[Effect of simvastatin plus inulin in comparison with simvastatin plus ezetimibe on the treatment of mixed dyslipidemia]. / Efecto de simvastatina más inulina en comparación con simvastatina más ezetimiba en el tratamiento de la dislipidemia mixta.

INTRODUCTION: Mixed dyslipidemia accelerates atherosclerosis and leads to cardiovascular disease and death. Non-soluble fibers such as inulin have been shown to have an effect on dyslipidemia. AIM: To assess the effect of the combination of simvastatin plus inulin in comparison with simvastatin plus ezetimibe in mixed dyslipidemia. MATERIAL AND METHODS: A randomized, double-blind, clinical trial with parallel control group was performed in 60 patients with mixed dyslipidemia, without drug treatment or failure to statins and lifestyle changes. INTERVENTION: simvastatin (20 mg), inulin from agave (7 g) and placebo of ezetimibe, or simvastatin (20 mg), ezetimibe (10 mg) and placebo of inulin from agave, daily at night, for 12 weeks. RESULTS: Both groups decreased total cholesterol (235 ± 29 vs. 182 ± 42 mg/dl; p = 0.001 and 236 ± 31 vs. 160 ± 48 mg/dl; p < 0.001), low-density lipoprotein cholesterol (141 ± 32 vs. 99 ± 34 mg/dl; p < 0.001 and 149 ± 35 vs. 89 ± 43 mg/dl; p < 0.001) and triglycerides (284 ± 117 vs. 214 ± 137 mg/dl; p = 0.027 and 241 ± 81 vs. 180 ± 68 mg/dl; p < 0.001), respectively, for simvastatin plus inulin and simvastatin plus ezetimibe. CONCLUSION: The combination of simvastatin plus inulin reduced total cholesterol, low-density lipoprotein cholesterol, and triglycerides the same as simvastatin plus ezetimibe.

Effect of metformin glycinate on glycated hemoglobin A1C concentration and insulin sensitivity in drug-naive adult patients with type 2 diabetes mellitus.

AIM: This study evaluated the effect of metformin glycinate on glycated hemoglobin A1c (A1C) concentration and insulin sensitivity in drug-naive adult patients with type 2 diabetes mellitus (T2DM). SUBJECTS AND METHODS: A randomized, double-blind, placebo-controlled clinical trial was carried out in 20 patients with drug-naive T2DM. Ten subjects received metformin glycinate (1,050.6 mg) once daily during the first month and force-titrated twice daily during the second month. Ten additional patients received placebo as the control group. Before and after the intervention, metabolic profile including A1C and insulin sensitivity (euglycemic-hyperinsulinemic clamp technique) was estimated. RESULTS: A1C concentrations decreased significantly with metformin glycinate administration (8.0 ± 0.7% vs. 7.1 ± 0.9%, P = 0.008) before and after the intervention, respectively. There were significant differences in changes from baseline of A1C between groups (0.0 ± 0.7% vs. -1.0 ± 0.5% for placebo and metformin glycinate groups, respectively; P = 0.004). A reduction of ≥1% in A1C levels was reached in 60.0% of patients with metformin glycinate administration (P = 0.02). Insulin sensitivity was not modified by the intervention. CONCLUSIONS: Administration of metformin glycinate during a 2-month period showed a greater decrease in A1C concentrations than placebo in a selected group of drug-naive adult patients with T2DM.