PMID- 15370723 OWN - NLM STAT- MEDLINE DCOM- 20041109 LR - 20181130 IS - 0300-9742 (Print) IS - 0300-9742 (Linking) VI - 33 IP - 4 DP - 2004 TI - Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. PG - 257-66 AB - BACKGROUND: Chronic low back pain (LBP) is a growing health problem. Non-steroidal anti-inflammatory drugs (NSAIDs) are used to treat this condition, but have not demonstrated efficacy beyond 2 weeks, and no studies have shown that NSAIDs produce durable improvements in disability. METHODS: To evaluate the efficacy and durability of effect of etoricoxib for chronic LBP, a randomized, double blind, placebo-controlled trial was conducted at 46 centres. Three hundred and twenty-five patients with chronic LBP requiring treatment with an NSAID or paracetamol were randomized 1:1:1 to etoricoxib 60 mg (n=109), 90 mg (n=106), or placebo (n=110), daily for 3 months. Pre-specified endpoints over 3 months included LBP intensity scale (visual analog scale 0-100 mm) time-weighted average change from baseline, the Roland-Morris Disability Questionnaire (RMDQ), the LBP bothersomeness scale, patient and investigator global assessments, and measures of quality of life. RESULTS: Both etoricoxib groups experienced significant reductions in LBP intensity at 4 weeks versus placebo [-15.15 mm and -13.03 mm for 60 and 90 mg, respectively, probability (p)<0.001 for each], which was maintained over 3 months. Treatment resulted in significant improvement from baseline compared to placebo in RMDQ scores (etoricoxib 60 mg, -2.82 and 90 mg, -2.38, p<0.001 for each) over 12 weeks and most other efficacy endpoints. There were no significant differences between treatments in incidence of adverse events (AEs) or discontinuations due to AEs. CONCLUSION: Etoricoxib provided significant relief of symptoms and disability associated with chronic LBP detected at 1 week, confirmed at 4 weeks, and maintained over 3 months. Reductions in chronic LBP severity corresponded to improvements in physical functioning and quality of life. All treatments were generally well tolerated. FAU - Pallay, R M AU - Pallay RM AD - Robert Wood Johnson University Medical Group PCC at Hillsboro, NJ, USA. FAU - Seger, W AU - Seger W FAU - Adler, J L AU - Adler JL FAU - Ettlinger, R E AU - Ettlinger RE FAU - Quaidoo, E A AU - Quaidoo EA FAU - Lipetz, R AU - Lipetz R FAU - O'Brien, K AU - O'Brien K FAU - Mucciola, L AU - Mucciola L FAU - Skalky, C S AU - Skalky CS FAU - Petruschke, R A AU - Petruschke RA FAU - Bohidar, N R AU - Bohidar NR FAU - Geba, G P AU - Geba GP LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Scand J Rheumatol JT - Scandinavian journal of rheumatology JID - 0321213 RN - 0 (Placebos) RN - 0 (Pyridines) RN - 0 (Sulfones) RN - WRX4NFY03R (Etoricoxib) SB - IM MH - Adult MH - Aged MH - Chronic Disease MH - Disabled Persons MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Etoricoxib MH - Female MH - Humans MH - Low Back Pain/*drug therapy MH - Male MH - Middle Aged MH - Placebos MH - Pyridines/administration & dosage/*therapeutic use MH - *Quality of Life MH - Sulfones/administration & dosage/*therapeutic use MH - Treatment Outcome EDAT- 2004/09/17 05:00 MHDA- 2004/11/13 09:00 CRDT- 2004/09/17 05:00 PHST- 2004/09/17 05:00 [pubmed] PHST- 2004/11/13 09:00 [medline] PHST- 2004/09/17 05:00 [entrez] AID - XKGAYKLQV515E2E8 [pii] AID - 10.1080/03009740410005728 [doi] PST - ppublish SO - Scand J Rheumatol. 2004;33(4):257-66. doi: 10.1080/03009740410005728.