Adjunctive Prednisolone in the Treatment of Effusive Tuberculous Pericarditis in HIV Seropositive Patients - Adjunctive Prednisolone in the Treatment of Effusive Tuberculous Pericarditis in HIV Seropositive Patients

Feb 02, 2005
Font Size
A
A
A
Date Published:
01/01/2000
Date Updated:
02/02/2005
Original Posted Date:
02/02/2005
References

Description:

The goal of this randomized, double-blind, placebo-controlled trial was to evaluate use of adjunctive prednisolone on morbidity and mortality among HIV positive patients with effusive tuberculous pericarditis.

Hypothesis:

Prednisolone, in addition to the standard antituberculous regimen, may reduce morbidity and mortality among HIV seropositive patients with effusive tuberculous pericarditis.

Study Design

Study Design:

Patients Enrolled: 58
Mean Follow Up: 18 months
Mean Patient Age: 19-53

Patient Populations:

  • Age 18-55 years
  • Residence in Harare, Zimbabwe
  • HIV seropositive
  • Large (>1 cm anteriorly and posteriorly by echocardiogram) pericardial effusion
  • Pericardial aspirate with >50% lymphocytes and protein content >30 g/l

Exclusions:

  • Tuberculous treatment started more than 48 hours prior to recruitment
  • Corticosteroid treatment within the previous month
  • Known Kaposi's Sarcoma or other malignancy
  • Diagnosis of tuberculosis within the past two years
  • Coexisting life-threatening disease
  • Bacterial pneumonia
  • Pregnancy
  • Cavitating pulmonary tuberculosis
  • Other known cause of pericardial effusion

Primary Endpoints:

  • Resolution of pericardial effusion
  • Death

Secondary Endpoints:

  • Resolution of symptoms (including cough, hemoptysis, chest pain, and physical activity) and signs (including elevated jugular venous pressure, hepatomegaly, ascites, fever, and tachycardia) present on admission
  • Low voltage (<6 mm in V5 or V6 and <4 mm in the limb leads) ECG
  • Corticosteroid-related side effects (including bacterial and viral infections)

Drug/Procedures Used:

  • Prednisolone 60 mg (12 tablets) with 10 mg/wk taper for six weeks
  • Placebo 60 mg (12 tablets) with 10 mg/wk taper for six weeks

Concomitant Medications:

All patients received rifampicin, isoniazid, pyrazinamide, and ethambutol for two months, followed by isoniazid and rifampicin for an additional four months in standard doses.

Principal Findings:

  • Fewer deaths in the prednisolone group at 18 months (5 vs. 10, p=0.004)
  • Significantly faster improvement in physical activity (p=0.02), elevated jugular venous pressure (p=0.017), hepatomegaly (p=0.007), and ascites (p=0.015) in the prednisolone group
  • No significant difference in resolution of pericardial effusion by serial echocardiography (anterior, p=0.19; posterior, p=0.80; subcostal, p=0.39)
  • No significant difference in measured complications of corticosteroids
  • Higher compliance with treatment in the prednisolone group (79.3% vs. 65.4% with >90% of tablets consumed, p=0.008)

Interpretation:

Among HIV positive patients with tuberculous pericarditis with large pericardial effusions, adjunctive treatment with 60 mg prednisolone taper was associated with significantly lower mortality and improvement in physical activity level without increase in corticosteroid-induced complications at 18-month follow-up. There was no significant difference in resolution of pericardial effusion by echocardiography.

References:

Hakim JG, Ternouth I, Mushangi E, Siziya S, Robertson V, Malin A. Double blind randomised placebo controlled trial of adjunctive prednisolone in the treatment of effusive tuberculous pericarditis in HIV seropositive patients. Heart 2000;84:183-8.

Keywords: Venous Pressure, Zimbabwe, Prednisolone, Pericarditis, Tuberculous, HIV Seropositivity, Lymphocytes, Motor Activity, Pericardial Effusion, Patient Compliance, Hepatomegaly, Echocardiography


< Back to Listings