Daily statins can significantly reduce the risk of a first heart attack, stroke or major heart procedure in otherwise healthy people aged 70 and over, without a corresponding increase in serious adverse effects, according to a landmark clinical trial led by Australian researchers.
The decade-long study is the first large randomized trial specifically designed to answer whether statins can safely prevent cardiovascular disease in older adults who have never previously suffered a major cardiac event.
Researchers at Monash University analyzed almost 10,000 participants aged over 70 who were randomly assigned to receive either a statin or a placebo. Nearly 3,400 GPs across Australia helped recruit participants for the study.
The researchers found that statin treatment reduced the risk of a first major cardiovascular event by about 30%.
The benefit was equivalent to preventing one heart attack, stroke or major cardiac procedure for every 37 people treated for almost six years.
The findings could influence treatment guidelines and encourage doctors to consider statins more routinely for older patients who are otherwise healthy but face an elevated risk of cardiovascular disease.
Adjunct Prof Mark Nelson, a co-author from Monash University’s school of public health and preventive medicine, said the evidence addressed an important gap in medical research.
The risk of serious cardiovascular disease rises substantially with age, he said, while populations are also getting older.
“Our society is ageing, and therefore the burden of disease is increasing,” Nelson said, adding that researchers needed evidence to determine whether preventive treatment worked in this age group.
Older people overlooked in statin research
Statins are already widely prescribed to younger adults who have conditions such as high cholesterol or diabetes that put them at increased risk of cardiovascular disease.
They are also routinely given to people who have already experienced a heart attack, stroke or other major cardiovascular event, regardless of age.
What has remained less clear is whether healthy older adults who have never had such an event should take the drugs preventively.
Nelson said older people had historically been underrepresented in statin research. Four decades ago, cardiovascular disease was viewed largely as a problem affecting middle-aged people, particularly smokers, prompting prevention campaigns to focus heavily on premature deaths.
Older adults can also have multiple illnesses and take several medications, making clinical trials more complicated and raising concerns about potential side effects.
The new trial excluded people whose existing medical conditions made statin treatment inappropriate, those who were not living independently and people who already had a clear medical reason to take the drugs because of previous cardiovascular disease.
No evidence of increased dementia
The study could also reassure older people who have avoided statins because of concerns that the drugs might increase the risk of dementia.
Prof Tom Marwick, a cardiologist at the Royal Hobart Hospital, said misinformation surrounding statins and dementia had contributed to reluctance among some older patients.
The trial found no statistically significant difference in dementia rates between participants taking statins and those receiving the placebo.
Marwick described the research as an important and well-conducted study that provided substantial evidence on the question.
However, he noted that adherence remained a challenge, with more than 15% of participants stopping their assigned treatment during the trial.
Fewer heart events, but no longer healthy lifespan
The researchers cautioned that preventing cardiovascular events did not necessarily translate into a longer or healthier life.
Although participants taking statins experienced fewer major cardiovascular events, the study found no significant difference in disability-free survival between the statin and placebo groups.
In practical terms, the medication reduced serious heart-related events but did not appear to extend the period of life people spent free from disability.
Marwick said this was an important distinction when discussing preventive treatment with older adults.
“We can reduce cardiovascular events, but the health burdens of ageing are less amenable,” he said.
Prof James Chong, a cardiologist at Sydney’s Westmead Hospital, said wider use of statins could nevertheless have a substantial effect on the overall burden of cardiovascular disease.
He suggested the results could give more older patients confidence in taking statins over the long term.
But he also pointed to an important limitation: the trial population was overwhelmingly white and had an average age of about 75.
That means further evidence may be needed before the findings can be assumed to apply equally to older populations around the world.
Researchers call for updated guidelines
The results were published in the New England Journal of Medicine and presented at the European Society of Cardiology Congress in Germany.
Lead researcher Adjunct Prof Sophia Zoungas said the strength of the evidence should prompt a review of existing treatment recommendations.
Researchers said older adults should discuss their individual cardiovascular risk and whether statin treatment is appropriate with their GP rather than assuming that age alone means they should or should not take the medication.
The study does not suggest that every healthy person over 70 should automatically be prescribed a statin. Instead, it provides evidence that preventive treatment can reduce cardiovascular risk in carefully selected older adults without increasing dementia or other major safety concerns.
For an ageing global population, researchers say that evidence could help doctors make more informed decisions about preventing heart attacks and strokes later in life.
