Efficacy and safety of etodolac-paracetamol fixed dose combination in patients
with knee osteoarthritis flare-up: a randomized, double-blind comparative
evaluation.
Author(s): Pareek A, Chandurkar N, Ambade R, Chandanwale A, Bartakke G.
Affiliation(s): Medical Affairs and Clinical Research, Ipca Laboratories Ltd, Kandivli Industrial
Estate, Kandivli (West), Mumbai, India. anilpareek@ipca.co.in
Publication date & source: 2010, Clin J Pain. , 26(7):561-6
OBJECTIVE: To evaluate the efficacy and safety of etodolac-paracetamol
combination in comparison with etodolac alone in patients with knee
osteoarthritis (OA) flare-up.
METHODS: In this double-blind, double-dummy, randomized, comparative,
multicentric, parallel group study, 220 patients of either sex in the age range
of 40 to 70 years with an OA flare-up were randomized either to etodolac (300
mg)-paracetamol (500 mg) combination or etodolac (300 mg) alone twice a day for
10 days. Efficacy outcomes were an average daily pain intensity score on 11-point
visual analog scale, Western Ontario and McMaster score (WOMAC), and Lequesne
Severity Index; total pain relief score at 30 minutes, 1, 2, and 4 hours after
first-dose administration; OA flare-up symptoms resolution; patient's and
investigator's overall assessment of study treatments.
RESULTS: Etodolac-paracetamol was significantly superior to etodolac alone in
reducing pain intensity (P<0.001), achieving pain relief (P<0.05) during the
first 4 hours after the study dose administration, and resolution of the clinical
signs and symptoms of OA flare-up such as morning stiffness,
swelling/inflammation, and erythema. The combination showed significantly greater
improvement in WOMAC scores and Lequesne Severity Index (P<0.001) than in
etodolac monotherapy. Peak pain intensity difference over a period of 10 days was
also significantly (P<0.001) higher in combination-treated patients compared with
monotherapy-treated patients. The combination had significantly better patient's
and investigator's global efficacy assessment (P=0.001). Both treatments were
well tolerated and safe in patients with OA flare-up.
DISCUSSION: For the treatment of painful OA flare-ups, the etodolac-paracetamol
combination can offer improved clinical outcomes by targeting multiple pain
pathways. The results of the current study show that etodolac-paracetamol is more
effective in the treatment of OA flare-up than etodolac alone.
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