Many people who take cholesterol-lowering statins may not benefit from them, researchers say.
Drugs like atorvastatin (Lipitor) and fluvastatin (Lescol) provide little value to people without heart disease, new research shows. Yet these heart-healthy folks represent a sizable number of statin users.
While statins for people with heart disease isn’t controversial, their use in people without heart disease (known as “primary prevention”) is the subject of debate.
The use of statins for primary prevention “warrants more careful consideration,” concluded researchers led by Paula Byrne of the National University of Ireland Galway.
Used in this way, statins “may be an example of low value care and, in some cases, represent a waste of health care resources,” the study authors said.
Changes in clinical guidelines have increased the number of people eligible to take statins. In many countries, the majority of people taking the drugs do so for primary prevention.
For the study, Byrne’s team analyzed data from Ireland from 1987 through 2016. The investigators found that the proportion of adults older than 50 eligible for statins rose from 8% under 1987 guidelines to 61% under 2016 guidelines. That means a far greater number of lower-risk people became eligible for statin treatment.
The number of people who would need to be treated with statins to prevent one major cardiovascular event also increased substantially, from 40 at the lowest risk under 1987 guidelines to 400 at the lowest risk under 2016 guidelines.
As part of the study, the investigators also analyzed primary prevention data for people with an average age of 62 to 69, who were taking statins for one to five years.
Overall, there were significant reductions in death from any cause, cardiovascular deaths, and major coronary or cardiovascular events. However, when the baseline risk of developing heart disease was taken into account, most outcomes were not statistically significant, “raising uncertainty about the benefits of statins for primary prevention,” Byrne and her colleagues wrote.
The findings showed that none of the people classified as low or moderate risk in primary prevention would achieve acceptable levels of risk reduction to justify taking a daily statin. The results were published Oct. 16 in the BMJ.
“We need to assess and understand the evidence underlying these trends,” the study authors wrote in a journal news release.
Statins are one of the most commonly used medicines worldwide, with sales estimated to approach $1 trillion by 2020. But important clinical trial data on statins is not available for independent analysis, the researchers noted.
The American Heart Association has more on cholesterol-lowering drugs.