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All-cause mortality in patients with long-term opioid therapy compared with non-opioid analgesics for chronic non-cancer pain: a database study.

ABSTRACT: BACKGROUND:Hitherto 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). METHODS:The 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. RESULTS:The 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. CONCLUSIONS:LTOT 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 REGISTRATION:ClinicalTrials.gov, NCT03778450, Registered on 7 December 2018.

SUBMITTER: Hauser W

PROVIDER: S-EPMC7362543 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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All-cause mortality in patients with long-term opioid therapy compared with non-opioid analgesics for chronic non-cancer pain: a database study.

Häuser Winfried W Schubert Tino T Vogelmann Tobias T Maier Christoph C Fitzcharles Mary-Ann MA Tölle Thomas T

BMC medicine 20200715 1

<h4>Background</h4>Hitherto 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).<h4>Methods</h4>The study used the InGef (Institute for Applied Health Research Berlin) database ...[more]

PMID: 32664901

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Project description:IntroductionAlthough 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.MethodsWe 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.ResultsOf 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.ConclusionUse 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 registrationUMIN000043985.

Project description:ObjectivesThis study investigates utilisation patterns for prescription opioid analgesics in the Australian community and how these are associated with a framework of individual-level factors related to healthcare use.MethodsSelf-reported demographic and health information from participants in the 45 and Up Study cohort were linked to pharmaceutical claims from 2006-2009. Participants comprised 19,816 people with ?1 opioid analgesic dispensing in the 12-months after recruitment to the cohort and 79,882 people not dispensed opioid analgesics. All participants were aged ?45 years, were social security pharmaceutical beneficiaries, with no history of cancer. People dispensed opioid analgesics were classified as having acute (dispensing period <90 days), episodic (?90 days and <3 'authority' prescriptions for increased quantity supply) or long-term treatment (?90 days and ?3 authority prescriptions).ResultsOf participants dispensed opioid analgesic 52% received acute treatment, 25% episodic treatment and 23% long-term treatment. People dispensed opioid analgesics long-term had an average of 14.9 opioid analgesic prescriptions/year from 2.0 doctors compared with 1.5 prescriptions from 1.1 doctors for people receiving acute treatment. People dispensed opioid analgesics reported more need-related factors such as poorer physical functioning and higher psychological distress. Long-term users were more likely to have access-related factors such as low-income and living outside major cities. After simultaneous adjustment, association with predisposing health factors and access diminished, but indicators of need such as osteoarthritis treatment, paracetamol use, and poor physical function were the strongest predictors for all opioid analgesic users.ConclusionsPeople dispensed opioid analgesics were in poorer health, reported higher levels of distress and poorer functioning than people not receiving opioid analgesics. Varying dispensing profiles were evident among people dispensed opioid analgesics for persistent pain, with those receiving episodic and long-term treatment dispensed the strongest opioid analgesics. The findings highlight the broad range of factors associated with longer term opioid analgesics use.

Project description:BACKGROUND:The continued rise in fatalities from opioid analgesics despite a steady decline in the number of individual prescriptions directing ??90 morphine milligram equivalents (MME)/day may be explained by patient exposures to redundant prescriptions from multiple prescribers. OBJECTIVES:We evaluated prescribers' specialty and social network characteristics associated with high-risk opioid exposures resulting from single-prescriber high-daily dose prescriptions or multi-prescriber discoordination. DESIGN:Retrospective cohort study. PARTICIPANTS:A cohort of prescribers with opioid analgesic prescription claims for non-cancer chronic opioid users in an Illinois Medicaid managed care program in 2015-2016. MAIN MEASURES:Per prescriber rates of single-prescriber high-daily-dose prescriptions or multi-prescriber discoordination. KEY RESULTS:For 2280 beneficiaries, 36,798 opioid prescription claims were submitted by 3532 prescribers. Compared to 3% of prescriptions (involving 6% of prescribers and 7% of beneficiaries) that directed ??90 MME/day, discoordination accounted for a greater share of high-risk exposures-13% of prescriptions (involving 23% of prescribers and 24% of beneficiaries). The following specialties were at highest risk of discoordinated prescribing compared to internal medicine: dental (incident rate ratio (95% confidence interval) 5.9 (4.6, 7.5)), emergency medicine (4.7 (3.8, 5.8)), and surgical subspecialties (4.2 (3.0, 5.8)). Social network analysis identified 2 small interconnected prescriber communities of high-volume pain management specialists, and 3 sparsely connected groups of predominantly low-volume primary care or emergency medicine clinicians. Using multivariate models, we found that the sparsely connected sociometric positions were a risk factor for high-risk exposures. CONCLUSION:Low-volume prescribers in the social network's periphery were at greater risk of intended or discoordinated prescribing than interconnected high-volume prescribers. Interventions addressing discoordination among low-volume opioid prescribers in non-integrated practices should be a priority. Demands for enhanced functionality and integration of Prescription Drug Monitoring Programs or referrals to specialized multidisciplinary pain management centers are potential policy implications.

Project description:Background Opioids are currently prescribed for chronic non-cancer pain (CNCP), and some patients use opioids continuously for long-term treatment. Stakeholders’ awareness about long-term opioid therapy is essential for improving the safety and effectiveness of pain treatment. The purpose of this study is to explore the perspectives of pain specialists, patients, and family caregivers about long-term opioid use in CNCP management. Methods This study was a qualitative study and adhered to the COREQ guidelines. Pain specialists (n = 12), patients (n = 14), and family members (n = 9) were recruited to the study by purposive sampling at the Pain Clinic of Ramathibodi Hospital. Semi-structured interviews were recorded, verbatim transcribed, conceptually coded, and analyzed using Atlas.ti 8.0. Results All groups of participants described opioids as non-first-line drugs for pain management. Opioids should be prescribed only for severe pain, when non-opioid pharmacotherapy and non-pharmacological therapies are not effective. Patients reported that the benefits of opioids were for pain relief, while physicians and most family members highlighted that opioid use should improve functional outcomes. Physicians and family members expressed concerns about opioid-related side effects, harm, and adverse events, while patients did not. Patients confirmed that they would continue using opioids for pain management under supervision. However, physicians stated that they would taper off or discontinue opioid therapy if patients’ pain relief or functional improvement was not achieved. Both patients and family members were willing to consider non-pharmacological therapies if potential benefits existed. Patient education, doctor–patient/family relationships, and opioid prescription policies were proposed to enhance CNCP management. Conclusion Long-term opioid therapy for CNCP may be beneficial in patients who have established realistic treatment goals (for both pain relief and functional improvement) with their physicians. Regular monitoring and evaluation of the risks and benefits, adverse events, and drug-related aberrant behaviors are necessary. Integrated multimodal multidisciplinary therapies and family member collaborations are also important for improving CNCP management. Supplementary Information The online version contains supplementary material available at 10.1186/s12871-021-01501-8.

Project description:BackgroundEveryday people die unnecessarily from opioid overdose-related addiction. Dentists are among the leading prescribers of opioid analgesics. Opioid-seeking behaviors have been linked to receipt of initial opioid prescriptions following the common dental procedure of third molar extraction. With each opioid prescription, a patient's risk for opioid misuse or abuse increases. With an estimated 56 million tablets of 5 mg hydrocodone annually prescribed after third molar extractions in the USA, 3.5 million young adults may be unnecessarily exposed to opioids by dentists who are inadvertently increasing their patient's risk for addiction.MethodsA double-blind, stratified randomized, multi-center clinical trial has been designed to evaluate whether a combination of over-the-counter non-opioid-containing analgesics is not inferior to the most prescribed opioid analgesic. The impacted 3rd molar extraction model is being used due to the predictable severity of the post-operative pain and generalizability of results. Within each site/clinic and gender type (male/female), patients are randomized to receive either OPIOID (hydrocodone/acetaminophen 5/300 mg) or NON-OPIOID (ibuprofen/acetaminophen 400/500 mg). Outcome data include pain levels, adverse events, overall patient satisfaction, ability to sleep, and ability to perform daily functions. To develop clinical guidelines and a clinical decision-making tool, pain management, extraction difficulty, and the number of tablets taken are being collected, enabling an experimental decision-making tool to be developed.DiscussionThe proposed methods address the shortcomings of other analgesic studies. Although prior studies have tested short-term effects of single doses of pain medications, patients and their dentists are interested in managing pain for the entire post-operative period, not just the first 12 h. After surgery, patients expect to be able to perform normal daily functions without feeling nauseous or dizzy and they desire a restful sleep at night. Parents of young people are concerned with the risks of opioid use and misuse, related either to treatments received or to subsequent use of leftover pills. Upon successful completion of this clinical trial, dentists, patients, and their families will be better able to make informed decisions regarding post-operative pain management.Trial registrationClinicalTrials.gov NCT04452344 . Registered on June 20, 2020.

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All-cause mortality in patients with long-term opioid therapy compared with non-opioid analgesics for chronic non-cancer pain: a database study.

Publications

All-cause mortality in patients with long-term opioid therapy compared with non-opioid analgesics for chronic non-cancer pain: a database study.

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