Safety and efficacy of long-term intraarticular XXXX injections in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled trial.

@entity1 @entity2995 @entity571 @entity134 @entity158 @entity230
OBJECTIVE: To evaluate the safety and efficacy of long-term intraarticular (IA) @entity134 injections for knee @entity158 related to @entity571 ( @entity571 ). METHODS: In a randomized, double-blind trial, 68 @entity1 with @entity571 of the knee received IA injections of @entity2995 40 mg (34 @entity1 ) or saline (34 @entity1 ) into the study knee every 3 months for up to 2 years. The primary outcome variable was radiologic progression of joint space narrowing of the injected knee after 2 years. Measurements of minimum joint space width were performed by an automated computerized method on standardized fluoroscopically guided radiographs taken with the @entity1 standing and with the knee in a semiflexed position. The clinical efficacy measure of primary interest was the @entity158 subscale from the Western Ontario and McMaster Universities @entity571 Index (WOMAC). Efficacy measures of secondary interest were the total score on the WOMAC, physician's global assessment, @entity1 's global assessment, @entity1 's assessment of @entity158 , range of motion (ROM) of the affected knee, and 50-foot walking time. Clinical symptoms were assessed just before each injection. RESULTS: At the 1-year and 2-year followup evaluations, no difference was noted between the two treatment groups with respect to loss of joint space over time. The @entity134 -injected knees showed a trend toward greater symptom improvement, especially at 1 year, for the @entity158 subscale, night @entity158 , and ROM values (P = 0.05) compared with the saline-injected knees. Using area under the curve analyses, knee @entity158 and stiffness were significantly improved throughout the 2-year study by repeated injections of @entity2995 , but not saline (P < 0.05). CONCLUSION: Our findings support the long-term safety of IA @entity134 injections for @entity1 with symptomatic knee @entity571 . No deleterious effects of the long-term administration of IA @entity230 on the anatomical structure of the knee were noted. Moreover, long-term treatment of knee @entity571 with repeated @entity134 injections appears to be clinically effective for the relief of symptoms of the disease.
