Efficacy and Safety Profile of Extended Release Tolterodine in Symptomatic Overactive Bladder

Background: Overactive Bladder (OAB) is a debilitating medical condition having the symptoms of urinary frequency and urgency with or without urge incontinence. Tolterodine was the first drug developed specifically for the treatment of OAB. It is a competitive muscarinic antagonist that exhibits similar affinities for muscarinic receptor subtypes M1 to M3. Tolterodine may be a more target specific drug that possesses stronger selectivity for the urinary bladder than for the salivary glands. In a pilot study in healthy volunteers, tolterodine was well-tolerated and showed greater function than on salivation. Objectives: To study the efficacy of tolterodine (ER) in relieving symptoms of overactive bladder with its adverse effects to determine the safety of the drug. Methods: This study was conducted at the Department of Urology, Chittagong Medical College Hospital, Chittagong, Bangladesh, from March, 2014 to June, 2015. Purposive sampling was done. Bladder diary was used for evaluating the symptoms of the patient during baseline and 08 weeks follow up. Perceived level of benefit of the patients was assessed and graded using Likert scale. Data analysis was conducted by SPSS version-21. Results: Out of 80 patients, 19 (23.75%) were male and 62 (76.25%) were female with a male: female ratio 1:3.2. The study revealed that the most of the patients, 48 (60.0%) were subjected to much benefit followed by 23 (28.75%) patients experienced little benefit and 09 (11.25%) patients with no benefit from the treatment. Conclusion: With mild form of side effects tolterodine showed a significant level of efficacy on overactive bladder. Chatt Maa Shi Hosp Med Coll J; Vol.17 (1); Jan 2018; Page 34-37

Efficacy and safety of daily mirabegron 50 mg in male patients with overactive bladder: a critical analysis of five phase III studies

Background: Oral pharmacotherapies to treat overactive bladder (OAB) are used less in men despite a similar prevalence of storage symptoms as women. The efficacy and safety of once-daily mirabegron 50 mg was evaluated in male OAB patients from five phase III studies that included placebo or antimuscarinic (tolterodine ER 4 mg or solifenacin 5 mg) as a comparator. Methods: Three pooled 12-week placebo-controlled studies (mirabegron 50 mg versus placebo) and one 12-week non-inferiority phase IIIb study (BEYOND; mirabegron 50 mg versus solifenacin 5 mg) were used for efficacy (daily micturition frequency, urgency and incontinence episodes) and safety analyses. An additional 52-week active-controlled phase III safety study (mirabegron 50 mg versus tolterodine ER 4 mg) was included in the safety analysis. Male patients aged ⩾18 years with OAB for ⩾3 months were included in the analyses. Patients may also have a history of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)/benign prostatic enlargement (BPE) or concomitant use of α1-blockers. Results: In the pooled studies, mirabegron 50 mg demonstrated superiority versus placebo (treatment difference: −0.37 [95% confidence interval (CI): −0.74, −0.01]) for reducing micturition frequency; improvements in urgency and incontinence were not significantly different between mirabegron 50 mg and placebo. In BEYOND, mirabegron 50 mg was comparable with solifenacin 5 mg for reducing micturition frequency, urgency, and incontinence episodes. Mirabegron was well tolerated at 12 and 52 weeks and overall treatment-emergent adverse events (AEs) were similar to those with placebo. Conclusions: In a male OAB population with or without LUTS associated with BPH/BPE, mirabegron 50 mg provided similar improvements in urgency, frequency, and incontinence as solifenacin 5 mg, and is a well-tolerated alternative to antimuscarinics. In the three pooled 12-week studies, significant differences were not seen for urgency and incontinence versus placebo, although mirabegron 50 mg did demonstrate significant improvements versus placebo for frequency.

Supplementary data: Cost-effectiveness of mirabegron compared to tolterodine ER 4 mg for overactive bladder in Canada

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Cost-effectiveness of mirabegron compared to tolterodine ER 4 mg for overactive bladder in Canada

Introduction: This analysis compared the cost-effectiveness of once-daily regimens of mirabegron 50 mg and generic tolterodine ER 4 mg in a hypothetical cohort of previously treated patients with overactive bladder (OAB) in Canada.Methods: A Markov model was developed to represent different health states according to OAB symptoms (frequency, incontinence), presence/absence of adverse events (AEs; dry mouth, constipation, blurred vision), and treatment status (on-treatment, discontinue treatment, restart previous treatment). The time horizon used was one year, with monthly transitions between health states. The model was populated using data from a phase 3, placebo-controlled trial of mirabegron that included tolterodine as an active comparator (SCORPIO), as well as other published literature and expert opinion. Cost-effectiveness was calculated from Canadian public payer (based on Quebec list prices) and societal perspectives.Results: The incremental one-year cost per patient for mirabegron over tolterodine was $182 CAD and $157 CAD from the payer and societal perspectives, respectively. The incremental quality-adjusted life year (QALY) gain for mirabegron was 0.0066 when using EQ-5D health-state utilities. Mirabegron was cost-effective compared with tolterodine, from both payer and societal perspectives, and remained cost-effective vs. tolterodine across the majority of sensitivity analyses. The model was based on limited clinical trial evidence supplemented with expert opinion and assumptions; a select number of OAB symptoms, AEs, and direct and indirect medical costs associated with OAB; and a timeframe of only one year.Conclusions: From the payer and societal perspectives, the health economic model indicates that in Canada, mirabegron is a cost-effective treatment strategy compared with tolterodine, leading to improved health outcomes (QALYs) at an acceptable incremental cost.