Biotech Values

[DewDiligence]

From ABT’s own PR on the ACCORD study:

http://finance.yahoo.com/news/Abbott-Statement-ACCORD-Lipid-prnews-851660241.html?x=0&.v=1

The average triglyceride level of a patient that starts fenofibrate [TriCor or TriLipix] in the United States is 302 mg/dL, according to medical claims data. The median triglyceride level in ACCORD Lipid was 162 mg/dL. The subgroup of patients in this study with triglycerides at or above 204 mg/dL reflects real-world fibrate usage.

…In a pre-specified subgroup of patients with both high triglycerides (at or above 204 mg/dL) and low HDL (at or below 34 mg/dL), there was a 31 percent lower rate of cardiovascular events in the fibrate-plus-statin arm compared to the statin-only arm (p = 0.057).

In other words, the 31% risk reduction in the “real world” fenofibrate-indicated subgroup missed the typical 0.05 definition of statsig by a whisker. (Whether a p-value of 0.05-epsilon would have been deemed statsig for this subset analysis is unclear from the information at hand but, ordinarily, success on a secondary endpoint or subgroup analysis is not given any standing statistically unless the primary endpoint has been met for the ITT group.)