Abstract

COMPARATIVE ASSESSMENT OF ADVERSE DRUG REACTIONS IN TYPE 2 DIABETES MELLITUS PATIENTS RECEIVING MONOTHERAPY VERSUS COMBINATION THERAPY: A PROSPECTIVE OBSERVATIONAL STUDY IN A TERTIARY CARE HOSPITAL

Chanda Sundarasa Pawar, Gayatri Jaju, Yasmin Moulasab Dakhani, Pushkar Vasant Joshi, M. G. Keshannavar*, Naveen Sardar, Raghavendra S. Hegde

Abstract

Background: Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder that almost always demands lifelong pharmacotherapy, and as the disease advances patients are frequently escalated from single-agent to multi-agent regimens. Both approaches carry a risk of adverse drug reactions (ADRs), yet real-world comparative safety data remain limited. Objectives: To compare the pattern, severity and outcome of ADRs in T2DM patients receiving monotherapy versus combination therapy in a tertiary care hospital. Methods: A prospective, comparative, observational study was carried out over four months in the general medicine and surgery wards of a tertiary care teaching hospital. Forty consenting adults with T2DM were enrolled by universal sampling and divided equally into a monotherapy group (n=20) and a combination therapy group (n=20). ADRs were captured through case-sheet review, patient interview and treatmentchart analysis, and were graded for severity using the modified Hartwig and Siegel scale. Data were summarised as frequencies and percentages, and the two groups were compared using the chi-square (or Fisher exact) test, with p

Keywords: Adverse drug reactions, Antidiabetic agents, Combination therapy, Hypoglycaemia, Monotherapy, Type 2 diabetes mellitus.