scholarly journals Fixed-dose combination associated with faster time to smear conversion compared to separate tablets of anti-tuberculosis drugs in patients with poorly controlled diabetes and pulmonary tuberculosis in Qatar

2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Mohammad H. Al-Shaer ◽  
Hazem Elewa ◽  
Yosra Alkabab ◽  
Lama H. Nazer ◽  
Scott K. Heysell
Keyword(s):  
Pulmonary Tuberculosis ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Dose Combination ◽  
Separate Tablets

scholarly journals Bioequivalence of a Fixed-Dose Combination Tablet of the Complete Two-Drug Regimen of Dolutegravir and Rilpivirine for Treatment of HIV-1 Infection

2018 ◽  
Vol 62 (9) ◽  
Author(s):  
Rashmi Mehta ◽  
Allen Wolstenholme ◽  
Kristin Di Lullo ◽  
Caifeng Fu ◽  
Shashidhar Joshi ◽  
...  
Keyword(s):  
Statistical Power ◽  
Drug Regimen ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Combination Tablet ◽  
Reference Treatment ◽  
Dose Combination ◽  
Hiv 1 ◽  
Test Treatment ◽  
Separate Tablets

ABSTRACTA complete 2-drug regimen of dolutegravir at 50 mg and rilpivirine at 25 mg was approved to treat HIV-1 infection in virologically suppressed patients after demonstrating acceptable efficacy and tolerability. This study investigated the bioequivalence and pharmacokinetics of the fixed-dose combination tablet compared with those of separate tablets. Secondary endpoints were the tolerability and safety of the fixed-dose combination tablet. In this open-label, randomized-sequence, 2-way crossover trial, single doses of the fixed-dose combination tablet (the test treatment) and the combination of separate tablets (the reference treatment) were administered to healthy adults after a moderate-fat meal, with a 21-day washout between treatments. Pharmacokinetic samples were collected through 12 days after dosing. The primary endpoints were the area under the plasma concentration-time curve (AUC) and the maximum concentration of drug in plasma (Cmax). The study employed a prespecified sample size reestimation based on a blind midpoint review ofCmaxvariability to update the enrollment size to achieve statistical power. Of 118 participants enrolled, 113 received both treatments and underwent pharmacokinetic assessment. The 90% confidence intervals for the geometric least-squares mean ratios for the AUC from 0 h to infinity, the AUC from 0 h to the last quantifiable measurement, andCmax(test treatment versus reference treatment) were within the bioequivalence range of 0.80 to 1.25 for both drugs, indicating bioequivalence. In this study, a single dose of either treatment was well tolerated overall, with 4% (n= 5) and 3% (n= 3) of participants reporting adverse events considered related to the test and reference treatments, respectively. The dolutegravir-rilpivirine fixed-dose combination tablet is bioequivalent to a combination of separate tablets, and no new safety signals emerged. (This study has been registered at ClinicalTrials.gov under identifier NCT02741557.)

scholarly journals KADAR SERUM GLUTAMIC OXALOACETAT TRANSAMINASE DAN SERUM GLUTAMIC PYRUVIC TRANSAMINASE PADA PASIEN TUBERKULOSIS PARU SELAMA DUA BULAN BERJALANNYA PEMBERIAN OBAT ANTI TUBERKULOSIS KOMBINASI DOSIS TETAP

e-CliniC ◽  
2014 ◽  
Vol 2 (3) ◽  
Author(s):  
Ayu R. Pribadini Nelwan ◽  
Stella Palar ◽  
Julia C. M. Lombo
Keyword(s):  
Pulmonary Tuberculosis ◽  
Serum Levels ◽  
Fixed Dose Combination ◽  
World Health ◽  
Fixed Dose ◽  
Glutamic Pyruvic Transaminase ◽  
Cross Sectional ◽  
The World ◽  
Dose Combination ◽  
Health Organization

Abstract: Tuberculosis (TB) is still a health problem around the world. According to statistics of the World Health Organization (WHO) showed that Indonesia’s ranking were down from third to fifth in the world. However there are also challenges in the treatment of tuberculosis worldwide and in Indonesia, like treatment failure, dropping out of treatment, and inappropriate treatment. This study aimed to compare the serum levels of SGOT (AST) and SGPT (ALT) in patients with pulmonary TB during two months administration of OAT KDT. This study was a cross sectional analytic study using secondary data and blood sample from patients with pulmonary TB. The samples in this study was patients with pulmonary tuberculosis, pulmonary tuberculosis first category, pulmonary tuberculosis BTA smear (+), pulmonary tuberculosis with controlled hypertension, pulmonary tuberculosis suspected MDR, pulmonary tuberculosis with secondary infections, pulmonary tuberculosis on treatment, and pulmonary tuberculosis which dropping put of treatment. The analysis of data changes on SGOT levels before and after administration of Anti-Tuberculosis Drugs (OAT) shows that the value of zcount: 2,223 >ztable: 1,645 with a significance value of p= 0,026 < 0,05. This indicates that there is an effect of the Anti Tuberculosis Drugs (OAT) fixed-dose combination toward SGOT levels. The analysis of data changes on SGPT levels before and after administration of Anti-Tuberculosis Drugs (OAT) shows that the value of zcount: 2,045 >ztable: 1,645 with a significance value of p= 0,041 < 0,05. This indicates that there is an effect of the Anti Tuberculosis Drugs (OAT) fixed-dose combination toward SGPT levels. There are a significant correlation between serum levels of glutamic oxaloacetat transaminase and glutamic pyruvic transaminase in patients with pulmonary tuberculosis during two months administration of anti-tuberculosis medication with a fixed-dose combination and an increasing levels of SGOT and SGPT in pulmonary tuberculosis patients.     Abstrak: Penyakit Tuberkulosis (TB) masih merupakan masalah kesehatan di dunia. Menurut data statistik World Health Organization (WHO) menunjukkan Indonesia turun dari peringkat tiga menjadi peringkat kelima dunia. Namun masih terdapat pula tantangan dalam pengobatan TB di dunia dan Indonesia, antara lain kegagalan pengobatan, putus pengobatan, dan pengobatan yang tidak tepat. Penelitian ini ditujukan untuk mengetahui perbandingan kadar serum SGOT dan SGPT pada pasien TB Paru selama dua bulan pemberian OAT KDT. Penelitian ini merupakan penelitian analitik cross sectional dengan menggunakan data sekunder dan pengambilan sampel darah pada pasien TB Paru. Pada penelitian ini sampel yang digunakan adalah penderita TB Paru, TB Paru kategori 1, TB paru BTA (+), TB Paru dengan Hipertensi terkontrol, TB paru suspek MDR, TB Paru dengan infeksi sekunder, TB paru on treatment, dan TB paru putus obat. Hasil analisis data perubahan kadar SGOT sebelum dan setelah diberikan Obat Anti Tuberkulosis menunjukkan bahwa nilai zhitung: 2,223 >ztabel : 1,645 dengan nilai signifikansi p= 0,026 < 0,05. Hal ini menunjukkan bahwa terdapat pengaruh pemberian Obat Anti Tuberkulosis (OAT) kombinasi dosis tetap terhadap kadar SGOT. Hasil analisis data perubahan kadar SGPT sebelum dan setelah diberikan Obat Anti Tuberkulosis menunjukkan bahwa nilai zhitung: 2,045 >ztabel : 1,645 dengan nilai signifikansi p= 0,041 < 0,05. Hal ini menunjukkan bahwa terdapat pengaruh pemberian Obat Anti Tuberkulosis (OAT) kombinasi dosis tetap terhadap kadar SGPT. Terdapat hubungan yang signifikan antara kadar serum glutamic oxaloacetic transaminase dan serum glutamic pyruvic transaminase pada pasien tuberkulosis paru selama dua bulan berjalannya pemberian obat anti tuberkulosis kombinasi dosis tetap dan terdapat peningkatan kadar SGOT dan SGPT pada pasien tuberkulosis paru.

scholarly journals Baseline Characteristics of Patients and the Effect of Fixed-Dose Combination Chemotherapy on Sputum Conversion Time in Active Pulmonary Tuberculosis: A Preliminary Study in Kandy District, Sri Lanka

2010 ◽  
Vol 5 (1) ◽  
pp. 1-6
Author(s):  
KAS Jayawardena ◽  
M Samarathunga
Keyword(s):  
Sri Lanka ◽  
Pulmonary Tuberculosis ◽  
Conversion Rate ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Heavy Smoking ◽  
Active Pulmonary Tuberculosis ◽  
Sputum Conversion ◽  
Dose Combination ◽  
Conversion Time

Main Objective: To evaluate the effect of Fixed-Dose Combination (FDC) drugs on sputum conversion time in active tuberculosis. Method: A prospective study of 58 active pulmonary tuberculosis patients in Kandy District Sri Lanka. Results: The mean sputum conversion time was 3.836 weeks (SD 2.599) and the median was 4.00 weeks. The sputum conversion rate at the end of 8 weeks was 96.36%. Initial bacillary load indicated by sputum smear grading was highly correlated with sputum conversion time (r = 0.531 P = 0.000). Gender was associated with sputum conversion time. Women had significantly shorter sputum conversion time. (T value =2.23, P = 0.03, Df = 48). Heavy smoking was associated with delayed sputum conversion in male patients (p = 0.01). Conclusion: Use of FDC in active pulmonary tuberculosis yields high sputum conversion rate with a mean sputum conversion time of 3.4 weeks. Faster sputum conversion among women may be attributed to their stronger genetic constitution and healthy lifestyles. Heavy smoking is associated with delayed sputum conversion. Key words: FDC Drugs; sputum conversion time; pulmonary tuberculosis; Sri Lanka DOI: 10.3126/saarctb.v5i1.3076 SAARC J. Tuber. Lung Dis. HIV/AIDS 2008 Vol.5(1) 1-6

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