Judy W M Cheng1. 1. Long Island University, New York, NY, USA. judy.cheng@liu.edu
Abstract
OBJECTIVE: To review published evidence on the use of nonselective, non-aspirin nonsteroidal antiinflammatory drugs (NANSAIDs) and the risks of cardiovascular events and examine the justification for Food and Drug Administration (FDA) in recommending that a cardiovascular risk warning statement be included in all NANSAIDs' product information inserts. DATA SOURCES: Peer-reviewed articles in MEDLINE (1966-August 2006) and Current Contents were identified using the key words NSAID, naproxen, ibuprofen, heart diseases, myocardial infarction, and cardiovascular events. Citations from available articles and related FDA Web sites were reviewed for additional references. STUDY SELECTION AND DATA EXTRACTION: No randomized, placebo-controlled studies have been published evaluating this subject. Epidemiologic evidence published in English was examined. Sixteen relevant studies were identified (5 cohort, 3 nested case-control, 8 case-control). DATA SYNTHESIS: Six of the 16 studies demonstrated increased risk for one or more NANSAIDs (rate or ORs varied from 1.13 to 3.08). Five studies demonstrated cardioprotective effect for one or more NANSAIDs used (rate or ORs varied from 0.48 to 0.84). None of the other studies demonstrated an association between use of NANSAIDs and risk of cardiovascular events. CONCLUSIONS: After adjustment of baseline risk factors for cardiovascular events, epidemiologic studies demonstrated conflicting results regarding the risk of cardiovascular events with long-term use of nonselective NANSAIDs. However, considering the large number of patients consuming NANSAIDs and the potential public health impact, until data from long-term, randomized, controlled trials become available, the FDA's recommendation that a warning statement be included in all nonselective NANSAIDs product package inserts is justified.
OBJECTIVE: To review published evidence on the use of nonselective, non-aspirin nonsteroidal antiinflammatory drugs (NANSAIDs) and the risks of cardiovascular events and examine the justification for Food and Drug Administration (FDA) in recommending that a cardiovascular risk warning statement be included in all NANSAIDs' product information inserts. DATA SOURCES: Peer-reviewed articles in MEDLINE (1966-August 2006) and Current Contents were identified using the key words NSAID, naproxen, ibuprofen, heart diseases, myocardial infarction, and cardiovascular events. Citations from available articles and related FDA Web sites were reviewed for additional references. STUDY SELECTION AND DATA EXTRACTION: No randomized, placebo-controlled studies have been published evaluating this subject. Epidemiologic evidence published in English was examined. Sixteen relevant studies were identified (5 cohort, 3 nested case-control, 8 case-control). DATA SYNTHESIS: Six of the 16 studies demonstrated increased risk for one or more NANSAIDs (rate or ORs varied from 1.13 to 3.08). Five studies demonstrated cardioprotective effect for one or more NANSAIDs used (rate or ORs varied from 0.48 to 0.84). None of the other studies demonstrated an association between use of NANSAIDs and risk of cardiovascular events. CONCLUSIONS: After adjustment of baseline risk factors for cardiovascular events, epidemiologic studies demonstrated conflicting results regarding the risk of cardiovascular events with long-term use of nonselective NANSAIDs. However, considering the large number of patients consuming NANSAIDs and the potential public health impact, until data from long-term, randomized, controlled trials become available, the FDA's recommendation that a warning statement be included in all nonselective NANSAIDs product package inserts is justified.