Effects of nandrolone decanoate compared with placebo or testosterone on HIV‐associated wasting

Abstract

ObjectivesCurrent research is unclear about the most effective pharmacological agents for managing the loss of weight and fat-free mass common in HIV/AIDS. The aim of this study was to compare nandrolone decanoate with placebo and testosterone. MethodsThe study was a multicentre randomized double-blind placebo-controlled trial. Three hundred and three adult HIV-positive male patients with a weight loss of 5-15% in the last 12 months, or a body mass index of 17-19 kg/m 2 , or a body cell mass/height ratio lower than 13.5 kg/m, were randomly assigned to receive nandrolone decanoate (150 mg), testosterone (250 mg) or placebo intramuscularly every 2 weeks for 12 weeks. Fat-free mass, weight, immune markers and perception of treatment were the main outcome measures. ResultsTreatment with nandrolone resulted in significantly greater increases in fat-free mass [mean increase 1.34 kg; 95% confidence interval (CI) 0.60; 2.08 kg] and in weight (mean increase 1.48 kg; 95% CI 0.82; 2.14 kg) compared with placebo. The mean increase in weight with nandrolone of 1.00 kg (95% CI 0.27; 1.74 kg) when compared with testosterone was significant, although the difference in fat free mass did not reach significance (mean increase 0.69 kg; 95% CI-0.13; 1.51 kg). Patient perception of benefit was significantly greater in the nandrolone group when compared with both the placebo and the testosterone groups. ConclusionsTreatment with nandrolone decanoate increased body weight when compared with placebo and testosterone. Nandrolone decanoate treatment resulted in greater increases in fat-free mass than placebo and demonstrated a trend for a significant increase when compared with testosterone.Keywords: anabolic steroids, HIV, nandrolone decanoate, testosterone, weight loss IntroductionDespite the introduction of highly active antiretroviral therapy (HAART), weight loss continues to be prevalent in HIV disease [1,2]. More importantly, the introduction of [6]. Lowered testosterone levels have also been associated with loss of fat-free mass in HIV disease [7]. There are a number of different pharmacological agents available to assist in management of HIV-associated weight loss [8]. These agents include appetite stimulants such as corticosteroids, megestrol acetate, thalidomide and anabolic and androgenic agents (e.g. growth hormone, nandrolone decanoate and testosterone). The anabolic and androgenic agents are the only ones to have shown consistent improvements in both weight and fat-free mass [9][10][11][12].Currently, in the clinical management of weight loss in HIV-infected patients, there remains uncertainty about the best approach. After investigation of any underlying cause of weight loss, such as inadequate dietary intake, diarrhoea, opportunistic infections or malignancy, there are no clear guidelines as to the most appropriate agent to use to assist patients to increase fat free mass.There were two primary aims of this study. First, we intended to compare the effectiveness of 12 weeks of therapy with nandrolone decanoate with placeb...

Quantification of lean tissue losses during cancer and HIV infection/AIDS

“…Other studies suggest that a specific treatment of muscle wasting with testosterone (by gel or intramuscular injection), as compared with a placebo, could increase FFM and decrease fat mass, assessed by DEXA or BIA [53,54]. Intramuscular injection of nandrolone may have a positive effect on weight and a tendency to a better increase in FFM in comparison with testosterone [54].…”

Exercise therapy for human immunodeficiency virus/AIDS patients: Guidelines for clinical exercise therapists

“…10 Individual studies have shown an improvement in VO 2max and other measures of fitness; 8,23,35 improvement in body composition (decreases in fat percentage, increases in leg muscle area, and abdominal fat loss); 8,11 reduced anxiety, stress, and depressive mood; 31 improvement in QOL; 2 as well as improvement in lipid profile 6,8,31 and glucose tolerance. 6 Crossover effects have also been reported whereby AE may lead to improved strength.…”

“…It is defined as a low BMI, < 20 kg/m 2 or > 5e15% recent weight loss from baseline bodyweight. 23 (2) Lipodystrophy: HAART is associated with lipodystrophy, which is the redistribution of fat stores from the arms, legs, and face to the abdomen and lower cervical region. 16,22 (3) Dyslipidemia: HAART is associated with hypercholesterolemia, increases in LDL-C, hypertriglyceridemia, and HDL-C. 24 (4) Diabetes: HAART adversely affects insulin sensitivity and glucose tolerance.…”

ASHP Guidelines on Pharmacist Involvement in HIV Care

“…150,151 Specifically, pharmacists may assist in testosterone formulation selection, contraindication assessment, laboratory test monitoring, and counseling on proper testosterone administration and adverse effects. [152][153][154] Pharmacists should also minimize ART agents that have adverse metabolic effects and recommend appropriate alternatives. 147 In addition, pharmacists should work closely with dietitians to ensure appropriate nutrition support for the complete care of the HIV-infected patient.…”

“…147 In addition, pharmacists should work closely with dietitians to ensure appropriate nutrition support for the complete care of the HIV-infected patient. 154 Morphological complications may have detrimental physical and psychological effects on patients, which may decrease adherence to ART. Pharmacists should be cognizant of morphological complications, recommend medical and lifestyle modifications as appropriate, and work with patients and providers to maximize treatment and adherence to HIV therapies.…”