Abstract
<p><strong>Objective: </strong>To comparatively analyze the peak serum concentration (Cmax) of rifampicin and to determine the incidence of decreased Cmax between diabetic and non-diabetic adult pulmonary tuberculosis patients.</p><p><strong>Methods: </strong>A cross-sectional observational study was carried out in the chest and tuberculosis (TB) department of a tertiary care hospital after the approval of the institutional ethics committee. Five millilitre (ml) of blood was withdrawn by venipuncture from each patient at a time point of 2 h post dose administration at steady state concentration (C<sub>ss</sub>). The separated serum was centrifuged at a rate of 3500 rotations per minute (rpm) for a period of fifteen minutes and the resultant serum was stored at-70 ° C until analysis. Estimation of rifampicin concentration was carried out in Thermo TSQ Ultra (MS/MS) with Shimadzu 20 AD UFLC LC-MS.</p><p><strong>Results: </strong>The mean (Standard Deviation (SD)) age of the study population was 46.8 (14.2) years. The mean serum C<sub>max</sub> of rifampicin was significantly less in diabetic patients with pulmonary tuberculosis (p=0.0305).<strong> </strong>Statistically, a significant difference in the incidence of a decrease in C<sub>max </sub>was found between diabetic and non-diabetic patients (p=0.0335). Diabetes mellitus was found to be the predominant factor that affects rifampicin C<sub>max</sub>.</p><p><strong>Conclusion: </strong>In this study, an effect of diabetes mellitus (DM) on the peak serum concentration of rifampicin was observed. Patients with hyperglycemia levels had significantly reduced levels of rifampicin serum concentrations, thus showing an inversely proportional relationship between blood glucose and rifampicin serum levels.</p>
Highlights
The “captain of all these men of death”, tuberculosis (TB) has been a menace to the humankind since the ancient time
This study has examined the effect of diabetes on the peak serum rifampicin concentration in patients with pulmonary tuberculosis, by comparing the expected rifampicin Cmax of patients with PTB only
A near inverse correlation was obtained in diabetic patients (Pearson’s correlation=-0.402, P value=0.001); such a correlation was not observed in non-diabetic pulmonary tuberculosis patients suggesting that the drug absorption is disfavoured only under hyperglycemic conditions and linear relationship does not exist between blood glucose and rifampicin Cmax (Pearson’s correlation=0.006, P Value=0.962)
Summary
The “captain of all these men of death”, tuberculosis (TB) has been a menace to the humankind since the ancient time. TB-a serious and highly infectious disease caused by mycobacterium tuberculosis is the second leading cause for the high incidence of mortality rates worldwide. TB affects the lungs (Pulmonary tuberculosis-PTB) more commonly than the other parts including pleura, central nervous system, lymphatic system, bone and joints (extra-pulmonary tuberculosis). Hemoptysis, night sweats, loss of appetite and weight loss are the common symptoms of PTB [1, 2]. According to the world health organization (WHO) 2014 estimates, incidence of 2.5 million cases of active TB was reported to be in India out of 9.6 million cases incident globally. It adds that “about 40% of the Indian population and one-third of the world’s population are infected with the mycobacterium tuberculosis, where most of them have a latent infection rather than the active disease” [5, 6]
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