660 CONDYLE FRACTURE DURING THE CHILDBIRTH

660 CONDYLE FRACTURE DURING THE CHILDBIRTH

S172 European Journal of Pain 2006, Vol 10 (suppl S1) 656 OPIOID-INDUCED CONSTIPATION – A FREQUENT AND DISTRESSING SIDE EFFECT IN DAILY PRACTICE AFF...

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S172

European Journal of Pain 2006, Vol 10 (suppl S1)

656 OPIOID-INDUCED CONSTIPATION – A FREQUENT AND DISTRESSING SIDE EFFECT IN DAILY PRACTICE AFFECTING ORAL AND TRANSDERMAL OPIOID APPLICATIONS M.A. Ueberall1 ° , G. Mueller-Schwefe2 . 1 FNAP, Institute for Neurological Sciences, Nuernberg, 2 DGS, Interdisciplinary Pain Center, Goeppingen, Germany Background and Aims: Constipation of the gastrointestinal-tract (GIT) is a distressing side effect of opioid use affecting compliance and qualityof-life of patients suffering from chronic pain (CPP). Marketing strategies and lay publications pretend lower constipation rates for transdermal opioid systems (TDS) compared to conventional oral opioid preparations (COP). To evaluate these differences we performed a cross-sectional census focusing on differences between TDS vs. COP in opioid-treated CPPs as part of a shared-decision-making program of the German Pain Society. Methods: Large cross-sectional nationwide census focusing on constipation and related symptoms of opioid-induced bowel dysfunction in CPPs. Results: 4613 CPPs (x% female, age: 53.5±16.8 yrs.) treated with a WHO-III opioid monotherapy (COP: n = 3241, 70.3%; TDS: n = 1372, 29.7%) participated. Mean opioid treatment duration was 12.1±7.9 yrs. in COP and 11.0±7.8 in TDS patients. Opioid doses (calculated on the basis of established morphine equivalents) were comparable between both groups. Laxatives were taken by 70.0/65.8% of COP/TDS opioid users. The degree of constipation (quantified using a 5-point verbal rating scale) was “none” in 29.8/29.6%, “mild” in 35.6/35.7%, “moderate” in 22.7/29.6%, “severe” in 10.8/4.1% and “extreme” in 1.1/1.0% of COP/TDS users. Overall GIT-tolerability was rated as 5.2±2.3/4.8±2.2 on an 11-point numerical ranting scale (with 0 = very good and 10 = very poor). Conclusions: Opioid-induced constipation is a frequent and severe adverse event affecting >2/3 of CPPs despite adequate laxative therapies. Observed (minor) differences in incidence and severity between transdermal and extended-release oral opioid preparations are far away from significance, supporting current recommendations to use oral opioids first.

657 A PRECLINICAL COMPARISON BETWEEN MORPHINE AND HYDROMORPHONE: ANTINOCICEPTIVE VERSUS ADVERSE EFFECTS T.F. Meert, F. Geenen, H. Vermeirsch ° . CNS-Pain & Neurology, Johnson & Johnson Pharmaceutical Research & Development, Beerse, Belgium Many patients with severe and/or chronic pain can obtain good analgesia by using morphine, but often at a cost of significant side-effects. Refining the analgesic actions and reducing the unwanted side-effects of opioids may enhance the patients quality of life and decrease the incidence of opioid-insensitive pain. Literature offers few comparative data between different opioids at equianalgesic doses. As a continuation of a previous study, in which several opioids were compared for analgesic properties and side-effect profiles in rats, the activities of morphine and hydromorphone were determined in several behavioral analgesia tests and both opioids were evaluated for side-effect profiling. Analgesic efficacy was analysed using a tail-withdrawal test for acute thermal nociception, a formalin test for chemically-induced inflammatory pain and a von Frey test for mechanical hypersensitivity. For side-effect profiling inhibition of gastrointestinal activity was evaluated in a charcoal and ricinus-oil test, arterial PCO2 was determined for measuring respiratory depression, and motor coordination was tested through rotarod performance. Hydromorphone had a stronger analgesic potency and, compared to morphine a better side-effect profiling at analgesic ED50’s. For both opioids a decreased propulsive activity in the small intestines was the most important side-effect, for morphine also a negative influence was observed on fluid transport and propulsion in the large intestine at the ED50’s for the different analgesic tests. This additional effect leading to constipation was not observed for hydromorphone at most analgesic ED50’s.

Abstracts, 5th EFIC Congress, Free Presentations

D15 OPIOIDS IN NON-CANCER PAIN 658 EFICACY-TOLERANCE PROFILE OF THE OXICODONE IN TREATMENT OF CHRONIC NON-MALIGNANT PAIN AS OPPOSED TO OTHER OPIATES D. Abej´on ° , C. Del Pozo, J. Del Saz. Puerta De Hierro Hospital (Pain Unit), Madrid, Spain A study with 100 patients with different pathologies from chronic pain (always non-oncological), which they have received treatment with at least two opiates (fundamentally morphine, fentanyl or metadone), and that, either they did not obtain a satisfactory control of the pain, or displayed important indirect effect that they disabled to continue the increasing guideline of dose. Method: it has been come to the substitution of the opiate corresponding by oxicodone to similar doses, collecting later following: degree of satisfaction of the patient, analogical visual scale, dose reached of oxicodone, adverse events showed and if it has been possible or not its control. The objective of this study is to display oxicodone as a good option for opiate initial use in the treatment of the chronic non-malignant pain, due to its low profile of indirect effects, as well as in the rotation of opiates. 659 IMPACT OF OPIOID-INDUCED CONSTIPATION ON HHEALTHCARE RESOURCE UTILISATION AND PATIENT FUNCTIONING K. Annunziata1 ° , T. Bell2 . 1 Consumer Health Sciences, Princeton, NJ, Research Triangle Park, NC, USA

2 GlaxoSmithKline,

Background and Aims: The impact of constipation associated with opioid treatment on healthcare resource utilisation and work productivity in the US and EU was assessed. Methods: 67,189 responses to the international National Health and Wellness Survey (2004) were analysed. Healthcare resource utilisation and Work Productivity and Activity Impairment questionnaire responses were assessed for patients taking opioids for 6 months, and compared between those who did or did not report constipation using t-tests or linear regression. Results: Data were available from 1606 and 824 opioid-treated patients in the US and EU, respectively. Although the number of emergency room visits and days hospitalised did not differ significantly between opioid-treated patients with and without constipation, t-tests revealed significantly more visits to physicians in the US and EU, and to alternative healthcare providers in the US, by patients with constipation than without (p < 0.05). US patients with constipation reported increased percentage impairment while working and overall work impairment, and EU patients reported significantly more work time missed (all p < 0.05 versus patients without constipation; t-test). With the exception of US physician visits, significant differences between patients with and without constipation were maintained when factors including age, gender and number of comorbid conditions were controlled for using linear regression. Conclusions: The results from this survey showed that opioid-treated patients with constipation demonstrate significantly higher healthcare resource utilisation than those without constipation. The burden of constipation associated with opioid use also includes loss of work productivity due to impaired performance and/or increased absence of individuals. 660 CONDYLE FRACTURE DURING THE CHILDBIRTH D. Araque ° . Hendiduras Labiopalatinas, Universidad Santa Mar´ıa, Caracas, DC, Venezuela Through the presentation of clinical cases fractures provoked condilares are shown during and like consequence of distocic or complicate childbirths, their precocious treatment and their late treatment. Establish that in the

Topic D: TREATMENT APPROACHES (MEDICAL/INTERVENTIONAL) event of anchylosis, when reestablishing the function of the “Mouth Organ”, with Maxillary Functional Orthopedics, it is obtained new bone like the original bone and the reestablishment of the function.

661 LONG-TERM ASSESSMENT OF THE CLINICAL EFFICACY AND SAFETY OF ONCE-DAILY OROS® HYDROMORPHONE IN PATIENTS WITH SEVERE CHRONIC PAIN M. Ates1 ° , U. Richarz2 , S. Waechter2 , J. Thipphawong3 , J.C. Tudor3 . 1 Janssen-Cilag Turkey, Istanbul, Turkey, 2 Medical Affairs, Janssen-Cilag Europe, Baar, Switzerland, 3 ALZA Corporation, Mountain View, CA, USA Background and Aims: The efficacy and safety of once-daily OROS® hydromorphone has been established. Data from open-label extension (OLE) studies is presented. Methods: Study 1: Patients with severe chronic pain (n = 388; neuropathic pain n = 133) from 3 short-term trials enrolled in a 1-year OLE, with therapy continued at established doses. Patients were assessed monthly. Study 2: Patients with severe chronic low back pain (n = 113; neuropathic pain, n = 12) who participated in a 7-week study were enrolled in a 6-month OLE, with therapy continued at established doses. Patients were evaluated monthly. Results: Study 1: 150 patients completed 1 year of therapy. Mean of the average daily doses were 80.1, 86.4, 92.7, 97.4, and 99.8 mg/day at extension baseline and months 3, 6, 9, and 12 of therapy, respectively. Reductions in BPI pain relief were maintained over the OLE. At extension month 12 (n = 128), 80.5% of patients and 82% of investigators rated treatment as good to excellent. Study 2: The mean duration of therapy was 129.2 days; 83 patients completed 6 months. Average daily doses were 52.9 and 48.6 mg/day at start and end of OLE, respectively. Mean±SD pain relief remained constant (baseline, 2.4±0.7; endpoint, 2.5±0.8), and 72.3% of patients and 82.1% of investigators rated treatment as good to excellent at endpoint. The AE profile was typical of long-term opioid use. Conclusions: OROS® hydromorphone is an effective long-term treatment for severe chronic pain.

S173 663 PREVALENCE, SEVERITY AND IMPACT OF OPIOID-INDUCED GI SIDE EFFECTS IN THE EU: RESULTS OF A PATIENT SURVEY T. Bell1 ° , T. Milanova1 , G. Grove1 , R. Williamson1 , S. Bolge2 . 1 GlaxoSmithKline, Research Triangle Park, NC, 2 Consumer Health Sciences, Princeton, NJ, USA Background and Aims: GI side effects are a consequence of opioid therapy for persistent pain. However, the impact of these side effects has not been well documented. A patient survey was conducted to characterise the prevalence, frequency, severity and impact of opioid-induced GI side effects on quality of life (QoL) and activities of daily living (ADLs) in subjects receiving opioids for persistent pain and taking laxatives. Methods: 361 subjects suffering from persistent pain receiving oral opioids and taking laxatives responded to the survey, administered at a single time point (January 2006) via the internet in France, Germany, Italy, Spain and the UK. Results: Many subjects (56%) used an opioid on a daily basis and 66% had been taking opioids for 1 year. Opioid-induced GI side effects most frequently reported were constipation (61%), straining (41%), too small/hard stools (37%), incomplete evacuation (32%) and heartburn (30%). 48–67% of subjects with these side effects reported them on 4 days/week, and 75–94% rated them as moderate-to-severe. The majority of subjects considered the effects as having a moderate-to-great negative impact (scored as 2–4 on a 5-point scale) on QoL (68–82%) and ADLs (59–68%). Conclusions: In this survey, a high proportion of subjects reported moderate-to-severe opioid-induced GI side effects, which occurred frequently during the week and had a negative impact on QoL and ADLs, despite the fact that subjects were taking laxatives. Novel therapies that relieve these symptoms and restore GI function without compromising analgesia are under investigation.

664 THE USE OF METHADONE IN THE TREATMENT OF CHRONIC NON-CANCER PAIN A. Bendiksen ° , E. McGehee, G. Handberg. The Pain Center of Funen County, The University of Odense, Denmark

662 USE OF TTS DUROGESIC IN CASES OF LOW BACK PAIN NO CORRESPONDING TO NSAIDS AND EPIDURAL ANALGESIA M. Bakopoulou1 ° , A. Petsiti2 , G. Stamatiou2 , E. Theodorou2 . 1 Neurosurgical Clinic University Hospital Larisa, 2 Anaesthetic Department University Hospital Larisa, Greece Background: It is well known that low back pain is so common that it will affect everybody at some time. In many countries there are guidelines for the management of acute low back pain. Because of that the majority of patients with acute or sub-acute low back pain is being treated by primary care physicians. Patients coming in pain management clinics are usually patients with chronic low back pain. This sort of patients is difficult to be treated. Material and Methods: 14 patients presented to our pain management clinic suffering from chronic low back pain with limited home and work activity Before proceeding to us they have been treated with NSADs and physiotherapy. As first approach we treated them with epidural analgesia but we came out with poor results. Our second choice was the administration of TTS Durogesic 25mg/h every three days. Results: 12 of 14 patients responded extremely well to the treatment with TTS Durogesic. In an one year follow up they were free of pain with no limited activity.

Introduction: The use of methadone may be difficult and is to chronic non-cancer pain only sparsely described in the literature, whereas several works have shown advantage by methadone in the treatment of cancer pain. The aim of this analysis is to assess advantages and disadvantages by methadone in the treatment of chronic pain and to evaluate the method used in The Pain Centre of Funen County, Denmark when initiating the treatment. Material and Method: The analysis is retrospective and includes 83 patients with chronic pain, treated with methadone either as the primary choice of opioid or by rotation from another opioid, initially using a rotation ratio of 10:1 (morphine:methadone) and afterwards titrated till maximal effect with fewest adverse events. Results: Among rotated patients 59% had good pain relief on methadone with a daily dose of 20.5 (1.5−82.5) mg, the frequency for ceasing methadone because of adverse events was 24%, mainly drowsiness occurring in 50%, and 17% because of lack of effect. Among opioid naive 12% had good pain relief. Daily dose was 3.75 (3.5−4) mg. Here adverse events caused methadone ceased in 76% of the cases, mainly dizziness occurring in 38%, and lack of effect in 12%. Conclusion: Opioid treated chronic pain patients whose pain relief is insufficient may benefit from conversion to methadone, as 59% in our analysis achieved better pain relief, while the rotation generally was opioid saving. The method was safe and acceptable.