Hirudin clinical trials

Direct thrombin inhibitors such as hirudin, Hirulog, the peptide aldehyde efegatran, and peptidomimetic compound argatroban have undergone clinical trials. Their application in the prevention and treatment of deep vein thrombosis contin-... 

Table 4 Clinical trials of hirudin in acute myocardial infarction with thrombolytics ...

Recently, several reports comparing the effects of heparin and hirudin on various parameters have become available. A study comparing heparin and recombinant hirudin for the prophylaxis of deep venous thrombosis (DVT) provided impressive data in favor of hirudin. In a second study, LMWHs also were compared with hirudin for postsurgical prophylaxis of DVT the results favored hirudin. Both studies emphasize an important point about the validity of well-designed clinical trials, It is important to understand that the efficacy and safety of a new drug may not be determined by trials for a single indication, Therefore, clinical trials are needed for various specific indications. 

In the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)-llb trial, the effects of UFH and hirudin in combination with either t-PA or SK were compared in 3289 patients with AMI (53), When dosed in combination with SK, the benefit of hirudin over UFH was observed in the clinical efficacy endpoint with the same levels of bleeding complications, In the TIMI 9b trial, 3002 patients with AMI were dosed with hirudin or UFH in combination with t-PA or SK, but no difference between the groups was observed in the clinical efficacy endpoint up to 30 days after administration (54). The administration of UFH or hirudin was not initiated... 

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