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Aktuelle Rheumatologie 2001; 26(2): 75-81
DOI: 10.1055/s-2001-14217
ORIGINALARBEIT
© Georg Thieme Verlag Stuttgart · New York

Klinische Studien zum selektiven Cyclooxygenase-2-Inhibitor Celecoxib

Clinical Data on the Selective Cyclooxygenase-2-Inhibitor CelecoxibU. W. Fisch1 , G. Mahr2 , H. Vergin1
  • 1 Pharmacia GmbH, Erlangen
  • 2 mcp, Erlangen
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Publication History

Publication Date:
31 December 2001 (online)

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Zusammenfassung

Die vorliegende Übersichtsarbeit fasst die wesentlichen klinischen Daten zur Wirksamkeit, Sicherheit und Verträglichkeit von Celecoxib bei der Therapie von Arthrose und rheumatoider Arthritis zusammen. Darüber hinaus werden für das Sicherheitsprofil des Arzneimittels relevante hämatologische, immunologische, hepatische, renale und kardiovaskuläre Daten präsentiert. Celecoxib erwies sich in kontrollierten klinischen Studien Plazebo als signifikant überlegen und als gleich wirksam wie Diclofenac oder Naproxen. Die Häufigkeit schwerer gastrointestinaler Nebenwirkungen (Blutung, Perforation, Magenobstruktion) unter Celecoxib war der von Plazebo vergleichbar und statistisch signifikant niedriger als unter Diclofenac, Ibuprofen und Naproxen. Celecoxib ist ein selektiver COX-2-Hemmer mit sehr günstigem Nutzen-Risiko-Verhältnis.

Clinical Data on the Selective Cyclooxygenase-2-Inhibitor Celecoxib

This review presents the essential clinical data on efficacy, safety and tolerability of celecoxib in the therapy of osteoarthritis and rheumatoid arthritis. Moreover hematologic, immunologic, hepatic, renal and cardiovascular data which are relevant for the safety profile are shown. In controlled clinical trials celecoxib was found to be significantly superior to placebo and equally efficacious as diclofenac or naproxen. On celecoxib therapy the frequency of severe gastrointestinal adverse events (bleeding, perforation, gastric outlet obstruction) was comparable to placebo and significantly lower than on diclofenac, ibuprofen and naproxen. The presented data prove celecoxib to be a selective COX-2 inhibitor with a very favourable benefit-risk-ratio.

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Dr. med. U. W. Fisch

Pharmacia GmbH

Am Wolfsmantel 46
91058 Erlangen