Efficacy and Cardiac Safety of Propiverine in Elderly Patients &amp;ndash; A Double&amp;ndash;Blind, Placebo&amp;ndash;Controlled Clinical Study

Dorschner, Wolfgang; Stolzenburg, Jens‐Uwe; Griebenow, R.; Halaška, Michael; Schubert, G.; Mürtz, Gerd; Frank, Martin J.; Wieners, F

doi:10.1159/000020221

Cited by 75 publications

(69 citation statements)

References 16 publications

(15 reference statements)

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“…In other studies, propiverine IR has already shown a good efficacy within treatment duration of 4 weeks in comparison with other drugs and in comparison with placebo [4,5,9] . The quick onset of action helps the patient and increases the compliance of the therapy.…”

Section: Discussionmentioning

confidence: 83%

Propiverine Hydrochloride Immediate and Extended Release: Comparison of Efficacy and Tolerability in Patients with Overactive Bladder

Jünemann¹,

Heßdörfer²,

Unamba-Oparah

et al. 2006

Urol Int

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Introduction: This study aims to compare the efficacy of propiverine hydrochloride immediate release (IR), propiverine hydrochloride extended release (ER) and placebo for the treatment of overactive bladder syndrome. The primary outcome measure is incontinence episode frequency, with secondary outcome measures including mean volume per void and quality of life as assessed on King’s Health Questionnaire. Material and Methods: The double-blind, double-dummy, randomized study compared IR 15 mg twice daily, ER 30 mg once daily and placebo in 3 parallel groups. After a run-in period of 7 days, the patients were treated for 32 days. Nine hundred and eighty-eight patients were randomized, and 910 patients completed the protocol without major violations. Results: The number of incontinence episodes/24 h decreased by 2.26 in the IR group (p < 0.001 vs. placebo), by 2.46 in the ER group (p < 0.0001 vs. placebo) and by 1.75 in the placebo group. The most frequent adverse event was dry mouth with 22.8% of the patients in the IR group, 21.7% in the ER group and 6.4% in the placebo group. The overall tolerability was rated ‘very good’ or ‘good’ by more than 80% of the investigators and patients in all 3 groups. Conclusions: Propiverine ER 30 mg once daily and propiverine IR 15 mg twice daily significantly reduce the number of incontinence episodes/24h within a treatment period of 32 days. Both formulations are safe and well tolerated. The extended release formulation of propiverine is a suitable new option for the treatment of the overactive bladder.

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Section: Discussionmentioning

confidence: 83%

Propiverine Hydrochloride Immediate and Extended Release: Comparison of Efficacy and Tolerability in Patients with Overactive Bladder

Jünemann¹,

Heßdörfer²,

Unamba-Oparah

et al. 2006

Urol Int

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“…The efficacy and safety profiles of fesoterodine in the SOFIA trial support the favorable benefit:risk ratio of antimuscarinic drugs in older adults with OAB reported in previous trials. [14][15][16][17] In addition, the study provides valuable data for individuals older than 75, indicating that fesoterodine is effective and well tolerated in this elderly subgroup. These results in this subgroup support those of the post hoc analysis of data from two randomized, fixeddose, placebo-controlled studies that indicated that the 4-and 8-mg doses of fesoterodine effectively treated OAB symptoms in individuals younger than 75, with the 8-mg dose being most effective in those aged 75 and older.…”

Section: Discussionmentioning

confidence: 95%

“…Few placebo-controlled studies have prospectively evaluated or reported age-stratified data on the efficacy and safety of antimuscarinics in this population. [14][15][16][17] Significantly greater improvements in OAB symptoms and patient-reported outcomes in the general population with OAB have been demonstrated with fesoterodine 4 and 8 mg than with placebo in fixed-and flexible-dosing clinical trials. [18][19][20][21] In a post hoc analysis of data from a fixed-dose trial of individuals with OAB stratified according to age, fesoterodine 4 and 8 mg improved OAB symptoms and HRQL significantly more than placebo in participants younger than 65 and in a group aged 65 to 74; only fesoterodine 8 mg was effective in participants aged 75 and older, 22 although this analysis included a limited number of individuals aged 75 and older.…”

mentioning

confidence: 99%

Flexible‐Dose Fesoterodine in Elderly Adults with Overactive Bladder: Results of the Randomized, Double‐Blind, Placebo‐Controlled Study of Fesoterodine in an Aging Population Trial

Wagg

Khullar

Marschall-Kehrel³

et al. 2013

J American Geriatrics Society

117

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“…Several studies evaluated the efficacy and tolerability of propiverine, demonstrating a significant reduction in number of incontinence episodes and a significant increase in the average micturition volume over placebo [69]. Lee et al [70] investigated the effects of propiverine in patients with OAB, focusing on improving urgency, the cornerstone symptom of OAB.…”

Section: Propiverinementioning

confidence: 99%

“…Several studies have demonstrated an overall favorable benefit-risk ratio without the induction of any cardiac arrhythmia in the treatment of elderly patients suffering from urgency, urge incontinence or combined urge-stress incontinence for propiverine [69,77]. …”

Section: Cardiovascular Safetymentioning

confidence: 99%

An Overview on Mixed Action Drugs for the Treatment of Overactive Bladder and Detrusor Overactivity

Asimakopoulos

Cerruto²,

Popolo³

et al. 2012

Urol Int

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Objectives: To provide an overview on the efficacy, tolerability, safety and health-related quality of life (HRQoL) of drugs with a mixed action used in the treatment of overactive bladder (OAB). Evidence Acquisition: MEDLINE database and abstract books of the major conferences were searched for relevant publications from 1966 to 2011 and using the key words ‘overactive bladder’, ‘detrusor overactivity’, ‘oxybutynin’, ‘propiverine’, and ‘flavoxate’. Two independent reviewers considered publications for inclusion and extracted relevant data, without performing a meta-analysis. Evidence Synthesis: Old and conflicting data do not support the use of flavoxate, while both propiverine and oxybutynin were found to be more effective than placebo in the treatment of OAB. Propiverine was at least as effective as oxybutynin but with a better tolerability profile even in the pediatric setting. Overall, no serious adverse event for any product was statistically significant compared to placebo. Improvements were seen in HRQoL with treatment by the oxybutynin transdermal delivery system and propiverine extended release. Conclusions: While there is no evidence to suggest the use of flavoxate in the treatment of OAB, both oxybutynin and propiverine appear efficacious and safe. Propiverine shows a better tolerability profile than oxybutynin. Both drugs improve HRQoL of patients affected by OAB. Profiles of each drug and dosage differ and should be considered in making treatment choices.

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Efficacy and Cardiac Safety of Propiverine in Elderly Patients – A Double–Blind, Placebo–Controlled Clinical Study

Cited by 75 publications

References 16 publications

Propiverine Hydrochloride Immediate and Extended Release: Comparison of Efficacy and Tolerability in Patients with Overactive Bladder

Propiverine Hydrochloride Immediate and Extended Release: Comparison of Efficacy and Tolerability in Patients with Overactive Bladder

Flexible‐Dose Fesoterodine in Elderly Adults with Overactive Bladder: Results of the Randomized, Double‐Blind, Placebo‐Controlled Study of Fesoterodine in an Aging Population Trial

An Overview on Mixed Action Drugs for the Treatment of Overactive Bladder and Detrusor Overactivity

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