Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10158574 | Pulmonary Pharmacology & Therapeutics | 2018 | 21 Pages |
Abstract
This pooled analysis of double-blind, randomized, placebo-controlled trials aimed to investigate the impact of DOxofylline compaRed tO THEOphylline (DOROTHEO 1 and DOROTHEO 2 studies) on functional and clinical outcomes in asthma. Asthmatic patients â¥16 years of age with forced expiratory volume in 1â¯s (FEV1) â¥50% and <80% and with â¥15% post-bronchodilator increase in FEV1 were randomized in a 1:1:1:1 ratio in DOROTHEO 1 to receive doxofylline 200â¯mg, doxofylline 400â¯mg, theophylline 250â¯mg, or placebo; in DOROTHEO 2 patients were randomized in a 1:1:1 ratio to receive doxofylline 400â¯mg, theophylline 250â¯mg, or placebo. All double-blind treatments were taken orally with immediate release formulations and three times daily. Data evaluating the effect of doxofylline 400â¯mg, theophylline 250â¯mg and placebo on FEV1, asthma events rate, use of salbutamol as rescue medication and adverse events (AEs) were pooled from both studies. The pooled-analysis of 483 patients demonstrated that both doxofylline 400â¯mg and theophylline 250â¯mg significantly increased FEV1, reduced the rate of asthma events and use of salbutamol to relieve asthma symptoms compared to placebo (pâ¯<â¯0.01). No significant differences were detected between doxofylline 400â¯mg and theophylline 250â¯mg. Doxofylline 400â¯mg did not significantly (pâ¯>â¯0.05) increase the risk of AEs compared to placebo, conversely in patients treated with theophylline 250â¯mg the risk of AEs was significantly (pâ¯<â¯0.05) greater than in those that received placebo. We conclude that doxofylline seems to offer a promising alternative to theophylline with a superior efficacy/safety profile in the management of patients with asthma.
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Authors
Luigino Calzetta, Nicola A. Hanania, Frank L. Dini, Marc F. Goldstein, William R. Fairweather, William W. Howard, Mario Cazzola,