Initiating or changing to a fixed-dose combination of Fluticasone propionate/Formoterol over Fluticasone propionate/Salmeterol: A real-life effectiveness and cost impact evaluation

Respir Med. 2017 Aug;129:199-206. doi: 10.1016/j.rmed.2017.06.016. Epub 2017 Jun 24.


Objective: Asthma has a substantial impact on quality of life and health care resources. The identification of a more cost-effective, yet equally efficacious, treatment could positively influence the economic burden of this disease. Fluticasone propionate/Formoterol (FP/FOR) may be as effective as Fluticasone Salmeterol (FP/SAL). We evaluated non-inferiority of asthma control in terms of the proportion of patients free from exacerbations, and conducted a cost impact analysis.

Methods: This historical, matched cohort database study evaluated two treatment groups in the Optimum Patient Care Research Database in the UK: 1) an FP/FOR cohort of patients initiating treatment with FP/FOR or changing from FP/SAL to FP/FOR and; 2) an FP/SAL cohort comprising patients initiating, or remaining on FP/SAL pMDI combination therapy. The main outcome evaluated non-inferiority of effectiveness (defined as prevention of severe exacerbations, lower limit of the 95% confidence interval (CI) of the mean difference between groups in patient proportions with no exacerbations is -3.5% or higher) in patients treated with FP/FOR versus FP/SAL.

Results: After matching 1:3, we studied a total of 2472 patients: 618 in the FP/FOR cohort (174 patients initiated on FP/FOR and 444 patients changed to FP/FOR) and 1854 in the FP/SAL cohort (522 patients initiated FP/SAL and 1332 continued FP/SAL). The percentage of patients prescribed FP/FOR met non-inferiority as the adjusted mean difference in proportion of no severe exacerbations (95%CI) was 0.008 (-0.032, 0.047) between the two cohorts. No other significant differences were observed except acute respiratory event rates, which were lower for patients prescribed FP/FOR (rate ratio [RR] 0.82, 95% CI 0.71, 0.94).

Conclusions: Changing to, or initiating FP/FOR combination therapy, is associated with a non-inferior proportion of patients who are severe exacerbation-free at a lower average annual cost compared with continuing or initiating treatment with FP/SAL.

Keywords: Asthma; Cost-effectiveness; Fixed-dose combination inhalers; Formoterol; GINA; Real-life.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Androstadienes / administration & dosage
  • Androstadienes / economics
  • Androstadienes / therapeutic use*
  • Anti-Asthmatic Agents / economics*
  • Anti-Asthmatic Agents / therapeutic use
  • Asthma / drug therapy*
  • Asthma / economics*
  • Cohort Studies*
  • Cost-Benefit Analysis / economics*
  • Drug Combinations
  • Drug Therapy, Combination / methods*
  • Ethanolamines / administration & dosage
  • Ethanolamines / economics
  • Ethanolamines / therapeutic use*
  • Female
  • Fluticasone
  • Fluticasone-Salmeterol Drug Combination / administration & dosage
  • Fluticasone-Salmeterol Drug Combination / economics
  • Fluticasone-Salmeterol Drug Combination / therapeutic use*
  • Formoterol Fumarate
  • Humans
  • Male
  • Middle Aged
  • Patient Acceptance of Health Care / statistics & numerical data
  • Quality of Life
  • Treatment Outcome
  • United Kingdom / epidemiology


  • Androstadienes
  • Anti-Asthmatic Agents
  • Drug Combinations
  • Ethanolamines
  • Fluticasone-Salmeterol Drug Combination
  • fluticasone-formoterol
  • Fluticasone
  • Formoterol Fumarate