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Workplace and nonworkplace productivity in chronic noncancer pain patients: the Opioid Utilization Study (OPUS)
Abstracts (296) Workplace and nonworkplace productivity in chronic noncancer pain patients: the Opioid Utilization Study (OPUS) S Stanos, C Argoff, G Irving, L Yanni, R Puenpatom, E Gould, T Victor, B De Jong, R White; Rehabilitation Institute of Chicago Center for Pain, Chicago, IL Chronic pain negatively affects personal health and productivity generating direct and indirect costs to individuals, workplaces, and society. Studies have estimated costs of lost productivity due to common pain conditions (eg, back pain, osteoarthritis), primarily through loss of work days (absenteeism). However, there are few data on the cost of reduced workplace performance (presenteeism) or non-workplace (unpaid or household) productivity declines. The Opioid Utilization Study (OPUS) is a 12-month, multicenter, prospective, observational, cohort study to characterize opioid therapy utilization in patients with chronic noncancer pain. As part of OPUS, the Short Form Health and Labor Questionnaire (SF-HLQ), a validated instrument, is being used to collect data about productivity losses related to health problems including absence from work, reduced productivity at paid and unpaid work, and impediments to paid and unpaid work. Enrollment is currently 342 patients: 83.6% with chronic pain and 69.9% treated with opioids for >1 year. Sex, race, and duration of chronic pain (<1 y vs $1 y) had no significant influence on number of workdays missed, which was 5.9 (10.3) (mean[SD]) work days per month. In 80.7% pain limited work or other activities, while in 58.5% pain interfered with normal work Quite a Bit or Extremely. The OPUS registry will continue to accumulate clinical practice-based data from academic and private practices on the effects of chronic pain and pain treatment on workplace and non-workplace productivity. (Supported by Endo Pharmaceuticals Inc., Chadds Ford, PA.)
(297) Baseline demographic data from OPUS: The Opioid Utilization Study in chronic noncancer pain L Yanni, C Argoff, G Irving, S Stanos, R Puenpatom, E Gould, T Victor, X Hu, B De Jong, R White; Virginia Commonwealth University Medical Center, Richmond, VA Use of opioid analgesics for chronic noncancer pain is increasingly common. However, most opioid clinical trials are relatively short-term studies that do not reflect typical real-world clinical practices, such as switching and rotation to provide effective pain relief with acceptable tolerability. There is also a need to assess the long-term economic impact of chronic opioid use. The Opioid Utilization Study (OPUS) is a 12-month, multicenter, prospective, observational cohort study that seeks to characterize the utilization of opioid therapy (titration, additions, changes, and/or rotation) in patients with chronic noncancer pain. Secondary objectives include analyzing quality-of-life measures, economic patient-reported outcomes, and healthcare resource utilization. To represent clinical practice, inclusion criteria are broad ($18 y of age with chronic noncancer pain for $3 mo) and exclusion criteria are limited (cancer pain, substance abuse, or an open workers’ compensation claim). Of the total enrolled patients to date (N = 342), 66.7% are women, 88.3% European American, 8.2% African American, 1.5% Native American, and 7.0% other ethnicity. Most patients (60.4%) have a net annual household income <$40,000, with 78.7% <$60,000. Pain has persisted for >1 year in most patients (83.6%), and most patients (69.9%) have been on an opioid for >1 year. Chronic pain patients’ households comprise an average of 2.4 people (SD = 1.3), of whom 1.7 are dependents of the patient (SD = 1.2). The OPUS Registry will characterize typical opioid utilization patterns and the economic impact of long-term opioid therapy on patients and the healthcare system in a population representative of chronic noncancer pain patients in current clinical practice. (Supported by Endo Pharmaceuticals Inc., Chadds Ford, PA.)
S49 (298) Two exploratory double-blind crossover studies of the treatment of chronic noncancer pain: efficacy and safety of concurrent dosing of morphine plus oxycodone vs morphine alone P Richards, W Stern, F de la Iglesia, G Pace; Greenslopes Private Hospital, Greenslopes, NJ Animal studies have shown that coadministration of morphine and oxycodone (M1O) produced synergistic reductions in acute pain with minimal AEs. Two double-blind, randomized, crossover studies in patients with chronic, moderate-to-severe, noncancer pain (Study A, N = 21; Study B, N = 23) evaluated the efficacy and safety of concurrent oral dosing of M1O (liquid formulation) at fixed ratios (Study A, 3:2; Study B, 1:2) vs equianalgesic doses of oral liquid morphine. Period 1: randomized patients received flexible M1O or morphine alone q4h for 3-7 days to achieve steady-state pain relief. Period 2: patients received alternate treatment (no washout). Rescue medication was study medication at 25% of the randomized dose. In both studies, M1O and morphine alone achieved similar analgesic efficacy. However, Study A patients achieved equianalgesic effects using (mean6SD) 40.5628.4 mg/day (36%) less morphine equivalents with M1O vs morphine alone (P < 0.006). Study B patients achieved equianalgesic effects using 20.5620.9 mg/day (31.9%) less morphine equivalents with M1O vs morphine alone (P = 0.0026). There were no unusual AEs seen with M1O. M1O was associated with less nausea (Study A: P < 0.05), less constipation (Study B: P = 0.025), and less drowsiness (Study A, Days 2, 3, & 5: P < 0.05) vs morphine alone. Pooled analysis showed 1.5 times greater risk of constipation with morphine alone vs M1O (P < 0.044; RR = 1.554; 95% CI = 1.000-2.418) and a trend toward greater risk of drowsiness with morphine alone (P = 0.154; RR = 1.363, 95% CI = .887-2.094). M1O was well tolerated and provided equianalgesic pain relief at significantly lower morphine-equivalent doses vs morphine alone. (Supported by QRxPharma, Bedminster, NJ.)
(299) Open-label extension study on the long-term efficacy, safety, and impact on quality of life of OROSÒ hydromorphone extended release in patients with chronic low back pain M Wallace, J Thipphawong; Center for Pain Medicine, La Jolla, CA Hydromorphone is safe and effective for managing moderate-to-severe pain; however, a once-daily form is not available. This 6-month extension of a short-term (28-day), open-label study characterized the efficacy, safety, and impact on quality-of-life (QOL) measures of long-term repeated dosing of once-daily OROSÒ hydromorphone extended-release (ER) (8, 16, 32, and 64 mg) in patients with chronic LBP. Evaluations included a pain relief rating, the Brief Pain Inventory (BPI), QOL assessment (Short Form-36 [SF-36]), and adverse events (AEs). A total of 113 patients were included in the study. Significant improvements from baseline in mean pain relief ratings observed at the end of the short-term study were maintained for all visits (mean [6SD] change range: 0.53 [1.012] to 0.72 [0.881]; P < 0.001, for all visits including the final visit). Significant changes from the short-term study baseline to the final extension study visit were observed in mean monthly BPI scores for pain relief (P = 0.0007), pain right now (P = 0.0002), and interference with general activity (P = 0.001). Significant increases from baseline also were found for mean monthly SF-36 physical (P < 0.0001) and mental (P = 0.0006) composite scores. The most common AEs (>5%) during the extension study included back pain (8.9%), nausea (8.9%), vomiting (8.9%), constipation (7.1%), influenza (7.1%), diarrhea (5.4%), fall (5.4%), insomnia (5.4%), and muscle spasm (5.4%). The results of this study suggest that the efficacy and safety of OROS hydromorphone ER were maintained for up to 6 months in patients with chronic LBP. (This study was supported by Knoll Pharmaceutical Company, ALZA Corporation and Neuromed Pharmaceuticals. Editorial support for this abstract was provided by Neuromed Pharmaceuticals.)
(297) Baseline demographic data from OPUS: The Opioid Utilization Study in chronic noncancer pain L Yanni, C Argoff, G Irving, S Stanos, R Puenpatom, E Gould, T Victor, X Hu, B De Jong, R White; Virginia Commonwealth University Medical Center, Richmond, VA Use of opioid analgesics for chronic noncancer pain is increasingly common. However, most opioid clinical trials are relatively short-term studies that do not reflect typical real-world clinical practices, such as switching and rotation to provide effective pain relief with acceptable tolerability. There is also a need to assess the long-term economic impact of chronic opioid use. The Opioid Utilization Study (OPUS) is a 12-month, multicenter, prospective, observational cohort study that seeks to characterize the utilization of opioid therapy (titration, additions, changes, and/or rotation) in patients with chronic noncancer pain. Secondary objectives include analyzing quality-of-life measures, economic patient-reported outcomes, and healthcare resource utilization. To represent clinical practice, inclusion criteria are broad ($18 y of age with chronic noncancer pain for $3 mo) and exclusion criteria are limited (cancer pain, substance abuse, or an open workers’ compensation claim). Of the total enrolled patients to date (N = 342), 66.7% are women, 88.3% European American, 8.2% African American, 1.5% Native American, and 7.0% other ethnicity. Most patients (60.4%) have a net annual household income <$40,000, with 78.7% <$60,000. Pain has persisted for >1 year in most patients (83.6%), and most patients (69.9%) have been on an opioid for >1 year. Chronic pain patients’ households comprise an average of 2.4 people (SD = 1.3), of whom 1.7 are dependents of the patient (SD = 1.2). The OPUS Registry will characterize typical opioid utilization patterns and the economic impact of long-term opioid therapy on patients and the healthcare system in a population representative of chronic noncancer pain patients in current clinical practice. (Supported by Endo Pharmaceuticals Inc., Chadds Ford, PA.)
S49 (298) Two exploratory double-blind crossover studies of the treatment of chronic noncancer pain: efficacy and safety of concurrent dosing of morphine plus oxycodone vs morphine alone P Richards, W Stern, F de la Iglesia, G Pace; Greenslopes Private Hospital, Greenslopes, NJ Animal studies have shown that coadministration of morphine and oxycodone (M1O) produced synergistic reductions in acute pain with minimal AEs. Two double-blind, randomized, crossover studies in patients with chronic, moderate-to-severe, noncancer pain (Study A, N = 21; Study B, N = 23) evaluated the efficacy and safety of concurrent oral dosing of M1O (liquid formulation) at fixed ratios (Study A, 3:2; Study B, 1:2) vs equianalgesic doses of oral liquid morphine. Period 1: randomized patients received flexible M1O or morphine alone q4h for 3-7 days to achieve steady-state pain relief. Period 2: patients received alternate treatment (no washout). Rescue medication was study medication at 25% of the randomized dose. In both studies, M1O and morphine alone achieved similar analgesic efficacy. However, Study A patients achieved equianalgesic effects using (mean6SD) 40.5628.4 mg/day (36%) less morphine equivalents with M1O vs morphine alone (P < 0.006). Study B patients achieved equianalgesic effects using 20.5620.9 mg/day (31.9%) less morphine equivalents with M1O vs morphine alone (P = 0.0026). There were no unusual AEs seen with M1O. M1O was associated with less nausea (Study A: P < 0.05), less constipation (Study B: P = 0.025), and less drowsiness (Study A, Days 2, 3, & 5: P < 0.05) vs morphine alone. Pooled analysis showed 1.5 times greater risk of constipation with morphine alone vs M1O (P < 0.044; RR = 1.554; 95% CI = 1.000-2.418) and a trend toward greater risk of drowsiness with morphine alone (P = 0.154; RR = 1.363, 95% CI = .887-2.094). M1O was well tolerated and provided equianalgesic pain relief at significantly lower morphine-equivalent doses vs morphine alone. (Supported by QRxPharma, Bedminster, NJ.)
(299) Open-label extension study on the long-term efficacy, safety, and impact on quality of life of OROSÒ hydromorphone extended release in patients with chronic low back pain M Wallace, J Thipphawong; Center for Pain Medicine, La Jolla, CA Hydromorphone is safe and effective for managing moderate-to-severe pain; however, a once-daily form is not available. This 6-month extension of a short-term (28-day), open-label study characterized the efficacy, safety, and impact on quality-of-life (QOL) measures of long-term repeated dosing of once-daily OROSÒ hydromorphone extended-release (ER) (8, 16, 32, and 64 mg) in patients with chronic LBP. Evaluations included a pain relief rating, the Brief Pain Inventory (BPI), QOL assessment (Short Form-36 [SF-36]), and adverse events (AEs). A total of 113 patients were included in the study. Significant improvements from baseline in mean pain relief ratings observed at the end of the short-term study were maintained for all visits (mean [6SD] change range: 0.53 [1.012] to 0.72 [0.881]; P < 0.001, for all visits including the final visit). Significant changes from the short-term study baseline to the final extension study visit were observed in mean monthly BPI scores for pain relief (P = 0.0007), pain right now (P = 0.0002), and interference with general activity (P = 0.001). Significant increases from baseline also were found for mean monthly SF-36 physical (P < 0.0001) and mental (P = 0.0006) composite scores. The most common AEs (>5%) during the extension study included back pain (8.9%), nausea (8.9%), vomiting (8.9%), constipation (7.1%), influenza (7.1%), diarrhea (5.4%), fall (5.4%), insomnia (5.4%), and muscle spasm (5.4%). The results of this study suggest that the efficacy and safety of OROS hydromorphone ER were maintained for up to 6 months in patients with chronic LBP. (This study was supported by Knoll Pharmaceutical Company, ALZA Corporation and Neuromed Pharmaceuticals. Editorial support for this abstract was provided by Neuromed Pharmaceuticals.)