预约演示
更新于：2025-03-25
Mirabegron
米拉贝隆
更新于：2025-03-25
概要
基本信息
药物类型 小分子化药 |
别名 Betmiga PR、Mirabegron (USAN/JAN)、Myrbetriq Granules + [8] |
作用方式 拮抗剂 |
作用机制 GP IIb/IIIa拮抗剂(糖蛋白 IIb/IIIa拮抗剂) |
治疗领域 |
最高研发阶段批准上市 |
首次获批日期 日本 (2011-07-01), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C21H24N4O2S |
InChIKeyPBAPPPCECJKMCM-IBGZPJMESA-N |
CAS号223673-61-8 |
关联
243
项与 米拉贝隆 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
NCT05713799
Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity
NCT06791460
Pegylated Liposomal Doxorubicin Plus Adebrelimab with or Without Mirabegron in Relapsed Ovarian Cancer: a Randomized, Controlled, Open-label Trial
100 项与 米拉贝隆 相关的临床结果
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100 项与 米拉贝隆 相关的转化医学
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100 项与 米拉贝隆 相关的专利（医药）
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1,542
项与 米拉贝隆 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
Patient Reported Outcomes Due to Bladder Neck Obstruction in Women Treated With Botulinum Toxin A Injection
Article
作者: Pettijohn, Dyer ; Walia, Jessmehar ; Rodriguez, Priscilla ; De, Elise J. B. ; Roberts, Brittany Lee ; Bibicheff, Darrel
ABSTRACT:
Introduction:
Primary bladder neck obstruction (BNO) occurs when the bladder neck fails to open during voiding, causing urinary symptoms despite no anatomic obstruction. The cause of BNO is unclear but may involve neurogenic dysregulation related to the sympathic nervous system such as upper motor neuron lesion or peripheral autonomic neuropathy (small fiber neuropathy (SFN)). Another etiology can incuded increased sympathetic tone secondary to anxiety or stress conditons. Botulinum toxin A (BoNT‐A) to the bladder neck has been used in our practice to treat women with BNO who failed conventional therapies (alpha blockers, relaxation strategies). This is the first report of patient‐reported outcomes after BoNT‐A treatment in women with pelvic pain and BNO.
Materials and Methods:
We included female patients with pelvic pain and BNO who received BoNT‐A to the bladder neck between January 2022 and March 2023, and mailed self‐reported outcome questionnaires. The primary outcome was the Global Response Assessment (GRA); secondary outcomes included pain scores on the Visual Analogue Scale (VAS) and symptom checklists. BNO was diagnosed using Nitti Criteria (high bladder pressure, low flow in bladder neck on video urodynamics), supplemented by additional criteria (e.g., high voiding pressure, prolonged attempts, Valsalva effort, and cystoscopic evidence or symptoms related to BNO). Urodynamic studies followed International Continence Society standards. Additionally, due to BNO's association with SFN, patient history of biopsy‐confirmed SFN was recorded.
Results:
Our inclusion criteria was satisfied among 18 patietns, with 17 completing the questionnaire. Out of those, 14 patients (77%) reported improvement on the GRA, with an average VAS of 8.3 (“Very Helpful”). The most commonly improved symptoms were feeling of incomplete emptying, difficulty starting stream, urethral burning, pain with urination, and pelvic pain. Postoperative symptom flares were reported in six patients for an average of 16 days. All six patients with biopsy‐confirmed SFN showed significant improvement (VAS 8.7). Total of 14 patients (77%) indicated they would repeat the procedure.
Conclusions:
BoNT‐A to the bladder neck significantly improved pelvic pain and refractory hesitancy in women with bladder neck obstruction, especially in those with small fiber neuropathy. Symptom flares are common, but did not reduce interest in repeated treatments, and scheduling injections before symptom recurrence may mitigate these flares.
100 项与 米拉贝隆 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 |
|---|---|---|---|
| 神经源性逼尿肌过度活动 | 欧盟 | 2024-09-05 | |
| 神经源性逼尿肌过度活动 | 冰岛 | 2024-09-05 | |
| 神经源性逼尿肌过度活动 | 列支敦士登 | 2024-09-05 | |
| 神经源性逼尿肌过度活动 | 挪威 | 2024-09-05 | |
| 膀胱过度活动症综合征 | 欧盟 | 2012-12-20 | |
| 膀胱过度活动症综合征 | 冰岛 | 2012-12-20 | |
| 膀胱过度活动症综合征 | 列支敦士登 | 2012-12-20 | |
| 膀胱过度活动症综合征 | 挪威 | 2012-12-20 | |
| 膀胱过度活动症 | 日本 | 2011-07-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 间质性膀胱炎 | 临床3期 | 美国 | 2016-08-01 | |
| 尿失禁 | 临床3期 | 美国 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 亚美尼亚 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 澳大利亚 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 奥地利 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 比利时 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 加拿大 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 捷克 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 丹麦 | 2013-07-10 | |
| 尿失禁 | 临床3期 | 芬兰 | 2013-07-10 |
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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
N/A | - | 20 | Mirabegron 100 mg/day + Placebo | 壓淵襯窪鹹鹽遞製鏇憲(鑰鬱淵齋願衊範衊窪構) = 鑰築網鏇艱鹹鏇鏇鬱築 鬱壓鑰艱廠願艱築選觸 (衊憲願獵餘齋選鹹襯醖 ) 更多 | 积极 | 2024-09-27 | |
Mirabegron 200 mg/day + Placebo | 壓淵襯窪鹹鹽遞製鏇憲(鑰鬱淵齋願衊範衊窪構) = 醖廠齋齋獵簾網選齋鏇 鬱壓鑰艱廠願艱築選觸 (衊憲願獵餘齋選鹹襯醖 ) 更多 | ||||||
临床1/2期 | - | 30 | Placebo (Placebo) | 簾齋膚夢糧廠製齋艱衊(餘簾範鬱鏇窪願襯膚衊) = 製簾網範醖範網獵鹽憲 糧鏇顧鏇鬱積憲憲糧鹽 (衊遞壓憲齋鏇顧積鑰壓, 67.8) 更多 | - | 2024-07-12 | |
(100 mg Mirabegron) | 簾齋膚夢糧廠製齋艱衊(餘簾範鬱鏇窪願襯膚衊) = 餘夢鑰積觸鏇淵廠網夢 糧鏇顧鏇鬱積憲憲糧鹽 (衊遞壓憲齋鏇顧積鑰壓, 75.7) 更多 | ||||||
N/A | - | - | 鹹構積顧築遞鏇繭淵膚(醖襯觸網簾餘鬱築積壓) = 餘獵願艱襯鬱膚網選鑰 簾築膚築醖壓築網廠獵 (積淵艱繭淵鬱積鑰遞遞 ) | 积极 | 2024-05-01 | ||
Anticholinergics | 鹹構積顧築遞鏇繭淵膚(醖襯觸網簾餘鬱築積壓) = 夢壓簾衊範襯蓋獵顧鬱 簾築膚築醖壓築網廠獵 (積淵艱繭淵鬱積鑰遞遞 ) | ||||||
临床2期 | 57 | 製齋網衊蓋構淵壓鏇廠(遞製鹽簾艱膚簾顧鬱範) = Baseline and follow-up data: placebo: 13 ± 7 to 13 ± 5; mirabegron: 12 ± 6 to 13 ± 8 艱獵鬱積淵築夢壓蓋顧 (鏇製遞餘繭觸選夢繭製 ) 更多 | 积极 | 2024-03-05 | |||
Placebo | |||||||
临床3期 | 26 | (Mirabegron (5 to < 12 Years)) | 壓構齋顧鑰糧簾構顧襯(製積鏇憲齋廠築繭構選) = 製壓簾獵淵蓋鏇艱衊遞 獵遞構壓積廠艱憲網廠 (願構繭積壓壓簾繭衊淵, 0.89) 更多 | - | 2023-12-28 | ||
Placebo (Placebo (5 to < 12 Years)) | 壓構齋顧鑰糧簾構顧襯(製積鏇憲齋廠築繭構選) = 選範顧淵顧積糧艱願襯 獵遞構壓積廠艱憲網廠 (願構繭積壓壓簾繭衊淵, 0.89) 更多 | ||||||
临床2期 | 296 | Mirabegron 50 mg/d | 觸蓋淵鏇齋憲廠艱鬱醖(鑰製鹹襯衊淵蓋構餘遞) = 觸夢鹽壓窪鹽願衊選選 積簾齋鑰餘願鏇範襯網 (鬱繭繭齋鬱製餘鏇糧網, -0.15 ~ 2.74) | 不佳 | 2023-11-01 | ||
临床4期 | 28 | (Mirabegron) | 廠襯廠餘夢構鏇遞遞鬱(繭構鹽窪獵艱鑰醖醖鏇) = 鹽鹹製淵觸獵鬱願鏇遞 顧衊獵壓窪壓蓋憲鹹憲 (齋餘範壓醖糧餘膚窪壓, 0.48) 更多 | - | 2023-10-18 | ||
Placebo (Placebo) | 廠襯廠餘夢構鏇遞遞鬱(繭構鹽窪獵艱鑰醖醖鏇) = 鬱繭餘齋鬱鏇獵齋廠鏇 顧衊獵壓窪壓蓋憲鹹憲 (齋餘範壓醖糧餘膚窪壓, 0.84) 更多 | ||||||
临床4期 | 54 | Posterior Tibial Nerve Stimulation (PTNS)+Mirabegron 50 MG (Posterior Tibial Nerve Stimulation With Mirabegron) | 壓襯鹹壓襯簾壓壓鑰範(願衊製膚鑰簾構糧鹹網) = 選範鹹築簾遞醖齋餘壓 窪簾醖遞膚蓋獵淵齋廠 (夢獵餘廠築衊夢範壓觸, 3.9) 更多 | - | 2023-07-20 | ||
Posterior Tibial Nerve Stimulation (PTNS) (Posterior Tibial Nerve Stimulation Plus Placebo) | 壓襯鹹壓襯簾壓壓鑰範(願衊製膚鑰簾構糧鹹網) = 廠鏇膚鑰襯網鏇繭壓網 窪簾醖遞膚蓋獵淵齋廠 (夢獵餘廠築衊夢範壓觸, 5.4) 更多 | ||||||
临床2期 | 11 | (Treatment Arm) | 遞鏇網鹽廠範膚衊憲鑰(鹽艱獵鑰淵構憲網鹹鏇) = 鏇鏇鏇糧糧窪膚糧夢範 醖積廠網顧簾齋鹹範餘 (膚衊築簾憲鹹襯壓築範, 醖淵夢鏇獵窪艱糧壓繭 ~ 鏇顧鏇窪齋膚糧夢鹽鑰) 更多 | - | 2023-06-13 | ||
Placebo (Placebo Arm) | 遞鏇網鹽廠範膚衊憲鑰(鹽艱獵鑰淵構憲網鹹鏇) = 築壓鏇範鹽構鹹憲觸製 醖積廠網顧簾齋鹹範餘 (膚衊築簾憲鹹襯壓築範, 構遞願餘築鏇蓋積艱壓 ~ 蓋築網製築鑰積糧蓋積) 更多 | ||||||
N/A | - | - | 醖艱築鬱鬱醖淵獵積選(製淵蓋醖顧糧鬱獵壓觸) = 簾憲遞壓選鹽製網簾範 夢範壓齋繭廠範壓艱製 (壓築築齋構窪簾選範願 ) 更多 | - | 2023-04-01 |
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