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Chronic noncancer pain severity and interference with daily life: data from the Opioid Utilization Study (OPUS)
S52
Abstracts
(308) Subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic non-malignant pain
(310) Impact of chronic noncancer pain on utilization of pain medications and healthcare resources: data from the Opioid Utilization Study (OPUS)
R Blonsky, E Michna, S Schulman, E Tzanis, A Manley, H Zhang, B Randazzo; Pain & Rehabilitation Clinic of Chicago, Chicago, IL Long-term use of opioid analgesics for the treatment of chronic pain may be complicated by dose-limiting side effects, most commonly opioid-induced constipation (OIC). Methylnaltrexone, a selective peripherally acting m-opioid receptor antagonist, decreases the peripheral side effects of opioids without affecting centrally mediated analgesia. The purpose of this double-blind, randomized, placebo-controlled phase 3 study was to determine if subcutaneous methylnaltrexone alleviates OIC in patients with chronic non-malignant pain. This study included 469 patients on stable doses of opioids with <3 rescue-free bowel movements (RFBMs)/ week. Patients were randomized to one of two different regimens of methylnaltrexone bromide or placebo for 4 weeks. Use of routine laxatives was not permitted; however, ‘‘rescue’’ laxative use was standardized and allowed if needed. Co-primary endpoints were rescue-free laxation response within 4 hours of first dose and rescue-free laxation response within 4 hours after all active doses. Methylnaltrexone demonstrated a 34.2% response rate within 4 hours compared with 9.9% for placebo (p<0.001). Methylnaltrexone also maintained a consistent response rate of 28.9% and 30.2% for the first and second dose regimens, respectively, within 4 hours of dose compared with 9.4% and 9.3% for placebo (p<0.001) for the 4-week period. Time to first bowel movement was significantly shorter for patients receiving active treatment than placebo (p<0.001), with 46% in the methylnaltrexone group having an RFBM within 24 hours vs 25.3% placebo. Methylnaltrexone patients showed improvements in straining, stool consistency, and completeness of evacuation compared with placebo. Methylnaltrexone treatment groups also had significantly less need for rescue laxative use (p<0.001 vs placebo). The most common AEs with frequency notably different from placebo were abdominal pain, dizziness, vomiting, nausea and diarrhea. The results of this study will help determine the safety and efficacy of subcutaneous methylnaltrexone in providing rapid and reliable laxation in patients with chronic non-malignant pain and OIC. (Supported by a grant from Wyeth Research, Collegeville, PA.)
S Stanos, C Argoff, G Irving, L Yanni, R Puenpatom, X Hu, E Gould, T Victor, B De Jong, R White; Rehabilitation Institute of Chicago Center for Pain, Chicago, IL Clinical trials support opioid effectiveness in patients with chronic noncancer pain, but because treatment conditions are different in practice, observational studies in the actual clinical practice setting are important. We used baseline data from the Opioid Utilization Study (OPUS), an ongoing US, 1-year, multicenter, prospective, observational cohort study, to examine use of pain medication and healthcare services by chronic noncancer pain patients prescribed opioid pain therapy. At baseline, patients $18 years on or starting opioid pain therapy answered questions about healthcare visits and pain medications in the past 30 days, and physicians recorded time on opioid therapy. Of the 342 patients, 66.7% (n = 228) were female, and 88.3% (n = 302) were white. 83.6% (n = 286) had experienced chronic noncancer pain for >1 year. 69.9% (n = 232/332) had been using an opioid for >1 year, whereas 6.6% (n = 22/332) were new users. Physical therapy was the most frequent type of healthcare visit in the past 30 days (mean [SD] 2.8 [3.8], n = 68), Patients averaged approximately 1 visit to a general primary care physician or internist (1.2 [1.5], n = 132), pain clinic (1.4 [1.4], n = 204), and psychologist or psychiatrist (1.3 [2.1], n = 42). The average estimated co-payment was $96.50 (311.30) (n = 309) for physician visits and $81.20 (179.20) (n = 279) for other healthcare expenses. Most patients (68.3%, n = 224/328) paid for prescriptions with a co-pay and health insurance; 13.4% (n = 44/328) paid entirely out of pocket. These baseline OPUS registry data show that long-term opioid therapy is common among chronic noncancer pain patients and a range of health services is used during the normal course of treatment. (Supported by Endo Pharmaceuticals Inc., Chadds Ford, PA.)
(309) Chronic noncancer pain severity and interference with daily life: data from the Opioid Utilization Study (OPUS)
(311) The design of OPUS: the Opioid Utilization Study in chronic noncancer pain
C Argoff, L Yanni, S Stanos, G Irving, E Gould, T Victor, X Hu, R Puenpatom, B De Jong, R White; Albany Medical College, Albany, NY Given increasing opioid use in patients with chronic noncancer pain, it is essential to evaluate the impact of opioid utilization and switching on the patient and the healthcare system. The Opioid Utilization Study (OPUS) is an ongoing 12-month, multicenter, prospective, observational cohort study examining opioid treatment outcomes and the economic impact of opioid utilization in patients with chronic noncancer pain. As part of OPUS, opioid-treated patients (aged $18 years) completed the Brief Pain Inventory (BPI) short-form, a validated 10-point scale that measures pain (0 = no pain, 10 = worst possible pain), its interference with daily activities (0 = none, 10 = completely interferes), and pain relief from current medication (0 = no relief, 10 = complete relief). Data on 342 OPUS participants were available. Of these, 66.7% (228 of 342) were female and 88.3% (302 of 342) were white. The majority of patients had pain lasting >1 year (286 of 342; 83.6%) and had used opioids >1 year (232 of 332; 69.9%). BPI scores (mean [SD]) indicated a moderate level of average pain (5.8 [1.9]) and a severe level of worst pain (7.7 [1.5]). Current medications provided substantial pain relief (6.1 [2.3]). Mean BPI scores indicated that pain interferes moderately with general activities (6.4 [2.4]), mood (5.5 [2.7]), walking (6.0 [2.8]), normal work (6.6 [2.6]), relationships (4.7 [3.0]), sleep (6.1 [3.0]), and enjoyment of life (5.8 [3.0]). OPUS data highlight a need for improved pain management to reduce the burden of chronic noncancer pain. (Supported by Endo Pharmaceuticals Inc., Chadds Ford, PA.
C Argoff, E Gould, G Irving, S Stanos, L Yanni, R Puenpatom, T Victor, B De Jong, R White; Albany Medical College, Albany, NY Prescribing opioids for chronic noncancer pain is common, as is switching opioids if physical tolerance, intolerable adverse events, or worsening pain develop. However, current literature has few data on opioid prescribing patterns and their impact on physicians, patients, and the healthcare system. The Opioid Utilization Study (OPUS) is a 12-month, multicenter, prospective, observational cohort study, with a planned enrollment of 2000 patients prescribed opioid therapy for chronic noncancer pain at 100 academic and private primary care and pain management practices. Treating physicians have discretion over all pain management and toxicology monitoring decisions. At enrollment, 6 months, and 12 months, physicians will record current opioid and nonopioid pain treatment, changes in pain treatment, and healthcare utilization data. At the same intervals, patients will complete questionnaires covering current and past pain treatment, estimates of personal financial impact, and several validated quality of life assessment tools (Brief Pain Inventory; Short Form-12 Health Survey; Depression, Anxiety, and Positive Outlook Scale; and Health and Labor Questionnaire). Descriptive statistics will report patient demographics, primary pain diagnoses, and patterns of opioid utilization. Growth models and analyses will be used to characterize trends in opioid utilization including effects on secondary objectives. The study has 42 sites, including 25 Pain Management Centers, 15 private practices, and 2 other. Enrollment began April 2008 and is currently 342 patients (114 male, 228 female). The study is still seeking participants and sites. At present, study closure is projected to be March 2010.
Abstracts
(308) Subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic non-malignant pain
(310) Impact of chronic noncancer pain on utilization of pain medications and healthcare resources: data from the Opioid Utilization Study (OPUS)
R Blonsky, E Michna, S Schulman, E Tzanis, A Manley, H Zhang, B Randazzo; Pain & Rehabilitation Clinic of Chicago, Chicago, IL Long-term use of opioid analgesics for the treatment of chronic pain may be complicated by dose-limiting side effects, most commonly opioid-induced constipation (OIC). Methylnaltrexone, a selective peripherally acting m-opioid receptor antagonist, decreases the peripheral side effects of opioids without affecting centrally mediated analgesia. The purpose of this double-blind, randomized, placebo-controlled phase 3 study was to determine if subcutaneous methylnaltrexone alleviates OIC in patients with chronic non-malignant pain. This study included 469 patients on stable doses of opioids with <3 rescue-free bowel movements (RFBMs)/ week. Patients were randomized to one of two different regimens of methylnaltrexone bromide or placebo for 4 weeks. Use of routine laxatives was not permitted; however, ‘‘rescue’’ laxative use was standardized and allowed if needed. Co-primary endpoints were rescue-free laxation response within 4 hours of first dose and rescue-free laxation response within 4 hours after all active doses. Methylnaltrexone demonstrated a 34.2% response rate within 4 hours compared with 9.9% for placebo (p<0.001). Methylnaltrexone also maintained a consistent response rate of 28.9% and 30.2% for the first and second dose regimens, respectively, within 4 hours of dose compared with 9.4% and 9.3% for placebo (p<0.001) for the 4-week period. Time to first bowel movement was significantly shorter for patients receiving active treatment than placebo (p<0.001), with 46% in the methylnaltrexone group having an RFBM within 24 hours vs 25.3% placebo. Methylnaltrexone patients showed improvements in straining, stool consistency, and completeness of evacuation compared with placebo. Methylnaltrexone treatment groups also had significantly less need for rescue laxative use (p<0.001 vs placebo). The most common AEs with frequency notably different from placebo were abdominal pain, dizziness, vomiting, nausea and diarrhea. The results of this study will help determine the safety and efficacy of subcutaneous methylnaltrexone in providing rapid and reliable laxation in patients with chronic non-malignant pain and OIC. (Supported by a grant from Wyeth Research, Collegeville, PA.)
S Stanos, C Argoff, G Irving, L Yanni, R Puenpatom, X Hu, E Gould, T Victor, B De Jong, R White; Rehabilitation Institute of Chicago Center for Pain, Chicago, IL Clinical trials support opioid effectiveness in patients with chronic noncancer pain, but because treatment conditions are different in practice, observational studies in the actual clinical practice setting are important. We used baseline data from the Opioid Utilization Study (OPUS), an ongoing US, 1-year, multicenter, prospective, observational cohort study, to examine use of pain medication and healthcare services by chronic noncancer pain patients prescribed opioid pain therapy. At baseline, patients $18 years on or starting opioid pain therapy answered questions about healthcare visits and pain medications in the past 30 days, and physicians recorded time on opioid therapy. Of the 342 patients, 66.7% (n = 228) were female, and 88.3% (n = 302) were white. 83.6% (n = 286) had experienced chronic noncancer pain for >1 year. 69.9% (n = 232/332) had been using an opioid for >1 year, whereas 6.6% (n = 22/332) were new users. Physical therapy was the most frequent type of healthcare visit in the past 30 days (mean [SD] 2.8 [3.8], n = 68), Patients averaged approximately 1 visit to a general primary care physician or internist (1.2 [1.5], n = 132), pain clinic (1.4 [1.4], n = 204), and psychologist or psychiatrist (1.3 [2.1], n = 42). The average estimated co-payment was $96.50 (311.30) (n = 309) for physician visits and $81.20 (179.20) (n = 279) for other healthcare expenses. Most patients (68.3%, n = 224/328) paid for prescriptions with a co-pay and health insurance; 13.4% (n = 44/328) paid entirely out of pocket. These baseline OPUS registry data show that long-term opioid therapy is common among chronic noncancer pain patients and a range of health services is used during the normal course of treatment. (Supported by Endo Pharmaceuticals Inc., Chadds Ford, PA.)
(309) Chronic noncancer pain severity and interference with daily life: data from the Opioid Utilization Study (OPUS)
(311) The design of OPUS: the Opioid Utilization Study in chronic noncancer pain
C Argoff, L Yanni, S Stanos, G Irving, E Gould, T Victor, X Hu, R Puenpatom, B De Jong, R White; Albany Medical College, Albany, NY Given increasing opioid use in patients with chronic noncancer pain, it is essential to evaluate the impact of opioid utilization and switching on the patient and the healthcare system. The Opioid Utilization Study (OPUS) is an ongoing 12-month, multicenter, prospective, observational cohort study examining opioid treatment outcomes and the economic impact of opioid utilization in patients with chronic noncancer pain. As part of OPUS, opioid-treated patients (aged $18 years) completed the Brief Pain Inventory (BPI) short-form, a validated 10-point scale that measures pain (0 = no pain, 10 = worst possible pain), its interference with daily activities (0 = none, 10 = completely interferes), and pain relief from current medication (0 = no relief, 10 = complete relief). Data on 342 OPUS participants were available. Of these, 66.7% (228 of 342) were female and 88.3% (302 of 342) were white. The majority of patients had pain lasting >1 year (286 of 342; 83.6%) and had used opioids >1 year (232 of 332; 69.9%). BPI scores (mean [SD]) indicated a moderate level of average pain (5.8 [1.9]) and a severe level of worst pain (7.7 [1.5]). Current medications provided substantial pain relief (6.1 [2.3]). Mean BPI scores indicated that pain interferes moderately with general activities (6.4 [2.4]), mood (5.5 [2.7]), walking (6.0 [2.8]), normal work (6.6 [2.6]), relationships (4.7 [3.0]), sleep (6.1 [3.0]), and enjoyment of life (5.8 [3.0]). OPUS data highlight a need for improved pain management to reduce the burden of chronic noncancer pain. (Supported by Endo Pharmaceuticals Inc., Chadds Ford, PA.
C Argoff, E Gould, G Irving, S Stanos, L Yanni, R Puenpatom, T Victor, B De Jong, R White; Albany Medical College, Albany, NY Prescribing opioids for chronic noncancer pain is common, as is switching opioids if physical tolerance, intolerable adverse events, or worsening pain develop. However, current literature has few data on opioid prescribing patterns and their impact on physicians, patients, and the healthcare system. The Opioid Utilization Study (OPUS) is a 12-month, multicenter, prospective, observational cohort study, with a planned enrollment of 2000 patients prescribed opioid therapy for chronic noncancer pain at 100 academic and private primary care and pain management practices. Treating physicians have discretion over all pain management and toxicology monitoring decisions. At enrollment, 6 months, and 12 months, physicians will record current opioid and nonopioid pain treatment, changes in pain treatment, and healthcare utilization data. At the same intervals, patients will complete questionnaires covering current and past pain treatment, estimates of personal financial impact, and several validated quality of life assessment tools (Brief Pain Inventory; Short Form-12 Health Survey; Depression, Anxiety, and Positive Outlook Scale; and Health and Labor Questionnaire). Descriptive statistics will report patient demographics, primary pain diagnoses, and patterns of opioid utilization. Growth models and analyses will be used to characterize trends in opioid utilization including effects on secondary objectives. The study has 42 sites, including 25 Pain Management Centers, 15 private practices, and 2 other. Enrollment began April 2008 and is currently 342 patients (114 male, 228 female). The study is still seeking participants and sites. At present, study closure is projected to be March 2010.