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image of Comorbidity-Associated Adverse Drug Reactions During Tuberculosis Treatment: A Prospective Study

Abstract

Introduction

Adverse drug reactions (ADRs) to antitubercular therapy (ATT) pose a major challenge in tuberculosis (TB) management, especially in patients with comorbidities. This study evaluated the prevalence, patterns, and risk factors for ADRs among TB patients with and without comorbidities receiving first-line ATT in India.

Methods

A prospective observational study was conducted at Erode Tertiary Care Hospital from July 2023 to January 2024. A total of 300 TB patients (207 without comorbidities, 93 with comorbidities such as diabetes mellitus, HIV, hypertension, and COPD) were enrolled. ADRs were assessed through clinical monitoring, lab investigations, and structured interviews using the WHO causality and Modified Hartwig and Siegel severity scales.

Results

The prevalence of ADR was 49.33%, which was significantly higher in patients with comorbidities (55.91%) than those without (46.37%, = 0.048; RR = 1.20, 95% CI: 0.96-1.52). Diabetes mellitus had the highest ADR rate (60.53%, = 0.032). ADRs were more frequent in comorbid patients during the intensive phase (59.32% 41.61%, = 0.018) and in pulmonary TB. Gastrointestinal ADRs were most common, with nausea/vomiting, gastritis, and diarrhea significantly more frequent in comorbid groups. Comorbid patients also had more multiple ADRs (40.38% 33.33%, = 0.027) and required more medication changes (17.31% 7.29%, = 0.013). Discussion: Higher ADR frequency in patients with comorbidities may reflect the impact of disease. The increased burden during the intensive phase and in pulmonary TB underscores the importance of tailored pharmacovigilance.

Conclusion

TB patients with comorbidities, particularly diabetes, face significantly higher ADR risks. Enhanced pharmacovigilance is essential. Age-related physiological vulnerability may independently increase ADR risk in elderly patients without comorbidities.

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2025-09-02
2025-09-17

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Comorbidity-Associated Adverse Drug Reactions During Tuberculosis Treatment: A Prospective Study
Bentham Science Publishers ; https://doi.org/10.2174/011573398X422511250828173106
/content/journals/crmr/10.2174/011573398X422511250828173106
/content/journals/crmr/10.2174/011573398X422511250828173106
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  • Article Type:     Research Article
Keywords: Tuberculosis (TB) ; diabetes mellitus ; hypertension ; pharmacovigilance ; prevalence ; HIV ; adverse drug reactions (ADRs) ; comorbidities

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