Replicating RCT Results With Real-World Data in Patients with COPD

An analysis of real-world data demonstrated that patients taking fluticasone propionate-salmeterol for chronic obstructive pulmonary disease (COPD) had outcomes that closely matched results of randomized controlled trials (RCTs), according to results published in the European Respiratory Journal.

Historical outcomes data for patients with COPD prescribed fluticasone propionate-salmeterol were obtained from the UK Clinical Practice Research Datalink (CPRD). Data were compared to outcomes from the landmark TORCH (Towards a Revolution in COPD Health) trial. Control groups included patients with COPD not prescribed fluticasone propionate-salmeterol, and patients with COPD prescribed salmeterol. Outcomes of interest were COPD exacerbations, death from any cause, and pneumonia.

Of the 2652 fluticasone propionate-salmeterol exposed people matched to 2652 fluticasone propionate-salmeterol unexposed people, and 991 fluticasone propionate-salmeterol exposed people matched to 991 salmeterol exposed people, the exacerbation rate ratio was comparable to TORCH for fluticasone propionate-salmeterol vs salmeterol (0.85; 95% CI, 0.74-0.97 vs 0.88; 95% CI, 0.81-0.95), but not for fluticasone propionate-salmeterol vs no fluticasone propionate-salmeterol (1.30; 95% CI, 1.19-1.42 vs 0.75; 95% CI, 0.69-0.81).

Fluticasone propionate-salmeterol vs salmeterol results were also consistent with TORCH for mortality (hazard ratio, 0.93; 95% CI, 0.65-1.32 vs 0.93; 95% CI, 0.77-1.13) and pneumonia (risk ratio, 1.39; 95% CI, 1.04-1.87 vs 1.47; 95% CI, 1.25-1.73).

“We obtained very similar results to the TORCH trial for active comparator analyses, but were unable to reproduce placebo-controlled results,” the study authors wrote. “Application of these validated methods for active comparator analyses to groups excluded from RCTs provides a practical way for contributing to the evidence base and supporting COPD treatment decisions.”

Disclosures: The TORCH study was supported by GlaxoSmithKline. Please see the original reference for a full list of authors’ disclosures.    

Reference

Wing K, Williamson E, Carpenter JR, et al. Real world effects of COPD medications: a cohort study with validation against RCT results. Eur Respir J. Published online October 22, 2020. doi:10.1183/13993003.01586-2020