Titre du document / Document title

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

Auteur(s) / Author(s)

MALONNE H. ⁽¹⁾ ; COFFINER M. ⁽²⁾ ; FONTAINE D. ⁽¹⁾ ; SONET B. ⁽²⁾ ; SERENO A. ⁽²⁾ ; PERETZ A. ⁽³⁾ ; VANDERBIST F. ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Laboratoire de Physiologie et de Pharmacologie, Institut de Pharmacie, Université Libre de Bruxelles, Brussels, BELGIQUE
⁽²⁾ Laboratoires SMB S.A., Rue de la Pastorale, Brussels, BELGIQUE
⁽³⁾ Service de Rhumatologie, Hôpital Brugmann, Université Libre de Bruxelles, Brussels, BELGIQUE

Résumé / Abstract

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

Revue / Journal Title

Journal of clinical pharmacy and therapeutics   ISSN 0269-4727 

Source / Source

2005, vol. 30, n^o2, pp. 113-120 [8 page(s) (article)] (26 ref.)

Langue / Language

Anglais

Editeur / Publisher

Blackwell, Oxford, ROYAUME-UNI  (1987) (Revue)

Mots-clés anglais / English Keywords

Spine disease ; Rachialgia ; Diseases of the osteoarticular system ; Degenerative disease ; Arthropathy ; Lumbar spine ; Pain ; Analgesic ; Low back pain ; Osteoarthritis ; Human ; Formulation ; Tramadol ; Toxicity ; Long term ;

Mots-clés français / French Keywords

Rachis pathologie ; Rachialgie ; Système ostéoarticulaire pathologie ; Maladie dégénérative ; Arthropathie ; Rachis lombaire ; Douleur ; Analgésique ; Lombalgie ; Arthrose ; Homme ; Formulation ; Tramadol ; Toxicité ; Long terme ;

Mots-clés espagnols / Spanish Keywords

Raquis patología ; Raquialgia ; Sistema osteoarticular patología ; Enfermedad degenerativa ; Artropatía ; Raquis lumbar ; Dolor ; Analgésico ; Lumbalgia ; Artrosis ; Hombre ; Formulación ; Tramadol ; Toxicidad ; Largo plazo ;

Mots-clés d'auteur / Author Keywords

low back pain ; once daily formulation ; osteoarthritis ; tolerability ; tramadol ;

Localisation / Location

INIST-CNRS, Cote INIST : 17816, 35400012561099.0040