1. PLAVIX HISTORY

How was Plavix discovered?
Plavix, Clopidogrel was discovered by Sanofi-Synthelabo and initially approved for marketing in the European Union in 1998 and in the U.S. in 1997.

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

2. PLAVIX FACTS

Plavix is a product of Sanofi-Synthelabo and Bristol-Myers Squibb Company.
Plavix is the only antiplatelet medication approved by the U.S. Food and Drug Administration to reduce the risk of heart attack, stroke, or vascular death in patients with established peripheral arterial disease (PAD).

3. ABOUT PLAVIX MEDICATION

What is Plavix?
Plavix is a prescription medication that when taken daily can help reduce your risk of having a future heart attack or stroke.

Plavix is recommended for people who have suffered from a recent heart attack or recent stroke, or who have peripheral arterial disease (PAD), poor circulation in the legs, which may cause pain during exercise (such as walking) that is relieved by rest.

Plavix helps keep platelets in the blood from sticking together and forming clots, which helps keep your blood flowing. This helps protect you from a future heart attack or stroke.

Diagram 1

What are platelets?
Platelets are active agents of inflammation when damage occurs to a blood vessel. They are not actually cells, but fragments released by megakaryocyte cells. A megakaryocyte is a large cell in the bone marrow whose function is to produce platelets. When vascular damage (i.e. damage to blood vessels) occurs, the platelets stick to the vascular walls, forming clots to prevent the loss of blood. Thus, it is important to have adequate numbers of normally functioning Platelets to maintain effective coagulation (clotting) of the blood. There are drugs that can potentially alter the platelet count, making it necessary to monitor the count.

What is Platelet aggregation?
Platelets aggregation refers to platelets arriving to and sticking to the site of injury in a vessel. However, in terms of heart health, platelets aggregate at the site of plaque formations along blood vessel walls. This leads to the development of localized blood clots, which further block the flow of blood in the artery.

Diagram 2

Diagram 3

What are antiplatelets?
Antiplatelet drugs are a group of powerful medications that prevent the formation of blood clots.

Antiplatelet drugs protect against myocardial infarction, stroke, cardiovascular death and other serious vascular events in patients with a history of previous vascular events or known risk factors for cardiovascular disease.

Plavix is the most common antiplatelet drug. Other antiplatelet drugs commonly used to treat heart disease include Aspirin and Ticlid.

Antiplatelets are used to treat:

• Coronary artery disease (Coronary artery disease is atherosclerosis of the coronary arteries. Atherosclerosis is when the arteries become clogged and narrowed, restricting blood flow to the heart. Without adequate blood, the heart becomes starved of oxygen and vital nutrients it needs to work properly).
• Heart attack (If taken while an attack is in progress or within 30 minutes of symptoms, antiplatelets may reduce heart damage.)
• Angina (chest pain)
• Stroke and mini-strokes
• Peripheral artery disease

Antiplatelets are also used:

• After angioplasty
• After heart bypass surgery
• To prevent the formation of blood clots in people with atrial fibrillation

How Plavix works?
Plavix works by preventing a natural substance called ADP from binding to its receptors on platelets. ADP is one of the chemicals in the body that cause platelets to clump together and start the process of blood clotting. As Plavix stops ADP from binding to platelets, it reduces the likelihood of clots forming in the blood.

A blood clot that forms inside the blood vessels is known as a thrombosis and can be dangerous, as it can cause a blockage that cuts off the blood supply to an organ. A blockage in the arteries supplying blood to the heart or brain can cause a heart attack or stroke. A blockage in the blood vessels in the extremities, e.g. legs, may result in gangrene.

Blood clot and blockages mainly result from a build up of atherosclerosis on the inside of blood vessels. Atherosclerosis is a build up of cholesterol and fat cells that narrows the blood vessels and makes their interiors rough and bumpy. This makes it more difficult for blood to flow through the vessels, and increases the likelihood of clots forming in the vessels.

People who have already suffered a heart attack or stroke are at risk of having another because of the atherosclerosis in their arteries. People with unstable angina are also at risk of a heart attack because of the atherosclerosis in their arteries. Similarly, people who have narrowed arteries in their extremities, e.g. legs, (peripheral arterial disease) are also at risk of blood clots. These events are known as atherothrombotic events. Plavix is used to prevent blood clots forming within blood vessels, and therefore reduce the risk of further atherothrombotic events in these groups of people.

Diagram 4

 

Diagram 5

4. PLAVIX EFFECTIVENESS

When is Plavix best taken?
After repeated 75-mg oral doses of Plavix , plasma concentrations of the parent compound, which has no platelet inhibiting effect, are very low and are generally below the quantification limit (0.00025 mg/L) beyond 2 hours after dosing. The liver extensively metabolizes Plavix . The main circulating metabolite is the carboxylic acid derivative, and it too has no effect on platelet aggregation. It represents about 85% of the circulating drug-related compounds in plasma.

Following an oral dose of Plavix in humans, approximately 50% was excreted in the urine and approximately 46% in the feces in the 5 days after dosing. The elimination half-life of the main circulating metabolite was 8 hours after single and repeated administration.

Effect of Food: Administration of Plavix (clopidogrel bisulfate) with meals did not significantly modify the bioavailability of Plavix as assessed by the pharmacokinetics of the main circulating metabolite.

Absorption and Distribution : Plavix is rapidly absorbed after oral administration of repeated doses of Plavix 75 mg with peak plasma levels (3 mg/L) of the main circulating metabolite occurring approximately 1 hour after dosing. The pharmacokinetics of the main circulating metabolite is linear in the dose range of 50 to 150 mg of Plavix . Absorption is at least 50% based on urinary excretion of clopidogrel-related metabolites.

Plavix and the main circulating metabolite bind reversibly in vitro to human plasma proteins (98% and 94%, respectively). The binding is nonsaturable in vitro up to a concentration of 100 µg/mL.

Metabolism and Elimination: In vitro and in vivo, Plavix undergoes rapid hydrolysis into its carboxylic acid derivative. In plasma and urine, the glucuronide of the carboxylic acid derivative is also observed.

5. PLAVIX EFFECTS ON SPECIAL POPULATION

How do different people react to Plavix?
Geriatric Patients : Plasma concentrations of the main circulating metabolite are significantly higher in elderly (>75 years) compared to young healthy volunteers, but these higher plasma levels were not associated with differences in platelet aggregation and bleeding time. No dosage adjustment is needed for the elderly.

Renally Impaired Patients: After repeated doses of Plavix 75 mg per day, plasma levels of the main circulating metabolite were lower in patients with severe renal impairment (creatinine clearance from 5 to 15 mL/min) compared to subjects with moderate renal impairment (creatinine clearance 30 to 60 mL/min) or healthy subjects. Although inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy volunteers, the prolongation of bleeding time was similar to healthy volunteers receiving 75 mg of Plavix per day.

Gender : No significant difference was observed in the plasma levels of the main circulating metabolite between males and females. In a small study comparing men and women, less inhibition of ADP-induced platelet aggregation was observed in women, but there was no difference in prolongation of bleeding time. In the large, controlled clinical study, the incidence of clinical outcome events, other adverse clinical events, and abnormal clinical laboratory parameters was similar in men and women.

Race: Pharmacokinetic differences due to race have not been studied.

6. PLAVIX EFFECTS ON MEDICAL CONDITIONS

How does Plavix affect your existing condition/ailment?
As with other anti-platelet agents, Plavix prolongs the bleeding time and therefore should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or other pathological conditions (particularly gastrointestinal and intraocular). If a patient is to undergo elective surgery and an antiplatelet effect is not desired, Plavix should be discontinued 5 days prior to surgery.

Due to the risk of bleeding and undesirable hematological effects, blood cell count determination and/or other appropriate testing should be promptly considered, whenever such suspected clinical symptoms arise during the course of treatment.

GI Bleeding : Plavix was associated with a rate of gastrointestinal bleeding of 2.0%, vs. 2.7% on aspirin. Plavix should be used with caution in patients who have lesions with a propensity to bleed (such as ulcers). Drugs that might induce such lesions should be used with caution in patients taking Plavix.

Use in Hepatically-Impaired Patients : Experience is limited in patients with severe hepatic disease, who may have bleeding diatheses. Plavix should be used with caution in this population.

Use in Renally-Impaired Patients : Experience is limited in patients with severe renal impairment. Plavix should be used with caution in this population.

7. OTHER/ALTERNATE USES OF PLAVIX

What else does Plavix treat?
Plavix is used to reduce risk of atherothrombotic events (e.g. further heart attacks) in people who have had a heart attack or an Ischemic stroke and in people with unstable angina.

8. ADVERSE/SIDE EFFECTS of PLAVIX

What are the side effects of Plavix?
If you experience any of the following serious side effects of Plavix, stop taking Plavix and seek emergency medical attention or notify your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• bloody (or black) vomit or stools;
• severe headache, confusion, or dizziness;
• unexplained bruising or bleeding; or
• bleeding nose.

Other, less serious side effects of Plavix may be more likely to occur. Continue to take Plavix and talk to your doctor if you experience

• upset stomach;
• diarrhea or constipation; or
• headache or dizziness.

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