A new cure for "bad" cholesterol and pharmacoeconomics
A new tool for the prevention of heart attacks is more effective – and more expensive – than statins
Anna Stavina, XX2 century
A drug to reduce the level of low-density lipoproteins (LDL) – or "bad" cholesterol – reduces the risk of heart attack and some other serious heart problems by 15-20%. This conclusion was reached by scientists who studied the effectiveness of Repatha, a new drug intended for the prevention of cardiovascular diseases.
Classic drugs to combat "bad" cholesterol, statins – for example, Lipitor or Crestor – are cheap. However, not all patients tolerate these medications well, and not all patients prescribe statins leads to the desired results. The use of the drug Repata (INN – evolocumab) produced by the American pharmaceutical company Amgen makes it possible to achieve unprecedented low LDL levels. In addition, a Repata injection (the drug is injected) is enough to do 1 or 2 times a month.
However, the annual Repata rate today costs more than 14 thousand US dollars. Therefore, American insurance companies decided not to include the drug in the list of medicines covered by insurance until evolocumab proves its ability to reduce the risks of developing cardiovascular diseases, and not only the level of LDL. The authors of the new study managed to demonstrate that Repata is effective – but the benefits of its use are not as great as many doctors believed.
Out of every 200 people who receive Repata for two years, three – thanks to this drug – will be able to avoid a heart attack, stroke or death from heart and vascular diseases.
"This is a great advantage," says the head of the new study, Dr. Marc Sabatine from Brigham and Women's Hospital. – For millions of people suffering from cardiovascular diseases, or having a high risk of their development, taking a new drug is worth the investment." But Dr. Donald Lloyd-Jones, a leading specialist in preventive medicine at Northwestern University (USA) and speaker of the American Heart Association, called the results of the work "modest," adding that they were "not quite what we had hoped for or they were counting on it."
The results of the study were published in the publication New England Journal of Medicine (Sabatine et al., Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease). They were also discussed at the conference American College of Cardiology.
Repata and another drug with a similar mechanism of action, Praluent, belong to the group of PCSK9 inhibitors (Proprotein convertase subtilisin-kexin type 9, Eng. proprotein convertase subtilisin / kexin type 9). In 2015 they have been approved for use in patients with a high hereditary risk of hypercholesterolemia or cardiovascular diseases that have already caused a heart attack or other serious problems. The new study examined the effectiveness of Repata in more than 27,500 patients whose LDL concentration exceeded the recommended level of 70 mg / dl, despite taking statins at the maximum dosage.
After two years of taking Repata in combination with statins, the average LDL concentration of volunteers decreased from 92 mg / dl to 30 mg / dl. At the same time, Repata demonstrated its safety – the side effects of taking the drug were comparable to those that occurred against the background of using a placebo. The new drug reduced the combined risk of heart attack, stroke and death from heart disease by about 20%. At least one of these events occurred during follow-up in less than 6% of participants in the experimental group and more than 7% of placebo recipients. With an increase in the duration of taking Repata, the benefits increased – in the second year of using the drug, the risk decreased by 25%. Also, against the background of the use of evolocumab, the frequency of other events decreased by about 15%, for example, hospitalizations for chest pain or due to the need for a procedure to expand the lumen of the arteries.
The last indicator studied in the course of the study has become the subject of special interest from insurance companies. To what extent can the use of Repata reduce the cost of expensive treatment? If this drug is 50 times more expensive than statins, does that mean it's 50 times better?
Representatives of Amgen claim that the effectiveness of the Repata justifies its cost. The developers of the drug even offered insurance companies to reimburse the costs of treating patients who had a heart attack or stroke after six or more months of taking Repata.
Dr. Lloyd-Jones noted: "Perhaps we should use [evolocumab] only in patients from high-risk groups who do not receive sufficient effect from taking statins. At least until the Repata price changes."
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20.03.2017