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Cholesterol studies highlight heart conference

TRENTON, N.J. — A huge study of AstraZeneca PLC's blockbuster cholesterol drug Crestor is the main attraction for investors at this year's American Heart Association conference in New Orleans.
/ Source: The Associated Press

TRENTON, N.J. — A huge study of AstraZeneca PLC's blockbuster cholesterol drug Crestor is the main attraction for investors at this year's American Heart Association conference in New Orleans.

Crestor currently has about $3.5 billion in annual sales — an impressive performance that's still dwarfed by the nearly $13 billion in revenue Pfizer Inc. gets from its Lipitor, which loses patent protection in a few years. But even in the top-selling drug category in the United States, competitors are constantly jockeying for an advantage they can promote to boost their sales over those of rivals.

One reason for interest in the 18,000-patient study, called JUPITER, is that it was halted several months early because a clear benefit was shown. The study compared the 20-milligram, or second-lowest, dose of Crestor with a placebo in men and women 55 and older who had relatively good cholesterol levels and no heart disease or other serious health problems — a generally untapped market for cholesterol pill makers. The patients did have elevated levels of a substance called C-reactive protein that's linked to inflammation of blood vessels, but doctors now are starting to think it's more a sign of trouble than a cause of heart disease.

Dr. Howard Weintraub, head of the NYU Langone Center for Prevention of Cardiovascular Disease, said the results are particularly important because this is the first Crestor study looking at whether the medicine prevents heart attacks and strokes, rather than just controlling cholesterol.

Positive results could help overcome bad press Crestor has gotten because at high doses it has been linked to a dangerous, muscle-weakening condition called rhabdomyolysis.

The official results don't come out until Sunday, when they are being published online by the New England Journal of Medicine, followed by an afternoon presentation at the conference in New Orleans, which runs Saturday through Wednesday.

Analyst Steve Brozak of WBB Securities said analysts have "very, very high expectations" for the study and that if the results are good, they will enable AstraZeneca to further ramp up sales and promotion of Crestor.

Edward Jones analyst Linda Bannister said JUPITER is the "most anticipated study" at the conference and that positive results could increase the number of patients put on statins, the class of cholesterol drugs that includes Crestor, Lipitor and Zocor.

"Crestor has the most to potentially gain coming out of AHA this year," Bannister wrote in an e-mail interview.

Other study presentations drawing strong interest include:

_ A seven-year study that included more than 12,000 patients who had had a heart attack, compared how well 80-milligram and 20-milligram doses of Merck & Co.'s now-generic Zocor prevented heart attacks and strokes.

Zocor is a component of Vytorin, a combination cholesterol drug jointly sold by Merck and partner Schering-Plough Corp. Vytorin sales have taken a beating this year due to evidence the pricey drug is no better at preventing plaque buildup or aorta damage than much-cheaper generic Zocor, plus a possible link to cancer still being investigated.

However, Bannister thinks that if there are safety problems with the 80-milligram Zocor dose, "it could give high-potency brands such as Vytorin" a boost.

No new data specifically on Vytorin is to be presented, but a panel of experts is to discuss it at a session Tuesday. "If the panel takes a negative tone, it could potentially further impacts sales of the drug," according to Bannister.

_Abbott Laboratories Inc. is presenting a final-stage, year-long study Tuesday on its experimental cholesterol drug Trilipix, which is designed to be used in combination with a statin to control all three kinds of lipids, or fats in the blood: good cholesterol, bad cholesterol and triglycerides.

_France's Sanofi-Aventis SA, which co-markets the blockbuster blood thinner Plavix with Bristol-Myers Squibb Co., is presenting a study Tuesday looking at how effective and safe Plavix is in patients who have acute coronary syndrome and are at high risk of bleeding, a difficult-to-treat combination.

_Britain's GlaxoSmithKline PLC on Wednesday presents an 18-month study comparing its diabetes drug Avandia, under fire recently for links to heart and liver damage, with the older diabetes drug glipizide or Amaryl, in controlling progression of hardening of the arteries in patients with both type 2 diabetes and heart disease, an increasingly common combination in overweight people.

Besides drug and device studies, doctors particularly are looking forward to numerous studies on efforts in various countries to prevent cardiovascular disease, rather than wait until expensive drugs or even-more expensive surgical procedures are needed to save patients, said Dr. Valentin Fuster, past president of the heart association and director of the Mount Sinai Heart Center in New York.

"This is very important," said Fuster. "We can have fantastic drugs to treat blood pressure," but nearly half of Americans with high blood pressure don't know it and half of stroke patients had unknown or untreated high blood pressure.

"What we should do is to promote health," given the obesity epidemic causing so many heart problems, he said.