Development of efficacy-tolerability composite measures integrating measures of pain reduction and the severity and duration of AEs

s The Journal of Pain S77 (404) Development of efficacy-tolerability compositemeasures integrating measures of pain reduction and the severity and duration of AEs N Katz, J Mou, J Trudeau, C Orman, J Xiang, G Vorsanger, and M Kim; Analgesic Solutions, Natick, MA The objective of this analysis was to evaluate a family of novel risk-benefit composite measures integrating measures of pain reduction (benefit) and severity and duration of AEs (risk) using data from a controlled clinical trial in subjects with chronic back pain to determine which risk-benefit composite measure(s) are most predictive of best performance characteristics. A number of benefit composite scores were evaluated based upon combinations of pain reduction and alternative levels of TEAE [no AE, or no or only mild AE]). Additional analyses used pain reduction and the presence of opioid-related TEAEs (none or only mild opioid-related AEs). For all analyses, a subject was required to have a baseline pain score and at least one post-baseline value. The efficacy endpoint of interest was the proportion of study days a subject met the various risk-benefit composite definitions based upon percent pain reduction and good tolerability to treatment as judged by no or mild AEs. The number of days a subject met the risk-benefit definition divided by number of days the subject could participate in the study, i.e., the study duration, was the patient’s risk-benefit composite score. The mean of all the risk-benefit composite scores in each treatment group constituted the mean risk-benefit composite score for that treatment group. Findings demonstrated that the mean proportion of days meeting the risk-benefit composite score was different for active treatments. Results describing the performance of this newmethod, including comparisons between the two active agents and placebo, will be presented in the poster. Supported by Janssen. (405) Correlates of high-dose opioid medication use for low back pain in primary care A Kobus, D Smith, B Morasco, E Johnson, X Yang, A Petrik, and R Deyo; Oregon Health & Science University, Portland, OR Little is known about patients who are prescribed high doses of opioidmedication for the treatment of chronic non-cancer pain.We sought to determine the prevalence of high-dose opioid therapy, as well as associated demographic, clinical, and utilization correlates. Study was conducted in the Kaiser Permanente Northwest health system in Portland, Oregon. Participants were ambulatory adults, age 18 or above. Using electronic medical records, we chose as an index visit, the first visit in 2004 associatedwith an ICD-9 code for back pain.We assessed data six-months previous and subsequent care around this index date for a total of 26,000 participants. Patients prescribed high-dose opioids (> 100 mg/day morphine equivalent at last dispensing) for 90+ consecutive days were compared to two groups with back pain: Traditional-dose (199 mg/day) or no opioids. Demographic and clinical data were analyzed using Chi-squares for categorical variables and Kruskall-Wallis nonparametric test for continuous variables. A multivariate logistic regression was performed to evaluate characteristics associated with high-dose opioids. High-dose opioid therapy was prescribed to 8.6% of back pain patients who were prescribed opioids long-term. The average patient was female (55.63%), aged 54.76 (SD = 14.97), non-Hispanic white (79.91%), and overweight (mean BMI = 31.0, SD = 7.48). Patients in the high-dose group had higher rates of psychiatric and substance use disorder diagnoses, comorbidity, concurrent sedative-hypnotics (60.5%), and higher utilization. After controlling for select demographic, medical/psychiatric, and utilization factors, male gender, higher comorbidity, medicare, mental health/substance use diagnosis, co-prescriptions of sedative-hypnotics, ED visits, pain clinic visits were associated with increased likelihood of high-dose prescriptions. High-dose opioid therapy is being prescribed to substantial proportion of back pain patients who are also prescribed opioids long-term. These patients were also found to have greater psychopathology, co-morbidity, and co-prescriptions of sedative-hypnotics raising significant safety concerns. (406) Opioid wean does not increase chronic pain J Beneciuk, E Adams, and V Wittmer; Brooks Rehabilitation, Jacksonville, FL The purpose of this study was to investigate if opioid weaning was associated with pain and depression outcomes in a group of chronic pain patients that completed an intensive 5-week interdisciplinary pain rehabilitation program. Patientswere categorized into three groups based on setting and opiateweaning status. Patients were administered the Medical College of Virginia’s Pain Questionnaire (MCVPQ) and Beck Depression Inventory (BDI) at admission and discharge. Group differences on demographic and clinical variables were tested with one-way ANOVA and chi-square analyses. Outcomes for MCVPQ (pain intensity, pain interference, depression) and BDI scores based on group status were tested with repeated measures ANOVA. Patients were categorized as: 1) inpatient, opiate weaned (mean reduction = 269.6 mg) (n = 66; 28.4%); 2) outpatient, opiate weaned (mean reduction = 72.8 mg) (n = 56; 24.1%); or 3) outpatient, no opiate use on admission or discharge, (n = 110; 47.4%). Groups were similar across most important variables; however inpatients were associated with greater depression scores at admission and discharge compared to outpatients (p .05). Main effects were identified for improvements in MCVPQ [pain intensity (m=2.4; sd=1.9), depression (m=3.0; sd=2.4), pain interference (m=4.9; sd=2.3)] and BDI (m=15.7; sd=9.6) scores (p’s < .01). These findings contradict traditional pain management training which predicts increased pain when opioids are weaned from patients suffering from chronic pain. Weaning from moderate (outpatients) or high (inpatients) opioid dosages did not adversely affect overall pain outcomeswhen compared to patients whowere not using opioids during program admission. Adverse consequences of chronic high dose opioid use is a public health concern, therefore traditional assumptions of opioid effectiveness for treatment of chronic pain (particularly associated with patient-focused clinical outcomes) should be reconsidered. (407) Long-term efficacy and safety of opioid therapy for chronic non-cancer pain: evidence from randomized and open-label studies R Matsuno, L Wallace, R Glanzman, B Martell, and P Coplan; Purdue Pharma