Amiprilose hydrochloride for the treatment of rheumatoid arthritis.
The intent of this study was to compare, in a monotherapy framework, an optimal dose of the synthetic hexose sugar, amiprilose hydrochloride (HCl), to a placebo in the treatment of rheumatoid arthritis. In this double-blind, randomized, multi-center study, patients first underwent a washout period from disease-modifying antirheumatic drugs. Those who subsequently met flare criteria within 14 days of discontinuing previously stable doses of nonsteroidal anti-inflammatory drugs were randomized to amiprilose HCl (103 patients) or a placebo (115 patients) for the subsequent 20 weeks. Glucocorticoid or nonsteroidal anti-inflammatory drugs use was not permitted. At the baseline, demographic and disease characteristics were similar in both groups. Of patients completing the course of therapy, 73% were in the amiprilose HCl group and 66% were in the placebo group. Using an intent-to-treat analysis, numeric trends favoring amiprilose HCl treatment were found for clinical and laboratory parameters of disease activity. Compared with the placebo group, statistically significant degrees of improvement were achieved for the number of swollen joints (p </= 0.04), number of patients who experienced a >/= \50% reduction in swollen joints (p </= 0.04), number who improved by the Paulus composite score criteria (p </= 0.02), improvement in the frequency distribution in Functional Class (p </= 0.01), and improvement in the mean erythrocyte sedimentation rate (p </= 0.03). Significant worsening in the duration of morning stiffness (p </= 0.05) and in 4 of the 5 items in the clinical health assessment questionnaire (p </= 0.004) occurred in the placebo but not in the amiprilose HCl group. No side effects clearly attributable to the drug were noted. This study provides an independent confirmation that the novel and nontoxic carbohydrate, amiprilose HCl, provides an effective approach to the treatment of rheumatoid arthritis. The Food and Drug Administration will now consider whether it should be approved for this indication.
Trentham
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Division of Rheumatology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.
Fife
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RS
Carpenter
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Box
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JH
Trout
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Lanser
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ME