The U.S. Preventative Services Task Force recently updated its 2008 recommendation for lipid disorders in adults by issuing a recommendation statement for the initiation of statins to prevent cardiovascular disease in adults aged 40 to 75 years.
“Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States,” the USPSTF wrote in its evidence report. “A challenge in reducing adverse outcomes of CVD is that the first clinical manifestation can be catastrophic, including sudden cardiac death, acute myocardial infarction, or stroke. Statins reduce the risk of CVD-associated morbidity and mortality through their effects on lipids and are also thought to have anti-inflammatory and other plaque-stabilization effects. Although statin therapy for patients with prior cardiovascular events is widely supported, use in patients without prior cardiovascular events is controversial.”
The USPSTF based its recommendations on a systematic evidence review of 19 trials including 71,344 patients that investigated the benefits and harms of statin use for preventing CVD. Overall, the task force found that statin therapy reduced the risk of all-cause and CVD-related mortality and harms, while presenting benefits for patients who had a higher baseline risk.
The update, a B-grade recommendation, suggests clinicians offer low- to moderate-dose statins to adults who have one or more risk factors for CVD such as dyslipidemia, diabetes, hypertension or smoking, and a calculated 10-year CVD event risk of 10% or more, but do not have a history of CVD. In addition, the task force recommends, with C-grade evidence, that low- to moderate-dose statins should be offered selectively to adults who have one or more risk factors of CVD and a calculated 10-year CVD event risk of 7.5% to 10%, but do not have a history of CVD. The USPSTF did not obtain sufficient evidence to determine whether statins have a similar benefit in adults aged 76 years or older.
In a related editorial, Rita F. Redberg, MD, MSc, from the University of California, San Francisco, and Mitchell H. Katz, MD, from the Department of Health Services in Los Angeles, California, argue that there are limitations to the evidence that the USPSTF used as a basis of their recommendations that were not adequately considered and thus, caution against the use of statins in primary prevention, especially in asymptomatic patients.
They wrote that the primary data from the statin clinical trials were not available to the USPSTF; therefore, the task force utilized evidence from peer-reviewed reports. In addition, the evidence used to inform the current recommendations may have contained biases due to a majority of the trials being industry-funded.
“It is incumbent on clinicians to be sure that before recommending that a patient take a daily pill that has multiple adverse effects, there is evidence that the medication will lead to a better quality of life, longer life, or both. Such evidence is lacking for statins in primary prevention,” Redberg and Katz concluded. “Given the serious concerns about the harms of the reliance on statins for primary prevention, it is in the interest of public health and the medical community to refocus efforts on promoting a heart-healthy diet, regular physical activity, and not smoking.”
In an additional editorial, Ann Marie Navar, MD, PhD, and Eric D. Peterson, MD, MPH, both of the Duke Clinical Research Institute, pointed to similar limitations of the USPSTF recommendations for statin use for prevention of CVD.
“Randomized clinical trials can neither represent the full spectrum of patients nor evaluate all questions and decisions faced in clinical practice. Guideline writers must therefore decide whether and how to generalize from incomplete evidence to care recommendations,” they wrote. – by Alaina Tedesco
Bibbins-Domingo K, et al. JAMA. 2016;doi:10.1001/jama.2016.15450.
Chou R, et al. JAMA. 2016;doi:10.1001/jama.2015.15629.
Redberg RF, et al. JAMA. 2016;doi:10.1001/jamainternmed.2016.7585.
Navar AM, et al. JAMA. 2016;doi:10.1001/jama.2016.15094.
Disclosure: The USPSTF reports support from the Agency for Healthcare Research and Quality. Please see full study or editorials for complete list of all author’s relevant financial disclosures.