Abstract

Tramadol is a low-level opioid increasingly recommended to treat moderate-to-severe acute and chronic pain. Although characterized as having fewer opioid-related adverse events, the longer term safety of tramadol use among older adults has not been thoroughly documented. Thus, the primary objective was to examine the risk of safety events associated with chronic tramadol use compared to other chronic opioid use or no opioids among older adults with osteoarthritis. Safety events considered included: ≥3 emergency room (ER) visits, falls/hip fractures, cardiovascular (CVD) hospitalization, composite safety event hospitalization, and all-cause mortality. The study population included older adults ages ≥65 years diagnosed with osteoarthritis and classified into new or continuing tramadol use, new or continuing other opioid use, or nonuse. Inclusion criteria included: 6-month pre period and up to 33 months post period. Tramadol, other opioid, and no opioid users were 1:1 propensity-matched providing study populations of 25,899 within each category; 72% were new chronic opioid users. Multiple logistic regression or Cox proportional hazard ratios were used to document risk. Generally, tramadol users had fewer adverse event risks compared to other opioid users but higher risks than nonusers. New users of tramadol or other opioids had higher risks than continuing users. Tramadol use was associated with increased risk of multiple ER utilizations, falls/fractures, CVD hospitalizations, safety event hospitalizations, and mortality (new users only) compared to nonuse. Thus, although tramadol use may be appropriately recommended within a pain management strategy for older adults with osteoarthritis, careful monitoring for adverse safety events is warranted.

Highlights

  • Tramadol is a low-level opioid increasingly recommended for the treatment of moderate-to-severe acute and chronic pain when acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs) no longer provide adequate analgesic effectiveness.[1,2,3,4,5] As of 2012, the American College of Rheumatology and the American Academy of Orthopedic Surgeons updated their guidelines to recommend tramadol as a first-line treatment option, along with NSAIDs, for osteoarthritic pain.[6]

  • Prevalence rates for potential side effects associated with pain or medications including insomnia, pneumonia, serotonin syndrome, and respiratory distress were significantly higher among tramadol and other opioid users compared to nonusers

  • Strengths of the study include a large realworld community-based study population that included multiple safety event outcomes for new and continuing tramadol users and included comparisons with other opioids and no opioid subgroups. These results provide a systematic comparison of multiple safety event outcomes across new and continuing users of tramadol compared to new and continuing other opioid users and nonusers

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Summary

Introduction

Tramadol is a low-level opioid increasingly recommended for the treatment of moderate-to-severe acute and chronic pain when acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs) no longer provide adequate analgesic effectiveness.[1,2,3,4,5] As of 2012, the American College of Rheumatology and the American Academy of Orthopedic Surgeons updated their guidelines to recommend tramadol as a first-line treatment option, along with NSAIDs, for osteoarthritic pain.[6]. Contraindications associated with tramadol listed by the US Food and Drug Administration (FDA) include: prolonged elimination half-life for patients ages >75 years with recommended adjustment in daily dosages; a risk of serotonin syndrome and seizures, especially in combination with antidepressants; respiratory distress with high doses; and a Shirley Musich et al 2020; Published by Mary Ann Liebert, Inc. Contraindications associated with tramadol listed by the US Food and Drug Administration (FDA) include: prolonged elimination half-life for patients ages >75 years with recommended adjustment in daily dosages; a risk of serotonin syndrome and seizures, especially in combination with antidepressants; respiratory distress with high doses; and a Shirley Musich et al 2020; Published by Mary Ann Liebert, Inc

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