International Journal of COPD (May 2024)
Budesonide/Glycopyrrolate/Formoterol for the Management of COPD in a UK Primary Care Population: Real-World Use and Early Medication Success
Abstract
Hana Müllerová,1 Jeffrey Shi Kai Chan,2 Heath Heatley,2 Victoria Carter,2 John Townend,2 Derek Skinner,2 Stefan Franzén,3 Jonathan Marshall,4 David Price2,5 1Medical Evidence Strategy, Biopharmaceuticals R&I Medical, AstraZeneca, Cambridge, UK; 2Observational and Pragmatic Research Institute, Singapore, Singapore; 3BPM Evidence Statistics, Biopharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden; 4Global Medical Affairs, Biopharmaceuticals R&I Medical, AstraZeneca, Cambridge, UK; 5Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UKCorrespondence: David Price, Observational and Pragmatic Research Institute, 22 Sin Ming Lane, #06 Midview City, Singapore, 573969, Singapore, Tel +65 3105 1489, Email [email protected]: Real-life research is needed to evaluate the effectiveness of budesonide/glycopyrrolate/formoterol (BGF) in routine COPD primary care management. We assessed the frequency of medication success among patients with COPD who initiated BGF using real-world data.Patients and Methods: Patients with a recorded diagnostic COPD code who started BGF with ≥ 2 prescriptions within 90-days were identified in the UK Optimum Patient Care Research Database and followed from first prescription until censoring at the end of follow-up (180-days), death, leaving database or end of data at 24/10/2022. The primary outcome was medication success at 90-days post-BGF initiation, defined as no major cardiac or respiratory event (ie no complicated COPD exacerbation, hospitalization for any respiratory event, myocardial infarction, new/hospitalized heart failure, and death) and no incidence of pneumonia. Medication success was also assessed at 180-days post-BGF initiation. Overall real-life medication success was claimed if the lower 95% confidence interval (CI) for the proportion of patients meeting the primary outcome was ≥ 70% (defined a priori).Results: Two hundred eighty-five patients were included. Prior to BGF initiation, these patients often had severe airflow obstruction (mean ppFEV1: 54.5%), were highly symptomatic (mMRC ≥ 2: 77.9% (n = 205/263); mean CAT score: 21.7 (SD 7.8)), with evidence of short-acting β2-agonist (SABA) over-use (≥ 3 inhalers/year: 62.1%, n=179/285), repeat OCS prescriptions (≥ 2 courses/year: 33.0%, n = 95/285) and multiple primary care consultations (≥ 2 visits/year: 61.1%, n = 174/285). Overall, 39.6% of patients (n = 113/285) switched from previous triple therapies. Real-life medication success was achieved by 96.5% of patients (n = 275/285 [95% CI: 93.6, 98.3]) during 90-days treatment with BGF and by 91.8% (n = 169/184 [95% CI: 86.9, 95.4]) of patients at 180-days. The prescribed daily dose of SABA remained stable over the study period.Conclusion: The majority of patients initiating BGF experienced real-life medication success reflecting the absence of severe cardiopulmonary events. These benefits were apparent after 90-days of treatment and sustained over 180-days.Keywords: death, exacerbation, heart failure, myocardial infarction, pneumonia
