Should Elders Take Cholesterol-lowering Drugs (“statins”)

Should Seniors Take Cholesterol-lowering Drugs (“statins”)

Background
Although there is research encouraging people to take drugs called “statins” (such as Crestor, Lipitor, Pravachol, Zocor) to lower their cholesterol and the risk of a heart attack or stroke, how much benefit is there particularly for those over 75 years of age?


What’s the Evidence?
1. Do these drugs lower cholesterol?  Yes.  
Numerous studies demonstrate they reduce total blood cholesterol up to 20% (e.g. from 240 to 192) and bad cholesterol (LDL) up to 28% or more (e.g. from 150 to 108).

2. But, do these drugs reduce heart attacks and deaths?  Yes and No.  
A Cochrane review in 2014 found no reduction in deaths, heart attacks, or strokes for those treated after having been in hospital for a heart attack, for the four months following admission.
A large study in 2011 reviewed results from 26 different studies and found statin treatment reduced the risk of a heart attack, death, stroke from 5.3% [no statin] to 4.5% [took the drug]—only a 0.8% reduction in heart attacks, stroke, etc, which translates into a NNT [Number Needed to Treat] of 200. NNT refers to how many patients must be treated with the drug to prevent one person from having the event (heart attack, stroke, etc.).  The lower the NNT and the closer to “1”, the better.  A NNT of less than “40” is considered beneficial; higher NNT’s are not cost-effective or of much benefit to one individual.    
The British National Institute of Clinical Effectiveness (NICE) in 2008 recommended that patients with elevated lipids but without heart disease should take statins only if their 10-year risk of having a heart attack is greater than 20% (meaning they have a greater than 1 chance in 5 that they will have a heart attack).  [to determine your personal risk, go to http:// hp2010.nhlbihin.net/atpiii/calculator.asp?usertype=prof]
    
3. Do these drugs reduce your risk of having a stroke?  Not much.  See above.
    
4. Are there side-effects from these drugs?   Several side-effects have been described, but tend to be minimized [by the drug companies and doctors]:  muscle aching (30%), more falls, nausea, paresthesias (pins/needles, numbness), confusion, and abnormal liver tests.  Many elders report that their ‘achiness’ disappears when they stop their statin.  Dr. Barbara Roberts has an excellent summary of the pros and cons about ‘statins’ [The Truth about Statins].
Perhaps this is why 50% of people stop taking the drugs within six months.  And, one study has found that low cholesterol in elders over 75years actually increases the risk of dying!

How do You Interpret the Evidence
There is no guarantee that these drugs will prevent heart disease, stroke, or death—they may only reduce the risk.  Therefore, each person must weigh the potential benefits against the risks.  It is difficult to estimate how much gain one person can expect based on studies involving thousands of people.  For some people, a 0.8% reduction in their risk is worth any cost [they are expensive] or irritation.  A 0.8% benefit means that out of 1000 people taking the drug, only eight (8) will avoid a heart attack or stroke or die (in other words, only 45 people instead of 53 will be affected; and the remaining 955 will still not have had a heart attack, stroke, or death).
These drugs seem to benefit most those who:  1) are relatively healthier (meaning they don’t have a lot of other chronic illnesses) and under age 75;  2) have the highest cholesterol levels (over 240);  3) have risk factors for heart disease and/or have already had a heart attack.  But, older seniors with multiple other chronic diseases making them more frail or vulnerable to dying prematurely may not benefit as much.

What Should YOU do?
1. First, identify your healthcare goals (see HealthCare Goals handout).  
This is the most important consideration because it will help guide your decisions about any drug or treatment:  is your goal longevity, or comfort.  For example, if it is comfort only (do nothing which does not improve comfort and avoid anything which might increase pain/suffering), then these drugs may not be appropriate.

2. Assess your current state of health.  
If you are fairly healthy, independent in your daily activities, not taking a lot of medications already, and have a history of heart disease and elevated cholesterol, then – if changing your diet hasn’t helped – taking one of the “statins” may be appropriate, regardless of your age.  
Find out what the actual guidelines are for taking statins and if you meet them.  Know that exercise can decrease your total cholesterol 5% and a high fiber diet can
drop it another 14%!
If you have a number of chronic ailments (diabetes, arthritis, heart failure, emphysema), and depend on others to help you for some daily activities, then you may not benefit from these drugs as much.  Residents of nursing homes are in this category [Both the American Geriatrics Society and the American Medical Directors Association do not recommend statins for seniors over 75].
For those with any dementia (for example, Alzheimer’s), because it is a terminal disease, preserving thinking ability as long as possible should be important – this means avoiding as many drugs as possible (especially any, such as a statin, which could cause more confusion).

3. Put the issue in proper perspective.
The average life expectancy for Americans is now 78 years.  Once you’ve reached that, some say every day is a gift.  Will taking pills give additional days of true comfort or be more of a nuisance and an unwelcome expense?  Is an elder entitled to “eat and do what I want” (within reason) once she reaches that age?  Which is more important to you:  the quality of the years lived or living more years?  
Finally, elders are not simply “older adults”.  Because their bodies metabolize drugs differently, there are more side-effects.  Generally, elders feel better and look better if they take fewer pills.
If you are taking one of these drugs and aren’t sure what to do, stop taking your statin for a month and see how you feel; if you feel better, resume it and see if your symptoms recur.  Then, you be the judge.
Finally, reading Dr. Roberts book, The Truth About Statins, may provide additional perspective.  

References:
1. Bandolier: evidence based healthcare.  Cholesterol & Statins. Oxford University April 2004.
2. Cooper A, O’Flynn N. Risk assessment and lipid modification for primary and secondary prevention of cardiovascular disease: summary of NICE guidance. BMJ 2008;336:1246-48.
3. Afilalo J, et al. Statins for secondary prevention in elderly patients. J Am Coll Cardiol 2008;51:37-45.
4. Strandberg TE. Multifactorial intervention to prevent recurrent cardiovascular events in patients 75 years or older. The Drugs & Evidence-Based Medicine in the Elderly (DEBATE) study: a randomized, controlled trial. Am Heart J 2006; 152:585-92.
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10. Hebert PR, et al. Cholesterol lowering with statin drugs, risk of stroke, and total mortality:  an overview of randomized trials. JAMA 1997; 278:313-21.
11. ALLHAT officers & coordinators. Major outcomes in moderately hypercholeserolemic, hypertensive patients randomized to pravastatin vs usual care. The Antihypertensive and lipid-lowering treatment to prevent heart attach trial (ALLHAT-LLT). JAMA 2002;288:2998-07.
12. Shepherd J, et al. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomized controlled trial. Lancet 2002;360:1623-30.
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14. Frolkis JP, et al. Statin do not meet expectations for lowering low-density lipoprotein cholesterol levels when used in clinical practice. Am J Med 202; 113:625-9.
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16. Behar S, et al. Low total cholesterol is associated with high total mortality in patients with coronary heart disease. The Bezafibrate Infarction Prevention (BIP) Study Group. Eur Heart J. 1997;18:52-9.
17. Beers MH.  Explicit criteria for determining potentially inappropriate medication use by the elderly.  Arch Intern Med. 1997; 157:1531-7.
18. Collins R, et al. Effects of cholesterol-lowering with simvastatin on stroke and other major vascular events in 20,536 people with cerebrovascular disease or other high-risk conditions. Lancet 2004; 363:757-67.
19. Roberts, Barbara.  The Truth About Statins.  2012. Pocket Books.
20. Cholesterol Treatment Trialists’ (CTT) Collaboration.  Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomized trials. Lancet 2010.
21. Vale N, et al. Statins for acute coronary syndrome. Cochrane Database Syst Rev 2014.
22. Han BH, et al. ALLHAT collaborative research group.  Effect of statin treatment vs usual care on primary cardiovascular prevention among older adults. JAMA Intern Med 2017.
23. Choosing Wisely.  AMDA.  Cholesterol drugs for people 75 and older. 2015.

 
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