[Tilidine/naloxon retard in long-term administration in chronic pain and multimorbidity. Multicenter study of long-term tolerance and effectiveness in 2 years observation].

Abstract

Background and method: 335 patients (51% female, 49% male, mean age 56 years) with chronic pain and multimorbidity have been included in a multi-center 2-years' study with slow release Tilidine/Naloxone for efficacy and safety which included detailed laboratory examinations. 316 patients had already been treated with analgesics. 159 patients (47.5%) finished the study as planned, 176 patients finished the study earlier.

Results: Parameters of quality of life such as persistent pain, sleep, mood and activity have improved. Tolerance has not been observed. In 85 patients (25%) adverse events had occurred (nausea, vomiting, dizziness) which are related to the study-medication. Constipation was documented in only 4 patients. After 2 years of therapy with Tilidine/Naloxone there has been no relevant changes in laboratory findings. There has been no sign of organ damage or interactions with concomitant medication.

Conclusion: Tilidine/Naloxone is an effective and safe analgesic (WHO II) suitable for the longterm treatment of patients with chronic pain.