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High Dose Statins Lower Heart Attack Risk

Armen Hareyan's picture

Heart Attack Risk Reduction

Aggressive cholesterol-lowering treatment with high doses of statins reduced the risk of cardiovascular events by 16 percent compared to low-dose statin therapy, after nearly five years, in a study presented at a late-breaking clinical trials session at the American Heart Association's Scientific Sessions 2005.

The study compared high and low doses of statins. The high-dose group had no increased risk of non-cardiac deaths compared to patients in the low-dose group.

The primary cardiovascular disease event endpoint included a composite of heart attack, coronary heart disease death or cardiac arrest with resuscitation, a condition also known as "sudden death." The study's secondary endpoint included the primary events plus hospitalized unstable angina and bypass surgery or PCI (opening of a blocked artery in the heart by using a catheter).

"This finding may help calm concerns that high-dose statins contribute to excess non-cardiac deaths, such as cancer, but benefits apparent in this trial were more modest than we had expected," said Terje R. Pedersen, M.D., lead author of the The Incremental Decrease in Clinical Endpoints Through Aggressive Lipid Lowering (IDEAL) Trial.

The researchers found that high-dose statins reduced the risk of the study's secondary endpoint by a highly statistically significant 16 percent. Nonfatal heart attacks were reduced by 17 percent.

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The high-dose approach resulted in an 11 percent drop in the primary endpoint compared to the rate in the low-dose group. But those results did not reach statistically significant difference, Pedersen said.

Researchers performed a post-hoc analysis of the primary endpoint that adjusted for risk factors that resulted in a P value of 0.04, which means the findings reach statistical significance. Because it was post-hoc, the analysis' significance was in showing researchers directions for future investigations.

"We found that our results were in line with other recent studies on the same question that found that high doses of statins would improve outcomes," said Pedersen, who is also professor of medicine at UllevalUniversity Hospital and director of the Center for Preventive Medicine in Oslo, Norway.

The low-dose simvastatin used in this study is the same statin and dosage used in Pedersen's landmark 4S trial presented at an American Heart Association meeting in 1994 that demonstrated statins' life-saving properties. The 4S trial is widely regarded to have ushered in the statin era in medicine.

This trial included 8,888 patients, average age 62 and 19 percent female. They received either 80 milligrams (mg) of atorvastatin, one of the newer and stronger statin drugs, or a 20 mg dose of simvastatin that was raised to 40 mg after six months if the initial dose didn't reduce patients' total cholesterol below the U.S. equivalent of 193 mg/deciliter (dL) or reduce low-density lipoprotein (LDL) below 115 mg/dL.

The high-dose treatment reduced LDL to an average 81 mg/dL, compared to 104 mg/dL for the low-dose group. During the study's 4.8 years of follow-up, 874 patients was experienced by, 1,957 patients.

Pedersen said that if the primary endpoint might have reached statistical significance had researchers continued the study for another three months.