Statins are medications that are commonly used to reduce the risk of brain and heart attacks. Nowadays, more and more older patients are being prescribed statins. However, many of these patients tend to stop taking the medication at some point. Previous studies have shown that discontinuing statins can increase the risk of having new cardiovascular events, such as another brain or heart attack. However, these studies didn't specifically focus on the frailest patients who might not benefit from statin treatment in the first place.
To address this gap in knowledge, our goal is to investigate whether stopping statin treatment after a brain or heart attack in older patients actually raises the risk of new cardiovascular events. Our study will use anonymous data of patients aged 65 years or older with a brain or heart attack and receiving statin treatment therafter. We will analyze whether these patients eventually discontinue statin treatment and compare the rate of new brain or heart attacks, or cardiovascular-related deaths between those who continued statin treatment and those who stopped it.
To ensure a fair comparison between the two groups, we will take into account various risk factors for heart disease, such as age, smoking, body weight and frailty status. By considering these factors, we aim to determine whether ceasing statin therapy increases the likelihood of experiencing a brain or heart attack, or even death. The results of our study could provide valuable insights for healthcare professionals when making decisions about discontinuing statin therapy in older patients.
The primary aim is to investigate the effect of discontinuing statin treatment in older patients that were initially initiated on statin treatment after a stroke or MI primarily on the recurrence of cardiovascular events and secondarily on non-cardiovascular mortality. All covariates will be investigated as potential effect modifiers. A retrospective cohort study with data from The Clinical Practice Research Datalink (CPRD) will be performed. Patients eligible for participation are those aged 65 and older following hospitalisation for a first AMI or iCVA and not having received a statin for at least one year prior to hospital admission and having received a statin prescription within 90 days after hospital discharge. Time-dependent Cox regression models will be used to calculate hazard ratios for cardiovascular events and cardiovascular deaths for statin treated time compared to statin discontinued time as the time-dependent variable. Analysis will be stratified for inclusion diagnosis, age and frailty level. Results of this study can help clinicians in their discussion with older patients about weighting the risks of statin discontinuation, especially in older frail patients.
- Primary outcome: time until the composite end point first recurrent non-fatal myocardial infarction (ICD-10 I21) or first recurrent non-fatal cerebrovascular ischemic event (ICD-10 I63) according to the HES APC and cardiovascular mortality after the first cardiovascular event according to the ONS database or death within 30 days after a recurrent myocardial infarction or iCVA.
- Secondary outcome: Non-cardiovascular mortality
- Tertiary outcome: time until the composite end point first recurrent non-fatal myocardial infarction or first recurrent non-fatal cerebrovascular ischemic event according to the Read & HES APC and cardiovascular mortality after the first cardiovascular event according to the ONS database or death within 30 days after a recurrent myocardial infarction or iCVA.
Anthonius de Boer - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
marcel bouvy - Collaborator - Utrecht Institute for Pharmaceutical Sciences
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation