Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment

Wu, Jiunn Yih; Chiu, Chih-Yi; Wei, Yufeng; Lai, Yung-Fa

doi:10.6061/clinics/2015(06)08

Cited by 13 publications

(27 citation statements)

References 15 publications

(18 reference statements)

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“…Of the 12 trials that included patients with DM comorbidity regardless of severity, 5 studies did not report the diagnostic criteria for DM. Three studies used random blood glucose . One study used fasting plasma glucose and 2‐hour oral glucose tolerance test and 3 studies obtained DM comorbidity from patients' history .…”

Section: Resultsmentioning

confidence: 99%

Diabetes mellitus comorbidity in patients enrolled in tuberculosis drug efficacy trials around the world: A systematic review

Lutfiana

Boven

Zubair

et al. 2019

Brit J Clinical Pharma

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Aims With a prevalence of 16%, diabetes mellitus (DM) is one of the most frequent non‐communicable comorbidities of tuberculosis (TB). DM is a major risk factor for adverse TB outcomes and may require personalized TB drug dosing regimens. However, information on the inclusion of DM in TB drug trials is lacking. We aimed to assess the percentage of recent TB drug efficacy trials that included DM patients. Methods A systematic review was performed and reported according to PRISMA guidelines. PubMed, Science Direct, and http://ClinicalTrials.gov databases were systematically searched for TB drug trials published between 1 January 2012 and 12 September 2017. Primary outcome was the percentage of TB drug trials performed around the world that included DM patients. Results Out of the included 41 TB drug trials, 12 (29.3%) reported DM comorbidity among the study participants. Nine trials (21.9%) excluded all patients with DM comorbidity, ten (24.4%) excluded only insulin‐dependent or uncontrolled DM, and 10 (24.4%) did not mention whether DM was included or excluded. Of the 12 trials that included DM comorbidity, the majority did not report the diagnostic criteria for DM and none reported outcomes in the DM subpopulation. Inclusion of DM was higher in drug‐resistant‐TB trials (67%, P = .003, vs drug‐susceptible) and trials performed in Asia (60%, P = .006, vs Africa). Conclusions Fewer than 1/3 recent TB drug trials reported the inclusion of DM. To better reflect real‐world DM prevalence and differential TB drug effectiveness, inclusion of DM patients requires increased attention for future TB drug trials.

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Section: Resultsmentioning

confidence: 99%

Diabetes mellitus comorbidity in patients enrolled in tuberculosis drug efficacy trials around the world: A systematic review

Lutfiana

Boven

Zubair

et al. 2019

Brit J Clinical Pharma

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“…The RCTs were conducted in different continents and countries. Eight trials were conducted in Asia ( RCTAI 1989 ; Su 2002 ; Suryanto 2008 ; Teo 1999 ; Wu 2015 ; Zaka‐Ur‐Rehman 2008 ; Zhang 1996 ; Zhu 1998 ), two in Europe ( Munteanu 2004 ; Semenova 2003 ), one in Africa ( Chaulet 1995 ), and one in the USA ( Geiter 1987 ). Two trials involved several countries ( Bartacek 2009 ; Lienhardt 2011 ).…”

Section: Resultsmentioning

confidence: 99%

Fixed-dose combinations of drugs versus single-drug formulations for treating pulmonary tuberculosis

Gallardo

Comas

Rodríguez

et al. 2016

Cochrane Database of Systematic Reviews

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Background People who are newly diagnosed with pulmonary tuberculosis (TB) typically receive a standard first‐line treatment regimen that consists of two months of isoniazid, rifampicin, pyrazinamide, and ethambutol followed by four months of isoniazid and rifampicin. Fixed‐dose combinations (FDCs) of these drugs are widely recommended. Objectives To compare the efficacy, safety, and acceptability of anti‐tuberculosis regimens given as fixed‐dose combinations compared to single‐drug formulations for treating people with newly diagnosed pulmonary tuberculosis. Search methods We searched the Cochrane Infectious Disease Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL, published in the Cochrane Library, Issue 11 2015); MEDLINE (1966 to 20 November 2015); EMBASE (1980 to 20 November 2015); LILACS (1982 to 20 November 2015); the metaRegister of Controlled Trials; and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), without language restrictions, up to 20 November 2015. Selection criteria Randomized controlled trials that compared the use of FDCs with single‐drug formulations in adults (aged 15 years or more) newly diagnosed with pulmonary TB. Data collection and analysis Two review authors independently assessed studies for inclusion, and assessed the risk of bias and extracted data from the included trials. We used risk ratios (RRs) for dichotomous data and mean differences (MDs) for continuous data with 95% confidence intervals (CIs). We attempted to assess the effect of treatment for time‐to‐event measures with hazard ratios and their 95% CIs. We used the Cochrane 'Risk of bias' assessment tool to determine the risk of bias in included trials. We used the fixed‐effect model when there was little heterogeneity and the random‐effects model with moderate heterogeneity. We used an I² statistic value of 75% or greater to denote significant heterogeneity, in which case we did not perform a meta‐analysis. We assessed the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Main results We included 13 randomized controlled trials (RCTs) in the review, which enrolled 5824 participants. Trials were published between 1987 and 2015 and included participants in treatment with newly diagnosed pulmonary TB in countries with high TB prevalence. Only two trials reported the HIV status of included participants. Overall there is little or no difference detected between FDCs and single‐drug formulations for most outcomes reported. We did not detect a difference in treatment failure between FDCs compared with single‐drug formulations (RR 1.28, 95% CI 0.82 to 2.00; 3606 participants, seven trials, moderate quality evidence ). Relapse may be more frequent in people treated with FDCs compared to single...

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“…Some authors have found that changing treatment to RHZE/FDCs led to a trend toward increased recurrence. 11 , 25 - 27 In contrast, other studies have found no differences in the recurrence rate between the groups (FDC vs. single-drug formulation) 8 15 A recently published review found little or no difference in the rates of death or in the frequency of adverse effects between the groups 27 .…”

Section: Discussionmentioning

confidence: 95%

Estimated rates of recurrence, cure, and treatment abandonment in patients with pulmonary tuberculosis treated with a four-drug fixed-dose combination regimen at a tertiary health care facility in the city of Rio de Janeiro, Brazil

2017

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Objective: To estimate the rates of recurrence, cure, and treatment abandonment in patients with pulmonary tuberculosis treated with a four-drug fixed-dose combination (FDC) regimen, as well as to evaluate possible associated factors. Methods: This was a retrospective observational study involving 208 patients with a confirmed diagnosis of pulmonary tuberculosis enrolled in the Hospital Tuberculosis Control Program at the Institute for Thoracic Diseases, located in the city of Rio de Janeiro, Brazil. Between January of 2007 and October of 2010, the patients were treated with the rifampinisoniazid-pyrazinamide (RHZ) regimen, whereas, between November of 2010 and June of 2013, the patients were treated with the rifampin-isoniazid-pyrazinamide-ethambutol FDC (RHZE/FDC) regimen. Data regarding tuberculosis recurrence and mortality in the patients studied were retrieved from the Brazilian Case Registry Database and the Brazilian Mortality Database, respectively. The follow-up period comprised two years after treatment completion. Results: The rates of cure, treatment abandonment, and death were 90.4%, 4.8%, and 4.8%, respectively. There were 7 cases of recurrence during the follow-up period. No significant differences in the recurrence rate were found between the RHZ and RHZE/FDC regimen groups (p = 0.13). We identified no factors associated with the occurrence of recurrence; nor were there any statistically significant differences between the treatment groups regarding adverse effects or rates of cure, treatment abandonment, or death. Conclusions: The adoption of the RHZE/ FDC regimen produced no statistically significant differences in the rates of recurrence, cure, or treatment abandonment; nor did it have any effect on the occurrence of adverse effects, in comparison with the use of the RHZ regimen.

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Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment

Cited by 13 publications

References 15 publications

Diabetes mellitus comorbidity in patients enrolled in tuberculosis drug efficacy trials around the world: A systematic review

Diabetes mellitus comorbidity in patients enrolled in tuberculosis drug efficacy trials around the world: A systematic review

Fixed-dose combinations of drugs versus single-drug formulations for treating pulmonary tuberculosis

Estimated rates of recurrence, cure, and treatment abandonment in patients with pulmonary tuberculosis treated with a four-drug fixed-dose combination regimen at a tertiary health care facility in the city of Rio de Janeiro, Brazil

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