What is Pravafenix- pravastatin / fenofibrate?
Pravafenix is a medicine based on the active ingredients pravastatin and fenofibrate. It is available in green and olive 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 levels of LDL cholesterol (or bad cholesterol) already controlled with a therapy based on pravastatin alone, but to improve cholesterol levels need to further reduce the levels of triglycerides (a type of fat).
The drug can only be obtained with a prescription.
How is Pravafenix- pravastatin / fenofibrate used?
Before starting Pravafenix therapy, the treating physician should examine every possible cause of abnormal cholesterol and triglyceride levels in the patient and establish a suitable diet.
The recommended dose is one capsule a day, taken during the evening meal. The medicine must always be taken with food, as its absorption on an empty stomach is decreased. The patient should be regularly subjected to blood sampling to verify the effectiveness of the medicine. The treating physician should stop the 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.
Pravastatina is part of the "statin" group. Reduces total blood cholesterol by inhibiting the action of HGM CoA reductase, a liver enzyme involved in cholesterol production. Since the liver needs cholesterol to produce bile, reduced levels of cholesterol in the blood lead the liver to produce receptors that attract cholesterol present in the blood, further reducing its level. The cholesterol attracted in this way is of the LDL type, or "bad" cholesterol.
Fenofibrate is a "PPAR agonist". Activates a type of receptor called "receptor activating the proliferation of alpha-type peroxisomes", whose task is to destroy the fats introduced by the diet, and especially the triglycerides. When the receptors are activated, fat destruction 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 their studies the company presented data extracted from scientific literature.
The company conducted a pivotal study comparing Pravafenix with pravastatin alone on 248 patients at high risk of heart disease with abnormal levels of cholesterol and triglycerides. The main measure of effectiveness was the reduction in cholesterol levels after 12 weeks (excluding HDL cholesterol 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 in reducing non-HDL cholesterol levels. Non-HDL cholesterol levels were reduced by about 14% on average in patients who took Pravafenix compared to 6% in patients who took only pravastatin.
What are the risks associated with Pravafenix- pravastatin / fenofibrate?
The most common side effects associated with Pravafenix (seen in between 1 and 10 patients in 100) are abdominal distension (swelling), abdominal pain (stomach ache), constipation, diarrhea, dry mouth, dyspepsia (heartburn), belching, flatulence (gas), nausea, abdominal discomfort, vomiting and increase in the level of liver enzymes in the blood. For the full list of all side effects reported with Pravafenix, see the Package Leaflet.
Pravafenix should not be used in people who may be hypersensitive (allergic) to the active substance or 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) during treatment 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 administration of statins or fibrates. It must not be given 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 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 given marketing authorization.
Further information on Pravafenix- pravastatin / fenofibrate
On 14 April 2011, the European Commission issued a marketing authorization for Pravafenix to Laboratoires SMB sa, valid throughout the European Union. The marketing authorization is valid for five years, after which it can be renewed.
For more information on treatment with Pravafenix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 02-2011.
