In a trial spanning six continents, 21 countries and 12,705 ethnically diverse participants, the researchers randomly assigned placebos and low dosages of statins or antihypertensives, such as rosuvastatin and candesartan plus hydrochlorothiazide. The study is the first of its kind to include a diverse group of of patients. Some 80% of participants were not white.
All were at intermediate risk for cardiovascular disease but did not have it. The study included men 55 and older and women who were 65 and older with at least one risk factor for heart disease, from family history to obesity. Otherwise, their cholesterol levels were moderate and blood pressure was under the high benchmark, of 140 over 90.
Over 5.6 years, 3.7% of those who got 10 milligrams of the statin had heart attacks, strokes or heart-related deaths compared with 4.8% of those taking a placebo, or dummy pill. That was a 24% reduction in risk among those who took 10 milligrams of the drug Crestor. The researchers believe the same effect would occur in patients using the same dose of any statin.
Side effects of the dual treatment group taking statins and antihypertensives included muscle weakness and dizziness, which are known side effects associated with these medications.
According to the study authors, "the HOPE-3 trial provides evidence to reinforce some current guideline recommendations and to influence future guidelines."
The trial was funded by Canadian Institutes of Health and Research and AstraZeneca, the pharmaceutical company that makes the statin Crestor, which was used in the study, among other drugs. The findings were also presented at the annual scientific meeting of the American College of Cardiology, ongoing through Wednesday. The trial combined two studies that looked specifically at lowering blood pressure
and lowering cholesterol
"This will make the case that statins should be used more broadly, in more countries around the world, and in a more diverse population of people," CNN Chief Medical Correspondent Dr. Sanjay Gupta said.
Gupta also noted that in the United States, there is no longer a specific blood cholesterol or lipid level that is targeted, routine blood testing is no longer recommended,and the overall group of patients being recommended statins has increased. In addition to people who have known heart disease, very high cholesterol or are diabetics, the list of people now being recommended statins was widened to include people older than 40 who have a 7.5% or higher risk of heart attack or stroke within 10 years.
The study authors believe this represents a very simple approach to treatment around the world: 10mg of statins without the need for routine blood tests or clinic visits, he said.
The recent trend has been to recommend statins more broadly and to increasingly include borderline patients. This study reinforces the value of that approach, Gupta said. There has also been controversy and debate
over who should be taking them.
CNN has previously reported that critics of the current cholesterol guidelines say they grossly overestimate the risk of people recommended to take statins. In terms of numbers, the new guidelines increase the number of Americans eligible for statins from about 40 million to 60 million people, according to a 2014 study
"The bottom line for statins is that this is consistent with all of the other trials in that people who have some risk but are not already at risk for primary prevention, about 1 in 100 will benefit from taking a statin, which is not a lot," said Dr. Eric Topol, a cardiologist and director for the Scripps Translational Science Institute. "If you look at the overall for all the trials, it's somewhere from 1 to 1.3 or 1.5, not even 2. Only a very small number derive benefit, so we need better tools to define who are those men and women at risk."
Topol, who was not involved in this study, also highlighted that in this trial, cataracts are a newly identified side effect associated with the medication for lowering cholesterol. He said that even though the study is co-funded by a major pharmaceutical company and that it's good for people to know about that, the trial is still valid.
Topol, a proponent of individualized medicine, suggested patients should speak with their doctors and have a genomic risk score taken, which would help showcase whether someone would benefit from taking preventative measures.
"The use of statins in the U.S. is extra high, many want to urge to be higher, but the data aren't compelling until we know who this benefits. The good part about the global picture of this trial is that we start to get information about all ancestries," Topol said.
Dr. Mary Norine Walsh, the vice president of the American College of Cardiology, also believed that one of the strengths of the study was the inclusion of varied ethnic groups but also said that it was important to realize that very few black Africans in the United States were included, so the data can't be extrapolated to African Americans. But she was pleased to see that 46% of the participants were women.
"It is important to note that this is a study that has been done at a time when statin therapy is generic and less costly to patients than it has been and that this is not driven by use of a new drug or expensive agent," she said. "It is a population health study that can be applied in an economically beneficial way."
As far as updating guidelines in the United States and elsewhere, Walsh expects that while the guideline-writing groups will take time to give their opinions, clinicians will find the data strong enough to talk about the results of the trial with their patients and begin changing their practice.