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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 dprice@opri.sgPurpose: 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 |
