The trade-off between cardiovascular and gastrointestinal effects of rofecoxib

Abstract

An Erratum has been published for this article in Pharmacoepidemiology and Drug Safety 14(9), 2005, 669. Background The cyclooxygenase‐2 (COX‐2) inhibitor rofecoxib was registered in 1999. By 2000, the first reports were published indicating that the agent was possibly associated with an increased risk of myocardial infarction. Since then a surge of data supporting this association has become available. To interpret these data it is essential to ascertain the cardiovascular risk profile of users of rofecoxib relative to other non‐steroidal anti‐inflammatory drug (NSAID) recipients. Objective To assess differences in cardiovascular risk between starters of rofecoxib versus starters of any other NSAID. Setting Data sampled from a representative research network of Dutch general practitioners (GPs) in 2001. Design New users (starters) of rofecoxib were compared to starters of any other NSAID, unmatched and matched on age, gender, and indication nested in the cohort of the second Dutch National Survey of General Practice. Results A total of 40.4% of patients starting on rofecoxib had cardiovascular co‐morbidity. Patients starting on rofecoxib were twice more likely to have a history of gastrointestinal (GI) morbidity, compared to patients starting on other NSAIDs (OR_adj = 2.09; 95%CI = 1.65–2.66). These patients were also more likely to have cardiovascular co‐morbidity (OR = 1.90; 95%CI = 1.60–2.24) compared to recipients of rofecoxib with no GI co‐morbidity. Cardiovascular morbidity was present at the time of rofecoxib exposure in over 61% of carriers of a composite risk profile including age 60 years or older, GI co‐morbidity and diagnosis of rheumatoid arthritis and osteoarthritis. Conclusions In general, a typical recipient of an NSAID is aged and carrier of a serious cardiovascular risk profile. Selective prescribing of rofecoxib to provide claimed gastroprotection, indirectly and unintentionally resulted in prescribing rofecoxib in a population with high frequencies of cardiovascular morbidities. Copyright © 2005 John Wiley & Sons, Ltd.