Role of aspirin in tuberculous meningitis: a randomized open label placebo
controlled trial.
Author(s): Misra UK, Kalita J, Nair PP.
Affiliation(s): Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical
Sciences, Lucknow, India. ukmisra@sgpgi.ac.in
Publication date & source: 2010, J Neurol Sci. , 293(1-2):12-7
OBJECTIVE: To evaluate the efficacy and safety of aspirin in preventing stroke
and mortality in tuberculous meningitis (TBM).
METHODS: Patients with TBM diagnosed on the basis of clinical, MRI and
cerebrospinal fluid (CSF) criteria were randomized into aspirin 150 mg daily or
placebo. All the patients received four drug antitubercular treatment- RHZE
(rifampicin, isoniazide, pyrazinamide and ethambutol) with or without
corticosteroid. The primary endpoint was MRI proven stroke at 3 months and
secondary end points were mortality and functional outcome assessed by Barthel
Index score at 3 months. The adverse drug reactions were also analyzed.
RESULTS: 118 TBM patients were randomized into aspirin and placebo groups. The
baseline demographic, clinical (severity of meningitis, MRI and CSF changes) were
not significantly different between the two groups. 19 (16.1%) patients lost from
follow up. 21 (33.3%) patients developed stroke after randomization which was
insignificantly lesser in aspirin (24.2%) compared to the placebo group (43.3%;
OR 0.42, 95%CI 0.12-1.39). Aspirin resulted in absolute risk reduction of stroke
in 19.1% and significant reduction in mortality compared to placebo (21.7% Vs
43.4%, P=0.02). On binary logistic regression analysis, the age (OR 1.09, CI
1.03-1.14, P=0.001) was the only independent risk factor of stroke and aspirin
was significantly related to survival (OR 3.17, 95% CI 1.21-8.31). Aspirin was
well tolerated and was not withdrawn in any patient because of side effects.
INTERPRETATION: Aspirin resulted in insignificantly lesser strokes and
significantly reduced 3 month mortality in patients with TBM.
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