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- Title
Efficacy and Safety of Once-Daily Extended-Release ( ER) Hydrocodone in Individuals Previously Receiving ER Morphine for Chronic Pain.
- Authors
Broglio, Kathleen; Pergolizzi, Joseph; Kowalski, Maribeth; Lynch, Shau Yu; He, Ellie; Wen, Warren
- Abstract
Objectives This post hoc analysis examined the effectiveness and safety of hydrocodone bitartrate ( HYD) in patients with moderate-to-severe chronic pain who were previously taking extended-release morphine (morphine ER) for pain management. Study Design The primary analysis was an open-label, 12-month study. Setting The study was conducted in 88 sites in the United States. Methods The study was approved by an institutional review board. Eligible patients were enrolled and titrated to a once-daily dose of HYD 20, 40, 60, 80, or 120 mg for a 45-day period. The subgroup of patients in this report was using morphine ER prior to study entry. After achieving a stable HYD daily dose, patients entered a 12-month maintenance period during which additional dose adjustment could be made and nonopioid or short-acting opioid medications could be received. Average pain over the last 24 hours was recorded daily (on a scale of 0 to 10) Patients completed the Brief Pain Inventory ( BPI) short form, which assessed pain severity and the interference of pain in daily life, every 4 weeks during the maintenance period. Safety was assessed routinely. Results Of the 26 patients who switched from morphine ER to HYD, 19 entered the maintenance period. At study entry, mean 'average pain over the last 24 hours' was scored as 5.21. This was reduced to 3.90 by the time patients entered the maintenance phase; this level of pain control was maintained over the 12-month period, with 16 patients requiring no further HYD dose adjustment. BPI scores decreased for both pain severity and pain interference during the maintenance period. HYD was well tolerated. Conclusions The results of this subgroup analysis suggest that rotation from morphine ER to once-daily HYD in patients with moderate-to-severe chronic pain maintains or improves pain relief and does not increase safety concerns.
- Subjects
UNITED States; CHRONIC pain treatment; SUBSTANCE abuse prevention; ANALGESIA; ANALGESICS; CHRONIC pain; CODEINE; CONFIDENCE intervals; CONTROLLED release preparations; DRUG administration; DOSAGE forms of drugs; GENETIC techniques; MORPHINE; NARCOTICS; RESEARCH funding; STATISTICS; PAIN management; DATA analysis; PAIN measurement; TREATMENT effectiveness; PATIENT selection; DATA analysis software; THERAPEUTICS
- Publication
Pain Practice, 2017, Vol 17, Issue 3, p382
- ISSN
1530-7085
- Publication type
Article
- DOI
10.1111/papr.12462