Safety and Tolerability of Biphasic Immediate‐Release/Extended‐Release Oxycodone/Acetaminophen Tablets: Analysis of 11 Clinical Trials

Abstract

Safety and tolerability of IR/ER OC/APAP are similar to other low-dose opioid/APAP analgesics.

Clinical Practice Guidelines for Pain Management in Acute Musculoskeletal Injury

“…166,177 Common non–life-threatening side effects seen in approximately 10% of patients prescribed immediate-release opioids are pruritus, nausea, vomiting, dizziness, headache, and somnolence. 178,179 Addiction and abuse are complications often seen by psychiatrists or psychologists. Despite early, unsubstantiated claims of improved safety with long-acting opioids, 180 the relative abuse and addiction potential with short-acting or long-acting opioids remains a question.…”

Systematic Review on Opioid Treatments for Chronic Pain: Surveillance Report 1

“…All trials excluded patients with a history of substance use disorder or active substance use and mental health comorbidities or severe mental health comorbidities; or did not describe eligibility status based on these factors. Fifteen trials restricted enrollment to opioid-naïve patients, 51,54,76,77,81,84,88,99,100,104,107,108,110,111,[123][124][125]127 seven trials to opioid-experienced patients, 68,70,72,73,83,91,98,115 and 37 trials to mixed populations of opioid-naïve and experienced patients; 50,52,55,56,[58][59][60][61][62][65][66][67]69,74,75,79,80,82,[85][86][87]89,90,92,[94][95][96]…”

“…In 10 trials, the opioid was buprenorphine and the MED/day was not calculated. Five trials were rated good-quality, 53,55,75,76,92 55 trials fair-quality, 50,52,54,[56][57][58][59][60][61][62][63][65][66][67][68][69][70][71][72][73][74]77,[79][80][81][82][83][85][86][87]90,91,[93][94][95]97,99,100,[102][103][104][105][107][108][109][111][112][113][114][115][116][117]…”

“…Methodological shortcomings frequently present in the fair-and poor-quality trials included unclear randomization, unclear allocation concealment, unclear whether outcome assessors were blinded, high attrition, and differences between groups in attrition. Fourteen trials used a crossover design 61,67,70,71,78,82,89,95,105,106,109,118,119,122 and 25 trials used an enriched enrollment randomized withdrawal (EERW) design; 51,55,57,65,68,[72][73][74][75][79][80][81]91,[97][98][99][100][101][102]107,108,113,115,116,121,[123][124][125][126][127][128][129] the remainder used a parallel group non-EERW randomized trial design. All trials except eight 60,67,82,84,93,…”

“…Fourteen trials used a crossover design 61,67,70,71,78,82,89,95,105,106,109,118,119,122 and 25 trials used an enriched enrollment randomized withdrawal (EERW) design; 51,55,57,65,68,[72][73][74][75][79][80][81]91,[97][98][99][100][101][102]107,108,113,115,116,121,[123][124][125][126][127][128][129] the remainder used a parallel group non-EERW randomized trial design. All trials except eight 60,67,82,84,93,95,120,122 reported industry funding.…”