Single dose oral lumiracoxib for postoperative pain
Abstract
Background
Lumiracoxib is a novel selective cyclooxygenase‐2 (COX‐2) inhibitor. COX‐2 inhibitors have been developed to avoid COX‐1 related gastrointestinal (GI) problems. Lumiracoxib has analgesic and anti‐inflammatory activity comparable with traditional non‐steriodal anti‐inflammatory drugs (tNSAIDs) in the management of post‐operative pain, but with the advantage of better GI tolerability.
Objectives
To review the analgesic efficacy, duration of analgesia, and adverse effects of a single oral dose of lumiracoxib for moderate to severe postoperative pain in adults and compare it with established analgesics.
Search methods
We searched CENTRAL (The Cochrane Library Issue 1, 2006), MEDLINE (1966 to March 2007), EMBASE (1974 to 2006), and PubMed (February 2007).
Selection criteria
Single oral dose, randomised placebo controlled trials of lumiracoxib, in acute postoperative pain, in adult patients.
Data collection and analysis
Trials were quality scored and data extracted by two review authors independently. Summed pain relief (TOTPAR) was extracted and converted into dichotomous information yielding the number of patients with at least 50% pain relief. These derived results were used to calculate the relative benefit (RB) and number‐needed‐to‐treat (NNT) for one patient to achieve at least 50% pain relief.
Main results
Three studies (737 patients) met the inclusion criteria. In total 211 patients were treated with lumiracoxib 400 mg, 51 with lumiracoxib 100 mg, and 161 with placebo. Active comparators were naproxen 500 mg (60 patients), rofecoxib 50 mg (102), celecoxib 200 mg (101), and ibuprofen 400 mg (51). One hundred patients (48%) given lumiracoxib 400 mg had at least 50% pain relief over six hours, compared with 17 (11%) given placebo; RB 4.8 (95% CI 2.9 to 7.9), NNT 2.7 (2.2 to 3.5).
Weighted median time to use of rescue medication was 7.4 hours for lumiracoxib 400 mg and 1.8 hours for placebo. Patient global assessment at study endpoint was rated as "excellent" by 71 patients (34%) given lumiracoxib 400 mg and 5 (3%) given placebo. Median time to onset of analgesia was shorter for lumiracoxib 400 mg (0.6 to 1.5 hours) than placebo (>12 hours), and use of rescue medication within 12 hours occurred in 64 patients (58%) given lumiracoxib 400 mg and 100 (91%) given placebo.
Adverse events reported were generally mild to moderate in severity, with one serious adverse event reported in a patient given placebo.
Authors' conclusions
Lumiracoxib 400 mg given as a single oral dose, is an effective analgesic for acute postoperative pain.
PICOs
Plain language summary
Single dose oral lumiracoxib (Prexige®) for treatment of postoperative pain relief in knee and hip arthroplasty and dental surgery
Postoperative pain is often poorly managed. Cyclooxygenase inhibitors (COX‐2) pain relieving drugs were developed with the aim of reducing the gastrointestinal side effects of non‐steroidal anti‐inflammatory drugs (NSAIDs). Lumiracoxib, one of the latest COX‐2 drugs to be developed, given in a 400 mg dose, appears to provide, rapid, effective and sustained relief of postoperative pain in three studies with a total of 737 participants. Two hundred and eleven patients were treated with lumiracoxib 400 mg and 100 of these patient (48%) had at least 50% pain relief over a six hour period, compared with 17 patients (11%) given placebo. Adverse event data was inconsistently reported, but no serious adverse events occurred in any patient taking lumiracoxib in these trials.
