Sunday, September 23, 2007

Ouch! and a Clever Concept

I was reading the accounts of BioCryst's initial flu study failure with interest.

The study was a well-designed randomized, double-blind, placebo-controlled clinical trial designed to test whether peramivir, when administered intramuscularly during the acute infection, could reduce the duration of influenza symptoms.

Biocryst used elevated levels of a muscle enzyme, CPK, as a surrogate marker to show whether the patients had received intra-muscular injections, as was intended, as the levels of that enzyme rises with muscle injury. (Unfortunately, it can also rise if someone has severe fever or chills).

Analysis of the study results showed that while a single dose of peramivir did demonstrate improvement compared to placebo, the improvement was not statistically significant. On the other hand, for those patients who showed an elevation in CPK levels compared to their baseline, peramivir showed a dose-related improvement of 64.8 hours at the 300mg dose, and an improvement of 44.6 hours over placebo at the 150mg dose.

The most interesting discussion I read was "Size Does Matter" by Brian Orelli in the Motley Fool. I'm thinking that a 3" needle would be better for many of my patients...but that is another story. I'll be looking forward to seeing the results of further trials.

No comments:

Post a Comment