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See detailPlasma Concentration of Estradiol Following Transdermal Administration of Systen 50 or Menorest 50
Reginster, Jean-Yves ULg; Albert, Adelin ULg; Deroisy, Rita ULg et al

in Scandinavian Journal of Rheumatology. Supplement (1996), 103

Circulating levels of 17 beta estradiol (E2) following the administration of fixed doses of E2, show a great variability in kinetics depending upon the product administrated, the routes of administration ... [more ▼]

Circulating levels of 17 beta estradiol (E2) following the administration of fixed doses of E2, show a great variability in kinetics depending upon the product administrated, the routes of administration, and the interindividual variations in absorption and metabolism. This might have important implications both in terms of tolerance and effectiveness. Two new forms of transdermal E2 (SYSTEN Cilag and MENOREST Rhone-Poulenc Rorer) have been recently accepted in Europe for the treatment of climacteric symptoms. The present study was undertaken to compare the pharmacokinetic characteristics of plasma E2 profile under these two drugs. It was carried out in 30 healthy postmenopausal volunteers according to good clinical practice after informed consent, as a single blind, randomised, cross-over study during the classical wearing period of 4 days. Plasma E2 concentration was determined 24 hours before, 1/2 hour before and then 2, 4, 8, 12, 24, 48, 72, 84, 96 hours after the first patch administration. E2 measurement was performed using a specific direct radioimmunoassay developed in the FRH laboratories. The main criteria for this method were an intraassay coefficient of variation (CV) less than 6%, an interassay CV less than 8% in a concentration range of 15-140 pg/ml and a quantitative detection limit (LOQ) of 2.7 pg/ml with a 20% CV. The following kinetic parameters were analysed: C(max), C(mean), C96 and MRT. The bioequivalence was assessed by analysis of variance of C(max), C(mean), C96 and AuC after logarithmic transformation, complemented by Westlake test (95%). Data show that these two products are identical in terms of C(max) but C(mean), C96 and AuC are statistically greater when MENOREST 50(R) is administered; furthermore, E2 levels decrease more rapidly and more deeply with SYSTEN 50 than MENOREST 50. The differences of pharmacokinetic profiles after administration of two different forms of the same dose of 50 micrograms transdermal 17 beta estradiol might have important medical consequences. [less ▲]

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See detailMethods of clinical and biological assessment of rheumatoid arthritis
Malaise, Michel ULg; Franchimont, P.

in Scandinavian Journal of Rheumatology. Supplement (1987), 65

Inflammation has long been recognised as notoriously difficult to measure both in clinical practice and in the laboratory. Of all the cardinal features of inflammation, pain relief is really what the ... [more ▼]

Inflammation has long been recognised as notoriously difficult to measure both in clinical practice and in the laboratory. Of all the cardinal features of inflammation, pain relief is really what the patients want, and among disabled persons, rheumatic patients are the only ones who must cope with chronic pain. The rheumatologist, however, is also interested in other parameters that are thought to reflect improvement of the inflammatory process. The methods used to clinically assess rheumatoid arthritis (RA) should share the following four parameters: validity, sensitivity, reliability and simplicity. Unfortunately, at present, no single ideal method is capable of accurately reflecting disease activity in RA. The measurement of pain relief by the visual analogue scale, the determination of the Ritchie index and the duration of morning stiffness, plus patient assessment of global response should be enough to detect clinical activity of the drug in RA. If we are working with slow-acting drugs or so-called disease modifying antirheumatic drugs (DMARDs), it should be appropriate to include X-ray analysis and laboratory tests in the evaluation. A reduction in the number of fresh erosions and/or the healing of present erosions can give reliable information on the capacity of the drug to really modify the course of the disease. At present, measurement of the erythrocyte sedimentation rate and of acute phase serum proteins seems to offer the best available assessment during early weeks of therapy. The other biological tests are of limited value in reflecting or predicting a beneficial clinical response to DMARDs. [less ▲]

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