METFORMIN IN THE PREVENTION OF METABOLIC SYNDROME ASSOCIATED WITH INITIATION OF ATYPICAL ANTIPSYCHOTIC THERAPY IN ADOLESCENTS AND YOUNG ADULTS - A RANDOMIZED, OPEN LABELLED, SINGLE CENTERED STUDY
Abstract
Objective: The aim of the study was to evaluate the effectiveness and safety of Metformin along with Risperidone to prevent antipsychotic-induced metabolic syndrome in first-episode schizophrenia patients.
Methods: This was a randomized, open labelled, prospective study conducted in the Department of psychiatry, Tirunelveli medical college. Around 96 patients diagnosed with first episode schizophrenia were randomized into 2 groups. Group 1 patients were given T. Risperidone (2 mg twice daily, n=48) and group 2 patients were given T. Metformin (500 mg twice daily, n=48) along with T. Risperidone for 6 mo.
The primary endpoint assessed was the proportion of patients developing metabolic syndrome at the end of 6 mo in both the groups. The secondary endpoints were the changes in body mass index (BMI), waist circumference (WC), fasting blood sugar (FBS) and triglycerides (TGL) from baseline to the end point.
Results: There was a significant reduction in BMI and WC at the end of 3 mo (p<0.001) and at the end of 6 mo (p<0.001) when compared to baseline in group II individuals. There was a significant reduction in FBS and TGL levels at the end of 6 mo of treatment (p<0.001) in group II individuals. There was the significant statistical difference between both the groups (p<0.05) in terms of BMI, WC, FBS, triglycerides. The treatment emergent adverse effects with Metformin were generally mild and did not lead to any discontinuation.
Conclusion: The use of Metformin along with Risperidone may have a better impact on the long-term cardiovascular morbidity and mortality of the schizophrenia patients.
Keywords: Schizophrenia, Metabolic syndrome, Atypical antipsychotics, Body mass index, Waist circumference, Fasting blood sugar, Triglycerides
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