Abstract
BackgroundThe most common adverse event (AE) associated with opioid analgesics is opioid-induced constipation (OIC). Naldemedine (NAL) is widely used for the treatment of OIC. However, diarrhea has been reported as the most common treatment-emergent AE of NAL, and little is known about the risk factors associated with the development of diarrhea during NAL administration. This study examined the risk factors for NAL-induced diarrhea via a retrospective chart review of hospitalized patients.MethodsThe data of 101 hospitalized adult patients who received NAL for the first time for the treatment of OIC at Mie University Hospital between June 2017 and December 2018 were extracted from electronic medical records. According to the inclusion and exclusion criteria, 70 of the 101 patients were enrolled in this study. Diarrhea was defined as “diarrhea” on the medical record within 2 weeks of NAL administration. Univariate and multivariate analyses were performed to identify risk factors for the development of diarrhea in patients receiving NAL.ResultsTwenty-two of the 70 patients enrolled (31%) developed diarrhea within 2 weeks of NAL administration. The median duration (range) of NAL treatment before diarrhea onset was 3 (1–12) days. Patients with diarrhea had a significantly longer duration of opioid therapy before NAL administration than patients without diarrhea (P=0.002). Multivariate logistic regression analysis indicated that the independent risk factors for the development of NAL-induced diarrhea were NAL administration after more than 17 days of opioid therapy (odds ratio [OR]=7.539; P=0.016) and pancreatic cancer (OR=6.217; P=0.025). In fact, the incidence of diarrhea in patients who were administered NAL within a day of opioid therapy was significantly lower than that in patients who were administered NAL after more than 17 days of opioid therapy (13% vs. 54%, P=0.030).ConclusionsThese results suggested that a prolonged duration of opioid therapy prior to NAL initiation is associated with increased incidence of diarrhea.
Highlights
The most common adverse event (AE) associated with opioid analgesics is opioid-induced constipation (OIC)
Nineteen patients who had NAL dosing period of less than 3 days were excluded for the following reasons: hospital stay of less than 2 days (10 cases), discontinuation of opioid (3 cases), defecation without oral administration (3 cases), discontinuation due to peristaltic pain after NAL administration (1 case), use only for one time (1 case), and oral administration not possible (1 case)
In 60 eligible patients, excluding the patients who could not be evaluated bowel movements before NAL administration (n=10), significant differences regarding bowel movements during 7 days before NAL administration were not observed between the patients with and without diarrhea (n=16 [89%] vs n=35 [83%], P=0.710)
Summary
The most common adverse event (AE) associated with opioid analgesics is opioid-induced constipation (OIC). Naldemedine (NAL) is widely used for the treatment of OIC. The most common adverse event (AE) associated with opioid analgesics include opioid-induced constipation (OIC). Naldemedine (NAL) is a peripherally acting μ-opioid receptor antagonist (PAMORA) that is widely used for OIC treatment [6,7,8,9,10]. PAMORAs are effective in patients with laxative-resistant OIC and their large side chains helps them attain bulky molecular sizes. They can avoid the infiltration of the blood-brain barrier at therapeutic doses, resulting in the maintenance of the central analgesic effects of opioids [11]
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