Zinner Norman, Noe Les, Rasouliyan Lawrence, Marshall Thomas, Seifeldin Raafat
Western Clinical Research, Torrance, CA, USA.
Curr Med Res Opin. 2008 Jun;24(6):1583-91. doi: 10.1185/03007990802081766. Epub 2008 Apr 17.
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.
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.
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.
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.
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.
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。
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。
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。
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。
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。