Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial.
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.


CONCLUSIONS
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.
Pallay
R M
RM
Robert Wood Johnson University Medical Group PCC at Hillsboro, NJ, USA.
Seger
W
W
Adler
J L
JL
Ettlinger
R E
RE
Quaidoo
E A
EA
Lipetz
R
R
O'Brien
K
K
Mucciola
L
L
Skalky
C S
CS
Petruschke
R A
RA
Bohidar
N R
NR
Geba
G P
GP
D000328:Adult; D000368:Aged; D002908:Chronic Disease; D006233:Persons with Disabilities; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000077613:Etoricoxib; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011725:Pyridines / Q000008:administration & dosage / Q000627:therapeutic use*; D011788:Quality of Life; D013450:Sulfones / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D010919:Placebos; D011725:Pyridines; D013450:Sulfones; D000077613:Etoricoxib