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1 October 2006

Volume 43, Number 7
Clinical Infectious Diseases 2006;43:848–854
© 2006 by the Infectious Diseases Society of America. All rights reserved.
1058-4838/2006/4307-0008$15.00
DOI: 10.1086/507543
MAJOR ARTICLE

Exposure to Rifampicin Is Strongly Reduced in Patients with Tuberculosis and Type 2 Diabetes

Hanneke M. J. Nijland,1

Rovina Ruslami,4

Janneke E. Stalenhoef,2

Erni J. Nelwan,5

Bachti Alisjahbana,3

Ron H. H. Nelwan,5

Andre J. A. M. van der Ven,2

Halim Danusantoso,6

Rob E. Aarnoutse,1 and

Reinout van Crevel2

Departments of 1Clinical Pharmacy and 2Internal Medicine, Radboud University Nijmegen Medical Centre, The Netherlands; 3Department of Internal Medicine, Hasan Sadikin Hospital, and 4Department of Pharmacology, Medical Faculty, University of Padjadjaran, Bandung, and 5Division of Tropical Medicine and Infectious Diseases, Department of Internal Medicine, University of Indonesia, and 6Indonesian Tuberculosis Control Association, Jakarta Branch, Jakarta, Indonesia

Background.Type 2 diabetes (DM) is a strong risk factor for tuberculosis (TB) and is associated with a slower response to TB treatment and a higher mortality rate. Because lower concentrations of anti‐TB drugs may be a contributing factor, we compared the pharmacokinetics of rifampicin in patients with TB, with and without DM.

Methods.Seventeen adult Indonesian patients with TB and DM and 17 age‐ and sex‐matched patients with TB and without DM were included in the study during the continuation phase of TB treatment. All patients received 450 mg of rifampicin (10 mg/kg) and 600 mg of isoniazid 3 times weekly. Steady‐state plasma concentrations of rifampicin and its metabolite desacetylrifampicin were assessed at 0, 2, 4, and 6 h after drug intake.

Results.Geometric means of rifampicin exposure (AUC0–6 h) were 12.3 mg × h/L (95% confidence interval [CI], 8.0–24.2) in patients with TB and DM, and 25.9 mg × h/L (95% CI, 21.4–40.2) in patients with TB only ( ). Similar differences were found for the maximum concentration of rifampicin. No significant differences in time to maximum concentration of rifampicin were observed. The AUC0–6 h of desacetylrifampicin was also much lower in patients with TB and DM versus patients with TB only (geometric mean, 0.60 vs. 3.2 mg × h/L; ). Linear regression analysis revealed that higher body weight ( ), the presence of DM ( ), and plasma glucose concentration ( ) were correlated with exposure to rifampicin.

Conclusion.Exposure (AUC0–6 h) to rifampicin was 53% lower in Indonesian patients with TB and DM, compared with patients with TB only. Patients with TB and DM who have a higher body weight may need a higher dose of rifampicin.

Received 28 April 2006; accepted 13 June 2006; electronically published 22 August 2006.

Reprints and correspondence: Dr. Reinout van Crevel, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands ().

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