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J Thorac Cardiovasc Surg 2003;125:1481-1492
© 2003 The American Association for Thoracic Surgery
Cardiopulmonary Support and Physiology |
From the Ischemia Research and Education Foundation, San Francisco, Calif (P.H H., L.S., D.T.M.),b the McSPI Research Group, San Francisco, Calif (E.O., N.N., P.D., R.F., P.A., L.S., D.T.M.),a the Departments of Anesthesiology at Ludwig-Maximilians University, Munich, Germany (E.O.),c the Texas Heart Institute, Houston, Texas (N.A.N.),d University of Manitoba Health Sciences Center, Winnipeg, Canada (P.C.D.),e Saint Thomas' Hospital, London, United Kingdom (R.O.F.),f the Royal Infirmary of Edinburgh, Edinburgh, Scotland, United Kongdom (R.P.A.),g Stanford University Medical Center (L.S.),i Stanford, Calif, and Pharmacia Corporation, Skokie, Ill (M.C.S. and R.H.).h
Received for publication June 26, 2002. Revisions requested Aug 26, 2002; revisions received Oct 8, 2002. Accepted for publication Oct 18, 2002. Address for reprints: Dennis T. Mangano, PhD, MD, c/o Editorial Office, Ischemia Research and Education Foundation, 250 Executive Park Blvd, Suite 3400, San Francisco, CA 94134 (E-mail: dnmngn{at}aol.com).
Objective: Inhibition of cyclooxygenase 2 provides analgesia in ambulatory patients. We prospectively evaluated the safety and efficacy of a newly introduced cyclooxygenase 2 inhibitor in patients undergoing coronary artery bypass grafting surgery through a median sternotomy in a randomized clinical trial.
Methods: A total of 462 patients with New York Heart Association classes I to III who were less than 77 years of age and were from 58 institutions in the United States, Canada, Germany, and the United Kingdom participated in this multicenter, phase III, placebo-controlled, double-blind, randomized, parallel-group trial. Patients were allocated at a ratio of 2:1 to parecoxib/valdecoxib or standard care (control) groups, respectively. Intravenous study drug (40 mg) was administered within 30 minutes after extubation and every 12 hours for a minimum of 3 days. Subsequently, oral treatment at a dose of 40 mg every 12 hours was initiated and administered for a combined total of 14 days. Patient-controlled analgesia with morphine, oral opioids, or acetaminophen was available as required. Assessment of the analgesic efficacy of the study drug was primarily based on morphine and morphine equivalent use. Additional efficacy evaluations included daily pain intensity, patient and physician global evaluation of study medication, and pain effect on quality of life. Clinical adverse events were assessed by the principal investigator at each site from the time of the first dose through the 30-day postdosing period.
Results: Patients in the parecoxib/valdecoxib group received significantly less morphine or morphine equivalents than patients in the control group during the 0- to 24-hour (P = .009), 24- to 48-hour (P = .017), 72- to 96-hour (P = .002), 96- to 120-hour (P = .004), and 120- to 144-hour (P = .037) periods. Both patients (P < .001) and physicians (P < .001) evaluated the study medication as significantly better than control therapy. The modified Brief Pain Inventory questionnaire used in the oral dosing period detected significant improvements in the parecoxib/valdecoxib treatment group in 6 of 8 domains tested (eg, current pain, worst pain, and mood) beginning on day 4 and continuing for at least 4 days. Although there were no differences between the groups in overall adverse events, serious adverse events occurred twice as frequently in parecoxib/valdecoxib-treated patients (19.0%, 59/311 patients) than in control patients (9.9%, 15/151 patients; P = .015). Regarding individual serious adverse events, a greater incidence in sternal wound infection was found in the parecoxib/valdecoxib patients (10 [3.2%]) versus control patients (0 [0%]) (P = .035). The incidences of other individual serious adverse events, including cerebrovascular complications, myocardial infarction, and renal dysfunction, were proportionally greater but not significantly different between the groups.
Conclusions: In patients undergoing coronary artery bypass grafting surgery, the cyclooxygenase 2 inhibitor combination, parecoxib/valdecoxib, was effective for postoperative analgesia. However, the 14-day treatment regimen also was associated with an increased incidence of serious adverse events overall and sternal wound infections in particular. Therefore our study raises important concerns requiring their comprehensive evaluation in a large-scale trial before these cyclooxygenase 2 inhibitors are used in patients undergoing coronary artery bypass grafting surgery.
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