AB1193\u2005OBSERVATIONAL PROSPECTIVE COHORT STUDY TO EVALUATE EFFICACY AND SAFETY OF TAPENTADOL IN PATIENTS WITH RESPIRATORY DISEASE

Abstract

Background Chronic pain analgesia is a concern in clinical practice in rheumatic patients, especially when the intensity is severe. In this case opioids are indicated but also contraindicated in cases of important respiratory depression and, therefore, must be administered with caution to patients with respiratory disease (1). Many of our patients are not in the condition of severe respiratory depression although they present plurypathologies, which could be triggered at the use of certain doses (2). For this reason, it is important the existence of a study that shows that tapentadol is safe in pluripathological patients when used at regular doses in clinical daily practice in Reumathology (3). Objectives Single site, non-postmarketing observational study. The main objective is to evaluate the safety of tapentadol prolonged release (TPR) 50 mg/12h, measured as tolerance (“good”, “bad” or “not too bad”) and by the comparative analysis of gradients between both groups of the study (control group and pathological group), the basal oxygen saturation, and after the dose of TPR (basal pulse oximetry minus the mean of the oxygen saturation after 30 days of study). Methods Inclusions criteria arepatients with severe chronic pain (Visual Analogical Scale, VAS>4) diagnosed from mild to severe chronic obstructive pulmonary disease (COPD) (spirometry after bronchodilatation with forced expiratory volume (FEV)/forced vital capacity (FVC)< 70% and FEV1=50%), and/or obesity, and/or controlled asthma and/or other conditions likely to produce respiratory depression with opioids (pathological group). Exclusion criteria consists in basal oxigen saturation measured by the pulse oximeter inferior to 92%. A descriptive analysis of variables and a comparison of the means were performed. Results 29 patients; 12 in control group and 17 pathological group (obesity: 9, controlled asthma: 3; mild to moderate COPD: 7; other pathologies: 7). Overall, the type of pain was nociceptive 59%, neuropathic 21% and mixed 20%; mainly women (67%), caucasic race (92%), median age 60 years old, and with 93% good tolerability and 97% good treatment adherence. Concerning results per groups, at control group, VAS mean, arterial pressure (AP), oxygen saturation (SO2) and heart rate (HR) before and after treatment. 8,3 vs 5,8; 127/74 vs 124/73 (mmHg); 95,6 vs 95,7 (%); 76 vs 73 (bpm). In the pathological group: 7,5 vs 5,6; 131/82 vs 127/78 (mmHg); 96 vs 95,5 (%); 75 vs 76 bpm. Regarding the results as per gradients between groups, no statistically significant differences were found, except for VAS, (p=0,00008). There were no cases of decrease of the oxygen saturation below 92% along the study. Conclusion The results support the safety of tapentadol from the respiratory point of view, measured by oxygen saturation, since no statistically significant differences were found between both groups, and, due to the excellent tolerability, as no clinical data showed signs of hypercapnia. No statistically significant differences were found in the oxygen saturation between both groups with the intake of TPR, with excellent tolerability and treatment adherence. There were no cases of decrease of the oxygen saturation below 92% along the study. References [1] Carr DB, How prevalent is chronic pain?. Pain clinical updates 2003; (11) 2:1-4 [2] Breivik H, ColletB, Ventafridda V, Cohen R, Gallacher, D. Survey of chronic pain in Europa: Prevalence, impact on daily life, and treatment. Eur J Pain 2006; 10 (4) 287-333 [3] Ficha Tecnica Palexia® Retard. Disclosure of Interests None declared