发明名称 PHARMACEUTICAL COMBINATION COMPRISING SEPARATE DOSAGE FORMS IN A COMPLIANCE PACKAGE OF AN INHIBITOR OF HMG CoA REDUCTASE AND A FIBRIC ACID DERIVATIVE, PROVIDING FOR PATIENT'S COMPLIANCE AND ANTIPATED TO RETAIN EFFICACY, IMPROVE SAFETY AND REDUCE....
摘要 The present invention relates to a pharmaceutical combination comprising an inhibitor of the enzyme 3-hydroxy-3-methyl-glutaryl coenzyme A (HMG CoA) reductase (statin), which is simvastatin, fluvastatin,a torvastatin or cerivastatin and a fibric acid derivative (fibrate), which is fenofibrate, ciprofibrate or bezafibrate, and to a method of administering these medicaments for the treatment of dyslipidemia (especially mixed hyperlipidemia and familial combined hyperlipidemia) in diabetics and non-diabetics.According to the method claimed herein, separate dosage forms of statin-fibrate combinations properly ordered in a common blister card or a dispenser releasing one-tablet-per-day could be an effective approach for the treatment at different days of dyslipidemia, providing for patient's compliance, efficacy in normalising lipid parameters, safety in terms of myopathy and lower cost, as compared to conventional every day treatment.Selection of the statin and the fibrate for combination should depend both on pharmacokinetic (or the formulation characteristics of each drug) and pharmacodynamic properties of drugs. Regarding pharmacokinetic properties, each drug of the combination should eliminate during the day of treatment. In this order, interactions of each other should be avoided. Relating to pharmacodynamic properties, most suitable statin for the combination is one that effectively lowers LDL-cholesterol but also lowers triglycerides. Respectively, most suitable fibrate for the combination is one that effectively lowers triglycerides and raises HDL-cholesterol but also lowers LDL-cholesterol to a certain degree. A combination comprising a statin and a fibrate with pharmacodynamic properties complementry to each other should provide for efficacy at different days of treatment comparable to the efficacy of conventional everyday treatment with the same combination.
申请公布号 GR990100388(A) 申请公布日期 2001.07.31
申请号 GR19990100388 申请日期 1999.11.09
申请人 SPYRIOUNIS MICHAIL DIMITRIOS;ALEXIDIS NIKOLAOU ALEXANDROS 发明人 ALEXIDIS NIKOLAOU ALEXANDROS;SPYRIOUNIS MICHAIL DIMITRIOS
分类号 A61K31/365;A61K31/40;A61K31/405;A61P3/06 主分类号 A61K31/365
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