While around one in three people in the U.S. over the age of 75 are taking statins to lower cholesterol and reduce risk of heart attack, the benefits for older adults without heart disease are not fully understood. The PREVENTABLE trial was established to help answer this question.
This is expected to be the largest-ever health study in older adults with a goal of understanding whether statins can help us live healthily longer. VA is recruiting volunteers nationwide for this trial at select VA facilities across the country. More than 40 VA hospitals are joining 100 sites across the nation to enroll 20,000 participants.
You are invited to join PREVENTABLE to update treatment guidelines and determine if statins can help adults aged 75 and over without cardiovascular disease live better by preventing dementia, disability and heart disease. The study designed to evaluate statins’ effectiveness under real-life conditions, making participation easy for research volunteers.
As a research study participant, you will help us:
- Assess the usefulness of statins for prolonging healthy life years and primary cardiovascular prevention in adults over age 75.
- Understand the usefulness of statins in addressing other common conditions, such as mild cognitive impairment, dementia and physical disability.
Participation in this study is strictly voluntary. You will go through an informed-consent process that ensures you understand the risks and benefits of joining before committing to this study.
What should you expect if you decide to participate?
Participating in PREVENTABLE is easy. You can enroll remotely, receive the study drug via mail and complete follow-up visits by phone. It’s important for you to know the study will last approximately five years.
If you join the trial, you will:
- Have blood drawn.
- Do brief memory and physical tests.
- Have one annual follow-up phone call.
- Be randomized to take the study drug or the placebo.
- Take one pill daily.
You can join the study or learn more (in English and Spanish) by calling 833-385-3899 or by visiting the study website.
Where can I get more information?
The PREVENTABLE website can help you decide to participate or not. Additionally, the nearest VA facility will offer assistance with signing up.
If you are not eligible for the trial but know a Veteran in your life who would be a good fit, please encourage them to read about the trial and sign up for PREVENTABLE.
The VA National Network Coordinating Center, led by Dr. Jacob Joseph, coordinates and assists VA sites and sponsors navigating VA regulations and privacy guidelines. The Center also provides support with central contracting of VA sites, study conduct and data collection, regulatory, privacy regulations and VA site monitoring.
Link to register for weekly PREVENTABLE informational meeting (TUESDAYS 4:00 PM EST).
Link to register for weekly PREVENTABLE informational meeting (SPANISH).
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Will be 74 in January 2025, am experiencing symptoms of dementia
now. Can I be permitted to join the study?
I’m computer illiterate can i still why join.
I have been diagnosed with Dementia at the MCI stage.
I am interested to join in this study/research. I am currently 62 years old (turning 63 this month.
My current medications: Azorvastatin 20mg, Primidone 50mg for my benign tremor, and OTC Naproxyn for my TMJ disorder
Overprescribing Statins
Worst Pills, Best Pills Newsletter article March, 2015
An article in the November 2014 issue of Worst Pills, Best Pills News discussed newly issued prescribing guidelines for statin drugs and criticized the validity of recommending statins for many more patients, especially for preventing a heart attack or stroke in patients who have not previously had one (primary prevention). These guidelines were partly based on a new patient risk calculator that had not been adequately tested and thereby overestimated the 10-year risk of cardiovascular disease for patients, one important factor in deciding whether to prescribe statins.[1]
Since then, a study has been published analyzing the magnitude of this overestimation of risk by comparing the guideline-calculated risk with the actual risk outcomes in 27,500 patients, half of whom had been followed for more than 10 years.[2] The study found that the size of the calculated risk, depending on the particular patient group, varied from 40 to 90 percent higher than the cardiovascular diseases that actually occurred in the patients who had been followed.
Accompanying this study was a commentary by Dr. Steven Nissen of the Cleveland Clinic, criticizing the guideline-setting process and putting the above results into perspective.[3] He stated that the new risk-calculator-based guideline was “overestimating risk by at least 50%. … While statins are valuable drugs, particularly in secondary prevention [for people with previous heart attacks or strokes], they do have downsides, and prudence requires not administering drugs to patients who will likely not benefit. The implications of the overestimation of risk are profound. A 50% overestimation by the guideline risk equations would likely add millions of Americans to the roles [sic] of patients for whom statins are recommended.”
Nissen’s opposition was so strong that he advised the American College of Cardiology and the American Heart Association to promptly revise the guidelines and, before finalizing them, allow public comment to avoid a repeat of the inadequately vetted guidelines.
An editorial in the U.K.’s The Lancet, titled “Statins: New US Guideline Sparks Controversy,” charged that the guidelines systematically overestimated cardiovascular risks and could “therefore lead to overtreatment of a substantial fraction of the 33 million Americans potentially affected by the guideline.”[4]
As discussed before in Worst Pills, Best Pills News, there is much less dispute about the need for statins for those with previous heart attacks or strokes. The controversy of the new guidelines centers on its recommendation of statins for primary prevention. In that case, millions of people needlessly would become statin users, with the risks of these drugs exceeding the often nonexistent benefits for these additional people.
An op-ed in The New York Times summed up this situation, stating the new guideline “essentially declared, in one fell swoop, that millions of healthy Americans should immediately start taking pills — namely statins — for undefined health ‘benefits.’ This announcement is not a result of a sudden epidemic of heart disease, nor is it based on new data showing the benefits of lower cholesterol. Instead, it is a consequence of simply expanding the definition of who should take the drugs — a decision that will benefit the pharmaceutical industry more than anyone else.”[5]
References
[1] New cholesterol treatment guidelines recommend statins for more patients. Worst Pills, Best Pills News. November 2014. /newsletters/view/927.
[2] Cook NR, Ridker PM. Further insight into the cardiovascular risk calculator. The roles of statins, revascularizations, and underascertainment in the Women’s Health Study. JAMA Intern Med. 2014;174(12):1964-1971.
[3] Nissen SE. Prevention guidelines; bad process bad outcome. JAMA Intern Med. 2014;174(12):1972-1973
[4] Editorial: Statins: New US guideline sparks controversy. Lancet. 2013;382:1762-1765
[5] Abramson, J, Redberg, R. Don’t Give More Patients Statins. New York Times. November 23, 2013. http://www.nytimes.com/2013/11/14/opinion/dont-give-more-patients-statins.html
Presently taking a Staten nightly and have been taking for many years turned 80 in August. Use Hines VA
I would like to join the study, however, I have medical appointments on Tuesdays at the same time as the study is scheduled. Is there any way I can join in?
I have Afib and take medication for it. Metropolol, Diltiazem and blood thinner Pradaxa. I am 87 years young. Have had surgery for breast cancer and treatment with radiation. Am I eligible to participate?
Existe en puertorico, donde debe ir si es con cita o
i AM A 85 YEAR OLD U.S. NAVY VETERAN WITH 23 YEARS SERVICE. I ALSO OWNED AND OPERATED A COMPUTER-DRIVE LANGUAGE (18 COMMON LANGUAGES) COMPANY AND SOLD IT TO MY PARTNER IN 1985.
I HAVE EARLY SIGNS OF DIAMANTE, LOSS OF VISION IN MY RIGHT EYE AND SEE ONLY MOVEMENT IN MY LEFT EYE. I HAVE AN INTERNAL HEART PACEMAKER AND ON AN ASSORTMENT OF DRUGS, WHICH I CAN PROVIDE.
I HAVE HAD NY GALL BLADDER REMOVED AND BEEN ON A RESPIRATOR SINCE 2019, (WITH REMOTE MONITORING) DURING THE MY SLEEPING HOURS (9PM TO 6AM). I AM MOBILE, DRIVE A CAR, AND DO OUTSIDE LIMITED WORK IN AND OUTSIDE MY HOME.
This sounds like a beneficial project. I am a MVP already.
This survey was helpful
Firstly, one of the key side effects of taking a statin in people 70 years old and older is mild cognitive impairment, more commonly called brain fog. I can attest to that side effect personally!
Secondly, there have been two recent random clinical trial results released that show no correlation between a reduction in cholesterol and a reduction in heart attacks and death. Those results are not surprising considering that the amount of cholesterol in the blood stream is not the issue. Cholesterol does not stick to the walls of healthy arteries. It will stick to the wall of those arteries when they become inflamed. One of the chief causes of arterial inflammation is the over-consumption of carbohydrates. If the VA wants to study something, then it should be how a person’s diet can impact the level of cardiovascular inflammation and what changes in that diet can reduce the inflammation.
Yes Todd! You are spot on here. Another potential side effect if peripheral neuropathy in statin users. Cholesterol is demonized too much to begin with, but the FIRST thing that should be looked at for heart disease prevention, lowering cholesterol, triglycerides, blood sugar, cognitive function is nutrition, movement/exercise, and a well balanced lifestyle.
Unfortunately, the VA falls in cahoots with the pharmaceutical industry rather that actual integrative patient care.
Are they interested in people who are 90 years old ?
Can you join if you are already taking a statin?
Thanks from Richard Kendall
I am interested in this program. I want to help in any way I possible can. I’m in.
Why are you waiting to age 75? The are plenty of younger veterans with dementia.
I’ll be 77 on December 1, 2024. Physically, I think I’m healthy… not like I once was, but healthy.
I started taking a statin , however I had to stop because it was making the my feet and thighs swell up, so the doctor toke me off the statin and prescribed a water pill ( hydrochlorothiazide ) .Can I still participate in the study ?
Interesting. I have been on and off statins for many years. I have found that being on them for more than 2 or 3 months, results in a noticeable loss of strength. As an example, off of them I can lift my 18 foot garage door up (remember they are on springs) by one hand. On them, I have to use both hands and my body. When going off of them, it usually takes 1 to 2 months before I feel “normal” again. I have had multiple nurses (inside and outside of the VA) tell me that is one of satin’s downsides. Even though my cholesterol readings have always been very good-my Dr is still pushing them
I an 77 years old and take no meds.l am 5 year out from head and neck cancer.
That is fantastic Steve! Congratulations!
I have been taking statin Drugs for ten years. Am I eligible.