| Title |
Efficacy and tolerability of a hydrocodone extended-release tablet formulated with abuse-deterrence technology for the treatment of moderate-to-severe chronic pain in patients with osteoarthritis or low back pain
|
|---|---|
| Published in |
Journal of Pain Research, September 2015
|
| DOI | 10.2147/jpr.s83930 |
| Pubmed ID | |
| Authors |
Martin E Hale, Charles Laudadio, Ronghua Yang, Arvind Narayana, Richard Malamut |
| Abstract |
This double-blind, placebo-controlled study evaluated the efficacy and safety of hydrocodone extended release (ER) developed with abuse-deterrence technology to provide sustained pain relief and limit effects of alcohol and tablet manipulation on drug release. Eligible patients with chronic moderate-to-severe low back or osteoarthritis pain were titrated to an analgesic dose of hydrocodone ER (15-90 mg) and randomized to placebo or hydrocodone ER every 12 hours. The primary efficacy measure was change from baseline to week 12 in weekly average pain intensity (API; 0=no pain, 10=worst pain imaginable). Secondary measures included percentage of patients with >33% and >50% increases from baseline in weekly API, change from baseline in weekly worst pain intensity, supplemental opioid usage, aberrant drug-use behaviors, and adverse events. Overall, 294 patients were randomized and received ≥1 dose of placebo (n=148) or hydrocodone ER (n=146). Weekly API did not differ significantly between hydrocodone ER and placebo at week 12 (P=0.134); although, in post hoc analyses, the change in weekly API was significantly lower with hydrocodone ER when excluding the lowest dose (15 mg; least squares mean, -0.20 vs 0.40; P=0.032). Significantly more patients had >33% and >50% increase in weekly API with placebo (P<0.05), and mean weekly worst pain intensity was significantly lower with hydrocodone ER at week 12 (P=0.026). Supplemental medication usage was higher with placebo (86%) than hydrocodone ER (79%). Incidence of aberrant drug-use behaviors was low, and adverse events were similar between groups. This study did not meet the primary endpoint, although results support the effectiveness of this hydrocodone ER formulation in managing chronic low back or osteoarthritis pain. Use of the hydrocodone ER 15-mg dose, a robust placebo response, and use of supplemental analgesics, particularly in the placebo group, may have limited detection of a statistically significant treatment effect, and additional research is needed to clarify these findings. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 65 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 65 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 11 | 17% |
| Student > Bachelor | 11 | 17% |
| Student > Master | 8 | 12% |
| Other | 4 | 6% |
| Student > Ph. D. Student | 4 | 6% |
| Other | 8 | 12% |
| Unknown | 19 | 29% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 13 | 20% |
| Nursing and Health Professions | 7 | 11% |
| Psychology | 5 | 8% |
| Pharmacology, Toxicology and Pharmaceutical Science | 5 | 8% |
| Social Sciences | 4 | 6% |
| Other | 11 | 17% |
| Unknown | 20 | 31% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 25 September 2015.
All research outputs
#20,655,488
of 25,371,288 outputs
Outputs from Journal of Pain Research
#1,575
of 1,979 outputs
Outputs of similar age
#203,160
of 276,785 outputs
Outputs of similar age from Journal of Pain Research
#27
of 31 outputs
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