Dataset Information

A Survey of the Incidence of Constipation in Patients with Chronic Non-cancer Pain Using Opioid Analgesics in Japan.

ABSTRACT:

Introduction

Although opioids have potent analgesic properties, their use is associated with side effects, including opioid-induced constipation (OIC). This study investigated the incidence of OIC based on the Rome IV diagnostic criteria in patients using opioid analgesics for chronic non-cancer pain and to explore and compare the risk factors for the development of OIC in opioid analgesic users.

Methods

We surveyed patients aged 20 years or more living in Japan via the internet; who had been using opioid or non-opioid analgesics (N = 500 each) for at least 3 months for relief from chronic non-cancer musculoskeletal pain (low back pain or osteoarthritis); and who provided electronic consent to participate in and complete the survey. The groups were matched for age and sex.

Results

Of the patients using opioid analgesics, 89% were taking weak opioids. The proportion of patients perceiving constipation was comparable between the opioid and non-opioid analgesic groups (34% vs 29%, respectively); however, a significantly higher proportion of patients in the opioid group, compared to the non-opioid group, reported self-assessed constipation (40% vs 18%, respectively) after using an analgesic and fulfilled two or more symptoms of the Rome IV diagnostic criteria for constipation (28% vs 19%, respectively). A higher proportion of patients were taking prescribed medicine for constipation in the opioid group compared with the non-opioid group (33% vs 18%, respectively). Low back pain, but not opioid strength and scheduled dosing, was identified as a risk factor for OIC among various covariates assessed in the logistic regression analysis in 81 patients with OIC and Rome IV diagnosis vs 419 patients without OIC in the opioid group.

Conclusion

Use of opioid analgesics, including weak opioids, for treating chronic non-cancer musculoskeletal pain is associated with OIC. This finding highlights the need for appropriate treatment of constipation in patients with chronic non-cancer pain in Japan.

Trial registration

UMIN000043985.

SUBMITTER: Sonohata M

PROVIDER: S-EPMC9314494 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundHitherto only studies with selected populations have found an increased all-cause mortality of some selected opioids compared to selected non-opioids for chronic non-cancer pain (CNCP). We have examined the all-cause mortality for CNCP associated with all established opioids compared to non-opioid analgesic therapy (anticonvulsants, antidepressants, dipyrone, non-steroidal agents).MethodsThe study used the InGef (Institute for Applied Health Research Berlin) database which is an anonymized healthcare claims database including 4,711,668 insured persons who were covered by 61 German statutory health insurances between 2013 and 2017.The health insurance companies are the owners of the database. All-cause mortality was determined from death certificates. Adjusted hazard ratios (HRs) including age, gender, comorbidity index, and propensity score as covariates and risk differences (RD) in incidence of death between patients with long-term opioid therapy (LTOT) and control-drug therapy were calculated.ResultsThe mean age of participants was 66 years; 55% were women. There were 554 deaths during 10,435 person-years for the LTOT patients, whereas there were 340 deaths during 11,342 person-years in the control group. The HR for all-cause mortality was 1.59 (95% CI, 1.38-1.82) with a risk difference of 148 excess deaths (95% CI 99-198) per 10,000 person-years. The elevated risk of death for LTOT was confined to the out-of-hospital deaths: LTOT patients had 288 out-of-hospital deaths during 10,435 person-years (276 per 10,000 person-years) whereas there were 110 deaths during 11,342 person-years (97 per 10,000 person-years) in the control group. HR was 2.29 (95% CI 1.86, 2.83). Although our propensity score matching model indicated a good classification, residual confounding cannot be fully excluded. The opioid group had a higher prevalence of heart failure and a higher use of anti-thrombotic and antiplatelet agents and of psycholeptics.ConclusionsLTOT for CNCP compared to non-opioid analgesics was associated with an increased risk for all-cause mortality. When considering treatment options for patients with CNCP, the relevant risk of increased all-cause mortality with opioids should be discussed.Trial registrationClinicalTrials.gov, NCT03778450, Registered on 7 December 2018.

Project description:The use of opioids in the treatment of chronic pain is widespread; the prevalence of specific opioids varies from country to country and depends on product availability, national formulary systems, and provider preferences. Patients often receive opioids for legitimate treatment of pain conditions, but on the opposite side of the spectrum, nonmedical use of opioids is a significant public health concern. Opioids are associated with several side effects, and constipation is the most commonly reported and persistent symptom. Unlike some adverse effects associated with opioid use, tolerance does not develop to constipation. Opioid-induced constipation (OIC) is the most prevalent patient complaint associated with opioid use and has been associated with declines in various quality of life measures. OIC can be extremely difficult for patients to tolerate and may prompt patients to decrease or discontinue opioid treatment. Current management strategies for OIC are often insufficient. A prolonged-release formulation of oxycodone/naloxone (OXN) has been investigated for the treatment of nonmalignant and cancer pain and mitigation of OIC, and evidence is largely favorable. Studies have demonstrated the capability of OXN to alleviate OIC while maintaining pain control comparable to oxycodone-only regimens. There is insufficient evidence for OXN efficacy for patients with mild OIC or patients maintained on high doses of opioids, and use in these populations is controversial. The reduction of costs associated with OIC may provide overall cost effectiveness with OXN. Additionally, the presence of naloxone may deter abuse/misuse by those seeking to misuse the formulation by modes of administration other than oral ingestion. Most studies to date have occurred in European countries, and phase 3 trials continue in the United States. This review will include current therapeutic options for pain and constipation, unique characteristics of OXN, evidence related to use of OXN and its place in therapy, discussion of opioid abuse/misuse, and various abuse-deterrent mechanisms, and areas of continuing research.

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