An assessment of the efficacy and safety of diclofenac potassium liquid-filled capsules in patients with various levels of baseline pain intensity

Current Medical Research and Opinion
Stephen E DanielsStephen E Boesing

Abstract

Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC; Zipsor*) is a novel formulation of diclofenac potassium used to treat mild to moderate acute pain. To investigate whether DPSGC 25 mg provided significant reduction in pain intensity compared with placebo, regardless of baseline pain intensity, a post hoc analysis was performed of pooled data from two replicate randomized controlled trials (NCT00366444 and NCT00375934) that evaluated the safety and efficacy of DPSGC in postbunionectomy treatment. Patients from the two randomized trials were assigned to one of two subgroups: patients with baseline numerical pain rating scale (NPRS) scores of 4 or greater to less than 7 and those with baseline NPRS scores of 7 or greater. Within each subgroup, efficacy and safety of DPSGC was compared with placebo. Across the two studies, 73 DPSGC- and 59 placebo-treated patients had baseline pain intensity scores ranging from 4 or greater to less than 7, while 128 DPSGC- and 141 placebo-treated patients had baseline pain intensity scores of 7 or greater. Significantly lower mean 48-hour NPRS scores were observed in the DPSGC group, regardless of baseline pain intensity (P < 0.0001). In both subgroups, at least twice as many patients...Continue Reading

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Citations

Jan 16, 2014·Anesthesia Progress·Mana Saraghi, Elliot V Hersh
Mar 21, 2016·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Charles ArgoffClarence Young
Jul 8, 2015·The Cochrane Database of Systematic Reviews·Sheena DerryR Andrew Moore
Jul 1, 2020·Regional Anesthesia and Pain Medicine·Katarzyna Korwin-KochanowskaUNKNOWN PROSPECT/ESRA Working Group Collaboration

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