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Systemic Opioid Reduction and Discontinuation Following Implantation of Intrathecal Drug-Delivery Systems for Chronic Pain: A Retrospective Cohort Analysis.

ABSTRACT: OBJECTIVE:The study evaluated systemic opioid utilization before and after initiation of intrathecal drug therapy in patients with chronic, noncancer pain, as well as the effect of opioid elimination on payer costs. METHODS:This was a retrospective cohort analysis of administrative claims data (2011-2016), evaluating patients using systemic opioids for chronic, noncancer pain, newly implanted with an intrathecal drug-delivery system. Patients were excluded for spasticity, cancer, and device explant. The primary outcome was reduction or discontinuation of systemic morphine milligram equivalents during a 395-day follow-up period. The secondary outcome was total commercial insurer payments. RESULTS:Of 9223 total patients, 631 met selection criteria. From baseline to 395-day follow-up, average daily morphine milligram equivalents decreased in 81.5% of patients, and 43.3% discontinued systemic opioid therapy entirely. Among patients who continued systemic opioids, average daily morphine milligram equivalents decreased in 74.9% of patients. Logistic regression found that morphine milligram equivalents of <50?mg/day prior to initiation of intrathecal drug delivery was associated with two times the odds of discontinuation vs. ?90?mg/day (odds ratio = 2.08, 95% confidence interval 1.42-3.02, p =?0.001). Mean annual payer costs were reduced 29% for patients who discontinued vs. continued systemic opioids (-$11,115 per patient). CONCLUSIONS:A meaningful proportion of patients discontinue or decrease systemic opioid use following initiation of intrathecal drug delivery. Standard of care should include opioid dose tapering prior to intrathecal drug delivery to maximize the probability of systemic opioid discontinuation.

SUBMITTER: Hatheway JA

PROVIDER: S-EPMC7687163 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Systemic Opioid Reduction and Discontinuation Following Implantation of Intrathecal Drug-Delivery Systems for Chronic Pain: A Retrospective Cohort Analysis.

Hatheway John A JA Bansal Megha M Nichols-Ricker Christine I CI

Neuromodulation : journal of the International Neuromodulation Society 20191011 7

<h4>Objective</h4>The study evaluated systemic opioid utilization before and after initiation of intrathecal drug therapy in patients with chronic, noncancer pain, as well as the effect of opioid elimination on payer costs.<h4>Methods</h4>This was a retrospective cohort analysis of administrative claims data (2011-2016), evaluating patients using systemic opioids for chronic, noncancer pain, newly implanted with an intrathecal drug-delivery system. Patients were excluded for spasticity, cancer, ...[more]

PMID: 31603605

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Project description:BACKGROUND:The safety and efficacy of intrathecal drug delivery systems (IDDSs) for the treatment of cancer-related pain have been demonstrated in randomized controlled clinical trials (RCTs). Despite positive evidence for this therapy, IDDS remains underutilized to treat cancer pain. Real-world registry data augment existing safety and effectiveness data and are presented here to broaden awareness of this therapeutic option, needed for adequate cancer-related pain treatment, and as a viable tool addressing concerns with systemic opioid use. METHODS:This prospective, long-term, multicenter (United States, Western Europe, and Latin America) registry started in 2003 to monitor the performance of SynchroMed Infusion Systems. Patient-reported outcomes were added in 2013. Before data acquisition, all sites obtained Ethics Committee/Institutional Review Board approval and written patient consent. The study was registered (NCT01524276 at clinicaltrials.gov) before patients were enrolled. Patients who provided informed consent were enrolled in the registry at initial IDDS implant or replacement. RESULTS:Through July 2017, 1403 patients with cancer pain were enrolled and implanted. The average (minimum/maximum) age of patients was 59 years (13/93 years), with 56.6% female. The most frequent cancer types were lung, breast, colon/rectal, pancreatic, and prostate. The majority of patients whose registry follow-up ended (87%; 1141/1311) were followed through death, with 4.3% (n = 57) exiting due to device explant or therapy discontinuation; the remaining 113 (8.6%) discontinued for reasons such as transfer of care, lost to follow-up, and site closure. Pain scores within the cohort of patients providing baseline and follow-up data improved significantly at 6 (P = .0007; n = 103) and 12 (P = .0026; n = 55) months compared to baseline, with EuroQol with 5 dimensions (EuroQol-5D) scores showing significant improvement at 6 months (P = .0016; n = 41). Infection requiring surgical intervention (IDDS explant, replacement, pocket revision, irrigation and debridement, etc) was reported in 3.2% of patients. CONCLUSIONS:Adequate and improved pain control in patients with cancer, even in advanced stages, with concurrent quality of life maintenance is attainable. Results from this large-scale, multicenter, single-group cohort supplement existing RCT data that support IDDS as a safe and effective therapeutic option with a positive benefit-risk ratio in the treatment of cancer pain.

Project description:ObjectiveThis study aimed to investigate the efficacy of intrathecal morphine in the long term by hypothesising that a reduction of the intrathecal opioid dose following long-term administration would increase the level of pain intensity.DesignRandomised, double-blind, controlled, parallel group trial.SettingDepartment of Pain Management, Russells Hall Hospital, Dudley, UK.Participants24 patients with non-cancer pain implanted with morphine reservoirs were assessed for eligibility.InterventionsParticipants were randomly allocated to one of two parallel groups in which one of the groups had no change in morphine dose and the other group had a small reduction (20%) in dosage every week during a 10-week follow-up.OutcomePrimary outcomes were visual analogue scale (VAS) pain score change and withdrawal from the study due to lack of efficacy.Results9 of the patients assessed for eligibility declined to participate in the study. 15 patients were randomised to control (n=5) or intervention (n=10) and included in an intention-to-treat analysis. Owing to worsening of pain, seven patients withdrew from the study prematurely. None knew prior to withdrawal which arm of the study they were in, but all turned out to be in the dose-reduction arm. The calculation of dropout rates between groups indicated a significant statistical difference (p=0.026) and recruitment was ceased. The VAS change between baseline and the last observation was smaller in the control group (median, Mdn=11) than in the intervention group (Mdn=30.5), although not statistically significant, Z=-1.839, p=0.070; r=-0.47. Within groups, VAS was significantly lower at baseline (Mdn=49.5) than at the last observation (Mdn=77.5) for the reduction group, Z=-2.805, p=0.002; r=-0.627 but not for the control group (p=0.188).ConclusionsThis double-blind randomised controlled trial of chronic intrathecal morphine administration suggests the effectiveness of this therapy for the management of chronic non-cancer pain. However, owing to the small number of patients completing the study (n=8), further studies are warranted.Trial registrationInternational Standard Randomised Controlled Trials Centre (ISRCTN 33733462).

Project description:BackgroundMany clinicians are reevaluating the use of long-term opioid therapy (LTOT) for chronic pain in response to the opioid crisis and calls from organizations including the Centers for Disease Control & Prevention to limit prescribing of high-dose opioids. However, this practice change is occurring largely in the absence of data regarding patient outcomes. A 2017 systematic review found inconclusive evidence on the impact of LTOT dose reduction and discontinuation on pain severity and function, quality of life, withdrawal symptoms, substance abuse, and adverse effects. This rapid systematic review provides an updated evidence synthesis of patient outcomes following LTOT dose reduction including serious harms such as overdose and suicide.MethodsWe systematically searched numerous bibliographic databases from January 2017 (the end search date of the 2017 systematic review) through May 2020. One reviewer used prespecified criteria to assess articles for inclusion, evaluate study quality, abstract data, and grade strength of evidence, with a second reviewer checking.ResultsWe included 49 studies-1 systematic review, 34 studies included in that systematic review, and 14 new studies. We prioritized evidence synthesis of 19 studies with the most applicability to the Veteran population and outpatient settings. Among these studies, improvements in mean pain scores were common among patients tapering opioids while participating in intensive multimodal pain interventions and mostly unchanged with less intensive or nonspecific co-interventions. Our confidence in these findings is low due to methodological limitations of the studies. Observational data suggests that serious harms such as opioid overdose and suicidal ideation can occur following opioid dose reduction or discontinuation, but the incidence of these harms at the population level is unknown.DiscussionThe net balance of benefits and harms of LTOT dose reduction for patients with chronic pain is unclear. Clinicians should closely monitor patients during the tapering process given the potential for harm.

Dataset Information

Systemic Opioid Reduction and Discontinuation Following Implantation of Intrathecal Drug-Delivery Systems for Chronic Pain: A Retrospective Cohort Analysis.

Publications

Systemic Opioid Reduction and Discontinuation Following Implantation of Intrathecal Drug-Delivery Systems for Chronic Pain: A Retrospective Cohort Analysis.

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