Treatment outcomes of fixed-dose combination versus separate tablet regimens in pulmonary tuberculosis patients with or without diabetes in Qatar

Mohammad H Al-Shaer,Hanine Mansour,Fatima Iqbal,Hazem Elewa,Pascale Salameh

doi:10.1186/s12879-017-2231-1

Abstract

BackgroundTuberculosis is considered the second most common cause of death due to infectious agent. The currently preferred regimen for treatment of pulmonary tuberculosis (PTB) is isoniazid, rifampin, pyrazinamide, and ethambutol, which has been used either as separate tablets (ST) or as fixed-dose combination (FDC). To date, no studies have compared both regimens in Qatar. We aim to evaluate the safety and effectiveness of FDC and ST regimen for treating PTB, in addition to comparing safety and efficacy of FDC and ST regimens in patients with diabetes treated for TB.MethodsA retrospective observational study was conducted in two general hospitals in Qatar. Patients diagnosed with PTB received anti-tuberculosis medications (either as FDC or ST) administered by the nurse. Sputum smears were tested weekly. We assessed the time to negative sputum smear and incidence of adverse events among FDC and ST groups.ResultsThe study included 148 patients. FDC was used in 90 patients (61%). Effectiveness was not different between FDC and ST regimens as shown by mean time to sputum conversion (29.9 ± 18.3 vs. 35.6 ± 23 days, p = 0.12). Similarly, there was no difference in the incidence of adverse events, except for visual one that was higher in ST group. Among the 33 diabetic patients, 19 received the FDC and had faster sputum conversion compared to those who received ST (31 ± 12 vs. 49.4 ± 30.9 days, p = 0.05). Overall, diabetic patients needed longer time for sputum conversion and had more hepatotoxic and gastric adverse events compared to non-diabetics.ConclusionST group had higher visual side effects compared to FDC. FDC may be more effective in diabetic patients; however, further studies are required to confirm such finding.

Highlights

Tuberculosis is considered the second most common cause of death due to infectious agent
Data collection We identified patients from the hospital admission database, while medical records and laboratory and pharmacy databases were used to collect patients’ demographics, comorbidities, vitamin D levels, anti-TB regimens and adverse events, and time to negative sputum AFB
Asians accounted for 88.9% in the fixed-dose combination (FDC) group and 84.5% in the separate tablets (ST) group

Summary

Introduction

Tuberculosis is considered the second most common cause of death due to infectious agent. The currently preferred regimen for treatment of pulmonary tuberculosis (PTB) is isoniazid, rifampin, pyrazinamide, and ethambutol, which has been used either as separate tablets (ST) or as fixed-dose combination (FDC). The usual TB treatment regimen is a standard 2-month regimen of isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and ethambutol (EMB), followed by a 4-month regimen of isoniazid and rifampin. This classic regimen is associated with poor compliance and adherence which leads to the development of resistant strains and multidrug resistant bacilli [6]. Several studies tested the safety and efficacy in different parts of the world using different brands of FDC regimens.

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