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Safety and Efficacy of the Cyclooxygenase-2 Inhibitors Parecoxib and Valdecoxib after Noncardiac Surgery
- Source :
- Anesthesiology. 104:518-526
- Publication Year :
- 2006
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 2006.
-
Abstract
- Background Valdecoxib and its intravenous prodrug parecoxib are reported to increase thromboembolic risk after coronary artery bypass grafting. The authors conducted a randomized trial to examine their safety and analgesic efficacy in patients recovering from major noncardiac surgical procedures. Methods The trial was randomized and double-blind, with 10 days of treatment and 30 days of follow-up. Patients (n = 1,062) received either parenteral parecoxib for 3 days and oral valdecoxib for the rest of the treatment period or placebo medications throughout. The frequency of predefined adjudicated postrandomization adverse events, including cardiovascular thromboembolism, renal dysfunction, gastroduodenal ulceration, and wound-healing complications, was assessed in each group. Secondary efficacy endpoints included patients' pain ratings, opioid analgesic consumption (recorded as morphine equivalents), and reports of opioid-related adverse effects. Results Predefined adjudicated adverse events had similar frequencies among patients who received parecoxib and valdecoxib (2.7%) and placebo patients (3.2%) (P = 0.58), including cardiovascular thromboembolic events (1.0% in each group; P = 1.0). Placebo patients consumed more morphine equivalents (66.2 +/- 92.4 mg) than did patients receiving parecoxib and valdecoxib (43.2 +/- 65.7 mg) (P < 0.001). Placebo patients had higher mean pain ratings on each of study days 2-10 (P < 0.01) and reported more opioid-related symptom distress on days 2-6 (P < 0.01). Conclusions Parecoxib and valdecoxib are useful adjuncts to opioids for the treatment of postoperative pain in noncardiac surgical patients. Further study will be required to determine the safety profile of parecoxib and valdecoxib administered to patients with known atherosclerotic disease after noncardiac surgery.
- Subjects :
- Adult
Male
medicine.medical_specialty
Bypass grafting
Analgesic
law.invention
Double-Blind Method
Randomized controlled trial
Parecoxib
law
medicine
Humans
Aged
Pain, Postoperative
Sulfonamides
Cyclooxygenase 2 Inhibitors
Morphine
biology
business.industry
Isoxazoles
Middle Aged
Prodrug
Valdecoxib
Surgery
Anesthesiology and Pain Medicine
Anesthesia
biology.protein
Female
Cyclooxygenase
business
Noncardiac surgery
medicine.drug
Subjects
Details
- ISSN :
- 00033022
- Volume :
- 104
- Database :
- OpenAIRE
- Journal :
- Anesthesiology
- Accession number :
- edsair.doi.dedup.....92b3944035736d5d48d47cc948c8506e