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Biomedical subjects

J Varady

Publications and source records attributed to J Varady.

10 recordsLinked to original sources

The use of a 51Cr technique to detect gastrointestinal microbleeding associated with nonsteroidal antiinflammatory drugs.

Of techniques used to evaluate gastrointestinal (GI) bleeding, use of radiochromium (51Cr)-tagged erythrocytes is the most quantitative and scientifically acceptable method. The value of this technique as well as systematic errors possible with its use are discussed. The medical literature concerning 51Cr evaluation of GI microbleeding with naproxen therapy is critically reviewed. We suggest that future studies using this technique be parallel, randomized, double-blind, and include a 1-week placebo baseline phase for all subjects. Treatment with nonsteroidal antiinflammatory drugs (NSAIDs) should last 3 to 4 weeks. A parallel group of subjects should receive placebo throughout the study. For valid statistical analyses, randomization must achieve baseline comparability of weight, height, age, and sex in the treatment groups. Data transformations may be necessary to satisfy the assumptions of the statistical model. Following these guidelines will enable investigators to better evaluate GI microbleeding during treatment with naproxen or other NSAIDs, and, hopefully, to establish the safety profiles of these drugs.

Anti-Inflammatory Agents, Non-Steroidal

Drug trial in rheumatoid arthritis: a new design.

The comparative efficacy and safety of naproxen and ibuprofen were studied in 64 patients with rheumatoid arthritis. A new trial design with three aspirin periods interspersed during the study was used. By passing a smooth curve through the values obtained for the various measures of disease activity during the aspirin periods, one could calculate the difference between what would have been expected on aspirin therapy and what was found during therapy with the two trial drugs. These differences, or "incremental values," allowed each patient's variations to be analyzed individually, thus eliminating the necessity of assuming that a patient's disease was constant. Napoxen and ibuprofen were comparable in efficacy to each other and to aspirin, but both drugs caused significantly less severe side effects than aspirin. Although analysis of the incremental values showed essentially the same results as a standard analysis of the raw data with only a modest increase in sensitivity in this particular study, the novel trial design may prove useful in future drug studies in patients with rheumatoid arthritis and other chronic but fluctuating diseases.

Adult

Gastrointestinal microbleeding after aspirin and naproxen.

Gastrointestinal bleeding is the most serious side effect encountered with the anti-inflammatory antirheumatic drugs. Using the 51Cr labeling technique, the comparative quantity of blood loss with aspirin or naproxen has been previously done on normal volunteers. With the present study, 12 rheumatoid arthritic patients were controlled in a double-blind crossover study with the same radioactive technique. There is a difference in favor of naproxen. The difference between the baseline period and naproxen administration was not statistically significant.

Adult

Effect of naproxen on gastrointestinal microbleeding following acetylsalicylate medication.

This study was undertaken to determine if substitution of naproxen for ASA does influence salicylate-induced gastrointestinal bleeding. Twelve normal volunteers were selected and given increasing doses of salicylate until guaiac tests were consistently positive. Autologous labeling of their red blood cells with 51-Cr was used to quantitate the microbleeding. After two weeks on ASA, six subjects were double blindly switched to naproxen and six to placebo for another two weeks of observation. Two-way analysis of variance on the raw data shows a significant treatment effect associated with a significant interaction in both groups. Final analysis on a logarithmic scale permits orthogonal contrasts to be accurately made without any significant remaining interaction. It is concluded that substitution of naproxen for ASA at a dose of 500 mg daily is accompanied by a rapid reduction of microbleeding to "normal" levels.

Analysis of Variance