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Effects of drug cessation after flexible-dose fesoterodine in patients with overactive bladder.
BJU Int. 2013 Oct; 112(6):820-9.BI

Abstract

OBJECTIVE

To determine the course of overactive bladder (OAB) symptoms after 4 weeks of no treatment following a 12-week study of the efficacy and safety of flexible-dose fesoterodine in patients with OAB who were enrolled in the UK healthcare system. There are limited data available on the natural time course of OAB symptoms after the cessation of treatment.

PATIENTS AND METHODS

In the open-label UK Study Assessing Flexible-dose Fesoterodine in Adults trial, patients aged ≥18 years with self-reported OAB symptoms for ≥3 months, a mean of at least eight micturitions per 24 h and three or more urgency episodes per 24 h on a 3-day bladder diary at baseline, and at least moderate bladder-related problems reported on the Patient Perception of Bladder Condition (PPBC) at baseline, were treated with fesoterodine for 12 weeks. All patients received fesoterodine 4 mg once daily for the first 4 weeks, at which time they could choose to increase the dose to 8 mg once daily, based on a discussion of treatment efficacy and tolerability with the investigator, or they could remain on fesoterodine 4 mg for the remaining 8 weeks. The 12-week treatment period was followed by a 4-week follow-up period of no fesoterodine treatment. Patients completed 3-day bladder diaries and the PPBC at baseline, week 4, end of treatment (week 12) and end of the follow-up period (week 16); the King's Health Questionnaire at baseline, end of treatment (week 12) and end of the follow-up period (week 16); and the Benefit, Satisfaction and Willingness to Continue questionnaire at week 12.

RESULTS

After 12 weeks of fesoterodine treatment, patients had clinically meaningful improvements in bladder diary variables and King's Health Questionnaire domains; 79% (254/322) of patients reported an improvement on the PPBC. After 4 weeks of no treatment, most patients deteriorated back to week 4 levels or worse on all bladder diary and patient-reported outcomes. Patients who expressed a benefit from fesoterodine treatment, satisfaction with their treatment or a willingness to continue treatment showed greater improvement from baseline to week 12 and greater deterioration from week 12 to week 16 than patients who did not respond positively on the Benefit, Satisfaction and Willingness to Continue questionnaire. Both men and women showed a meaningful deterioration in bladder diary variables and patient-reported outcomes at week 16; baseline symptom severity, age and week 4 dose escalation status did not appear to affect outcome deterioration at week 16.

CONCLUSIONS

At 4 weeks after fesoterodine was discontinued, patients showed an increase in the frequency of OAB symptoms, an increase in the severity of bladder-related problems and a reduction in health-related quality of life. Many patients with OAB who respond to antimuscarinics may require treatment for more than 12 weeks because symptoms recur as early as 4 weeks after the cessation of therapy.

Authors+Show Affiliations

St Mary's Hospital, London, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23465055

Citation

Khullar, Vik, et al. "Effects of Drug Cessation After Flexible-dose Fesoterodine in Patients With Overactive Bladder." BJU International, vol. 112, no. 6, 2013, pp. 820-9.
Khullar V, Cardozo L, Kelleher CJ, et al. Effects of drug cessation after flexible-dose fesoterodine in patients with overactive bladder. BJU Int. 2013;112(6):820-9.
Khullar, V., Cardozo, L., Kelleher, C. J., Hall, T., Ryan, J., Ebel Bitoun, C., Darekar, A., Arumi, D., & Wagg, A. (2013). Effects of drug cessation after flexible-dose fesoterodine in patients with overactive bladder. BJU International, 112(6), 820-9. https://doi.org/10.1111/bju.12006
Khullar V, et al. Effects of Drug Cessation After Flexible-dose Fesoterodine in Patients With Overactive Bladder. BJU Int. 2013;112(6):820-9. PubMed PMID: 23465055.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of drug cessation after flexible-dose fesoterodine in patients with overactive bladder. AU - Khullar,Vik, AU - Cardozo,Linda, AU - Kelleher,Con J, AU - Hall,Timothy, AU - Ryan,John, AU - Ebel Bitoun,Caty, AU - Darekar,Amanda, AU - Arumi,Daniel, AU - Wagg,Adrian, Y1 - 2013/03/07/ PY - 2013/3/8/entrez PY - 2013/3/8/pubmed PY - 2013/11/20/medline KW - UK KW - antimuscarinic KW - drug cessation KW - flexible dose KW - quality of life SP - 820 EP - 9 JF - BJU international JO - BJU Int VL - 112 IS - 6 N2 - OBJECTIVE: To determine the course of overactive bladder (OAB) symptoms after 4 weeks of no treatment following a 12-week study of the efficacy and safety of flexible-dose fesoterodine in patients with OAB who were enrolled in the UK healthcare system. There are limited data available on the natural time course of OAB symptoms after the cessation of treatment. PATIENTS AND METHODS: In the open-label UK Study Assessing Flexible-dose Fesoterodine in Adults trial, patients aged ≥18 years with self-reported OAB symptoms for ≥3 months, a mean of at least eight micturitions per 24 h and three or more urgency episodes per 24 h on a 3-day bladder diary at baseline, and at least moderate bladder-related problems reported on the Patient Perception of Bladder Condition (PPBC) at baseline, were treated with fesoterodine for 12 weeks. All patients received fesoterodine 4 mg once daily for the first 4 weeks, at which time they could choose to increase the dose to 8 mg once daily, based on a discussion of treatment efficacy and tolerability with the investigator, or they could remain on fesoterodine 4 mg for the remaining 8 weeks. The 12-week treatment period was followed by a 4-week follow-up period of no fesoterodine treatment. Patients completed 3-day bladder diaries and the PPBC at baseline, week 4, end of treatment (week 12) and end of the follow-up period (week 16); the King's Health Questionnaire at baseline, end of treatment (week 12) and end of the follow-up period (week 16); and the Benefit, Satisfaction and Willingness to Continue questionnaire at week 12. RESULTS: After 12 weeks of fesoterodine treatment, patients had clinically meaningful improvements in bladder diary variables and King's Health Questionnaire domains; 79% (254/322) of patients reported an improvement on the PPBC. After 4 weeks of no treatment, most patients deteriorated back to week 4 levels or worse on all bladder diary and patient-reported outcomes. Patients who expressed a benefit from fesoterodine treatment, satisfaction with their treatment or a willingness to continue treatment showed greater improvement from baseline to week 12 and greater deterioration from week 12 to week 16 than patients who did not respond positively on the Benefit, Satisfaction and Willingness to Continue questionnaire. Both men and women showed a meaningful deterioration in bladder diary variables and patient-reported outcomes at week 16; baseline symptom severity, age and week 4 dose escalation status did not appear to affect outcome deterioration at week 16. CONCLUSIONS: At 4 weeks after fesoterodine was discontinued, patients showed an increase in the frequency of OAB symptoms, an increase in the severity of bladder-related problems and a reduction in health-related quality of life. Many patients with OAB who respond to antimuscarinics may require treatment for more than 12 weeks because symptoms recur as early as 4 weeks after the cessation of therapy. SN - 1464-410X UR - https://www.unboundmedicine.com/medline/citation/23465055/Effects_of_drug_cessation_after_flexible_dose_fesoterodine_in_patients_with_overactive_bladder_ L2 - https://doi.org/10.1111/bju.12006 DB - PRIME DP - Unbound Medicine ER -