AstraZeneca Plc (AZN)’s Crestor failed to beat Pfizer Inc. (PFE)’s Lipitor in reducing the amount of plaque in arteries, a key cause of heart disease, in a study reported just weeks before cheaper copies of Lipitor will be available.
The research, reported today at the American Heart Association’s annual meeting, found that Crestor, at a cost of $5 a pill, reverses heart disease at about the same rate as the product sold by New York-based Pfizer, based on its ability to keep arteries open. Lipitor, the world’s best-selling drug, loses U.S. patent protection this month, and generic rivals may sell for less than a dollar after May.
The data suggest Lipitor and its copies will increase its dominance, said Roger Blumenthal, director of preventive cardiology at Johns Hopkins University in Baltimore. The branded drug currently accounts for 54 percent of the market, according to a report by Andrew S. Berens, a Bloomberg Industries analyst in Princeton, New Jersey.
“It’s a win for Lipitor,” Blumenthal said in an interview at the Orlando, Florida, meeting. “It’s probably good for our patients and the health-care system because we won’t feel compelled to use the more expensive agent,” which lowers cholesterol levels more than Lipitor, he said.
Still, the study, dubbed Saturn and funded by London-based AstraZeneca, confirmed that Crestor remains an option for those with the highest levels of the bad cholesterol, also known as LDL, or about 10 to 15 percent of patients, said Chris Cannon, a cardiologist at Brigham and Women’s Hospital in Boston.
30 Million Americans
“For people with sky-high LDL, Crestor is the most potent thing we can offer,” Cannon said in an interview. “There will definitely be a role for that.”
AstraZeneca rose less than 1 percent to 2,905 pence in London trading. Pfizer gained less than 1 percent to $19.87 in New York.
About 30 million Americans use cholesterol-cutting drugs, according to a survey by the Agency for Healthcare Research and Quality. Crestor and Lipitor are both statins that work by blocking an enzyme the body needs to produce bad cholesterol in the liver.
Crestor generated $5.7 billion last year as AstraZeneca’s best seller, or about 17 percent of the company’s revenue. Lipitor had $10.7 billion in sales for 2010, about half of that in the U.S., figures expected to drop substantially once it loses patent protection after Nov. 30.
“We’re not going to tell doctors which drug to use,” said Steven Nissen, chief of cardiology at the Cleveland Clinic and the senior author of the paper published in the New England Journal of Medicine, in a telephone interview.
The cholesterol cutting effects “favored Crestor, and some people will choose to use that drug preferentially,” he said. “Others will say they were the same on the primary endpoint, and we’ll save money” by using generic copies of Lipitor.
The study used ultrasound imaging equipment threaded into the arteries to measure the drugs’ ability to remove plaque buildup that causes heart disease. The percent of plaque in the arteries fell by 1.22 percent in those getting Crestor, compared with 0.99 percent for those on Lipitor. A second measure found the total plaque volume fell even more for those given Crestor.
Bad cholesterol reached lower levels for those on Crestor, at 62.6 mg per deciliter, compared with 70.2 mg per deciliter for Lipitor patients. Good cholesterol, used to ferry the fatty lipids out of the body, also were higher with Crestor.
“People will look at this and say generic statins are very good for a lot of patients,” Howard Hutchinson, AstraZeneca’s medical director, said in an interview. “However, there are a lot of patients out there that despite treatment with the best generic statins that are available still aren’t able” to get the cholesterol to the target levels that reduce heart risks.
“It’s for those patients we think Crestor is the most useful,” he said.
Some patients who are sensitive to the side effects of statin drugs may also remain on Crestor, Blumenthal said. A low dose of Crestor can dramatically lower cholesterol levels, with less risk of muscle aches and other complications, he said.
Both drugs substantially reversed signs of heart disease, said Stephen Nicholls, the lead author of the paper and a cardiologist at the Cleveland Clinic. The results show that plaque can be removed from the artery walls, particularly when patients take the highest drug doses, he said. The finding that aggressive treatment was safe should ease concerns about side effects that lead some to limit how much they take, he said.
“We see a degree of regression in this study that’s beyond anything we have ever seen before, and we see it in two-thirds of patients,” Nicholls said. “The drugs were enormously well tolerated and they seem very safe.”
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