Post Marketing Surveillance of Propiverine Hydrochloride (BUP-4 Tablets) in Pollakiuria and Urinary Incontinence.
| Accession number;03A0059393 |
| Title;Post Marketing Surveillance of Propiverine Hydrochloride (BUP-4 Tablets) in Pollakiuria and Urinary Incontinence. |
| Author;ITO KUNIO(Taiho Pharm. Co., Ltd.) NISHI TOSHIMICHI(Taiho Pharm. Co., Ltd.) |
Journal Title;Japanese Pharmacology & Therapeutics
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Journal Code:Z0947A
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ISSN:0386-3603
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VOL.30;NO.12;PAGE.1023-1036(2002)
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| Figure&Table&Reference;FIG.2, TBL.6, REF.9 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The safety and efficacy of propiverine hydrochloride (Bup-4 tablet) were examined using two different enrollment methods (a method involving sequential enrollment of newly medicated patients and a retrospective method in which inclusion of patients was entrusted to the investigators). The incidence of adverse reactions was 10.4% in the sequential investigation group (436/4186), 8.6% in the conventional investigation group (530/6181) and 9.3% for the overall investigation (966/10367). The highest incidence was 4.6% for dry mouth followed by 1.6% for dysuria. Serious adverse reactions occurred in a total of only 3 cases and included glaucoma, increased BUN and hepatic dysfunction. When the adverse reaction effects were analysed as stratified by the patients' backgrounds, the incidence of adverse reactions was significantly high in patients with complications, treatment of concomitant drugs, hepatic function disorder before administration or renal function disorder before administration. It was markedly high, in particular, in patients with prostatic disease as complication. The incidence of adverse reactions was also high in the elderly. Concerning the efficacy, the final overall improvement ratio was 64.3% (5870/9127 patients). Furthermore, the scores for subjective symptom items such as the frequency of urination in daytime, urination in nighttime and urinary incontinence were significantly improved. (author abst.) |
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