SHORT-TERM EFFICACY AND TOLERABILITY OF COMBINATION THERAPY WITH LOVASTATIN AND ACIPIMOX IN CHINESE PATIENTS WITH TYPE-2 DIABETES-MELLITUS AND MIXED DYSLIPIDEMIA

In type 2 diabetes, it is not uncommon to find an elevated serum trigl yceride and/or reduced high-density lipoprotein (HDL) cholesterol leve ls; elevated total cholesterol levels often occur as well. To evaluate the short-term efficacy and tolerability of combination therapy with lovastatin and acipimox in Chinese patients with type 2 diabetes who h ave mixed dyslipidemia, on open-label 6-month trial was conducted. All patients had type 2 diabetes (n = 33) with fetal cholesterol greater than or equal to 6.2 mmol/L and fasting triglyceride greater than or e qual to 2.8 mmol/L, which had been confirmed twice and persisted for a t least 12 weeks after introduction of diet control. After a C-week ru n-in period, they were given lovastatin 40 mg daily at night for 12 we eks. Acipimox 250 mg three times a day was then added for a further 12 weeks. After 12 weeks of treatment with lovastatin alone, improvement was observed in total cholesterol (21% reduction), triglyceride (32% reduction), low-density lipoprotein (LDL) cholesterol (5.5% reduction) , HDL cholesterol (11.6% elevation), apolipoprotein A-I (4.6% elevatio n), and apolipoprotein B (20.5% reduction). The addition of acipimox t o lovastatin for an additional 12 weeks further reduced serum total ch olesterol, triglyceride, LDL cholesterol, and apolipoprotein B, but th is additional decrease rt as not statistically significant. However, H DL cholesterol and apolipoprotein A-I levels were significantly increa sed by the addition of acipimox (a 14.2% and 9.0% elevation, respectiv ely). Serum creatine phosphokinase increased slightly after 12 weeks o f lovastatin but decreased to a concentration similar to baseline afte r 12 weeks of combination treatment. No patients reported muscle pain or weakness or other side effects. Combination treatment with lovastat in and acipimox appears to be a safe and effective therapy in patients with type 2 diabetes and mixed dyslipidemia, and has particular benef it in elevating serum HDL cholesterol and apolipoprotein A-I levels.