Double-blind randomized parallel group study comparing the efficacy and safety of tiotropium and ipratropium in the treatment of COPD patients in Taiwan.
J Formos Med Assoc
; 105(9): 708-14, 2006 Sep.
Article
em En
| MEDLINE
| ID: mdl-16959618
ABSTRACT
BACKGROUND/PURPOSE:
To compare the efficacy and safety of tiotropium and ipratropium in patients with chronic obstructive pulmonary disease (COPD) in Taiwan.METHODS:
This double-blind, randomized, placebo-controlled, parallel group study was conducted at six hospitals in Taiwan. COPD patients aged > or = 40 years, with a forced expiratory volume in 1 second (FEV1) < or = 65% of predicted and FEV1/forced vital capacity (FVC) < or = 70% were enrolled. After a 2-week screening/baseline period, 132 patients were randomized to receive 4 weeks of treatment with either tiotropium 18 microg once daily from a dry powder inhaler (HandiHaler) or two puffs of ipratropium 20 microg four times daily from a metered dose inhaler. The primary outcome was the change in trough FEV1 from baseline to week 4. The secondary outcome measures were trough FVC response, FEV1 and FVC responses at 2 hours postinhalation.RESULTS:
After 4 weeks, trough FEV1 had increased by 61.7 +/- 25.3 mL for tiotropium but decreased by 16.4 +/- 27.9 mL for ipratropium. The difference between groups was significant (p < 0.05; 95% CI, 10-146.1). The trough FVC also increased by 137.2 +/- 49.3 mL for tiotropium but was decreased by 84.5 +/- 54.5 mL for ipratropium (p < 0.001; 95% CI, 89.0-354.3). No major drug-related adverse events associated with tiotropium and ipratropium were observed.CONCLUSION:
Tiotropium 18 microg once daily using HandiHaler was significantly more effective than ipratropium 40 microg four times daily in improving trough FEV1 and FVC over a 4-week period. The safety profiles of both drugs are comparable.
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Base de dados:
MEDLINE
Assunto principal:
Derivados da Escopolamina
/
Broncodilatadores
/
Ipratrópio
/
Antagonistas Colinérgicos
/
Doença Pulmonar Obstrutiva Crônica
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Prognostic_studies
Limite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
País/Região como assunto:
Asia
Idioma:
En
Revista:
J Formos Med Assoc
Assunto da revista:
MEDICINA
Ano de publicação:
2006
Tipo de documento:
Article
País de afiliação:
Taiwan