Topic D: TREATMENT APPROACHES (MEDICAL/INTERVENTIONAL) S175 669 GASTROINTESTINAL (GI) SIDE EFFECTS ASSOCIATED WITH CHRONIC OPIOID ANALGESIC THERAPY IN A LARGE, PERSISTENT NON-CANCER PAIN POPULATION (SB-767905/011): BASELINE DATA K. Hermanns 1 , G. Irving 2 , M. Cousins 3 , A. Pierce 4 , J. Snidow 4 , E. Mortensen 4 , C. Kleoudis 4 , E. Carter 4 ° . 1 Regional Pain Center DGS Berlin Prenzlauer Berg, Germany, 2 Swedish Medical Center, Seattle, WA, USA, 3 Pain Management Research Institute, University of Sydney & Royal North Shore Hospital, Sydney, Australia, 4 GlaxoSmithKline, Research Triangle Park, NC, USA Background: Chronic opioid therapy is often complicated by persistent GI side effects, yet few well-controlled studies have described these symptoms in a pre-specified manner. Aim: To detail demographics, baseline characteristics and GI symptoms of a large, non-cancer pain cohort reporting opioid-induced constipation, specifically defined as infrequent and difficult defecation. Methods: This phase IIb study evaluated the investigational, peripherally acting mu-opioid receptor (PAM-OR) antagonist alvimopan for treatment of opioid-induced GI side-effects. Adults were evaluated who were using 30mg oral morphine equivalents/day, had a history of GI side-effects and reported an average weekly spontaneous bowel movement (SBM [BM in absence of laxative use within previous 24 h]) frequency <3 during the 2-week baseline period. Results: Of 522 eligible subjects, 92% were white, 64% female, and average age was 50.3 years. Opioids had been taken, on average, 6.9 years for pain conditions: back pain (58%), neuralgia (8%), fibromyalgia (8%) and arthritis (7%). Average baseline total daily dose (oral morphine equivalents) was 288.0mg. Laxatives/stool softeners were used by 80% of subjects within 30 days before screening, and 80% used rescue laxative during baseline. Subjects reported an average of 2.9 total BMs and 1.1 SBMs/week plus the following symptoms (moderate or greater severity): straining (83%), hard stools (87%), incomplete evacuation (88%). Most prevalent other GI-related symptoms were abdominal fullness (76%), intestinal gas (70%) and general malaise (59%). Conclusions: Chronic opioid analgesia is associated with persistent dys- function of the GI tract, despite laxative use. New therapies that relieve GI symptoms without compromising analgesia are under investigation. Presented at APS 2006. 670 RECOMMENDATIONS FOR THE USE OF OPIOIS IN NON ONCOLOGIC CHRONIC PAIN (NOCP). REVIEW OF THE CURRENT GUIDELINES E. Catala 1 ° , L. Lorente 2 , L.A. Nasif 1 , M. Ferrandiz 1 , G. Landaluze 2 , M. Genove 1 . 1 Pain Clinic, anesthesiology service, University hospital de la Santa Creu i SAnt Pau, Barcelona, 2 Pain clinic, anesthesiology service, Hospital General de Catalunya, St Cugat del Valles, Barcelona, Spain Background and Aims: We reviewed current clinical guidelines (CCG) cradles in criteria of evidence to obtain recommendations and define the quality of evidence by means of AGREE instrument for the use of opioids in NOCP. Methods: Thirteen evidence-based CCG on the use of opioids in treating NOCP were evaluated. Each CCG was reviewed by 4 observers using AGREE instrument, which consists of 23 points to evaluate the quality of the CCG. Results: We obtained different types of recommendations and degrees of evidence in the treatment of NOCP. The most significant were: 1. Identification of clinical conditions that may interfere with opioid use. 2. Indication for the use of opioids 3. To find the medication that combines maximum quality with minimum side effects 4. To increase doses by 25−50% in each control. If good effectiveness or intolerable adverse effects is not obtained: rotation of opioids 5. To maintain suitable doses to provide good pain relief and improve functionality. The patient must be reviewed each 4−9 weeks by the same medical team 6. Evaluation of compliance with the therapeutic plan. 7. Evaluation of the effectiveness of treatment. 8. Indications for withdrawing the medication. Recommended reduction: 20−50% weekly of the prescribed dose. Conclusions: 1. Opioid use in the treatment of NOCP is not necessarily controversial. 2. Dependency is inevitable with opioids treatment. 3. Dependency and addiction do not justify not relieving pain. 4. The main reason for using opioids in NOCP is to make the pain bearable, not to eliminate it. 671 DRIVING ABILITY UNDER LONG-TERM TREATMENT WITH CONTROLLED RELEASE OXYCODONE IN NON-CANCER PAIN PATIENTS O. Dagtekin 1 ° , H.J. Gerbershagen 1 , A. Delis 1 , J. G¨ artner 2 , F. Petzke 1 , L. Radbruch 3 , R. Sabatowski 1 . 1 Department of Anaesthesiology, 2 Department of Palliative Care, University of Cologne, Cologne, 3 Department of Palliative Care, University of Aachen, Aachen, Germany Background: Opioid therapy can be associated with impaired psychomo- tor function and cognition. This trial investigates the effect of long term treatment with controlled release oxycodone (CRO) on driving ability. Methods: 30 patients suffering from chronic non-cancer pain (CNCP) who had been treated with stable doses of CRO were included in this prospective trial. The patients were compared to 90 healthy volunteers (matched pairs) randomly selected from a pool of volunteers who had been tested at the Institute for Traffic Safety in Cologne, Germany. A computerised test battery that was developed to assess the driving ability of traffic delinquents in Germany was employed. Visual orientation, attention reaction, motor coordination and vigilance were evaluated. The data from a total of 11 parameters were assessed and for each test a relevant score was defined. As the primary endpoint the sum score of the three relevant scores was determined. A weaker statistical means to assess the patient’s performance is to compare the test results to an age-independent control group. Individuals performing worse than the 16th percentile of this control group are considered to be unable to drive according to German legislation. Results: For the primary endpoint significant non-inferiority could not be demonstrated. However, driving ability as defined as a result above the 16th percentile did not differ significantly between the patients receiving CRO and the age-independent control group. Conclusion: The use of CRO for the treatment of CNCP does not prohibit driving, but individual assessment is necessary due to individual variability of test results. 672 SAFETY, EFFICACY, AND HEALTH-RELATED QUALITY-OF-LIFE OUTCOMES FOR PATIENTS WITH CHRONIC OSTEOARTHRITIS PAIN TREATED WITH OROS ® HYDROMORPHONE VERSUS ER OXYCODONE D. Dubois 1 ° , M. Kosinski 2 , M. Hale 3 , J. Schein 4 , S. Kavanagh 1 . 1 Health Economics, Johnson & Johnson Pharmaceutical Services, Beerse, Belgium, 2 QualityMetric Incorporated, Lincoln, RI, 3 Gold Coast Research, LLC, Weston, FL, 4 Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, NJ, USA Background and Aims: Osteoarthritis (OA) is associated with significant pain and interference with daily life. The objective of this study was to compare the safety, efficacy, and health-related quality of life (HRQoL) effects of once-daily OROS ® hydromorphone and twice-daily sustained- release (SR) oxycodone in patients with OA of the knee or hip. Methods: In this 6-week, open-label, randomized, parallel-group study, patients recorded pain intensity and pain relief in daily diaries. The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index was completed every 2 weeks. Results: 140 patients were randomized; 138 received treatment (safety population). Data from 124 (OROS ® hydromorphone, n = 64; SR oxy- codone, n = 60) were included in the efficacy analyses. Mean±SD daily