CONTEXT: Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC; Zipsor*) is a novel formulation of diclofenac potassium used to treat mild to moderate acute pain. OBJECTIVE: 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. METHODS: 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. RESULTS: 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 treated with DPSGC rated the study drug as very good or excellent compared with patients taking placebo. Potential limitations for this post hoc analysis include study design and patient population. As with all studies investigating treatment for pain, the use of rescue medication may also be a potential limitation. CONCLUSIONS:DPSGC provided significantly greater improvements in pain compared with placebo following bunionectomy, regardless of patients' baseline pain level.
RCT Entities:
CONTEXT: Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC; Zipsor*) is a novel formulation of diclofenac potassium used to treat mild to moderate acute pain. OBJECTIVE: 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. METHODS: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. RESULTS: 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 treated with DPSGC rated the study drug as very good or excellent compared with patients taking placebo. Potential limitations for this post hoc analysis include study design and patient population. As with all studies investigating treatment for pain, the use of rescue medication may also be a potential limitation. CONCLUSIONS:DPSGC provided significantly greater improvements in pain compared with placebo following bunionectomy, regardless of patients' baseline pain level.