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(Circulation. 2005;112:1073-1079.)
© 2005 American Heart Association, Inc.

New Drugs and Technologies

Selective Cyclooxygenase-2 Inhibitors Development in Cardiovascular Medicine

Domenico Praticò, MD; Jean-Michel Dogné, PhD

From the Department of Pharmacology, University of Pennsylvania, School of Medicine, Philadelphia (D.P.), and Cardiovascular Research Center, University of Liège, Liège, Belgium (J.-M.D.).

Correspondence to Domenico Praticò, MD, University of Pennsylvania, Department of Pharmacology, 3620 Hamilton Walk, Room 124, John Morgan Building. E-mail domenico@spirit.gcrc.upenn.edu

Key Words: drugs • cyclooxygenase inhibitors • trials • cardiovascular diseases

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
At the end of September 2004, Merck & Co announced the voluntary withdrawal of rofecoxib (Vioxx) worldwide because of an increased risk of cardiovascular events. Since its approval in 1999, Vioxx, a selective cyclooxygenase-2 (COX-2) inhibitor, has been Merck & Co’s leading drug for control of acute pain and chronic pain associated with osteoarthritis, rheumatoid arthritis, and menstruation. Last year, worldwide sales of rofecoxib reached US $2.5 billion, and it is estimated that the drug was prescribed 10 million times per month in the United States.¹ Thus, given the number of patients involved and the serious nature of the side effects, the withdrawal raised serious concerns about the safety of other selective COX-2 inhibitors, collectively called coxibs, that are on the market and those currently under development. Celecoxib (Celebrex) and rofecoxib were the first 2 coxibs approved by the US Food and Drug Administration (FDA) and launched in 1999 by Pfizer and Merck & Co, respectively. Since then, a second generation of these drugs has emerged onto the market. Valdecoxib (Bextra) was approved by the FDA and launched in 2002. In that same year, the European regulatory authority approved 2 other coxibs: etoricoxib (Arcoxia) and parecoxib sodium (Dynastat), the prodrug of valdecoxib. Today, etoricoxib and a fifth coxib, lumiracoxib (Prexige), are under consideration for FDA approval. In view of the rapid development in this area, the main concern is whether the reported cardiovascular effects of rofecoxib are a class effect applicable to all coxibs that were initially designed to reduce . . . [Full Text of this Article]

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