Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0033774 (pruritus)
 14,546 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

In a 48-week, double-blind trial, 122 patients were randomly assigned to treatment with auranofin (60) and gold sodium thiomalate (GST) (62) at five centers. Both groups showed significant improvement (P less than 0.05) from baseline in parameters of disease activity. Results of the covariance analysis for all patients who completed the trial showed no significant differences (P less than 0.05) in efficacy between the two groups. The proportions of patients showing 50% or greater improvement in tender joints, swollen joints, activity index, severity of pain, general health rating, and erythrocyte sedimentation rate (ESR) were similar for both auranofin-treated and GST-treated patients who completed the 48-week trial. When all patients who entered the trial were evaluated, a slightly greater proportion of patients on auranofin had improved. Diarrhea occurred more frequently with auranofin (32%) compared to GST (19%), whereas rash and pruritus were twice as common in those patients treated with GST compared to those treated with auranofin. The withdrawal rate due to adverse reactions was 10% for auranofin vs 26% for GST. It was concluded that the efficacy of auranofin was comparable to that of injectable gold and was better tolerated, as evidenced by the lower withdrawal rate from adverse events for the auranofin patients.
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PMID:Auranofin and gold sodium thiomalate in the treatment of rheumatoid arthritis: a one-year, double-blind, comparative multicenter study. 313 71

Data about adverse events can be particularly useful when assessing newly marketed drugs. However, spontaneous reporting of adverse events does not generally provide sufficient or highly accurate data on incidence and prevalence. In order to provide the most complete and accurate data, a postmarketing surveillance program (PMSP) for auranofin (AF) oral gold therapy for rheumatoid arthritis (RA) was conducted in the Federal Republic of Germany (FRG) from December 1982 through December 1985. The objectives of the program were to observe a large population treated with AF for more than a year; to compare the safety profile of AF with experience from clinical trials; and to register rare or previously unknown adverse events. The program included 2,777 patients with RA from 928 test centers. Disease duration was less than 2 years in 29%. 2-5 in 23.2%, 5-10 in 32.5%, and more than 10 in 13.3% (no data for 2%); disease was mild or moderate in 67.4% and severe in 29.9% (no data for 2.7%). Auranofin was given 6 mg/day as either two 3-mg tablets at breakfast or 1 tablet at breakfast and 1 at the evening meal. Laboratory studies and efficacy, as indicated by increase in grip strength and decrease in number of tender and swollen joints, were monitored regularly. A total of 1,595 patients completed 1 year of treatment with AF. Withdrawals included 12.9% for adverse events, 4.2% for insufficient therapeutic effect, and 33.1% for a variety of administrative or technical reasons. The most common adverse event was alteration in stool pattern, which occurred in 22.5% of patients, compared with 46.6% in worldwide AF clinical trials. Other gastrointestinal symptoms occurred in 17.4%, compared with 22.4% worldwide. The occurrence of most adverse events in the PMSP was much less than in worldwide studies, for example: skin rash 7.3% vs. 24.2% worldwide, pruritus 4.2% vs. 16.6%, proteinuria 1.0% vs. 5.0%, and leukopenia 0.7% vs. 1.9%. These discrepancies may be explained by the method of monitoring employed in the postmarketing study, which favored the reporting of only clinically relevant adverse events. The pattern of occurrence of adverse events was similar to that seen during other AF trials, indicating that any intolerance to AF occurs primarily within the first 6 months of treatment. However, hematologic or nephrologic adverse events appear to be independent of time on therapy, with a constant monthly prevalence of about 0.1-0.2%.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:Postmarketing experience with auranofin in the Federal Republic of Germany. 329 83

A partially purified extract of an ant venom from the South American tree ant Pseudomyrmex sp. was tested in a double-blind, controlled study of patients with rheumatoid arthritis. Venom treated patients demonstrated an improvement in global efficacy and a decrease in the number of tender/painful joints and swollen joints. Swollen joint index improved in 60% of venom treated patients. Other parameters did not demonstrate significant change. Reduction of joint swelling was followed by symptomatic improvement that was sometimes delayed by weeks. Reactions were limited to erythema at the injection site (all patients), local pruritus (two-thirds of the patients), and fever with malaise (one-third of the patients). Further study of this venom in rheumatoid arthritis appears warranted in view of its apparent favorable efficacy-to-toxicity ratio.
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PMID:The effects of a partially purified fraction of an ant venom in rheumatoid arthritis. 636 51

A multicenter double-blind comparative study with auranofin (Ridaura) and Na-auro-thiomalate (Tauredon) was carried out in order to investigate under controlled conditions whether the new oral gold compound may be an alternative to injections of gold salts. 121 patients were included in the study, data of 86 patients treated for at least one year could be analysed. The following parameters were examined at regular intervals: number of painful and swollen joints, grip strength, morning stiffness, pain and general health on the visual analogue scale, ESR; from these data the articular index and activity index (according to Lansbury, with slight modifications) were calculated. Blood samples for routine safety monitoring and serum gold levels as well as urine tests were obtained regularly. Both treatment groups showed similar improvement in the values for efficacy measurements after one year, starting within 8 to 12 weeks. Patients in the auranofin group with a disease duration of less than 2 years showed greater improvement in the values for efficacy assessment with the exception of grip strength and the number of tender joints than patients with a disease duration of 2 years or more. No such trend was seen in the Tauredon-subgroups. Numerous side effects were recorded in both groups: 89.7% of the patients on Tauredon and 68.8% of the patients on auranofin had observed one symptom during the course of one year. There was a clear distinction concerning the nature of side effects: mucocutaneous symptoms, especially rash and pruritus, were approximately twice as common with Tauredon, whereas diarrhoea was much more frequent in patients treated with auranofin.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:[Multicenter double-blind comparison of auranofin and Tauredon]. 644 55

Sixty patients with active RA were evaluated over 6 months in a double-blind randomized dose range multicentre study comparing the efficacy and tolerance of three different doses of the slow-acting anti-rheumatic bacterial extract OM-8980 (6, 24 and 48 mg of active principle). No patients were withdrawn during the study. At the end of the 6-month trial, significant improvements were observed for the different RA signs and symptoms (Ritchie index, morning stiffness, swollen joints, grip strength, ESR, pain scale and categories) as well as for the concomitant intake of symptomatic drugs in the 24-mg dose group with respect to the 6-mg group and without significant differences between the 24- and 48-mg groups. Tolerance was very good with nine minor and transient side effects (five itching and four diarrhoea) reported altogether by seven patients, without establishment of a dose-effect correlation. In conclusion, the two higher doses of OM-8980, 24 and 48 mg, were significantly more efficient than 6 mg, with the effect of the 24-mg dose being even slightly superior to the 48-mg dose, confirming the former as the optimal and well-tolerated dose for the treatment of RA.
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PMID:A 6-month randomized dose range study of OM-8980 in rheumatoid arthritis. 834 80