[Post marketing surveillance study with an analgesic (transdermal buprenorphine patch) in patients with moderate to severe chronic pain]. / Transdermales Buprenorphinpflaster bei Patienten mit mässig starken bis starken chronischen Schmerzen. Multizentrische Anwendungsbeobachtung.

AIM: To obtain information on the efficacy, tolerability and safetyofa transdermal buprenorphine patch (Transtec PRO) in patients with moderate to severe chronic pain. In addition it should be evaluated to what extent the two fixed patch change days per weekare simplifyingthe therapy. METHODS: In this prospective multi-center post marketing surveillance study patients with chronic cancer and non-cancer pain were treated with transdermal buprenorphine for up to eight weeks. The evaluation included pain intensity, the dosage of the applied analgesics and additional therapies, the renal function (by serum creatinine) and adverse events. RESULTS: 3654 patients were treated for a mean of 50.4 days. Using the NRS-11 the mean pain intensity decreased from 6.3 at the time when patients were switched to the transdermal buprenorphine patch to 2.6 at the last treatment evaluation. The matrix patch was safe and well tolerated also in patients with advanced renal insufficiency. Adverse events were reported in 6.7% of the patients. 89.3% of the physicians quoted to prefer transdermal buprenorphine with the two fixed patch change days per week compared to the pre-treatment. CONCLUSION: The buprenorphine-containing matrix patch was effective and well tolerated in patients with moderate to severe chronic cancer and noncancer pain. From the physicians view the two fixed patch change days per week facilitate the guidance of therapy. In patients with advanced renal insufficiency a dose adjustment is not necessary.

Propiverine hydrochloride immediate and extended release: comparison of efficacy and tolerability in patients with overactive bladder.

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/24 h 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.

[Therapy for overactive detrusor using propiverine]. / Therapie der Detrusorhyperaktivität mit Propiverin.

BACKGROUND: Our aim was to evaluate the efficacy and tolerability of propiverine hydrochloride (propiverine) in daily practice and to check the risk-benefit relation using previously collected data on 4,390 patients. PATIENTS AND METHODS: A total of 2,932 patients with symptoms of overactive bladder were treated with propiverine over a period of 12 weeks using a multicentre post marketing surveillance. At three visits (inclusion, after 4 weeks, after 12 weeks), parameters from the micturition diary (incontinence episodes, frequency of micturition, micturition volume) were recorded. RESULTS: The number of incontinence episodes during daytime decreased during therapy from 3.6+/-3.8 to 1.2+/-2.3. The number of episodes at night decreased from 1.5+/-2.1 to 0.4+/-0.8 (both P<0.001). The mean volume per micturition improved during therapy (from 142.7 ml to 213.3 ml; +49.5%; P<0.0001). Some 85% of the investigators judged the efficacy of propiverine to be good or very good, 2.1% as not sufficient. The most frequent adverse event was dry mouth (17.3% of the patients after 12 weeks) mostly with low severity. More than 70% of the patients reported good or very good tolerability. Only 0.6% of the patients reported insufficient tolerability.

[The elderly patient with urge incontinence or urge-stress incontinence - efficacy and cardiac safety of propiverine]. / Der ältere Patient mit Drang-Symptomatik bzw. kombinierter Drang/Stress-Inkontinenz-Wirksamkeit und kardiale Sicherheit von Propiverin.

PURPOSE: The efficacy of propiverine in elderly patients suffering from urge incontinence or urge-stress incontinence was intended to be investigated. Especially in elderly patients a cardiac influence of propiverine is possible due to its dual mode of action. That is why besides the efficacy especially the cardiac safety was intended to be investigated. MATERIAL AND METHODS: Ninety-eight patients (21 male, 77 female; 67.7 +/- 6.3 years of age) suffering from urgency, urge incontinence or mixed urge-stress incontinence were included in the double-blind, multicentre, placebo-controlled, randomized study. After a two-week placebo run-in period, the patients received propiverine (15 mg t. i. d.) or placebo (t. i. d.) for four weeks. Before (U 1, U 2) and during the treatment period (U 3, U 4), standard ECG's and 24 h long-term ECG's were recorded. RESULTS: Propiverine caused a significant reduction in the micturition frequency (U 2 : 8.7 +/- 4.2, U 4 : 6.5 +/- 3.2 ml; p < 0.01) reflected in a significant increase in the average micturition volume (U 2 : 163.5 +/- 65.9, U 4 : 216.3 +/- 101.5 ml; p < 0.01) and a significant reduction in the episodes of incontinence (- 54 %; p < or = 0.05). These findings were confirmed by the overall assessment after four weeks in which approximately 90 % of patients under propiverine were either free from urge incontinence and urge symptoms or improved. The efficacy parameters demonstrated a better efficacy for urge incontinence than for mixed urge-stress incontinence. Resting and ambulatory electrocardiograms evidenced no significant changes. Neither QTc interval nor other cardiac parameters were relevantly altered. The frequency of cardiac events (Lown classes IV a/b) was fortuitous, revealing no difference between placebo and propiverine. The incidence of adverse events was very low (2 % dryness of the mouth under propiverine) and confirmed by the findings from the quality of life questionnaires. CONCLUSIONS: A favourable benefit-risk ratio in the treatment of elderly patients suffering from urgency, urge incontinence or combined urge-stress incontinence is therefore proven for propiverine. Cardiac arrhythmia were not induced.