Impact Of Opioid-induced Constipation Research Articles

Impact of opioid-induced constipation on opioid substitution therapy management: the patient perspective.

BackgroundAlthough opioid-induced bowel dysfunction is a well-known and frequent adverse event correlated with opioids, it is scarcely investigated in patients on opioid substitution treatment (OST) and no standard of care is currently available for this population. We aimed to explore the opinion of patients on the impact of constipation on the management of OST and quality of life (QoL).MethodsWe performed a survey that was directed to opioid-dependent patients treated with OST and followed-up in a Service for Addiction Treatment in Italy. The questionnaire included questions about sociodemographic characteristics, the experience of constipation, general QoL, OST management, interference of opioid-induced constipation (OIC) with opioid management, the experience of OIC treatment in the health system, and risk factors for constipation.ResultsConstipation at the moment of the survey (n=105) was reported by 81% of patients and was the most frequent adverse event of OST; 73% of respondents reported at least one severe or very severe symptom of constipation in the last 2 weeks. OIC was reported to hinder adherence to OST by 33% of respondents and 38% of them felt that control of craving had been more difficult since initiation of constipation. Overall, 34% of patients interfered with their OST by changing the schedule on their own in an attempt to improve constipation. Patients were proactive in looking for a solution for constipation but reported poor help from the healthcare system.ConclusionOur patient-based survey suggests that careful and efficient management of constipation could increase adherence to OST and improve patient satisfaction and QoL.

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

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.

Characterization and Associated Costs of Constipation Relating to Exposure to Strong Opioids in England: An Observational Study

PurposeOpioid use is associated with gastrointestinal adverse events, including nausea and constipation. We used a real-world dataset to characterize the health care burden associated with opioid-induced constipation (OIC) with particular emphasis on strong opioids. MethodsThis retrospective cohort study was conducted using the Clinical Practice Research Datalink, a large UK primary care dataset linked to hospital data. Patients prescribed opioids during 2016 were selected and episodes of opioid therapy constructed. Episodes with ≥84 days of exposure were classified as chronic, with date of first prescription as the index date. The main analysis focused on patients prescribed strong opioids who were laxative naive. Constipation was defined by ≥2 laxative prescriptions during the opioid episode. Patients for whom initial laxative therapy escalated by switch, augmentation, or dose were defined as OIC unstable, and the first 3 lines of OIC escalation were classified. Health care costs accrued in the first 12 months of the opioid episode were aggregated and compared. FindingsA total of 27,629 opioid episodes were identified; 5916 (21.4%) involved a strong opioid for patients who were previously laxative naive. Of these patients, 2886 (48.8%) were defined as the OIC population; 941 (33.26%) were classified as stable. Of the 1945 (67.4%) episodes classified as unstable, 849 (43.7%), 360 (18.5%), and 736 (37.8%) had 1, 2, and ≥3 changes of laxative prescription, respectively. Patients without OIC had lower costs per patient year (£3822 [US$5160/€4242]) compared with OIC (£4786 [US$6461/€5312]). Costs increased as patients had multiple changes in therapy: £4696 (US$6340/€5213), £4749 (US$6411/€5271), and £4981 (US$6724/€5529) for 1, 2, and ≥3 changes, respectively. The adjusted cost ratio relative to non-OIC was 1.14 (95% CI, 1.09–1.32) for those classified as stable and 1.19 (95% CI, 1.09–1.32) for those with ≥3 laxative changes. Similar patterns were observed for patients taking anyopioid, with costs increased for those classified as having OIC (£3727 [US$5031/€4137] vs £2379 [US$3212 /€2641),and for those patients classified as unstable versus stable (£3931 [US$5307/€4363] vs £3432 [US$4633/€3810). Costs increased with each additional line of therapy from £3701 (US$4996/€4108), £3916 (US$5287/€4347), and £4318 (US$5829/€4793). ImplicationsOIC was a common adverse event of opioid treatment and was poorly controlled for a large number of patients. Poor control was associated with increased health care costs. The impact of OIC should be considered when prescribing opioids. These results should be interpreted with consideration of the caveats associated with the analysis of routine data.

Opioid-induced constipation in patients with cancer: a "real-world," multicentre, observational study of diagnostic criteria and clinical features.

The aim of this study was to investigate opioid-induced constipation (OIC) in a large cohort of "real-world" patients with cancer; the objectives were to determine the prevalence of OIC, the utility of a simple screening question, the accuracy of the Rome IV diagnostic criteria, the clinical features of OIC (physical and psychological), and the impact of OIC (quality of life). One thousand patients with cancer were enrolled in the study, which involved completion of the Rome IV diagnostic criteria for OIC, the Bowel Function Index, the Patient Assessment of Constipation Quality of Life questionnaire, and the Memorial Symptom Assessment Scale-Short Form. Participants also underwent a thorough clinical assessment by an experienced clinician (ie, "gold-standard" assessment of OIC). Fifty-nine percent of patients were clinically assessed as having OIC, 2.5% as having another cause of constipation, and 19% as not having constipation but were taking regular laxatives. The simple screening question produced a number of false-negative results (19% of patients), whereas the Rome IV diagnostic criteria had an accuracy of 81.9%. Patients with OIC had more symptoms overall, higher Memorial Symptom Assessment Scale-Short Form subscale scores (and total score), and higher Patient Assessment of Constipation Quality of Life questionnaire subscale scores (and the overall score). Opioid-induced constipation was not associated with demographic factors, cancer diagnosis, performance status, or opioid equivalent dosage: OIC was associated with opioid analgesic, with patients receiving tramadol and transdermal buprenorphine having less constipation. The study confirms that OIC is common among patients with cancer pain and is associated with a spectrum of physical symptoms, a range of psychological symptoms, and an overall deterioration in the quality of life.

Patients' Self-Assessment of the Symptoms and Impact of Opioid-Induced Constipation: Results From a Prospective Observational Cohort Study of Japanese Patients With Cancer

ContextMany patients who have cancer consider opioid-induced constipation (OIC) to be a burdensome side effect of opioid treatment. ObjectivesTo evaluate patient-reported outcomes in Japanese patients with cancer pain and OIC. MethodsThis prospective observational study evaluated OIC incidence for two weeks in patients with cancer after they initiated strong opioid therapy. Rome IV diagnostic criteria, a physician's diagnosis, spontaneous bowel movements, Bowel Function Index score, and patients' daily self-assessments were used. Changes from baseline in Patient Assessment of Constipation Symptoms and Patient Assessment of Constipation Quality of Life (PAC-QOL) scores were compared between patients with and without OIC. Patients and health care providers (HCPs) completed study-specific questionnaires regarding OIC burden, treatment satisfaction, and patient-provider communications. ResultsAmong 212 enrolled patients, the incidence of OIC was 47.6% by patients' self-assessments, with a cumulative incidence of 30.2% by Day 3 and 43.5% by Day 7. Patient Assessment of Constipation Symptoms and PAC-QOL overall scores from patients with OIC worsened significantly from baseline compared with patients without OIC by all diagnostic criteria, except for spontaneous bowel movement frequency for PAC-QOL. Patients and HCPs were generally satisfied with OIC treatment; however, 53.5% of patients and approximately 40.0% of HCPs reported that OIC affected pain management. Most patients and HCPs reported that OIC conditions were sufficiently or essentially communicated. ConclusionAfter starting opioid therapy, patients recognized OIC onset and its impact on cancer pain management, highlighting the need for effective patient-provider communications, diagnosis, and treatment of OIC to improve QOL for patients with cancer receiving opioid analgesics.

Impact of opioid-induced constipation on healthcare resource utilization and costs for cancer pain patients receiving continuous opioid therapy.

Opioid therapy is often associated with adverse effects, including opioid-induced constipation (OIC), in patients receiving opioids for cancer pain. This retrospective observational cohort study evaluated healthcare utilization and costs during the first year after initiating opioid therapy among cancer patients with (cohort 1) and without (cohort 2) constipation. This study used administrative claims data from the HealthCore Integrated Research Environment between January 1, 2006, and April 30, 2014. Eligible patients included adults ≥ 18years with a diagnosis of cancer who initiated continuous opioid therapy (≥ 30days). Propensity scores were used to match patients with constipation in a 1:1 ratio to those without constipation. Generalized linear models were used to evaluate healthcare utilization and costs during the 12months after initiating opioid therapy. After matching, 1369 patients were included in each cohort. Patients with constipation were more than twice as likely as those without constipation to have an all-cause inpatient hospitalization (odds ratio [95% confidence interval (CI)], 2.47 [2.11-2.90]), or pain-related hospitalization (2.15 [1.82-2.54]) during the 12months after initiating therapy. Mean unadjusted overall healthcare costs during the first 12months post-index were $21,629 (95% CI, $14,850-$29,018) higher for patients with constipation than for those without constipation. For patients with constipation, total mean (SD) constipation-related costs were $9196 ($26,896). These results suggest that OIC is associated with significantly increased healthcare and economic burden in cancer pain patients and that early and ongoing recognition and management of OIC are unmet needs in this population.

The Burden of Opioid-Induced Constipation in Younger Patients with Chronic Noncancer Pain.

The purpose of this analysis was to evaluate the experience of opioid-induced constipation in younger patients and identify differences in the experience of opioid-induced constipation and its symptoms between younger patients (<50 years) and older patients (50-64 years). Post hoc analysis of data from a 24-week prospective, multinational, longitudinal observational cohort study (NCT01928953). Outpatient clinics in the United States, Canada, Germany, and United Kingdom. Two age-based subgroups of adult patients with chronic noncancer pain receiving four or more weeks of daily opioid therapy and experiencing opioid-induced constipation within the previous two weeks. The number of spontaneous bowel movements, frequency of constipation symptoms, amount of bother associated with symptoms, Patient Assessment of Constipation-Symptoms questionnaire, and health-related quality of life and function outcomes. Overall, 419 patients were included in this analysis (younger patients, N = 184; older patients, N = 235). Among younger and older patients, respectively, constipation occurred within the first week after initiating opioid therapy for 32.8% and 35.9%. At baseline, the mean numbers of spontaneous bowel movements/week were 1.3 and 1.5, and moderate opioid-induced constipation-related interference with pain management was reported by 46.6% and 44.5%. Younger patients generally reported that opioid-induced constipation symptoms were more bothersome than did older patients. The impact of opioid-induced constipation on health-related quality of life, work productivity, and day-to-day activities was comparable. In these patients receiving opioid therapy for chronic noncancer pain, the burden of opioid-induced constipation was comparable or greater for patients aged <50 years compared with that for patients aged 50-64 years.

The impact of opioid-induced constipation among chronic pain patients with sufficient laxative use.

The impact of sufficient laxative use on opioid-induced constipation (OIC) is not known. To understand the experience and symptom burden over time among chronic non-cancer pain patients with OIC who are sufficient laxative users. A prospective longitudinal study was conducted in United States, Canada, Germany and UK which included medical record abstraction, patient surveys and physician surveys. Patients on daily opioid therapy for ≥ 4 weeks for chronic non-cancer pain with OIC were recruited from physician offices and completed the survey at Baseline and Weeks 2, 4, 6, 8, 12, 16, 20 and 24. Sufficient laxative use was defined as at least one laxative remedy 4 or more times in the prior 2 weeks. Of the 489 patients who completed the Baseline survey and met OIC criteria, 234 (48%) were categorised as sufficient laxative users; 65% were female; 90% were white and 75 (32%) maintained sufficient laxative use for > 7 of the 8 follow-up periods. Patient Assessment of Constipation-Symptom (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL) scores indicated moderate symptom severity and impact. PAC-SYM and PAC-QOL scores remained relatively unchanged over time with a maximum score change of 0.5 points. Work productivity and activity impairment remained relatively constant. Mean per cent activity impairment because of constipation was 37% at Baseline and 34% at Week 24. These findings demonstrate constipation persists despite sufficient laxative use with little improvement in symptoms, HRQL or activity impairment. This ongoing burden emphasises the need to identify more efficacious constipation therapies for this chronic pain patient population.

Emerging treatments in neurogastroenterology: a multidisciplinary working group consensus statement on opioid‐induced constipation

Opioids are effective for acute and chronic pain conditions, but their use is associated with often difficult-to-manage constipation and other gastrointestinal (GI) effects due to effects on peripheral μ-opioid receptors in the gut. The mechanism of opioid-induced constipation (OIC) differs from that of functional constipation (FC), and OIC may not respond as well to most first-line treatments for FC. The impact of OIC on quality of life (QoL) induces some patients to decrease or stop their opioid therapy to relieve or avoid constipation. At a roundtable meeting on OIC, a working group developed a consensus definition for OIC diagnosis across disciplines and reviewed current OIC treatments and the potential of treatments in development. By consensus, OIC is defined as follows: 'A change when initiating opioid therapy from baseline bowel habits that is characterized by any of the following: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, or harder stool consistency'. The working group noted the prior validation of a patient response outcome and end point for clinical trials and recommended future efforts to create treatment guidelines and QoL measures specific for OIC. Details from the working group's discussion and consensus recommendations for patient care and research are presented in this article.

(120) Impact of opioid-induced constipation on opioid therapy management among chronic opioid users based on a patient survey

Management of persistent pain in patients with opioid-induced constipation (OIC) is not optimal. The objective was to measure the impact of OIC on pain management and adherence to opioid medication. Data were collected from an online self-reported survey of 504 adults ($18 years old) using opioids chronically (>30 days) for pain and who had reported constipation as a side-effect related to opioid use. Adherence to opioids was measured using the Morisky Medication Adherence Scale (MMAS-4, 0=high to 4=low adherence), and questions focused on opioids and OIC treatment history, pain severity (0=no pain to 10=worst pain), and modifications to opioid therapy management due to constipation was collected. The average age of respondents was 57.4 years (standard deviation [SD] =11.8), 50.4% (n=254) were female, 80.6% (n=406) were using opioids for more than a year, and 70% (n=353) were treating their constipation for 3.2 years (SD=3.5). On average patients missed 2 doses of opioid treatments in the past 14 days and only 30% (n=151) were completely adherent to their opioid medication (MMAS=0). Over 80% of respondents reported experiencing pain for half the day or more and for 5 or more days per week. Patients reported a mean pain severity score of 6.8 (SD=1.8). Overall 49.6% (n=250) of patients reportedmodifications to their opioid therapy because of constipation in the past 6 months: 37.7% (n=190) reduced, 14.1% (n=71) switched and 36.9% (n=186) skipped doses of their opioid medication. Approximately 20% (n=98) discontinued an opioid medication because of constipation. Almost half of study respondents modified their opioid therapy to manage constipation side-effects. This analysis showed that constipation related to use of opioids can impact adherence to opioid therapy and pain management. Sponsored by Takeda Pharmaceuticals International, Inc.

PGI22 - The Impact Of Opioid-Induced Constipation (Oic) On Quality Of Life – A 10-Year Literature Review

Constipation is the most common and often most debilitating side effect of opioid therapy for chronic pain. It has been reported that some patients rank constipation as a more common source of distress than their pain. Opioid-induced constipation (OIC) compounds the burden in these patients and may lead to opioid alterations in dosing regimen, discontinuation, inadequate pain management, and increased cost of care Using standard methodology, a targeted literature review was undertaken of studies published in the last 10 years (2002–2012) reporting quality of life (QOL) in patients with OIC receiving opioid therapy for cancer or noncancer pain. The review focused on PubMed (MEDLINE) and Embase; abstracts from recent key conferences/meetings for gastroenterology and pain were also reviewed A limited number of publications (one review, four surveys, two small qualitative studies) were identified. While only the PAC-QOL has been validated in this population, various additional instruments were used to describe OIC impact on QOL, such as EQ-5D, the SF-8 questionnaire, a 5-point scale, an 11-point scale, and qualitative descriptions. The burden of OIC on patient QOL was found to be considerable, with OIC patients experiencing worse QOL than patients without OIC in all four surveys. Of note, one survey showed that increasing severity of constipation correlated with decreasing QOL, while another indicated that patients with severe constipation were less satisfied with their pain treatment versus patients with mild, moderate, or no constipation. Mean satisfaction with pain treatment with no, mild, moderate and severe constipation was 6.6, 6.6, 6.2 and 5.2 (10-very satisfied) Current literature on the impact of OIC on QOL is very limited but consistently suggests that OIC adversely impacts QOL. More research is needed to fully quantify the impact on QOL and standardize research methodology. Alleviation of OIC may improve QOL and optimize pain management among these patients

PGI21 - Impact Of Opioid-Induced Constipation: A Multinational Cross-Sectional Survey Of Patients And Health Care Providers

PGI21 - Impact Of Opioid-Induced Constipation: A Multinational Cross-Sectional Survey Of Patients And Health Care Providers

The Impact of Opioid-Induced Constipation on Patients Near the End of Life

The purpose of this study was to gain a better understanding of how opioid-induced constipation (OIC) influences pain management and quality of life in patients with cancer near the end of life. This was a descriptive study consisting of a national sample of HPNA members (n = 502) working with hospice or palliative care patients, cancer patients (n = 109) who were hospice eligible or with end-stage disease, and informal caregivers (n = 200) of cancer patients. Parallel survey instruments were developed and sent via the Internet to all three groups. Data were analyzed using frequencies, percentages, means, and SDs. Results demonstrate that patients, family caregivers, and nurses all recognize the significance of OIC and its negative impact on both patients and families, and all three groups appreciate the importance of successful management of this distressing symptom.

The Impact of Opioid-Induced Constipation on Patients Near the End of Life

The Impact of Opioid-Induced Constipation on Patients Near the End of Life

Negative impact of opioid-induced constipation on QOL

Negative impact of opioid-induced constipation on QOL

Negative impact of opioid-induced constipation on QOL

Negative impact of opioid-induced constipation on QOL

Negative impact of opioid-induced constipation on QOL

Negative impact of opioid-induced constipation on QOL

(897): Opioid-induced constipation increases healthcare resource use and impairs work productivity: Comparison with other patient groups with and without constipation

Opioids play an important role in chronic pain management, but are often associated with gastrointestinal side effects, most commonly constipation. The impact of opioid-induced constipation (OIC) on healthcare resource utilization and work productivity was assessed, and compared with the impact of constipation-free opioid use and constipation in the absence of opioids, in an analysis of 2004 National Health and Wellness Survey data – a comprehensive cross-sectional survey conducted annually in the US and EU. Respondents were divided into four groups: OIC (opioid use ≥6 months, constipation reported as an AE; n=73); no OIC (opioid use ≥6 months, without constipation; n=1,031); constipation, no opioids; (CNO; n=10,190); no opioids and no constipation (NONC; n=10,000). Data were not collected to assess the incidence of OIC, and in the absence of opioid dosing information this can not be determined. Analyses of variance (ANOVA) revealed a significant effect of opioid/constipation status on multiple measures of healthcare resource use, work productivity and quality of life (p<0.05). For each outcome except number of days hospitalized, the degree of impact followed the pattern OIC>no OIC>CNO>NONC. The most notable areas of additional burden with OIC versus other groups were physician visits (average 11.5 in the previous 6 months, versus 8.5, 5.6 and 4.0, respectively), alternative care provider visits (6.1 in the previous six months, versus 4.3, 2.0 and 1.5, respectively), work impairment (49% versus 30%, 20% and 13% overall impairment, respectively) and activity impairment (64% versus 51%, 28% and 19%, respectively). Both pain requiring opioid treatment and constipation have a negative impact on individuals’ functioning. These data reveal that, for several important aspects of patient function, the impact of OIC is more severe than that of non-opioid-related constipation, and suggest that OIC places a greater burden on patients and society than that associated with constipation-free opioid use or non-opioid-related constipation.