Atorvastin, a new HMG-CoA reductase inhibitor is safe and effective in NIDDM patients: Multicenter, open label study

Atorvastin, a new HMG-CoA reductase inhibitor, has demonstrated significant lipid lowering effects in previous trials. Currently marketed HMG-CoA reductase inhibitors have shown to be effective in lowering LDL-C with little effect on triglycéride levels. The information about its efficacy in diabetic patients is insufficient. The 22-week study was designed to determine the efficacy and safety of atorvastatin (A) in 100 patients with NIDDM, with metabolic disease control (HBA_lc <10%) and LDL cholesterol > 130 mg/dl, after following a standard lipid lowering diet. The patients were titrated with up to 80 mg of atorvastatin, regardless of their cholesterol LDL levels < 100 mg/dl. These patients were 60 ±10 yr average age and 8.4 ±7 years of evolution. 40.6% were males. Their BMI was of 26.9 ± 4.7 kg/m2. At the start, their serum glucose was 143 ±46 mg/dl, HbAlc 8.1 ±1.6% and the concentration of fructosamine was 247 ±87 umol/1. Concentrations of total cholesterol, triglycérides, HDL cholesterol and LDL cholesterol were 267 ±3, 210 ± 110, 49.2 ±26.8 and 182 ±33 mg/dl, respectively. After 16 weeks of supplying 10mg per day of atorvastatin, the result was a lowering of 33 ±11% in the concentration of total cholesterol, 42 ±14% in LDL cholesterol, and 19% in triglycérides. Minimal modification in HDL cholesterol was observed. The average concentration in LDL cholesterol under 100 mg/dl. Additionally there was a direct relation between the average level of cholesterolemia with the necessary dose to reach a correction in the concentration of LDL cholesterol under 100 mg/dl. No significant side effects were present. There were no cases of muscular damage. Thus, atorvastatin significantly reduces LDL cholesterol and total cholesterol in NIDD patients. The 10 mg/day dose is sufficient to reach the goals of treatment in 66% of the cases. The drug was not related to any significant side effects.