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Health & Medicine for Senior Citizens

New Statin Guidelines Not Supportive of Starting Therapy for Elderly Over 75

The few data available did not clearly support initiation of high-intensity statin therapy for secondary prevention in individuals 75 and older

Nov. 13, 2013 – The new clinical practice guideline released yesterday for the use of statins in the treatment of blood cholesterol in people at high risk for cardiovascular diseases caused by atherosclerosis, or hardening and narrowing of the arteries, that can lead to heart attack, stroke or death, identified four “major groups” to target and at least two of them exclude seniors over age 75. It does, however, “support the continuation of statins beyond 75 years of age in persons who are already taking and tolerating these drugs.”

The American College of Cardiology and the American Heart Association created the new guideline.

The guideline recommends moderate- or high-intensity statin therapy for the four groups of patients for whom it has determined cholesterol-lowering HMG-CoA reductase inhibitors, or statins, have the greatest chance of preventing stroke and heart attacks. :The groups are as follows:

• Patients who have cardiovascular disease;  
• Patients with an LDL, or “bad” cholesterol level of 190 mg/dL or higher;
• Patients with Type 2 diabetes who are between 40 and 75 years of age; and
• Patients with an estimated 10-year risk of cardiovascular disease of 7.5 percent or higher who are between 40 and 75 years of age (the report provides formulas for calculating 10-year risk). 

In terms of clinical practice, physicians can use risk assessment tools in some cases to determine which patients would most likely benefit from statin therapy, rather than focusing only on blood cholesterol to determine which patients would benefit. 

About those age 75 and older

In the report, the panel said the following:

“Fewer people >75 years of age were included in the statin RCTs (randomized controlled trials) reviewed. RCT evidence does support the continuation of statins beyond 75 years of age in persons who are already taking and tolerating these drugs. A larger amount of data supports the use of moderate-intensity statin therapy for secondary prevention in individuals with clinical ASCVD >75 years of age. However, the few data available did not clearly support initiation of high-intensity statin therapy for secondary prevention in individuals >75 years.

“Few data were available to indicate an ASCVD event reduction benefit in primary prevention among individuals >75 years of age who do not have clinical ASCVD. Therefore, initiation of statins for primary prevention of ASCVD in individuals >75 years of age requires consideration of additional factors, including increasing comorbidities, safety considerations, and priorities of care.

“The Pooled Cohort Equations can also provide information on expected 10-year ASCVD risk for those 76 to 79 years of aged that may inform the treatment decision. These factors may influence decisions about cholesterol-lowering drug therapy, especially in the primary prevention setting. Accordingly, a discussion of the potential ASCVD risk reduction benefits, risk of adverse effects, drug-drug interaction, and patient preferences precede the initiation of statin therapy for primary prevention in older individuals.”

 

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The guideline also emphasizes the importance of adopting a heart-healthy lifestyle to prevent and control high blood cholesterol.

“This guideline represents a departure from previous guidelines because it doesn’t focus on specific target levels of low-density lipoprotein cholesterol, commonly known as LDL, or ‘bad cholesterol,’ although the definition of optimal LDL cholesterol has not changed. Instead, it focuses on defining groups for whom LDL lowering is proven to be most beneficial, said Neil J. Stone, MD, Bonow professor of medicine at Northwestern University Feinberg School of Medicine and chair of the expert panel that wrote the new guideline.

“The new guideline uses the highest quality scientific evidence to focus treatment of blood cholesterol on those likely to benefit most.

“The likely impact of the recommendations is that more people who would benefit from statins are going to be on them, while fewer people who wouldn’t benefit from statins are going to be on them,” Dr. Stone said. Doctors may also consider switching some patients to a higher dose of statins to derive greater benefit as a result of the new guidelines.  

The guideline was prepared by a panel of experts based on an analysis of the results of randomized controlled trials. The panel was charged with guiding the optimal treatment of blood cholesterol to address the rising rate of cardiovascular disease, currently the leading cause of death and disability in the U.S.

The panel chose to focus on the use of statins after a detailed review of other cholesterol-lowering drugs.

“Statins were chosen because their use has resulted in the greatest benefit and the lowest rates of safety issues. No other cholesterol-lowering drug is as effective as statins,” said Dr. Stone. He added that there is a role for other cholesterol-lowering drugs, for example, in patients who suffer side effects from statins. 

The report also stresses the importance of lifestyle in managing cholesterol and preventing heart disease. “The cornerstone of all guidelines dealing with cholesterol is a healthy lifestyle,” said Dr. Stone.

“That is particularly important in the young, because preventing high cholesterol later in life is the first and best thing someone can do to remain heart-healthy. On the other hand, if someone already has atherosclerosis, lifestyle changes alone are not likely to be enough to prevent heart attack, stroke, and death, and statin therapy will be necessary.”

In addition to identifying patients most likely to benefit from statins, the guideline outlines the recommended intensity of statin therapy for different patient groups. Rather than use a “lowest is best” approach that combines a low dose of a statin drug along with several other cholesterol-lowering drugs, the panel found that it can be preferable to focus instead on a healthy lifestyle along with a higher dose of statins, eliminating the need for additional medications

“The focus for years has been on getting the LDL low,” said Dr. Stone. “Our guidelines are not against that. We’re simply saying how you get the LDL low is important. Considering all the possible treatments, we recommend a heart-healthy lifestyle and statin therapy for the best chance of reducing your risk of stroke or heart attack in the next 10 years.”

The guidelines are intended to serve as a starting point for clinicians. Some patients who do not fall into the four major categories may also benefit from statin therapy, a decision that will need to be made on a case-by-case basis. 

The expert panel that wrote the report was convened by the National Heart, Lung, and Blood Institute of the National Institutes of Health. At the invitation of the NHLBI, the American Heart Association and American College of Cardiology assumed the joint governance, management and publication of this guideline, along with four other prevention guidelines, in June. Committee members volunteered their time and were required to disclose all healthcare-related relationships, including those existing one year before the initiation of the writing project.

The full text of the report, “2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults,” will be published in future print issues of the of the Journal of the American College of Cardiology and the American Heart Association’s journal Circulation. It will also be accessible today on the ACC website and AHA.

The American College of Cardiology states its mission is to transform cardiovascular care and improve heart health. The College is a 43,000-member medical society comprised of physicians, surgeons, nurses, physician assistants, pharmacists and practice managers. For more information, visit www.cardiosource.org.

The American Heart Association states it is devoted to saving people from heart disease and stroke – America’s No. 1 and No. 4 killers. The Dallas-based association is the nation’s oldest and largest voluntary organization dedicated to fighting heart disease and stroke. To learn more or to get involved, call 1-800-AHA-USA1, visit heart.org.

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