Lubiprostone Shown to Be Effective in Improving Bowel Movement Frequency and Other Symptoms of Opioid-Induced Constipation
MAY 10, 2013
Constipation is a common and often severe side effect of the opioid therapy patients take for chronic non-cancer pain. Opioid-induced constipation (OIC) can compromise a patient’s quality of life and reduce the effectiveness of pain management. Although OTC stool softeners and bulk laxatives are commonly prescribed as therapy for the prevention and management of OIC, their usefulness may be limited by poor efficacy and adverse effects. There is also little data to support the efficacy and safety of these OTC options. The CIC-2 chloride channel activator lubiprostone, which is approved for the treatment of OIC in adults, may offer a more effective option for these patients.
According to results from a phase III, multicenter, randomized, placebo-controlled study presented presented at the American Pain Society’s 32nd Annual Scientific Meeting, held May 8-13, 2013, in New Orleans, LA, patients with OIC who were treated with twice-daily oral lubiprostone 24 mcg reported significant improvements in spontaneous bowel movement (SBM) and other symptoms associated with OIC compared to patients who received placebo.
For the study, 438 patients with chronic non-cancer pain who had been on a stable dose of opioids for at least 30 days prior to study enrollment (patients continued receiving opioid treatment during this study), and who reported having fewer than three SBMs per week during a three-week screening period (SBM defined here as any bowel movement that did not occur within 24 hours after use of rescue medication), were randomized to receive either placebo (n=217) or twice-daily lubiprostone 24 mcg (n=221) for 12 weeks.