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索利那新对从托特罗定缓释制剂转换过来的膀胱过度活动症患者资源利用、工作生产力及健康效用的影响

Impact of solifenacin on resource utilization, work productivity and health utility in overactive bladder patients switching from tolterodine ER.

作者信息

Zinner Norman, Noe Les, Rasouliyan Lawrence, Marshall Thomas, Seifeldin Raafat

机构信息

Western Clinical Research, Torrance, CA, USA.

出版信息

Curr Med Res Opin. 2008 Jun;24(6):1583-91. doi: 10.1185/03007990802081766. Epub 2008 Apr 17.

Abstract

OBJECTIVE

Assess changes in resource utilization, work and activity impairment, and health utility among OAB patients continuing to have urgency symptoms with tolterodine ER 4 mg and willing to try solifenacin 5/10 mg.

RESEARCH DESIGN AND METHODS

This was an open-label, non-comparative, flexible-dosing, multicenter, 12-week study assessing the efficacy and safety of solifenacin 5/10 mg/day. Patients receiving tolterodine ER 4 mg/day for >/=4 weeks but continuing to experience residual urgency symptoms (>/=3 urgency episodes/24 h) were enrolled into the study. After a 14-day washout, patients began treatment with solifenacin 5 mg/day with dosing adjustments allowed at Weeks 4 and 8.

MAIN OUTCOME MEASURES

Outcomes were assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP), Health Utilities Index (HUI), and a resource utilization questionnaire administered at Pre-Washout and Week 12.

RESULTS

Patients (n=440) reported significantly fewer physician office visits (p<0.0001), UTIs (p<0.0001), and pads/diapers (p=0.0009) during the study period while receiving solifenacin 5/10 mg/day, compared with the Pre-Washout period when receiving tolterodine ER 4 mg/day. After 12 weeks of treatment with solifenacin 5/10 mg/day, patients reported a reduction in work time missed (p=0.0017), less impairment while working (p<0.0001), less overall work impairment (p<0.0001) and a reduction in activity impairment (p<0.0001) compared to Pre-Washout. There was no significant difference in health utility scores. Treatment-emergent adverse events were mostly anticholinergic in nature, and were mild to moderate in severity.

CONCLUSION

Overall, solifenacin 5/10 mg/day improved work productivity, activity participation, and reduced medical care use in OAB patients who continued to have urgency symptoms with tolterodine ER 4 mg/day and wished to switch to solifenacin 5/10 mg. This was an open-label, non-comparative study; therefore, further research is needed to confirm these results.

摘要

目的

评估在使用4毫克缓释托特罗定后仍有尿急症状且愿意尝试5/10毫克索利那新的膀胱过度活动症(OAB)患者中,资源利用、工作及活动受限情况以及健康效用的变化。

研究设计与方法

这是一项开放标签、非对照、灵活给药、多中心、为期12周的研究,旨在评估5/10毫克/天索利那新的疗效和安全性。接受4毫克/天缓释托特罗定治疗≥4周但仍有残余尿急症状(≥3次尿急发作/24小时)的患者被纳入研究。经过14天的洗脱期后,患者开始接受5毫克/天的索利那新治疗,并允许在第4周和第8周调整剂量。

主要观察指标

在洗脱前和第12周使用工作效率和活动受限问卷 - 特定健康问题(WPAI - SHP)、健康效用指数(HUI)以及一份资源利用问卷来评估结果。

结果

与接受4毫克/天缓释托特罗定的洗脱前期相比,440名患者在接受5/10毫克/天索利那新治疗期间,报告的看医生次数(p<0.0001)、尿路感染次数(p<0.0001)和护垫/尿布使用量(p = 0.0009)显著减少。在接受5/10毫克/天索利那新治疗12周后,与洗脱前相比,患者报告的误工时间减少(p = 0.0017)、工作时的受限情况减轻(p<0.0001)、总体工作受限减轻(p<0.0001)以及活动受限减轻(p<0.0001)。健康效用评分无显著差异。治疗中出现的不良事件大多具有抗胆碱能性质,且严重程度为轻至中度。

结论

总体而言,对于使用4毫克/天缓释托特罗定后仍有尿急症状且希望改用5/10毫克索利那新的OAB患者,5/10毫克/天的索利那新提高了工作效率、活动参与度并减少了医疗护理的使用。这是一项开放标签、非对照研究;因此,需要进一步研究来证实这些结果。

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