Title: A comparative study of efficacy and safety of Ezetimibe and Fenofibrate versus Atorvastatin alone in the treatment of dyslipidemia

Author: Dr Nagula Jayababu

 DOI: https://dx.doi.org/10.18535/jmscr/v7i10.166

Abstract

Background: The incidence of dyslipidemia is on the rise in our country due to lifestyle changes and exposure to fast food. This study was done to determine the efficacy and safety of the combination of ezetimibe plus fenofibrate as an alternative to statin monotherapy in patients with dyslipidemia attending our hospital.

Methods: This prospective cross-sectional study was done in the Departments of General Medicine and Pharmacology, Kakatiya Institute of Medical Sciences and MGM Hospital, Warangal from May 2018 to January 2019 (9 Months). A total of n=110 patients were identified with dyslipidemia. However, 10 were excluded because they were not fitting in inclusion and exclusion criteria. The remaining n=100 patients were randomly assigned into two groups of n=50 each. Two patients in group I left the study on their own hence in group total number of patients was n=48. They were given Ezetimibe (10 mg/day) and Fenofibrate (160 mg/day) combination. In Group II out n=50 patients one patient left the study and two were lost in follow up hence the total number of patients was n=47. They were prescribed Atorvastatin 20mg/day.

Results: The comparison of baseline parameters with that of post-treatment (8 weeks) was done there was a significant decrease in all the lipid parameters in the group I indicated by all the p values that were found to be significant. Similarly in group II the comparison of parameters post 8 weeks therapy showed a significant decrease in all the lipid parameters except for Apo A values. When intergroup comparison of change of parameters was done the p values were not found to be significant in any of the parameters indicating no significant differences between the decreases of lipid parameters in both the groups.

Conclusion: the present study concluded that ezetimibe 10mg/day plus fenofibrate 160mg/day appeared to affect the lipid metabolism similarly to monotherapy with Atorvastatin 20mg/day. The combination, as well as monotherapy with a statin, was tolerated well and incidences of minor adverse effects were similar in both the groups of patients.

Keywords: Ezetimibe and Fenofibrate, Atorvastatin, dyslipidemia.

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