Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain

Combined oral prolonged-release oxycodone and naloxone in chronic pain management

“…Severe adverse effects were slightly more frequently reported in PR OXN group than in PR OX group. In the study by Simpson et al [15], the incidence of adverse effects was similar between the two groups. There were fewer gastrointestinal adverse effects, including nausea, vomiting, abdominal pain and dyspepsia in the PR OXN group, and mean duration of treatment-related diarrhea was slightly shorter in the PR OXN group.…”

“…In a randomized, double-blind, double-dummy 12-week trial of 322 patients with chronic non-cancer pain, PR OXN and PR OX were compared, after a run-in phase with doses of PR OX ranging 20 --50 mg/day. A significant improvement in bowel function index, less use of laxatives and complete spontaneous bowel movements were reported with PR OXN in comparison with PR OX, without compromising analgesia [15].…”

“…The two randomized 12-week, double-blind, parallel-group, multicenter studies [14,15] comparing PR OXN and PR OX alone on symptoms of opioid-induced bowel dysfunction in patients with moderate-to-severe nonmalignant pain were prospectively designed to be pooled, and the primary outcome measure of the pooled analysis was to demonstrate noninferiority in 12-week analgesic efficacy of PR OXN versus PR OX alone. This pooled analysis demonstrated that during a 12-week period, PR OXN provided analgesia that was as effective as PR OX alone, as indicated by the noninferiority of PR OXN versus PR OX in mean pain intensity, and a low and comparable use of supplemental analgesic medication in both treatment arms.…”

Avaliação do hábito intestinal em pacientes com câncer que utilizam morfina para o controle da dor

“…However, the effectiveness of the therapy should be analyzed with caution considering that, for ethical reasons, it would be impossible to have a control group. In addition, 40% of patients had constipation in spite of preventive measures, suggesting the need for studies with laxatives acting on specific intestinal receptors with higher effectiveness and few side effects [20][21][22] . During the study, nine clinical fecaloma were diagnosed and fecal desimpaction was a difficult stage of patients' management, generating pain and discomfort.…”

Peripheral opioid antagonism

“…In this study, a subset analysis of 59 patients with a higher bowel function index, (a patient-reported quantitative measure of constipation) reported a decrease in scores (improving constipation) over a period of 12 weeks. A comparative study of oral prolonged-release oxycodone vs a combination of oral prolonged-release oxycodone and naloxone, in patients with moderate to severe non-malignant pain, reported a similar improvement in bowel function without reducing analgesic efficacy [21]. Available for use in Europe since 2006 and now available in UK in a fixed-dose preparation of prolongedrelease oxycodone hydrochloride ⁄ naloxone combination (10 mg ⁄ 5 mg and 20 mg ⁄ 10 mg), it is currently licensed for treatment of severe pain that can only be managed with opioid analgesics.…”