“After vaccines and antibiotics, statins are
the drugs that have saved the most lives
in the history of modern medicine,” says doctor Pablo Corral, former president of the Argentine Lipid Society (SAL).
It talks about the drugs that constitute a
fundamental tool
not only for the control of high cholesterol, but also for atherosclerotic cardiovascular disease, the main cause of death in Argentina and the world.
Despite their effectiveness and safety demonstrated over four decades, statins are
underused
: they are indicated in fewer people than would really need them or in lower doses and rates of non-compliance and abandonment of treatment are high.
These behaviors are largely associated with the bad reputation they have acquired as a result of
myths, misinformation and the overestimation
of their adverse effects.
“That is why it is of utmost importance to recognize and measure these events, in order to avoid greater damage to the benefit sought, as well as
not falling into the overdiagnosis
of intolerance or attributing adverse reactions that are unrelated to the use of statins” , highlights a group of specialists from our country and the region in the Position Document of the Argentine Lipid Society on adverse effects and intolerance to statins.
—Why did you decide to write this position document?
—We found that there was nothing written locally and in Latin America about statin intolerance, which is a relatively common adverse effect, one in 10 patients has it, but it is overstated based on the popular belief of patients about it. these drugs.
And even in the scientific and medical field where it is not very clear how to approach that patient who reports having intolerance or not being able to receive statins adequately due to some adverse effect.
The objective was to prepare a document on this topic based on scientific evidence—
Pablo Corral, first author of the article published in the Revista Argentina de Lípidos in 2023, responded
to Clarín.
—For whom is the use of statins indicated? What is the decision to indicate them based on?
—Statins are indicated basically in any patient who has suffered an ischemic stroke (CVA), an acute myocardial infarction, or who has what is called peripheral arterial disease (who has plaques in the carotids or the arteries of the legs). .
These are the most frequent indications.
When the patient also has a high cardiovascular risk and has not had any type of cardiac event (that is, what is called primary prevention), which includes those who have genetic forms of high cholesterol, diabetes or chronic kidney disease , statins are also indicated in these groups.
The decision is based on a correct clinical examination, history collection and the performance of complementary studies.
The accumulation of cholesterol in the arteries increases the risk of heart attack and stroke.
Shutterstock illustration.
—How underused are statins?
—Unfortunately, only a third of patients receive the appropriate dose and reach the LDL cholesterol targets stipulated by the various national and global guidelines and recommendations.
There is what is called therapeutic inertia and this is the doctors' fault.
There is also a refusal by some patients to take them.
There are a multitude of causes that explain why patients do not take statins and those who do take them often do so in inadequate doses and do not reach the indicated therapeutic goals of LDL cholesterol, which is basically what one should have as their main goal. in the treatment of this group of patients.
Statin intolerance: what it is and how it is diagnosed
The position document admits that the definition of intolerance to statins and the estimation of its prevalence are complex and represent a challenge, “both due to the
difficulty in verifying the symptoms reported
by the patient and the consequences that this diagnosis entails depending on the driving".
In general terms, the authors define intolerance to statins as the presence of
one or more adverse effects
associated with their use.
This intolerance can be complete (the impossibility of ingesting them, regardless of the dose) or partial (the maximum tolerated dose does not reach the necessary decrease to obtain the therapeutic objective).
At the same time, they point out that it is vitally important to highlight
the role of the nocebo effect
, which is defined as the situation in which a patient presents the possible side effects or symptoms produced by a medication or treatment only because he believes they may occur.
“However, this does not make them less clinically relevant,” they clarify.
—What are the most frequent adverse effects?
—The most common adverse effect of statins is myopathy.
Myopathy includes myalgia, which is pain (the patient reports that his muscles hurt and feels like cramps) and myositis, which is pain with elevated muscle enzymes, which is very rare.
—How is statin intolerance diagnosed? Is it based only on the discomfort or symptoms perceived by the patient?
—The way to diagnose intolerance to statins involves a whole process of studies and therapeutic tests that are used depending on what the patient reports.
It begins by analyzing the medical history and background of each of the patients, we must collect reports on the concomitant medication they are taking, rule out that they do not have some type of untreated disorder such as hypothyroidism, vitamin D deficiency. And then we begin to rotate statins. : change the dose, the type of statin, change the time of taking.
This process often takes weeks, even months, until a real intolerance to statins can be diagnosed.
It is not based only on the symptoms that the patient has, but we have a series of studies, including approved tables to be more objective in the diagnosis.
Managing LDL levels is a therapeutic objective.
Photo Shutterstock.
—How much influence does the "nocebo effect" have?
—The nocebo effect has a huge influence because statins are drugs that unfortunately have a very bad reputation, in the sense that any pain, discomfort, muscle ailment, even joint pain, that has nothing to do with statins ends up being attributed to them.
And the reality is that they are drugs that - and this is important to know - changed the natural history of cardiovascular disease.
Statin intolerance: modifiable risk factors
Although there are non-modifiable factors associated with intolerance to statins (women are more vulnerable, as well as those over 80 and people of Asian descent, among others), there are several that can be intervened on and thus mitigate the effects
. adverse effects
of these drugs.
The most common modifiable factors associated with statin intolerance are untreated hypothyroidism, the concomitant use of other drugs with potential interactions with statins, high intensity or recent exercise, severe vitamin D deficiency, obesity, diabetes and kidney failure, as well as the consumption of alcohol, cocaine or amphetamines, or the ingestion of large quantities of grapefruit juice, the SAL document states.
How to manage statin intolerance
“When cholesterol-lowering pills do their job but also harm your muscles, significantly deteriorating your quality of life, what other alternative is used to lower cholesterol and not use statins or fibrates?
The question that a reader sent to the Questions to Buena Vida channel is the same one that many patients ask their doctors.
—Are there strategies to improve tolerance? What percentage of patients respond to them?
-Yeah.
First of all, there are strategies that are based on ruling out everything that is secondary causes of intolerance.
With them, up to 5% of the 10% of people with intolerance improve.
When one makes a real diagnosis of statin intolerance and verifies that the patient is really incapable of receiving statins, there are today other alternative drugs with scientific evidence such as bempedoic acid, which does not act at the muscle level.
Although it does not have the same potency and benefit as statins, it has been shown specifically in this group of patients that replacing statins with this drug does lower cholesterol and prevent cardiac events.
—At what point did you decide to move on to other therapeutic alternatives?
—It is decided to move to a therapeutic alternative when the confirmation is definitive.
The alternatives are bempedoic acid first, generally added to taking ezetimibe, which is another drug that lowers cholesterol levels associated with LDL or low-density lipoprotein.
In other cases you can see if it is necessary to use other types of drugs, such as those for subcutaneous application (inclisiran is applied every six months, and evolocumab every 15 days).
But these are more complex cases, they are not very frequent.
We need to resort to this type of drugs mainly in patients who have already suffered a heart attack or have had a cardiac event and we really verify that they are intolerant to statins.
***
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