Solifenacin Is Effective for the Treatment of OAB Dry Patients: A Pooled Analysis
Bristol Urological Institute, Department of Urology, Southmead Hospital, UK. European Urology
(Impact Factor: 13.94).
10/2005; 48(3):483-7. DOI: 10.1016/j.eururo.2005.06.007
The aim of this analysis was to determine the effects of solifenacin in patients considered overactive bladder (OAB) dry at baseline.
This was a pooled analysis of 4 randomized, placebo-controlled 12-week, phase 3 studies. Patients received placebo or solifenacin 10 mg once daily (2 studies), or placebo or solifenacin 5 mg or 10 mg once daily (2 studies). A subgroup of patients without incontinence at baseline was identified from a 3-day diary. Mean changes from baseline to endpoint for urgency episodes, micturition, frequency and nocturia episodes per 24 hours, and volume voided/micturition were evaluated. The proportion of patients with normalization of micturition frequency (<8 micturitions), resolution of urgency, or resolution of nocturia at endpoint was also determined.
Of 2848 evaluable patients treated with placebo or solifenacin, 975 (34%) were OAB dry at baseline. Solifenacin 5 mg and 10 mg were significantly (p < 0.001) more effective than placebo for improving urgency, micturition frequency, and volume voided. In addition, solifenacin 10mg was significantly (p < 0.01) more effective than placebo for improving nocturia. Resolution of urgency occurred significantly (p < 0.05) more often with solifenacin 5 mg (37%) and 10 mg (33%) than with placebo (25%). Significantly (p < 0.01) more OAB dry patients had normalization of micturition frequency with solifenacin 5 mg (29%) and 10 mg (35%) compared with placebo (19%). Resolution of nocturia occurred in 14%, 21%, and 13% of patients treated with solifenacin 5mg, solifenacin 10 mg, and placebo, respectively (p < 0.01 for solifenacin 10 mg versus placebo).
Solifenacin significantly improved urgency, frequency, and nocturia symptoms and increased volume voided in OAB dry patients.
Available from: Myung-Soo Choo
- "Data from numerous flexible-dose studies of solifenacin demonstrated significantly improved urgency, frequency, and nocturia symptoms and increased volume voided in OAB dry patients [6,7,8,9]. However, these clinical trials were conducted with OAB patients for 14 weeks and offered only one opportunity for dose escalation. "
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ABSTRACT: To determine the baseline clinical characteristics associated with dose escalation of solifenacin in patients with overactive bladder (OAB).
We analyzed the data of patients with OAB (micturition frequency ≥8/day and urgency ≥1/day) who were treated with solifenacin and followed up for 24 weeks. According to our department protocol, all the patients kept voiding diaries, and OAB symptom scores (OABSS) were monitored at baseline and after 4, 12, and 24 weeks of solifenacin treatment.
In total, 68 patients (mean age, 60.8±10.0 years) were recruited. The dose escalation rate by the end of the study was 41.2%, from 23.5% at 4 weeks and 17.6% at 12 weeks. At baseline, the dose escalator group had significantly more OAB wet patients (53.6% vs. 20.0%) and higher total OABSS (10.2±2.4 vs. 7.9±3.5, P=0.032) than the nonescalator group. OAB wet (odds ratio [OR], 4.615; 95% confidence interval [CI], 1.578-13.499; P<0.05) and total OABSS (OR, 1.398; 95% CI, 1.046-1.869; P<0.05) were found to be independently associated with dose escalation.
Patients who have urgency urinary incontinence and high total OABSS have a tendency for dose escalation of solifenacin.
Available from: Ruth Klara, Maria Kirschner-Hermanns
- "Also, the placebo effect is very high, as shown in studies comparing an antimuscarinic drug and a placebo . The advantage of examining new drugs during in vitro experiments, as in the present study, is that the placebo effect often found in clinical studies is eliminated , making the in vitro experiments very helpful for choosing potent substances before conducting clinical trials. Urinary incontinence is a common disease in elderly patients. "
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ABSTRACT: ATP-sensitive potassium channels represent promising drug targets for treating specific bladder diseases. The inhibitory effects of ATP-selective potassium channel openers (PCOs) on the carbachol–response curve in porcine detrusor muscle were examined.Materials and methodsEach of the three substances used in the study represent one prototype of a different class of PCO: cromakalim belongs to the benzopyran series, pinacidil is a cyanoguanidine derivative, and minoxidil represents a pyrimidine derivative. The porcine detrusor muscle represents one of the best models for human detrusor. Experiments were conducted on muscle strips of porcine detrusor muscle suspended in a tissue bath. Concentration–response curves of carbachol were constructed after pretreatment with cromakalim at 10−7, 10−6 and 10−5 M, and with pinacidil and minoxidil at 10−6, 10−5.5 and 10−5 M, respectively. Each muscle strip was only used to examine one concentration of one substance.ResultsCromakalim had the greatest inhibitory effect, significantly suppressing the carbachol–response curve at 10−6 and 10−5 M. Pinacidil showed a significant inhibitory effect at 10−5.5 and 10−5 M, which was smaller than that of cromakalim. Minoxidil did not significantly inhibit the contractions at all examined concentrations.Conclusions
The examined ATP-sensitive PCOs belonging to the benzopyrans and cyanoguanidines significantly suppressed detrusor contractions. The development of derivatives of these prototypes could open new possibilities for the pharmacological treatment of selected bladder diseases.
Available from: Anastasios Athanasopoulos or Athanassopoulos
- "A pooled analysis of four randomized, placebo-control1ed, phase III studies of solifenacin in OAB patients without incontinence, showed a significant improvement of symptoms and voided volume after 12 weeks of treatment . "
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ABSTRACT: Overactive bladder is a common and bothersome condition. Antimuscarinic agents, as a class, are the cornerstone of medical treatment of overactive bladder. They offer significant improvements in symptoms and patients' quality of life. Antimuscarinics are generally well tolerated with mild and predictable side effects. Available antimuscarinics have small, yet statistically significant, differences in their efficacy and tolerability profiles. In clinical practice, finding the agent that offers the optimum balance of efficacy and side effects for an individual patient remains the major challenge.
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