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Wednesday November 16, 12:58 AM

Mixed Results for Lipitor Vs. Zocor

High doses of the cholesterol-lowering drug Lipitor were no better at preventing major heart problems than regular doses of the competing drug Zocor, according to the latest study on efforts to aggressively treat heart conditions.

The study, funded and conducted by Lipitor's maker Pfizer Inc., was presented Tuesday at an American Heart Association meeting in Dallas. It also appears in Wednesday's Journal of the American Medical Association.

Many heart specialists recommend aggressively lowering LDL cholesterol levels, the bad kind, to help heart patients avoid future cardiovascular problems. So Pfizer tried that with a much higher dose of its statin drug, Lipitor.

Lipitor patients did appear to fare better when the researchers grouped together any cardiovascular problem including strokes and heart surgery, results that echo findings in previous research on aggressively lowering cholesterol.

When the study was planned in the 1990s, doctors didn't think stroke would be a big factor and decided to leave it out of the main result tabulation, said lead author Dr. Terje Pedersen, who presented the research at the conference.

"We burned our fingers on that," he said.

The study involved 8,888 mostly male Scandinavian patients aged 61 on average who had previous heart attacks and were given either a high dose of Lipitor or a standard dose of Merck & Co.'s Zocor.

The researchers didn't find the main difference they were looking for _ fewer "major coronary events" in the Lipitor group during an average follow-up of almost five years. That category lumped together cardiovascular deaths, nonfatal heart attacks and nonfatal cardiac arrest. These events totaled 463 in the Zocor patients and 411 in the Lipitor patients, a difference that was not statistically significant.

One caveat was that people stuck to the lower dose of Zocor more than the higher dose of Lipitor. Because no increased deaths were seen from the higher dose, several doctors predicted it would soon become a new standard of care.

"I think physicians are going to look at the totality of the evidence," Dr. Steven Nissen, a Cleveland Clinic cardiologist with no role in the study, said at the conference. "If you put it all together, you will see a drifting toward intensive treatment."

Pedersen, of Ulleval University Hospital in Oslo, Norway, consults for various statin makers. Nissen does, too, but takes no personal income from it.

Lipitor is the top-selling statin but is expected to get much competition when Zocor goes off patent next year and generic versions become available.

The results can't be considered a direct comparison because different doses of the competing drugs were used. It was meant to be a test of aggressive treatment, not a head-to-head comparison, Pedersen said.

Two Pfizer employees were among the co-authors.

Pfizer shares fell 36 cents to $21.89 in late morning trading on the New York Stock Exchange while Merck shares added 10 cents to $30.33. ___

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