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Dr. Rick Nishimura
Mr Bongani Mawethu Mayosi,
By Bongani Mawethu Mayosi, FESC (Cape Town, South Africa)View Discussant report
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List of Authors: Bongani M Mayosi, Mpiko Ntsekhe, Jackie Bosch, Shaheen Pandie, Veronica Francis, Laura Joldersma, Freedom Gumedze, Hyejung Jung, Janice Pogue, Salim Yusuf for The IMPI Trial Investigators
STUDY OUTLINEThe Investigation of the Management of Pericarditis (IMPI) trial was a multicenter randomized double-blind placebo-controlled 2 × 2 factorial study. Eligible patients are randomly assigned to receive oral prednisolone or placebo for 6 weeks and Mycobacterium indicus pranii injection or placebo for 3 months. The primary outcome was the first occurrence of death, cardiac tamponade requiring pericardiocentesis, or constrictive pericarditis. The secondary outcome was safety of immunomodulatory treatment measured by effect on opportunistic infections and malignancy and impact on measures of immunosuppression and the incidence of immune reconstitution disease.BACKGROUNDTuberculous (TB) pericarditis affects a million individuals in Africa and the morbidity and mortality are very high despite anti-TB therapy. We evaluated the effectiveness and safety of adjunctive corticosteroids and Mycobacterium indicus pranii in patients with tuberculous pericarditis treated with anti-TB drugs, especially in those with concomitant human immunodeficiency virus (HIV) infection.METHODSWe randomized 1,400 people (mean age, 38.7 years) with definite or probable tuberculous pericardial effusion to receive adjunctive prednisolone for 6 weeks or placebo, and to receive Mycobacterium indicus pranii immunotherapy or placebo for 3 months with the use of a 2-by-2 factorial design. The primary outcome was a composite of death, cardiac tamponade requiring pericardiocentesis, or constrictive pericarditis. The secondary safety outcomes were the occurrence of opportunistic infection and malignancy (in all patients), and immunosuppression measured by CD4+ T cell count and immune reconstitution disease (in HIV positive patients). RESULTSIn the prednisolone comparison, the median follow-up was 636.5 days (interquartile range, 317.5 to 1085.5 days); at study end, the primary-outcome status was known for 1371 participants (97.9%). In the Mycobacterium indicus pranii comparison, the median follow-up was 720.5 days (interquartile range, 368.0 to 1095.0); at study end, the primary-outcome status was known for 1223 participants (97.8%). There was no significant difference between prednisolone and placebo (23.8% vs. 24.8%; hazard ratio, 0.95; 95% confidence interval [CI], 0.77 to 1.18; P=0.66), or between Mycobacterium indicus pranii immunotherapy and placebo (25.0% vs. 24.3%; hazard ratio, 1.03; 95% CI, 0.82 to 1.29; P=0.81) with respect to the primary outcome. Prednisolone was associated with a significant reduction in constrictive pericarditis (4.4% vs. 7.8%; hazard ratio, 0.56; 95% CI, 0.36 to 0.85; P=0.009) and hospitalizations (20.7% vs. 25.2%; hazard ratio, 0.79; 95% CI, 0.63 to 0.99; P=0.04). Prednisolone and Mycobacterium indicus pranii were associated with a significant increase in malignancy (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), mainly due to an increase in HIV-associated malignancies. There was no difference in median CD4+ T cell count during the study and in the occurrence of immune reconstitution disease between the two groups for the two comparisons in HIV infected individuals.CONCLUSIONSIn patients with tuberculous pericarditis, neither prednisolone nor Mycobacterium indicus pranii had a significant effect on the composite of death, cardiac tamponade or constrictive pericarditis. Both therapies were associated with an increased risk of HIV-associated malignancies. However, use of adjunctive steroids reduced the incidence of pericardial constriction and hospitalization. The beneficial effects of prednisolone on constriction and hospitalization were similar in HIV-positive and HIV-negative patients.
By Rick Nishimura (Rochester, United States of America)See Presenter abstract
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