THE NUMBER OF statin-taking adults looks like it is about to exceed expectations. Research supported by the Duke Clinical Research Institute and published in the New England Journal of Medicine ties the expected spike to the new clinical guidelines published by the ACC and the AHA in November.
The two heart authorities backed offfrom target cholesterol levels, recommending statin use based on factors like age and past heart history. Researchers found that this shift, particularly in terms of age, was more significant, in terms of potential statin patients, than they expected.
Their tally indicates that 12.8 million adults will now be eligible for statin therapy, the majority of patients being on the older side. The reason: more than 77% of the 60-75 age group is now considered statin-eligible, though researchers do note that the risk for heart attack rises with age.
The new guidelines also mean that around 30% of patients ages 40-59 will now be eyed for statin prescriptions. The new guidelines will also increase the likelihood that the pool of diabetes patients taking statins will grow from 4.5 million to 6.7 million.
Yet this overall increase does not mean the cholesterol blockbuster era is back. The number of protected branded statins is waning, and conversion to generics can be quick: sales of Pfizer's Lipitor plummeted 59% in 2012 after the US patent lapsed in November of 2011.
Companies can try to capitalize on brand equity, which is what Pfizer is attempting with its possible OTC Lipitor, but this market has a different scale and margin equation.
This could be an opening for PSCK9s. Right now these experimental drugs are being considered appropriate for patients who cannot tolerate statins or for those with the rare high-cholesterol disease called homozygous familial hypercholesterolemia, known as HofH.
New clinical guidelines are expected to lead to a spike in statin use