Frequency, management and impact of adverse events on treatment outcomes in patients with multidrug resistant tuberculosis in Balochistan, Pakistan

ABSTRACT

Background:

Early detection, monitoring, and managing adverse events (AEs) are crucial in optimising treatment for multidrug-resistant tuberculosis (MDR-TB) patients.

Objectives:

To investigate the incidence, factors, management, and impact of AEs on treatment outcomes in MDR-TB patients.

Methods:

This study reviewed the medical records of 275 MDR-TB patients at Fatimah Jinnah Institute of Chest Diseases in Quetta, Pakistan. Patient information was collected using a designed data collection form. Mann–Whitney U and Kruskal–Wallis tests examined the difference in AEs occurrences based on patients’ characteristics. Multiple binary logistic regression identified factors associated with unsuccessful outcomes, with statistical significance set at a p-value < 0.05.

Results:

Almost all patients (99.6%) experienced at-least one AE (median = 4/patient, interquartile range:3-6). The most common were GI disturbance (95.3%), arthralgia (80.4%), body pain and headache (61.8%), ototoxicity (61.4%), psychiatric disturbance (44%), hypokalaemia (40.4%), dermatological reactions (26.2%) and hypothyroidism (21.5%). AEs led to treatment modification in 7.3% patients. Educated patients, those with a history of TB treatment, previous use and resistance to any second-line drug had significantly higher number of AEs. A total of 64.0% were declared cured, 3.6% completed treatment, 19.6% died and 12.7.9% were lost to follow-up. Patients’ age of 41-60(OR = 9.225) and >60 years(OR = 23.481), baseline body weight of 31–60 kg(OR = 0.180), urban residence(OR = 0.296), and experiencing ototoxicity (OR = 0.258) and hypothyroidism (OR = 0.136) were significantly associated with unsuccessful treatment outcomes.

Conclusion:

AEs were highly prevalent but did not negatively impact treatment outcomes. Patients at higher risk of developing AEs and unsuccessful outcomes should receive special attention for its early management.

KEYWORDS:

• Adverse events
• hypokalaemia
• hypothyroidism
• MDR-TB
• Pakistan
• ototoxicity

Acknowledgement

We are thankful to all the medical and support staff of FJICD Quetta for their support during the data collection.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Ethical approval and consent to participate

Ethical approval to conduct this study was obtained from the Ethics and Research Committee of Faculty of Pharmacy and Health Sciences, University of Balochistan, Quetta. Additionally, permission to conduct this study was taken from the relevant authorities at FJICD Quetta. As it was a retrospective review of patients’ medical records, it was not possible to trace all the included patients for taking consent, therefore, the Ethics and Research Committee of Faculty of Pharmacy and Health Sciences, University of Balochistan, Quetta, granted the consent waiver. All the patients’ information was anonymised before data analysis.

Data and materials availability statement

All data gathered or analysed during this study are included in the article. The raw data on which conclusions of this manuscript is based is available upon request. Please contact Nafees Ahmad at [email protected].

Authors’ contributions

Conceptualisation: Nafees Ahmad, Sara Rafique, Shereen Khan, Hira Waheed and Muhammad Atif. Data collection: Sara Rafique. Formal analysis: Sara Rafique, Abdul Wahid, Asad Khan. Methodology: Nafees Ahmad, Sara Rafique, Shereen Khan, Amjad Khan. Writing original draft: Nafees Ahmad and Sara Rafique. Supervision: Nafees Ahmad.