合併治療可改善膀胱控制


  【24drs.com】根據第3b期BESIDE試驗的結果,對於膀胱過動症患者,併用mirabegron (商品名Myrbetriq,Astellas Pharma藥廠)與solifenacin (商品名Vesicare,Astellas Pharma藥廠)可以提高控制與效果,且無令人困擾的副作用。
  
  英國Bristol泌尿科研究中心、Bristol大學Marcus Drake醫師表示,對於那些對單一治療無反應的患者來說,這是個好消息;他在美國泌尿科協會(AUA)2015年會中表示,膀胱過動症的不利影響是明確的,特別是急迫尿失禁患者。
  
  Mirabegron是美國食品藥物管理局已經核准的一種beta-3腎上腺素致效劑,此藥與之前核准的療法有不同的作用機轉;Drake醫師解釋,提出了併用治療的明顯可能。
  
  明尼蘇達州羅徹斯特梅約診所、AUA膀胱過動症指引委員會成員Deborah Lightner醫師表示,自從mirabegron核准上市之後,許多醫師都曾嘗試併用療法,但是沒有安全性或效果方面的資料。
  
  她表示,我相當高興他們進行這個齊頭式對比研究,但是我不太清楚這令人印象深刻的結果是不是他們想要的。
  
  研究對象被隨機分組到三種療法之一:併用處方組,包括solifenacin 5 mg加上mirabegron 25 mg治療4週,之後以mirabegron 50 mg治療8週;單以solifenacin 5 mg治療12週;或單以solifenacin 10 mg治療12週。
  
  全部2,172名研究對象都曾有膀胱過動症狀至少3個月;2週的清除期之後,他們接受1個月的每日solifenacin 5 mg療程,但是依舊至少發生1次失禁。
  
  併用組的每日平均失禁次數減少程度顯著優於5 mg單一治療組(1.84 vs 1.55;P= .001),但是與10 mg單一治療組(1.67)沒有顯著差異。
  
  每日排尿的平均次數減少方面,併用組也優於5 mg單一治療組(1.59 vs 1.14)。整體而言,併用組並未優於10 mg單一治療組,但是在每日排尿次數減少方面有比較好。
  
  Lightner醫師表示,併用組在次數與漏尿頻率減少都比較顯著,但是,這有臨床意義嗎?我認為還無法從這研究中確認。
  
  併用組的副作用較少,不過併用組有36%發生至少一次治療引起的副作用,而5 mg單一治療組有33%、10 mg 單一治療組有39%,最常見的是口乾、便祕與周邊水腫。
  
  Drake醫師報告指出,併用組的口乾比率明顯優於solifenacin 10 mg組;各組的便祕率相當,沒有急性尿滯留事件。
  
  Drake醫師報告指出,這些療法與個別單一療法的已知問題相同,沒有生命徵象方面的問題。
  
  Lightner醫師表示,副作用減少會─特別是口乾─是一大效益。
  
  這篇研究顯示,你可以避免使用較高劑量的抗毒蕈劑,且達到至少相同的結果;Lightner醫師指出,這意味著患者的治療堅持度會增加。
  
  她指出,有藥物治療的研究是很好的,但是我不會忽視這是由業界贊助的試驗這個事實。
  
  Lightner醫師表示,藥物不能個別考量,對於膀胱過動症患者,行為治療是主要的有效療法。
  
  資料來源:http://www.24drs.com/
  
  Native link:Combination Therapy Improves Bladder Control

Combination Therapy Improves Bladder Control

By Alicia Ault
Medscape Medical News

NEW ORLEANS — For patients with overactive bladder, the addition of mirabegron (Myrbetriq, Astellas Pharma) to solifenacin (Vesicare, Astellas Pharma) appears to confer added control and benefit without any troubling adverse effects, according to results from the phase 3b BESIDE trial.

This is good news for patients who don't respond to monotherapy, said Marcus Drake, BM BCh, from the University of Bristol and the Bristol Urological Institute in the United Kingdom.

"The detrimental impact of overactive bladder is clear, especially for patients with urgency urinary incontinence," he said here at the American Urological Association (AUA) 2015 Annual Meeting.

Mirabegron, a beta-3 adrenergic agonist already approved by the US Food and Drug Administration, has a different mechanism of action than previously approved pharmacologic therapies, which "raised the obvious possibility of combination treatment," Dr Drake explained.

Many clinicians have been trying out combination therapy since the approval of mirabegron, but no safety or efficacy data are available, said Deborah Lightner, MD, from the Mayo Clinic in Rochester, Minnesota, who is on the AUA guidelines committee for overactive bladder.

"I'm really pleased they did this head-to-head study," she told Medscape Medical News. But "I'm not quite sure that the results are as impressive as they want them to be."

Patients were randomized to one of three treatments: a combination regimen consisting of solifenacin 5mg plus mirabegron 25mg for the 4 weeks followed by mirabegron 50mg for 8 weeks; monotherapy with solifenacin 5mg for 12 weeks; or monotherapy with solifenacin 10mg for 12 weeks.

The BESIDE Study

All 2172 participants who completed the study experienced symptoms of overactive bladder for at least 3 months. After a 2-week washout period, they received a month-long course of solifenacin 5mg daily, but still experienced at least one incontinence episode.

The decrease in mean daily incontinence episodes was significantly greater in the combination group than in the 5mg monotherapy group (1.84 vs 1.55; P= .001), but was not significantly different in the 10mg monotherapy group (1.67).

The decrease in the mean number of daily micturitions was also greater in the combination group than in the 5mg monotherapy group (1.59 vs 1.14). Overall, the combination was noninferior to 10mg monotherapy, but it was superior for daily reduction in micturitions.

The reduction in the number and frequency of leaks was significant with the combination, but "is that clinically meaningful? I'm not sure we know from the study," said Dr Lightner.

Reduction in Adverse Effects

There were fewer adverse effects with the combination, although at least one treatment-emergent adverse event was reported by 36% of the combination group, 33% of the 5mg monotherapy group, and 39% of the 10mg monotherapy group. The most common events were dry mouth, constipation, and peripheral edema.

"The dry mouth rate was noticeably better for the combination therapy than for solifenacin 10mg," Dr Drake reported. The rate of constipation was similar in all groups, and there were no acute retention incidents.

"The treatments are compatible with known problems with the individual monotherapies, with no problems in vital signs," Dr Drake reported.

A reduction in adverse effects — in particular dry mouth — could be a huge benefit, said Dr Lightner.

This study shows that "you can avoid higher doses of an antimuscarinic and achieve at least the same result," she told Medscape Medical News. That could mean that patients are more likely to stay on therapy, Dr Lightner pointed out.

Having studies of the drug therapies is good, "but I don't want to lose sight of the fact that this is an industry-sponsored trial," she added.

Medications should not be considered in isolation, said Dr Lightner. "Behavioral therapy is the primary effective therapy for patients with overactive bladder."

This study was funded by Astellas Pharma. Dr Drake reports financial relationships with Allergan, Astellas, and Ferring. Dr Lightner has disclosed no relevant financial relationships.

American Urological Association (AUA) 2015 Annual Meeting: AbstractPII-LBA9. Presented May17, 2015.

    
相關報導
肉毒桿菌對於膀胱過動症的神經調節效果可能最好
2016/10/21 上午 10:08:58
Solabegron可安全有效地治療膀胱過動症
2012/5/28 上午 10:50:41
對於膀胱過動症男性患者 行為治療可和藥物治療匹敵
2010/6/14 下午 04:33:00

上一頁
   1   2   3  




回上一頁