| Autor: |
Brazinsky, Shari A., Lapidus, Robert J., Weiss, Laurence A., Ghafouri, Mo, Fagan, Nora M., Witek, Theodore J. |
| Předmět: |
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| Zdroj: |
Clinical Drug Investigation; 2003, Vol. 23 Issue 3, p181-191, 11p |
| Abstrakt: |
Introduction: Ipratropium bromide (IB) is an established and effective first-line maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). A new IB metered-dose inhaler (MDI) using hydrofluoroalkane 134a propellant (IB HFA) has been developed as an alternative to the MDI containing chlorofluorocarbon (IB CFC). Objective: To compare the long-term safety and efficacy of IB HFA and IB CFC in patients with COPD. Study design: This was a randomised, open-label, parallel-group, 1-year, multicentre trial. Primary endpoints included adverse events (AEs) and vital signs. Secondary endpoints included therapeutic response (>15% increase in forced expiratory volume in 1 second [FEV[sub 1]] peak change from baseline), FEV[sub 1] area under the response-time curve (AUC). Patients and interventions: Patients (n = 456) with moderate-to-severe COPD, who received either IB HFA (n = 305) or IB CFC (n = 151), both 42μg four times daily. Results: There were no significant differences in the incidences of individual AEs between groups over the short and long term; respiratory disorders were the most common. The incidence of anticholinergic AEs possibly related to treatment was low (1.3% IB HFA, 0.7% IB CFC). Serious AEs occurred in 19.0% and 20.5%, and discontinuations due to AEs in 7.2% and 7.3%, of patients receiving IB HFA and IB CFC, respectively. Therapeutic bronchodilatory responses were achieved in 76-81% and 72-84% of patients, and AUC ranged from 0.117-0.148L and 0.117-0.174L, in patients receiving IB HFA and IB CFC, respectively. Conclusions: IB HFA had similar efficacy and tolerability to IB CFC over 1 year, supporting a seamless transition from the CFC MDI to the HFA MDI in both short- and long-term treatment. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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