DEMOGRAPHIC DISTRIBUTION AND ADVERSE DRUG REACTION PATTERN OF ANTI-TUBERCULAR AND ANTIDIABETIC THERAPY IN PATIENTS OF TUBERCULOSIS WITH DIABETES MELLITUS: A PROSPECTIVE OBSERVATIONALSTUDY AT TERTIARY CARE HOSPITAL

Abstract

Objective: The objectives of present study to evaluate the prevalence of diabetes mellitus among tuberculosis patient at a tertiary health care center and to study the adverse drug reaction due to simultaneous use of anti-tubercular drugs with anti-diabetic drugs.

Methods: A prospective observational cohort study was conducted from March 10, 2021, to July 9, 2022, at a tertiary care hospital, involving a total of 134 patients. The patient was approached as per NTEP guidelines. Age, gender, occupation, weight, and socioeconomic position were among the demographics that were noted and thoroughly examined. The screening for diabetes mellitus was done in patients with newly diagnosed tuberculosis. The adverse drug reactions due to the simultaneous use of antitubercular drugs with antidiabetic drugs were observed and compared with patients with tuberculosis without diabetes mellitus according to outcome parameters.

Results: Glycosylated hemoglobin (HbA1c) was used to screen for diabetes mellitus in a representative sample of TB patients. Patients who self-reported having DM or whose HbA1c was ≥6.5% were considered diabetics. Out of the 323 newly diagnosed TB patients that were examined, 67 (18%) had diabetes mellitus; 31 (8%) had DM that they had previously identified, and 36 (10%) had just received a diagnosis. Men, whose average age was 47, had a higher prevalence (P=0.00001). 31 (23.13%) of the 134 TB patients who had previously been diagnosed with diabetes mellitus had an HbA1c of 10%, which indicates inadequate glycemic management. In the summarized result, we can observe that the prevalence rate of DM is 20.74% among TB patients. Compared to other research, this is higher. Over the course of the study, 35 ADRs were identified, recorded, evaluated, and reported. Assessment of the severity of the suspected ADRs revealed that 28.57% of suspected ADRs were severe and 71.42% of ADRs were moderate in severity as per the Modified Hartwig and Siegel Severity Assessment Scale. On the causality assessment by the WHO scale, most ADRs were classified as “possible” among both groups. Most patients who experienced adverse drug reactions were older than 50. The most frequently impacted system was the gastrointestinal tract (9.7%). As per the Modified Schumock and Thornton Preventability Assessment Scale, the preventability of ADRs was assessed, and the results revealed that 11.19% of ADRs were preventable.

Conclusion: This study emphasizes that all newly diagnosed tuberculosis patients should be screened for diabetes mellitus, as there is a high prevalence of diabetes mellitus in tuberculosis patients. The concomitant use of anti-tubercular therapy and anti-diabetic therapy can cause adverse drug reactions as each group interacts with the other. Also,anti-tubercular therapy and anti diabetic therapy alone can cause adverse drug reactions.