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Pain characteristics of patients prescribed chronic opioid therapy for chronic noncancer pain: data from the opioid utilization study (OPUS)
S48 (288) Safety and efficacy of oxymorphone extended release for chronic low back pain in patients with comorbidities M Wieman, J Peniston, T Ma, and E Gould; Endo Pharmaceuticals Inc., Chadds Ford, PA The safety and efficacy of oxymorphone extended release (ER) for chronic low back pain (CLBP) were established in 2 multicenter, enriched-enrollment, randomized-withdrawal trials. These trials were pooled in this post hoc subanalysis to examine the safety of oxymorphone ER in patients with comorbidities of hypertension, diabetes, and cardiovascular disease. During open-label titration of oxymorphone ER, 348 of 575 patients achieved an effective and generally welltolerated dose (median stabilized dose 40 mg, all comorbidity subgroups); $1 adverse event (AE) was reported by a similar proportion of patients with and without hypertension (69.1% [141/204] vs 69.3% [257/371]), diabetes (73.8% [48/65] vs 68.6% [350/510]), and cardiovascular disease (73.8% [59/80] vs 68.5% [339/495]). During double-blind treatment with oxymorphone ER at the individually titrated dose, incidence of $1 AE was reported by a similar proportion of patients with and without diabetes (56.5% [13/23] vs 52.0% [79/ 152]), cardiovascular disease (72.7% [16/22] vs 49.7% [76/153]), and hypertension (58.5% [38/65] vs 49.1% [54/110]).The most frequent treatment-related AEs were nausea, constipation, somnolence, headache, and diarrhea, irrespective of comorbidity. A mean (SD) increase in visual analog scale pain intensity from baseline to final visit was observed for placebo patients, respectively, with and without hypertension (27.9 [29.8] vs 28.4 [26.7]), diabetes (26.6 [30.5] vs 28.4 [27.4]), and cardiovascular disease (30.3 [26.2] vs 28.0 [27.8]). In the oxymorphone ER group, a smaller increase was observed for patients with and without hypertension (9.8 [22.1] vs 9.6 [23.7]), diabetes (13.3 [25.0] vs 9.2 [22.8]), and cardiovascular disease (13.0 [24.5] vs 9.2 [22.9]). Oxymorphone ER was generally well tolerated and effective for CLBP in patients with or without hypertension, diabetes, and cardiovascular disease. (Supported by Endo Pharmaceuticals Inc.) (Hale, J Pain, 2007; Katz, Cur Med Res Opin, 2007.)
(289) Psychometric characteristics of patients prescribed chronic opioid therapy for chronic noncancer pain: data from the opioid utilization study (OPUS) C Argoff, S Stanos, G Irving, R Puenpatom, S Zhao, and E Gould; Endo Pharmaceuticals Inc., Chadds Ford, PA There is increasing acceptance of opioid therapy for patients with chronic noncancer pain (CNCP) conditions such as low back pain (LBP) and osteoarthritis (OA), but there is a paucity of data derived from clinical practice on mental health comorbidity in these patients. The Opioid Utilization Study (OPUS) is a multicenter trial gathering long-term observational data on opioid therapy for CNCP in clinical practice, encompassing physical and mental health outcomes and quality of life measures, pharmacoeconomics, patient economic impact, and healthcare resource utilization. OPUS includes men and women aged $18 years prescribed opioid therapy for CNCP of $3 months duration, who do not have cancer pain, history of substance abuse, or an open workers’ compensation claim. Baseline data are presented here from the Depression, Anxiety, and Positive Outlook Scale (DAPOS), designed for use in nonpsychiatric pain populations. The scale quantifies domains of Depression, Anxiety, and Positive Outlook using 11 items on a 5-point Likert-type scale (1 = Almost Never, 5 = Almost All the Time). Mean scores rate each domain from 1–5: higher scores indicate greater depression, anxiety, or positive outlook. Of 2000 enrolled OPUS patients, 1336 (66.8%) have LBP and 416 have OA (20.8%) . Baseline DAPOS scores (mean [SD]) in patients with CLBP and OA, respectively, indicate mild depression (2.0 [1.0], 1.8 [1.0]), mild anxiety (2.0 [1.1], 2.0 [1.1]), and a moderately positive outlook (3.4 [1.0], 3.5 [1.1]). DAPOS scores will be reassessed and compared at 6 months and 12 months postbaseline. (This research was supported by Endo Pharmaceuticals Inc., Chadds Ford, PA.)
Abstracts (290) Pain characteristics of patients prescribed chronic opioid therapy for chronic noncancer pain: data from the opioid utilization study (OPUS) C Argoff, S Stanos, G Irving, R Puenpatom, S Zhao, and E Gould; Endo Pharmaceuticals Inc., Chadds Ford, PA The Opioid Utilization Study (OPUS) is an ongoing, 12-month, multicenter, prospective, observational study designed to characterize current clinical practice in opioid therapy for chronic noncancer pain (CNCP), in terms of economic impact of opioid titrating, switching, and rotation; pain relief and quality-of-life measures; economic patient-reported outcomes; and healthcare resource utilization. Baseline data presented here characterize pain intensity and pain interference with activities of daily living in OPUS patients with low back pain (LBP) and osteoarthritis (OA). OPUS entry criteria were age $18 years and CNCP for $3 months; exclusion criteria were cancer pain, history or high risk of substance abuse, or an open workers’ compensation claim. The Brief Pain Inventory (BPI) evaluated pain intensity (0 = none to10 = worst imaginable) and pain interference with activities (0 = none to10 = complete). Of 2000 enrolled patients, 1336 (66.8%) have LBP and 416 have OA (20.8%) . Patients with LBP and OA, respectively, reported similar mean (SD) scores for pain intensity: worst pain (7.5 [1.8]; 7.6 [1.8]), average pain (5.8 [1.9]; 5.7 [1.9]); and pain interference with: general activity (6.4 [2.4]; 6.3 [2.5]), walking (5.8 [2.9]; 6.1 [2.9]); mood (5.2 [2.8]; 5.0 [3.0]), sleep (6.1 [3.0]; 5.8 [3.2]), relationships (4.5 [3.1]; 4.3 [3.1]), work (6.7 [2.6]; 6.6 [2.7]), and enjoyment of life (5.8 [3.0]; 5.4 [3.0]) at baseline. OPUS is an ongoing 12-month study. BPI scores will be reassessed and compared at 6 months and 12 months postbaseline, as part of the overall goal of characterizing current clinical practice and outcomes related to opioid utilization for CNCP. (This research was supported by Endo Pharmaceuticals Inc., Chadds Ford, PA.)
(291) Spurious urine drug screen results with continuous intrathecal morphine therapy: a case report J Alexander, V Manchanda, A Bernhard, and H Akbik; University of Cincinnati, Cincinnati, OH Urine drug screening (UDS) has become a common part of the management of patients on chronic opioid therapy. At the same time, the use of implantable intrathecal opioid delivery systems for chronic non-malignant pain has become more popular. There is minimal data in the literature on the use of UDS in patients on continuous intrathecal morphine therapy. This case report highlights the need for further studies in this patient population. A 49 year-old man with continuous intrathecal morphine at 1.448 mg/day for rheumatoid arthritis had a random UDS that was negative for morphine. Comparison with a previous random UDS while the patient was at a lower daily dose of morphine (1.4448 vs 0.9997 mg/day) was positive. Repeat testing of the urine sample showed no detectable levels of morphine. The drug delivery device was working properly when interrogated, the proper volume of drug was in the chamber and the patient had adequate pain control. There is minimal data in the literature regarding the use of UDS in the management of patients with continuous intrathecal morphine. The data does indicate that morphine metabolites can appear in the urine during continuous intrathecal morphine therapy, but we have presented a case where this did not occur. The possibility of such an inconsistency is an important finding for the clinician managing patients on continuous intrathecal morphine therapy. Further studies are needed to determine the proper role of UDS in managing these patients.
(289) Psychometric characteristics of patients prescribed chronic opioid therapy for chronic noncancer pain: data from the opioid utilization study (OPUS) C Argoff, S Stanos, G Irving, R Puenpatom, S Zhao, and E Gould; Endo Pharmaceuticals Inc., Chadds Ford, PA There is increasing acceptance of opioid therapy for patients with chronic noncancer pain (CNCP) conditions such as low back pain (LBP) and osteoarthritis (OA), but there is a paucity of data derived from clinical practice on mental health comorbidity in these patients. The Opioid Utilization Study (OPUS) is a multicenter trial gathering long-term observational data on opioid therapy for CNCP in clinical practice, encompassing physical and mental health outcomes and quality of life measures, pharmacoeconomics, patient economic impact, and healthcare resource utilization. OPUS includes men and women aged $18 years prescribed opioid therapy for CNCP of $3 months duration, who do not have cancer pain, history of substance abuse, or an open workers’ compensation claim. Baseline data are presented here from the Depression, Anxiety, and Positive Outlook Scale (DAPOS), designed for use in nonpsychiatric pain populations. The scale quantifies domains of Depression, Anxiety, and Positive Outlook using 11 items on a 5-point Likert-type scale (1 = Almost Never, 5 = Almost All the Time). Mean scores rate each domain from 1–5: higher scores indicate greater depression, anxiety, or positive outlook. Of 2000 enrolled OPUS patients, 1336 (66.8%) have LBP and 416 have OA (20.8%) . Baseline DAPOS scores (mean [SD]) in patients with CLBP and OA, respectively, indicate mild depression (2.0 [1.0], 1.8 [1.0]), mild anxiety (2.0 [1.1], 2.0 [1.1]), and a moderately positive outlook (3.4 [1.0], 3.5 [1.1]). DAPOS scores will be reassessed and compared at 6 months and 12 months postbaseline. (This research was supported by Endo Pharmaceuticals Inc., Chadds Ford, PA.)
Abstracts (290) Pain characteristics of patients prescribed chronic opioid therapy for chronic noncancer pain: data from the opioid utilization study (OPUS) C Argoff, S Stanos, G Irving, R Puenpatom, S Zhao, and E Gould; Endo Pharmaceuticals Inc., Chadds Ford, PA The Opioid Utilization Study (OPUS) is an ongoing, 12-month, multicenter, prospective, observational study designed to characterize current clinical practice in opioid therapy for chronic noncancer pain (CNCP), in terms of economic impact of opioid titrating, switching, and rotation; pain relief and quality-of-life measures; economic patient-reported outcomes; and healthcare resource utilization. Baseline data presented here characterize pain intensity and pain interference with activities of daily living in OPUS patients with low back pain (LBP) and osteoarthritis (OA). OPUS entry criteria were age $18 years and CNCP for $3 months; exclusion criteria were cancer pain, history or high risk of substance abuse, or an open workers’ compensation claim. The Brief Pain Inventory (BPI) evaluated pain intensity (0 = none to10 = worst imaginable) and pain interference with activities (0 = none to10 = complete). Of 2000 enrolled patients, 1336 (66.8%) have LBP and 416 have OA (20.8%) . Patients with LBP and OA, respectively, reported similar mean (SD) scores for pain intensity: worst pain (7.5 [1.8]; 7.6 [1.8]), average pain (5.8 [1.9]; 5.7 [1.9]); and pain interference with: general activity (6.4 [2.4]; 6.3 [2.5]), walking (5.8 [2.9]; 6.1 [2.9]); mood (5.2 [2.8]; 5.0 [3.0]), sleep (6.1 [3.0]; 5.8 [3.2]), relationships (4.5 [3.1]; 4.3 [3.1]), work (6.7 [2.6]; 6.6 [2.7]), and enjoyment of life (5.8 [3.0]; 5.4 [3.0]) at baseline. OPUS is an ongoing 12-month study. BPI scores will be reassessed and compared at 6 months and 12 months postbaseline, as part of the overall goal of characterizing current clinical practice and outcomes related to opioid utilization for CNCP. (This research was supported by Endo Pharmaceuticals Inc., Chadds Ford, PA.)
(291) Spurious urine drug screen results with continuous intrathecal morphine therapy: a case report J Alexander, V Manchanda, A Bernhard, and H Akbik; University of Cincinnati, Cincinnati, OH Urine drug screening (UDS) has become a common part of the management of patients on chronic opioid therapy. At the same time, the use of implantable intrathecal opioid delivery systems for chronic non-malignant pain has become more popular. There is minimal data in the literature on the use of UDS in patients on continuous intrathecal morphine therapy. This case report highlights the need for further studies in this patient population. A 49 year-old man with continuous intrathecal morphine at 1.448 mg/day for rheumatoid arthritis had a random UDS that was negative for morphine. Comparison with a previous random UDS while the patient was at a lower daily dose of morphine (1.4448 vs 0.9997 mg/day) was positive. Repeat testing of the urine sample showed no detectable levels of morphine. The drug delivery device was working properly when interrogated, the proper volume of drug was in the chamber and the patient had adequate pain control. There is minimal data in the literature regarding the use of UDS in the management of patients with continuous intrathecal morphine. The data does indicate that morphine metabolites can appear in the urine during continuous intrathecal morphine therapy, but we have presented a case where this did not occur. The possibility of such an inconsistency is an important finding for the clinician managing patients on continuous intrathecal morphine therapy. Further studies are needed to determine the proper role of UDS in managing these patients.