PFE
>The company said overall phase III data show patients taking the combination pill had an average gain in systolic blood pressure of roughly one millimeter above the two-to-three-millimeter increase found in phase II studies.<
According to data from the Prospective Studies Collaboration, each 20 mm Hg increase in SBP is associated with a 2-fold increase in the risk for death from ischemic heart disease and a slightly greater than 2-fold increase in the risk of death from stroke. The change in risk for these events across SBPs ranging from 115 to 180 mm Hg is strikingly linear, so a 2-mm increase in SBP would be expected to increase the risk for death from ischemic heart disease and death from stroke by about 10%.
Now, a 27% incremental reduction in LDL-C starting from, say, 100 mg/dL with Lipitor 10 mg alone would yield an LDL-C of 73 mg/dL. If epidemiologic evidence is to be trusted, each 10 mg/dL incremental decrease in LDL-C yields about a 10% reduction in the 10-year risk for CHD events in primary prevention patients (note: this is CHD events, not death from ischemic heart disease, and CHD events doesn't include stroke). This would yield a 27% reduction in 10-year risk for CHD events.
So as a very conservative guess, I'd say that the risk:benefit is either a wash or weighted toward the combination pill. And that's completely discounting the effect of raising HDL-C by 56%, which is likely to tip the balance strongly in favor of the combination pill. It also discounts the effect of Lipitor on triglycerides.
I can pretty much guarantee that this is the kind of logic Pfizer will use to defend the utility of the combination pill, although my math might be off. I still use my fingers to count.
My strategy for the combo pill would be to get it approved first for patients with diabetic dyslipidemia. These patients generally have very depressed HDL-C levels and are at very high risk for events.
AI
