Abstract

Aim: Evaluation of adverse drug reactions in patients of diabetes mellitus on 1^st line Anti-tubercular treatment.
Methods: Patients presenting to the Medicine OPD (Diabetic clinic), and Respiratory medicine OPD, KGMU, on specified days of the week diagnosed to be diabetes mellitus with tuberculosis was screened based on selection criteria. Written informed consent was taken from patients. Demographic details of the participants were recorded in semi-structured proforma. The overall description of the adverse drug effect was done for the selected patients. Seriousness of adverse drug effects were evaluated. Assessment of the severity of adverse drug effects were done. Causality assessment of ADRs was assessed by the WHO-UMC causality assessment system and Naranjo’s causality assessment scale. The severity of ADRs was assessed by Hartwig’s Severity Assessment and scale.
Results: In our study, incidence of Adverse Drug Reactions (ADRs) in diabetes mellitus patients receiving 1st line antitubercular treatment was 61.82% (68). Out of 110 patients, 68 patients developed a total 83 ADRs. Most common system involved was gastrointestinal system (24, 28.92%) followed by hepatobiliary system (21, 25.30%) and dermatological system (17, 20.48%). Least common system involvement was oto-vestibular, musculoskeletal and urinary system. Most common ADRs were Hepatitis/Jaundice (25.30%), Pruritis/rashes (20.48%) and Nausea/Vomiting (14.46%). Epigastric pain, Diarrhoea, Anemia/thrombocytopenia, Peripheral neuropathy and Headache was reported in 7.23%, 6.02%, 7.23%, 3.60% and 3.60% of the subjects respectively. According to WHO causality assessment scale, majority of ADRs were classified as probable (48, 57.83%). Possible ADRs were found in 33.74% of the subjects. Certain ADRs were found in 2.41% of the subjects. According to Naranjo’s causality assessment scale, majority of ADRs were classified as Probable (54, 65.06%). Possible ADRs were found in 30.12% of the subjects. Definite and Doubtful ADRs were reported in 2.41% of the subjects
According to Hartwig’s severity assessment level, mild, moderate and severe ADRs were reported in 80.72%, 15.67% and 3.61% of the subjects respectively. According to kappa analysis, the strength of association between Naranjo’s causality assessment scale and WHO Causality Assessment scale to assess ADR is good (kappa value: 0.72, p value: 0.008).
Conclusion: Most of the ADRs belonged to mild category according to the Modified Hartwig and Siegel scale for severity assessment. ADRs induced by ATT are common, which can result in discontinuation of treatment and development of resistant bacilli.