Pravafenix- pravastatin / fenofibrate

What is Pravafenix-pravastatin / fenofibrate?

Pravafenix is ​​a medicine based on the active substances pravastatin and fenofibrate. It is available in green and olive colored capsules containing 40 mg of pravastatin and 160 mg of fenofibrate.

What is Pravafenix- pravastatin / fenofibrate used for?

Pravafenix is ​​indicated for the treatment of adult patients at high risk of heart disease with LDL cholesterol (or bad cholesterol) levels already controlled with pravastatin-only therapy, but who need to further reduce cholesterol levels to improve cholesterol levels. triglycerides (a type of fat).
The medicine can only be obtained with a prescription.

How is Pravafenix- pravastatin / fenofibrate used?

Before initiating therapy with Pravafenix, the treating physician should examine any possible cause of the patient's abnormal cholesterol and triglyceride levels and establish a suitable dietary regimen.
The recommended dose is one capsule a day, taken with the evening meal. The medicine must always be taken with food, as its absorption on an empty stomach is decreased. The patient should have regular blood tests to check the effectiveness of the medicine. The treating physician should stop treatment if an adequate response is not found within three months.

How does Pravafenix- pravastatin / fenofibrate work?

The active ingredients of Pravafenix, pravastatin and fenofibrate, have different actions and complementary effects.
Pravastatin belongs to the "statin" group. It reduces total blood cholesterol by inhibiting the action of HGM CoA reductase, a liver enzyme involved in the production of cholesterol. Since the liver needs cholesterol to produce bile, reduced blood cholesterol levels cause the liver to produce receptors that attract cholesterol in the blood, further reducing its level. The cholesterol attracted in this way is LDL, or "bad" cholesterol.
Fenofibrate is a "PPAR agonist". It activates a type of receptor called "receptor activating the proliferation of peroxisomes type alpha", whose task is to destroy the fats introduced with the diet, and in particular the triglycerides. When the receptors are activated, the breakdown of fat is accelerated, helping to eliminate cholesterol and triglycerides from the blood.

How has Pravafenix- pravastatin / fenofibrate been studied?

Since pravastatin and fenofibrate have been used for many years, in addition to the results obtained from its own studies, the company presented data extracted from the scientific literature.
The company conducted a pivotal study comparing Pravafenix with pravastatin monotherapy in 248 high-risk heart disease patients with abnormal cholesterol and triglyceride levels. The main measure of effectiveness was the reduction in cholesterol levels after 12 weeks (excluding HDL or "good" cholesterol).

What benefit has Pravafenix- pravastatin / fenofibrate shown during the studies?

In the pivotal study, Pravafenix was shown to be more effective than pravastatin alone at lowering non-HDL cholesterol levels. Non-HDL cholesterol levels were reduced on average by approximately 14% in patients who took Pravafenix compared to 6% in patients who took pravastatin alone.

What are the risks associated with Pravafenix- pravastatin / fenofibrate?

The most common side effects associated with Pravafenix (seen between 1 and 10 patients in 100) are abdominal distension (bloating), abdominal pain (stomach pain), constipation, diarrhea, dry mouth, dyspepsia (heartburn), belching, flatulence (gas), nausea, abdominal discomfort, vomiting and an increase in the level of liver enzymes in the blood. For the full list of side effects reported with Pravafenix, see the package leaflet.
Pravafenix must not be used in people who are hypersensitive (allergic) to the active substance or to any of the other ingredients. Pravafenix should not be used in patients under the age of 18 or with severe liver problems, moderate to severe kidney problems, photoallergy or phototoxic reactions (allergic reactions or skin damage caused by "exposure to light) while being treated with fibrates or ketoprofen. It must not be used in patients with gallbladder disease, acute or chronic pancreatitis (inflammation of the pancreas) or with a history of myopathy (muscle problems) or rhabdomyolysis (destruction of muscle fibers) following the administration of statins or fibrates. administered to pregnant or lactating women.

Why has Pravafenix- pravastatin / fenofibrate been approved?

The CHMP reviewed the recently published data on the benefits of the combination of statins and fenofibrate. The committee also noted that Pravafenix was shown to be particularly beneficial in patients with high triglyceride levels and low HDL cholesterol levels. The Committee therefore decided that the benefits of Pravafenix outweigh its risks in this patient group and recommended that it be granted marketing authorization.

Other information about Pravafenix- pravastatin / fenofibrate

On April 14, 2011, the European Commission released to Laboratoires SMB s.a. a "Marketing Authorization" for Pravafenix, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
For more information about treatment with Pravafenix, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 02-2011.

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