Patients receiving atorvastatin, one of a group of drugs called statins, were more than a third less likely to have heart attacks and more than a quarter less likely to suffer from strokes. The results were so striking the authors of a study in the April 2 online issue of The Lancet stopped the trial early so the control group could benefit from the drug.
Their findings were also announced April 2 at the American College of Cardiology's annual scientific sessions in Chicago.
"This adds more credence to the idea that we need to be much more aggressive," says Dr. Leonard Lefkovic, divisional director of cardiology at Staten Island University Hospital in New York City. "Heart disease is still rampant in the U.S., and we're not being aggressive enough."
Statins lower cholesterol, a leading cause of atherosclerosis. This buildup of plaque in the arteries can lead to heart attacks and strokes.
The findings are in keeping with the new "global risk" approach that has been gaining favor among cardiologists, says Dr. Richard Stein, chief of cardiology at Brooklyn Hospital Center in New York City and a spokesman for the American Heart Association. Global risk refers to the sum of various factors including cholesterol, blood pressure, diabetes and inactivity, along with all kinds of unknowns in contributing to heart disease.
"The approach is why not reduce what's reducible as opposed to looking at the worst risk factors," Stein explains. So even if your cholesterol is normal or near normal, reducing it further may be an added benefit. "It may be a small reduction in absolute risk, but it clearly is a meaningful value nonetheless."
This study looked at 10,305 people (mostly white men) between the ages of 40 and 80 who had high blood pressure along with three or more risk additional risk factors for cardiovascular disease and normal or near-normal cholesterol levels. The participants, all part of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), were randomly assigned to receive atorvastatin or a placebo in addition to medication to lower their blood pressure.
Those in the atorvastatin group were 36 percent less likely to suffer heart attacks and 27 percent less likely to have a stroke than people in the placebo group. As a result, the trial, initially scheduled to last five years, was halted at 3.3 years.
The study authors believe higher doses of the drug would have resulted in even better results, and they noted few side effects.
This benefit may be coming from one or both of two places. Lowering cholesterol levels, even when they're normal, may reduce risk. Additionally, statins may have an effect independent of that it has on cholesterol. "There's a thought now that statins may decrease oxidation or the inflammatory process that destabilizes plaques and causes them to fracture," Stein says. When plaque breaks off, it can form blood clots.
An editorial in the same issue of The Lancet questions the actual clinical benefit that may come from these findings. Admittedly, the relative risk is low, Stein says, and translates into health benefits for about two patients per year per 100 people treated.
The real question is whether future data continues to show a good safety profile. "If so, then there will be a strong push to identify people with elevated global risk," Stein says.