Early occurrence of drug intolerance as risk factor during follow-up in patients with acute coronary syndrome or coronary revascularization

Albani, Stefano; Fabris, Enrico; Doimo, Sara; Barbati, Giulia; Perkan, Andrea; Merlo, Marco; Gatti, Giuseppe; Lenarda, Andrea Di; Hof, Arnoud W.J. van’t; Maras, Patrizia; Sinagra, Gianfranco

doi:10.1093/ehjcvp/pvy017

Cited by 8 publications

(4 citation statements)

References 23 publications

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“…20,26 Another study by Albani et al which focused on patients with history of acute coronary syndrome, showed that the intolerance to medications used for secondary CVD prevention, including ACEI/ARB, were independently associated with recurrent CVD event. 38 This is consistent with our findings. Another study by Schmidt et al showed that elevated creatinine levels of ≥ 30% following ACEI/ARB use were associated with CVD events, mortality, and end-stage renal diseases.…”

Section: Comparison With Existing Literaturesupporting

confidence: 94%

Impact of ACEIs and ARBs-related adverse drug reaction on patients’ clinical outcomes: a cohort study in UK primary care

Insani

Whittlesea

et al. 2023

Br J Gen Pract

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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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Section: Comparison With Existing Literaturesupporting

confidence: 94%

Impact of ACEIs and ARBs-related adverse drug reaction on patients’ clinical outcomes: a cohort study in UK primary care

Insani

Whittlesea

et al. 2023

Br J Gen Pract

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“…MI or stroke) and physician-driven events like revascularization procedures. 12 The former represent the natural progression of disease similarly to mortality and can be proven by ECG/troponins or imaging, respectively. The latter are open to judgement of the clinician for indication and therefore less objective.…”

Section: Non-fatal Endpointsmentioning

confidence: 99%

The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid and diabetes trials

Drexel

Rosano

Lewis

et al. 2019

European Heart Journal - Cardiovascular Pharmacotherapy

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Randomized clinical trials (RCTs) are important and the Gold Standard for drugs in modern cardiovascular (CV) therapy. The cornerstone of RCTs is the recording of hard clinical endpoints instead of surrogates. It is important to select an appropriate endpoint. Efficacy endpoints must be clinically relevant and can be hierarchically divided. A very interesting innovation in endpoint acquisition is the total event paradigm.

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“…Adverse drug reactions (ADRs) represent a significant barrier in cardiovascular treatment, as they can lead to treatment discontinuation, non-adherence, or the need for additional medications to manage the symptoms [ 6 – 9 ]. Patients on cardiovascular drugs are particularly vulnerable to ADRs as these patients may have an altered metabolism, advanced age, comorbidities, and concomitant medications [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

Prevalence of cardiovascular drug-related adverse drug reactions consultations in UK primary care: A cross-sectional study

Insani,

Whittlesea,

Wei

2024

PLoS ONE

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Background Adverse drug reactions (ADRs) represent a significant barrier to achieve optimal treatment outcomes. Cardiovascular drugs, including antihypertensive drugs, lipid-lowering drugs, and antithrombotic drugs, are among the most prescribed medications in the primary care setting. Objectives To estimate the prevalence of cardiovascular drug-related ADRs consultations in United Kingdom (UK) primary care and identify risk factors of these ADRs. Methods This was a cross-sectional study of cardiovascular drug users between 2000–2019 using UK IQVIA Medical Research Data. ADRs consultations were identified using database screening method employing standardised designated codes. The overall and annual age-standardised prevalence was estimated using direct standardisation method using 2019 mid-year UK population. Risk factors of ADRs consultations were estimated using logistic regression model stratified by therapeutic areas. Results The standardised prevalence of consultations related to cardiovascular drugs ADRs was 10.60 (95% CI. 10.46, 10.75) per 1000 patients. Patients aged 70–79 years had the highest occurrence of ADRs consultations. The most frequently drug classes implicated in the ADRs consultations were statins (n = 9,993 events, 27.09%), beta-blockers (n = 8,538 events, 23.15%), ACEIs/ARBs (n = 8,345 events, 22.62%), and aspirin (n = 6,482 events, 17.57%). Risk factors of ADRs consultations were previous history of cardiovascular diseases, e.g., myocardial infarction and stroke; advanced age, comorbidities; diabetes and dyslipidaemia; and polypharmacy. Conclusions The burden of cardiovascular drug-related ADRs consultations in primary care was considerable. Statins, beta-blockers, ACEIs/ARBs, and aspirin were the most frequently implicated drug classes. Closer clinical monitoring should be performed for patients affected by the ADRs to mitigate the risk of suboptimal treatment outcomes.

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Early occurrence of drug intolerance as risk factor during follow-up in patients with acute coronary syndrome or coronary revascularization

Abstract: DI was frequently encountered in real-world clinical practice and was significantly associated with MACCE during follow-up. This study suggests that early occurrence of DI could be considered to be an adjunctive cardiovascular risk factor during secondary prevention.

Cited by 8 publications

References 23 publications

Impact of ACEIs and ARBs-related adverse drug reaction on patients’ clinical outcomes: a cohort study in UK primary care

Impact of ACEIs and ARBs-related adverse drug reaction on patients’ clinical outcomes: a cohort study in UK primary care

The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid and diabetes trials

Prevalence of cardiovascular drug-related adverse drug reactions consultations in UK primary care: A cross-sectional study

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