Clinical Research Of The Coadministration Of Statin With Fenofibrate In Patients With Dyslipidemia And Coronary Heart Disease

Objectives To compare lipid levels and high-sensitive C-reactive protein (hsCRP)levels before treatment and after, and to evaluate the safety of8weeks’combined statinand fenofibrate therapy in patients with coronary heart disease whose triglyceride（TG）was unsatisfactorily controlled after statin monotherapy.Methods120patients with coronary heart disease and normal liver and kidney functionwho had taken Statins for more than two months (1.70mmol/L≤TG＜5.65mmol/L) wererandomly selected in China Meitan General Hospital and Beijing Hospital from October2012to December2013. The clinical basic data were recorded，including age，sex，history of smoking，drinking，hypertension and diabetes，the patients’height，weight，and BMI (body mass index，BMI)．The patients took Fenofibrate200mg inthe morning and Statins at night orally. The patients were following up for8weeksduring drug treatment and for an additional four weeks after trail end. SPSS17.0statisticssoftware was used to compare the clinical data，and to evaluated the efficacy and safetyof8weeks’combined statin and fenofibrate therapy. Effectiveness evaluation:1) Changesin the rate of lipid parameters: Changes in the rate of serum lipid parameters before andafter treatment (%)=[(Serum concentration after treatment–baseline serum concentratio-ns)×100%]/baseline concentrations;2) Achievment rate: The target of lipid-loweringtherapy was referenced from China Adult Dyslipidemia Prevention Guide in2007,achievment rate=(the number of achievment cases/total number of cases)×100%;3)Total effective rate: It was referenced from the guiding principles of drug cardiovascularsystem in guidanceprinciple of clinical study which was formulated by Bureau of drugadministration of the Ministry of health in China. Total effective rate (%)=[(the numberof excellence+the number of improvement)×100%]/total number of cases.Any of thefollowing items is defined as effective: The rate of reduction of TC levels≥20%, therate of reduction of LDL-C levels≥20%, the rate of reduction of TG levels≥40%or therise of HDL-C levels≥0.26mmol/L.Any of the following items is defined as improved:the rate of reduction of TC levels≥10%and <20%, the rate of reduction of LDL-Clevels≥10%and <20%, the rate of reduction of TC levels≥20%and <40%or the riseof HDL-C levels≥0.10and <0.26mmol/L. It is defined as invalid if it is not effective, improved or deteriorated. Safety assessment:1)Abnormal laboratory data were recordedwhich have clinical signifince (ALT or AST>3ULN, CK>10ULN, BUN>1.5ULN, orCr>1.5ULN).2) Definition and diagnosis of myopathy was referenced from the adviceof American covege of Cardiology (ACC): Myalgia is defined as the muscle pain orweakness without CK elevation.Myositis is defined as Musculoskeletal symptoms withCK elevation. Rhabdomyolysis is defined as Musculoskeletal symptoms with CKsignificantly increased(>10ULN).3)Adverse reactions were recorded during thetreatment.Results After the combination therapy for8weeks, the levels of TG decreased by49.84%, HDL-C increased by21.57%, non-HDL-C decreased by7.60%and apoA1increased by12.42%significantly compared with the lipid levels before the therapy (P＜0.05). However, TC decreased by0.46%, LDL-C increased by2.88%, apoB decreasedby6.98%and Lp(a) decreased by0.15%, which were not significantly different (P＞0.05). After the8weeks combination therapy, the achievement rate for TG was71.21%,for HDL-C was83.33%, for TC was86.36%, and for LDL-C was93.94%. hsCRPdecreased by35.83%after the8weeks combination therapy significant (P＜0.05).During treatment, six patients suffered from gastrointestinal reaction,one patient sufferedfrom myodynia without rhabdomyolysis, one patient suffered from erythra, one case oftransaminase increased and one case of usea nitrogen increased. After drugdiscontinuation, all were back to normal. The liver and renal function were all normal.During the additional four weeks after drug discontinuation,there was no AE.Conclusions The combined therapy of statin and fenofibrate can improve the lipidprofile of the patiens with coronary heart disease (decrease levels of TC, increase levelsof HDL-C) and improve the achievment rate of serum lipids. The combined therapy ofstatin and fenofibrate is generally safe. The combined therapy of statin and fenofibratecan reduce the level of hsCRP.