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BACKGROUND/RATIONALE:
The cardiovascular and cerebrovascular risks associated with the use of cyclo-oxygenase-2 selective (COX2) non-steroidal anti-inflammatory drugs (NSAIDs) have received substantial attention recently. COX2 medications are associated with increased risk of heart attacks and strokes, which resulted in withdrawal of rofecoxib. However, less attention has been given to the cardiovascular and cerebrovascular safety of non-COX2 NSAIDs. The safety of long-term use of NSAIDs remains a topic of debate. There are some indications that the risk of heart attacks and strokes is increased with exposure to any NSAID and risks may be modified by baseline cardiovascular risk. Because cardiovascular risk varies based on patient characteristics it is important to understand if the risks associated with NSAID use are similar across diverse patient subgroups.
OBJECTIVE(S):
The objective of this study is to evaluate the risk of NSAID-related adverse events in patients exposed to NSAIDs. The specific aims of the project are: 1) examine whether pre-existing cardiovascular disease risk factors modify the risk for NSAID-related cardiovascular events; 2) Determine whether decreased kidney function modifies the risk of cardiovascular events in patients with osteoarthritis taking NSAIDs; and 3) Evaluate the impact of impaired drug metabolism by comparing risk in those exposed to NSAIDs with and without impaired liver function.
METHODS:
We will conduct an observational cohort study of VA patients with a diagnosis of osteoarthritis, in order to identify a group of patients appropriate for long-term NSAID use. We will identify a cohort of patients from FY2000 to FY2005 to evaluate outcomes associated with NSAID exposure. The patient cohort will be identified using national inpatient and outpatient data. Events will be identified using inpatient, outpatient, BIRLS and VA-Medicare data during follow-up. Medication exposure will be measured using VA pharmacy data. We will use results of laboratory tests for clinical measures of cholesterol and liver and kidney function to control for factors associated with baseline event risk or decreased medication clearance. Patients will be followed from their initial eligible medication exposure until their first event or the end of the study period. We will evaluate the risk of events for each unique NSAID product measuring exposure on a time-dependent basis. Results will be stratified based on cardiovascular risk across sub-groups with differences in the underlying risk of events.
FINDINGS/RESULTS:
None at this time.
IMPACT:
This study will inform healthcare providers and policymakers as to the adverse events associated with NSAID exposure. The results will provide evidence on which to base treatment decisions when faced with understanding the risk-benefit profile of NSAIDs in groups of patients with differences in underlying risk for events.
PUBLICATIONS:
None at this time.
DRA:
Chronic Diseases, Health Services and Systems
DRE:
Quality of Care, Treatment, Prevention
Keywords:
Adverse events, Practice patterns, Risk factors
MeSH Terms:
none
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