(60) Inhaled Corticosteroid Combinations in COPD-Safety and Efficacy: A Systematic Review of Real-World Data

Saturday, August 27, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 734

Presenting Author(s)

Ramesh Madhan, PhD
– Professor, JSS College of Pharmacy, Mysore, India

Co-Author(s)

Christy Thomas
– National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, Guwahati, Assam, India
Chalasani Sri Harsha, MPharm
– JSS College of Pharmacy, Dept of Pharmacy Practice, JSS College of Pharmacy, Mysuru, Karnataka, India
Krishna Murti
– NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH (NIPER), Hajipur, India

Background: Chronic obstructive pulmonary disease (COPD) is one of the most prevalent health concerns affecting globally around 251 million individuals, and it is assessed to be the third driving reason for death by 2030.

Objectives: To assess the efficacy and safety of inhaled corticosteroids (ICS) combinations in COPD patients.

Methods: A systematic review and meta-analysis was carried out by searching English language databases from January 2000 to January 2020. All parallel or cross-over randomized clinical trials (RCTs) evaluating the efficacy and safety of ICS combinations against placebo, no medication, or other comparators given for at least 12 weeks continuously were included. The study quality was assessed using the JADAD score. Two reviewers independently screened, extracted and assessed the studies. Any differences were resolved by discussion with a third reviewer. The results will be pooled using random-effects meta-analysis. The meta-analysis was conducted using Review Manager 5.3. The study was registered at PROSPERO [CRD42020176782].

Results: A total of 30 high quality RCTs out of 7470 screened studies, with 57% having a maximum JADAD score of 5 were selected for the review. The primary outcomes of ICS combinations of change from baseline in FEV1 trough [Mean Deviation (MD): 69.54; 95% Confidence Interval (CI): 22.5, 116.58; p< 0.0004], change from baseline in the SGRQ-C score [MD: -1.46; 95% CI: -2.23, -0.59; p< 0.0001], and change from baseline in COPD Assessment Test (CAT) score [MD: -1.08; 95% CI: -1.53, -0.63; p< 0.0001] were statistically significant. There was no statistically significant change in the patient reported acute exacerbation [Odds Ratio (OR): 0.85; 95% CI: 0.64, 1.07; p= 0.15], and no significant improvement in the Total Dyspnea Index (TDI) score [MD: -0.03; 95% CI: -0.15, -0.10; p= 0.14] found among the primary outcomes, when compared to control. The secondary outcomes related to safety aspects of the ICS combinations, the cardiovascular side-effects [OR: 0.88; 95% CI: 0.78, 1.00; p= 0.05], and treatment discontinuation due to lack of efficacy [OR: 0.64; 95% CI: 0.51, 0.81; p= 0.0001] were found to be statistically significant, when compared to control.

Conclusions: This meta-analysis results suggest ICS combinations was better efficacious in terms of controlling symptoms. However, long term studies are needed for further understanding on the safety aspects of the ICS combinations.