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All-cause and Fibromayalgia-related health care costs in Fibromyalgia patients prescribed pregabalin versus duloxetine
P70
The Journal of Pain
Abstracts
(376) The long-term efficacy of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic nonmalignant pain
(378) The long-term safety of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic nonmalignant pain
L Webster, E Michna, A Khan, R Israel, A Manley, H Zhang, E Maller, and E Tzanis; Lifetree Clinical Research & Pain Clinic, Salt Lake City, UT
L Webster, E Michna, A Khan, R Israel, A Manley, H Zhang, E Tzanis, and E Maller; Lifetree Clinical Research & Pain Clinic, Salt Lake City, UT
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 bromide, a selective peripherally acting muopioid receptor antagonist, decreases the peripheral side effects of opioids without affecting centrally mediated analgesia. The purpose of this open-label study was to determine the long-term safety and tolerability of subcutaneous (SC) methylnaltrexone in patients with chronic nonmalignant pain. The secondary objective was to explore the long-term efficacy of methylnaltrexone in this patient population. This study included 1034 patients on stable doses of opioids who demonstrated constipation over the month prior to screening. After a 14-day screening period, eligible patients received methylnaltrexone bromide SC at least once weekly and up to once daily for 48 weeks. Use of routine laxatives was permitted for the duration of the study. Important end points were the percentage of injections resulting in a bowel movement within 4 hours and change from baseline in number of weekly bowel movements. Methylnaltrexone demonstrated a response rate of 34.1% of injections per patient resulting in a bowel movement within 4 hours over the open-label period, with a monthly mean rate ranging from 33.0% to 37.4%. Patients on methylnaltrexone had a mean increase of 1.5 bowel movements per week compared with baseline over the open-label period. In addition, patients showed improvements from baseline in straining and stool consistency. The results of this study support the long-term efficacy of SC methylnaltrexone in providing rapid and reliable laxation in patients with chronic nonmalignant pain and OIC. This study was supported by a grant from Wyeth Research (acquired by Pfizer Inc in October 2009), Collegeville, PA.
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 bromide, a selective peripherally acting muopioid receptor antagonist, decreases the peripheral side effects of opioids without affecting centrally mediated analgesia. The purpose of this open-label study was to determine the long-term safety and tolerability of subcutaneous (SC) methylnaltrexone in patients with chronic nonmalignant pain. This study included 1034 treated patients on stable doses of opioids who demonstrated constipation over the month prior to screening. After a 14-day screening period, eligible patients received methylnaltrexone bromide SC at least once weekly and up to once daily for 48 weeks. Use of routine laxatives was permitted for the duration of the study. 81.2% of patients reported at least one adverse event (AE) during the course of the trial. The most common treatmentemergent AEs (TEAEs), with an incidence of at least 5%, were abdominal pain (24.0%), diarrhea (16.4%), nausea (15.1%), hyperhidrosis (8.9%), vomiting (7.2%), abdominal pain upper (6.7%), back pain (6.4%), influenza (6.2%), upper respiratory infection (5.8%), headache (5.6%), flatulence (5.5%), sinusitis (5.3%), and dizziness (5.0%). Serious AEs were reported in 10.1% of patients. Discontinuation from active treatment because of AEs occurred in 157 (15.2%) patients. The most common AEs resulting in discontinuation from active treatment (>1.0%) were abdominal pain (4.7%), nausea (2.5%), diarrhea (2.3%), hyperhidrosis (1.5%), and vomiting (1.5%). The results of this study demonstrate that methylnaltrexone is generally well tolerated in patients with chronic nonmalignant pain and OIC, with an AE profile similar to what has previously been reported in patients with either chronic nonmalignant pain or advanced illness in studies of shorter duration. This study was supported by a grant from Wyeth Research (acquired by Pfizer Inc in October 2009), Collegeville, PA.
(377) Epidural blood patch as treatment for CSF leak during spinal cord stimulator implantation
(379) All-cause and Fibromayalgia-related health care costs in Fibromyalgia patients prescribed pregabalin versus duloxetine
F Kia, L Zhou, and J Berk; Thomas Jefferson University Hospital, Philadelphia, PA This case series evaluates the use of epidural blood patches to treat dural punctures during interventional spine procedures. A total of seven patients were found to have a cerebrospinal fluid (CSF) leak during epidural injections and spinal cord stimulator (SCS) insertion. Five of these patients underwent an epidural blood patch to the contra-lateral side after the dural puncture was identified intra-operatively. Two of the patients did not receive an intra-operative blood patch and were monitored for symptoms. None of the five patients treated intra-operatively with an epidural blood patch complained of headache during the immediate post-operative period or as a long-term sequela. The two patients who did not receive an intra-operative blood patch developed symptoms consistent with post dural puncture headache (PDPH). One of the patients was treated with conservative measures and her symptoms resolved. The other patient failed conservative treatment and received an epidural blood patch one week later. This patient also failed the SCS trail due to headaches. Dural puncture is well recognized possible complication following epidural injections and SCS lead insertion. Post-dural puncture headaches can be very debilitating for the patient and difficult to treat. In patients undergoing SCS trials, pain resulting from a CSF leak could make it difficult to assess the efficacy of the SCS therapy. Based on our experience, performing an epidural blood patch intra-operatively after a CSF leak has been identified may prevent symptoms such as PDPH from occurring in the future. This treatment should especially be considered in patients undergoing SCS trials and implantation in order to accurately assess the level of pain reduction after the procedure.
R Sanchez, J Burke, A Joshi, M Cattaneo, J Cappelleri, M Kulakodlu, and R Halpren; Pfizer, New York, NY The objective was to compare changes in all-cause and fibromyalgia (FM)-related health care costs in FM patients initiated on pregabalin (PGB) and duloxetine (DLX) in real-world settings. Patients (3 18 years old) initiating PGB or DLX from 06/1/07-12/31/08 were identified. Those with 3 2 medical claims with primary diagnoses of FM 3 90 days apart or 3 1 medical claim with a primary diagnosis of FM followed within 30 days with a pharmacy claim for PGB or DLX, were selected. Multivariate difference-in-differences (DiD) models were performed. 1,616 PGB and 207 DLX patients were identified. The unadjusted differences (PGB vs. DLX) in mean (SD) pre-/post-index all-cause total health care costs [$1,307 (16,747) vs. -$158 (17,337); p=0.238] and FM-related total health care costs [$584 (3,834) vs. $759 (2,133); p=0.320] were not significant. The DiD models showed no significant difference in post-index versus pre-index all-cause health care costs (1.10, 95% CI: 0.87-1.39); no significant difference in all-cause costs attributable to PGB vs. DLX therapy (1.05, CI: 0.84-1.32); significantly higher post-index versus pre-index FM-related health care costs (1.68, CI: 1.18-2.38); and no significant difference in FM-related costs attributable to PGB vs DLX (0.85, CI: 0.61-1.18). There were no significant differences all-cause or FM-related total health care costs attributable to initiation of PGB vs DLX in FM patients.
The Journal of Pain
Abstracts
(376) The long-term efficacy of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic nonmalignant pain
(378) The long-term safety of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic nonmalignant pain
L Webster, E Michna, A Khan, R Israel, A Manley, H Zhang, E Maller, and E Tzanis; Lifetree Clinical Research & Pain Clinic, Salt Lake City, UT
L Webster, E Michna, A Khan, R Israel, A Manley, H Zhang, E Tzanis, and E Maller; Lifetree Clinical Research & Pain Clinic, Salt Lake City, UT
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 bromide, a selective peripherally acting muopioid receptor antagonist, decreases the peripheral side effects of opioids without affecting centrally mediated analgesia. The purpose of this open-label study was to determine the long-term safety and tolerability of subcutaneous (SC) methylnaltrexone in patients with chronic nonmalignant pain. The secondary objective was to explore the long-term efficacy of methylnaltrexone in this patient population. This study included 1034 patients on stable doses of opioids who demonstrated constipation over the month prior to screening. After a 14-day screening period, eligible patients received methylnaltrexone bromide SC at least once weekly and up to once daily for 48 weeks. Use of routine laxatives was permitted for the duration of the study. Important end points were the percentage of injections resulting in a bowel movement within 4 hours and change from baseline in number of weekly bowel movements. Methylnaltrexone demonstrated a response rate of 34.1% of injections per patient resulting in a bowel movement within 4 hours over the open-label period, with a monthly mean rate ranging from 33.0% to 37.4%. Patients on methylnaltrexone had a mean increase of 1.5 bowel movements per week compared with baseline over the open-label period. In addition, patients showed improvements from baseline in straining and stool consistency. The results of this study support the long-term efficacy of SC methylnaltrexone in providing rapid and reliable laxation in patients with chronic nonmalignant pain and OIC. This study was supported by a grant from Wyeth Research (acquired by Pfizer Inc in October 2009), Collegeville, PA.
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 bromide, a selective peripherally acting muopioid receptor antagonist, decreases the peripheral side effects of opioids without affecting centrally mediated analgesia. The purpose of this open-label study was to determine the long-term safety and tolerability of subcutaneous (SC) methylnaltrexone in patients with chronic nonmalignant pain. This study included 1034 treated patients on stable doses of opioids who demonstrated constipation over the month prior to screening. After a 14-day screening period, eligible patients received methylnaltrexone bromide SC at least once weekly and up to once daily for 48 weeks. Use of routine laxatives was permitted for the duration of the study. 81.2% of patients reported at least one adverse event (AE) during the course of the trial. The most common treatmentemergent AEs (TEAEs), with an incidence of at least 5%, were abdominal pain (24.0%), diarrhea (16.4%), nausea (15.1%), hyperhidrosis (8.9%), vomiting (7.2%), abdominal pain upper (6.7%), back pain (6.4%), influenza (6.2%), upper respiratory infection (5.8%), headache (5.6%), flatulence (5.5%), sinusitis (5.3%), and dizziness (5.0%). Serious AEs were reported in 10.1% of patients. Discontinuation from active treatment because of AEs occurred in 157 (15.2%) patients. The most common AEs resulting in discontinuation from active treatment (>1.0%) were abdominal pain (4.7%), nausea (2.5%), diarrhea (2.3%), hyperhidrosis (1.5%), and vomiting (1.5%). The results of this study demonstrate that methylnaltrexone is generally well tolerated in patients with chronic nonmalignant pain and OIC, with an AE profile similar to what has previously been reported in patients with either chronic nonmalignant pain or advanced illness in studies of shorter duration. This study was supported by a grant from Wyeth Research (acquired by Pfizer Inc in October 2009), Collegeville, PA.
(377) Epidural blood patch as treatment for CSF leak during spinal cord stimulator implantation
(379) All-cause and Fibromayalgia-related health care costs in Fibromyalgia patients prescribed pregabalin versus duloxetine
F Kia, L Zhou, and J Berk; Thomas Jefferson University Hospital, Philadelphia, PA This case series evaluates the use of epidural blood patches to treat dural punctures during interventional spine procedures. A total of seven patients were found to have a cerebrospinal fluid (CSF) leak during epidural injections and spinal cord stimulator (SCS) insertion. Five of these patients underwent an epidural blood patch to the contra-lateral side after the dural puncture was identified intra-operatively. Two of the patients did not receive an intra-operative blood patch and were monitored for symptoms. None of the five patients treated intra-operatively with an epidural blood patch complained of headache during the immediate post-operative period or as a long-term sequela. The two patients who did not receive an intra-operative blood patch developed symptoms consistent with post dural puncture headache (PDPH). One of the patients was treated with conservative measures and her symptoms resolved. The other patient failed conservative treatment and received an epidural blood patch one week later. This patient also failed the SCS trail due to headaches. Dural puncture is well recognized possible complication following epidural injections and SCS lead insertion. Post-dural puncture headaches can be very debilitating for the patient and difficult to treat. In patients undergoing SCS trials, pain resulting from a CSF leak could make it difficult to assess the efficacy of the SCS therapy. Based on our experience, performing an epidural blood patch intra-operatively after a CSF leak has been identified may prevent symptoms such as PDPH from occurring in the future. This treatment should especially be considered in patients undergoing SCS trials and implantation in order to accurately assess the level of pain reduction after the procedure.
R Sanchez, J Burke, A Joshi, M Cattaneo, J Cappelleri, M Kulakodlu, and R Halpren; Pfizer, New York, NY The objective was to compare changes in all-cause and fibromyalgia (FM)-related health care costs in FM patients initiated on pregabalin (PGB) and duloxetine (DLX) in real-world settings. Patients (3 18 years old) initiating PGB or DLX from 06/1/07-12/31/08 were identified. Those with 3 2 medical claims with primary diagnoses of FM 3 90 days apart or 3 1 medical claim with a primary diagnosis of FM followed within 30 days with a pharmacy claim for PGB or DLX, were selected. Multivariate difference-in-differences (DiD) models were performed. 1,616 PGB and 207 DLX patients were identified. The unadjusted differences (PGB vs. DLX) in mean (SD) pre-/post-index all-cause total health care costs [$1,307 (16,747) vs. -$158 (17,337); p=0.238] and FM-related total health care costs [$584 (3,834) vs. $759 (2,133); p=0.320] were not significant. The DiD models showed no significant difference in post-index versus pre-index all-cause health care costs (1.10, 95% CI: 0.87-1.39); no significant difference in all-cause costs attributable to PGB vs. DLX therapy (1.05, CI: 0.84-1.32); significantly higher post-index versus pre-index FM-related health care costs (1.68, CI: 1.18-2.38); and no significant difference in FM-related costs attributable to PGB vs DLX (0.85, CI: 0.61-1.18). There were no significant differences all-cause or FM-related total health care costs attributable to initiation of PGB vs DLX in FM patients.