Valdecoxib is as efficacious as diclofenac in the treatment of acute low back pain.
OBJECTIVE
To compare the efficacy of valdecoxib 40 mg q.d. (with a second dose on day 1) with diclofenac 75 mg b.i.d. in the treatment of acute low back pain.


METHODS
This was a multicenter, randomized, double-blind study. Patients with acute low back pain, class 1a or 2a (Quebec Task Force), with a visual analog scale score >/=50 mm (on a 100-mm scale) and moderate to severe pain on a categorical scale, were randomized to valdecoxib 40 mg q.d. (with a second dose on day 1) or diclofenac 75 mg b.i.d. for 7 days (170 patients per group). The primary efficacy end point was change in pain intensity (visual analog scale, mm) from baseline to day 3 for the per-protocol population.


RESULTS
Least squares mean reductions in pain intensity from baseline to day 3 were similar for valdecoxib (-42.02 mm) and diclofenac (-41.43 mm). Valdecoxib was comparable to diclofenac as the lower limit of the 95% confidence interval of the estimated difference (0.59 mm; 95% confidence interval, -3.40 to 4.59 mm) was within the prespecified noninferiority margin of -10 mm. The overall incidence of adverse events was similar for valdecoxib (28%) and diclofenac (26%). No statistically different moderate or severe upper gastrointestinal adverse events were reported, although they were numerically greater for diclofenac (8) than for valdecoxib (3).


CONCLUSIONS
Valdecoxib 40 mg q.d. (with a second dose on day 1) provides effective relief for acute low back pain, and was at least as efficacious as diclofenac 75 mg b.i.d., with a nonsignificant but numerically lower incidence of gastrointestinal adverse events.
Ximenes
Antonio
A
Department of Internal Medicine, Division of Rheumatology, Hospital Geral de Goiânia, Goiânia, GO, Brazil.
Robles
Manuel
M
Sands
George
G
Vinueza
Raul
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004008:Diclofenac / Q000627:therapeutic use*; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000627:therapeutic use*; D017116:Low Back Pain / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D013449:Sulfonamides / Q000627:therapeutic use*; D000096926:Benzenesulfonamides
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; D007555:Isoxazoles; D013449:Sulfonamides; C406224:valdecoxib; D000096926:Benzenesulfonamides