Effect of statin therapy in older patients after a first cerebrovascular event or myocardial infarction, a population based cohort study in the CPRD

Study type
Protocol
Date of Approval
Study reference ID
16_177
Lay Summary

Statins are medicines that lower cholesterol. Statins reduce the risk of stroke and heart attacks. The effect of statins was mainly investigated in patients younger than 75. The number of older patients using a statin increases drastically. There is little proof that older patients benefit from statins like younger patients. We want to investigate whether statins after a first heart attack or stroke in patients of 75 years and older prevent deaths, strokes or heart attacks. We want to investigate this by using routinely collected health information from the Clinical Practice Research Datalink. We will identify patients of 75 years and older with a first stroke or heart attack. We will determine if they use a statin after this event. We will compare the rate of stroke, heart attack or death between patients having received and patients not having received a statin. We will do this to investigate if statins prevent stroke, a heart attack or death from occurring. To make sure the two groups are comparable, we will compensate for risk factors for heart disease, like age, smoking and body weight. Results of this study may aid healthcare professionals in deciding on initiating statin therapy in older patients.

Technical Summary

The primary aim is to determine if initiation of statins is effective in preventing recurrence of the composite endpoint of cardiovascular events and cardiovascular mortality in patients aged 75 years and older following a first acute myocardial infarction (AMI) or ischemic cerebrovascular accident (iCVA). The secondary aim is to determine the effect of initiation of statins on the individual components of the primary objective’s composite endpoint and all cause mortality. A retrospective cohort study with data extracted 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. Data on patients baseline characteristics, statin and concomitant cardiovascular medication use will be gathered. Time-dependent Cox regression models will be used to calculate hazard ratios for cardiovascular events and cardiovascular deaths for statin users compared to nonusers with statin use as the time-dependent variable. Adjusted analysis will be performed using cardiovascular risk factors, baseline characteristics, comorbidity, frailty status and concomitant drug use. Furthermore age, gender, inclusion time-period, primary event and frailty status will be investigated as effect modifiers.

Collaborators

Anthonius de Boer - Chief Investigator - Utrecht University
Dineke Koek - Collaborator - University Medical Centre Utrecht
Geert Lefeber - Collaborator - University Medical Centre Groningen
Patrick Souverein - Collaborator - Utrecht University
Wilma Knol - Collaborator - University Medical Centre Utrecht

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation