ABSTRACT
AIMS: Guidelines propose additional therapy to statin to treat elevated triglycerides (TG) and low high-density lipoprotein cholesterol (HDLC) in dyslipidemic patients. We evaluated the effects of new fixed-dose combinations (FDC) of fenofibrate/simvastatin on plasma lipids versus simvastatin or fenofibrate monotherapies. METHODS: Subjects with mixed dyslipidemia at high or very high cardiovascular risk on stable statin therapy for at least 3 months were included in a randomized, double-blind, active-control, parallel-group study. Patients were treated with FDC fenofibrate/simvastatin 145/20 mg or 145/40 mg, simvastatin 20 mg or 40 mg, or fenofibrate 145 mg for 12 weeks. Plasma lipids, C-reactive protein, and cystatin C were measured before and after treatments. Differences in % changes were compared between FDC fenofibrate/simvastatin and monotherapies. RESULTS: Significant differences between FDC fenofibrate/simvastatin and simvastatin monotherapies were observed for the % change of TG (LS mean difference [two-sided 95% CI]: -32.2% [-38.6%, -25.8%], P < 0.001) and HDL-C (7.5% [4.7%, 10.2%], P < 0.001). A significant difference between the FDC fenofibrate/simvastatin and fenofibrate was observed for LDLC % changes (-34.7% [-40.8%, -28.5%], P < 0.001). Significant differences between FDC fenofibrate/simvastatin and their respective monotherapies were also observed for Apo B and non-HDLC % changes. The FDC were well tolerated with a similar safety profile compared with monotherapies. CONCLUSIONS: FDC fenofibrate/simvastatin are effective and well-tolerated therapies to improve the TG and HDLC profile in high-risk patients with mixed dyslipidemia.
Subject(s)
Cholesterol, HDL/blood , Dyslipidemias/drug therapy , Fenofibrate/therapeutic use , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Simvastatin/therapeutic use , Triglycerides/blood , Aged , Biomarkers/blood , C-Reactive Protein/metabolism , Cystatin C/blood , Double-Blind Method , Drug Combinations , Dyslipidemias/blood , Dyslipidemias/diagnosis , Female , Fenofibrate/adverse effects , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Male , Middle Aged , Simvastatin/adverse effects , Time Factors , Treatment OutcomeABSTRACT
Antecedentes. El magnesio participa en numerosas reacciones enzimáticas vitales para el organismo. Objetivo. Identificar la prevalencia de hipomagnesemia (Mg < 1.6 mg/dl), sus características clínicas y su relación con el tratamiento diurético. Material y métodos. Se evaluaron 43 pacientes adultos con diagnóstico de insuficiencia cardiaca congestiva (ICC), clase funcional I-IV, sin daño renal, que recibieran el mismo tratamiento en las cuatro semanas previas al estudio. Se midieron las concentraciones de magnesio, sodio, potasio y calcio. Se registró el tratamiento diurético que estaba recibiendo cada paciente. Resultados. Tuvieron hipomagnesemia siete pacientes (16.2 por ciento) (Mg 1.5 ñ 0.07), los restantes 36 (83.8 por ciento) fueron normales (Mg 2.1 ñ 0.58). Las manifestaciones clínicas no fueron estadísticamente diferentes en ambos grupos. Las concentraciones de potasio y calcio fueron menores en el grupo de hipomagnesemia que en el de magnesio normal. Cuando se utilizó furosemida la concentración de magnesio fue menor en ambos grupos. Conclusiones. En pacientes con insuficiencia cardiaca congestiva la hipomagnesemia es un trastorno común que debería investigarse con más frecuencia por los clínicos debido al riesgo potencial de complicaciones del ritmo cardiaco
