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Anabolic Effects of Nandrolone Decanoate in Patients Receiving Dialysis

Context Patients receiving dialysis commonly experience malnutrition, reduced muscle mass (sarcopenia), and fatigue for which no effective treatment has been identified. Anabolic steroids are known to increase muscle mass and strength in healthy individuals, but their effect on the sarcopenia and fatigue associated with long-term dialysis has not been evaluated.

Objective To assess the effects of an anabolic steroid, nandrolone decanoate, on lean body mass (LBM), functional status, and quality of life in dialysis patients.

Design Randomized, double-blind, placebo-controlled trial conducted between April 1996 and July 1997.

Setting Hospital-based outpatient dialysis unit.

Patients Twenty-nine patients undergoing dialysis for at least 3 months.

Intervention Nandrolone decanoate, 100 mg (n = 14), or placebo (n = 15) by intramuscular injection once a week for 6 months.

Main Outcome Measures Weight, LBM, fatigue, grip strength, walking and stair-climbing times, and treadmill performance after 3 and 6 months of treatment.

Results Lean body mass increased significantly in patients given nandrolone compared with patients given placebo (mean change [SD], +4.5 [2.3] kg; P<.001 compared with baseline). This effect was significantly greater than the change in LBM in the placebo group (mean change [SD], +1.9 [1.6] kg; P = .003 compared with baseline; P = .005 compared with nandrolone group). Serum creatinine levels increased in the nandrolone group (+168 [203] mmol/L [1.9 {2.3} mg/dL]; P = .02) but not in the placebo group (−4.0 [177] mmol/L [0.04 {2.0} mg/dL]; P = .95), suggesting an increase in muscle mass. Time to complete the walking and stair-climbing test decreased from 36.5 to 32.7 seconds in the nandrolone group, while those in the placebo group increased from 38.7 to 42.1 seconds (P = .05). Peak oxygen consumption increased in the individuals in the nandrolone group who performed treadmill tests, but not to a statistically significant degree. Grip strength did not change in either group.

Treatment with nandrolone for 6 months resulted in a significant increase in LBM associated with functional improvement in patients undergoing dialysis.

In the United States, the average life span of a patient entering a long-term dialysis program is less than half that of an age-matched control not receiving dialysis.1 Although the cause of this discrepancy is probably multifactorial, both malnutrition and reduced muscle mass are common in dialysis patients2-6 and have been shown to correlate with increased mortality.3,5-8 Therapies designed to improve the nutritional status of dialysis patients might therefore be expected to improve outcome. Anabolic agents, such as human growth hormone, can improve nitrogen balance in patients undergoing dialysis and in other catabolic states.9-14 Human growth hormone reduces urea generation and protein catabolic rate in long-term hemodialysis patients in short-term studies.12,13 However, human growth hormone can exacerbate hyperglycemia in patients with diabetes, who represent a large percentage of malnourished hemodialysis patients. Moreover, human growth hormone is expensive and may have limited potential as a long-term treatment.

Anabolic steroids, such as nandrolone decanoate, might be expected to accomplish some of the same anabolic effects of human growth hormone without leading to hyperglycemia. Nandrolone and other anabolic steroids have been used by athletes to build muscle mass and enhance weight-lifting performance, and a recent placebo-controlled study showed that supraphysiologic dosages of testosterone resulted in an increase in muscle mass and strength in normal subjects.15 Although nandrolone was used previously to treat anemia associated with end-stage renal disease, no controlled trial has been performed to test for anabolic effects in dialysis patients. Furthermore, the widespread availability of recombinant human erythropoietin for the treatment of anemia associated with chronic renal failure has virtually eliminated the use of nandrolone in dialysis patients in the United States.
The present study was undertaken to determine whether a 6-month course of nandrolone could improve nutritional and functional status in patients undergoing dialysis, using a randomized, double-blind, placebo-controlled design. Changes in lean body mass (LBM) measured by dual-energy x-ray absorptiometry (DEXA), treadmill exercise performance, walking and stair-climbing tests, and several quality-of-life measures were compared in the groups receiving nandrolone and placebo.

Subjects were randomly assigned to receive nandrolone decanoate, 100 mg/wk, by intramuscular injection or placebo injection of saline solution colored to resemble active study drug. Randomization was computer-generated in blocks of 4. Assignments were made sequentially by a research pharmacist who dispensed medications but was not otherwise involved in the study. Patients were given their injections at the dialysis unit by GCRC staff. Dialysis staff, patients, and investigators were blinded throughout the study to treatment assignment. Hematocrit and hemoglobin levels were measured monthly and erythropoietin dosages were adjusted to maintain hematocrit between 0.33 and 0.36. Monthly liver function tests were checked, and the dosage of study drug was reduced by half for any elevation of transaminases to more than 3 times the upper limit of normal. Dosages were also reduced for signs of virilization. After 3 and 6 months of treatment, patients returned to the GCRC for repeat testing of quality of life, body composition, functional performance, and hormone levels.

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