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Published ahead of print on May 18, 2006, doi:10.1164/rccm.200511-1834OC

Am. J. Respir. Crit. Care Med., Volume 174, Number 3, August 2006, 344-348

A more recent version of this article appeared on August 1, 2006
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Submitted on November 30, 2005
Accepted on May 16, 2006

Lack of Weight Gain and Relapse Risk in a Large Tuberculosis Treatment Trial

Awal Khan1*, Timothy R Sterling2, Randall Reves3, Andrew Vernon1, and C. Robert Horsburgh4

1 Centers for Disease Control and Prevention, Atlanta, GA, USA, 2 Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Services Research, Vanderbilt University Medical Center, Nashville, TN, USA, 3 Department of Public Health, Denver Health and Hospital, Denver, CO, USA, 4 Department of Epidemiology, Boston University School of Public Health, Boston, MA, USA

* To whom correspondence should be addressed. E-mail: aek5{at}cdc.gov.

Background: Readily identified markers of tuberculosis relapse risk are needed, particularly in resource-limited settings. The association between weight gain or loss during anti-tuberculosis therapy and relapse has not been well-studied. Methods: Subjects in Tuberculosis Trials Consortium Study 22 were studied. Underweight was defined as ≥ 10% below ideal body weight at diagnosis. Weight change was assessed between 1) diagnosis and completion of induction phase therapy, 2) diagnosis and end of continuation phase therapy, and 3) completion of induction to completion of continuation phase therapy. Results: 857 subjects were followed for 2 years, and 61/857 (7.1%) relapsed. Relapse risk was high among persons who were underweight at diagnosis (19.1% vs. 4.8%; P<0.001) or who had BMI < 18.5 kg/m2 (19.5% vs. 5.8%; P<0.001). Among persons who were underweight at diagnosis, weight gain of ≤ 5% between diagnosis and completion of 2-month intensive phase therapy was moderately associated with an increased relapse risk (18.4% vs. 10.3%; RR 1.79, 95% CI 0.96-3.32; P=0.06). In a multivariate logistic regression model that adjusted for other risk factors, ≤ 5% weight gain between diagnosis and completion of 2-month intensive phase therapy among persons underweight at diagnosis was significantly associated with relapse risk (OR=2.4;P=0.03). Conclusions: Among persons underweight at diagnosis, ≤ 5% weight gain during the first two months of treatment is associated with an increased relapse risk. Such high-risk patients can be easily identified, even in resource-poor settings. Additional studies are warranted to identify interventions to decrease risk of relapse in such patients. www.clinicaltrials.gov NCT00023335
Key words: Tuberculosis, weight, body mass index (BMI), relapse, clinical trial.




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