Is it time to reconsider the risks of statins?

Statins are commonly prescribed to treat high cholesterol, but a new study published in the journal Annals of Internal Medicine suggests that doctors should give more consideration to the risks associated with the drugs.

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Statins are cholesterol-lowering drugs used to prevent heart attacks and strokes. But in recent years there's been much debate about the drugs' life-saving capabilities and professional organizations have issued conflicting guidance on their use. For example, researchers previously have estimated 26.4 million adults would be recommended for statin therapy under American College of Cardiology and the American Heart Association's 2013 guidelines, compared with 17.1 million adults under U.S. Preventive Services Task Force recommendations. However, ACC just released new guidelines last month. 

Study details

In the latest study, researchers reviewed data from 40 previously published randomized controlled trials, as well as a number of observational studies, registries, and a patient preference survey to determine at what point the side effects of statin use as a preventive measure, outweigh the benefits.

The researchers focused on four commonly used statins:

  • Atorvastatin;
  • Pravastatin;
  • Rosuvastatin; and
  • Simvastatin.

Statin risks may not always outweigh benefits, study finds

The researchers found that, while statins were likely to provide a benefit, they did so at a significantly higher health risk level than expected. The risks were lower for atorvastatin and rosuvastatin than they were for simvastatin and pravastatin, according to the study.

Overall, the researchers found the 10-year risks for cardiovascular disease among statin users increased with age and varied by gender. For example, men ages 40 to 44 years old had a 10-year risk for cardiovascular disease of 14%, compared with 21% among men 70 to 75. For women ages 40 to 44, the 10-year risk of cardiovascular disease was 17%, compared with 22% among women 70 to 75.

Milo Puhan, lead author on the study and a professor of epidemiology and public health at the University of Zurich in Switzerland, said the data suggest around 15 to 20% of older adults should take statins—noticeably lower than the current 30 to 40% recommended by medical guidelines.

The authors acknowledged that the study had some limitations. First, it only involved data associated with the four most commonly prescribed statins, and it only measured risks of patients in the United States, United Kingdom, and Switzerland. According to Puhan, the side effect data in the study "are not ideal because [randomized controlled] trials are short-term and not ideal for capturing harms." He added that the researchers "tried to address that by including observational studies."

A complicated trade-off that should be made on an individual basis, experts say

Puhan said that taking statins in general is not "super risky," but said this study shows that patients considering statins need to "carefully look at the cardiovascular risk of an individual—a physician can determine that—and then have a conversation of whether the benefits exceed the harms."

Puhan explained, "It really depends on age, gender, and the type of overall health status. One size doesn't fit all. So the risk threshold increases with age, which basically means that you need to have a higher cardiovascular risk in order to get the net benefit from statins."

In an accompanying editorial, Ilana Richman and Joseph Ross, both physicians and faculty members at Yale School of Medicine, said, "The onus is on physicians to fairly summarize the evidence and guide patients through the decision-making process." They added that cardiovascular disease prevention "must be patient-centered, because healthy patients are asked to assume risk, benefits are experienced only as the absence of disease, and uncertainty lurks beneath every choice."

Michael Blaha, an associate professor and director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, who was not involved with the study, said the main takeaway is that "the threshold for starting statins in primary prevention is a complex one and must be individualized to the patient."

However, Roger Blumenthal, head of the Ciccarone Center, disagreed with the study and said the harms analyzed in it could "be dealt with by a smart clinician."

Amit Khera, professor and director of the UT Southwestern Medical Center's Preventive Cardiology Program, said whether a side effect outweighs the benefit of a statin depends on the patient's needs.

He explained that when it comes to headaches and nausea, "if I told you hypothetically that statins can prevent five heart attacks but cause five people to get mild headaches, are those equal?" Khera added, "I feel like this is sensationalism, and it's unfortunate, because it takes away from a balanced and important discussion on risks and side effects" (Howard, CNN, 12/3; Harris, "Shots," NPR, 12/3).

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