November 15, 2005
Lipitor Fails to Beat Zocor in Heart Study
By Bill Berkrot and Randell Pierson
DALLAS -- High doses of Pfizer Inc.'s cholesterol-lowering drug Lipitor failed in a high-stakes trial to help heart attack patients significantly more than moderate doses of Merck & Co.'s rival Zocor, researchers said on Tuesday.The aim of the study presented at the American Heart Association scientific meeting was to determine whether intensive lowering of "bad" LDL cholesterol with atorvastatin (Lipitor) would reduce the risk of death and other adverse events in heart attack patients more than the moderate, most widely used dose of Zocor, known by the chemical name simvastatin.
Instances of death, acute heart attack or cardiac arrest requiring resuscitation occurred in 10.4 percent of the Zocor group and 9.3 percent of the high-dose group, differences not considered statistically significant, researchers said.
The 80 milligram Lipitor group, however, did show a highly statistically significant reduction in nonfatal heart attacks and strokes compared to patients taking 20 mg to 40 mg of Zocor, the report added.
Non-fatal heart attacks were reduced by 17 percent in the Lipitor group.
There was no significant difference in death by causes not related to heart or vascular problems between the two groups, the Pfizer-funded study concluded.
"This finding may help calm concerns that high-dose statins contribute to excess non-cardiac deaths, such as from cancer, but benefits apparent in this trial were more modest than we had expected," said Dr. Terje Pedersen, the study's lead author.
Lipitor is the world's biggest-selling prescription medicine with sales approaching of $12 billion annually.
A decisive victory for Lipitor might have been a persuasive argument for keeping doctors and insurance companies from attempting to switch patients from Lipitor to cheaper generic versions of Zocor after Merck's blockbuster cholesterol drug goes off patent next year.
Pfizer shares were down 40 cents, or 1.8 percent, to $21.85 on the New York Stock Exchange.
Pedersen did say that if researchers had continued the study for another three months, Lipitor might have achieved the main goal of the trial. He added that the primary goal was more heavily weighted toward death rates than was the secondary goal.
The large trial was conducted on more than 8,800 heart attack patients from 1999 to 2005 in Northern Europe by researchers at Norway's Ulleval University Hospital in Oslo.