Opioid-Induced Constipation in Patients with Cancer Pain in Japan (OIC-J Study): A Post Hoc Analysis.

Akihiro Tokoro,Yoshiyuki Kizawa,Yusaku Akashi,Soichi Fumita,Toshiyuki Harada,Makio Gamoh,Toshio Noriyuki,Hisao Imai,Masaharu Okamoto

doi:10.3390/jcm10184193

Abstract

Opioid-induced constipation (OIC) can limit the clinical benefit of opioid treatment. This post-hoc analysis evaluated the association between the Rome IV diagnostic criteria and other measures for OIC, including the Bowel Function Index (BFI), correlation between demographics and OIC onset, impact of OIC on pain treatment, and impact of patient–healthcare professional (HCP) communication on patient satisfaction. Patients recorded bowel habits in paper diaries for 14 days following opioid initiation. Study-specific questionnaires were used to evaluate patient awareness of OIC and satisfaction. Patients were ≥20 years old, initiating strong opioid therapy for cancer pain, had an ECOG PS ≤ 2, and had no constipation (≥3 bowel movements within 7 days of enrollment). A total of 220 patients were enrolled. The sensitivity and specificity of BFI for identifying OIC were 81.2% and 54.7%, respectively. Age <65 versus ≥65 years (odds ratio (OR) = 0.510, 95% confidence interval (CI): 0.267–0.977) and the presence or absence of comorbidities (OR = 0.443, 95% CI: 0.221–0.885) were correlated with OIC onset. The proportion of inpatients with sustainable pain control at week 2 was similar in patients with or without OIC (60.0% vs. 67.2%, respectively). By patient assessment, there was a significant correlation between an adequate level of patient–HCP communication and satisfaction with OIC treatment (OR = 9.538 (95% CI: 1.577–57.681)). Using BFI to screen for OIC represents a valid approach in patients with cancer pain. Patient–HCP communication is essential for effective management of OIC in patients with cancer pain.

Highlights

Opioids are the standard of care for the treatment of moderate to severe cancer pain
Of the 220 patients enrolled in the Opioid-induced constipation (OIC)-J study, 212 patients were included in the full analysis set (FAS) 1 population
For correlations between the Rome IV criteria and Bowel Function Index (BFI), 85 patients in the FAS 2 population had OIC according to the Rome IV criteria, whereas 117 patients had OIC according to BFI (Table 1)

Summary

Introduction

Opioids are the standard of care for the treatment of moderate to severe cancer pain. While effective in pain management, opioids are associated with a number of gastrointestinal adverse events, including opioid-induced constipation (OIC), which can limit the clinical benefit of opioid treatment [1,2]. Up to 94% of patients receiving opioids for pain experience OIC [5], which has been shown to be a significant patient burden [6]. Evidence suggests that patients find it difficult to manage pain relief and OIC symptoms [6], with some patients indicating that they do not adhere to their prescribed opioid regimen in order to manage their OIC [6,9]. Some studies have demonstrated that patients believe that OIC interferes with their pain management [7,10]

Methods

Results

Discussion

Conclusion