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Christopher R. Chapple - One of the best experts on this subject based on the ideXlab platform.
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comparison of the efficacy safety and tolerability of propiverine and Oxybutynin for the treatment of overactive bladder syndrome
International Journal of Urology, 2007Co-Authors: Paul Abrams, Christopher R. Chapple, Linda Cardozo, Dzelal Serdarevic, Katherine Hargreaves, Vikram KhullarAbstract:Aim: To compare the effects of propiverine and Oxybutynin on ambulatory urodynamic monitoring (AUM) parameters, safety, and tolerability in patients with overactive bladder. Methods: This was a randomized, double-blind, placebo-controlled, multicentre, crossover study. Patients (n = 77) received two of the following treatments during two 2-week periods: propiverine 20 mg once daily, propiverine 15 mg three times daily, Oxybutynin 5 mg three times daily, and placebo. AUM parameters, salivary flow, visual near point, and heart rate were assessed. Results: A consistent order in the efficacy between active treatment groups was observed for the reduction in mean involuntary detrusor contractions (IDCs; Oxybutynin 15 mg ≤ propiverine 45 mg ≤ propiverine 20 mg). Differences between the Oxybutynin and propiverine 20 mg groups were statistically significant for several AUM endpoints. Statistically significant differences between the Oxybutynin and both propiverine groups were also noted in salivary flow rate and heart rate (Oxybutynin 15 mg < both propiverine regimens) and in heart rate variability (both propiverine regimens < Oxybutynin 15 mg). All active treatments lengthened visual near point. The incidence of dry mouth was significantly more pronounced in the Oxybutynin group than in either propiverine group. Treatment with propiverine 45 mg resulted in the highest rates of constipation, lengthening of the visual near point, and effects on heart rate. Conclusions: Oxybutynin 15 mg was more effective than propiverine 20 mg in reducing symptomatic and asymptomatic IDCs in ambulatory patients. The primary differences between the two drugs were the incidence and type of adverse events, which varied with the antimuscarinic receptor specificity of each agent.
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Comparison of the efficacy, safety, and tolerability of propiverine and Oxybutynin for the treatment of overactive bladder syndrome: Comparison of properine and Oxybutynin
International journal of urology : official journal of the Japanese Urological Association, 2006Co-Authors: Paul Abrams, Christopher R. Chapple, Linda Cardozo, Dzelal Serdarevic, Katherine Hargreaves, Vikram KhullarAbstract:To compare the effects of propiverine and Oxybutynin on ambulatory urodynamic monitoring (AUM) parameters, safety, and tolerability in patients with overactive bladder. This was a randomized, double-blind, placebo-controlled, multicentre, crossover study. Patients (n = 77) received two of the following treatments during two 2-week periods: propiverine 20 mg once daily, propiverine 15 mg three times daily, Oxybutynin 5 mg three times daily, and placebo. AUM parameters, salivary flow, visual near point, and heart rate were assessed. A consistent order in the efficacy between active treatment groups was observed for the reduction in mean involuntary detrusor contractions (IDCs; Oxybutynin 15 mg </= propiverine 45 mg </= propiverine 20 mg). Differences between the Oxybutynin and propiverine 20 mg groups were statistically significant for several AUM endpoints. Statistically significant differences between the Oxybutynin and both propiverine groups were also noted in salivary flow rate and heart rate (Oxybutynin 15 mg < both propiverine regimens) and in heart rate variability (both propiverine regimens < Oxybutynin 15 mg). All active treatments lengthened visual near point. The incidence of dry mouth was significantly more pronounced in the Oxybutynin group than in either propiverine group. Treatment with propiverine 45 mg resulted in the highest rates of constipation, lengthening of the visual near point, and effects on heart rate. Oxybutynin 15 mg was more effective than propiverine 20 mg in reducing symptomatic and asymptomatic IDCs in ambulatory patients. The primary differences between the two drugs were the incidence and type of adverse events, which varied with the antimuscarinic receptor specificity of each agent.
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Comparison of darifenacin and Oxybutynin in patients with overactive bladder: assessment of ambulatory urodynamics and impact on salivary flow.
European urology, 2005Co-Authors: Christopher R. Chapple, Paul AbramsAbstract:Abstract Objectives: To evaluate the effects of darifenacin, an M 3 selective receptor antagonist, compared with Oxybutynin, on ambulatory urodynamics, salivary flow, heart rate and visual nearpoint in patients with overactive bladder (OAB). Methods: A double-blind, randomized, crossover study ( n =65) with three treatment cohorts: darifenacin immediate release (IR) 2.5mg three times a day (t.i.d.) or Oxybutynin 2.5mg t.i.d.; darifenacin controlled release (CR) 15mg once daily (q.d.) or Oxybutynin 5mg t.i.d.; darifenacin CR 30mg q.d. or Oxybutynin 5mg t.i.d. Within cohorts, patients received 7 days' treatment with each agent separated by 14 days' washout. Results: All active treatments improved urodynamic parameters. Both darifenacin CR doses had significantly less effect on salivary flow than Oxybutynin. Effects on urodynamic parameters, heart rate and visual nearpoint were comparable. Conclusion: Ambulatory urodynamics appears to be an innovative and potentially useful investigative tool in the evaluation of the efficacy of new therapeutic agents. Darifenacin CR is an efficacious therapy for OAB with comparable effects on urodynamic parameters but producing significantly less dry mouth than Oxybutynin.
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Tolterodine: Selectivity for the Urinary Bladder Over the Eye (as Measured by Visual Accommodation) in Healthy Volunteers
Drugs in R & D, 2002Co-Authors: Christopher R. Chapple, Lisbeth NilvebrantAbstract:Objective: Tolterodine exhibits a favourable selectivity for the urinary bladder over salivary glands in vivo , in the anaesthetised cat, whereas Oxybutynin shows the opposite selectivity profile in this model. This study further evaluated the selectivity profiles of tolterodine and Oxybutynin by comparing the effects on bladder function and visual accommodation in the same individuals. Methods: In a double-blind, randomised, four-way crossover study, 16 healthy volunteers received single oral doses of tolterodine 5mg and Oxybutynin 2.5, 5 and 7.5mg. Voiding parameters were assessed for 12 hours post-dose, along with visual accommodation (near point of vision) at regular intervals. Results: Adose-dependent increase in maximum bladder capacity was observed for Oxybutynin [2.5mg (+35%), 5mg (+45%) and 7.5mg (+57%)]. The effect of tolterodine 5mg on bladder capacity was approximately twice (+93%) that seen after Oxybutynin 5mg and the onset of the effect was more rapid with tolterodine. Effects on visual accommodation were also dose-dependent for Oxybutynin (maximum changes in near point of vision were 13%, 20% and 29%, respectively). The maximum change observed after tolterodine 5mg was the same as after Oxybutynin 5mg (i.e. 20%). Conclusions: Tolterodine seems to exhibit selectivity for the bladder over the eye. Therefore, these results suggest that the normal dosage of tolterodine (2mg twice daily) may have less effect on visual accommodation than the equivalent dosage of Oxybutynin (5mg three times daily) in patients with an overactive bladder.
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Tolterodine: Selectivity for the Urinary Bladder Over the Eye (as Measured by Visual Accommodation) in Healthy Volunteers
Drugs in R & D, 2002Co-Authors: Christopher R. Chapple, Lisbeth NilvebrantAbstract:Objective: Tolterodine exhibits a favourable selectivity for the urinary bladder over salivary glands in vivo , in the anaesthetised cat, whereas Oxybutynin shows the opposite selectivity profile in this model. This study further evaluated the selectivity profiles of tolterodine and Oxybutynin by comparing the effects on bladder function and visual accommodation in the same individuals. Methods: In a double-blind, randomised, four-way crossover study, 16 healthy volunteers received single oral doses of tolterodine 5mg and Oxybutynin 2.5, 5 and 7.5mg. Voiding parameters were assessed for 12 hours post-dose, along with visual accommodation (near point of vision) at regular intervals. Results: Adose-dependent increase in maximum bladder capacity was observed for Oxybutynin [2.5mg (+35%), 5mg (+45%) and 7.5mg (+57%)]. The effect of tolterodine 5mg on bladder capacity was approximately twice (+93%) that seen after Oxybutynin 5mg and the onset of the effect was more rapid with tolterodine. Effects on visual accommodation were also dose-dependent for Oxybutynin (maximum changes in near point of vision were 13%, 20% and 29%, respectively). The maximum change observed after tolterodine 5mg was the same as after Oxybutynin 5mg (i.e. 20%). Conclusions: Tolterodine seems to exhibit selectivity for the bladder over the eye. Therefore, these results suggest that the normal dosage of tolterodine (2mg twice daily) may have less effect on visual accommodation than the equivalent dosage of Oxybutynin (5mg three times daily) in patients with an overactive bladder.
Lisbeth Nilvebrant - One of the best experts on this subject based on the ideXlab platform.
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Tolterodine: Selectivity for the Urinary Bladder Over the Eye (as Measured by Visual Accommodation) in Healthy Volunteers
Drugs in R & D, 2002Co-Authors: Christopher R. Chapple, Lisbeth NilvebrantAbstract:Objective: Tolterodine exhibits a favourable selectivity for the urinary bladder over salivary glands in vivo , in the anaesthetised cat, whereas Oxybutynin shows the opposite selectivity profile in this model. This study further evaluated the selectivity profiles of tolterodine and Oxybutynin by comparing the effects on bladder function and visual accommodation in the same individuals. Methods: In a double-blind, randomised, four-way crossover study, 16 healthy volunteers received single oral doses of tolterodine 5mg and Oxybutynin 2.5, 5 and 7.5mg. Voiding parameters were assessed for 12 hours post-dose, along with visual accommodation (near point of vision) at regular intervals. Results: Adose-dependent increase in maximum bladder capacity was observed for Oxybutynin [2.5mg (+35%), 5mg (+45%) and 7.5mg (+57%)]. The effect of tolterodine 5mg on bladder capacity was approximately twice (+93%) that seen after Oxybutynin 5mg and the onset of the effect was more rapid with tolterodine. Effects on visual accommodation were also dose-dependent for Oxybutynin (maximum changes in near point of vision were 13%, 20% and 29%, respectively). The maximum change observed after tolterodine 5mg was the same as after Oxybutynin 5mg (i.e. 20%). Conclusions: Tolterodine seems to exhibit selectivity for the bladder over the eye. Therefore, these results suggest that the normal dosage of tolterodine (2mg twice daily) may have less effect on visual accommodation than the equivalent dosage of Oxybutynin (5mg three times daily) in patients with an overactive bladder.
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Tolterodine: Selectivity for the Urinary Bladder Over the Eye (as Measured by Visual Accommodation) in Healthy Volunteers
Drugs in R & D, 2002Co-Authors: Christopher R. Chapple, Lisbeth NilvebrantAbstract:Objective: Tolterodine exhibits a favourable selectivity for the urinary bladder over salivary glands in vivo , in the anaesthetised cat, whereas Oxybutynin shows the opposite selectivity profile in this model. This study further evaluated the selectivity profiles of tolterodine and Oxybutynin by comparing the effects on bladder function and visual accommodation in the same individuals. Methods: In a double-blind, randomised, four-way crossover study, 16 healthy volunteers received single oral doses of tolterodine 5mg and Oxybutynin 2.5, 5 and 7.5mg. Voiding parameters were assessed for 12 hours post-dose, along with visual accommodation (near point of vision) at regular intervals. Results: Adose-dependent increase in maximum bladder capacity was observed for Oxybutynin [2.5mg (+35%), 5mg (+45%) and 7.5mg (+57%)]. The effect of tolterodine 5mg on bladder capacity was approximately twice (+93%) that seen after Oxybutynin 5mg and the onset of the effect was more rapid with tolterodine. Effects on visual accommodation were also dose-dependent for Oxybutynin (maximum changes in near point of vision were 13%, 20% and 29%, respectively). The maximum change observed after tolterodine 5mg was the same as after Oxybutynin 5mg (i.e. 20%). Conclusions: Tolterodine seems to exhibit selectivity for the bladder over the eye. Therefore, these results suggest that the normal dosage of tolterodine (2mg twice daily) may have less effect on visual accommodation than the equivalent dosage of Oxybutynin (5mg three times daily) in patients with an overactive bladder.
Roger R. Dmochowski - One of the best experts on this subject based on the ideXlab platform.
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Pharmacokinetics of Oxybutynin Chloride Topical Gel
Clinical Drug Investigation, 2011Co-Authors: Roger R. Dmochowski, Peter K Sand, Diane K. Newman, Delbert C. Rudy, Kim E. Caramelli, Heather Thomas, Gary HoelAbstract:Background: Oxybutynin chloride topical gel (OTG; Gelnique®) is an approved formulation for the transdermal administration of Oxybutynin, an established antimuscarinic therapy for overactive bladder (OAB). Transdermal administration of Oxybutynin minimizes plasma concentrations of the active metabolite N -desethylOxybutynin ( N -DEO), which can have anticholinergic adverse effects. Objectives: In four phase I studies, we separately assessed the effects of OTG application site selection on Oxybutynin bioavailability (site-to-site study); the effects of post-application showering on Oxybutynin steady-state pharmacokinetics (showering study); the effects of sunscreen application on Oxybutynin absorption (sunscreen study); and the person-to-person transfer of Oxybutynin through skin-to-skin contact at the application site (transference study). Methods: All four studies were open-label, randomized, phase I studies. The site-to-site and showering studies involved repeated administration of OTG to establish steady-state plasma concentrations of Oxybutynin and N -DEO; the other two studies involved single doses. Clinical visits were required for pharmacokinetic sampling, supervision of OTG self-application on pharmacokinetic sampling days, showering, sunscreen application and transference experiments. The study included healthy subjects aged 18–45 years. Subjects with conditions requiring medical therapy or interfering with the application of OTG or the interpretation of pharmacokinetic results were excluded. Participants applied OTG (1 g containing Oxybutynin chloride 10%, 1.14 m L/dose) once daily to the abdomen, upper arm/shoulder or thigh. Showering occurred 1–6 hours after dosing. Sunscreen was applied 30 minutes before or after OTG application. Abdomen-to-abdomen contact with movement for 15 minutes between treated and untreated participants was conducted 1 hour after dosing. Time points of serial blood sampling for pharmacokinetic analyses varied among studies. Plasma concentrations of Oxybutynin and N -DEO (except transference study) were measured. Bioequivalence was tested with ANOVA models for log_e-transformed plasma exposure (area under the plasma concentration-time curve [AUC]) and maximum plasma concentration (C_max) to generate 90% confidence intervals (CIs). Results: Oxybutynin and N -DEO exposures (AUCs) from time zero to 24 hours (AUC_24) were similar for the three application sites, with N -DEO/ Oxybutynin mean AUC_24 ratios of approximately 0.9. The 90% CIs for thigh-to-abdomen ratios of Oxybutynin AUC_24 (0.93, 1.23) and C_max(0.85, 1.16) were within the interval required for bioequivalence (0.8, 1.25); the other application site ratios for Oxybutynin had boundaries slightly outside this interval. Showering 1–6 hours and sunscreen application 30 minutes before or after OTG application had minor effects on Oxybutynin concentrations. After vigorous skin contact between treated and untreated participants at the application site, the mean± SD AUC from time zero to 48 hours (AUC_48) of Oxybutynin in 12 untreated participants was 29.8 ± 24.5 ng · h/mL, approximately one-quarter of the exposures generally seen in subjects treated with a single dose of OTG. Oxybutynin AUC_48 after clothing-to-skin contact was undetectable in 12 of 14 untreated participants and very low (mean ± SD 0.4 ± 0.8 ng · h/mL) in two untreated female participants. Conclusion: The bioavailability of Oxybutynin and its pharmacokinetic profile are not greatly affected by application site selection, post-application showering or sunscreen use shortly before or after dosing with OTG. Oxybutynin transference to untreated persons is essentially prevented by avoiding direct skin-to-skin contact with the application site.
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Pharmacokinetics of Oxybutynin Chloride Topical Gel
Clinical drug investigation, 2011Co-Authors: Roger R. Dmochowski, Peter K Sand, Diane K. Newman, Delbert C. Rudy, Kim E. Caramelli, Heather Thomas, Gary HoelAbstract:Background: Oxybutynin chloride topical gel (OTG; Gelnique®) is an approved formulation for the transdermal administration of Oxybutynin, an established antimuscarinic therapy for overactive bladder (OAB). Transdermal administration of Oxybutynin minimizes plasma concentrations of the active metabolite N-desethylOxybutynin (N-DEO), which can have anticholinergic adverse effects.
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Transdermal Oxybutynin for overactive bladder.
The Urologic clinics of North America, 2006Co-Authors: G. Willy Davila, Jonathan S. Starkman, Roger R. DmochowskiAbstract:Overactive bladder is commonly treated with oral anticholinergic drugs such as Oxybutynin chloride. Although oral anticholinergic agents have been effective in controlling urinary urgency and frequency and in decreasing incontinence episodes, adverse events, particularly dry mouth, often cause patients to discontinue oral therapy and to endure incontinence. Oxybutynin can be delivered transcutaneously, maintaining the efficacy of oral Oxybutynin while significantly minimizing the side effects (eg, dry mouth) that may complicate therapy. By avoiding hepatic and gastrointestinal metabolism of Oxybutynin, less N-desethylOxybutynin is produced (this compound is deemed responsible for the anticholinergic side effects such as dry mouth). This novel Oxybutynin formulation offers patients who have overactive bladder and urge urinary incontinence a well-tolerated option for managing the symptoms of overactive bladder.
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transdermal Oxybutynin in the treatment of adults with overactive bladder combined results of two randomized clinical trials
World Journal of Urology, 2005Co-Authors: Roger R. Dmochowski, Victor W Nitti, David R Staskin, Karl M Luber, Rodney A Appell, Willy G DavilaAbstract:The safety and efficacy of Oxybutynin transdermal delivery system (Oxybutynin-TDS) versus placebo in adults with urge and mixed urinary incontinence was investigated using combined results from double-blind stages of 2 phase3 clinical trials. Study 1: placebo-controlled, parallel-group comparison of 3 Oxybutynin–TDS doses in 12-week double-blind and open-label periods, followed by a 28-week open-label extension. Study 2 was a 12-week randomized, double-blind, placebo-controlled comparison of Oxybutynin-TDS versus long-acting tolterodine and placebo, followed by a 52-week open-label extension. Efficacy analysis included 241 patients receiving Oxybutynin-TDS, 244 receiving placebo. Most participants were Caucasian women (92%). Approximately 60% received prior anticholinergic therapy. Primary outcome was determined by changes from baseline to end of treatment in frequency of incontinence episodes, frequency of urination, and void volume. Oxybutynin-TDS was significantly more effective than placebo in reducing median daily incontinence episodes (−3.0 vs placebo −2.0; P=.00004) and daily urinary frequency (−2.0 vs −1.0; P=.0023), and in increasing void volume (25 mL vs 5.5 mL; P<.00001). Overall rates of anticholinergic adverse events (AEs) were 12.8% for Oxybutynin-TDS and 11.0% for placebo (P=0.5421). The most common systemic anticholinergic AEs were dry mouth (7.0% for Oxybutynin-TDS vs 5.3% for placebo) and constipation (2.1% vs 2.0%). Application site erythema occurred in 7.0% of participants who received Oxybutynin-TDS (3.7% discontinuation rate); pruritus occurred in 16.1% (3.3% discontinuation rate). Transdermal Oxybutynin was shown to be efficacious, with a proven safety profile. It may be utilized for patients with overactive bladder as a treatment option that could enhance compliance.
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prospective randomized double blind study of the efficacy and tolerability of the extended release formulations of Oxybutynin and tolterodine for overactive bladder results of the opera trial
Mayo Clinic proceedings, 2003Co-Authors: Ananias C Diokno, Roger R. Dmochowski, R A Appell, I. Klimberg, Peter K Sand, Bernard M Gburek, Sherron KellAbstract:Objective To compare the efficacy and tolerability of extended-release formulations of Oxybutynin chloride and tolterodine tartrate in women with overactive bladder. Patients and Methods The OPERA (Overactive bladder: Performance of Extended Release Agents) trial was a randomized, double-blind, active-control study performed at 71 US study centers from November 21, 2000, to October 18, 2001. Extended-release formulations of Oxybutynin at 10 mg/d or tolterodine at 4 mg/d were given for 12 weeks to women with 21 to 60 urge urinary incontinence (UUI) episodes per week and an average of 10 or more voids per 24 hours. Episodes of UUI (primary end point), total (urge and nonurge) incontinence, and micturition were recorded in 24-hour urinary diaries at baseline and at weeks 2, 4, 8, and 12 and compared. Adverse events were also evaluated. Results Improvements in weekly UUI episodes were similar for the 790 women who received extended-release formulations of Oxybutynin (n=391) or tolterodine (n=399). Oxybutynin was significantly more effective than tolterodine in reducing micturition frequency ( P =.003), and 23.0% of women taking Oxybutynin reported no episodes of urinary incontinence compared with 16.8% of women taking tolterodine ( P =.03). Dry mouth, usually mild, was more common with Oxybutynin ( P =.02). Adverse events were generally mild and occurred at low rates, with both groups having similar discontinuation of treatment due to adverse events. Conclusions Reductions in weekly UUI and total incontinence episodes were similar with extended-release formulations of Oxybutynin and tolterodine. In the Oxybutynin group, micturition frequency was significantly lower, and the percentage of women reporting no urinary incontinence episodes was significantly higher compared with the tolterodine group. Dry mouth was more common with Oxybutynin, but tolerability was otherwise comparable, including adverse events involving the central nervous system.
Linda Cardozo - One of the best experts on this subject based on the ideXlab platform.
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comparison of the efficacy safety and tolerability of propiverine and Oxybutynin for the treatment of overactive bladder syndrome
International Journal of Urology, 2007Co-Authors: Paul Abrams, Christopher R. Chapple, Linda Cardozo, Dzelal Serdarevic, Katherine Hargreaves, Vikram KhullarAbstract:Aim: To compare the effects of propiverine and Oxybutynin on ambulatory urodynamic monitoring (AUM) parameters, safety, and tolerability in patients with overactive bladder. Methods: This was a randomized, double-blind, placebo-controlled, multicentre, crossover study. Patients (n = 77) received two of the following treatments during two 2-week periods: propiverine 20 mg once daily, propiverine 15 mg three times daily, Oxybutynin 5 mg three times daily, and placebo. AUM parameters, salivary flow, visual near point, and heart rate were assessed. Results: A consistent order in the efficacy between active treatment groups was observed for the reduction in mean involuntary detrusor contractions (IDCs; Oxybutynin 15 mg ≤ propiverine 45 mg ≤ propiverine 20 mg). Differences between the Oxybutynin and propiverine 20 mg groups were statistically significant for several AUM endpoints. Statistically significant differences between the Oxybutynin and both propiverine groups were also noted in salivary flow rate and heart rate (Oxybutynin 15 mg < both propiverine regimens) and in heart rate variability (both propiverine regimens < Oxybutynin 15 mg). All active treatments lengthened visual near point. The incidence of dry mouth was significantly more pronounced in the Oxybutynin group than in either propiverine group. Treatment with propiverine 45 mg resulted in the highest rates of constipation, lengthening of the visual near point, and effects on heart rate. Conclusions: Oxybutynin 15 mg was more effective than propiverine 20 mg in reducing symptomatic and asymptomatic IDCs in ambulatory patients. The primary differences between the two drugs were the incidence and type of adverse events, which varied with the antimuscarinic receptor specificity of each agent.
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Transdermal Oxybutynin: Sticking to the Facts
European urology, 2006Co-Authors: Rufus Cartwright, Linda CardozoAbstract:Objectives: This article critically reviews all the available published and presented data about transdermal Oxybutynin to provide a summary of its efficacy, tolerability, and acceptability. Results: For patients with urge incontinence or mixed incontinence, transdermal Oxybutynin offers equivalent efficacy to variable dose oral Oxybutynin IR and tolterodine LA 4 mg/d. At present no data are available for patients with frequency and urgency but without incontinence (overactive bladder [OAB] dry). Transdermal Oxybutynin offers marked improvements compared with placebo in incontinence episodes, daily urinary frequency, and nocturia. These objective improvements are matched by improvements in quality of life. The rate of anticholinergic side-effects is lower than that for oral anticholinergic preparations. This benefit is offset by a rate of local skin reactions. Conclusions: The balance of efficacy and tolerability suggests that transdermal Oxybutynin should be considered as a potential first-line therapy in OAB or mixed incontinence.
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Comparison of the efficacy, safety, and tolerability of propiverine and Oxybutynin for the treatment of overactive bladder syndrome: Comparison of properine and Oxybutynin
International journal of urology : official journal of the Japanese Urological Association, 2006Co-Authors: Paul Abrams, Christopher R. Chapple, Linda Cardozo, Dzelal Serdarevic, Katherine Hargreaves, Vikram KhullarAbstract:To compare the effects of propiverine and Oxybutynin on ambulatory urodynamic monitoring (AUM) parameters, safety, and tolerability in patients with overactive bladder. This was a randomized, double-blind, placebo-controlled, multicentre, crossover study. Patients (n = 77) received two of the following treatments during two 2-week periods: propiverine 20 mg once daily, propiverine 15 mg three times daily, Oxybutynin 5 mg three times daily, and placebo. AUM parameters, salivary flow, visual near point, and heart rate were assessed. A consistent order in the efficacy between active treatment groups was observed for the reduction in mean involuntary detrusor contractions (IDCs; Oxybutynin 15 mg </= propiverine 45 mg </= propiverine 20 mg). Differences between the Oxybutynin and propiverine 20 mg groups were statistically significant for several AUM endpoints. Statistically significant differences between the Oxybutynin and both propiverine groups were also noted in salivary flow rate and heart rate (Oxybutynin 15 mg < both propiverine regimens) and in heart rate variability (both propiverine regimens < Oxybutynin 15 mg). All active treatments lengthened visual near point. The incidence of dry mouth was significantly more pronounced in the Oxybutynin group than in either propiverine group. Treatment with propiverine 45 mg resulted in the highest rates of constipation, lengthening of the visual near point, and effects on heart rate. Oxybutynin 15 mg was more effective than propiverine 20 mg in reducing symptomatic and asymptomatic IDCs in ambulatory patients. The primary differences between the two drugs were the incidence and type of adverse events, which varied with the antimuscarinic receptor specificity of each agent.
Blair Jarvis - One of the best experts on this subject based on the ideXlab platform.
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Tolterodine : A review of its use in the treatment of overactive bladder
Drugs & aging, 2001Co-Authors: Delyth Clemett, Blair JarvisAbstract:Tolterodine is a competitive muscarinic receptor antagonist that shows in vivo selectivity for the bladder over the salivary glands compared with oxybutinin. Results of randomised double-blind placebo-controlled studies indicate that tolterodine 4 mg/day (administered as immediate-release tablets 2mg twice daily or extended-release capsules 4mg daily) is superior to placebo in improving micturition diary variables in patients with overactive bladder. Moreover, tolterodine 2mg twice daily is as effective as Oxybutynin 5mg 3 times daily. Maximum treatment effects with both drugs occurred after 5 to 8 weeks of treatment and improvements were maintained during long term treatment for up to 24 months. In a pooled analysis of four 12-week studies, equivalent and significant reductions in micturition frequency (-2.3 and -2.0 vs -1.4, p < 0.001) and the incidence of urge incontinence episodes (-1.6 and -1.8 vs -1.1, p < 0.05) were reported for tolterodine 2mg twice daily and Oxybutynin 5mg 3 times daily compared with placebo. Functional bladder capacity was also significantly increased. Improvements in patient perceptions of their urgency symptoms and of problems caused by their bladder condition were significantly greater during treatment with tolterodine than with placebo. Tolterodine was generally well tolerated in clinical trials of up to 24 months' duration. Dry mouth was the most frequent adverse event. The incidence (40 vs 78%, p < 0.001) and intensity of this event was lower with tolterodine 2mg twice daily than Oxybutynin 5mg 3 times daily. Additionally, a 23% lower incidence of dry mouth was reported with once daily extended-release tolterodine capsules than with twice daily immediate-release tablets (p < 0.02). The incidence of adverse CNS events with tolterodine was low and similar to that of placebo. Tolterodine was well tolerated in elderly patients and no serious tolerability concerns were identified. Tolterodine is the first antimuscarinic agent to specifically developed for the treatment of overactive bladder. The functional selectivity of tolterodine for the bladder translates into good efficacy and tolerability in patients, including the elderly, with overactive bladder. Tolterodine is as effective as Oxybutynin in improving micturition diary variables but is associated with a significantly lower incidence and intensity of dry mouth. This favourable tolerability profile, together with sustained clinical efficacy during long term treatment, places tolterodine as valuable treatment for the symptoms of overactive bladder.
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tolterodine a review of its use in the treatment of overactive bladder
Drugs & Aging, 2001Co-Authors: Delyth Clemett, Blair JarvisAbstract:UNLABELLED Tolterodine is a competitive muscarinic receptor antagonist that shows in vivo selectivity for the bladder over the salivary glands compared with oxybutinin. Results of randomised double-blind placebo-controlled studies indicate that tolterodine 4 mg/day (administered as immediate-release tablets 2mg twice daily or extended-release capsules 4mg daily) is superior to placebo in improving micturition diary variables in patients with overactive bladder. Moreover, tolterodine 2mg twice daily is as effective as Oxybutynin 5mg 3 times daily. Maximum treatment effects with both drugs occurred after 5 to 8 weeks of treatment and improvements were maintained during long term treatment for up to 24 months. In a pooled analysis of four 12-week studies, equivalent and significant reductions in micturition frequency (-2.3 and -2.0 vs -1.4, p < 0.001) and the incidence of urge incontinence episodes (-1.6 and -1.8 vs -1.1, p < 0.05) were reported for tolterodine 2mg twice daily and Oxybutynin 5mg 3 times daily compared with placebo. Functional bladder capacity was also significantly increased. Improvements in patient perceptions of their urgency symptoms and of problems caused by their bladder condition were significantly greater during treatment with tolterodine than with placebo. Tolterodine was generally well tolerated in clinical trials of up to 24 months' duration. Dry mouth was the most frequent adverse event. The incidence (40 vs 78%, p < 0.001) and intensity of this event was lower with tolterodine 2mg twice daily than Oxybutynin 5mg 3 times daily. Additionally, a 23% lower incidence of dry mouth was reported with once daily extended-release tolterodine capsules than with twice daily immediate-release tablets (p < 0.02). The incidence of adverse CNS events with tolterodine was low and similar to that of placebo. Tolterodine was well tolerated in elderly patients and no serious tolerability concerns were identified. CONCLUSION Tolterodine is the first antimuscarinic agent to specifically developed for the treatment of overactive bladder. The functional selectivity of tolterodine for the bladder translates into good efficacy and tolerability in patients, including the elderly, with overactive bladder. Tolterodine is as effective as Oxybutynin in improving micturition diary variables but is associated with a significantly lower incidence and intensity of dry mouth. This favourable tolerability profile, together with sustained clinical efficacy during long term treatment, places tolterodine as valuable treatment for the symptoms of overactive bladder.
