Efficacy and Safety on 12-week Administration of Seratrodast, a Thromboxane A2 Antagonist, in Patients with Perennial Allergic Rhinitis.
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Accession number;99A0315574
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| Title;Efficacy and Safety on 12-week Administration of Seratrodast, a Thromboxane A2 Antagonist, in Patients with Perennial Allergic Rhinitis. |
| Author;
MASUDA YU
(Okayama Univ., Sch. of Med.)
OGAWARA TOSHIAKI
(Okayama National Hospital)
AKAGI SEIKO
(Okayama Red Cross Hosp.)
SAITO CHISATO
(Okayama Munic. Hosp.)
TAKEHISA TOORU
(Tsuyamachuobyoin)
SASAKI OSAMU
(Mizushima Kyodo Hosp.)
IGUCHI IKUO
(Soc. Insur., Hiroshima Munic. Hosp.)
AOCHI KATSUYA
(Kagawa Prefect. Cent. Hosp.)
NAGANO TOSHIAKI
(Mitoyo General Hosp.)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.15;NO.2;PAGE.355-371(1999)
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| Figure&Table&Reference;FIG.1, TBL.15, REF.15 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;AA-2414 (Seratrodast), a thromboxane A2 antagonist, at 80mg/day was given to the patients with perennial allergic rhinitis with moderate severity or worse for 12 weeks to 24 weeks if possible, and the efficacy and safety in a long-term administration were investigated. 1) Fourteen patients were given the test drug, and 11 completed 12-week or longer administration. Of the 11, 1 completed 24-week administration. 2) Improvement rate in nasal symptoms (primary end point): "moderate improvement" or better was 57.1% (8/14) at the final evaluation, and 63.6% (7/11) at week 12. 3) Improvement rate in nasal symptoms over the time course: "moderate improvement" or better at 4, 8, and 12 weeks after administration were 7.7% (1/13), 30.8% (4/13) and 63.6% (7/11), respectively. 4) Improvement rate classified by symptoms: "moderate improvement" or better at the final evaluation were 45.5% (5/11) for nasal obstruction, 35.7% (5/14) for nasal discharge, and 21.4% (3/14) for sneezing, demonstrating high improvement rate especially for nasal obstruction. 5) Improvement rate in nasal obstruction over the time course: "moderate improvement" or better at 4, 8, and 12 weeks after administration were 0.0% (0/10), 20.0% (2/10), and 55.6% (5/9), respectively. 6) Safety: incidence of accompanying symptoms where causality with the test drug could not be denied was 7.1%, and urticaria was found in 1 case; however, it was not serious, and disappeared soon after discontinuation. There were no abnormal changes in laboratory test values where causality with the test drug could not be denied. These results suggest that AA-2414 is markedly effective in treating the patients with perennial allergic rhinitis, and has no safety problems in a long-term administration. (author abst.) |
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