Impact of ACE Inhibitors and ARBs-related Adverse Drug Reactions Consultations on Patients’ Clinical Outcomes: A Cohort Study in UK Primary Care

Abstract

Background: Adverse drug reactions (ADRs)related to angiotensin-converting enzyme inhibitor(ACEI) and angiotensin receptor blocker(ARB) may negatively affect patients’ treatment outcomes. There is limited evidence on the impact of ADRs on patients’ outcome in real-world clinical setting. Aim: To investigate the impact of ACEI/ARB-related ADRs consultations in primary care on patients’ clinical outcomes. Design: Propensity score-matched cohort study of ACEI/ARB users during 2004-2019 using IQVIA medical research data. Methods: ACEI/ARB-related ADRs consultations were identified using standardised designated codes in primary care medical records data.Propensity scores were calculated based on comorbidities,concomitant medications,frailty index,polypharmacy,and interval between ACEI/ARB initiation and ADRs date.The outcomes of interest were cardiovascular disease (CVD) events and all-cause mortality.Cox proportional hazard regression models were used to compare the outcomes between ADRs and non-ADRs group. Results: Among 1,471,906 eligible ACEI/ARB users,13,652 patients(0.93%) had ACEI/ARB-related ADRs consultation in primary care. Mean follow-up duration were6.57and4.84years for the CVD primary(n=6,196) and secondary(n=14,238) prevention cohorts,respectively. ACEI/ARB-related ADRs were associated with CVD events and all-cause mortality in both primary(adjusted HR.1.22,95%CI1.05,1.43 and 1.14,95%CI1.01,1.27) and secondary prevention cohort (adjusted HR.1.13,95%CI1.05,1.21 and 1.15,95%CI1.09,1.21).Half (50.19%) patients with ADRs consultation continued to use ACEI/ARB and these patients had a reduced risk of mortality(adjusted HR.0.88,95%CI0.82,0.95) compared to those who discontinued ACEI/ARB. Conclusions: This study provides information on the burden of ADRs on patients and the health system. Patients with ACEI/ARB-related ADRs consultation had an increased risk of subsequent CVD events and mortality,indicating additional monitoring and treatment strategies by healthcare professionals for affected patients are needed to mitigate the risks of adverse clinical outcomes

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