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Cholib as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia

The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cholib 145mg/40mg and 145mg/20mg, film-coated tablets, intended to be indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL cholesterol levels when LDL cholesterol levels are adequately controlled with the corresponding dose of Simvastatin monotherapy 20 mg or 40 mg.

The active substances of Cholib are Fenofibrate / Simvastatin; Cholib being a combination of two lipid modifying substances ( HMG-CoA reductase inhibitors in combination with other lipid modifying substances ).
Fenofibrate, a Peroxisome Proliferator-Activated Receptor ( PPAR ) alpha agonist, reduces both, low-density lipoprotein ( LDL ) and very low density lipoprotein ( VLDL ) levels, increases high-density lipoprotein ( HDL ) levels and reduces triglycerides levels.
Simvastatin is an inhibitor of 3-Hydroxy-3-MethylGlutaryl-Coenzyme A ( HMG-CoA ) reductase and has been shown to reduce both normal and elevated LDL cholesterol concentrations.

The benefits with Cholib are the complementary lipid-modifying respective effects of Simvastatin and Fenofibrate.

The approved indication is: Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL cholesterol levels when LDL cholesterol levels are adequately controlled with the corresponding dose of Simvastatin monotherapy.

The most common side effects with Cholib are raised blood creatinine levels, upper-respiratory-tract infection ( colds ), increased blood platelet counts, gastroenteritis ( diarrhoea and vomiting ) and increased levels of alanine aminotransferase ( a liver enzyme ).

Cholib must not be used in people who are hypersensitive ( allergic ) to peanuts, soya lecithin or any of the ingredients of the medicine. It must also not be used in pregnant or breast-feeding women, in people known to have light-induced reactions to fibrates or Ketoprofen, or those who have liver or gallbladder disease, pancreatitis, or moderately or severely reduced kidney function, or who have previously had muscle problems while taking statins or fibrates. ( Xagena )

Source: EMA, 2013

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