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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. 2006 Sep; 105(9):708-14.JF

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.

Authors+Show Affiliations

Division of Chest Medicine, Taichung Veterans General Hospital, and Institute of Medicine, Chung-Shan Medical University, Taichung, Taiwan. hsujy@vghtc.gov.twNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16959618

Citation

Hsu, Jeng-Yuan, et al. "Double-blind Randomized Parallel Group Study Comparing the Efficacy and Safety of Tiotropium and Ipratropium in the Treatment of COPD Patients in Taiwan." Journal of the Formosan Medical Association = Taiwan Yi Zhi, vol. 105, no. 9, 2006, pp. 708-14.
Hsu JY, Perng RP, Lu JY, et al. 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. 2006;105(9):708-14.
Hsu, J. Y., Perng, R. P., Lu, J. Y., Wu, C. P., Huang, M. S., Luh, K. T., & Yang, P. C. (2006). Double-blind randomized parallel group study comparing the efficacy and safety of tiotropium and ipratropium in the treatment of COPD patients in Taiwan. Journal of the Formosan Medical Association = Taiwan Yi Zhi, 105(9), 708-14.
Hsu JY, et al. 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. 2006;105(9):708-14. PubMed PMID: 16959618.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Double-blind randomized parallel group study comparing the efficacy and safety of tiotropium and ipratropium in the treatment of COPD patients in Taiwan. AU - Hsu,Jeng-Yuan, AU - Perng,Reury-Perng, AU - Lu,Jau-Yeong, AU - Wu,Chin-Pyng, AU - Huang,Ming-Shyan, AU - Luh,Kwen-Tay, AU - Yang,Pan-Chyr, PY - 2006/9/9/pubmed PY - 2007/11/14/medline PY - 2006/9/9/entrez SP - 708 EP - 14 JF - Journal of the Formosan Medical Association = Taiwan yi zhi JO - J. Formos. Med. Assoc. VL - 105 IS - 9 N2 - 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. SN - 0929-6646 UR - https://www.unboundmedicine.com/medline/citation/16959618/Double_blind_randomized_parallel_group_study_comparing_the_efficacy_and_safety_of_tiotropium_and_ipratropium_in_the_treatment_of_COPD_patients_in_Taiwan_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0929-6646(09)60198-4 DB - PRIME DP - Unbound Medicine ER -