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Statins may be overprescribed

Statins provided a greater net benefit for primary prevention of CVD among patients with a 10-year risk for CVD that exceeded the current guideline recommendations of 7.5% to 10%, indicating that millions of patients may not need to be on statin therapy, according to research published in Annals of Internal Medicine.

“Many guidelines use expected risk for CVD during the next 10 years as a basis for recommendations on use of statins for primary prevention of CVD,” Henock G. Yebyo, MSc, from the University of Zurich, Switzerland, and colleagues wrote. “However, how harms were considered and weighed against benefits is often unclear.”

Yebyo and colleagues conducted a quantitative benefit-harm balance modeling study to evaluate the age- and sex-specific 10-year risk thresholds at which statins for primary prevention provide at least a 60% probability of net benefit among patients aged 40 to 75 years with no history of CVD. Four commonly used statins, including atorvastatin, rosuvastatin, simvastatin and pravastatin, were analyzed separately.

Harms assessed included disease-related events and drug-related adverse events, such as myopathy, hepatic dysfunction and incident diabetes.

The researchers found that statins showed a net benefit among younger men aged 40 to 44 years with a 10-year risk for CVD of 14% and older men aged 70 to 75 years with a 10-year risk for CVD of 21%. Similarly, there was net benefit of statins among younger women aged 40 to 44 years with a 10-year risk for CVD of 17% and older women aged 70 to 75 years with a 10-year risk for CVD of 22%.

Compared with simvastatin and pravastatin, atorvastatin and rosuvastatin provided net benefit for prevention of CVD at a lower risk threshold.

The harms consistently outweighed the benefits until CVD risk thresholds were significantly higher than currently recommended in guidelines, according to the researchers.

“Our results suggest that guidelines should use higher 10-year thresholds when recommending statins for primary prevention of CVD and should consider different recommendations based on sex, age group and statin type,” Yebyo and colleagues concluded. “Such recommendations would substantially improve selection of persons eligible for statin therapy for primary prevention of CVD.”

In an accompanying editorial, Ilana B. Richman, MD, and Joseph S. Ross, MD, MHS, both from Yale University School of Medicine, wrote that Yebyo and colleagues assessed many adverse events that were overlooked in other guidelines.

“The onus is on physicians to fairly summarize the evidence and guide patients through the decision-making process,” they wrote. “The work by Yebyo and colleagues 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 health patients are asked to assume risk, benefits are experienced only as the absences of disease, and uncertainty lurks beneath every choice.” – by Alaina Tedesco

Disclosures: Richman reports receiving grants from NIH. Ross reports receiving grants from Agency for Healthcare Research and Quality, Blue Cross-Blue Shield Association, CMS, FDA, Johnson & Johnson, Laura and John Arnold Foundation, Medtronic, Inc. and NIH/NHLBI. Yebyo and colleagues report no relevant financial disclosures.