Public Release:  Embargoed news on statins and personal genome services

Annals of Internal Medicine tip sheet for Feb. 11, 2014

American College of Physicians

1. Combo therapy with lower intensity statin may be an alternative to higher-intensity monotherapy for some patients

The recent American College of Cardiology and American Heart Association cholesterol guidelines recommend initiating moderate or high-intensity statin monotherapy for patients with low-density lipoprotein (LDL) cholesterol levels of 4.91 mmol/L or greater to reduce their risk for atherosclerotic cardiovacualr disease (ASCVD), the leading cause of death for both men and women in the United States. The challenge in clinical practice is that some patients do not respond to high-intensity statin monotherapy and adverse effects are common. Researchers reviewed published evidence to compare the clinical benefits, adherence, and harms of a lower-intensity statin combined with another lipid-modifying medication (bile acid sequestrant, ezetimibe, fibrate, niacin, or w-3 fatty acid) with those of higher-intensity statin monotherapy among adults at high risk for ASCVD. Combination therapy with bile acid sequestrants or ezetimibe decreased LDL cholesterol at least as well as higher-intensity monotherapy but data on adverse events was limited. There was insufficient evidence regarding LDL cholesterol reduction when comparing moderated combination therapy with fibrates, niacin, or w-3 fatty acids. The researchers also found insufficient evidence to compare long-term clinical outcomes, such as mortality or acute coronary events. The full review will be published in Annals of Internal Medicine.

Note: The URL will go live at 5:00 p.m. on Monday, February 10 and can be included in news stories. For an embargoed PDF, please contact Megan Hanks or Angela Collom. To interview an author, please contact Stephanie Desmon, 410-955-8665, sdesmon1@jhmi.edu.


2. Personal genome service lack evidence to substantiate findings

Recently, the company 23andMe launched an advertising campaign to promote its $99 Personal Genome Services (PGS) that provides a detailed analysis of a person's genomic data from one saliva sample taken at home and mailed to the company. 23andMe experts claim they can determine a person's predisposition for 254 diseases and conditions from one DNA sample. "Prove it," said the FDA, and halted the company's advertising campaign until it can substantiate its claims. While the dispute between 23andMe and the FDA continues, the author of an editorial being published in Annals of Internal Medicine says lack of evidence is the core problem with PGS. The author writes that the reports are based on genome wide association studies and appropriate screening tests for disease risk is not available for most of the conditions on which 23andMe reports. In addition, the health care system is not prepared for these "educated consumers." For example, how should the health care system handle a healthy 30-year-old man with no symptoms, signs, or family history of the Crohn's disease who requests a colonoscopy because his genetic report says he has many of the genetic variants associated with the disease? The author recommends that 23andMe invest in research that determines the actual clinical value of their tests as would any device maker under FDA jurisdiction.

Note: The URL will go live at 5:00 p.m. on Monday, February 10 and can be included in news stories. For an embargoed PDF, please contact Megan Hanks or Angela Collom. To interview an author, please contact Mike Ferlazzo, 570-214-7410, msferlazzo@geisinger.edu.

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