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Solifenacin and Tolterodine Are Equally Effective in the Treatment of Overactive Bladder Symptoms

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Solifenacin and Tolterodine Are Equally Effective in the Treatment of Overactive Bladder Symptoms View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Elsevier - Publisher Connector J Formos Med Assoc 2010;109(10):702–708 Contents lists available at ScienceDirect Volume 109 Number 10 October 2010 ISSN 0929 6646 Journal of the Journal of the Formosan Medical Association Formosan Medical Association New Delhi metallo-b-lactamase-1 HTLV-1 and adult T-cell leukemia Detection of nighttime melatonin level in Chinese original quiet sitting Solifenacin and Tolterodine in the treatment of overactive bladder symptoms Formosan Medical Association Journal homepage: http://www.jfma-online.com Taipei, Taiwan Original Article Solifenacin and Tolterodine are Equally Effective in the Treatment of Overactive Bladder Symptoms Chen-Hsun Ho,1,3 Ting-Chen Chang,2 Ho-Hsiung Lin,2 Shih-Ping Liu,1 Kuo-How Huang,1 Hong-Jeng Yu1* Background/Purpose: Various antimuscarinic agents have been developed for the treatment of overactive bladder (OAB). More data comparing these agents are still required. This study evaluated the efficacy and safety of solifenacin and tolterodine in Taiwanese patients with OAB symptoms. Methods: This was a prospective, randomized, open-label study. A total of 75 patients (25 men and 50 women) with OAB symptoms were randomized to treatment with solifenacin (n = 39) or tolterodine (n = 36). Efficacy and safety variables were assessed and compared with the baseline and between the two groups. Results: At week 12, solifenacin and tolterodine demonstrated equal efficacy in reducing the number of micturition (–2.56 ± 3.31 vs. –2.44 ± 4.56, p = 0.58), urgency (–1.70 ± 3.07 vs. –1.15 ± 2.68, p = 0.37) and incontinence (–2.79 ± 2.82 vs. –4.67 ± 9.29, p = 0.28) episodes per 24 hours. There was no difference in improvement of the quality of life. The patient and physician assessments of treatment benefit were not statistically different for solifenacin and tolterodine (p = 0.23 and p = 0.52, respectively), with the majority showing benefits in both groups. The incidence of major adverse events, including dry mouth (18.0% vs. 8.3%, p = 0.31) and constipation (12.8% vs. 2.8%, p = 0.20) was not significantly different. Compared with baseline, the severity of dry mouth did not increase in either group. Conclusion: Both solifenacin and tolterodine are effective in treating key OAB symptoms, including uri- nary frequency, urgency and incontinence in the Taiwanese population. Both medications are comparably effective and safe, with the most common adverse effects being dry mouth and constipation. Key Words: antimuscarinic agents, overactive bladder, solifenacin, tolterodine Overactive bladder (OAB) is defined by the Inter- An epidemiological survey of 1581 Taiwanese national Continence Society as a syndrome that women has demonstrated that OAB affects 18.6% comprises urgency, with or without incontinence, of this population,2 and the prevalence rate is sim- usually accompanied by frequency and nocturia.1 ilar to that of western populations.3,4 In addition ©2010 Elsevier & Formosan Medical Association ................................................... Departments of 1Urology and 2Obstetrics and Gynecology, National Taiwan University Hospital, and 3Division of Urology, Department of Surgery, Buddhist Tzu Chi General Hospital, Taipei Branch, Taipei, Taiwan. Received: October 4, 2009 *Correspondence to: Dr Hong-Jeng Yu, Department of Urology, National Taiwan Revised: September 16, 2009 University Hospital, 7 Chung-Shan South Road, Taipei, 100, Taiwan. Accepted: November 3, 2009 E-mail: [email protected] 702 J Formos Med Assoc | 2010 • Vol 109 • No 10 Solifenacin and tolterodine in overactive bladder to its high prevalence rate, several lines of evidence Patients and Methods have shown that OAB adversely affects quality of life5 and is associated with an increased risk Subjects were enrolled from the outpatient clin- of urinary tract infection, skin infection, and fall ics of Urology, and Obstetrics and Gynecology at injury.6,7 These health-related consequences war- the National Taiwan University Hospital between rant appropriate management of OAB. February 2007 and May 2008. Patients were eligi- Treatment for OAB includes behavioral, phar- ble for the study if all of the following applied: macological, and surgical therapy. Among these (1) male or female aged ≥ 18 years; (2) informed choices, antimuscarinic agents remain the main- consent had been obtained; (3) the patient was stay of treatment.8 There are five subtypes of mus- willing and able to complete the micturition carinic receptors (M1–M5) throughout the human diary correctly; (4) the OAB symptoms, including body. In the urinary bladder, although M2 recep- urinary frequency, urgency, or urge incontinence, tors predominate in number, normal bladder con- had persisted for ≥ 3 months; (5) the patient must traction is mainly mediated by stimulation of M3 have experienced frequency, defined as ≥ eight receptors,9 which are also the target of antimus- micturitions per 24 hours. Exclusion criteria in- carinic agents. By blocking the muscarinic recep- cluded: (1) pregnant and lactating women or tors, antimuscarinic agents inhibit the abnormal those who intended to become pregnant during bladder contractions (detrusor overactivity) and the study; (2) clinically significant bladder out- subsequently reduce OAB symptoms. However, flow obstruction (such as men with benign pro- antimuscarinic agents also act on other muscarinic static hyperplasia or women with bladder outlet receptors throughout the body and therefore cause obstruction); (3) significant post-void residual adverse effects, including dry mouth, constipa- (PVR) volume (> 200 mL); (4) genuine stress uri- tion, drowsiness, and blurred vision. Clinically, nary incontinence; (5) evidence of symptomatic it is these adverse effects that limit the use of urinary tract infection, chronic inflammation, antimuscarinics. bladder stones, previous pelvic radiation ther- In recent decades, several new compounds have apy, or previous or current malignant disease of been developed to reduce these unfavorable ad- the pelvic organs; (6) patients with any medical verse effects. Tolterodine was the first agent in- condition that contraindicated the use of anti- troduced for this purpose. It is bladder-selective muscarinic medication; (7) uncontrolled narrow and has been shown in animal studies to have a angle glaucoma, urinary or gastric retention, or greater affinity in the bladder than in the salivary any other medical condition that, in the opinion glands.10 Clinically, tolterodine has been demon- of the investigator, contraindicated the use of strated to have less side effects than other anti- antimuscarinics. muscarinic agent.11 A newer antimuscarinic agent, Eligible patients were randomized to one of the solifenacin, has also proved to be bladder-selective following two treatment groups: 5 mg solifenacin and even M3-receptor-selective. Clinical trials have once daily or 4 mg tolterodine once daily. At base- shown that solifenacin is effective in the treatment line, a complete medical history, medication his- of OAB and is generally well tolerated.12 tory, physical examination, urinalysis, and blood Although several studies have compared both test (complete blood count and routine biochem- medications in western populations,13,14 to the istry) were obtained. Patients were instructed to best of our knowledge, a comparison based on a complete a 3-day voiding diary as a baseline con- Taiwanese population has not been reported. For dition before the intervention. Recorded items in this purpose, we conducted a prospective and the voiding diary included times of micturition, randomized trial to compare the efficacy and urgency and incontinence episodes, time of ris- safety of 5 mg solifenacin once daily and 4 mg ing and going to bed, void volume of each mic- tolterodine once daily. turition, and numbers of pads used. A validated J Formos Med Assoc | 2010 • Vol 109 • No 10 703 C.H. Ho, et al six-point categorical scale, the Patient Perception (PPS). All efficacy analyses were based on the PPS. of Bladder Condition (PPBC), was used to assess Changes from baseline to endpoint for mean mic- the severity of OAB.15 Also, to evaluate the ad- turition number, mean urgency episodes, mean in- verse effect of dry mouth that either intervention continence episodes, and PPBC were compared can cause, a visual analogue scale (VAS) was used between the two treatment groups by Student’s to assess its severity. The response to the treat- t test. All safety analyses were based on the safety ment was assessed with a three-point scale (not, population. Adverse events as recorded by the a little, and much improved) by patients and investigators were coded using the World Health investigators. Organization Adverse Reaction Terminology cod- Visits were scheduled at weeks 4, 8 and 12. ing system.16 Comparisons of incidence rates be- Patients were instructed to complete a 3-day void- tween the treatment groups were performed using ing diary 3 days before each scheduled visit. Fisher’s exact test. All statistical tests were two- PPBC and VAS for dry mouth were evaluated at sided, with a significance level of α=0.05. each visit. All observed or spontaneously reported adverse events were also recorded at each visit. PVR volume was assessed by ultrasonography at the Results visit at week 12. From the diary data, we obtained the follow- A total of 75 patients (25 men and 50 women) ing parameters: micturition numbers, urgency were randomized into two group: 39 in the so- episodes, incontinence episodes, and total vol- lifenacin group (5 mg once daily) and 36 in the ume voided per 24 hours. Mean volume voided tolterodine group (4 mg once daily). Two patients per micturition was calculated as the total voided in the tolterodine group withdrew from the study volume divided by the micturition number. The without any efficacy assessment; three patients primary efficacy endpoint was the change from in the solifenacin group and one in the toltero- baseline to endpoint for the mean number of dine group did not complete the 12-week treat- micturitions per 24 hours.
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