TY - JOUR
T1 - Prednisolone and Mycobacterium indicus pranii in tuberculous pericarditis
AU - The Impi Trial Investigators
AU - Mayosi, B. M.
AU - Ntsekhe, M.
AU - Bosch, J.
AU - Pandie, S.
AU - Jung, H.
AU - Gumedze, F.
AU - Pogue, J.
AU - Thabane, L.
AU - Smieja, M.
AU - Francis, V.
AU - Joldersma, L.
AU - Thomas, K. M.
AU - Thomas, B.
AU - Awotedu, A. A.
AU - Magula, N. P.
AU - Naidoo, D. P.
AU - Damasceno, A.
AU - Banda, A. C.
AU - Brown, B.
AU - Manga, P.
AU - Kirenga, B.
AU - Mondo, C.
AU - Mntla, P.
AU - Tsitsi, J. M.
AU - Peters, F.
AU - Essop, M. R.
AU - Russell, J. B.W.
AU - Hakim, J.
AU - Matenga, J.
AU - Barasa, A. F.
AU - Sani, M. U.
AU - Olunuga, T.
AU - Ogah, O.
AU - Ansa, V.
AU - Aje, A.
AU - Danbauchi, S.
AU - Ojji, D.
AU - Yusuf, S.
N1 - Publisher Copyright:
Copyright © 2014 Massachusetts Medical Society.
PY - 2014/9/18
Y1 - 2014/9/18
N2 - Background 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.Methods 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.Results 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.Conclusions 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.
AB - Background 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.Methods 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.Results 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.Conclusions 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.
UR - http://www.scopus.com/inward/record.url?scp=84907406784&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1407380
DO - 10.1056/NEJMoa1407380
M3 - Article
C2 - 25178809
AN - SCOPUS:84907406784
SN - 0028-4793
VL - 371
SP - 1121
EP - 1130
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 12
ER -
