A pharmacovigilance safety assessment and prescription patterns analysis of delamanid among global tertiary care multi-drug resistant tuberculosis patients: a study, in rational pharmacotherapeuticappraisal

Introduction: Delamanid, a nitro-dihydro-imidazoxazole, is a bactericidal cell wall methoxy-mycolic and keto-mycolic acids biosynthesis inhibitor in actively replicating, dormant, and intracellular Mycobacterium tuberculosis, and both drug-susceptible and drug-resistant strains of M. tuberculosis and M.kansasii, decreasing hydrophobicity and facilitating better bacterial drug penetration. Delamanid promotes intracellular generation of microbiocidal nitrogen oxidative intermediaries including nitric oxide, toxic even to dormant M. tuberculosis.
Objectives: The objective of this rational pharmacotherapeutic appraisal study was the pharmacovigilance safety assessment and prescription patterns analysis of delamanid among global tertiary care multi-drug resistant tuberculosis patients.
Methods: A multi-centre, prospective, open-labelled study of 100 multi-drug resistant tuberculosis patients, was performed. For 24 – 48 weeks, the patients were prescribed oral delamanid 100 mg twice daily, in accordance with the followed anti multi-drug resistant tubercular treatment regimens and the respective tuberculosis patient category. The anti-tubercular pharmacotherapeutic occurrence of adverse effects, due to oral delamanid therapy, was thoroughly analysed. The pharmacovigilance safety assessment was done by the monitoring of adverse drug reactions, like nausea, vomiting, headache, insomnia, dizziness, tinnitus, hypokalaemia, gastritis, decreased appetite and asthenia, among the patients, with Adverse Event Case Report Forms, on days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360 and on further follow-ups. A thorough evaluation of the prescription contents of all the patients was also done.
Results: The safety assessment showed that the occurrence of adverse effects was statistically non-significant. The completeness of prescription contents was observed in 100% of prescriptions.
Conclusions: Delamanid was safe and tolerable among multi-drug resistant tuberculosis patients. Prescription content analysis showed 100% completeness.