Treatment of dyslipidaemia with fluvastatin in patients with type 2 diabetes mellitus: Effects on lipids, mental state and fibrinolysis

Objective: To determine the effects of fluvastatin on lipids, mood and fibrinolysis in dyslipidaemic patients with type 2 diabetes mellitus. Design and Setting: Randomised, double-blind, placebo-controlled study in 12 outpatient clinics of general hospitals in The Netherlands evaluating the use of the HMG-CoA reductase inhibitor fluvastatin for dyslipidaemia [low-density lipoprotein (LDL)-cholesterol >4.1 mmol/L] in patients with type 2 diabetes mellitus receiving insulin therapy. Effects on lipids, lipoproteins, fibrinolysis and mood were evaluated. Patients: 42 patients with type 2 diabetes mellitus and dyslipidaemia (LDL-cholesterol >4.1 mmol/L) were treated with fluvastatin 40mg once daily and 45 patients received placebo for 12 weeks followed by open-label treatment with fluvastatin for 12 weeks. Results: Fluvastatin reduced serum levels of LDL-cholesterol by 25.5% (p < 0.05) compared with placebo after 12 weeks of treatment, but did not affect the levels of the fibrinolytic parameters plasminogen activator inhibitor-1 (PAI-1) and tissue-plasminogen activator (t-PA) or the levels of lipoproteins Lp(a) and apolipoprotein (Apo) A1. Fluvastatin also did not change the mental status of patients with type 2 diabetes mellitus as assessed with the Zung questionnaire. Adverse reactions were equally distributed between the fluvastatin and placebo groups. Conclusions: In conclusion, fluvastatin treatment for dyslipidaemia in patients with type 2 diabetes mellitus on insulin therapy is effective and well tolerated. Fibrinolysis and mood were not affected by this treatment.