Statin Therapy May Reduce Key Heart Disease Risk Factors in Hispanics

Heart Disease Treatment

Two drugs commonly used to lower high cholesterol in the general population also reduced heart disease markers in Hispanics, researchers reported today at the American Heart Association's 46th Annual Conference on Cardiovascular Disease Epidemiology and Prevention.

In this first large prospective study of statin therapy in Hispanic Americans, researchers looked at the drugs' effects on C-reactive protein (CRP), a marker of inflammation. Studies indicate that high levels of CRP correlate with elevated risk of coronary heart disease. They also measured low-density lipoprotein (LDL), known as "bad" cholesterol.

"Despite Hispanics being the fastest growing minority in the United States, there are relatively little data in large-scale studies about treating cardiovascular risk factors in this population," said the study's lead author, Ramon Luis Lloret, M.D., cardiologist and president of the Cardiovascular Center of South Florida in Miami. "The findings were important because Hispanics are under-diagnosed and under-treated for heart disease."

Study participants had LDL levels of 130 milligrams per deciliter (mg/dL) or greater at the start of the trial and were at high risk for having a coronary event within the next 10 years. After a six-week dietary lead-in researchers randomly selected study participants to be in one of four statin groups:

• Two groups received atorvastatin daily for six weeks; one received 10 mg, and the other, 20 mg.

• Two groups received the drug rosuvastatin every day for six weeks; one received 10 mg, and the other, 20 mg.

They measured 635 participants' CRP and LDL levels before and after treatment.

"LDL levels fell significantly in all four statin-treatment groups after six weeks," Lloret said. "Rosuvastatin, at both doses, reduced LDL significantly more than atorvastatin did at the same dose. Both the drugs had similar effects on the participants' CRP levels."

At the start of the study, the average CRP level in the overall group was 2.5 mg/L. More than half of those participants had CRP levels higher than 2 mg/L - making them at significantly higher risk of coronary disease than people at levels below 2 mg/L.

Researchers found:

• In the rosuvastatin group taking 10 mg daily, the average CRP reduction from baseline was 18.8 percent.

• In the atorvastatin/10 mg group, the average CRP reduction from baseline was 16.8 percent.

• In the rosuvastatin/20 mg group, CRP levels dropped 26.7 percent after six weeks, versus a 23.8 percent decrease in the atorvastatin/20 mg group.

• CRP reductions were greatest in the group at most risk for heart disease - the subgroup of patients with CRP levels higher than 2 mg/L.

• The rosuvastatin/10 subgroup experienced an average 20.8 percent CRP reduction, versus 23.9 percent for the atorvastatin/10 mg subgroup. In this subgroup, after six weeks the rosuvastatin/20 mg subgroup fell an average 38 percent in its CRP levels, compared to the atorvastatin/20 mg group, which experienced a 41.2 percent decrease.

• CRP differences were not statistically significant between the two drugs in any of the groups.

"Rosuvastatin and atorvastatin were well tolerated in this study population, with no unexpected adverse events," Lloret said. "We did not see any of the real concerns with muscle problems, which are rare side effects of statins. No patients developed clinical worsening of kidney function while on the medications."

Patients in the study had high percentages of many factors prevalent among Hispanics that put them at risk for heart disease, including elevated lipids, high body mass index (BMI), diabetes, high blood pressure and elevated CRP. These risk factors can be treated by proper medical care.

"Although rosuvastatin and atorvastatin significantly lowered CRP, the most effective way to reduce the cardiovascular risk of elevated blood levels of CRP is not yet known," Lloret said. "The cause and effect relation between elevated CRP, or other inflammatory markers, and heart disease is not well understood."

The JUPITER trial, currently underway, is examining the effects of rosuvastatin treatment on primary prevention of cardiovascular events in patients with normal cholesterol and elevated CRP. JUPITER is a randomized, double-blind, placebo-controlled, multicenter, Phase II study of an estimated 15,000 patients.

AstraZeneca Pharmaceuticals funded the study.