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Thursday, November 21, 2019

Cautionary Data on Rapid Opioid Tapering

As the frequency of opioid tapering increased over the past decade, many patients had doses reduced faster than is recommended, potentially leading to withdrawal symptoms, a large retrospective study showed.
Almost 1 in 5 patients undergoing opioid tapering had dose reductions that exceeded the CDC-recommended maximum of 10% per week. During the same time period, 2008 to 2017, the proportion of opioid-treated patients undergoing tapering more than doubled.
Rapid tapering occurred more often in women and in patients who had higher baseline opioid doses, Joshua J. Fenton, MD, of the University of California Davis, and coauthors reported in JAMA Network Open.
“I wouldn’t want to overinterpret the findings, but I think they ultimately call for a more nuanced approach to clinical practice with regard to opioids, as well as the research landscape which is starting to answer the questions that might better guide patients and providers,” coauthor Alicia L. Agnoli, MD, also of UC Davis, told MedPage Today.
“The big take-away is that these processes need to be individualized, both patient- and patience-centered,” she added.
In 2016 the CDC published an opioid prescribing guideline that encouraged use of nonopioid therapies for chronic pain, questioned the use of daily doses higher than 50 morphine milligram equivalents (MMEs), and recommended avoiding daily dosages ≥90 MMEs. Additionally, the guideline recommended tapering opioids when the risks outweigh the benefits.
Authors of the CDC guideline recommended gradual dose reduction when tapering, approximately 10% per week and perhaps slower for patients with long-term use. Recently, the Department of Health and Human Services published additional recommendations for opioid tapering or discontinuation. Some of the authors of the HHS document followed up with a summary of the recommendations and a call for a “patient-centered” approach.
Earlier this year, the FDA issued a safety announcement addressing the potential harms of sudden discontinuation of opioids or rapid dose tapering. The announcement came after the agency had received reports about patients who had “serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide” following rapid tapering or abrupt discontinuation of opioids.
To examine current trends in opioid tapering, Fenton, Agnoli, and colleagues retrospectively reviewed medical and pharmacy claims data for 100,031 patients covered by commercial insurance plans or Medicare during 2008-2017. The patients were all adults who had stable higher-dosage (mean ≥50 MMEs) opioid prescriptions for a 12-month period and two additional months of follow-up. The primary objectives were to determine the frequency of tapering and the frequency of rapid tapering.
Participants’s mean age was 58, and women accounted for 53.4% of the total study population. The patients were representative of the population of insured individuals, with varied diagnoses and indications for opioid pain medication. Patients with cancer were excluded from the study, as they represent a distinct population with regard to pain-relief needs, said Agnoli.
Investigators defined opioid tapering as ≥15% relative reduction in mean daily MME during any six overlapping 60-day windows within a 7-month follow-up period. Rapid tapering was defined in accordance with the CDC guideline (>10%/week).
The data showed that the proportion of patients with opioid tapering increased from 10.5% to 13.7% from 2008 to 2015. The frequency then rose to 16.2% in 2016 and to 22.4% in 2017, following publication of the CDC guideline. Analysis of covariates showed that tapering occurred more frequently among women (adjusted incidence rate ratio 1.13, 95% CI 1.10-1.15) and among patients who had higher baseline opioid doses (IRR 2.57 for ≥300 MMEs/day vs 50-89 MMEs/day, 95% CI 2.48-2.65).
Among patients with tapering, the mean maximum dose reduction was 27.6% per month, but 18.8% of the subgroup had maximum tapering rates >40% per month, exceeding the CDC-recommended 10% maximum weekly reduction. Rapid tapering was associated with later study year (adjusted difference 1.4%, 2016-2017 vs 2008-2015) and higher baseline opioid dose (adjusted difference 2.7%, 90-149 vs 50-89 MMEs/day).
Providers seeking guidance on the issue of opioid tapering need look no further than the CDC guidance on opioid use and dose reductions, said Agnoli.
“The revised guidelines from the CDC as well as the FDA safety alert are worth examining more closely,” she said. “The FDA noted significant harms from reported sudden discontinuation of opioids and recommended gradual, individualized tapering among patients for whom the risks of continuing a prescribed opioid outweigh the analgesic benefits.”
“I think that is the most sage guidance that one could follow from these data and numerous other reports. Keep that risk-benefit framework in mind and caution with regard to safety concerns.”
The study was supported by the University of California-OptumLabs Research Credit.
Authors reported receiving grant support for the study from UC Davis and OptumLabs.

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