Search

Joachim Grifka1, Rudolf Enz2, Joachim Zink3, Jean Louis Hugot4, Andreas Kreiss5, Udayasankar Arulmani4, Vincent Yu6, Rosemary Rebuli4, Gerhard Krammer4 1Orthopädische Klinik der Univ, Regensburg, Germany; 2DiaMed Centrum, Klinik Neuendettelsau, Neuendettelsau, Germany; 3Orthopädische Fachpraxisgemeinschaft, Jena Zwätzen, Deutschland, Germany; 4Novartis Pharma AG, Basel, Switzerland; 5Novartis Pharma GmbH, Nürnberg, Germany; 6Novartis Pharma AG, East Hanover, NJ, USAAbstract: We compared the efficacy and safety of preemptive vs postoperative dosing of lumiracoxib 400 mg in patients undergoing minor ambulatory arthroscopic knee surgery. Eligible patients were randomized to preemptive lumiracoxib, postoperative lumiracoxib, and placebo. The main efficacy parameter was pain intensity (PI) (0–100 mm visual analog scale) in the target knee upon movement, 2 hours after surgery. Other efficacy variables included PI in the target knee at rest and upon movement at 1, 3, 4, and 24 hours, time to first rescue medication intake. In the lumiracoxib preemptive and postoperative groups, the estimated treatment difference compared to placebo for primary endpoint was –4.0 (95% CI: –9, –1; p = 0.007) and –3.5 (95% CI: –8.5, 0; p = 0.052), respectively. There was no statistical significant difference between two active treatment groups (p = 0.602). Both preemptive and postoperative lumiracoxib resulted in significantly lower PI scores at rest and after movement at all time-points and no statistically significant difference was observed between the active treatments. Time to rescue medication intake was comparable for both active treatments. The proportion of adverse events was similar among all groups. We conclude that the efficacy of lumiracoxib 400 mg is not affected by the timing of administration (preemptive or postoperative).Keywords: arthroscopy, arthroscopic knee surgery, lumiracoxib, NSAIDs, postoperative pain, preemptive dosing