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 MedVolume 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