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Impact of Medication Adherence on Mortality and Cardiovascular Morbidity: Protocol for a Population-Based Cohort
Maria Giner-Soriano1,2,3, Gerard Sotorra Figuerola1,4, Jordi Cortés1,4,5,6
1Medicines Research Unit, Institut Universitari d'Investigació en Atenció Primària Jordi Gol, Barcelona, Spain.
Insights
Adherence to cardiovascular medications improves survival in patients with established coronary heart disease (CHD). This study investigates the link between medication adherence and clinical outcomes in acute coronary syndrome (ACS) patients.
Area of Science:
- Cardiology
- Pharmacology
- Public Health
Background:
- Cardiovascular disease (CVD) is a leading global health threat, encompassing conditions like coronary heart disease (CHD).
- Standard secondary prevention for established CHD includes aspirin, statins, beta-blockers, and ACE inhibitors/ARBs.
- Poor medication adherence is a significant challenge in long-term CVD management.
Purpose of the Study:
- To assess the relationship between adherence to four key drug classes and clinical outcomes in patients with established CHD.
- To evaluate cardiovascular morbidity and mortality based on adherence levels in a cohort of acute coronary syndrome (ACS) patients.
Main Methods:
- Population-based cohort study using the SIDIAP database (2006-2015) for first-time ACS episodes.
- Estimation of patient adherence to aspirin, statins, beta-blockers, and ACE inhibitors/ARBs.
- Primary endpoint: composite of all-cause mortality, recurrent ACS, and ischemic stroke, analyzed using Cox proportional hazard regression.
Main Results:
- The study aims to quantify adherence rates to the four drug classes.
- Expected to determine the incidence of major adverse cardiovascular events (MACE).
- Analysis will investigate the association between adherence levels and MACE incidence.
Conclusions:
- Higher adherence to prescribed secondary prevention medications is anticipated to correlate with reduced risk of primary endpoints.
- Findings are expected to support the importance of medication adherence in improving outcomes for CHD patients post-ACS.
Background:
Cardiovascular disease (CVD) is a group of disorders of the heart and blood vessels, such as coronary heart disease (CHD), cerebrovascular disease, and peripheral artery disease. CVD is the leading threat to global health, whether measured by mortality, morbidity, or economic cost. Long-term administration of aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers improves survival in patients with stablished coronary heart disease. Nevertheless, adherence to prescribed medication is poor for long-term drug treatment.
Objective:
We aim to assess the relationship between adherences to the four pharmacological groups recommended for secondary prevention and the clinical outcomes of cardiovascular morbidity and mortality in patients with established CHD according to the level of adherence to these drugs in a population of incident cases of acute coronary syndrome (ACS).
Methods:
Population-based cohort study of patients with a first episode of ACS during 2006-2015 in the Information System for Research in Primary Care (SIDIAP) database. We will estimate adherence to these drugs. The primary endpoint is a composite of all-cause mortality, ACS, and ischaemic stroke. Bivariate analyses will be performed estimating odds ratios for categorical variables and mean differences for continuous variables. Hazard ratios for adherences will be calculated for outcome events using Cox proportional hazard regression models, and proportionality of hazards assumption will be tested.
Results:
We expect to estimate adherence to all four study treatments, the incidence of MACE, and to analyze if this incidence is associated with the level of drug adherence.
Conclusions:
We expect to find that adherent patients have a lower risk of the primary endpoints compared with nonadherent patients.
Trial Registration:
This study protocol was classified as EPA-OD by the AEMPS (IJG-EST-2017-01-2017-01, 07/04/2017) and registered in the EU PAS register (EUPAS19017, 09/05/2017).
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