(485) A comparison of the pharmacokinetics and tolerability of diclofenac sodium 2% and 1.5% topical solutions

Abstract

s The Journal of Pain S97 (484) An assessment of the efficacy and tolerability of diclofenac sodium 2% topical solution for treating osteoarthritis of the knee T Barrett, R Franke, N Cheruvu, M Giuliani, J Ward, and K Devarakonda; Mallinckrodt Inc., Hazelwood, MO This double-blind, randomized, controlled, parallel-group study assessed the efficacy and tolerability of diclofenac sodium 2% topical solution in patients with primary osteoarthritis of the knee. Patients were randomly assigned to receive diclofenac sodium 2% topical solution or vehicle, applied twice daily for 4 weeks on an outpatient basis. The primary efficacy outcome was change from baseline to final visit in the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain subscale, expressed as least square means (LSM) with standard errors (SE). Secondary outcomes included WOMAC physical function and stiffness subscales; patient global assessment (PGA) of osteoarthritis status; knee pain intensity measured at midday, evening, and over the previous 24 hours with a numeric rating scale (NRS); and use of supplemental analgesics. Between-group statistical comparisons were made using analysis of covariance at an a=0.10. Adverse event (AE) occurrence was also assessed. Two hundred fifty-nine patients were enrolled and received $1 dose of diclofenac sodium 2% topical solution (n=130) or vehicle (n=129). Significantly greater reductions in LSM (SE) WOMAC pain scores were observed for patients receiving diclofenac sodium 2% topical solution (-4.4 [0.4]) compared with vehicle (-3.4 [0.4]; P=0.040) at the final visit. Similar results were observed for WOMAC physical function (-13.9 [1.2] vs -10.7 [1.3]; P=0.061) and stiffness (-1.7 [0.2] vs -1.3 [0.2]; P=0.097) and PGA (-1.1 [0.1] vs -0.8 [0.1]; P=0.085). The vehicle control group experienced slightly more AEs than active treatment (38.8% vs 31.5%), which primarily involved application site reactions. Regardless of missing data imputationmethod used, diclofenac sodium 2% topical solution using a twice daily dosing regimen produced significantly greater improvements in pain reduction associated with osteoarthritis of the knee compared to vehicle control and was generally well tolerated. Supported by funding from Mallinckrodt Inc. (485) A comparison of the pharmacokinetics and tolerability of diclofenac sodium 2% and 1.5% topical solutions R Franke, T Barrett, N Cheruvu, M Giuliani, and K Devarakonda; Mallinckrodt