What is Cholib - fenofibrate and simvastatin used for?
Cholib is a medicine used to improve blood fat levels. Contains two active ingredients, fenofibrate and simvastatin, and is used in conjunction with a low-fat diet and exercise in order to reduce triglyceride levels (a type of fatty substance) and increase cholesterol levels " good "(HDL cholesterol). Cholib is indicated in adults at high risk of heart disease in which the levels of cholesterol defined as "bad" (LDL cholesterol) are already controlled with the corresponding dose of simvastatin taken alone.
How is Cholib - fenofibrate and simvastatin used?
Before starting therapy with Cholib, the possible causes of abnormal levels of fat in the blood must be adequately treated and patients must undergo a standard diet to lower these levels of fat. Cholib can only be obtained with a prescription and is available as tablets (145/20 mg and 145/40 mg). The recommended dose is one tablet a day, which must be swallowed whole with a glass of water. Avoid consuming grapefruit juice during Cholib therapy, because it is known that grapefruit juice alters the concentration of simvastatin in the blood.
How does Cholib - fenofibrate and simvastatin work?
The active ingredients of Cholib, fenofibrate and simvastatin, act differently and their actions have a complementary effect. Fenofibrate is a "agonist of PPARα". This means that it activates a type of receptor called "receptor activated by the peroxisome alpha proliferator", which is implicated in the metabolism of dietary fat, especially triglycerides. When these receptors are activated, the metabolism of fats accelerates and, in this way, the blood is cleared of "bad" cholesterol and triglycerides. The second active ingredient, simvastatin, belongs to the group of "statins" and reduces total blood cholesterol by blocking the action of HMG-CoA reductase, an enzyme present in the liver involved in cholesterol secretion. Since the liver needs cholesterol to produce bile, the reduced level of cholesterol in the blood stimulates liver cells to produce receptors that take cholesterol from the blood, further reducing its concentration. Blood cholesterol is "bad" cholesterol
What benefit has Cholib - fenofibrate and simvastatin shown during the studies?
Cholib has been shown to be more effective than statins taken on its own in reducing blood levels of triglycerides and increasing levels of "good" cholesterol. In a main study comparing Cholib 145/20 mg with simvastatin 40 mg in 1, 050 patients inadequately treated with simvastatin 20 mg monotherapy, triglyceride levels decreased by approximately 36% with Cholib after 12 weeks compared to the reduction 12% observed with simvastatin. Furthermore, the concentration of "good" cholesterol increased by 7% with Cholib compared to an increase of about 2% recorded with simvastatin. Another study compared Cholib 145/40 mg with simvastatin 40 mg in 450 patients inadequately treated with simvastatin 40 mg taken on its own. The study showed that Cholib induced a greater reduction in triglyceride levels (33% compared to 7%) and an increase in the concentration of "good" cholesterol (6% increase compared to a 1% decrease). In two other studies, Cholib was compared with other statins (atorvastatin and pravastatin) and was more effective than those statins taken alone.
What is the risk associated with Cholib - fenofibrate and simvastatin?
The most common side effects of Cholib are: increased blood levels of creatinine, upper respiratory tract infection (cold), increased platelet count, gastroenteritis (diarrhea and vomiting) and increased levels of alanine aminotransferase (a liver enzyme). For the full list of all side effects reported with Cholib, see the package leaflet. Cholib should not be used in people who are hypersensitive (allergic) to peanuts, soy lecithin or any of the other ingredients of the medicine. It must also not be used in pregnant or lactating women or in subjects who have had light sensitivity reactions while taking fibrates or ketoprofen, with liver or gall bladder disease, pancreatitis or impairment of moderate or severe renal function or that in the past have had muscle problems during treatment with statins or fibrates. For the full list of limitations, see the package leaflet.
Why has Cholib - fenofibrate and simvastatin been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the combination of fenofibrate and simvastatin has been shown to be effective in improving blood fat levels. In all the studies the reduction of triglycerides and the increase in "good" cholesterol were greater with Cholib than with statin therapy alone. The committee also noted that the combination of fenofibrate and simvastatin is already used in clinical practice. As for the safety of Cholib, the side effects reported in the studies were consistent with the knowledge available on the two active ingredients and did not give rise to serious concerns. The Committee therefore decided that Cholib's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Cholib - fenofibrate and simvastatin?
A risk management plan has been developed to ensure that Cholib is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cholib, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information on Cholib - fenofibrate and simvastatin
On 26 August 2013, the European Commission issued a marketing authorization for Cholib, valid throughout the European Union. For more information on Cholib therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 08-2013.
