Benhamou C L, Feldmann J L, Dropsy R
Service de rhumatologie, hôpital La Source, Orléans, Paris.
Rev Med Interne. 1989 Mar-Apr;10(2):163-73. doi: 10.1016/s0248-8663(89)80099-2.
Efficacy, safety and therapeutic benefit of etodolac (Lodine 200) in rheumatological practice. An open clinical trial performed by 974 rheumatologists enabled an evaluation of efficacy, safety and therapeutic benefit of etodolac (Lodine 200) on 4,947 patients with rheumatoid arthritis, ankylosing spondylitis and osteoarthritis of the lower limbs; the initial dosage was 600 mg/d (for 2 weeks), then 400 to 600 mg/d (for 2 to 4 weeks, according to the indication). Efficacy, assessed by classical items for NSAID's, was shown to be excellent to good by 61-77 p. 100 of patients, according to the indication. 7.7 p. 100 of patients only dropped out for lack of efficacy. 20.4 p. 100 of patients developed adverse effect(s) (AE), but the relationship between etodolac and AE was assessed "possible" or "probable" only for 9.6 p. 100 of patients; this figure should be compared to the 7.6 p. 100 of patients who dropped out for AE and to the 92 p. 100 of patients who assessed the global safety as "excellent or good". The therapeutic benefit was estimated very favorable: 75 p. 100 of patients felt better than at the beginning of the study, 64.5 p. 100 of patients wished to continue the treatment and the (mean) benefit-risk ratio assessed with a logarithm scale (-1 to +1), ranged from 0.45 to 0.6 according to the indication. Therefore, this trial confirmed the good efficacy and safety profile of etodolac on a large scale in normal clinical practice in France, following assessments during controlled trials. It also permitted to perfect new items of evaluation for NSAID's, in particular for therapeutic benefit.