A few years after new guidelines recommended that several million more Americans take a cholesterol-lowering drug to reduce their risk of having a heart attack or stroke, an extensive international investigation has come to a similar conclusion.
The study known as HOPE-3 sought to find the best way to prevent cardiovascular disease in people who were considered at an intermediate risk. Researchers pursued this from four angles: giving medicines to lower blood pressure; giving a cholesterol-lowering drug known as a statin; giving a combination of all those medicines and doing nothing.
The biggest benefits came from the statin. This echoes the 2013 guidelines for doctors published by the American Heart Association and the American College of Cardiology, which are considered the standard for treatment in the United States.
The investigation is likely to give doctors more reason to prescribe statins for patients who fall within the new risk category.
When the guidelines were originally published in November 2013, controversy followed. Much of the backlash was over lowering the bar for recommending who should be prescribed a statin, which in turn drastically increased the number of people encouraged to take the pill.
“Everybody is beginning to see that what was considered very disruptive when we published it happens to be right,” said Sidney Smith, M.D., one of the 20 experts who wrote the 2013 guidelines.
Donald Lloyd-Jones, M.D., was among a panel that discussed the findings of HOPE-3 on Saturday during the ACC’s annual Scientific Session & Expo. He also was among the 2013 guidelines authors. Speaking before an audience of several thousand convention-goers, Dr. Lloyd-Jones referenced the AHA-ACC guidelines and said, “I think we got it right.” HOPE-3 principal investigator Salim Yusuf, M.D., smiled and agreed.
“This should reassure anyone who still had questions,” said Smith, a professor of medicine at the University of North Carolina at Chapel Hill who served as senior advisor to the National Heart, Lung, and Blood Institute for the development of the cholesterol and other CVD prevention guidelines.
Just as the cholesterol guidelines were reviewed and then updated 2½ years ago, now experts are in the midst of updating guidelines for the management of blood pressure. The HOPE-3 findings provide more data for the writing group to consider.
Eva Lonn, the researcher who oversaw the blood pressure component of the study, broke down her findings into three groups. For the one-third of people that went into the study with the highest systolic blood pressure (the top number in a reading), there were clear benefits to taking the blood-pressure-lowering medication.
“We did not see benefits in the middle third,” said Lonn, M.D. “And there was a suggestion of possible harm for individuals who did not have very high blood pressure to begin with.”
Dr. Lonn, Dr. Yusuf and other researchers from McMaster University in Canada conducted this study, formally called the Heart Outcomes Prevention Evaluation-3. It cost between $36 million and $38 million, with funding from the Canadian Institutes of Health Research and AstraZeneca, maker of the popular statin Crestor.
For more than 5½ years, researchers followed 12,705 people who had never had a heart attack or stroke. Participants were men 55 or older and women 60 or older who had one more risk factor for cardiovascular disease, such as a family history of heart attack or stroke, elevated waist-to-hip ratio, or recent tobacco use.
Everyone who received medicine got the same dosage, and that amount never changed over the course of the study. They also rarely followed up with doctors. These aspects were part of the study’s aim for simplicity.
The study group was ethnically diverse: 29 percent Chinese; 27 percent Hispanic; 20 percent white; 20 percent other Asian; 2 percent black; and 2 percent “other.” They were geographically diverse, too, coming from 21 countries.
The findings were presented at the ACC convention and simultaneously published in the New England Journal of Medicine.