PMID- 15476906 OWN - NLM STAT- MEDLINE DCOM- 20041029 LR - 20190922 IS - 0149-2918 (Print) IS - 0149-2918 (Linking) VI - 26 IP - 8 DP - 2004 Aug TI - Effects of valdecoxib in the treatment of chronic low back pain: results of a randomized, placebo-controlled trial. PG - 1249-60 AB - BACKGROUND: Valdecoxib, a cyclooxygenase (COX)-2 specific inhibitor, is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and primary dysmenorrhea. Therapeutic doses of COX-2 specific inhibitors are as effective as nonspecific nonsteroidal anti-inflammatory drugs in reducing inflammatory pain while sparing the gastrointestinal and platelet toxicity associated with nonspecific COX-1 inhibition. OBJECTIVE: The aim of this study was to assess the analgesic efficacy and tolerability of valdecoxib 40 mg/d compared with placebo in the treatment of chronic low back pain. METHODS: This 4-week, prospective, randomized, double-blind placebo-controlled, parallel-group study was conducted at 37 centers across the United States and 5 centers in Canada. Patients aged > or =18 years with chronic low back pain in flare were enrolled. Patients were randomized to receive valdecoxib 40-mg/d or placebo tablets, once daily for 4 weeks. Patients rated low back pain intensity on a visual analog scale and completed the Roland-Morris Disability Questionnaire and the modified Brief Pain Inventory-Short Form (mBPI-SF) at each visit. RESULTS: Two hundred ninety-three patients were enrolled. The valdecoxib group comprised 148 patients (81 women, 67 men; mean [SD] age, 48.6 [13.3] years; mean [SD] body weight, 86.6 [20.9] kg), and the placebo group included 145 patients (85 women, 60 men; mean [SD] age, 48.7 [12.6] years; mean [SD] body weight, 85.6 [19.9] kg). Of the enrolled patients, 249 completed the study: 134 patients (91%) who received valdecoxib and 115 patients (79%) who received placebo. No statistically significant differences in patient baseline characteristics were noted between treatment groups, except in response to 1 mBPI-SF question; patients in the valdecoxib group reported significantly greater interference in relations with other people due to pain than did those in the placebo group (P = 0.048). Changes from baseline in low back pain intensity were significantly greater in valdecoxib-treated patients at each assessment (all, P < 0.001 vs placebo). Pain scores on the mBPI-SF indicated significantly greater pain relief with valdecoxib at each assessment (all, P < or = 0.014 vs placebo). Improvements in mean Roland-Morris Disability Questionnaire score with valdecoxib were significantly greater than with placebo at each assessment (all, P < or = 0.003). Although the overall incidence of adverse events (AEs) was significantly higher among patients receiving valdecoxib than those receiving placebo (35.1% vs 24.1%, respectively; P = 0.042), no significant differences were found between groups for the incidence of any individual AE. Most AEs (89% [77/87 total events]) were mild or moderate in severity. CONCLUSIONS: In this study of patients with chronic low back pain, valdecoxib 40 mg/d provided rapid relief (within 1 week) and consistent relief (over 4 weeks). In addition, significant improvement in function and decreased disability were found with valdecoxib compared with placebo. FAU - Coats, Teresa L AU - Coats TL AD - Benchmark Research, Austin, Texas 78705, USA. annrutledge@benchmarkresearch.net FAU - Borenstein, David G AU - Borenstein DG FAU - Nangia, Narinder K AU - Nangia NK FAU - Brown, Mark T AU - Brown MT LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - Clin Ther JT - Clinical therapeutics JID - 7706726 RN - 0 (Cyclooxygenase Inhibitors) RN - 0 (Isoxazoles) RN - 0 (Sulfonamides) RN - 2919279Q3W (valdecoxib) SB - IM MH - Adult MH - Aged MH - Canada MH - Cyclooxygenase Inhibitors/administration & dosage/*therapeutic use MH - Double-Blind Method MH - Female MH - Humans MH - Isoxazoles/administration & dosage/*therapeutic use MH - Low Back Pain/*drug therapy/pathology MH - Male MH - Middle Aged MH - Pain Measurement MH - Prospective Studies MH - Sulfonamides/administration & dosage/*therapeutic use MH - Surveys and Questionnaires MH - Treatment Outcome MH - United States EDAT- 2004/10/13 09:00 MHDA- 2004/10/30 09:00 CRDT- 2004/10/13 09:00 PHST- 2004/05/14 00:00 [accepted] PHST- 2004/10/13 09:00 [pubmed] PHST- 2004/10/30 09:00 [medline] PHST- 2004/10/13 09:00 [entrez] AID - S0149-2918(04)80081-X [pii] AID - 10.1016/s0149-2918(04)80081-x [doi] PST - ppublish SO - Clin Ther. 2004 Aug;26(8):1249-60. doi: 10.1016/s0149-2918(04)80081-x.