Global study shows statins benefit lower risk patients

CHICAGO, Ill. (WPVI) -- The first major research of its kind shows that cholesterol-lowering statins can prevent heart attacks and strokes in a globally diverse group of older people who don't have heart disease.

The results bolster recommendations in recent guidelines on who should consider taking the drugs.

The aim was to prevent heart problems using a statin alone, blood pressure drugs or a combination of the two.

The three approaches are commonly used in high risk patients or those with evidence of heart disease.

The patients in the study did not have heart disease and faced lower risks of developing it, and the statin approach worked best.

The research involved nearly 13,000 men and women from 21 countries on six continents.

Most previous studies on heart disease prevention have been in white, North American patients with higher risks because of high blood pressure, unhealthy cholesterol levels or other conditions.

But with heart disease a leading global killer, causing 18 million deaths each year, there is a trend toward recommending preventive drug treatment to more borderline patients.

The benefits of this strategy were "seen in people from every part of the world," said study co-author Dr. Salim Yusuf, a professor of medicine at McMaster University in Hamilton, Ontario. "This is globally applicable."

The research was published online Saturday in the New England Journal of Medicine and presented at an American College of Cardiology meeting in Chicago.

Study sites included Canada, Europe, China, South America and South Africa. About 20 percent of patients were white.

Patients were at moderate risk because of age - men were 55 and older and women were at least age 60 - and because they had another heart disease risk factor, including obesity, family history or smoking.

On average, their cholesterol levels were nearly normal and blood pressure was slightly lower than the cutoff for high blood pressure, which is 140 over 90.

They were randomly assigned to receive one of the treatments in low doses or dummy pills for almost six years.

The drug treatments all reduced cholesterol and blood pressure levels but other results varied.

Statin-only patients were about 25 percent less likely to have fatal or nonfatal heart-related problems than those given dummy pills. Those in the combined drug group fared slightly better and the researchers credit the statin for the benefit.

Blood pressure drugs alone worked no better than dummy pills at preventing these events, except in the fraction of patients who had high blood pressure.

The drug doses used may have been too low to provide much benefit to low-risk patients, although longer follow-up may be needed, according to a journal editorial published with the research.

Heart problems and deaths were relatively rare in the three study groups.

In the combined drug group, less than 4 percent of patients had those outcomes, versus 5 percent of those on dummy pills.

Nearly similar results were seen in the statin-only group. Those outcomes occurred in about 4 percent of patients on only blood pressure drugs and in those on dummy pills.

Patients on statins had slightly more muscle pain or weakness - known statin side effects, than those on dummy pills.

Statin patients also had slightly more cataract surgeries but the researchers said it isn't known if the drug played a role.

Dr. Clyde Yancey, cardiology chief at Northwestern Medicine in Chicago, said the results add important evidence favoring drug treatment for lower-risk patients, but emphasized that lifestyle approaches including diet and activity should be included. He wasn't involved in the research.

The study used 10 milligrams daily of rosuvastatin, sold as a generic or under the brand name Crestor.

The editorial authors said other statins would likely have similar results. Crestor's maker, AstraZeneca, and the Canadian Institutes of Health Research paid for the study.

Yusuf reported receiving grants from both; and several co-researchers reported grants and personal fees from the company and other drugmakers.

The blood pressure drugs were candesartan, sold as a generic and by AstraZeneca as Atacand; and hydrochlorothiazide, a generic diuretic.