PRODUCT LITERATURE

A Comparison of Oral Procaterol and Albuterol in Reversible Airflow Obstruction

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The efficacy and safety of orally administered procaterol hydrochloride, a potent ~2adrenergic bronchodilator, was compared with that of albuterol in an eight-center, double-blind study conducted in 223 patients with mild to moderate, reversible bronchial airway obstruction. After a 1-wk placebo washout period, patients were administered either procaterol 0.05mg twice daily for
2 wk followed by 0.10mg twice daily for 10wk or albuterol 2 mg three times a day for 2 wk followed by 4 mg three times a day for 10wk. Spirometry determinations 1.5h postdose showed consistently greater percent improvements from predose in FVC, FEV" and FEF25- 75 with procaterol than with albuterol at Weeks 1,2,4,8, and 12. 1i'eatment differences were statistically significant (a =0.05)
after 2 wk, 2 months, and 3 months of treatment. Bronchodllatation was evident 0.5 h after dosing and peakedat 1.5to 3 h postdose for both treatments. The duration of action (i.e., time until spirometry determinations were lower than those at 0.5 h postdose) was at least 5 h after procaterol but only 3 h after albuterol. There was no evidence of tolerance with continued procaterol treatment,
whereas a diminished duration of response to albuterol was observed with long-term treatment.
Tremorwas reported statistically more frequently In patients receiving procaterol than in those receiving albuterol (a = 0.05); the frequencies of other adverse events were similar for the two groups.
No statistically significant treatment differences were noted for asthma symptoms, global evaluations, ECGresults, vital signs, or clinical laboratory measurements. Under the dose regimen selected for this stUdy, oral procaterol (0.1mg twice daily) was found to have a rapid onset of action and a duration and magnitude of bronchodilatation superior to that of oral albuterol (4 mg three times a day)

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Publisher

: .,

Collation

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Language

English

ISBN/ISSN

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Classification

NONE

Content Type

LITERATURE

Media Type

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Carrier Type

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Edition

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Subject(s)

Proterol
Oral Procaterol
Airflow Obstruction

Specific Detail Info

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Statement of Responsibility

AM REV RESPIR DIS 1988; 138:1504-1509

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