In February, the U.S. Food and Drug Administration approved new criteria for the prescribing of the cholesterol-lowering drug (statin) Crestor (rosuvastatin calcium) to include people at low risk for heart attack or stroke — potentially expanding the use of the medication as a preventive regimen for millions of people who don’t struggle with high cholesterol.
The FDA based the decision on findings of a nearly two-year study including 18,000 people with low cholesterol, but high levels of C-reactive protein (CRP), which is an indicator of inflammation in the body and may be indicative of increased risk for heart disease.
Study authors tout the research as showing that Crestor reduced the incidence of heart attack by 55%, stroke by 48% and angioplasty bypass surgery by 45%, among people who took the statin manufactured by AstraZeneca, the New York Times reports.
Yet, those promising figures may oversell the preventive benefits of the drug, Duff Wilson writes for the Times. Wilson frames the data slightly differently:
The rate of heart attacks, for example, was 0.37 percent, or 68 patients out of 8,901 who took a sugar pill. Among the Crestor patients it was 0.17 percent, or 31 patients. That 55 percent relative difference between the two groups translates to only 0.2 percentage points in absolute terms — or 2 people out of 1,000. Stated another way, 500 people would need to be treated with Crestor for a year to avoid one usually survivable heart attack. Stroke numbers were similar.
What’s more, given that statins can have harmful side effects including severe muscle pain, and that recent findings published in the medical journal the Lancet suggest the cholesterol drugs may actually increase the risk for developing Type 2 diabetes by 9%, that relatively small level of risk reduction for people who don’t have high cholesterol in the first place has some doctors questioning the value of prescribing Crestor preventively.
Speaking with the Times, cardiologist Dr. Steven W. Seiden expressed his skepticism:
The benefit is vanishingly small. It just turns a lot of healthy people into patients and commits them to a lifetime of medication.
An additional cause for concern over more widespread prescription of statins is whether their benefit — in people with high cholesterol or otherwise — extends to both genders. Writing for TIME, Catherine Elton explains that, until this recent Crestor trial, there was little evidence that statins prevent heart disease in women — despite the fact that nearly 12 million women are prescribed the drugs each year in the U.S.
In the women included in the study — who again, didn’t have high cholesterol but did have high levels of C-reactive protein — a daily regimen of Crestor was associated with a 46% reduction in cardiovascular events. Yet, that dramatic statistic looks slightly different when Elton parses the data:
The reduction in cardiovascular events sounds impressive until you take a closer look. Men taking Crestor had a lower risk of hard events, including fatal and nonfatal heart attack and stroke. But the only statistically significant benefits for women treated with Crestor involved less extreme end points, like hospitalization for unstable chest pain and arterial revascularization (a category of procedures that includes major surgery). To prevent one event, 36 women would need to take the statin for five years — a modest result, critics say.
What’s more, unlike men, women taking the drug were more likely to develop diabetes compared to those taking a placebo, Elton reports.
Statins have been widely credited with saving lives by lowering bad cholesterol (LDL) and raising good cholesterol (HDL) in people at risk for heart disease, and the drugs are already the most widely prescribed medication in the U.S., according to the New York Times. But as for whether they provide a preventive benefit for healthy patients without high cholesterol — or have significant protective effects that outweigh risks for women — is still up for debate.
And, according to Dr. Mark A. Hlatky, a professor of health research and cardiovascular medicine at the Stanford University medical school, continuing that debate may be in patients’ best interest. As he told the Times: “It’s a good thing to be skeptical about whether there may be long-term harm from healthy people taking a drug like this.”