Incidence of opioid-induced constipation in Japanese patients with cancer pain: A prospective observational cohort study.

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

doi:10.1002/cam4.2341

Abstract

This multicenter, prospective, observational cohort study assessed opioid induced constipation (OIC) in Japanese patients with cancer. Eligible patients had stable cancer and an ECOG PS of 0‐2. OIC incidence based on the Rome IV diagnostic criteria was determined by patient diary entries during the first 14 days of opioid therapy. The proportion of patients with OIC was calculated for each 1‐week period and the overall 2‐week study period. Secondary measurements of OIC included the Bowel Function Index (BFI) score (patient assessment administered by physician), spontaneous bowel movements (SBMs) per week (patient assessment), and physician assessments. Medication for constipation was allowed. Two hundred and twenty patients were enrolled. The mean morphine‐equivalent dose was 22 mg/day. By Rome IV criteria, the cumulative incidence of OIC was 56% (95% CI: 49.2%‐62.9%); week 1, 48% (95% CI: 40.8%‐54.6%); week 2, 37% (95% CI: 30.1%‐43.9%). The cumulative incidence of OIC was lower in patients who received prophylactic agents for constipation (48% [95% CI: 38.1%‐57.5%]) than in patients who did not (65% [95% CI: 55.0%‐74.2%]). The cumulative incidences of OIC were 59% (95% CI: 51.9%‐66.0%), 61% (95% CI: 54.3%‐68.1%), and 45% (95% CI: 38.0%‐51.8%) based on BFI scores, physician assessments, and SBM frequency, respectively. Frequency of BMs/week before starting opioids was the most influential factor for the occurrence of OIC. Utilization of prophylactic agents for constipation was associated with a modest effect on reducing the incidence of OIC. The incidences of OIC reported were variable depending on the diagnostic tool involved.

Highlights

Opioid analgesics are the mainstay treatment for moderate‐to‐ severe cancer pain and have been reported to provide relief in many patients.[1,2] A Cochrane review of randomized clinical trials of morphine for cancer pain reported that greater than 90% of patients with cancer pain achieved “no worse than mild pain” with morphine.[3]
These results indicate that even low‐dose opioids used to treat pain in patients with cancer are associated with an early onset of opioid‐induced constipation (OIC)
Patients rate for the previous 7 days on a numerical analog scale of 0 to 100.20. This current study showed that the use of prophylactic treatment was associated with a reduction in the incidence of OIC, which is consistent with findings from the retrospective J‐RIGID study

Summary

Introduction

Opioid analgesics are the mainstay treatment for moderate‐to‐ severe cancer pain and have been reported to provide relief in many patients.[1,2] A Cochrane review of randomized clinical trials of morphine for cancer pain reported that greater than 90% of patients with cancer pain achieved “no worse than mild pain” (a score of ≤30 on a 100‐mm visual analog pain intensity scale) with morphine.[3]. Stimulation of these receptors can delay gastric emptying, prolong colonic transit time, alter anal sphincter tone, and inhibit defecation.[9]

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