Bowel function following tapentadol and oxycodone immediate release (IR) Treatment in subjects with end stage joint disease: post-hoc analysis of data from a randomized, double-blind, active- and placebo-controlled study

Abstract

Constipation is a common side effect of opioid therapy. Patient-reported bowel function was examined in post-hoc analyses of the Bowel Movement Questionnaire (BMQ) data from a randomized, double-blind, active- and placebo-controlled, parallel-group efficacy and safety study in which end stage joint disease patients (N = 666) were randomly assigned 1:1:1:1 to receive tapentadol immediate release (IR) 50mg, 75mg, oxycodone IR 10mg, or placebo every 4-6 hours for 10 days. BMQ responses were recorded every evening and consisted of 4 questions assessing 1) presence, 2) consistency, 3) completeness, and 4) straining severity of bowel movements. Tapentadol IR 50mg and 75mg had similar proportions of patient days without a bowel movement (95%CI) as placebo [tapentadol 50mg 11% (7-14%); tapentadol 75mg 10% (7-13%); placebo 8% (5-12%); p>0.05 both comparisons vs. placebo] and all were significantly lower than oxycodone [25% (21-28%), p<0.05 all comparisons vs. oxycodone]. Both tapentadol IR doses also had similar proportions of patient days with incomplete bowel movement (95% CI) as placebo [tapentadol 50mg 20% (14-26%); tapentadol 75mg 23% (17-28%); placebo 25% (18-30%); p>0.05 both comparisons vs. placebo], and significantly fewer days with incomplete bowel movement than oxycodone [36% (31-42%), p<0.05 all comparisons vs. oxycodone]. Tapentadol IR patients were significantly less likely to report symptoms of moderate/severe straining [odds ratios (OR) vs. oxycodone (95% CI): tapentadol 50mg 0.49 (0.32-0.77); tapentadol 75mg 0.53 (0.34-0.82)] and hard stools [ORs vs. oxycodone: tapentadol 50mg 0.37 (0.22-0.62); tapentadol 75mg, 0.47 (0.29-0.76)] than oxycodone patients, while differences between tapentadol IR 50mg and placebo were not significant [ORs vs. placebo: moderate/severe straining, 0.90 (0.58-1.41); hard stools, 0.92 (0.52-1.63)]. Consistent with data from the same study that showed tapentadol IR 50 and 75mg provided comparable analgesia to oxycodone IR 10mg and had lower incidence rates of constipation (Afilalo 2008), tapentadol IR also had less bowel function impairment than oxycodone IR. (Funded by Johnson and Johnson Pharmaceutical Services, L.L.C.) Constipation is a common side effect of opioid therapy. Patient-reported bowel function was examined in post-hoc analyses of the Bowel Movement Questionnaire (BMQ) data from a randomized, double-blind, active- and placebo-controlled, parallel-group efficacy and safety study in which end stage joint disease patients (N = 666) were randomly assigned 1:1:1:1 to receive tapentadol immediate release (IR) 50mg, 75mg, oxycodone IR 10mg, or placebo every 4-6 hours for 10 days. BMQ responses were recorded every evening and consisted of 4 questions assessing 1) presence, 2) consistency, 3) completeness, and 4) straining severity of bowel movements. Tapentadol IR 50mg and 75mg had similar proportions of patient days without a bowel movement (95%CI) as placebo [tapentadol 50mg 11% (7-14%); tapentadol 75mg 10% (7-13%); placebo 8% (5-12%); p>0.05 both comparisons vs. placebo] and all were significantly lower than oxycodone [25% (21-28%), p<0.05 all comparisons vs. oxycodone]. Both tapentadol IR doses also had similar proportions of patient days with incomplete bowel movement (95% CI) as placebo [tapentadol 50mg 20% (14-26%); tapentadol 75mg 23% (17-28%); placebo 25% (18-30%); p>0.05 both comparisons vs. placebo], and significantly fewer days with incomplete bowel movement than oxycodone [36% (31-42%), p<0.05 all comparisons vs. oxycodone]. Tapentadol IR patients were significantly less likely to report symptoms of moderate/severe straining [odds ratios (OR) vs. oxycodone (95% CI): tapentadol 50mg 0.49 (0.32-0.77); tapentadol 75mg 0.53 (0.34-0.82)] and hard stools [ORs vs. oxycodone: tapentadol 50mg 0.37 (0.22-0.62); tapentadol 75mg, 0.47 (0.29-0.76)] than oxycodone patients, while differences between tapentadol IR 50mg and placebo were not significant [ORs vs. placebo: moderate/severe straining, 0.90 (0.58-1.41); hard stools, 0.92 (0.52-1.63)]. Consistent with data from the same study that showed tapentadol IR 50 and 75mg provided comparable analgesia to oxycodone IR 10mg and had lower incidence rates of constipation (Afilalo 2008), tapentadol IR also had less bowel function impairment than oxycodone IR. (Funded by Johnson and Johnson Pharmaceutical Services, L.L.C.)