The American Heart Association (AHA) and the American College of Cardiology (ACC) created a risk calculator that tells physicians and patients when someone should take a statin-type cholesterol-lowering drug. Men in very good health will be told they need statins if they are over 64. You could be a vegetarian, run 5 miles daily, have blood pressure readings of 120/80, total cholesterol of 170, HDL cholesterol of 65 and no diabetes. The ACC/AHA says you need statins anyway! If you are a woman in equally good health and over 70, you too will be told:
“On the basis of your age and calculated risk for heart disease or stroke over 7.5%, the ACC/AHA guidelines suggest you should be on a moderate to high intensity statin.”
In other words, the medical establishment tells healthy older people they need statins, regardless of anything but their age. A new analysis of data from a randomized clinical trial questions that American Heart Association dogma (JAMA Internal Medicine, online, May 22, 2017).
The ALLHAT-LLT Clinical Trial Defies Conventional Wisdom
ALLHAT-LLT stands for the “Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.” This was a carefully planned randomized clinical trial. The people who participated in this study were 65 or older. They had high blood pressure but no obvious signs of heart disease. The study ran from February 1994 until March 2002. Over 500 clinical sites recruited patients.
What They Did:
1,467 patients were randomly assigned to receive 40 mg of pravastatin (Pravachol) and 1,400 patients were randomized to usual care (UC). They were checked at 3, 6, 9 and 12 months for the first year and then every four months thereafter. The study ran for six years.
What They Found:
The subjects were surprisingly compliant. That is to say, most took their blood pressure meds and their statins throughout the clinical trial. Of those assigned to pravastatin, 86% were taking the cholesterol-lowering drug at year 2 and 78% were taking the statin at year 6.
At the end of the trial, the people assigned to pravastatin had mean LDL cholesterol levels of 109. The usual care (UC) group had mean LDL cholesterol levels of 129. Here are the results as reported in JAMA Internal Medicine (online, May 22, 2017):
“There was no benefit of pravastatin for any of the primary and secondary outcomes. For the primary outcome, all-cause mortality, more deaths occurred in the pravastatin group compared with the UC group in both age groups. For participants aged 65 to 74 years, there were 141 deaths in the pravastatin group and 130 deaths in the UC group. For participants 75 years and older, there was a nonsignificant increase in mortality in the pravastatin group, with 92 deaths vs 65 deaths in the UC group.”
The authors go on to discuss the significance of their findings:
“Our study found that newly administered statin use for primary prevention had no benefit on all-cause mortality or CHD [coronary heart disease] events compared with UC in the subset of adults 65 years and older with hypertension and moderate hypercholesterolemia in the ALLHAT-LLT. We noted a nonsignificant direction toward increased all-cause mortality with the use of pravastatin in the age group 75 years and older, but there was no significant interaction between treatment group and age. The use of statins may be producing untoward effects in the function or health of older adults that could offset any possible cardiovascular benefit.”
“Statins may have an effect on the physical or mental functioning of older adults, and studies have shown that any negative effect on function places older adults at higher risk for functional decline and death. Older adults are at increased risk for statin-induced muscle problems…”
Translating This Research into Plain English:
Here is our understanding of the ALLHAT-LLT research. Older people taking pravastatin did not live longer or have fewer heart attacks than those not assigned to the statin drug. There was actually a nonsignificant trend towards more deaths in the 75 and older group if they were assigned to pravastatin.
Another Big Study:
There are surprisingly few large clinical trials that have answered the question of whether healthy older people really do need statins. One trial called PROSPER (Prospective Study of Pravastatin in the Elderly at Risk) attempted to answer that question. Over 3,000 older adults were recruited. They did not have heart disease at the onset of the study. The authors of the JAMA Internal Medicine study noted:
“…the use of pravastatin did not result in significant reductions in CHD [coronary heart disease] or stroke events during a mean 3.2-year follow-up…the mortality rate in the PROSPER participants without CHD at baseline was 8.8% in those receiving placebo vs. 9.6% in those receiving statin therapy.”
Implications of This Research:
As already mentioned, the American Heart Association and the American College of Cardiology make it very clear that all older people need statins. If you use their risk calculator, that means healthy men over 64 need statins. So do healthy women over 70.
One study reported that 28% of people 75 to 79 were taking statins. The researchers noted that over one fifth of those older than 80 were taking statins for primary prevention (American Journal of Cardiology, Nov. 15, 2012). There is growing evidence that doctors and older patients are hopping on the statin bandwagon. In the decade between 2000 and 2012, statin use in octogenarians went from 8.8% to 34.1% (JAMA Internal Medicine, Oct. 2015). These older people had not experienced a heart attack or other vascular event.
The research we have described involves what is referred to as “primary prevention.” That means preventing heart attacks in people who have no heart disease. From these studies, it would appear that older people who have not had a heart attack, stroke or a diagnosis of heart disease do not get measurable benefit from statins.
Do they need statins nevertheless? The ACC and the AHA say yes! If you would like to better understand the recommendations of the ACC and AHA, here is an article we wrote about the risk calculator:
An editorial in the same issue of JAMA Internal Medicine (May 22, 2017) as the report on the ALLHAT results offers a different perspective from the ACC and AHA:
“Statin therapy may be associated with a variety of musculoskeletal disorders, including myopathy, myalgias, muscle weakness, back conditions, injuries, and arthropathies [joint problems]. These disorders may be particularly problematic in older people and may contribute to physical deconditioning and frailty. Statins have also been associated with cognitive dysfunction, which may further contribute to reduced functional status, risk of falls, and disability. The combination of these multiple risks and the ALLHAT-LLT data showing that statin therapy in older adults may be associated with an increased mortality rate should be considered before prescribing or continuing statins for patients in this age category.”
We leave it to you and your physician to review the new data and determine what is best for you. There may be extenuating circumstances that call for statin therapy. If so, your physician should be able to explain them clearly.
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