Osteoarthritis and Cartilage 1994; 2 (Suppl 1)
Rovati LC, Giacovelli G, Annefeld M, Dreiser RL, Avouac B
Second International Congress of the Osteoarthritis Research Society. Orlando, Florida December 9-11, 1994
METHODS: 329 patients (245 women, 84 men; median age 67 years) were enrolled in this multicentre study and randomized in 4 homogenous groups. The following once-a-day oral treatments were given for 90 days: 1) 1500 mg glucosamine sulfate (GS); 2) 20 mg piroxicam (Pir); 3) their association (GS+Pir); 4) placebo (Plac). Patients were then followed-up for further 60 days without treatment. The main efficacy variable was represented by the Lequesne index.
RESULTS: Analysis of variance for repeated measures was performed according to an intention to treat approach (last value carried forward) on the 310 evaluable patients, including drop-outs for inefficacy, worsening, or concomitant use of other symptomatic drugs. There were significant (p=0.0001) treatment effects, time effects and treatment time interactions. Adverse events during treatment were present in 19 patients with Plac (i.e. 24.4%, yielding 3 drop-outs: d-o), 12 with GS (14.8%, no d-o), 36 with Pir (40.9%, 20 d-o) and 28 with the association (35.9%, 3 d-o): p=0.0001.
CONCLUSION: GS was confirmed an effective and well tolerated Symptomatic Slow Acting Drug in OA, with a steadily increasing effect, persisting after drug withdrawal. Pir was less tolerated, had a similar efficacy at the beginning of treatment, but that wore off at withdrawal.