Long-term tolerability of tramadol LP, a new once-daily formulation, in patients with osteoarthritis or low back pain.

摘要: Introduction Tramadol hydrochloride is a centrally acting analgesic, which possesses opioid agonist properties and activates monoaminergic spinal inhibition of pain. An oral, once day, sustained release formulation tramadol thought to be advantageous compared with immediate preparations as it prevents plasma peaks associated increased side-effects the drug. It may also improve compliance. The purpose study was assess long-term safety new sustained-release (tramadol LP) in patients knee or hip osteoarthritis refractory low back Study design phase III, open, multicentre, international, tolerability LP at dose titrated by patient between 100 400 mg daily, according intensity treatment administered for continuous period 4 weeks followed an intermittent intake 5 months 204 patients. criteria evaluation were recording adverse events, laboratory tests, electrocardiogram, radiography, global assessed investigators. Results Long-term use reasonably well tolerated. Most reported events expected occurred within first month treatment. Roughly half (49%) 66% related Gastrointestinal (nausea vomiting) most frequent. Serious 6.4% patients, from only two cases There no sign tolerance development percentage presenting withdrawal symptoms after end (6%). Conclusion daily generally safe