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

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.

Key words: :

• Activity impairment
• Overactive bladder
• Resource utilization
• Solifenacin
• Tolterodine
• Work productivity

Acknowledgments

Declaration of interest: This study was supported by Astellas Pharma US and GlaxoSmithKline. NZ is a Speaker for Astellas, Esprit, and Watson; is on the Advisory Board for Allergan, Astellas, Esprit, Medtronics, and Watson; and has been involved in Research Studies for Allergan, Astellas, GlaxoSmithKline, Indevus, and Watson. LN and LR are employees of ICON Clinical Research, which received research support from Astellas and GlaxoSmithKline. TM and RS are employees of Astellas. The authors thank Carolyn Roberts, ICON Clinical Research, for providing word processing support. Clinical Trial Registry number: NCT00454740.