2023-11-18 09:19:21
The European Medicines Agency (EMA) approved inclisiran (active ingredient of Leqvio) in 2020. This drug acts on blood cholesterol levels to reduce them. According to what the agency itself states in this informative document, inclisiran is used in patients with primary hypercholesterolemia or mixed dyslipidemia, both ailments that cause high levels of lipids, such as cholesterol, in the blood. In addition, they point out that it should be combined with a low-fat diet.
The Ministry of Health, in response to Infoveritas’ consultation, reports that the Interministerial Commission on Drug Prices decided to begin financing inclisirán on September 20. From the institution’s press department they point out that the medication is used in adults with the aforementioned diseases, along with diet, with a statin (another drug to lower cholesterol) and other similar treatments “in patients who cannot achieve their goals. “LDL-C (bad cholesterol) with the maximum dose of a statin.”
The statin is administered alone or in combination with other lipid-lowering treatments in patients who are intolerant to statins, or for those for whom statins are contraindicated. Following the approval and financing of inclisiran, various messages on social networks and media headlines are reporting the news as if a “vaccine” against cholesterol had begun to be used. And this nomenclature is wrong. At Infoveritas we explain why and give you all the keys to understand how this medication works.
Inclisiran is not a cholesterol vaccine
Dr. Manuel Anguita, spokesperson for the Spanish Society of Cardiology (SEC), explains to Infoveritas why it is wrong to call inclisiran a “vaccine.” First of all, he reasons that the mechanism of vaccines causes the body to produce antibodies “against the substance against which it wants to be vaccinated. In this case, what a supposed vaccine for cholesterol would do is produce antibodies, an immune response of the body , to destroy cholesterol. Just like other vaccines.”
Inclisiran is not a vaccine, it is a drug that lowers blood cholesterol. But it doesn’t end cholesterol. “If it were a vaccine, which would be ideal, there would be no need to take any treatment, because cholesterol would disappear from the blood, which is not appropriate either because cholesterol is necessary for the functions of the entire organism. Of course, at certain levels low,” he points out.
The identification of inclisiran with a vaccine, for this expert, lies in the vaccine against covid-19. This serum against the coronavirus was a protein of the virus that was produced using messenger RNA technology, a protein that this drug also carries. But Leqvio’s “has nothing to do” with the COVID.19 vaccine, it is another type of messenger RNA technology.
How does inclisiran work?
The mechanism of action of inclisiran is based on a “novel, quite intelligent and very specific pathway, which is already being used to develop other drugs in other diseases.” It acts through messenger RNA, as has been said. This acts “as if it were a false RNA that blocks the true messenger RNA, which is the one that carries the information so that a protein called PCSK9 is produced in the liver cells, which causes the blood plasma levels of LDL to increase. cholesterol (bad cholesterol)”, develops Dr. Manuel Anguita.
The protein “traps” bad cholesterol receptors inside the liver cells, which are responsible for eliminating it from the blood “and pass it to the liver so that it is then eliminated through the bile.” “If we are able to block the effect of this protein, through different mechanisms, we achieve an increase in the number of receptors for LDL cholesterol and, therefore, more LDL cholesterol passes from the blood to the liver and reduces plasma levels of LDL cholesterol,” he concludes.
What benefits does it bring?
The main effect that inclisiran has is to lower LDL cholesterol in the blood “by approximately 50% compared to basal levels,” highlights the spokesperson for the Spanish Society of Cardiology. This means that it would practically reduce it to half of what a patient had before starting to administer it. Leqvio, in this sense, is injected subcutaneously twice a year.
The EMA information document states that a total of 3,660 patients participated in three main studies, the main conclusions of which showed the effectiveness of this medicine in reducing levels of bad cholesterol in the blood. “More than 94% of the patients who participated in the studies were also taking statins or other medications to reduce lipid (fat) levels in the blood,” the agency states.
This research involved people with a certain form of hypercholesterolemia that affects families and patients with high levels of bad cholesterol with, in addition, “atherosclerotic cardiovascular disease (in which fatty deposits have accumulated in the blood vessels) or prone to suffering from disease atherosclerotic cardiovascular disease.
Approximately 15 months later, the conclusions “were similar in all studies, and overall, LDL cholesterol levels had decreased by more than 50% in patients treated with Leqvio compared to those who received a placebo,” they emphasize.
Which patients will receive inclusion?
Dr. Manuel Anguita states that, “as it is a very powerful and very expensive medication,” it is mainly indicated in patients with a high cardiovascular risk who, despite oral lipid-lowering treatment, “of which we already have many,” continue to have a higher presence “than they should” of LDL cholesterol in the blood.
“Basically, for people who have already had a coronary problem, a heart attack, angina or a stroke…, and who are taking statins or other oral lipid-lowering treatments” and who, even so, continue to have levels above the recommended cholesterol. “In Spain it will be a hospital prescription drug, and the financing and authorization for it to be prescribed is in patients with these characteristics who have LDL cholesterol above 100 grams per deciliter.”
Furthermore, the spokesperson for the Spanish Society of Cardiology asserts that, after six or eight years of follow-up of these patients, there have been practically no major side effects, “only the local irritation effects derived from the puncture of the injection.”
Likewise, other medications have been available for “seven or eight years, also injectable, and that have the same powerful effect in lowering cholesterol and that act on that PCSK9 protein, but instead of preventing it from being produced, they is synthesized, as inclisiran does, what they do is block its effect. They are called PCSK9 inhibitors “and they have been used in Spain for seven or eight years now, with the same indications that inclisiran will have and with very important safety as well.”
Will it have other possible benefits?
Dr. Manuel Anguita explains, on the other hand, that inclisiran does not yet have studies that have analyzed the risk of having new cardiovascular problems or long-term mortality, “because it is a drug that takes a short time to develop. So, the only thing “What we know is that it lowers cholesterol a lot. There are already studies underway that will tell us in two or three years.”
However, what is known with other medications, he continues, those that have been around for longer and that have the same effect as Leqvio, is that they effectively reduce the incidence of cardiovascular events in the medium and long term; “that is, the risk of heart attack, stroke, etc., and, therefore, improves the prognosis of patients,” he concludes.
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