Metabolic effects of fluvastatin extended release 80 mg and atorvastatin 20 mg in patients with type 2 diabetes mellitus and low serum high-density lipoprotein cholesterol levels: a 4-month, prospective, open-label, randomized, blinded—end point (probe) trial

Abstract

Background: Diabetic dyslipidemia is characterized by greater triglyceridation of all lipoproteins and low levels of plasma high-density lipoprotein cholesterol (HDL-C). In this condition, the serum level of low-density lipoprotein cholesterol (LDL-C) is only slightly elevated. The central role of decreased serum HDL-C level in diabetic cardiovascular disease has prompted the establishment of a target of ->50 mg/dL in patients with diabetes mellitus (DM). Objective:The aim of the study was to assess the effects of once-daily administration of fluvastatin extended release (XL) 80 mg or atorvastatin 20 mg on serum HDL-C levels in patients with type 2 DM and low levels of serum HDL-C.Methods: prospective, randomized, point (PROBE) trial was conducted at Endocrinology and Diabetology Service, L. Sacco-Polo University Hospital (Milan, Italy). Patients aged 45 to 71 years with type 2 DM receiving standard oral antidiabetic therapy, with serum HDL-C levels <50 mg/dL, and with moderately high serum levels of LDL-C and triglycerides (TG) were enrolled. After 1 month of lifestyle modification and dietary intervention, patients who were still showing a decreased HDL-C level were randomized, using a 1:1 ratio, to receive fiuvastatin XL 80-rag tablets or atorvastatin 20-rag tablets, for 3 months. Lipoprotein metabolism was assessed by measuring serum levels of LDL-C, HDL-C, TG, apolipoprotein (apo) A-I (the lipoprotein that carries HDL), and apo B (the lipoprotein that binds very low-density lipoprotein cholesterol, intermediate-density lipoprotein, and LDL on a molar basis). Patients were assessed every 2 weeks for treatment corn- Accepted for publication May 4, 2004.Reproduction in whole or part is not permitted. Conclusions: Fluvastatin XL 80 mg and atorvastatin 20 mg achieved mean serum LDL-C (-<100 mg/dL) and apo B target levels (-<100 mg/dL) in the majority of this population of patients with type 2 DM, but mean serum HDL-C level was increased significantly only with fluvastatin--16 patients (32%) in the fluvastatin group compared with none in the atorvastatin group achieved HDL-C levels ->50 mg/dL. The increase in HDL-C in the fluvastatin-treated patients was associated with an increase in apo A-I, suggesting a potential pleiotropic and selective effect in patients with low HDL-C levels. (Curr Ther Res Clin Exp.

The role of clinical pharmacist on lipid control in dyslipidemic patients in North of Jordan

“…Patients who were started on statin therapy or had undergone doubling of a statin dose experienced a decrease in HDL-C levels. This unexpected effect was also reported in other studies [18,19]. The results of three randomized, multicenter clinical studies comparing the effects of atorvastatin and simvastatin on HDL-C were analyzed by Davidson et al (2003); who found that both drugs increased HDL-C consistently at low doses but at higher doses, simvastatin retained its raising effect on HDL-C while atorvastatin showed a negative dose response pattern [18], this may explain our results bearing in mind that majority of our study population were on atorvastatin.…”

Effects of fluvastatin extended-release (80 mg) alone and in combination with ezetimibe (10 mg) on low-density lipoprotein cholesterol and inflammatory parameters in patients with primary hypercholesterolemia: A 12-week, multicenter, randomized, open-label, parallel-group study

“…11 Fluvastatin XL 80 mg/d has been reported to provide comprehensive lipid management with a good safety profile similar to that of placebo in clinical trials across a broad range of patient groups, including the elderly, renal transplant recipients, and patients with type 2 diabetes. [12][13][14] Whereas fluvastatin XL inhibits cholesterol synthesis in the liver, the cholesterol-lowering agent ezetimibe blocks absorption of dietary and biliary cholesterol. Furthermore, ezetimibe 10 mg/d has been reported to have an adverse-event (AE) profile similar to that of placebo in clinical trials.…”

Fluvastatin Sodium Ameliorates Obesity through Brown Fat Activation

“…FS is a statin that functions by reducing cholesterol levels in serum and is a popular drug for treating hypercholesteremia and cardiovascular diseases [23,24,25,26,27,28,29,30,31,32,33]. It has been reported that FS has an anti-obesity and cardioprotective effect [34].…”