- The Washington Times - Tuesday, March 14, 2006

ATLANTA — High doses of a powerful cholesterol-lowering drug seemed to actually reverse heart disease — not just keep it from getting worse, new research showed.

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 yesterday.

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. The drug is under fire by the consumer group Public Citizen, which contends it has more side effects than its competitors.

The group said yesterday 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.

The study was paid for by AstraZeneca PLC, the maker of Crestor. Some reports have linked it to higher rates of serious muscle problems and kidney damage, especially among Asians, and the Food and Drug Administration last year required a warning on its label.

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 see whether people who already had heart disease, 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.

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 say 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 Dr. 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 also had no role in the research.

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