Cholib

Cholib (Simvastatin fenofibrate) is a medicine used to improve blood fat levels. It contains two active ingredients, fenofibrate, and simvastatin, and is used in combination with a low-fat diet and exercise 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.

Cholib, known as fat reducing tablets contain the active ingredient Simvastatin Fenofibrate is an agonist of activated alpha receptors of peroxisome proliferators (PPARα), which increases lipolysis and removal of TG-rich atherogenic particles from plasma, activating lipoprotein lipase. Simvastatin inhibits HMG-CoA reductase, which has been shown to reduce both normal and high LDL cholesterol.

The objective of the clinical pharmacology program with the combination was to demonstrate bioequivalence between combination of a fixed dose and mono components. Considering that both medications are widely known, they were not carried out specific pharmacokinetic/pharmacodynamic studies.

The multiple benefits and uses of Cholib tablets have been shown to be more effective than statins taken as monotherapy in reducing blood triglyceride levels and increasing "good" cholesterol levels. In the main study comparing Cholib 145/20 mg with simvastatin 40 mg in 1,050 patients not adequately treated with 20 mg simvastatin monotherapy, triglyceride levels decreased by approximately 36% with Cholib after 12 weeks compared to the reduction 12% observed with simvastatin. In addition, the concentration of "good" cholesterol increased by 7% with Cholib compared to a 2% increase recorded with simvastatin. Another study compared Cholib 145/40 mg with simvastatin 40 mg in 450 patients not adequately treated with 40 mg of simvastatin taken alone. The study found 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 these statins taken alone.

Before initiating Cholib therapy, possible causes of abnormal blood fat levels should be adequately treated and patients should undergo a standard diet to lower these fat levels. Cholib can only be obtained with a prescription and is available in tablet form (145/20 mg and 145/40 mg). The recommended dose is one tablet per day, which must be swallowed whole with a glass of water. Avoid consuming grapefruit juice during Cholib therapy, because grapefruit juice is known to alter the concentration of simvastatin in the blood.

Always use this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist again. For doses regarding the Cholib tablets, the following list will have all the necessary information:

Dose / application

The recommended dose is one tablet a day. Grapefruit juice should be avoided.

The response to treatment should be controlled by determining the levels of lipids in the blood (total cholesterol (GC), LDL cholesterol (LDL-C), triglycerides (TG)).

Special dosing instructions

Elderly patients (65 years and older)

No dose adjustment is required. Cholib is contraindicated in the case of reduced renal function with an estimated glomerular filtration rate of <60 ml/min / 1.73 m 2 Patients with renal dysfunction.

Cholib is contraindicated in patients with moderate to severe renal impairment and an estimated glomerular filtration rate of <60 ml/min / 1.73 m 2. Cholib should be used with caution in patients with mild renal impairment and an estimated glomerular filtration rate of 60 to 89 ml/min / 1.73 m.

Patients with liver failure.

Cholib has not been studied in patients with hepatic impairment and is, therefore, contraindicated in this population.

Children and adolescents

Cholib should not be used in children and adolescents up to the age of 18 years.

Side effects cause treatment interruption in 2% of patients. The most common side effects are affecting the gastrointestinal tract, the musculoskeletal system (muscle pain), and the liver (abnormal liver function tests). Cholib tablets side effects have been shown to include:

Cardiovascular:

Hypotension; angioneurotic edema.

Central:

(0.5-0.9%) headache, fatigue, reduced sleep duration, dizziness, paraesthesia, peripheral neuropathy; (sporadic) cognitive changes.

Dermatological​:

Skin reactions (15% of patients), alopecia.

Gastrointestinal:

Cramps, abdominal pain, constipation, flatulence, nausea, dyspepsia, diarrhea, pancreatitis, vomiting.

Blood:

Anemia: (rare) thrombotic thrombocytopenic purpura, hemolytic uremic syndrome.

Endocrines:

Impotence (Boyd, 1996; Jackson, 1997).

Hepatic:

An increase in transaminase levels (up to three times normal values); hepatitis, jaundice

In the 4S study

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