ラマトロバンの鼻アレルギー臨床第皿相試験-テルフェナジンとの比較-

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タイトル別名
  • A Comparison of the Efficacy and Safety between Ramatroban (BAY u 3405) and Terfenadine on Perennial Allergic Rhinitis -A Phase M, Randomized, Double-blind, Parallel Group, Comparative Study-
  • ラマトロバンの鼻アレルギー臨床第3相試験--テルフェナジンとの比較
  • ラマトロバン ノ ハナ アレルギー リンショウ ダイ 3ソウ シケン テルフェ

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The efficacy and safety of ramatroban (BAY u 3405), a thromboxane A2 receptor antagonist, was compared against terfenadine, a H1-blocker, in a randomized, double-blind, parallel group study on patients with perennial allergic rhinitis. One hundred and fifty mg/day of ramatroban was given to patients in Group B, and 120 mg/day of terfenadine was given to Group T patients for 4 weeks. A total of two hundred and three cases were enrolled in this study. Eighty-nine cases in Group B and 79 cases in Group T were valid for the efficacy comparison,95 patients in Group B and 89 in Group T were valid for the safety comparison, and 86 cases in Group B and 75 in Group T were valid for the usefulness comparison.<BR>In the final overall improvement rate,67.4% of the patients in Group B and 43.0% of those in Group T were evaluated as moderately or markedly improved. This reveals the significant improvement in Group B patients over Group T patients (U-test: p=0.011; Fisher: p=0.002). In the improvement of symptoms, nasal obstruction (U-test: p=0.004; Fisher: p=0.001) and daily discomfort due to nasal symptoms (U-test: p=0.009; Fisher: p=0.007) were significantly improved in Group B as compared to Group T. However, the nasal provocation (house dust) test was better controlled in Group T than in Group B (U-test: p=0.046).<BR>Subjective or objective adverse drug reactions were observed in 7 episodes in 5 cases (5.3%) from Group B, and 4 episodes in 3 cases (3.4%) from Group T, with no serious events. Abnormal clinical laboratory findings were noted in 9 tests in 5 cases (3.4%) from Group B and in 8 tests in 6 cases (6.7%) from Group T. In the overall safety comparison, there were no significant differences between the two groups; thus the safety of both drugs was equivalent.<BR>Based on these results, it can be concluded that ramatroban was significantly superior to terfenadine, especially in the improvement of nasal obstruction.

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