The entry criteria included 10% to 20% of unintentional loss of weight or a BMI ≤20 kg/m2. These criteria allowed patients who were over their ideal body weight or even obese at baseline to enter the study if they had lost 10% to 20% of their body weight. Five subjects were obese (>120% ideal body weight), with the highest weight at entry being 107 kg. Twenty-four percent of the patients had a BMI >22.5 kg/m2. Therefore, we performed post hoc analysis evaluating changes in body weight and composition in subjects with a BMI ≤22.5 kg/m2 on an intent-to-treat basis at 12 weeks or last measurement. Their weight increase over baseline at 12 weeks was 0.8 ± 2.7 kg on placebo, 2.7 ± 4.0 kg on 20 mg of oxandrolone, 2.9 ± 2.6 kg on 40 mg of oxandrolone, and 2.5 ± 2.8 kg on 80 mg of oxandrolone (all significantly increased over baseline). Compared with placebo, subjects receiving 20mg, 40 mg, or 80 mg of oxandrolone had significantly higher weights at week 12 (P = 0.0026, P = 0.0005, and P = 0.0041, respectively). Similar changes were found for BCM,where the increases at 12 weeks over baseline were 0.2 ± 1.5 kg in the placebo group, 1.1 ± 2.1 in the 20-mg oxandrolone group; 1.8 ± 1.5 kg in the 40-mg oxandrolone group, and 2.0 ± 1.7 kg in the 80-mg oxandrolone group. Compared with placebo, subjects receiving 20, 40, or 80 mg of oxandrolone had a significantly higher BCM at week 12 (P= 0.0122, P < 0.0001, and P < 0.0001, respectively).
No significant differences were seen in MOS HIV health surveys for any treatment group. There was no significant change from baseline in total work output in the subset of subjects who underwent treadmill testing in any treatment group. There was no correlation between change in weight and QOL score or total work output.
Serum albumin, total protein, bilirubin, alkaline phosphatase, lactate dehydrogenase (LDH), and gamma-glutamyl transferase (GGT) levels were not significantly changed (see Table 3). However, there were dose-dependent increases in AST and ALT appearing by the first 4 to 8 weeks of therapy. The increase in AST was significant at the 80-mg dose compared with baseline, whereas the increase in ALT was significant at the 40-mg and 80-mg doses. Furthermore, there was a dose-related increase in the incidence of WHO grade III and IV liver toxicity for ALT and AST with increasing dose of oxandrolone (Table 4). For AST, WHO grade III and IV toxicity occurred in 2 of 61 subjects on placebo, 2 of 60 on 20 mg of oxandrolone, 6 of 61 on 40 mg of oxandrolone, and 9 of 61 on 80 mg of oxandrolone. For ALT, WHO grade III and IV toxicity occurred in 1 of 61 subjects on placebo, 3 of 60 on 20 mg of oxandrolone, 7 of 61 on 40 mg of oxandrolone, and 9 of 61 on 80 mg of oxandrolone (for trend, P = 0.0047). Three subjects receiving the 40-mg dose and 4 subjects receiving the 80-mg dose were discontinued from the drug because of laboratory abnormalities.
Glucose, triglyceride, and total cholesterol levels in patients receiving oxandrolone were not significantly different from those receiving placebo (see Table 3). There was a significant decrease in uric acid and plasma high-density lipoprotein (HDL) cholesterol levels at all doses. Furthermore, there was a significant increase in low-density lipoprotein (LDL) cholesterol levels at the 40-mg and 80-mg doses.
Baseline total testosterone levels averaged close to the lower limits of normal (270 ng/dL; Table 5). At 12 weeks, serum LH and FSH concentrations decreased significantly from baseline in all oxandrolone-treated groups, consistent with an androgenic action. Serum SHBG concentrations also decreased with increasing doses of oxandrolone, which also suggests an androgenic effect of oxandrolone (SHBG was determined in a subset of patients, and total testosterone levels in the subset were similar to those in the larger cohort; data not shown).
Total and free testosterone concentrations measured bydirect RIA did not show a dose-related change. We used celite chromatography to separate testosterone from oxandrolone before RIA and found that serum total testosterone concentrations were significantly decreased from baseline at all doses of oxandrolone but not with placebo treatment (see Table 5).
After the double-blind placebo-controlled study, a subset of subjects opted to take 20 mg of oxandrolone in an open-label study. All 4 groups receiving 20 mg of oxandrolone during this 12-week open-label phase continued to gain weight (Table 6). By the end of the open-label phase, there were no significant differences in weight gain among the groups. AST levels decreased; although AST levels remained above baseline, they were no longer significantly different from baseline (see Table 6).
Oxandrolone treatment was associated with significantly greater body weight gain above baseline than with placebo. A major portion of this weight gain occurred in the lean body compartment, as reflected in the significant gains in BCM, intracellular water, and serum creatinine levels. The gains in body weight during the double-blind phase of the study were sustained during the open-label phase of the study.
Oxandrolone administration has been shown to increase muscle protein synthesis in emaciated burn patients,56 muscle mass and maximal voluntary strength in older men at risk for sarcopenia,57-60 and weight in patients with cancer cachexia. Most previous studies have included small numbers of subjects, however; this study is the largest randomized placebo-controlled trial of an androgen in patients with HIV-associated weight loss.
Serum LH and FSH levels decreased significantly during oxandrolone administration, consistent with its androgenic activity. Whereas conventional measurement of testosterone did not show consistent decreases, assay after chromatographic separation did show suppression of testosterone, confirming the androgenic effect and indicating that oxandrolone or a metabolite cross-reacted in the conventional testosterone assay. This dose-ranging study did not include women; therefore, we cannot determine whether the level of androgenic activity seen with oxandrolone would have the expected detrimental virilizing effects in women.
Oxandrolone administration was generally well tolerated. Grade III and IV elevations of transaminases were observed in >5% of study participants, however, especially atthe80-mg dose. Careful monitoring of these parametersistherefore indicated after the initiation of oxandrolone therapy. Furthermore, LDL levels increased and HDL levels decreased.
There has been considerable debate about what magnitude of change in body weight is clinically meaningful. An AIDS Clinical Trial Group (ACTG) expert panel on HIV-associated wasting expressed the opinion that a gain of 1.5 kg is clinically meaningful (Fred Sattler, MD, personal communication). The average weight gain at each of the oxandrolone doses exceeded 1.5 kg, whereas the increase in the placebo group was less than 1.5 kg. Only the 40-mg dose of oxandrolone induced more than a 1.5-kg increase in weight over that attained with placebo (an increase over placebo of 1.7 kg based on a 2.8-kg increase for 40 mg of oxandrolone vs. a 1.1-kg increase for placebo). For subjects whose BMI was ≤22.5 kg/m2, all 3 doses of oxandrolone induced more than a 1.5-kg increase over placebo (20 mg induced a 1.9-kg increase, 40 mg induced a 2.1-kg increase, and 80 mg induced a 1.7-kg increase). In subjects whose BMI was ≤22.5 kg/m2, the mean increases in BCM in patients treated with the 40- or 80-mg dose of oxandrolone were also greater than 1.5 kg above that attained with placebo. These changes in weight and BCM compare favorably with those observed during administration of rhGH27,28 and testosterone.31-36 In a meta-analysis of placebo-controlled, randomized, clinical trials of testosterone, the average gain in lean body mass was 1.3 kg in testosterone-treated HIV-infected men.61
In spite of significant body weight gains and lean mass accretion, total work output during treadmill exercise did not significantly change during treatment. This is consistent with the growing body of data that androgenic steroids increase muscle mass but do not affect measures of endurance, such as treadmill performance.62-64 Reports of randomized clinical trials published subsequent to the initiation of this study have reported significant gains in maximal voluntary strength with androgen supplementation of HIV-infected men with weight loss35; gains in muscle strength are generally proportional to increases in muscle mass.35
Participants in this study were able to consume a well-balanced diet at study entry as assessed by a dietitian. In developing countries of Africa and Asia, many HIV-infected patients have an overall energy deficit, with varying macro- and micronutrient deficiencies. We do not know whether androgen administration would be efficacious in preventing weight loss in HIV-infected patients with severe wasting or in nutritionally depleted individuals.
Administration of oxandrolone has been associated with significant decreases in plasma HDL cholesterol levels and increases in LDL cholesterol levels.60,65,66 The administration of the 40- and 80-mg doses was associated with significant increases in ALT and AST; these increases were transient and returned toward baseline in most subjects. Treatment discontinuations attributable to persistent and marked increases in transaminases were common and occurred in more than 5% of individuals. We found no increase in bilirubin or alkaline phosphatase.
The gains in body weight and BCM were related to oxandrolone dose. Similarly, there were dose-dependent increases in AST and ALT levels and common treatment discontinuations attributable to AST and ALT elevations. Thus, the best trade-off between the anabolic effects and AST and ALT elevation was achieved at the 40-mg daily dose. The therapeutic efficacy and safety of this dose should be further evaluated in subsequent clinical trials.
The decreases in HDL and increases in LDL represent a proatherogenic lipoprotein profile. Clinicians therefore need to weigh the risk-benefit ratio of this therapy. Wasting syndrome predicts a significant risk of complications and death, but even studies as large as this one are not large enough and have not been carried out long enough to determine whether reversal of that risk occurs with treatment of wasting and to determine the risk of cardiovascular disease. The risk of atherosclerosis predicted by this lipoprotein profile suggests that such therapy should be restricted to those with significant wasting or should be terminated when wasting has improved. Mean CD4 lymphocyte counts in this study were >200 × 106/L, which is higher than in most earlier studies of HIV-associated wasting (which often had mean values ≤50 × 106/L), indicating better health later in the epidemic. In that light, future studies should likely exclude those with obesity even in the presence of weight loss. In post hoc analysis, we found that the 20-mg dose was more effective in those with a BMI at entry of ≤22.5 kg/m2. The lower dose was accompanied by lesser increases in LDL and transaminases. Thus, a prospective study excluding obese patients could establish that a 20-mg dose is efficacious and associated with a lower frequency of adverse events.
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The following individuals were participants in the Oxandrolone Study Group:
Victor Beer, MD, Beer Medical Group, 5901 West Olympic Boulevard, Suite 505, Los Angeles, CA 90036
Daniel Berger, MD, Center for Special Immunology, 2835 North Sheffield Avenue, Suite 104, Chicago, IL60657
Shalender Bhasin, MD, Charles R. Drew University of Medicine and Science, 1621 East 120th Street, MP-02, Los Angeles, CA 90059
Eric S. Daar, MD, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, B217, Los Angeles, CA 90048
Douglas Dieterich, MD, Liberty Medical, LLP, 345 East 37th Street, Suite 306, New York, NY 10016
Adrian S. Dobs, MD, Johns Hopkins University, Department of Endocrinology and Metabolism, Blalock 906, 600 North Wolfe Street; Baltimore, MD 21287-4904
Richard Elion, MD, Community Care Center, 1737 20th Street NW, Washington, DC 20009
Jeffrey Fessel, MD, Kaiser Permanente Medical Center, HIVResearch Unit, 4141 Geary Boulevard, Room 221, SanFrancisco, CA 94115
Marshall J. Glesby, MD, Community Research Initiative onAIDS, 230 West 38th Street, 17th Floor, New York, NY10018
Carl Grunfeld, MD, PhD, University of California at San Francisco, Metabolism Section (111F), and Department of Veterans Affairs Medical Center, 4150 Clement Street, San Francisco, CA 94121
Barbara Johnston, MD, St. Vincent's Hospital and Medical Center, 36 Seventh Avenue, Suite 415, New York, NY 10011
Donald Kotler, MD, St. Luke's-Roosevelt Hospital Center, Gastrointestinal Immunology S&R 1301, 1111 Amsterdam Avenue, New York, NY 10025.
Craig A. Lindquist, MD, PhD, Marin County Specialty Clinic, 161 Mitchell Boulevard, Suite 200, San Rafael, CA94903
Alvin E. Fisher, MD, Omega Medical Research, 400 Reservoir Avenue, Suite LL 1J, Providence, RI 02907
Jeff P. Nadler, MD, University of South Florida, Division ofInfectious Disease Center, 12901 North 30th Street, Box 19, Tampa, FL 33612
Dorece Norris, MD, Center for Quality Care, 508 SouthHabana Avenue, Suite 240, Tampa, FL 33609
Richard Pollard, MD, University of Texas Medical Branch atGalveston, 301 University Boulevard, Suite 722, Galveston, TX 77555-0882
Peter Shalit, MD, 600 Broadway, Suite 420, Seattle, WA 98122
Daniel Skiest, MD, University of Texas Southwestern Medi-cal Center at Dallas, Division of InfectiousDiseases, 5323 Harry Hines Boulevard, Dallas, TX75235
Paul Skolnik, MD, Division of Geographic Medicine and Infectious Diseases, New England Medical Center, 750 Washington Street, NEMC 67, Boston, MA02111
James Sosman, MD, HIV Program, University of Wisconsin, J5/215 CSC, 600 Highland Avenue, Madison, WI 53792
Corklin Steinhart, MD, Special Immunology Services/Mercy Hospital, Steinhart Medical Group, 3569 South Miami Avenue, Suite 4006, Miami, FL 33133
James H. Von Roenn, MD, Northwestern University, Hematology/Oncology Division, 233 East Erie, Suite 700, Chicago, IL 60611