Abstract

EFFECTS OF FENOFIBRATE IN COMBINATION WITH ATORVASTATIN/ ROSUVASTATIN ON GLYCEMIC PARAMETERS OF DYSLIPIDEMIC PATIENTS: A PROSPECTIVE STUDY

Ahmad J., Azmi S., Ahmad F. and Chughtai A. M.*

ABSTRACT

Background: Statins (HMG-CoA reductase enzyme inhibitors) constitute the mainstay treatment for atherosclerotic cardiovascular diseases, but several studies suggest that Rosuvastatin and Atorvastatin increase the risk of new-onset diabetes mellitus (NODM). However, Fenofibrate a PPARα agonist used in the treatment of dyslipidemia has shown a favourable influence on glucose homeostasis. Aims & Objectives: To determine the effect of Fenofibrate-Statin combination therapy on glycemic parameters of nondiabetic patients with dyslipidemia. The present study addresses the question whether Fenofibrate addition to statins therapy in dyslipidaemic patients leads to favourable glycaemic parameters (Fasting plasma glucose, Post prandial plasma glucose and Haemoglobin A1c). Material and Methods: Randomized, prospective, parallel groups, open labelled, 24 weeks study of Fenofibrate in a combination with an Atorvastatin and Rosuvastatin was conducted on newly diagnosed, but non-diabetic patients of dyslipidemia with a definite indication for starting hypolipidemic drugs. Eligible 40 patients were randomized into two groups, Group-1 (Atorvastatin-Fenofibrate) and Group-2 (Rosuvastatin -Fenofibrate). The Fasting plasma glucose (FPG), 2 hour post prandial plasma glucose (2-hour PPG) and Haemoglobin A1c(HbA1c) were analyzed at 24 weeks of study. Results: The mean HbA1c increased from 5.24% (at a baseline) to 5.25% at 12 weeks and 5.31% at 24 weeks in Group-1 patients while in Group-2 the increased was from 5.48% (at baseline) to 5.49% at 12 weeks and 5.61% at 24 weeks (p>0.05). The increase in mean values of HbA1c, when compared to a baseline (0 weeks) was insignificant (p>0.05) in both the Groups at 12 and 24 weeks. The increase in mean values of FPG and PPG, when compared to baseline values were also found to be insignificant (p>0.05) at 12 and 24 weeks Conclusion: In the current study of 24 weeks the Atorvastatin-Fenofibrate and Rosuvastatin-Fenofibrate combinations have shown statistically insignificant increase in mean FPG, 2 hours PPG and HbA1c levels(p>0.05). These findings suggest that fibrates have a favourable influence on glucose homeostasis and prevents the glycemic effect of these statins. These observations might help clinicians to consider the risk associated with different statins when they are contemplating the treatment for individuals particularly in prediabetics with dyslipidaemia.

Keywords: Atorvastatin, Rosuvastatin, Fenofibrate, Haemoglobin A1c, New onset Diabetes mellitus.