Efficacy and safety profile of doxofylline in asthma: a meta-analysis

This work aims to explore the effectiveness and safety of doxofylline in asthma treatment.

Relevant studies published before March 2023 were retrieved from EMBASE, Cochrane Library, PubMed, and Web of Science databases.

Risk of Bias tool (RoB 2) was applied to determine the quality of randomized controlled trials (RCTs). Relative risks (RR, 95% confidence intervals [CI]) and weighted mean differences (WMD, 95% CI) were calculated for dichotomous and continuous outcomes, respectively, under fixed or random-effects models.

A total of eight clinical trials comprising 1627 patients were analyzed. The meta-analysis revealed no notable change in forced expiratory volume in 1 s (FEV1) (WMD = 0.48; 95% CI: −2.09 to 3.05), the use of albuterol as a rescue medication (WMD = −0.02; 95% CI: −0.57 to 0.52), forced vital capacity (FVC) (WMD = 0.19; 95% CI: −0.28 to 0.67) and FEV1 predicted value (WMD = 1.53; 95%CI: −0.88 to 3.94) between doxofylline and control groups. However, doxofylline treatment significantly reduced adverse reactions (RR = 0.71; 95% CI: 0.60 to 0.84) and decreased the incidence of asthma events (WMD = −0.18; 95% CI: −0.33 to 0.03). Subgroup analysis results indicated that the improvement in FEV1 with doxofylline combined with budesonide was superior to that of budesonide combined with montelukast or tiotropium but inferior to that of budesonide plus formoterol combination.

Doxofylline treatment significantly reduces the risk of asthma events and adverse events (AEs), demonstrating good safety and longer-term benefits.