NSAIDs and acetaminophen: Response to treatment relative to baseline pain severity with Etoricoxib and Indomethacin for acute gouty arthritis

Two similarly designed studies in acute gout demonstrated the comparable efficacy of etoricoxib and indomethacin. Combined analysis of the studies was performed to evaluate efficacy of etoricoxib and indomethacin in subgroups of patients according to severity of pain. Patients in two 8-day studies were randomly assigned to double-blind treatment with etoricoxib 120 mg once daily or indomethacin 50 mg three times daily. Subgroup analysis was performed of response to treatment relative to patients' baseline level of pain (moderate or severe/extreme). Primary endpoint was mean change from baseline in Patient Assessment of Pain averaged over Days 2 to 5 using a 0- to 4- point Likert scale. Secondary endpoints included Patient and Investigator Global Assessment of Response to Therapy and Study Joint Tenderness. An ANCOVA model was utilized to evaluate treatment-by-subgroup interaction. This model was also used to construct the 95% confidence interval (CI) for within-treatment least-square means and least-square mean difference between treatments. 339 patients were randomized to etoricoxib (n=178) or indomethacin (n=161). Baseline characteristics were similar across treatment groups within the two studies. Difference in patient pain scores between etoricoxib and indomethacin was -0.16 (95% CI: -0.49, 0.17) for patients with moderate pain and 0.06 (95% CI -0.14, 0.26) for patients with severe/extreme pain. Differences were within pre-specified comparability bounds of ±0.5 on the Likert scale. Test for treatment by subgroup interaction was not significant. There was a greater reduction from baseline pain in those with severe/extreme versus moderate pain. Treatments were comparable for secondary endpoints in the subgroups.This subgroup analysis showed that treatment with etoricoxib 120 mg once daily and indomethacin 50 mg three times daily provided comparable and effective pain relief in the setting of acute pain when comparing patients with moderate pain and even those with severe/extreme pain. Two similarly designed studies in acute gout demonstrated the comparable efficacy of etoricoxib and indomethacin. Combined analysis of the studies was performed to evaluate efficacy of etoricoxib and indomethacin in subgroups of patients according to severity of pain. Patients in two 8-day studies were randomly assigned to double-blind treatment with etoricoxib 120 mg once daily or indomethacin 50 mg three times daily. Subgroup analysis was performed of response to treatment relative to patients' baseline level of pain (moderate or severe/extreme). Primary endpoint was mean change from baseline in Patient Assessment of Pain averaged over Days 2 to 5 using a 0- to 4- point Likert scale. Secondary endpoints included Patient and Investigator Global Assessment of Response to Therapy and Study Joint Tenderness. An ANCOVA model was utilized to evaluate treatment-by-subgroup interaction. This model was also used to construct the 95% confidence interval (CI) for within-treatment least-square means and least-square mean difference between treatments. 339 patients were randomized to etoricoxib (n=178) or indomethacin (n=161). Baseline characteristics were similar across treatment groups within the two studies. Difference in patient pain scores between etoricoxib and indomethacin was -0.16 (95% CI: -0.49, 0.17) for patients with moderate pain and 0.06 (95% CI -0.14, 0.26) for patients with severe/extreme pain. Differences were within pre-specified comparability bounds of ±0.5 on the Likert scale. Test for treatment by subgroup interaction was not significant. There was a greater reduction from baseline pain in those with severe/extreme versus moderate pain. Treatments were comparable for secondary endpoints in the subgroups.This subgroup analysis showed that treatment with etoricoxib 120 mg once daily and indomethacin 50 mg three times daily provided comparable and effective pain relief in the setting of acute pain when comparing patients with moderate pain and even those with severe/extreme pain.