73245
document
Amiprilose hydrochloride for rheumatoid arthritis . STUDY OBJECTIVE To assess the safety and efficacy of amiprilose hydrochloride ( HCl ) , a novel synthetic carbohydrate with anti-inflammatory and immunomodulatory properties , in patients with rheumatoid arthritis . DESIGN Prospective , multicenter , randomized , parallel group , double-blind placebo-controlled 12-week trial . PATIENTS Two hundred and one functional class I and II patients with definite or classic rheumatoid arthritis , previously untreated with disease modifying antirheumatic drugs . INTERVENTIONS Patients were withdrawn from nonsteroidal anti-inflammatory drug therapy . Those who flared were randomly assigned to amiprilose HCl , 6 g/d , or placebo for 12 weeks . No concomitant anti-inflammatory or antirheumatic drug therapy was permitted during the study . Combination acetaminophen and propoxyphene napsylate was the only supplemental analgesic medication allowed . MEASUREMENTS AND MAIN RESULTS The number of painful joints and swollen joints , joint pain and joint swelling indices , left and right grip strength , investigator global assessment , and patient global assessment returned to baseline for the amiprilose group and showed statistically significant ( P less than 0.05 ) differences from the placebo group within 4 to 6 weeks . The protocol criteria for overall therapeutic response were satisfied by 41 % of the amiprilose patients , compared with 21 % of the placebo group ( P = 0.003 ) . Approximately 0.5 tablet per day less analgesic medication was taken by the amiprilose group ( P less than 0.05 at weeks 6 and 12 ) . There were no statistically significant differences in morning stiffness , walking time , erythrocyte sedimentation rate , C-reactive protein , or rheumatoid factor between the groups . A similar number of adverse experiences were reported by the patients on amiprilose ( 67 % ) and on placebo ( 63 % ) . One patient on amiprilose developed thrombocytopenia of unknown cause ; no other reported adverse effects were serious . CONCLUSIONS Amiprilose HCl has significant anti-inflammatory activity and a favorable safety profile when used as the sole antirheumatic therapy in patients with active rheumatoid arthritis . Synthetic carbohydrates may represent an important new class of drugs for the treatment of inflammatory , autoimmune diseases .
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Intervention_Pharmacological
Amiprilose hydrochloride
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Intervention_Pharmacological
amiprilose hydrochloride ( HCl )
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
amiprilose HCl , 6 g/d
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Intervention_Pharmacological
amiprilose
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Intervention_Control
placebo
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Intervention_Pharmacological
amiprilose
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Intervention_Control
placebo
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Intervention_Pharmacological
amiprilose
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Intervention_Control
placebo
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Intervention_Pharmacological
amiprilose
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Intervention_Pharmacological
Amiprilose HCl
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Outcome_Other
safety
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Outcome_Other
efficacy
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Outcome_Physical
number of painful joints
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Outcome_Physical
swollen joints
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Outcome_Pain
joint pain
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Outcome_Physical
joint swelling indices
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Outcome_Physical
left and right grip strength
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Outcome_Physical
investigator global assessment
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Outcome_Physical
patient global assessment
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Outcome_Other
overall therapeutic response
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Outcome_Other
analgesic medication
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Outcome_Physical
morning stiffness , walking time , erythrocyte sedimentation rate
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Outcome_Physical
C-reactive protein
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Outcome_Physical
rheumatoid factor
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Outcome_Adverse-effects
adverse experiences
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Outcome_Adverse-effects
thrombocytopenia
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Outcome_Other
anti-inflammatory activity
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Outcome_Other
favorable safety profile
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Participant_Condition
rheumatoid arthritis .
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Participant_Condition
rheumatoid arthritis
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Participant_Sample-size
Two hundred and one
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Participant_Condition
rheumatoid arthritis
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Participant_Condition
active rheumatoid arthritis