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



A 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.



The 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.



ST 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.
Department of Pharmacy, Al Wakra Hospital - Hamad Medical Corporation, Doha, Qatar.|Present address: Department of Pharmacotherapy and Translational Research, Infectious Disease Pharmacokinetics Laboratory, College of Pharmacy and Emerging Pathogens Institute, University of Florida, Gainesville, FL, 32610, USA.
Mohammad H
MH
Al-Shaer
School of Pharmacy, Lebanese American University, P.O Box 36-S 23, Byblos, Lebanon. hanine.mansour@lau.edu.lb.
Hanine
H
Mansour
College of Pharmacy, Qatar University, Doha, Qatar.
Hazem
H
Elewa
School of Pharmacy, Lebanese American University, P.O Box 36-S 23, Byblos, Lebanon.|Present address: Faculty of Medical Sciences, Lebanese University, Beirut, Lebanon.
Pascale
P
Salameh
Department of Pharmacy, Rumailah Hospital - Hamad Medical Corporation, Doha, Qatar.
Fatima
F
Iqbal
D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D048909:Diabetes Complications / Q000175:diagnosis; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D064420:Drug-Related Side Effects and Adverse Reactions; D004977:Ethambutol / Q000627:therapeutic use; D005260:Female; D006769:Hospitals, General; D006801:Humans; D007538:Isoniazid / Q000627:therapeutic use; D008297:Male; D011718:Pyrazinamide / Q000627:therapeutic use; D011780:Qatar; D012189:Retrospective Studies; D012293:Rifampin / Q000627:therapeutic use; D013183:Sputum / Q000382:microbiology*; D013607:Tablets; D016896:Treatment Outcome; D014397:Tuberculosis, Pulmonary / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*
D000995:Antitubercular Agents; D013607:Tablets; D011718:Pyrazinamide; D004977:Ethambutol; D007538:Isoniazid; D012293:Rifampin
Effectiveness; Fixed-dose; Pulmonary tuberculosis; Safety; Separate tablets