Clinical pharmacology and drug safety: Lessons from hirudin*

✍ Scribed by Conrad, Kenneth A.

• Book ID: 103037293
• Publisher: Nature Publishing Group
• Year: 1995
• Tongue: English
• Weight: 392 KB
• Volume: 58
• Category: Article
• ISSN: 0009-9236
• DOI: 10.1016/0009-9236(95)90187-6

✦ Synopsis

The challenge of developing safe and effective drugs has been exemplified recently by reports of phase III studies that have failed to show drug efficacy or have shown excess adverse events. These reports have caused concern in the biomedical and investment communities regarding the ability of the industry to develop novel compounds in an expeditious, but safe, way. This article will discuss the unfortunate outcome of excess bleeding seen in large-scale clinical trials of hirudin in patients undergoing thrombolysis after acute myocardial infarction or in patients with an acute coronary syndrome. l-3 Hirudin is a direct-acting antithrombin that forms an irreversible complex with thrombin. It produces diverse biological effects, including platelet inhibition and anticoagulant effects, as a result of its displacement of factor Xa from endothe-From Gensia, Inc. The opinions expressed in this commentary are those of the author alone and do not necessarily reflect the opinions of Gensia management or staff.