Objective: To review the chemistry, pharmacology, available clinical data, and adverse effects of the hirudin anticoagulants.
Data sources: A MEDLINE search and a review of recent scientific abstracts was conducted to identify pertinent literature.
Study selection: Focus was placed on studies conducted in humans. Because hirudin is still an investigational agent, however, relevant animal data, particularly pharmacokinetic studies and studies of preclinical efficacy, were also selected.
Data extraction: Data from both human and animal studies were evaluated; emphasis was placed on human trials.
Data synthesis: Hirudin has demonstrated potent anticoagulant effects. Although hirudin could have a significant impact on the therapeutic management of patients requiring anticoagulant therapy, only a limited number of human studies have been published to date. Trials comparing hirudin and heparin in specific patient populations are still ongoing.
Conclusions: Although still in clinical trials, hirudin is a unique agent that may represent a breakthrough in anticoagulant therapy. The specific role that this agent will play in the management of patients has yet to be determined.