Effect of twelve-months therapy with oral ambroxol in preventing exacerbations in patients with COPD. Double-blind, randomized, multicenter, placebo-controlled study (the AMETHIST Trial)

被引:65
作者
Malerba, M
Ponticiello, A
Radaeli, A
Bensi, G
Grassi, V
机构
[1] Univ Brescia, Spedali Civili, Div Med 1, Dipartimento Med Interna, I-25100 Brescia, Italy
[2] Univ Naples Federico II, Dept Resp Dis, Naples, Italy
[3] Boehringer Ingelheim Italia SpA, Dept Med, Milan, Italy
关键词
chronic obstructive pulmonary disease; exacerbation; mucolytics; prevention;
D O I
10.1016/j.pupt.2003.08.004
中图分类号
R9 [药学];
学科分类号
1007 [药学];
摘要
The objective of this prospective, randomized, double-blind, placebo-controlled, multicenter parallel-group study was to evaluate the effect of long-term ambroxol treatment in preventing exacerbations of chronic obstructive pulmonary disease (COPD). Two hundred and forty-two outpatients with COPD defined by ATS criteria with value of FEV1 between greater than or equal to 60 and 80% of predicted and history of one or more exacerbations in the previous year were recruited by 26 Respiratory Medicine Centers in Italy and treated for 1 year with one ambroxol retard capsule of 75 mg twice daily or placebo. The percentage of patients free from exacerbation at 6 months was 63% with ambroxol and 60% with placebo (p = 0.366) and at 12 months 56% with ambroxol and 53% with placebo (p = 0.363). In a subset of 45 patients with more severe baseline symptoms, ambroxol therapy was associated with a significant higher percentage of patients free from exacerbation compared to placebo: 63 vs. 38% (p = 0.038). In conclusion, we did not find a significant difference between long-term ambroxol therapy and placebo, in preventing exacerbations in patients with COPD. In patients with more severe respiratory symptoms at baseline, however, we observed a significant difference in the cumulative exacerbation-free persistence between ambroxol and placebo, suggesting that long-term muco-regulatory therapy with ambroxol could be useful in highly symptomatic patients with COPD. (C) 2004 Elsevier Ltd. All rights reserved.
引用
收藏
页码:27 / 34
页数:8
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