chapter from the book «Great medications: In the struggle for life»
Unfortunately, cardiovascular disease (CVD) have become major killers of people all around the world - each year die from them about 12 million people.According to official statistics, their "contribution" in Russian mortality has already reached 57%.And most often caused by atherosclerosis, which occurs due to increased cholesterol levels.
According to the State Research Center of Preventive Medicine, 60% of the adult population of Russia are increasing the concentration of total cholester
In fact, cholesterol - a substance needed by the body for a number of critical processes.For example, synthesized on the basis thereof and sex hormones adrenal hormones (corticosteroids).Therefrom by chemical reactions in the liver, bile acids are formed, which is not possible without the normal digestive process.Cholesterol is a part of cell membranes.However, an excessive amount thereof in the blood (hypercholesterolemia) leads to the formation of atherosclerotic plaques in blood vessels, atherosclerosis develops.
With continuing high level of cholesterol plaque grows increasingly narrowing the lumen and disrupting blood flow in the body.Over time it is impregnated protein substances, calcium.The surface of the plaque may be inflamed and rupture.When you break the plaque in the vessel lumen output active substances promoting platelet agglutination, the formation and growth of the thrombus.When a blood clot completely blocks the lumen of the vessel, develops an acute oxygen starvation of the body - ischemia.Acute ischemia of the heart muscle leads to myocardial infarction, acute cerebral ischemia - a stroke.
results of numerous epidemiological studies have shown that there is a direct correlation between cholesterol levels and the probability of developing coronary heart disease and myocardial infarction.When scientists realized this, it began to look for treatments that can affect one of the root causes of vascular events - high cholesterol.
Initially it was found that a large role in reducing the level of "bad" cholesterol (LDL or) plays power.Indeed, a change in the direction of healthy food often leads to a decrease of this parameter in the blood.Yet there comes a time when the vast majority of patients with hypercholesterolemia require drug therapy.Today, according to the latest European, American and Russian recommendations, the first-line drugs in the treatment of hypercholesterolemia are statins.They block the liver enzyme that is used for the production of cholesterol by the body.When cholesterol is made smaller, the liver takes more cholesterol from the blood.This leads to a decrease in its level in blood.
Statins block a liver enzyme that is used by the body to produce cholesterol.
statins appeared in the pharmaceutical market relatively recently - in the mid-80s of the last century.In 1982, scientist Bruce Roth begins the study of statins in the laboratory of the company Parke-Davis / Warner-Lambert.Three years later, he managed to synthesize a new substance, which was given the code name CI 981, and subsequently - international non-proprietary name (INN) "atorvastatin".More than ten years of clinical trials lasted a new substance.
Like all statins, the brainchild of Bruce Roth works by inhibiting the action of HMG-CoA reductase - an enzyme that is in the liver and plays a key role in the production of cholesterol in the body.As they say, nothing new.And yet, in its preparation of popularity far outstripped all competitors.What is the secret?
Its popularity is due to the crazy huge amount of research around the world, which could prove highly effective medicines (decrease in the average value of LDL reaches 39-60%) in various diseases.This was the deliberate policy of the company - so to speak, to crush competitors killer evidence from comparative studies.And it succeeded.According
drug "Lipitor" done a lot more research than on any other statin.In total, its evidence base includes more than 400 studies involving more than 80,000 patients worldwide.As a result of numerous clinical trials it revealed that "Lipitor" is able to significantly reduce not only the number of cardiovascular events - heart attacks and strokes, but overall mortality in a huge number of patients.
name "Lipitor" medicine received only in 1996 when Warner-Lambert and Pfizer, have signed an agreement on a joint withdrawal of the drug on the market.
first country where "Lipitor" has been approved for use and placed on the market, was the United Kingdom (1997).Just a few months there was a cure, and in the United States.In general, "Lipitor" is the fifth statin approved by the FDA for the treatment of patients with high cholesterol.While market leadership belonged to simvastatin, which is produced under the brand name 'Zocor'.Well, the very first statin, appeared on the market, has become a "Lovastatin" (1987).
By drug "Lipitor" done a lot more research than on any other statin.
atorvastatin, known in our country as "Lipitor", was not the first drug of this group.Even today, he is not the only one.However, its ability to effectively lower the cholesterol level today has made him one of the most popular among many patients and physicians.
In late 1997, the long-term prognosis for "Lipitor" predicted peak sales of $ 6 billion. However, as a result of the drug is the first prescription pharmaceutical product, reached in the course of the year sales of $ 10 billion. However, his financial success was just beginning.And in 2000, the company absorbed Pfi zer company Warner-Lambert.
In 2004, the list of indications for use "Lipitor" was first extended, and it began to be used not only to lower cholesterol.Based on the FDA approved the research "Lipitor" to reduce the risk of heart attack, treatment of angina pectoris, as well as for revascularization procedures in patients with normal or even slightly elevated cholesterol levels, if those there are numerous factors of cardiovascular risk.
A year later, in the list of indications for use "Lipitor" added the decline in the risk of stroke and heart attack in people with diabetes type 2 without evidence of heart disease, but with the additional risk factors.In 2007, "Lipitor" allowed to prescribe to patients with heart failure to reduce the risk of heart attacks and strokes, as well as its use in stroke, transient ischemic attacks and a number of operations on the heart.
Numerous studies have shown that the use of "Lipitor" effective coronary angioplasty (surgery on the heart vessels) reduces the incidence of complications in patients with coronary heart disease and atherosclerosis in postmenopausal women.It prevents the development of cardiovascular complications in patients with diabetes.Significantly reduces mortality in patients with coronary heart disease.It prevents the risk of recurrent ischemic stroke ...
To date, scientists have strong evidence that the use of the drug in combination with diet reduces the risk of heart attack, stroke and even save people from a series of heart surgeries, as well as relieves chest pain in people with heartdiseases;It reduces the risk of complications during and after operations on the coronary vessels.In the world, doctors prescribe this drug to patients with multiple factors for heart disease risk (such as family history, high blood pressure, age, low level of "useful" cholesterol, or smoking), to reduce the risk of vascular events.In cases where compliance with the prescribed diet and exercise is not enough, along with it to lower cholesterol in the blood is taken, "Lipitor".
Today "Lipitor" was the proud title of prescription drug number one in the world in terms of revenue generation;prescription drug protivoholesterinovogo brand number one in the world and prescription drug brand number one in the US.
That numerous studies of the drug "Lipitor" later became the basis of the updated recommendations for treating patients with a wide variety of conditions.For example, the guidelines for clinicians was last modified in 2006, which is now instructed to carry out secondary prevention statin patients, even at a relatively low level of cholesterol.In addition, there are new recommendations of the American diabetologists Association (ADA) in 2007, supporting the use of statins in patients aged 40 years or older with diabetes and lack of cardiovascular disease but with risk factors for their development.
To date, 400 spent on the drug "Lipitor" research outcomes for cardiovascular disease 11 belong to the category of innovation.Six of them have influenced the science of statins and helped bring new information to the management of various medical associations (including the American Heart Association, the American Association for the Study of Stroke, the National Cholesterol Education Program, American Association of Diabetes and the European Society of Cardiology, the European Association for the Study ofdiabetes, the European society of hypertension, and so on.).In addition, 20 studies have completely changed the idea of doctors about the possibilities of lipid-lowering therapy.
creators of "Lipitor" indicate that the drug's effectiveness is confirmed by its use in clinical practice for more than 20 years and more than 230 million (!) Person-years.
Today "Lipitor" was the proud title of prescription drug number one in the world in terms of revenue generation;prescription drug protivoholesterinovogo brand number one in the world and prescription drug brand number one in the US.In addition, "Lipitor" has become the most commonly prescribed pharmaceutical drug in the world, used to reduce total cholesterol levels in the blood.
Since 1997, the total profit from sales of the drug reached $ 126 billion - a quarter of all revenues biopharmaceutical giant Pfizer.
November 30, 2011 Pfizer patent for the exclusive production of "Lipitor" is ended, and other companies were able to produce its generic drugs (analogs).Atorvastatin is marketed under various trade names already in 137 countries.
Meanwhile, "Lipitor" molecule inventor Bruce Roth received for his discovery of many different prestigious awards.In 2008, the American Chemical Society awarded him the title of Hero of Chemistry.
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