Pharmacovigilance and Adverse Drug Reactions in Type 2 Diabetes Mellitus: Insights from a Tertiary Care Hospital in Central India
Abstract
Background: Type 2 Diabetes Mellitus is a chronic condition that frequently necessitates prolonged pharmacological treatment and is frequently complicated by polypharmacy and comorbid conditions. These components elevate the likelihood of adverse drug reactions that demand active pharmacovigilance to enhance drug safety and patient adherence.
Methods: A prospective observational study was carried out over duration of 12 months at a tertiary care teaching hospital located in Central India. A total of 964 adults diagnosed with type 2 diabetics were enrolled. Data on demographics, comorbidities, and drug prescriptions were recorded. ADRs were identified through clinical evaluation and assessed for causality, severity, and preventability. Chi-square tests and logistic regression were utilized for statistical evaluation.
Results: Among 964 patients (mean age 46.9 ± 12.4 years), the highest prevalence was observed in the 41–50 age group (32.6%). ADRs were reported in 231 patients (23.96%). Hypoglycemia (notably with sulfonylureas, p < 0.01) and gastrointestinal disturbances (mainly with metformin) were the most common ADRs. The Naranjo assessment categorized 62.3% of ADRs as probable, with 89.1% classified as mild-to-moderate in severity. According to Schumock and Thornton criteria, 54.5% of ADRs were preventable. Logistic regression revealed polypharmacy (OR = 2.73, p < 0.01) and kidney dysfunction (OR = 2.21, p < 0.01) as significant predictors of ADRs.
Conclusion: This research underscores a significant prevalence of ADRs in patients with T2DM, with many being preventable. Sulfonylureas and metformin were frequently implicated. Strengthening pharmacovigilance practices and promoting rational drug use are necessary for improving patient safety and therapeutic results in diabetes management.
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