New heart-disease guidelines could mean 12.8M new statin patients, NEJM study finds

New statin-use guidelines divided cardiologists when they were rolled out in November, because they would put millions more patients in line for drugs like AstraZeneca's ($AZN) Crestor and Pfizer's ($PFE) off-patent Lipitor. Now, new research estimating their impact puts the number of eligible statin patients even higher than some originally thought.

The new prescribing rules, issued by the American Heart Association and the American College of Cardiology, could make 56 million people--nearly half the U.S. population between the ages of 40 and 75--eligible to take the cholesterol-lowering drugs, according to a New England Journal of Medicine study. That could hike the total number of patients taking statins by 12.8 million.

The new recommendations reject the numbers-centric approach to statin use. Previously, the guidelines advised doctors to prescribe statins--and tailor their dosage--based on levels of "bad" LDL cholesterol. The goal was to lower those levels to a certain magic number. The new rules use a risk-based analysis to determine whether a patient should take statins. Docs should consider other variables, including age, family history, smoking history and the like, to determine which higher-risk patients need statins to fend off heart disease, the guidelines say.

It's a big opportunity for statinmakers like AstraZeneca, which is keen to boost Crestor sales before the drug loses patent protection in 2016. Doctors see the $5 billion drug as a potent solution for the hardest-to-treat patients, and the guidelines identify a new high-risk class that could benefit from it.

On the flip side, the statin-user pool could siphon off patients who take other types of cholesterol-lowering meds, like Merck's ($MRK) Vytorin and Zetia and AbbVie's ($ABBV) TriCor and Trilipix. Those drugs, used as statin add-ons, help force down LDL levels. Without an LDL threshold to shoot for, there's little case for adding them to statin treatment.

And while a patient group 56 million strong tops a November estimate reported by Bloomberg of 33 million, it may still undershoot the forthcoming spike in statin use. As Reuters notes, Coral Gables, FL-based cardiologist Dr. Jorge Bordenave, for one, has figured the rule change could add 31 million new statin users, rather than the New England Journal's 12.8 million figure.

"There were a lot of opinions various experts expressed," Michael Pencina, a biostatistician at Duke University's Clinical Research Institute and the leader of the NEJM study, told the news service. "Some quoted really high numbers."

But not everyone is in favor of bumping up statin use, and some, like outspoken Cleveland Clinic cardiologist Steven Nissen, say doctors need more time and clarity to understand the new rules' impact before putting them into play. "People are voting with their feet. We're not using the guidelines," he told Reuters.

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