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The STAREE study is a randomized controlled trial that involved 9,971 people over 70 years of age with no history of cardiovascular disease, diabetes or dementia to evaluate the effectiveness of atorvastatin in primary prevention of major cardiac events.
The STAREE study, conducted on almost 10 thousand people over 70 without cardiovascular disease, diabetes or dementia, shows that atorvastatin reduces the risk of major cardiovascular events by 30%. But the choice of therapy must be linked to the overall cardiovascular risk and the LDL reduction objective.
Lowering LDL cholesterol with statins can reduce the risk of heart attack and stroke even in people over 70 who have no previous cardiovascular disease, diabetes or dementia. It is the result of the STAREE study, conducted in Australia on 9,971 people and presented at the Congress of the European Society of Cardiology (ESC) in Munich, with contextual publication in the New England Journal of Medicine. The results show a 30% reduction in major cardiovascular events among those who took atorvastatin compared to those who received a placebo. The treatment, however, did not produce a significant difference in disability-free survival. The study thus brings a very concrete question back to the center: when are drugs really needed to lower LDL cholesterol and how do you decide which therapy to use?
LDL cholesterol, what the STAREE study says
The study involved 9,971 people aged 70 or older, without a history of cardiovascular disease, diabetes or dementia. Participants were divided into two groups: one received 40 milligrams of atorvastatin daily, the other a placebo. After an average observation period of 5.9 years, in the group treated with atorvastatin the risk of major cardiovascular events was 30% lower than in the placebo group.
The result therefore mainly concerns the possibility of experiencing events such as heart attack and stroke. However, the research did not reveal a substantial difference between the two groups regarding death, dementia or persistent physical disability. In other words, reducing cardiovascular events did not mean, in the study, living longer without disability.
“The Staree study is the first large randomized controlled trial to examine whether statins can be used for primary prevention in elderly patients, to help them live longer in good health,” explained Sophia Zoungas, lead investigator of the study. Which took into consideration the elderly because until now this age group had not been adequately analyzed to verify the relationship between benefits and risks of the treatment.
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Statins, it's not just the cholesterol value that counts
The study's findings do not mean that all people with high LDL cholesterol should automatically take a statin. The decision depends on the person's overall cardiovascular risk. The LDL value is in fact one of the elements to consider together with the other factors that can increase the probability of developing a cardiovascular disease.
According to Alberico Catapano, President of the SISA Foundation and former professor of Pharmacology at the University of Milan, the statin represents the starting point of therapy for hypercholesterolemia, except in situations of intolerance or failure to take the treatment. "The treatment begins in this way", he explained to Repubblica, "unless there is a clear and documented intolerance to these drugs or a 'phobia' for statins which leads to not taking the therapy". The principle, therefore, is to first evaluate the individual person's cardiovascular risk and then establish what reduction in LDL cholesterol is necessary.
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When other drugs are needed to lower LDL
If the statin alone does not allow you to reach the established goal, other drugs can be added. "If the desired objectives are not achieved, other oral drugs can be added, starting with ezetimibe and moving up to bempedoic acid, in immediate or subsequent association", said Catapano.
The strategy changes especially when the cardiovascular risk is greater and a greater reduction in LDL cholesterol must be achieved. In these cases, according to the expert, "the combination of different oral drugs is essential". And if even this strategy is not sufficient, treatment can be further intensified with PCSK9 inhibitors or other treatments such as inclisiran.
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The bottom line: lower LDL based on risk
The message of the STAREE study therefore concerns above all elderly people without previous cardiovascular events, diabetes or dementia: in this population atorvastatin significantly reduced the risk of major cardiovascular events. But the result is not equivalent to saying that the statin is necessary for all over 70s, nor that the LDL cholesterol value alone is sufficient to decide on a therapy.
The choice must be linked to the overall cardiovascular risk and the LDL reduction objective. When the statin is not enough, other oral medications may be added; in cases where it is necessary to obtain an even greater reduction, the treatment can be further intensified.
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