Source: DGNews  |  Posted 7 years ago

By Chris Berrie

VENICE, ITALY -- October 26, 2004 -- Daily fluvastatin extended-release (XL) appears to increases significantly the mean serum levels of high-density lipoprotein cholesterol (HDL-C) and apolipoprotein A-I (apo A-I) in patients with type 2 diabetes mellitus with low baseline HDL-C levels, according to a 4-month, prospective, open-label, randomised, blinded-end-point study.

In addition, fluvastatin promotes target mean low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (apo B) levels in these patients, researchers reported here on October 25th at the XV International Symposium on Drugs Affecting Lipid Metabolism.

"One of the major problems at present for diabetic patients with low HDL-C levels is that they are severely compromised in terms of cardiovascular pressure, and previous studies have only investigated the effects of statins in mixed populations of diabetics, with both normal and decreased HDL-C," said Dr. Maurizio Bevilaqua, PhD, principal coordinator, director, endocrinology and diabetology service, L. Sacco Polo University Hospital, Milan, Italy.

Dr. Bevilaqua and colleagues therefore conducted a study to assess the effects of once-daily fluvastatin XL 80 mg specifically in type-2 diabetics with HDL-C levels below 50 mg/dL and mixed dyslipidemia. As atorvastatin is known to be neutral in its effects on HDL-C, they compared fluvastatin XL to atorvastatin 20 mg.

The researchers enrolled 100 patients who were diagnosed with diabetes mellitus at least 12 weeks before study enrolment. Patients' were 45 to 71 years of age and were receiving standard oral antidiabetic therapy. Patients' serum levels of HDL-C were below 50 mg/dL, LDL-C levels were 150-300 mg/dL, and triglycerides (TG) were above 200 mg/dL.

After 4 weeks on the National Cholesterol Education Panel step I or step II diet, 50 subjects were randomised to receive fluvastatin XL 80 mg/day and 50 to atorvastatin 10 mg/day for 3 months. The 2 groups had no significant differences in baseline demographic and clinical characteristics.

Results show that 32% of fluvastatin XL patients and none of the atorvastatin patients achieved HDL-C levels of 50 mg/dL or greater after 12 weeks of treatment. The fluvastatin XL group showed a significant 12% increase over baseline in HDL-C (46 vs 41 mg/dL, respectively; P <.05).

In addition, the fluvastatin group had a significant 5% increase in levels of apo A-I (124 vs 118 mg/dL, respectively; P <.05) that was also not seen with atorvastatin.

There were significant decreases from baseline in LDL-C in the fluvastatin XL group (36%; P <.01) and in the atorvastatin group (40%; P <.01). Both groups also had significant decreases in levels of TG (40% vs 46%, respectively; P <.01) and apo B (30% vs 30%, respectively; P <.05).

Both treatments were well tolerated, and there were no significant changes in serum creatine phosphokinase or liver enzyme activities in either group.

Dr. Bevilaqua stressed the importance of these findings given that diabetic dyslipidemia is likely the main cause of cardiovascular mortality in patients with diabetes mellitus. He also noted that the accompanying increase in apo A-I levels seen in this study suggests a possible pleiotropic effect of fluvastatin XL in these patients.

This study was published in the current edition of Current Therapeutic Research (July/August 2004;65(4):330-344).

[Presentation title: 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, Randomised, Blinded-End-Point (PROBE) Trial. Abstract 556]