[Therapy of overactive bladder with propiverine ER: results of a non-interventional study with a propiverine retard formulation and comparison to clinical studies]. / Therapie der überaktiven Blase mit Propiverin ER : Ergebnisse einer nichtinterventionellen Studie mit einer Propiverin-Retardformulierung und Vergleich zur klinischen Studie.

BACKGROUND: The aim of this non-interventional study was to evaluate the efficacy and tolerability of propiverine ER under real life conditions. PATIENTS AND METHODS: The treatment of 5,565 patients with urge urinary incontinence, urgency or mixed urinary incontinence was documented over a 12-week period. Incontinence episodes, voiding frequency and voided volume were recorded at 3 visits (admission, after 4 and 12 weeks). Additionally the tolerability was evaluated at visits 2 and 3. RESULTS: The average incontinence episodes/24 h decreased during therapy from 4.23 to 2.89. The frequency of micturitions/24 h decreased by 5.50. The voided volume improved by 69 ml. Approximately 92 % of investigators and patients assessed the efficacy similarly with "very good" and "good". Dry mouth was the most frequent adverse drug reaction and decreased from 16.5 % after 4 weeks to 13.6 % after 12 weeks of treatment. CONCLUSION: The efficacy and tolerability of propiverine ER were confirmed under real life conditions.

[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.

[Gemcitabine/cisplatin vs. MVAC. 5 year survival outcome of the phase III study of chemotherapy of advanced urothelial carcinoma in Germany]. / Gemcitabin/Cisplatin vs. MVAC. 5-Jahres-Ergebnisse der Phase-III-Studie zur Chemotherapie des fortgeschrittenen Urothelkarzinoms in Deutschland.

Of 405 patients with stage IV transitional cell carcinoma from an international multicenter phase III trial, 70 were randomized in Germany to receive either gemcitabine/cisplatin or standard MVAC systemic chemotherapy for locally advanced or metastatic urothelial cancer. Overall survival as the primary endpoint of the study was similar in both arms (median survival GC 15.4 months vs MVAC 16.1 months), as were tumor-specific survival and time to progressive disease. In the intent-to-treat analysis, the 5-year overall survival rate was 10% for patients randomized to GC and 18% randomized to MVAC. Tumor overall response rates (GC 54%, MVAC 53%) were similar. The toxic death rate was 0% in the GC arm and 3% (one patient) in the MVAC arm. Significantly more GC than MVAC patients experienced grade 3/4 anemia (GC 52%, MVAC 20%) with significantly more red blood cell transfusions in the GC arm.Significantly more GC than MVAC patients had grade 3/4 thrombocytopenia (GC 54%, MVAC 17%) without grade 3/4 hemorrhage or hematuria in either arm. More MVAC patients experienced grade 3/4 neutropenia (GC 56%, MVAC 61%, p=1.000), neutropenic or leukopenic fever (GC 0%, MVAC 10%, p=0.237), mucositis (GC 0%, MVAC 7%, p=0.495), and alopecia (GC 6%, MVAC 36%, p=0.004). GC represents a reasonable alternative for the palliative treatment of patients with locally advanced and metastatic transitional cell carcinoma. Sustained long-term survival was only found for patients with locally advanced cancer, lymphatic metastases, or solitary distant metastasis but not for visceral metastatic disease.