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1.PRAVACHOL HISTORY
How was Pravachol discovered?

Pravastatin was identified originally in a mold called Nocardia autotrophica by researchers of the Sankyo Pharma Inc in 1989. The pharmaceutical company Bristol-Myers Squibb is presently marketing Pravachol outside Japan.

Note: World-drugs.net sells generic version of Pravachol

Sankyo Pharma Inc focuses on developing new therapies for cardiovascular disease, metabolic disorders, infection and cancer.

3.ABOUT PRAVACHOL MEDICATION
What is cholesterol and what does it have to do with heart disease?

Cholesterol is a waxy, fat-like material that is found in all parts of the body. It comes from two sources: the liver produces it, and we consume it in meat and dairy products.

Cholesterol is a chemical that can do both good and harm in the body. On the good side, Cholesterol plays important roles in the structure of cells and in the production of hormones. But too much Cholesterol in the blood can lead to heart and blood vessel disease. To complicate matters, not all cholesterol contributes to heart and blood vessel problems.

One type, called high-density lipoprotein (HDL) Cholesterol, or "good cholesterol," actually lowers the risk of these problems. High-density lipoprotein (HDL) Cholesterolremove Cholesterol from the bloodstream. The other type, low-density lipoprotein (LDL) Cholesterol, or "bad cholesterol," is the type that threatens people's health. Low-density lipoproteins (LDL) deliver Cholesterol to the body. To travel through the bloodstream, Cholesterol must attach itself to a protein. The combination of a protein and a fatty substance like Cholesterol is called a lipoprotein.

Many factors may contribute to the fact that some people have higher Cholesterol levels than others. A diet high in certain types of fats is one factor. Medical problems such as poorly controlled diabetes, an under active thyroid gland, an overactive pituitary gland, liver disease or kidney failure also may cause high cholesterol levels. And some people have inherited disorders that prevent their bodies from properly using and eliminating fats. This allows cholesterol to build up in the blood.

Treatment for high cholesterol levels usually begins with changes in habits. By losing weight, stopping smoking, exercising more and reducing the amount of fat and Cholesterol in the diet, many people can bring their Cholesterol levels down to acceptable levels. However, some may need to use cholesterol-reducing drugs to reduce their risk of health problems.

While some Cholesterol is needed for good health, too much Cholesterol in your blood can raise your risk of having a heart attack or stroke.

The extra Cholesterol in your blood may be stored in your arteries (blood vessels) and cause them to narrow. (This is called atherosclerosis.) Large deposits of Cholesterol can completely block an artery, so the blood cannot flow through.

If an artery that supplies blood to your heart becomes blocked, a heart attack can occur. If an artery that supplies blood to your brain becomes blocked, a stroke can occur.

Cholesterol Levels:

Total cholesterol level

LDL cholesterol levels

HDL cholesterol levels

What are Cholesterol Lowering agents?

Cholesterol-reducing drugs are medicines that lower the amount of Cholesterol in the blood.

• Bile acid sequestrants

They are drugs that act by binding with the bile produced by the liver. Bile helps the digestion and absorption of fats in the intestine. By blocking the digestion of fats, bile acid sequesterants prevent the formation of Cholesterol. Drugs in this class include:

• Cholestyramine,
• Colestipol, and
• Colesevelam.
• HMG-CoA inhibitors, often called "statins,"

They are drugs that block an enzyme called "3-hydroxy-3-methyl-glutaryl-coenzyme A reductase." This blocks one of the steps in converting fat to cholesterol. These are the most effective cholesterol lowering agents available and in recent years have received increased attention for their benefits beyond helping patients with high Cholesterol. In 2003, researchers reported that people with heart failure but no coronary artery disease received benefits after only 14 weeks of statin therapy. In addition, some research has connected the drugs to reduced risk for depression and dementia.

Drugs in this group include:

They include

Although these drugs are less effective than the statins at lowering total Cholesterol, they may be able to lower the low-density lipoprotein (LDL) Cholesterol while raising the high-density lipoprotein (HDL) Cholesterol. They probably act by inhibiting lipoprotein lipase activity.

4. Niacin, or vitamin B-3, also is effective in lowering Cholesterol levels. Although the normal vitamin dose of niacin is only 20 mg, the dose required to reduce cholesterol levels is at least 500 mg each day. Niacin probably helps reduce cholesterol by inhibiting very low-density lipoprotein (VLDL) secretion in the bloodstream.

How does Pravachol work?

Pravachol decreases the production of LDL cholesterol by blocking the action of the enzyme in the liver (called HMG-CoA reductase) that is responsible for its production. This decreases the amount of cholesterol in the liver cells, which causes them to take up LDL cholesterol from the blood. The decreased Cholesterol production and increased removal of LDL cholesterol from the blood ultimately results in lowered blood Cholesterol levels.

Pravachol is generally more effective if taken at night.

Pravachol also causes a small decrease in the production of other 'bad fats' in the blood called triglycerides, and a small increase in the level of HDL cholesterol. This results in lowered levels of 'bad fats' and raised levels of 'good fats' in the blood.

Pravachol has an important role in the prevention of coronary heart disease. They reduce the risk of excess cholesterol being deposited in the major blood vessels of the heart. Any blockage in the blood vessels limits the amount of blood and therefore oxygen being carried to the heart muscle. In severe cases this can result in a heart attack (myocardial infarction).

Pravachol may also reduce the risk of stroke by decreasing the risk of excess cholesterol being deposited in the blood vessels leading to the brain. These fat deposits can cause blockage and therefore limit blood and oxygen supply to certain parts of the brain.

Pravachol is used to reduce high blood levels of Cholesterol and other fats when these cannot be lowered by diet and exercise alone. This helps to reduce the risk of hardening of the arteries (atherosclerosis) and the problems described above that this could cause. It is important to continue to follow a cholesterol-lowering diet and exercise regime while taking Pravachol.

4.PRAVACHOL EFFECTIVENESS
When is Pravachol best taken?

Pravachol is administered orally in the active form. In clinical pharmacology studies in man, Pravachol is rapidly absorbed, with peak plasma levels of parent compound attained 1 to 1.5 hours following ingestion. Based on urinary recovery of radiolabeled drug, the average oral absorption of Pravachol is 34% and absolute bioavailability is 17%. While the presence of food in the gastrointestinal tract reduces systemic bioavailability, the lipid-lowering effects of the drug are similar whether taken with, or 1 hour prior, to meals.

5.PRAVACHOL EFFECTS ON SPECIAL POPULATION
How do different people react to Pravachol?

Nursing Mothers

A small amount of Pravachol is excreted in human breast milk. Because of the potential for serious adverse reactions in nursing infants, women taking Pravachol should not nurse.

Pediatric Use

The safety and effectiveness of Pravachol in children and adolescents from 8-18 years of age have been evaluated in a placebo-controlled study of two years duration. Patients treated with Pravachol had an adverse experience profile generally similar to that of patients treated with placebo with influenza and headache commonly reported in both treatment groups. Doses greater than 40 mg have not been studied in this population. Children and adolescent females of childbearing potential should be counseled on appropriate contraceptive methods while on Pravachol therapy.

Double blind, placebo-controlled Pravachol studies in children less than 8 years of age have not been conducted.

Geriatric Use

Two secondary prevention trials with Pravachol included a total of 6,593 subjects treated with Pravachol 40 mg for periods ranging up to 6 years. Across these two studies, 36.1% of Pravachol subjects were aged 65 and older and 0.8% was aged 75 and older. The beneficial effect of Pravachol in elderly subjects in reducing cardiovascular events and in modifying lipid profiles was similar to that seen in younger subjects. The adverse event profile in the elderly was similar to that in the overall population. Other reported clinical experience has not identified differences in responses to Pravachol between elderly and younger patients.

6.PRAVACHOL EFFECTS ON MEDICAL CONDITIONS
How does Pravachol affect your existing condition/ailment?

Pravachol should not be used in case of active liver disease.

7.OTHER/ALTERNATE USES OF PRAVACHOL
What else does Pravachol treat?

Pravachol is used to reduce the amounts of LDL (bad) cholesterol, total cholesterol, triglycerides (another type of fat), and apolipoprotein B (a protein needed to make cholesterol) in your blood. Pravachol is also used to increase the level of HDL (good) cholesterol in your blood. These actions are important in reducing the risk of hardening of the arteries, which can lead to heart attacks, stroke, and peripheral vascular disease.

8.ADVERSE/SIDE EFFECTS of PRAVACHOL
What are the side effects of Pravachol?

Pravachol is generally well tolerated; adverse reactions have usually been mild and transient. In 4-month long placebo-controlled trials, 1.7% of Pravachol treated patients and 1.2% of placebo-treated patients were discontinued from treatment because of adverse experiences attributed to study drug therapy; this difference was not statistically significant.

All adverse clinical events reported in more than 2% of Pravachol treated patients in placebo-controlled trials of up to 4 months duration are identified in the table below; also shown are the percentages of patients in whom these medical events were believed to be related or possibly related to Pravachol:

Events of probable, possible, or uncertain relationship to study drug that occurred in <1.0% of Pravachol treated patients in the long-term trials included the following; frequencies were similar in placebo-treated patients:

Dermatologic : pruritus, dermatitis, dryness of skin, scalp hair abnormality (including alopecia), urticaria.

Endocrine/Metabolic : sexual dysfunction, libido change.

Gastrointestinal : decreased appetite.

General : fever, flushing.

Immunologic : allergy, edema head/neck.

Musculoskeletal : muscle weakness.

Nervous System : paresthesia, vertigo, insomnia, memory impairment, tremor, neuropathy (including peripheral neuropathy).

Special Senses : lens opacity, taste disturbance.