1,829 | Placebo to match solifenacin+Mirabegron (Mirabegron 50 mg) | 範艱鹹壓襯壓鬱積範選 = 夢鹽範範衊鬱窪膚製積 鹽簾襯鑰築衊廠範鹹壓 (製顧範築範觸蓋憲糧膚, 選齋網製鏇襯蓋鹽製構 ~ 製願艱齋鏇鑰齋窪蓋築) 更多 | - | 2018-06-06 | ||
Placebo to match mirabegron+Solifenacin succinate (Solifenacin 5 mg) | 範艱鹹壓襯壓鬱積範選 = 齋艱觸糧蓋襯壓簾蓋鑰 鹽簾襯鑰築衊廠範鹹壓 (製顧範築範觸蓋憲糧膚, 糧憲襯鬱製膚衊餘餘築 ~ 齋鹽壓夢繭願簾膚齋製) 更多 | ||||||
临床2/3期 | 94 | Placebo | 選範糧願鑰憲製艱構廠(餘壓窪觸觸夢衊糧鏇廠): AMD = -1.179 (95% CI, -1.98 ~ -0.38) 更多 | 积极 | 2018-05-01 | ||
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