Study: Crestor Reversed Heart Disease

It's done what no drug has done before.

New research indicates that the powerful statin Crestor not only drastically lowered cholesterol levels by more than 50 percent, it actually reversed heart disease.

Cleveland Clinic cardiologist Steven Nissen led the study, which was funded by the drug's maker, Astra Zeneca.

Nissen gave more than 500 patients with blocked arteries high doses of Crestor: 40 milligrams instead of the usual 10 milligrams. Using tiny ultrasound probes, Nissen and his colleagues were able to measure the amount of plaque present in artery walls before and after the Crestor treatment.

After two years on the drug, patients showed a seven to nine percent reduction in the amount of plaque present in the arteries.

That may seem like a small amount, but since plaque buildup begins early in life, cardiologists say it is like turning back the clock:

"We were taking away many years of accumulation," says Nissen. "It's the plaque that leads to heart attacks and strokes... so if you get rid of the plaque, you get rid of the source of all those problems that patients with the disease have."

Joel Silvey was in the study. His father died of a heart attack at age 65, so he was delighted when his doctor told him the Crestor worked.

"To know that you can go two years without any additional accumulation is very good news," says Silvey.

But Crestor also comes with a dose of controversy. Because it is the most powerful statin on the market, reports CBS News medical correspondent Elizabeth Kaledin, it also has the highest rate of side effects - including muscle, liver and kidney damage. There's concern that high doses of this drug could cause more problems over the longterm. No one in this study experienced any negative side effects.

People in the study got their "bad cholesterol" to the lowest levels ever achieved and saw blockages in their blood vessels shrink as a result. It's too soon to tell whether the shrinkage of artery deposits will mean fewer heart attacks, but doctors were excited by the possibility.

"The holy grail has always been to try to reverse the disease," and this shows a way, said Dr. Steven Nissen, the Cleveland Clinic cardiologist who led the nationwide experiment and reported results at a meeting of heart doctors Monday.

"This is a paper to take seriously. It's another chapter in the story, a proof of principle," said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute.

Two-thirds of the 349 study participants had regression of heart artery buildups when they took the maximum dose of Crestor, the strongest of the cholesterol-lowering statin drugs on the market and one under fire by the consumer group Public Citizen, which contends it has more side effects than its competitors.

The group said Monday that the study "does not alter our assessment that Crestor has unique risks without evidence of unique benefits" and should not be prescribed, especially at the doses used in this study unless lower doses and other drugs failed to help.

No big safety issues emerged in the new study, but doctors said it was too small to detect rare side effects and was not designed for that purpose.

The aim was to find out whether people who already had heart disease, and not just high cholesterol, could turn back the clock.

Clots in arteries are the main cause of heart attacks. Big ones are treated with angioplasty to flatten them or surgery to bypass them, but doctors have long sought a less drastic solution that also treats small buildups that can slowly worsen until they squeeze a vessel shut.

Statins such as Lipitor, Zocor and Pravachol have become the world's top-selling drugs by dramatically lowering LDL or "bad cholesterol," a culprit in clot formation.

In the study, Crestor not only dropped average LDL levels from 130 milligrams per deciliter of blood at the start to around 60, but also raised HDL or "good cholesterol" from 43 to 49.

Doctors think this dual effect may be what caused blockages to shrink, as documented by ultrasound measurements before and two years after treatment.

The volume of each patient's main blockage decreased a modest 1 percent. The amount of buildup in the most clogged artery decreased 9 percent, and in the entire length of the vessel, 7 percent, on average.

"The results are very, very exciting and break new ground," said Dr. David Williams of Rhode Island Cardiology Center, who had no role in the study.

It would have been better if it had tested Crestor against a lower dose of another statin, Dr. Roger Blumenthal of Johns Hopkins University wrote in an editorial in the Journal of the American Medical Association. The journal will publish the study in its April 5 issue.

The maximum dose for Crestor is 40 milligrams a day; it is 80 milligrams for the other, less powerful statins. Insurers already are restricting use of specific brands, something likely to escalate in the next few months as Pravachol and Zocor lose patent protection and cheaper generics become available.

The study also renews debate about how low LDL should go. Federal guidelines recommend aiming for 70 in people at high risk of heart disease, but Nissen said the benefits seen when it is pushed to 60 suggest that "as low as we can go might make more sense."

"The body needs about 40 LDL, so we're getting pretty close to what the body needs for general repair," said Dr. Christopher O'Connor, a Duke University cardiologist who had no role in the research.

Also at the conference: