Identifying Vulnerabilities to NSAID Adverse Events in the US
Population: An Analysis of Pre-Existing Conditions and Sex
Abstract
Purpose: In 2005, the Food and Drug Administration (FDA) issued
a decision memorandum regarding nonsteroidal anti-inflammatory drugs
(NSAIDs). The memorandum recommended the withdrawal of certain NSAIDs
due to potential cardiovascular adverse effects. It highlighted the
issue of cardiovascular risk associated with NSAIDs as a class. The
NSAID medication guide includes a wide range of adverse drug reactions
(ADRs), such as increased blood pressure, liver failure, allergic
reactions, heart attack, and intestinal bleeding. Although both sexes
have an increased risk of ADRs with NSAID use, females have a greater
risk than males due to differences in pharmacodynamics and higher
medication concentrations (mg/kg). The prevalence of NSAIDs and the
disparity in risk of ADRs by sex within this class of medications make
this a significant public health issue. This study quantifies
sex-specific differences and other factors associated with prescription
NSAID use. Method: The data for this study was obtained from
the National Health and Nutrition Examination Survey (NHANES), a complex
survey conducted by the Centers for Disease Control and Prevention (CDC)
in two-year cycles. NHANES is designed to make inferences about the
health of the US civilian noninstitutionalized population. A
survey-weighted logistic regression model was utilized to investigate
potential sex differences with prescription NSAIDs in the context of
other factors including kidney disease, hypertension, liver disease,
insurance status, coronary heart disease, and age within the 2011-2018
NHANES survey data. Results: Females reported a slightly higher
percentage of high blood pressure and kidney disease than males, while
males reported a slightly higher percentage of coronary heart and liver
disease than females. Furthermore, a larger percentage of females
reported having health insurance coverage than males. Last, the model
indicated that females were 58% more likely to have used a prescription
NSAID than males. Conclusion: The results confirm that women
and people with medical conditions, who would potentially suffer greater
harm from NSAID ADRs, are more likely to use a prescription NSAID than
individuals without these conditions. Therefore, it is crucial to
continue investigating the safety and efficacy of medications,
particularly in specific populations, to reduce the risk of harmful side
effects from medication use.