Abstract
OBJECTIVE: To compare the efficacy and tolerability of once daily (OD) tramadol tablets with normal release tramadol capsules (50 mg) taken 3 or 4 times daily in a multicenter, double blind, double dummy parallel study. METHODS: Patients with moderate to severe pain due to osteoarthritis (OA) were recruited from general practice. Following a titration period of a week, patients were assessed over one month for the analgesic efficacy and tolerability of the test medications. RESULTS: Both treatments were shown to be effective. There was no difference between treatments and both produced good pain control as shown by clinically relevant decreases from baseline pain scores, low escape medication use, and sleep disturbance. The efficacy of the OD tramadol over the 24 h dosing interval was confirmed by the low sleep disturbance, absence of "end of dose" effects in morning pain scores, and low escape medication use. Of the 279 patients recruited, 140 withdrew, mostly because of adverse events. The adverse event profiles were typical of opioids and were similar for both treatments. CONCLUSION: Tramadol OD was at least as effective and well tolerated as normal release tramadol in the management of OA pain. However, OD tramadol offers the advantage of a reduced dosing regimen, which is especially valuable in the elderly population.
