Journal of Clinical and Diagnostic Research (May 2022)
Analysis of Burden and Outcomes of Oral Hypoglycaemic Agent Induced Adverse Drug Effects at a Tertiary Care Centre
Abstract
Introduction: Recent studies, both globally as well as in India, have depicted an alarming rise in the prevalence of Diabetes Mellitus (DM). Oral Hypoglycaemic Agents (OHAs) are the most common drugs used in the treatment of type 2 diabetes mellitus. There are numerous established Adverse Drug Reactions (ADR) associated with their use, such as, hypoglycaemia, weight gain, gastrointestinal disturbance, lactic acidosis and fluid retention. Aim: To assess the incidence of ADRs, clinical profile, severity and causality among the admitted patients, taking OHAs, in a tertiary care hospital. Materials and Methods: This was a hospital-based, prospective, observational, non interventional cohort study undertaken at the General Medicine Wards of a public teaching hospital, Seth GSMC and KEMH, Mumbai, Maharashtra, India. The present study was conducted in the Department of Medicine from June 2017 to December 2018. The patient’s data was recorded using a structured ADR reporting form. The baseline parameters, medical history and underlying diseases, clinical data, characteristics of ADRs and details of medication responsible for ADRs as well as medication for treatment of ADRs were recorded. The data was analysed using descriptive statistics with the Statistical Packages for the Social Sciences (SPSS) version 26.0 software. Results: Out of 164 patients admitted due to ADRs, within the study period, 48 (29.3%) patients had developed ADRs due to OHAs (sulfonylureas). The severity of ADRs of five patients fell under the moderate category (three males in the age group of 61-80 years and two females in the age group of 21-40 years), all of whom successfully recovered. The remaining 43 (89.6%) were associated with severe ADRs. Four patients had succumbed to the ADR while one reported further sequelae, and the rest of the patients recovered (one was still recovering at the time of data analysis). Conclusion: Sulfonylurea-induced hypoglycaemia is the most common ADR seen in patients on treatment of type 2 diabetes mellitus. Presence of systemic co-morbidities and polypharmacy are significant risk factors associated with OHA-induced ADRs.
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