Persistence of Cardiovascular Risk After Rofecoxib Discontinuation | Cardiology | JAMA Internal Medicine | JAMA Network
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Research Letter
December 13/27, 2010

Persistence of Cardiovascular Risk After Rofecoxib Discontinuation

Author Affiliations

Author Affiliations: Sections of General Internal Medicine (Dr Ross) and Cardiovascular Medicine and Robert Wood Johnson Foundation Clinical Scholars Program, Department of Medicine, and Section of Health Policy and Administration, School of Public Health (Dr Krumholz), Yale University School of Medicine, and Yale-New Haven Hospital Center for Outcomes Research and Evaluation (Drs Ross and Krumholz), New Haven, Connecticut; Department of Statistics, Columbia University, New York, New York (Dr Madigan); The CardioVascular Center and Department of Medicine, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts (Dr Konstam); and Department of Community Health, Brown University, Providence, Rhode Island (Dr Egilman).

Arch Intern Med. 2010;170(22):2035-2036. doi:10.1001/archinternmed.2010.461

Interim results from the Adenomatous Polyp Prevention on Vioxx (APPROVe) trial demonstrated that rofecoxib was associated with an increased risk of cardiovascular events,1 leading to Merck's withdrawal of rofecoxib from the worldwide market in September 2004. In October 2008, long-term follow-up findings were published2; during a 1-year period of postdrug observation, increased cardiovascular risk associated with rofecoxib use persisted after stopping treatment.

These findings raise concerns about long-term risks incurred by individuals who had taken the drug. Data from only 1 other rofecoxib clinical trial, study 078,3 provides information about long-term off-drug cardiovascular risk after clinical trial drug discontinuation. Accordingly, our objective was to examine whether increased cardiovascular risk of rofecoxib persisted after stopping treatment in study 078.