You are on page 1of 1

S46 Abstracts

(280) Pediatric pain management use of urine toxicology (282) Subcutaneous methylnaltrexone does not effect pain in-
D Miller-Saultz, J Saroyan, M Sullivan, W Cheng, and A Afzal; Columbia tensity and analgesic use in patients with chronic non-
University New York, NY malignant pain and opioid-induced constipation
Pediatric pain management use of urine toxicology The management of A Weil, M Duerden, S Schulman, E Tzanis, D Yu, A Manley, H Zhang,
chronic non malignant pain is evolving with a wide variety of pharmacologic and B Randazzo; Multicenter Study Various sites in US, Various sites
therapies which includes opioid in the comprehensive treatment. Pediatrics Patients with chronic, non-malignant pain often require opioid medications.
and adolescent pain management has enlarged the scope of opioid prescrip- Long-term opioid use may cause constipation. Methylnaltrexone, a selective
tion practice to include chronic nonmalignant conditions sub acute pain peripherally acting mu-opioid receptor antagonist, decreases peripheral
post-operative pain In both adults and pediatrics, guidelines have been re- effects of opioids without affecting centrally mediated analgesia. This analysis
cently recommended regarding protocols for monitoring chronic opioid ther- evaluated whether subcutaneous methylnaltrexone affected pain intensity
apy for non-malignant pain. Comprehensive review of the literature has not and analgesic use in patients with chronic, non-malignant pain and opioid-
revealed what clinician management practices are followed in adolescents induced constipation (OIC). In a double-blind, placebo-controlled trial,
who receive opioid therapy, or how to monitor the efficacy of the opioids patients taking opioids daily for chronic non-malignant pain were randomized
when prescribed for chronic pain states. The incidence of opioid misuse, diver- to receive methylnaltrexone 12 mg once daily (QD) or every other day (QOD), or
sion and abuse in adolescents with chronic pain is not known. As a first step in daily placebo for 4 weeks. Pain intensity was measured at baseline on study
the institution of monitoring practices for the pediatric and adolescent outpa- days 14 and 28 using an 11-point Pain Intensity Scale. Opioid analgesic use
tient pain center, urine toxicology results and medical records of a convenience was measured in daily oral morphine equivalents. Mean pain intensity scores
sample of eighteen patients seen in the Pediatric Pain Management (PPM) Cen- at day 14 were 6.2 methylnaltrexone QD; 6.1 QOD; 6.2 placebo. At day 28,
ter were reviewed. All patients were over the age of ten and did not have sig- adjusted mean scores were 6.1 QD; 5.9 QOD; 6.3 placebo. The adjusted changes
nificant neurodevelopmental impairment. All patients over the age of ten in pain scores from baseline were similar among all treatment groups. At day
years old provided a urine sample prior to their initial consultation after con- 14, adjusted mean changes from baseline were 0 and -0.1 for methylnaltrexone
sent had been obtained. The urine toxicology of five pediatric patients re- QD and QOD groups, respectively, compared with -0.1 for placebo. At day 28,
vealed positive findings either in the form of illicit substance e.g. cocaine, the mean changes were -0.2 and -0.3 for methylnaltrexone QD and QOD,
phencylicdine, Tetrahydrocannabinol, or prescription medication that have respectively, vs -0.1 for placebo. No treatment differences have been found
not been prescribed. Our preliminary results demonstrate that in a convenience in changes of pain scales from baseline. Average daily use of opioids was similar
sample of adolescent outpatients referred for management of chronic pain, at baseline among treatment groups (214, 225 and 225 mg for QD, QOD, and
the incidence of analgesic, illicit substances and benzodiazepenes was clinically placebo, respectively). During the double blind period no differences in opioid
significant. Urine toxicology findings were not consistent with history and use were observed for either treatment group vs placebo. Patients with chronic
therefore yielded unexpected results. Prospective evaluation of illicit and pre- non-malignant pain taking methylnaltrexone QD or QOD for treatment of OIC
scription use, misuse and abuse in adolescent patients who present with did not have noticeably different pain intensity scores or opioid use compared
chronic pain is planned. with patients taking placebo, suggesting the absence of significant methylnal-
trexone activity in the central nervous system.

(281) Demographic characteristics of patients prescribed (283) Subcutaneous methylnaltrexone improves bowel move-
chronic opioid therapy for chronic noncancer pain: data ment frequency and quality in patients with chronic
from the opioid utilization study (OPUS) non-malignant pain and opioid induced constipation
C Argoff, S Stanos, G Irving, R Puenpatom, S Zhao, and E Gould; Endo M Duerden, A Weil, D Yu, S Schulman, E Tzanis, A Manley, H Zhang,
Pharmaceuticals Inc., Chadds Ford, PA and B Randazzo; University of Indiana School of Medicine, Indianapolis, IN
Clinical trials of opioid therapy for chronic noncancer pain (CNCP) provide valu- The most common side effect of opioids is opioid-induced constipation (OIC).
able information about efficacy and safety, but only observational studies can No drug is specifically approved currently for treatment of OIC in patients re-
consider long-term outcomes and the uncontrolled conditions of clinical prac- ceiving opioids for chronic non-malignant pain. Subcutaneous (SC) methylnal-
tice. The Opioid Utilization Study (OPUS) is a 12-month, prospective, observa- trexone decreases constipating effects of opioids without affecting central
tional cohort study designed to characterize opioid therapy for CNCP in analgesia. We report additional efficacy results from the double-blind phase
clinical practice, examining economic outcomes, healthcare utilization, mea- of a randomized, placebo-controlled study of methylnaltrexone in patients
sures of physical and mental health, and quality of life. Baseline demographic taking opioids for chronic non-malignant pain. Patients on daily opioids who
and economic data are presented. Of the 2000 patients enrolled in OPUS, 1336 had OIC defined as #2 rescue free bowel movements (RFBMs) per week plus
(66.8%) have low back pain (LBP) and 416 (20.8%) have osteoarthritis (OA). The $25% of RFBMs with Bristol stool form (BSF) 1 or 2, straining or sensation of
majority of patients with LBP and OA, respectively, are aged <65 years (89.1% incomplete evacuation at baseline were randomized 1:1:1 to receive methyl-
[1133 of 1272], 79.5% [325 of 409]), women (57.7% [735 of 1275], 58.6% [241 of naltrexone 12 mg daily (QD), methylnaltrexone 12 mg every other day
411]), white (88.5% [1026 of 1159], 84.4% [313 of 371]), have a net annual (QOD), or placebo for 4 weeks. Only standardized rescue laxatives were al-
household income <$40,000 (54.9% [630 of 1148], 61.2% [226 of 369]), have lowed during the study. Stool consistency (scale 1-7), defecation straining (scale
health insurance (88.2% [1178 of 1336], 87.0% [362 of 416]), have experienced 0-4), and sensation of complete evacuation were recorded in patient diaries us-
CNCP >1 year (84.1% [937 of 1114], 80.5% [288 of 358]), and have been pre- ing standardized scales. 460 patients received $1 dose of study medication;
scribed opioids >1 year (78.4% [778 of 992], 76.6% [236 of 308]). Patients chronic back pain was the primary pain condition (60.4%). Mean age was
with LBP and OA, respectively, have a mean (SD) household size of 2.6 (1.4) 48.8 years; 60.2% were female. Mean change from baseline in weekly RFBMs
and 2.4 (1.3), of whom 1.8 (1.4) and 1.7 (1.3) are dependents. OPUS will con- with sensation of complete evacuation was significantly greater in patients
tinue to accumulate long-term data characterizing current clinical practice in treated with methylnaltrexone (QD 1.9, QOD 1.2) than placebo (0.8; p<0.001
opioid therapy for CNCP. (This research was supported by Endo Pharmaceuticals and p=0.012, respectively). Decrease from baseline in mean straining of RFBMs
Inc., Chadds Ford, PA.) was significantly greater in patients treated with methylnaltrexone (-1.1 in
each group) than placebo (-0.8, p=0.008 and p=0.015, respectively). Change
from baseline in mean BSF of RFBMs was greater with methylnaltrexone (QD
1.4, QOD 1.2) than placebo (0.9), with significant treatment difference be-
tween methylnaltrexone QD and placebo (p=0.002). The most common adverse
event was abdominal pain. The results of this study suggest that methylnaltrex-
one for the treatment of OIC in patients with chronic nonmalignant pain
improves bowel movement frequency and quality.