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[ The Atlanta Journal-Constitution: 11/14/03 ]

Cholesterol study's lesson: Aim lower
Drug debate continues and targets may get a new look

By VIRGINIA ANDERSON
The Atlanta Journal-Constitution

The standard for what is a healthy cholesterol level may need to be lower than the current suggestion of 100, and patients trying to get their cholesterol down may need stronger drugs.

Those were the assessments Thursday by metro Atlanta cardiologists in response to a study released Wednesday that pitted one cholesterol-lowering drug, Lipitor, against another, Pravachol.

The study, funded by the maker of Lipitor, is the first to compare different cholesterol-lowering drugs, called statins, in one study.

Drug companies are competing for the $25 billion market for statins.

The results showed that atherosclerosis, or hardening of the arteries, actually worsened in those taking Pravachol. But atherosclerosis was stopped in those who took Lipitor.

Simple as those results may seem on the surface, they do not mean that patients taking Pravachol should stop taking it, doctors said Thursday. It also does not mean they should start taking Lipitor.

It does mean they should talk to their doctors about the appropriate drug.

"I don't think we can necessarily say that people should not take Pravachol," said Dr. Laurence Sperling, director of preventive cardiology at Emory University. "It was not a fair comparison. Lipitor is a much stronger drug, and they gave it in much stronger doses."

Lipitor, or atorvastatin, and Pravachol, or pravastatin, are used to lower cholesterol, which contributes to heart disease.

Pravachol, manufactured by Bristol-Myers Squibb, is often given to patients who may not be able to tolerate Lipitor, Zocor or other, stronger statins, doctors said. Said company spokeswoman Bonnie Jacobs: "While the results are informative, additional clinical studies need to be conducted."

Cleveland Clinic cardiologist Steven Nissen's study looked at 502 patients over 18 months. At the outset, the patients had low density lipoprotein, or bad cholesterol, levels of about 150.

Half of the patients took 40 milligrams of Pravachol, the weaker drug, and the others took 80 mg of Lipitor. The bad cholesterol of those who took Pravachol averaged 110 at the study's end. It averaged 79 for those who took Lipitor.

"I don't doubt for a minute that Lipitor at 80 milligrams blew the doors off," said Dr. Winston H. Gandy Jr., consulting board member of the metro Atlanta Heart Association. "But they didn't compare apples to apples. Anybody who knows these drugs knows that Lipitor is the most potent."

Nissen said he knew that he was comparing Pravachol to "the gorilla drug." He said the most important finding of the study may be that plaque, which causes hardening of the arteries, did not progress in those whose cholesterol was lowered to 79. It did increase in those whose cholesterol hit 110.

That finding suggests that physicians may need to lower their target cholesterol level for those battling heart disease or at risk for it.

"It's a message that maybe our targets are not low enough," Nissen said.

He also concludes that drug selection matters, and that a stronger drug like Lipitor might be the best drug to use.

While Nissen's study seems to clearly favor Lipitor, he said he cannot advise that patients stop taking Pravachol.

"I served them up the data, and we will put the data out there and let practitioners decide."

Some people have side effects with the stronger statins like Lipitor and Zocor, the doctors said. Also, some drugs work better on some people than on others. Gandy said patients should discuss with their doctor the best drugs to take.

"As long as they are treated to goal, it doesn't matter," he said.

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