Study objective: Weight loss is a common complication of COPD, associated with negative outcomes. Weight restoration has been associated with improved outcomes. The effects of oxandrolone, an adjunct to help restore weight, were evaluated in patients with COPD.
Design: Prospective, open-label, 4-month clinical trial.
Setting: Twenty-five community-based pulmonary practices throughout the United States.
Patients: A primary pulmonary diagnosis of moderate-to-severe COPD as defined by FEV1 < 50% of predicted and FEV1/FVC ratio < 0.7, along with significant involuntary weight loss (weight < or = 90% ideal body weight).
Interventions: Oral oxandrolone, 10 mg bid.
Measurements and results: Body weight, body composition (bioelectric impedance analysis), spirometry, and 6-min walking distance were measured. Data for 82 patients at 2 months and 55 patients at 4 months are presented. At month 2, 88% of patients had gained a mean +/- SD of 6.0 +/- 4.36 lb (p < 0.05) and 12% had lost a mean of 1.7 +/- 2.15 lb (not statistically significant [NS]). At month 4, 84% had gained a mean of 6.0 +/- 5.83 lb (p < 0.05) and 16% had lost a mean of 1.8 +/- 1.74 lb (NS). Month 4 bioelectric impedance analysis showed the weight to be primarily lean tissue, with a mean increase in body cell mass of 3 +/- 2.6 lb (p < 0.05), and a mean increase in fat of 1.2 +/- 4.6 lb (NS).
Conclusions: Oxandrolone is an effective adjunct to facilitate weight restoration in patients with COPD-associated weight loss. Weight gain is primarily lean body mass. Oxandrolone was relatively well tolerated and, therefore, should be a consideration in the comprehensive management of patients with COPD and weight loss.