@article{29401,
  keywords = {Adult, Cardiac Tamponade, Combined Modality Therapy, Female, Glucocorticoids, HIV Infections, Humans, Immunotherapy, Kaplan-Meier Estimate, Male, Mycobacterium, Pericardiocentesis, Pericarditis, Constrictive, Pericarditis, Tuberculous, Prednisolone, Treatment Failure},
  author = {Mayosi BM and Ntsekhe M and Bosch J and Pandie S and Jung H and Gumedze F and Pogue J and Thabane L and Smieja M and Francis V and Joldersma L and Thomas K and Thomas B and Awotedu AA and Magula N and Naidoo D and Damasceno A and Chitsa Banda A and Brown B and Manga P and Kirenga B and Mondo C and Mntla P and Tsitsi J and Peters F and Essop MR and Russell J and Hakim J and Matenga J and Barasa AF and Sani MU and Olunuga T and Ogah O and Ansa V and Aje A and Danbauchi S and Ojji D and Yusuf S and IMPI Trial Investigators },
  title = {Prednisolone and Mycobacterium indicus pranii in tuberculous pericarditis.},
  abstract = {<p><strong>BACKGROUND: </strong>Tuberculous 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.</p>

<p><strong>METHODS: </strong>Using 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.</p>

<p><strong>RESULTS: </strong>There 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.</p>

<p><strong>CONCLUSIONS: </strong>In 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.).</p>
},
  year = {2014},
  journal = {The New England journal of medicine},
  volume = {371},
  pages = {1121-30},
  issn = {1533-4406},
  url = {https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4912834/pdf/nihms5772.pdf},
  doi = {10.1056/NEJMoa1407380},
  language = {eng},
}