Impact of Medication Adherence on Mortality and Cardiovascular Morbidity: Protocol for a Population-Based Cohort Study

Maria Giner-Soriano; Gerard Sotorra Figuerola; Jordi Cortés; Helena Pera Pujadas; Ana Garcia-Sangenis; Rosa Morros

doi:10.2196/resprot.8121

Impact of Medication Adherence on Mortality and Cardiovascular Morbidity: Protocol for a Population-Based Cohort Study

JMIR Res Protoc. 2018 Mar 9;7(3):e73. doi: 10.2196/resprot.8121.

Authors

Maria Giner-Soriano^#^{1

2

3}, Gerard Sotorra Figuerola^#^{1

4}, Jordi Cortés^#^{1

4

5

6}, Helena Pera Pujadas^#^{1

4

6}, Ana Garcia-Sangenis^#^{1

4}, Rosa Morros^#^{1

2

3

6}

Affiliations

¹ Medicines Research Unit, Institut Universitari d'Investigació en Atenció Primària Jordi Gol, Barcelona, Spain.
² Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Bellaterra, Spain.
³ Institut Català de la Salut, Barcelona, Spain.
⁴ Universitat Autònoma de Barcelona, Bellaterra, Spain.
⁵ Departament d'Estadística i Investigació Operativa, Universitat Politècnica de Catalunya, Barcelona, Spain.
⁶ Spanish Clinical Research Network, Unidad de Investigación Clínica y Ensayos Clínicos, Institut Universitari d'Investigació en Atenció Primària, Barcelona, Spain.

^# Contributed equally.

Abstract

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).

Keywords: acute coronary syndrome; adherence; angiotensin-converting enzyme inhibitors; angiotensin-receptor blockers; aspirin; beta-blockers; cardiovascular diseases; coronary heart disease; statins.

©Maria Giner-Soriano, Gerard Sotorra Figuerola, Jordi Cortés, Helena Pera Pujadas, Ana Garcia-Sangenis, Rosa Morros. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.03.2018.