CHICAGO — Cholesterol-lowering statins help prevent heart attacks and strokes in older people with high blood pressure and near-normal cholesterol levels who haven’t developed heart disease.
That’s the conclusion of a global study comparing the benefits and risks of taking a statin alone, blood pressure drugs alone, or a combination of the two. The three approaches are commonly used in individual with evidence of heart disease or at high risk for it.
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, professor of medicine at McMaster University in Hamilton, Ontario. “This is globally applicable.”
The research was presented Saturday at an American College of Cardiology meeting in Chicago and published online in the New England Journal of Medicine.
Participants from Canada, Europe, China, South America and South Africa were recruited for the study. All were at moderate risk of having a heart attack or stroke because of age — men were 55 and older and women were at least age 60 — and because they had another risk factor such as obesity, smoking, or family history of cardiovascular disease. 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 (placebo) pills for almost six years. The drug treatments all reduced cholesterol and blood pressure levels but other results varied.
Statin-only participants 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 placebo 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 an editorial on the research.
Heart problems and deaths were relatively rare in the three study groups. In the combined drug group, less than 4 percent of participants had those outcomes, versus 5 percent of those on dummy pills. Nearly similar results were seen in the statin-only group.
Those taking a statin had slightly more muscle pain or weakness — known statin side effects — than those taking placebo pills. Statin takers 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 authors of the related editorial said other statins would likely have similar results. Crestor’s maker, AstraZeneca (AZN), and the Canadian Institutes of Health Research paid for the study. Yusuf reported receiving grants from both; several co-researchers reported grants and personal fees from the company and other drug makers.
The blood pressure drugs were candesartan, sold as a generic and by AstraZeneca as Atacand; and hydrochlorothiazide, a generic diuretic.