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Prevention and management of diarrhea associated with naldemedine among patients receiving opioids: a retrospective cohort study.

ABSTRACT: BACKGROUND:Naldemedine, a novel peripherally-acting mu-opioid receptor antagonist, has improved opioid-induced constipation in randomized controlled trials. The most frequent adverse event of naldemedine is diarrhea, which can cause abdominal pain and often leads to treatment discontinuation. We aimed to identify risk factors and appropriate management strategies for key adverse events including diarrhea associated with naldemedine, since those have not been extensively studied. METHODS:We conducted a multi-center retrospective cohort study. Eligible patients had cancer, had undergone palliative care at participating centers, had been prescribed regular opioids, and had taken at least one dose of naldemedine between June 2017 and March 2018. The primary endpoint was the incidence of diarrhea according to baseline characteristics. Secondary endpoints included the duration of naldemedine administration, daily defecation counts before and after starting naldemedine, duration and severity of diarrhea as an adverse event of naldemedine, other adverse events, and the incidence of constipation within 7?days after recovery from diarrhea. We defined patients who started naldemedine within three days of starting a regularly prescribed opioid as the early group, and the remainder as the late group. RESULTS:Among 103 patients who received naldemedine, 98 fulfilled the eligibility criteria. The median age was 68?years and 48% of the patients were female. Median performance status was 3, and the median oral intake was 50%. The median duration of naldemedine administration and overall survival were 25 and 64?days, respectively. The incidence of diarrhea in the early group (n?=?26) was significantly lower than in the late group (n?=?72) (3.9% vs. 22.2%, p?=?0.02). Daily defecation counts increased after late (median 0.43 to 0.88, p?

SUBMITTER: Takagi Y

PROVIDER: S-EPMC6995158 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Prevention and management of diarrhea associated with naldemedine among patients receiving opioids: a retrospective cohort study.

Takagi Yusuke Y Osawa Gakuji G Kato Yoriko Y Ikezawa Eri E Kobayashi Chika C Aruga Etsuko E

BMC gastroenterology 20200131 1

<h4>Background</h4>Naldemedine, a novel peripherally-acting mu-opioid receptor antagonist, has improved opioid-induced constipation in randomized controlled trials. The most frequent adverse event of naldemedine is diarrhea, which can cause abdominal pain and often leads to treatment discontinuation. We aimed to identify risk factors and appropriate management strategies for key adverse events including diarrhea associated with naldemedine, since those have not been extensively studied.<h4>Metho ...[more]

PMID: 32005157

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Project description: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.

Project description:IntroductionNausea and vomiting (NV) are common side effects of opioid use and limiting factors in pain management. This study sought to quantify the frequency of antiemetic prescribing and the impact of NV on health care resource utilization and costs in outpatients prescribed opioids for acute pain. The perspective was that of a commercial health plan.MethodsMedical and pharmacy claims from IMS PharMetrics Plus were used to identify patients initiating opioid therapy with a prescription for an oxycodone-, hydrocodone- or codeine-containing immediate-release product for acute use (≤15-day supply) between October 1, 2013 and September 30, 2014. Patients with a medical claim for NV (International Classification of Diseases, Ninth Revision, Clinical Modification codes 787.0x), with or without an antiemetic prescription fill, were compared with patients with no NV claim or antiemetic prescription fill to assess differences in all-cause health care utilization and costs over 1 month. Propensity score matching (PSM) was used to adjust for between-group differences in baseline patient characteristics.ResultsThe co-prescribing of opioids with antiemetic agents was 10.2%. After PSM (n = 45,790 per group), patients with NV claims had significantly more hospitalizations (11.5% vs 4.2%), emergency department visits (65.0% vs 12.1%), and physician office visits (85.2% vs 64.5%) compared with patients with no NV claims (all P < 0.0001). Mean total health care costs were higher among patients with a NV claim versus those without evidence of the side effect ($6290 vs $2309; P < 0.0001). Among patients with a recent hospitalization, patients with NV claims had higher rates of 30-day rehospitalization than those with no NV claims (24.4% vs 3.0%; P < 0.0001).ConclusionsAmong outpatients prescribed opioids for management of acute pain, co-prescribing with antiemetics was low, and the economic burden associated with NV was high. Efforts to prevent NV in patients receiving opioid therapy may improve patient outcomes and provide cost savings to the health care system.FundingDaiichi Sankyo, Inc.

Project description:BackgroundBenzodiazepine hypnotics and the related nonbenzodiazepine hypnotics (z-drugs) are among the most frequently prescribed medications for older adults. Both can depress respiration, which could have fatal cardiorespiratory effects, particularly among patients with concurrent opioid use. Trazodone, frequently prescribed in low doses for insomnia, has minimal respiratory effects, and, consequently, may be a safer hypnotic for older patients. Thus, for patients beginning treatment with benzodiazepine hypnotics or z-drugs, we compared deaths during periods of current hypnotic use, without or with concurrent opioids, to those for comparable patients receiving trazodone in doses up to 100 mg.Methods and findingsThe retrospective cohort study in the United States included 400,924 Medicare beneficiaries 65 years of age or older without severe illness or evidence of substance use disorder initiating study hypnotic therapy from January 2014 through September 2015. Study endpoints were out-of-hospital (primary) and total mortality. Hazard ratios (HRs) were adjusted for demographic characteristics, psychiatric and neurologic disorders, cardiovascular and renal conditions, respiratory diseases, pain-related diagnoses and medications, measures of frailty, and medical care utilization in a time-dependent propensity score-stratified analysis. Patients without concurrent opioids had 32,388 person-years of current use, 260 (8.0/1,000 person-years) out-of-hospital and 418 (12.9/1,000) total deaths for benzodiazepines; 26,497 person-years,150 (5.7/1,000) out-of-hospital and 227 (8.6/1,000) total deaths for z-drugs; and 16,177 person-years,156 (9.6/1,000) out-of-hospital and 256 (15.8/1,000) total deaths for trazodone. Out-of-hospital and total mortality for benzodiazepines (respective HRs: 0.99 [95% confidence interval, 0.81 to 1.22, p = 0.954] and 0.95 [0.82 to 1.14, p = 0.513] and z-drugs (HRs: 0.96 [0.76 to 1.23], p = 0.767 and 0.87 [0.72 to 1.05], p = 0.153) did not differ significantly from that for trazodone. Patients with concurrent opioids had 4,278 person-years of current use, 90 (21.0/1,000) out-of-hospital and 127 (29.7/1,000) total deaths for benzodiazepines; 3,541 person-years, 40 (11.3/1,000) out-of-hospital and 64 (18.1/1,000) total deaths for z-drugs; and 2,347 person-years, 19 (8.1/1,000) out-of-hospital and 36 (15.3/1,000) total deaths for trazodone. Out-of-hospital and total mortality for benzodiazepines (HRs: 3.02 [1.83 to 4.97], p < 0.001 and 2.21 [1.52 to 3.20], p < 0.001) and z-drugs (HRs: 1.98 [1.14 to 3.44], p = 0.015 and 1.65 [1.09 to 2.49], p = 0.018) were significantly increased relative to trazodone; findings were similar with exclusion of overdose deaths or restriction to those with cardiovascular causes. Limitations included composition of the study cohort and potential confounding by unmeasured variables.ConclusionsIn US Medicare beneficiaries 65 years of age or older without concurrent opioids who initiated treatment with benzodiazepine hypnotics, z-drugs, or low-dose trazodone, study hypnotics were not associated with mortality. With concurrent opioids, benzodiazepines and z-drugs were associated with increased out-of-hospital and total mortality. These findings indicate that the dangers of benzodiazepine-opioid coadministration go beyond the documented association with overdose death and suggest that in combination with opioids, the z-drugs may be more hazardous than previously thought.

Project description:ImportanceOpioid-prescribing policies and guidelines aimed at reducing inappropriate opioid prescribing may lead physicians to stop prescribing opioids. Patients may thus encounter difficulties finding primary care practitioners willing to care for them if they take opioids.ObjectivesTo assess practitioner willingness to accept and continue prescribing opioids to new patients with pain and whether this willingness differs across payer types.Design, setting, and participantsThis survey study used a simulated patient call audit method. A brief telephone survey was administered to all clinics followed by a call using a patient script simulating an adult patient with chronic pain who was taking long-term opioids. The patient had Medicaid or private insurance. Calls were made between June 22 and October 30, 2018, to 667 primary care clinics that served a general adult population in Michigan. Clinics that accepted both Medicaid and private insurance, took new patient appointments, and were successfully recontacted for the simulated call were eligible for the study.Main outcomes and measuresPrevalence of clinics' acceptance of new patients receiving prescription opioids overall and by clinic characteristics and insurance type.ResultsOf the 194 eligible clinics, 94 (48.4%) were randomized according to insurance type to receive calls from research assistants posing as children of patients with Medicaid and 100 (51.5%) to receive calls from those with private insurance. Overall, 79 (40.7%) stated that their practitioners would not prescribe opioids to the simulated patient. Thirty-three clinics (17.0%) requested more information before making a decision. Compared with single-practitioner clinics, clinics with more than 3 practitioners were more likely (odds ratio [OR], 2.99; 95% CI, 1.48-6.04) to accept new patients currently taking opioids. No difference was found in access based on insurance status (OR, 0.92; 95% CI, 0.52-1.64) or whether the clinic offered medications for opioid use disorders (OR, 1.10; 95% CI, 0.45-2.69).Conclusions and relevanceThe findings suggest that access to primary care may be reduced for patients taking prescription opioids, which could lead to unintended consequences, such as conversion to illicit substances or reduced management of other medical comorbidities.

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Prevention and management of diarrhea associated with naldemedine among patients receiving opioids: a retrospective cohort study.

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Prevention and management of diarrhea associated with naldemedine among patients receiving opioids: a retrospective cohort study.

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