A POST-APPROVAL, OBSERVATIONAL STUDY TO ASSESS CLINICAL IMPACT OF GLYCOPYRRONIUM IN HIGH RISK COPD WITH FREQUENT EXACERBATIONS: POST HOC ANALYSES

Background: Exacerbations remain a distinct clinical challenge in Chronic obstructive pulmonary disease (COPD) with consequent use of ICS in real-world practice of India. LAMA add-on therapy has been well highlighted by UPLIFT, TRIBUTE & KRONOS studies. Glycopyrronium add on therapy offers quick control of morning symptoms for likely improved patient adherence rates in COPD Objectives: To assess the clinical impact and use of Glycopyrronium add-on therapy in outpatient settings, real world observational study was planned. Methods and Material: National, post-approval, observational, drug utilization, concurrent analyses was carried out at 128 centers during Sept '17 with institutional Ethics & CTRI registration. Post-hoc analyses was carried out by Quick Calcs GraphPad Prism ver. 7 software with p<0.05 considered as statistically significant Results: The per protocol analyses for 1117 consecutive Glycpyrronium & ICS/LABA combination cases was conducted for patients with baseline demographics included Male/Female (76%/24%); mean Age 59.5y; FEV1 (1.46 L/min, 48.9±16%), FEV1/FVC (58.7±13.3%); Reversibility (13.7±16.2%), Exacerbation (?1/y; 1117, 100%; ?2/y, 389,35%), CAT (22±10). At 12 weeks, the overall group (1117) and frequent exacerbators (389) showed prebronchodilator FEV1& CAT score change of 21% && 5.1 respectively (p<0.0001) at 12 wks. Post-hoc analyses for frequent exacerbators' (?2/y, BDR ?10%, n=152) showed clinically significant change in prebronchodilator FEV1& CAT score of 22.8% & 5.4 respectively (p<0.0001) respectively showing positive test of interaction. Similarly the prebronchodilator FEV1 improvement for Frequent exacerbators' with Reversibility (?2/y, BDR ?12%, n=156) was documented as 35% (p<0.0001). TEAEs included dry mouth (42, 3.8%), constipation (4,0.4%), exacerbation (2,0.2%) that were managed with symptomatic therapy