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By KATIE THOMAS
New guidelines governing the use of cholesterol-lowering medicines are a huge change for doctors and a vast number of patients, but the impact on the drug industry is expected to be less tumultuous.
The products that stand to gain the most from the new advice, statin drugs, are mostly sold as inexpensive generics and bring in relatively little revenue for the major pharmaceutical companies. Brand-name drugs that don’t fare as well in the guidelines, like Zetia by Merck and Vytorin, were already viewed with skepticism.
“From a Wall Street perspective, we don’t pay any attention anymore to statins,” said Mark Schoenebaum, a pharmaceutical analyst for the ISI Group. The focus instead, he said, “is on the next generation of still-unapproved drugs.”
It is those drugs — a promising new class of cholesterol-lowering drugs known as PCSK9 inhibitors — whose fate is most thrown into question by the new guidelines, released Tuesday by the two major heart associations. The recommendations place less emphasis on lowering cholesterol to a target level and do not advise using existing drugs other than statins to do so. The PCSK9 inhibitors, which are complex biological drugs that will be injected, have been shown in early trials to significantly lower cholesterol levels, but longer studies have not been completed showing that they reduce the risk of heart disease and death.
The guidelines will not determine whether the Food and Drug Administration approves these new drugs, but they could damp sales if they discourage physicians from prescribing them and insurance companies from paying for them.
Statins are among the most commonly used prescription drugs, and most are sold generically at low prices. One exception is Crestor, a statin made by the British company AstraZeneca, which brought in more than $5.1 billion in sales in 2012 with more than 25 million prescriptions, according to IMS Health, the health research firm.
But while some speculated that doctors might turn more often to Crestor, a powerful statin, because the advice suggests prescribing moderate- or high-intensity statins to patients who are seen to be at particular risk, others said any resulting sales increase was likely to be modest. Crestor is set to lose its patent protection in 2016, so its life span is limited.
Zetia lowers cholesterol in a different way than statins and has not been shown to reduce the risk of heart disease and death, so analysts have long viewed its potential as limited. Merck is awaiting the results of a long-term cardiovascular outcomes trial of Zetia, which are expected next year.
Supporters of the PCSK9 inhibitors said there was a need for new treatments. “Even the most powerful statins have not cured the disease,” said Dr. Jean-Claude Tardif, the director of the Research Centre at the Montreal Heart Institute and a primary investigator for the Pfizer PCSK9 inhibitor. “So we know there is a need for new drugs that are going to hopefully improve the fate of our patients with cardiovascular disease.”
Shares of Regeneron rose more than 4 percent Thursday after Bloomberg News reported that an F.D.A. official said that cardiovascular outcomes trials would not need to be completed before the agency would approve such drugs. An F.D.A. spokeswoman said Thursday that the agency would evaluate the drugs based on existing measures like whether they lowered cholesterol levels and blood pressure, in addition to their overall safety profile.
New Cholesterol Advice Startles Even Some Doctors
By GINA KOLATA
Steven L. Zweibel has been taking a statin drug to lower his cholesterol for seven years. It has worked, and he has suffered no problems or side effects.
But, like many patients taking these drugs, he is perplexed by new guidelines on preventing heart disease and stroke — despite the fact that he is the director of cardiac electrophysiology at Hartford Hospital.
“I am very happy to be on Zocor,” said Dr. Zweibel, 47, referring to the statin he takes. “But now the real question in my head is whether I need to be on it.”
The new guidelines, released on Tuesday by the American College of Cardiology and the American Heart Association, represent a remarkable and sudden departure from decades of advice on preventing cardiovascular disease.
According to the new advice, doctors should not put most people on cholesterol-lowering medications like statins based on cholesterol levels alone. And, despite decades of being urged to do so, patients need not monitor their cholesterol once they start taking medication. The guidelines do not even set target levels for LDL, the so-called bad cholesterol.
Doctors are also being told to stop adding other cholesterol-lowering drugs to statins, because those drugs have not been proved to reduce the risk of heart attacks and strokes.
For patients and doctors alike, all of this amounts to a surprising, and at times baffling, change in perspective.
Statins do more than just lower cholesterol, noted Dr. Valentin Fuster, director of the heart center at Mount Sinai Hospital in New York City. They also reduce inflammation and blood clotting, both of which are associated with heart attack and stroke risk. Drugs that only reduce LDL have not been shown to be effective in preventing heart attacks.
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