Abstract
PurposeThis prospective post-marketing surveillance (PMS) was designed to collect data on the safety and effectiveness of naldemedine in routine clinical practice in patients with opioid-induced constipation (OIC) and cancer pain in Japan and explore the characteristics of patients prone to diarrhea.MethodsThe enrolled patients received naldemedine (0.2 mg, once a day) orally for up to 12 weeks. In the safety analysis, adverse drug reactions (ADRs), including diarrhea as a special interest, were assessed. Effectiveness was evaluated, especially regarding the frequency and condition of bowel movement.ResultsIn the safety analysis set (n = 1177), 145 ADRs occurred in 133 (11.30%) patients, and diarrhea was the most frequent event (n = 107, 9.09%). Most cases of diarrhea were non-serious (98.1%). Most ADRs were non-serious (93.8%), and they resolved within 2 weeks (75.9%). No patient characteristics influenced the risk of diarrhea development or aggravation. Both the frequency (75.0% and 83.2%) and condition of bowel movement (80.0% and 88.0%) were improved at 2 and 12 weeks, respectively in the effectiveness analysis set (n = 953). Frequency and condition of bowel movement were also improved in patients excluded (e.g., Eastern Cooperative Oncology Group performance status was ≥ 3) or with very small numbers (e.g., received weak opioid) in the clinical trials.ConclusionsThis PMS indicates that naldemedine is well tolerated and effective in patients of various backgrounds in routine clinical practice who have OIC and cancer pain.Trial registrationUMIN000042851.
Highlights
Opioid-induced bowel dysfunction (OIBD) is a common side effect associated with the use of opioids, which are frequently prescribed for pain relief in patients with moderate-to-severe chronic or cancer pain [1]
The cumulative incidence of adverse drug reactions (ADRs) was calculated in the safety population
Factors that might affect the cumulative ADR incidence of naldemedine treatment were assessed using the chi-squared test to evaluate independence between categorical variables, and the CochranArmitage test was used to evaluate the trend associated with these variables
Summary
Opioid-induced bowel dysfunction (OIBD) is a common side effect associated with the use of opioids, which are frequently prescribed for pain relief in patients with moderate-to-severe chronic or cancer pain [1]. Supportive Care in Cancer in adults with OIC and cancer or chronic non-cancer pain [7,8,9,10,11]. These clinical trials were conducted under restricted conditions (e.g., patients who had never taken laxatives for the treatment of OIC and patients with an Eastern Cooperative Oncology Group performance status (ECOG-PS) of ≥ 3 were excluded, and only a small number of weak opioid-treated patients were included).
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