Author: Eli Lilly Nederland B.V.


Long information

What is it?

Efient is a medicine that contains the active substance prasugrel. It is available as double-arrow-shaped tablets (yellow: 5 mg; beige: 10 mg).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Efient is taken together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention. Acute coronary syndrome is a group of conditions that includes unstable angina (a severe type of chest pain) and heart attack. Percutaneous coronary intervention is an operation used to unblock narrowed coronary arteries (blood vessels in the heart).
The medicine can only be obtained with a prescription.

How is it used?

Efient treatment starts with one 60-mg dose. This is then followed by 10 mg taken once a day, except in patients weighing less than 60 kg, who should take 5 mg once a day. The medicine can be taken with or without food. Patients taking Efient should also take aspirin at a dose prescribed by their doctors. It is recommended that treatment with Efient and aspirin continue for up to a year. The use of Efient in patients below 18 years of age is not recommended because of a lack of information on safety and effectiveness in this age group. Its use is also not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Efient as necessary. In this case, the 5-mg daily dose should be used following a 60-mg starting dose.

How does it work?

The active substance in Efient, prasugrel, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating). Prasugrel stops the platelets aggregating by blocking a substance called ADP from binding to a receptor on their surface. This stops the platelets becoming ?sticky?, reducing the risk of a blood clot forming and helping to prevent a heart attack or a stroke.

How has it been studied?

The effects of Efient were first tested in experimental models before being studied in humans. In one main study Efient, given as a 60-mg starting dose followed by 10-mg ?maintenance? doses, was compared with clopidogrel (another inhibitor of platelet aggregation), both medicines taken in combination with aspirin. The study involved almost 14,000 adults with acute coronary syndrome who were about to undergo percutaneous coronary intervention. The main measure of effectiveness was the reduction in the total number of cardiovascular deaths (deaths due to problems in the heart or blood vessels), heart attacks or strokes. The patients were followed up for an average of 14.5 months.

What benefits has it shown during the studies?

Efient was more effective than clopidogrel at reducing the total number of cardiovascular deaths, heart attacks or strokes. At the end of the study, 9% of the patients taking Efient had died from cardiovascular causes or had a heart attack or stroke (643 out of 6,813) compared with 11% of the patients taking clopidogrel (781 out of 6,795).

What is the risk associated?

The most common side effects with Efient (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haematoma (a collection of blood under the skin or in a muscle), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), rash, haematuria (blood in the urine), bleeding from needle puncture sites, haematoma at puncture sites and bruising. For the full list of all side effects reported with Efient, see the Package Leaflet.
Efient should not be used in people who may be hypersensitive (allergic) to prasugrel or any of the other ingredients. It must not be used in patients who have a condition that causes excessive bleeding, who have had a stroke or transient ischaemic attack (a temporary reduction in the blood supply to part of the brain), or with severe liver problems.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Efient?s benefits are greater than its risks, when co-administered with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention. The Committee recommended that Efient be given marketing authorisation.

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