National characteristics of "cholesterol pills"

Alexey Vodovozov, ABC magazine"Two worlds are two systems," – so in the 70s of the last century, the observers of the International Panorama said about the differences between the USSR and the USA.

Time passed, some differences were erased, but many remained. And in the most unexpected areas and issues. For example, in the problem of prescribing drugs that lower cholesterol in the blood, the so-called statins. The events that are taking place now in our country and in America represent two sides of the same coin.
A look across the ocean

In the medical circles of the United States, the news is being vigorously discussed: The Administration for the Control of Medicines and Food (FDA) has expanded the list of indications for one of the most popular statins in America – Crestor (INN – rosuvastatin).

Now it can be prescribed to healthy people, for preventive purposes. However, three conditions must still be met:

• The first is a man over 50 or a woman over 60.
• The second is smoking or suffering from high blood pressure.
• The third is with an increased level of C–reactive protein in blood plasma (a marker of chronic inflammation).

Additions to the information about the drug were made based on the results of a study conducted under the guidance of a well-known cardiologist, Professor Paul Ridker of Harvard University.  More than 18 thousand patients were divided into two groups: one was given statins for two years, the other was given a placebo, a pacifier.

In the experimental group, there was a 55 percent reduction in the number of heart attacks, a 48 percent reduction in strokes and a 45 percent reduction in aorto-coronary bypass surgery in patients compared with the control group.

The FDA considered this data more than sufficient. Nevertheless, the results of Ridker's study were severely criticized by many leading cardiologists.  They emphasize that the study participants initially had a low risk of developing complications from the cardiovascular system. Dr. Steven Zeiden, a cardiologist at Rockville Center (New York) demonstrates this with the figures from the study: the heart attack rate in the control group was 0.37 percent, that is, 68 patients out of 8901 who took placebo. In the experimental group – 0.17 percent, that is, 31 patients. A 55 percent decrease in relative numbers is only 0.2 in absolute terms, that is, 2 people per thousand. "Statistically, this is significant, but not clinically," Dr. Zeiden concludes.

"It is necessary to take into account the possible long–term consequences of taking such medications," says cardiologist, professor at Stanford University Medical School Dr. Mark A. Hlatky. According to his estimates, the expansion of indications will allow prescribing statins to approximately 6.5 million people, in addition to the 80 million Americans already receiving these drugs. Meanwhile, Ridker's research was completed ahead of schedule, after 2 years instead of 5, as it showed, according to the author, "impressive results".

During this time, it is impossible to track long-term side effects, experts emphasize. And they cite as an example the fate of Bayer's Beikol, an extremely popular statin at the time, which was discontinued in 2001 – among the long-term consequences of its use, 52 deaths associated with the development of a rare muscle pathology were proven.

In February 2010, the authoritative medical journal The Lancet published a meta-analysis of randomized clinical trials on the use of statins, which took into account only large-scale studies with more than 1 thousand patients. It turned out that long-term use of statins (for 4 years) leads to a 9% increase in the risk of developing diabetes, while it was maximum in groups of elderly patients.

The FDA took this analysis into account and required the manufacturers of statins to include this information in the description of the drugs.  But she did not reject the extension of the testimony for the Crestor either.

The other side of the MoonBut if American cardiologists are arguing whether statins should be prescribed for preventive purposes, ours are not yet able to treat patients with them, those whose need for drugs of this group is not in doubt in the world medical community.

As stated with regret in the National Report "All about cholesterol", presented by leading cardiologists of Russia on March 30, 2010, statins do not affect the reduction of mortality from cardiovascular diseases in our country. Although they should have influenced.

There are several reasons. And most of them are not directly related to medicine – with the qualifications, knowledge and experience of doctors. As before, Russian doctors do not favor statins. From 2001 to 2006, the frequency of prescribing these drugs in real clinical practice increased by only 3 percent – from 10.6 to 13.4. Which, of course, is not enough.

And the patients themselves refuse to take statins. There are two main reasons:

1. high cost of treatment (28.8 percent of failures).
2. the drugs do not have a pronounced subjective effect on the patient. He drinks them for a month, three, six months, and does not feel any changes. And the fact that cholesterol levels change in the blood, most patients, unfortunately, do not care.  The vast majority of patients completely stop taking statins after 6 months after their appointment. Is it any wonder that they "don't work"?

Meanwhile, it is the complex drug therapy of high cholesterol in the blood, according to the president of the All-Russian Scientific Society of Cardiology, Academician of the Russian Academy of Medical Sciences Raphael Oganov, that can become the basis for reducing mortality from cardiovascular pathology in our country.

It is long-term statin therapy in combination with fibrates, nicotinic acid, omega-3 polyunsaturated fatty acids and cholesterol absorption inhibitors in the intestine that can become the "gold standard" of treatment. If patients understand that high cholesterol is a real risk factor for the development of many diseases. That it is impossible to correct it only by diet is also proved in international studies conducted in accordance with the requirements of evidence–based medicine.

Until cholesterol control becomes the norm of life for every inhabitant of Russia, we will be ahead of the entire planet in terms of the number of deaths from heart attacks and strokes. But this is preventable mortality, the one that modern medicine is able to influence. There would be a desire on the part of the patient.

Portal "Eternal youth" http://vechnayamolodost.ru02.04.2010