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Complications of the COX-2 Inhibitors Parecoxib and Valdecoxib after Cardiac Surgery. Nancy A. Nussmeier, M.D., Andrew A. Whelton, M.D., Mark T. Brown, M.D., Richard M. Langford, F.R.C.A., Andreas Hoeft, M.D., Joel L. Parlow, M.D., Steven W. Boyce, M.D. and Kenneth M. Verburg, Ph.D. N Engl J Med
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Complications of the COX-2 Inhibitors Parecoxib and Valdecoxib after Cardiac Surgery Nancy A. Nussmeier, M.D., Andrew A. Whelton, M.D., Mark T. Brown, M.D., Richard M. Langford, F.R.C.A., Andreas Hoeft, M.D., Joel L. Parlow, M.D., Steven W. Boyce, M.D. and Kenneth M. Verburg, Ph.D. N Engl J Med Volume 352;11:1081-1091 March 17, 2005
Study Overview • When administered to patients for pain control after coronary-artery bypass surgery, valdecoxib and its intravenous prodrug, parecoxib, were found to be associated with an increased risk of cardiovascular thromboembolic events • These findings add to the growing concern that the use of COX-2 inhibitors increases the risk of cardiovascular events, particularly in persons who are at risk for such events
Enrollment and Outcome Nussmeier, N. et al. N Engl J Med 2005;352:1081-1091
Preoperative Characteristics of All Randomized Patients Nussmeier, N. et al. N Engl J Med 2005;352:1081-1091
Characteristics of the Surgical Procedures Nussmeier, N. et al. N Engl J Med 2005;352:1081-1091
Incidence of and Risk Ratios for Predefined Adverse Events and Death among Patients Who Received the Assigned Treatment Nussmeier, N. et al. N Engl J Med 2005;352:1081-1091
Kaplan-Meier Estimates of the Time to a Cardiovascular Event Nussmeier, N. et al. N Engl J Med 2005;352:1081-1091
Conclusions • The use of parecoxib and valdecoxib after CABG was associated with an increased incidence of cardiovascular events, arousing serious concern about the use of these drugs in such circumstances