Titre du document / Document title

Tramadol/acetaminophen combination tablets for the treatment of pain associated with osteoarthritis flare in an elderly patient population

Auteur(s) / Author(s)

CAPSS-105 Study Group
ROSENTHAL Norman R. ⁽¹⁾ ; SILVERFIELD Joel C. ⁽²⁾ ; WU Sbu-Chen ⁽¹⁾ ; JORDAN Donna ⁽¹⁾ ; KAMIN Marc ⁽¹⁾ ;

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

⁽¹⁾ Ortho-McNeil Pharmaceutical, Raritan, New Jersey, ETATS-UNIS
⁽²⁾ Tampa Medical Group, PA, Tampa, Florida, ETATS-UNIS

Résumé / Abstract

OBJECTIVES: To evaluate the efficacy and safety of adding tramadol 37.5 mg/acetaminophen (APAP) 325 mg combination tablets (tramadol/APAP) to existing therapy for painful osteoarthritis (OA) flare in a subset of elderly patients. DESIGN: Randomized, double-blind, placebo-controlled, 10-day add-on study. SETTING: Thirty outpatient centers. PARTICIPANTS: Of 308 patients with painful OA flare, a subset of 113 patients aged 65 and older. MEASUREMENTS: Average daily pain intensity and pain relief scores for Days 1 through 5 and secondary quality-of-life measures and medication assessments. METHODS: Patients received one or two tramadol/APAP tablets or placebo four times per day for 10 days during ongoing nonselective or cyclooxygenase (COX)-2-selective nonsteroidal antiinflammatory drug (NSAID) therapy. RESULTS: Tramadol/APAP (n = 69) was significantly superior to placebo (n = 44) for average daily pain intensity (P=.034) and pain relief (P=.010) for Days 1 through 5 and Days 1 through 10 (P=.012 and P=.019, respectively). Tramadol/APAP had significantly better investigator (P<.001) and patient (P=.001) overall medication assessments and significantly better scores on three of four Western Ontario and McMaster Universities Osteoarthritis Index measures (P ≤.027). Most common adverse events with tramadol/APAP were nausea (18.8%), vomiting (13.0%), dizziness (11.6%), and constipation (4.3%), with an incidence similar to that of the overall study population. Mean daily dose of tramadol/APAP was 4.5 tablets (168 mg/1,458 mg). CONCLUSION: Tramadol/APAP add-on therapy effectively managed painful OA flare in this elderly subset and was generally well tolerated.

Revue / Journal Title

Journal of the American Geriatrics Society   ISSN 0002-8614 

Source / Source

2004, vol. 52, n^o3, pp. 374-380 [7 page(s) (article)] (27 ref.)

Langue / Language

Anglais

Editeur / Publisher

Wiley-Blackwell, Hoboken, NJ, ETATS-UNIS  (1953) (Revue)

Mots-clés anglais / English Keywords

Diseases of the osteoarticular system ; Degenerative disease ; Arthropathy ; Human ; Antimigrainous agent ; Antipyretic ; Analgesic ; Geriatrics ; Population ; Elderly ; Osteoarthritis ; Association ; Pain ; Treatment ; Tablet ; Paracetamol ; Tramadol ;

Mots-clés français / French Keywords

Système ostéoarticulaire pathologie ; Maladie dégénérative ; Arthropathie ; Homme ; Antimigraineux ; Antipyrétique ; Analgésique ; Gériatrie ; Population ; Personne âgée ; Arthrose ; Association ; Douleur ; Traitement ; Comprimé ; Paracétamol ; Tramadol ;

Mots-clés espagnols / Spanish Keywords

Sistema osteoarticular patología ; Enfermedad degenerativa ; Artropatía ; Hombre ; Agente antimigrañoso ; Antipirético ; Analgésico ; Geriatría ; Población ; Anciano ; Artrosis ; Asociación ; Dolor ; Tratamiento ; Tableta ; Paracetamol ; Tramadol ;

Localisation / Location

INIST-CNRS, Cote INIST : 8328, 35400011207389.0070