Disclosures JG, SJE and JM are full-time employees of AstraZeneca UK Ltd (correct at the time of final approval), the manufacturer of Symbicort®. DMGH received funding from AstraZeneca for his involvement in this analysis and, beyond this project, has received sponsorship to attend international meetings and honoraria for lecturing, attending advisory boards and preparing educational materials from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline (the manufacturer of Seretide®), Nycomed and Pfizer. His department has received research funding from AstraZeneca. DS received funding from AstraZeneca for his involvement in this analysis and, beyond this project, has received sponsorship to attend international meetings, honoraria for lecturing or attending advisory boards and research grants from various pharmaceutical companies including Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Forest, GlaxoSmithKline, Novartis, Pfizer and UCB.
Budesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials
Article first published online: 16 JUN 2011
© 2011 Blackwell Publishing Ltd
International Journal of Clinical Practice
Volume 65, Issue 7, pages 764–774, July 2011
How to Cite
Halpin, D. M. G., Gray, J., Edwards, S. J., Morais, J. and Singh, D. (2011), Budesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials. International Journal of Clinical Practice, 65: 764–774. doi: 10.1111/j.1742-1241.2011.02685.x
- Issue published online: 16 JUN 2011
- Article first published online: 16 JUN 2011
- Paper received August 2010, accepted March 2011
Aims: This analysis was designed to provide a comparison between budesonide/formoterol and salmeterol/fluticasone for the relative incidence of pneumonia adverse events, pneumonia serious adverse events and pneumonia-related mortality in patients being treated for chronic obstructive pulmonary disease.
Methods: An initial literature search revealed no suitable head-to-head trials between budesonide/formoterol and salmeterol/fluticasone and therefore a systematic review was conducted to find randomised controlled trials providing data for input into an adjusted indirect comparison of the two combination treatments using placebo as a common comparator. The Bucher adjusted indirect comparison method was used to calculate odds ratios and 95% confidence intervals.
Results: Eight salmeterol/fluticasone trials and four budesonide/formoterol trials were identified as being relevant for the analyses. The proportion of patients experiencing a pneumonia adverse event was significantly lower with budesonide/formoterol than salmeterol/fluticasone (odds ratio, 0.47; 95% confidence interval, 0.28–0.80). The proportion of patients experiencing a pneumonia serious adverse event was also significantly lower with budesonide/formoterol than salmeterol/fluticasone (odds ratio, 0.41; 95% confidence interval, 0.19–0.86). However, there were too few events to draw any firm conclusions on pneumonia-related mortality.
Conclusions: The results of the indirect comparison support the hypothesis that budesonide/formoterol is associated with fewer pneumonia events than salmeterol/fluticasone in chronic obstructive pulmonary disease. The limitations of the analysis are that the results from a single study, TORCH, have a large bearing on the overall findings of the analysis, and that there is heterogeneity in the length and the dosing of the included studies, although it does not appear that heterogeneity affected the reported results. Another important limitation is the lack of predefined diagnostic standards for pneumonia in these studies.