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Detectable prednisolone is delayed in pericardial fluid, compared with plasma of patients with tuberculous pericarditis: A pilot study.

ABSTRACT: Background:In patients with tuberculous pericarditis [TBP] adjunctive prednisolone reduces the incidence of constrictive pericarditis. It is unknown whether prednisolone permeates adequately into pericardial fluid. Drug measurements in pericardial fluid require invasive procedures, and thus less invasive methods are needed to perform full pharmacokinetic characterization of prednisolone in large numbers of patients. We sought to evaluate the relationship between prednisolone concentrations in pericardial fluid, plasma, and saliva. Methods:Plasma, pericardial fluid, and saliva samples were collected at 7 time points from TBP patients randomized to 120?mg prednisolone or placebo. Compartmental pharmacokinetic parameters, peak concentration [Cmax], and 0-24?h area under the concentration-time curve [AUC0-24] were identified in plasma, saliva and pericardial fluid. Results:There were five patients each in the prednisolone and placebo groups. Prednisolone concentrations were best described using a one compartment model. The absorption half-life into plasma was 1?h, while that into pericardial fluid was 9.4?h, which led to a median time-to-maximum concentration in plasma of 2.0?h versus 5.0?h in pericardial fluid [p?=?0.048]. The concentration-time profiles in pericardial fluid versus plasma exhibited system hysteresis. The pericardial fluid-to-plasma Cmax peak concentration ratio was 0.28 (p?=?0.032), while the AUC0-24 ratio was 0.793. The concentration-time profiles in saliva had a similar shape to those in plasma, but the saliva-to-plasma Cmax was 0.59 [p?=?0.032]. Conclusion:The prednisolone AUC0-24 achieved in pericardial fluid approximates that in plasma, but the Cmax is low due to delayed absorption. Saliva can be used as surrogate sampling site for pericardial fluid prednisolone.

SUBMITTER: Shenje J

PROVIDER: S-EPMC6437290 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Detectable prednisolone is delayed in pericardial fluid, compared with plasma of patients with tuberculous pericarditis: A pilot study.

Shenje Justin J Gumbo Tawanda T Wiesner Lubbe L Ntsekhe Mpiko M Mayosi Bongani B Ross Ian I

International journal of cardiology. Heart & vasculature 20190111

<h4>Background</h4>In patients with tuberculous pericarditis [TBP] adjunctive prednisolone reduces the incidence of constrictive pericarditis. It is unknown whether prednisolone permeates adequately into pericardial fluid. Drug measurements in pericardial fluid require invasive procedures, and thus less invasive methods are needed to perform full pharmacokinetic characterization of prednisolone in large numbers of patients. We sought to evaluate the relationship between prednisolone concentratio ...[more]

PMID: 30963091

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Project description:BackgroundTuberculous pericarditis is associated with high morbidity and mortality even if antituberculosis therapy is administered. We evaluated the effects of adjunctive glucocorticoid therapy and Mycobacterium indicus pranii immunotherapy in patients with tuberculous pericarditis.MethodsUsing a 2-by-2 factorial design, we randomly assigned 1400 adults with definite or probable tuberculous pericarditis to either prednisolone or placebo for 6 weeks and to either M. indicus pranii or placebo, administered in five injections over the course of 3 months. Two thirds of the participants had concomitant human immunodeficiency virus (HIV) infection. The primary efficacy outcome was a composite of death, cardiac tamponade requiring pericardiocentesis, or constrictive pericarditis.ResultsThere was no significant difference in the primary outcome between patients who received prednisolone and those who received placebo (23.8% and 24.5%, respectively; hazard ratio, 0.95; 95% confidence interval [CI], 0.77 to 1.18; P=0.66) or between those who received M. indicus pranii immunotherapy and those who received placebo (25.0% and 24.3%, respectively; hazard ratio, 1.03; 95% CI, 0.82 to 1.29; P=0.81). Prednisolone therapy, as compared with placebo, was associated with significant reductions in the incidence of constrictive pericarditis (4.4% vs. 7.8%; hazard ratio, 0.56; 95% CI, 0.36 to 0.87; P=0.009) and hospitalization (20.7% vs. 25.2%; hazard ratio, 0.79; 95% CI, 0.63 to 0.99; P=0.04). Both prednisolone and M. indicus pranii, each as compared with placebo, were associated with a significant increase in the incidence of cancer (1.8% vs. 0.6%; hazard ratio, 3.27; 95% CI, 1.07 to 10.03; P=0.03, and 1.8% vs. 0.5%; hazard ratio, 3.69; 95% CI, 1.03 to 13.24; P=0.03, respectively), owing mainly to an increase in HIV-associated cancer.ConclusionsIn patients with tuberculous pericarditis, neither prednisolone nor M. indicus pranii had a significant effect on the composite of death, cardiac tamponade requiring pericardiocentesis, or constrictive pericarditis. (Funded by the Canadian Institutes of Health Research and others; IMPI ClinicalTrials.gov number, NCT00810849.).

Project description:BACKGROUND:This study aimed to assess the diagnostic performance of Xpert MTB/RIF for tuberculous pericarditis (TBP) using pericardial tissues. METHODS:The study involved 30 patients admitted with suspected TBP from January-December 2016; three patients were later excluded. The interferon-? release assay (T-SPOT.TB) and the Xpert MTB/RIF test were performed using peripheral blood and pericardial tissues, respectively. TBP was confirmed using pericardial histopathology and a composite reference standard (CRS). We analyzed the sensitivity, specificity, predictive value (PV), likelihood ratio (LR), and area under curve (AUC) of both assays. RESULTS:Fourteen patients were confirmed as TBP, 10 as non-TBP, and 3 as probable TBP. The sensitivity, specificity, positive PV (PPV), negative PV (NPV), PLR, NLR, and AUC (95% confidence interval [CI]) of the Xpert MTB/RIF assay were 78.6% (49.2-95.3%) and 70.6% (44.0-89.7%); 92.3% (64.0-99.8%) and 100% (69.2-100%); 91.7% (61.5-99.8%) and 100% (73.5-100%); 80.0% (51.9-95.7%) and 66.7% (38.4-88.2%); 10.21 (1.52-68.49) and the PLR value was undefined with CRS as the reference; 0.23 (0.08-0.64) and 0.29(0.14-0.61); and 0.854 (0.666-0.959) and 0.853 (0.664-0.959), against histopathology and CRS, respectively. The sensitivity, specificity, PPV, NPV, PLR, NLR, and AUC values (95% CI) of T-SPOT.TB were 92.9% (66.1-99.8%) and 94.1% (71.3-99.9%); 15.4% (1.9-45.5%) and 20.0% (2.5-55.6%); 54.2% (32.8-74.5%) and 66.7% (44.7-84.4%); 66.7% (9.4-99.2%) and 66.7% (9.4-99.2%); 1.10 (0.83-1.44) and 1.18 (0.84-1.6); 0.46 (0.05-4.53) and 0.29 (0.03-2.85); and 0.541(0.340-0.733) and 0.571(0.367-0.758), against histopathology and CRS, respectively. The differences in sensitivity, PPV, and AUC of Xpert MTB/RIF and T-SPOT.TB were not statistically significant (P > 0.05), compared to those of histopathology and CRS. However, the differences in specificity and NPV of the two assays were significant (P < 0.05), compared to those of histopathology and CRS. CONCLUSIONS:Xpert MTB/RIF test is a valid diagnostic technique for TBP with higher sensitivity and specificity than T-SPOT.TB.

Dataset Information

Detectable prednisolone is delayed in pericardial fluid, compared with plasma of patients with tuberculous pericarditis: A pilot study.

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Detectable prednisolone is delayed in pericardial fluid, compared with plasma of patients with tuberculous pericarditis: A pilot study.

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