(183) Safety and Efficacy of Indacaterol/Glycopyrronium Versus Salmeterol/Fluticasone in Moderate-To-Severe Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis

Saturday, August 27, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 857

Presenting Author(s)

Maya T, PharmD
– Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India

Co-Author(s)

Alisha Mathew
– Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, India
Elstin Anbu Raj S
– Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India
Rajesh Vilakkathala, MPharm, PhD
– Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Manipal College of Pharmaceutical Sciences, Udupi, Karnataka, India

Background: Indacaterol/ Glycopyrronium (IND/GLY) has known to show the strongest evidence of efficacy and safety in COPD patients. Fixed dose combination of IND/GLY is the preferred drug for maintenance therapy in patients with moderate to severe COPD.

Objectives: The current meta-analysis aimed to assess the efficacy and safety of once daily IND/GLY (110/50 mcg) compared with twice daily Salmeterol/ Fluticasone (50/500 mcg) in moderate-to-severe COPD patients.

Methods: A systematic literature search was conducted in PubMed, EMBASE, Clinicaltrials.gov and manufacturers site (Novartis). Parallel-group blinded randomized controlled trials (RCTs) that assessed fixed dose combinations of IND/GLY (110/50 mcg) and SFC (50/500 mcg) with moderate-to-severe COPD were included. The efficacy outcomes included were SGRQ score (St George Respiratory Questionnaire), Trough (Forced Expiratory Volume) FEV1, FEV1 AUC, number of moderate-to-severe exacerbations and number of adverse events, serious adverse events and mortality were noted as safety outcomes. In case of dichotomous data, the number of events were used to calculate the overall odds ratio and risk ratio. On the other hand, the least squares mean and standard deviation were used for continuous variables. A meta-analysis of the included RCTs was performed using RevMan 5.4. A p > 0.05 was considered significant throughout the study.

Results: The search yielded a total of 634 articles of which three RCTs were included fulfilling the inclusion criteria. IND/GLY was found to be significantly effective than SFC in terms of trough FEV1 (0.27; [95% CI: 0.23-0.32]; p< 0.00001), FEV1 Area Under Curve (AUC) (0.35; [95% CI: 0.23-0.48]; p< 0.00001) and number of moderate-to-severe exacerbations (OR = 0.52; [95% CI: 0.38-0.71]; p< 0.0001).

Conclusions: The meta-analysis showed improved SGRQ-C scores, FEV1 and reduced rate of exacerbations in patients administered with IND/GLY (110/50 mcg) compared to SFC (50/500 mcg). However, a higher incidence of COPD aggravation and pneumonia were observed in patients treated with SFC across all three included trials.