Adults aged 75 and older who stopped taking their cholesterol pill were no more likely to die over the next three years than those who kept taking it, according to a randomized trial of 1,160 French patients published this week in the Lancet Healthy Longevity. Every participant was on a statin for prevention only, with no history of heart attack, stroke, or other atherosclerotic cardiovascular disease, and they were recruited through 297 primary care offices across France.
Key takeaways
- After three years, 7.2% of the stop group and 7.9% of the continue group had died, a difference of about 0.7 percentage points in favor of stopping.
- Side effects were just as common either way, reported by 74.0% of those who stopped and 73.1% of those who continued.
- This tested only people with no known heart or artery disease. It says nothing about anyone who has already had a heart attack or stroke.
What the study found
The SAGA/SITE trial, registered as NCT02547883, randomly assigned patients between June 15, 2016 and January 7, 2020 to either continue or stop the statin they had been taking for at least a year. Nobody was blinded. Follow-up ran 36 months.
Median age was 80 years, 66.8% were women, 29.5% had diabetes, and 77.2% had high blood pressure.
At 36 months, 48 of 604 patients (7.9%) in the continuation group and 35 of 484 (7.2%) in the discontinuation group had died. The absolute difference was 0.68 percentage points fewer deaths in the group that stopped (95% CI -3.95 to 2.60), meaning the true effect is very likely somewhere between about 4 percentage points fewer deaths and 2.6 percentage points more. Because the top of that range stayed under the 5 percentage point margin the researchers set in advance, stopping counted as non-inferior to continuing.
Side effects were the same in both arms: 73.1% of the continuation group and 74.0% of the discontinuation group reported an adverse event.
There was no significant difference in major cardiovascular events, including heart attacks and strokes, and quality of life scores stayed the same in both groups.
Dr. Kumar’s take
This trial exists because the observational data pointed the other way. That kind of study cannot separate the drug from the reason people quit it. Patients stop their pills when they get frail or sick. Randomizing removes that trap, and the signal disappears.
Non-inferiority is a narrower claim than most headlines will make of it. The margin was 5 percentage points of three-year mortality, so a trial this size cannot rule out a real but modest harm, and it was not built to. It also ran three years, while a healthy 80-year-old may have a decade left. My look at the statin primary prevention debate covers why the time horizon does most of the work in these decisions.
The enrolled group was also healthier than typical. Fewer than 8% of them died over three years in either arm.
None of this touches secondary prevention. If you have had a heart attack, a stent, a stroke, or documented artery disease, this trial enrolled nobody like you, and the evidence for staying on a statin there remains strong.
What it means for you
If you are over 75, have never had a cardiovascular event, and are on a statin mainly because your cholesterol number was high, this trial gives you and your doctor room to have a real conversation instead of refilling by reflex. That is what the authors themselves argue for.
Age alone is not the deciding factor. Life expectancy, other conditions, how many pills you already take, and whether the drug is causing muscle aches all matter more than your birth year. My review of LDL cholesterol and mortality in older adults covers why the cholesterol number itself becomes a weaker predictor with age.
Do not stop on your own. Bring the trial to your next visit and ask where you fall.