Open-label study of the safety and effectiveness of long-term therapy with extended-release tramadol in the management of chronic nonmalignant pain

ABSTRACT

Background: Tramadol ER is a once-daily oral analgesic for management of moderate-to-moderately severe chronic pain in adults who require around-the-clock treatment of pain. This study evaluated long-term safety of tramadol ER and effectiveness outcomes in the management of chronic, nonmalignant pain.

Methods: Patients enrolled directly for approximately 1 year of open-label tramadol ER treatment if they had chronic, nonmalignant pain (n = 919), or ‘rolled over’ for 38 weeks of open-label tramadol ER treatment if they completed either of two 12-week, placebo-controlled studies of tramadol ER for low back pain (n = 72) or osteoarthritis (n = 61). Tramadol ER was titrated to a dose of 300 mg once daily (patients ≥ 75 years) or 300–400 mg once daily (patients < 75 years).

Results: A total of 257 (24%) patients completed the study. Common adverse events, regardless of treatment relationship, were nausea, dizziness (excluding vertigo), and constipation. Mean scores for current pain intensity (from 0 = no pain to 100 = extreme pain) and least, worst, and average pain intensity over the past week improved at every post-baseline visit. At each post-baseline visit, > 50% of patients provided a global assessment rating of good, very good, or excellent. Study limitations were mandatory titration to 400 mg in some patients, concomitant analgesic therapy as a confounding variable, and lack of a placebo comparator.

Conclusions: Individualized dose titration and limiting once-daily therapy with tramadol ER to the maximum recommended daily dose of 300 mg may balance tolerability and analgesic effects of tramadol ER in patients with chronic, nonmalignant pain.

Key words: :

• Chronic pain
• Extended-release
• Low back pain
• Nonmalignant pain
• Osteoarthritis
• Tramadol

* ULTRAM ER (tramadol HCl) extended-release tablets; Manufactured by Biovail Corporation, Mississauga, Ontario, Canada; Distributed by PriCara, Unit of Ortho-McNeil, Inc., Raritan NJ, USA

* ULTRAM ER (tramadol HCl) extended-release tablets; Manufactured by Biovail Corporation, Mississauga, Ontario, Canada; Distributed by PriCara, Unit of Ortho-McNeil, Inc., Raritan NJ, USA

Notes

* ULTRAM ER (tramadol HCl) extended-release tablets; Manufactured by Biovail Corporation, Mississauga, Ontario, Canada; Distributed by PriCara, Unit of Ortho-McNeil, Inc., Raritan NJ, USA