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Old Mon, Dec-05-16, 07:13
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JEY100 JEY100 is online now
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Default More new guidelines for Statins in primary prevention of CVD

US Preventive Services Task Force Recommendation Statement
November 15, 2016
Statin Use for the Primary Prevention of Cardiovascular Disease in Adults
in JAMA.

Quote:
Abstract
Importance Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States, accounting for 1 of every 3 deaths among adults.

Objective To update the 2008 US Preventive Services Task Force (USPSTF) recommendation on screening for lipid disorders in adults.

Evidence Review The USPSTF reviewed the evidence on the benefits and harms of screening for and treatment of dyslipidemia in adults 21 years and older; the benefits and harms of statin use in reducing CVD events and mortality in adults without a history of CVD events; whether the benefits of statin use vary by subgroup, clinical characteristics, or dosage; and the benefits of various treatment strategies in adults 40 years and older without a history of CVD events.

Conclusions and Recommendations The USPSTF recommends initiating use of low- to moderate-dose statins in adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 10% or greater (B recommendation). The USPSTF recommends that clinicians selectively offer low- to moderate-dose statins to adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 7.5% to 10% (C recommendation). The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating statin use in adults 76 years and older (I statement).



MedPage Today has a regular feature titled Slow Medicine. Here are their comments about these, the ACC/AHA 2013 guidelines, etc.:

Quote:
While setting aside our Slow Medicine dieting principles and indulging over the Thanksgiving holiday, we spent some time pondering the new guidelines issued by the USPSTF on statin use for primary CV prevention. If ever there were a time when we'd be sympathetic to the idea of taking a pill to counteract poor lifestyle decisions, this would certainly be the week.
But even over a second helping of pumpkin pie, we had trouble stomaching the new recommendations.

Before we jump in, we will begin by acknowledging that statins do have well established benefits for primary cardiovascular disease prevention among those at risk for CV disease. In fact, high-quality randomized trials have demonstrated not just that statins improve lipid profiles among individuals without a history of CV disease, but also that they prevent "hard outcomes," including heart attacks, strokes, and all-cause mortality (see JUPITER trial and HOPE trial as examples). There are few other preventive interventions that have been proven to do this, at least with this degree of rigor.
Based on these benefits among those at increased CV risk, the USPSTF made the following new recommendations for use of statins for primary prevention:
The USPSTF recommends initiating low- to moderate-dose statins in adults age 40 to 75 without a history of CVD who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 10% or greater (B recommendation). The USPSTF recommends that clinicians selectively offer low- to moderate-dose statins to adults age 40 to 75 without a history of CVD who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 7.5% to 10% (C recommendation). The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating statin use in adults age 76 and older (I statement).

Mercifully, these new recommendations are generally consistent with the recent ACC/AHA 2013 guideline with respect to statin use for primary prevention. The key difference is that the USPSTF uses a higher bar (higher calculated 10-year CV risk) to recommend discussion of statins for primary prevention.

In spite of the strong data on the benefit of statins coupled with this carefully thought-out USPSTF recommendation, we still think the case is far from closed. Why? Here are some reasons suggested by our good friends from JAMA Internal Medicine.

First, the absolute benefits of statins among those without CV disease are small. According to the JAMA editorial, the absolute benefits are "0.40% for all-cause mortality and 0.43% for cardiovascular mortality" over 5 years, which translates into a number needed to treat of >200. (Still, this is nothing to sneeze at ... the "number needed to screen" with mammography to prevent one breast cancer death over 10 years is approximately 1,000).

Second, because the vast majority of statin trials have been industry-sponsored, we have reason to be skeptical. Companies have yet to share patient-level data for re-analyses. Have all the data been fully presented? Have data raising safety concerns been suppressed?

Third, statins have well-established adverse effects (see Paul Thompson's JAMA Viewpoint), including myalgias, a small increase in diabetes risk, and possible cognitive impairment ... and this is only what has been uncovered from current studies. What if there are longer term effects from using statins for multiple decades?

Fourth, there is some concern that statin therapy provides a false sense of security, promoting complacency about lifestyle choices.

Finally, many experts believe the risk calculator suggested by the ACC/AHA systematically overestimates risk.

Taken together, even in spite of the evidence of benefit for statins in primary CV prevention, one might reasonably have pause when considering whether or not to initiate statins for primary CV prevention. There are still many unknowns about the long-term impact of these medications.


What these new guidelines do embolden us to do, however, is to discourage the use of statins among the many statin users in the U.S. who do not meet the indications laid out by the USPSTF. For example, patients without CV disease who have a 10-year calculated risk of less than 7.5% and adults over 75 years old. (See this JAMA Viewpoint for a useful discussion of statins for primary prevention in older adults.)

And as for those who do meet USPSTF criteria, i.e., adults age 40 to 75 with 1 or more CVD risk factor and a calculated 10-year CVD event risk of 7.5% to 10%? This is a perfect opportunity to discuss the pros and cons of statins for primary prevention. Some may reasonably opt to initiate such treatment while others may decide to double down on lifestyle changes. Either approach would be perfectly reasonable.


"Updates in Slow Medicine" applies the latest medical research to support a thoughtful approach to clinical care. It is produced by Pieter Cohen, MD, of Harvard Medical School, and Michael Hochman, MD, MPH, of the Keck School of Medicine at the University of Southern California. To learn more, visit their website. http://slowmedupdates.com


None of the links copy, and MedPage is subscription, but opening a discussion on Lifestyle Changes seems a reasonable approach.
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