Statins May be Overprescribed, New Analysis Finds

December 6, 2018

By Reuters Staff

NEW YORK (Reuters Health) - A new modeling study suggests that too many people may be taking statins for primary prevention of cardiovascular disease.

The study suggests that the potential risks of statin therapy outweigh the benefits for adults whose 10-year risk of developing CVD is 7.5% to 10%, thresholds proposed in current guidelines.

"Our results suggest that higher 10-year risk thresholds for prescription of statins may be warranted than what current guidelines recommend and that the thresholds vary considerably by age, sex, and statin type," write Dr. Milo Puhan and colleagues of the University of Zurich, in Switzerland, in the Annals of Internal Medicine, online December 3.

"Guidelines emphasize benefits, and although harms are not ignored, they seem to have little effect on recommendations. The problem with such an approach is that eligibility for statins increases with age because more events can be prevented in elderly persons who are at higher CVD risk, as a recent study showed. However, when harm outcomes, which also increase with age, are considered, the benefit-harm balance of statins becomes less favorable," the authors note.

Most guidelines recommend statin therapy if the expected 10-year risk of CVD is 7.5% or higher, although the most recent U.S. guidelines also emphasize the importance of patient preference and suggest using coronary-artery calcium scores and clinical risk factors to guide statin therapy for primary prevention.

Dr. Puhan and colleagues did a modeling study to assess the balance of benefits and harms of statin therapy for primary CVD prevention and determine age- and sex-specific 10-year risk thresholds at which the net benefits statin treatment outweigh the net harms. They projected disease-related events and drug-related adverse events (myopathy, hepatic dysfunction, and new-onset diabetes) over time while accounting for competing mortality.

Consistently, say the authors, the harms of statin therapy exceeded the benefits until the 10-year CVD risk threshold was far higher than recommended by current guidelines.

For example, among men aged 70 to 75, the benefits of statin therapy did not outweigh harms until 10-year CVD risk was above 21%. Among women aged 70 to 75, risk would need to exceed 22% for there to be a net benefit.

Risk thresholds were lower for younger adults, likely owing to a lower risk of side effects from statins and lower competing mortality, the authors report. However, at a 10-year CVD risk of 7.5%, the benefits of a statin did not outweigh the harms for any age group, sex, or statin type. The lowest risk thresholds were 14% for men aged 40 to 49 and 17% for women aged 40 to 49 years, they say.

In a linked editorial, Dr. Ilana Richman and Dr. Joseph Ross from Yale University School of Medicine in New Haven, Connecticut, say this study reinforces the importance of including the patient in decisions about statin therapy for primary CVD prevention.

"The CVD risk threshold for initiation of statin therapy for primary prevention is sensitive to patient preferences, including the burden of taking a pill daily. Some patients may favor a risk-averse approach in which harms associated with therapy are given greater weight than potential benefits, but others may prefer to give greater weight to potential benefits," they write.

"The onus is on physicians to fairly summarize the evidence and guide patients through the decision-making process" and this study "can support that decision making, particularly for older adults or those who are more concerned about harms of treatment. Indeed, primary prevention of CVD 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," conclude Drs. Richman and Ross.

The study had no commercial funding.


Ann Intern Med 2018.

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