Statins Effective For Primary Prevention in Old and Very Old

Older adults without cardiovascular disease derive as much benefit from statin therapy as younger patients, with the reduction in CVD risk not coming at the expense of increased adverse events, an observational study shows.

The CVD risk reduction was observed even among the very elderly, which was defined as 85 years and older.

“Considering the increasing burden related to CVD in the aging population, our study results support the prescription of statin therapy for primary prevention of CVD in old and very old adults,” Wanchun Xu, MPhil (University of Hong Kong, China), and colleagues conclude in a paper published online this week in the Annals of Internal Medicine.

While the American College of Cardiology/American Heart Association cholesterol guidelines suggest that a moderate-intensity statin might be reasonable in those 75 years and older with LDL cholesterol levels of 70 to 189 mg/dL, other guidelines reflect the lack of data to inform clinical decisions in older adults. The primary prevention guidelines, for example, do not make any specific recommendations for statin therapy in this older population. Similarly, the US Preventive Services Task Force recently stated the evidence is insufficient to assess the relative risks and benefits of statin therapy for primary prevention in those 76 years and older. 

Guidelines from the European Society of Cardiology and European Atherosclerosis Society also do not have specific recommendations for those ages 75 years and older.

Christie Ballantyne, MD (Baylor College of Medicine, Houston, TX), who wasn’t involved in the study, said the care of older patients still needs to be individualized.

“I will often get a coronary calcium score,” Ballantyne told TCTMD. “At age 75, if their score is 0, or they have a pretty low score, they’re doing pretty darn well. I will also sometimes get an ultrasound to make sure they don’t have a lot of carotid plaque because you’re also worried about stroke and stroke prevention.” For those older patients without subclinical atherosclerosis, “I tell them you’ve got some good genes,” he added.

Ballantyne stressed that LDL cholesterol shouldn’t be the sole determinant of treatment in these older patients. In addition to subclinical disease, risk factors such as diabetes, hypertension, and lifestyle all play into the decision to start a statin in this older group.

“There are individuals with high cholesterol, but their other risk factors are fine, and they end up having zero calcium and no plaque, I'm not sure of the benefits in that patient,” said Ballantyne. “Do you need a statin? If you want to take a low dose of something, that would be fine, but if you're having trouble with it, then I don't think you need it.”

To TCTMD, senior investigator Eric Yuk Fai Wan, PhD (University of Hong Kong), said that starting statins in the elderly in Hong Kong “relies on a comprehensive process that involves cardiovascular risk assessment, evaluation of lipid profile, and shared decision-making between physicians and patients.” At present, he added, “there is no specific consensus on the use of statins for primary prevention in the adults aged over 75 in Hong Kong.”

The results of their study, Wan said in an email, suggest that in patients who meet the criteria for statins, such as those with CVD risk factors, diabetes, and/or elevated LDL cholesterol levels, “advanced age should not serve as a deterrent for potential patients seeking the benefits of statin therapy.” 

No Safety Concerns Observed

Recent analyses have highlighted the benefits of statins in older patients, a group that was largely excluded from the landmark statin trials. These studies have shown that older patients are able to tolerate LDL-lowering therapy and appear to gain as much as their younger counterparts. A large meta-analysis published in 2020 showed that treating adults ages 75 and older with lipid-lowering therapy, which included statins, ezetimibe, and PCSK9 inhibitors, reduced the risk of major atherosclerotic cardiovascular disease (ASCVD) as much as it does in younger patients.

The current study evaluated the treatment effect of statin therapy using electronic health records from the Hong Kong Health Authority. The analysis included adult patients older than 60 years without preexisting cardiovascular disease who met indications for statin therapy between 2008 and 2015. Patients were grouped into three categories: 60 to 74 years (n = 73,427 propensity-matched pairs of statin users and nonusers), 75 to 84 years (n = 21,340 matched pairs), and 85 years and older (n = 2,695 matched pairs).

Overall, use of statin therapy was associated with significant 11%, 6%, and 15% reductions in the primary composite endpoint of MI, heart failure, or stroke in the 60-74, 75-84, and 85 years and older patients, respectively. Over 5 years, the incidence of CVD events was 1.2% lower in statin users ages 75 to 84 years than in nonusers. For those 85 years and up, the incidence of CVD events was 4.4% lower in statin users.

In a per-protocol analysis, which accounted for adherence to treatment during the follow-up period, the relative reductions in the composite CVD endpoint were 23%, 21%, and 35% across the three age categories, respectively. The incidence of CVD events was 5.0% lower in statin users ages 75 to 84 years than in nonusers. In those aged 85 years and older, the incidence of CVD events was 12.5% lower in statin users.

Importantly, use of statins was not associated with an increased risk of myopathies or liver dysfunction in any of the three age groups. “A key argument for not initiating statins in older adults is the adverse events associated with statin therapy,” write Xu and colleagues. Despite those concerns, “our study confirmed the safety” of treatment in this population, they say.

Two ongoing trials should help further clarify the role of statins in elderly patients. The STAREE trial, which is led by Australian researchers, is testing whether atorvastatin 40 mg cuts the risk of ASCVD events in healthy adults 70 years and older. The National Institutes of Health-sponsored PREVENTABLE study also is testing atorvastatin 40 mg in elderly patients, with the primary endpoint being survival free of new dementia or persisting disability and secondary endpoints including key cardiovascular outcomes.