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Strategies & Market Trends : Bill Wexler's Profits of DOOM
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To: Bill Wexler who wrote (159)2/26/1998 7:03:00 PM
From: Jim Roof  Read Replies (1) of 4634
 
<<The data from the phase III trials showed no statistically significant difference between Hextend and Hespan. Hextend was dinged only in serious AEs (one more than Hespan). Did I miss anything?>>

Yes, you did. The Hespan patients had 8 serious complications that were attributed to the expander fluid and the Hextend patients had 3 serious incidents. These incidents were flagged prior to unblinding to ensure the validity of the final results. Other incidents ocurred but they were deemed as unrelated to the study fluids. It was in these non-related incidents that the Hextend group was higher than Hespan. Given that, I think it is remarkable that while the Hextend patients had more complications from their pre-operative conditions they stayed in the hospital on average one less day than those who received hespan. Also, the Hextend patients received less whole blood and less platelets. Also, the Hextend patients bled less despite the fact that they received less whole blood and platelets. Hextend patients maintained better calcium levels. Hextend patients had better post-operative cardiac function (less bradycardia).

Those are the ones that come to mind. I will grant you that the trials were not designed to show these superiorities and therefore not every item reached statistical significance but the evidence at this point says that in every regard Hextend had the edge over Hespan. I would think that if Hextend was not superior to Hespan then the non statistically significant findings would have been a mixed bag instead of supporting the superiority of Hextend by a preponderance of the evidence.

Jim
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