Can Statins Be Considered as a Tertiary Level Agent in Patients with Failure of Conventional Oral Hypoglycemic Agents?

Background: The effect of statins in diabetic dyslipidemia has been proven in terms of lipid lowering and mortality benefit in diabetic patients. Although experimental evidence supports the beneficial effect of statins in insulin resistance, their role in clinical practice has not been studied. In this study, the effect of rosuvastatin on fasting blood glucose (FBG) and its correlation with lipid lowering was analyzed ad hoc. Objective: This open-label, prospective rosuvastatin safety and efficacy (ROSE) study was conducted to assess the safety and efficacy of rosuvastatin in the treatment of diabetic dyslipidemia. Method: Male and female diabetic patients aged 18–75 years, with low-density lipoprotein cholesterol (LDL-C) levels greater than or equal to 2.5 mmol/l were enrolled. Rosuvastatin 10 mg once daily was administered for 8 weeks. The primary endpoint was a change in LDL-C from baseline. Secondary endpoints included a change from baseline in total cholesterol, high-density lipoprotein cholesterol and triglycerides. Liver enzymes, creatine kinase, creatinine and FBG were the safety laboratory parameters assessed. The correlation between reduction in FBG and lipid parameters was calculated using Pearson’s correlation coefficient. Results: Forty-one patients were screened and 34 were enrolled. Four were lost to follow-up and not included in efficacy analysis. Thirty patients completed 8 weeks of treatment and were analyzed for efficacy. Their mean LDL-C was significantly reduced from 4.1 mmol/l at baseline to 2.1 mmol/l (p < 0.0001) after 8 weeks of treatment. Total cholesterol, high-density lipoprotein cholesterol and triglycerides also showed a significant decrease from baseline. The mean FBG was reduced from 11.1 to 5.1 mmol/l (p < 0.0001) after 8 weeks. The decrease in lipid parameters correlated with the decrease in FBG (r = 0.083; p < 0.001). Clinically, no patient complained of any adverse event during the study period. Conclusion: Rosuvastatin significantly lowered FBG in addition to its cholesterol-lowering effect. This action could be attributed to an independent action by rosuvastatin or else be brought about indirectly by lowering lipids. Statins can be considered as a tertiary level agent when conventional oral hypoglycemic agents have failed. However, large-scale trials are necessary before application in clinical practice.