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...more of the same.. the whole medical community warnes the athletes and bodybuilders for the dangers of steroids especially the orals, today we see a lot of studies to their use especially for HIV-infected people and for a growing problem, people get older and older. To improve their life quality, overall health and libido all kinds of studies are being performed. If we read them carefully we can benefit from them.
Effects of an oral androgen on muscle and metabolism in older, community-dwelling men
E. Todd Schroeder1, Atam Singh2, Shalender Bhasin2, Thomas W. Storer2, Colleen Azen1, Tina Davidson2, Carmen Martinez1, Indrani Sinha-Hikim2, S. Victoria Jaque1, Michael Terk1, and Fred R. Sattler1
1 Departments of Medicine, Radiology, and Biokinesiology, Keck School of Medicine, University of Southern California, Los Angeles 90033; and 2 Division of Endocrinology, Metabolism, and Molecular Medicine, Charles Drew University School of Medicine, Los Angeles, California 90275
To determine whether oxymetholone increases lean body mass (LBM) and skeletal muscle strength in older persons, 31 men 65-80 yr of age were randomized to placebo (group 1) or 50 mg (group 2) or 100 mg (group 3) daily for 12 wk. For the three groups, total LBM increased by 0.0 ± 0.6, 3.3 ± 1.2 (P < 0.001), and 4.2 ± 2.4 kg (P < 0.001), respectively. Trunk fat decreased by 0.2 ± 0.4, 1.7 ± 1.0 (P = 0.018), and 2.2 ± 0.9 kg (P = 0.005) in groups 1, 2, and 3, respectively. Relative increases in 1-repetition maximum (1-RM) strength for biaxial chest press of 8.2 ± 9.2 and 13.9 ± 8.1% in the two active treatment groups were significantly different from the change ( 0.8 ± 4.3%) for the placebo group (P < 0.03). For lat pull-down, 1-RM changed by 0.6 ± 8.3, 8.8 ± 15.1, and 18.4 ± 21.0% for the groups, respectively (1-way ANOVA, P = 0.019). The pattern of changes among the groups for LBM and upper-body strength suggested that changes might be related to dose. Alanine aminotransferase increased by 72 ± 67 U/l in group 3 (P < 0.001), and HDL-cholesterol decreased by 19 ± 9 and 23 ± 18 mg/dl in groups 2 and 3, respectively (P = 0.04 and P = 0.008). Thus oxymetholone improved LBM and maximal voluntary muscle strength and decreased fat mass in older men.
Oxy combined with ketotifen:
OXYMETHOLONE PROMOTES SIGNIFICANT WEIGHT GAIN IN PATIENTS WITH ADVANCED HIV-1 INFECTION.
Conf Retroviruses Opportunistic Infect 1996 Jan 28-Feb 1; 3rd:126 (abstract no. 394)
Hengge UR, Baumann M, Maleba R, Brockmeyer N, Goos M
Univ. of Essen, FRG.
The effect of the testosterone derivative oxymetholone as monotherapy or in combination with the H1-receptor antagonist ketotifen, which has recently been shown to block tumor necrosis factor α (TNFα), on weight gain and performance status in HIV patients with chronic cachexia was evaluated in a 30-week prospective pilot study. Thirty patients were randomly assigned to either oxymetholone (n=l4) or oxymetholone plus ketotifen (n=16). Patients receiving treatment were compared to a group of 30 untreated matched controls. Body weight, the Karnofsky index and several quality of life parameters were measured to evaluate response to therapy. The average weight gain at peak was 8.2±6.2 kg (+14.5% relative to body weight at study entry) in the oxymetholone group (p < 0.001), and 6.1±4.6 kg (+10.9%) in the combination group (p < 0.005), compared to an average weight loss of 1.8±0.7 kg in the untreated controls. The onset of weight gain was observed after 3-4 weeks, peak weight was reached after 19.6 weeks in the monotherapy and 20.8 weeks in the combination group. The Karnofsky index improved equally in both groups from 56% before to 67% after 20 weeks of treatment (p < 0.05). The quality of life parameters (activities of daily life, and appetite/nutrition) improved in 68% (p < 0.05) and 91% (p < 0.01), respectively. Oxymetholone was safe and promoted weight gain in cachectic patients with advanced HIV-1 infection. The addition of ketotifen did not further support weight gain. These results suggest a randomized, double-blind, placebo-controlled multicenter trial.
The main outcome from this study is i.m.o, something bodybuilders knew already for a long time, abnormal high doses increase the negative side-effects and add nothing to little, increase on mass.
RANDOMIZED PHASE III TRIAL OF OXYMETHOLONE FOR THE TREATMENT OF HIV WASTING AND LIPODYSTROPHY
Antiviral Therapy 2001; 6(Suppl. 4):49 (abstract no. 70)
UR Hengge1, K Stocks1, S Unger1, S Faulkner2, M Goos1 and R Dudley2
1 STD Unit, Dept. of Dermatology, University of Essen, Germany; and 2 Unimed Pharmaceuticals Inc., Deerfield, III., USA
Although highly active antiretroviral therapy has greatly impacted treatment of HIV infection, lipodystrophy and HIV wasting still represent unresolved problems in HIV therapy and patient care. Oxymetholone, a testosterone derivative, has been shown to promote weight gain in AIDS-associated wasting. We analysed the effects of oxymetholone (50mg twice and three times daily) in a randomized (1:1:1), double-blind, placebo-controlled Phase III study with 92 subjects (all on antiretroviral therapy) experiencing unintended weight loss >10% of ideal weight according to Broca with special emphasis on body composition measurements. Eighty patients (69 men, 11 women; mean age: 38.8 years) completed the 16-week double-blind study phase. Mean weight gain was +3.7±3.5 and +3.1±2.7 kg in the oxymetholone groups (twice daily; n=25 versus three times daily; n=27) as opposed to +0.97±3.4 kg in the placebo group (P<0.0005). Importantly, statistically significant increases versus placebo were observed in body cell mass (30.6 before versus 32.5 after therapy), lean body mass (56.3 before versus 59.0 after therapy in the twice daily group) and body mass index (21.4 before versus 22.1 after therapy) exclusively in oxymetholone treated patients. The extracellular mass to body cell mass ratio, an indicator of body composition, significantly improved from 0.87 to 0.80 (P<0.0001).Total body fat was unchanged by oxymetholone treatment. Adverse events were mainly hepatic occurring in 14% of oxymetholone-treated patients with significant elevations of AST, ALT and GGT; two patients (7.4%) in the twice daily arm experienced grade 3 and 4 liver toxicity compared with six (21.4%) in the three times daily arm. Oxymetholone was found to have true anabolic effects in a double-blind, placebo-controlled Phase III trial. The twice daily (100 mg/day) regimen appeared equally effective to three times daily (150 mg/day) dosing while displaying reduced liver toxicity. Due to its favorable protein anabolism, it may be recommended for therapy of wasting and lipodystrophy in HIV-infected subjects.
Effects of an oral androgen on muscle and metabolism in older, community-dwelling men
E. Todd Schroeder1, Atam Singh2, Shalender Bhasin2, Thomas W. Storer2, Colleen Azen1, Tina Davidson2, Carmen Martinez1, Indrani Sinha-Hikim2, S. Victoria Jaque1, Michael Terk1, and Fred R. Sattler1
1 Departments of Medicine, Radiology, and Biokinesiology, Keck School of Medicine, University of Southern California, Los Angeles 90033; and 2 Division of Endocrinology, Metabolism, and Molecular Medicine, Charles Drew University School of Medicine, Los Angeles, California 90275
To determine whether oxymetholone increases lean body mass (LBM) and skeletal muscle strength in older persons, 31 men 65-80 yr of age were randomized to placebo (group 1) or 50 mg (group 2) or 100 mg (group 3) daily for 12 wk. For the three groups, total LBM increased by 0.0 ± 0.6, 3.3 ± 1.2 (P < 0.001), and 4.2 ± 2.4 kg (P < 0.001), respectively. Trunk fat decreased by 0.2 ± 0.4, 1.7 ± 1.0 (P = 0.018), and 2.2 ± 0.9 kg (P = 0.005) in groups 1, 2, and 3, respectively. Relative increases in 1-repetition maximum (1-RM) strength for biaxial chest press of 8.2 ± 9.2 and 13.9 ± 8.1% in the two active treatment groups were significantly different from the change ( 0.8 ± 4.3%) for the placebo group (P < 0.03). For lat pull-down, 1-RM changed by 0.6 ± 8.3, 8.8 ± 15.1, and 18.4 ± 21.0% for the groups, respectively (1-way ANOVA, P = 0.019). The pattern of changes among the groups for LBM and upper-body strength suggested that changes might be related to dose. Alanine aminotransferase increased by 72 ± 67 U/l in group 3 (P < 0.001), and HDL-cholesterol decreased by 19 ± 9 and 23 ± 18 mg/dl in groups 2 and 3, respectively (P = 0.04 and P = 0.008). Thus oxymetholone improved LBM and maximal voluntary muscle strength and decreased fat mass in older men.
Oxy combined with ketotifen:
OXYMETHOLONE PROMOTES SIGNIFICANT WEIGHT GAIN IN PATIENTS WITH ADVANCED HIV-1 INFECTION.
Conf Retroviruses Opportunistic Infect 1996 Jan 28-Feb 1; 3rd:126 (abstract no. 394)
Hengge UR, Baumann M, Maleba R, Brockmeyer N, Goos M
Univ. of Essen, FRG.
The effect of the testosterone derivative oxymetholone as monotherapy or in combination with the H1-receptor antagonist ketotifen, which has recently been shown to block tumor necrosis factor α (TNFα), on weight gain and performance status in HIV patients with chronic cachexia was evaluated in a 30-week prospective pilot study. Thirty patients were randomly assigned to either oxymetholone (n=l4) or oxymetholone plus ketotifen (n=16). Patients receiving treatment were compared to a group of 30 untreated matched controls. Body weight, the Karnofsky index and several quality of life parameters were measured to evaluate response to therapy. The average weight gain at peak was 8.2±6.2 kg (+14.5% relative to body weight at study entry) in the oxymetholone group (p < 0.001), and 6.1±4.6 kg (+10.9%) in the combination group (p < 0.005), compared to an average weight loss of 1.8±0.7 kg in the untreated controls. The onset of weight gain was observed after 3-4 weeks, peak weight was reached after 19.6 weeks in the monotherapy and 20.8 weeks in the combination group. The Karnofsky index improved equally in both groups from 56% before to 67% after 20 weeks of treatment (p < 0.05). The quality of life parameters (activities of daily life, and appetite/nutrition) improved in 68% (p < 0.05) and 91% (p < 0.01), respectively. Oxymetholone was safe and promoted weight gain in cachectic patients with advanced HIV-1 infection. The addition of ketotifen did not further support weight gain. These results suggest a randomized, double-blind, placebo-controlled multicenter trial.
The main outcome from this study is i.m.o, something bodybuilders knew already for a long time, abnormal high doses increase the negative side-effects and add nothing to little, increase on mass.
RANDOMIZED PHASE III TRIAL OF OXYMETHOLONE FOR THE TREATMENT OF HIV WASTING AND LIPODYSTROPHY
Antiviral Therapy 2001; 6(Suppl. 4):49 (abstract no. 70)
UR Hengge1, K Stocks1, S Unger1, S Faulkner2, M Goos1 and R Dudley2
1 STD Unit, Dept. of Dermatology, University of Essen, Germany; and 2 Unimed Pharmaceuticals Inc., Deerfield, III., USA
Although highly active antiretroviral therapy has greatly impacted treatment of HIV infection, lipodystrophy and HIV wasting still represent unresolved problems in HIV therapy and patient care. Oxymetholone, a testosterone derivative, has been shown to promote weight gain in AIDS-associated wasting. We analysed the effects of oxymetholone (50mg twice and three times daily) in a randomized (1:1:1), double-blind, placebo-controlled Phase III study with 92 subjects (all on antiretroviral therapy) experiencing unintended weight loss >10% of ideal weight according to Broca with special emphasis on body composition measurements. Eighty patients (69 men, 11 women; mean age: 38.8 years) completed the 16-week double-blind study phase. Mean weight gain was +3.7±3.5 and +3.1±2.7 kg in the oxymetholone groups (twice daily; n=25 versus three times daily; n=27) as opposed to +0.97±3.4 kg in the placebo group (P<0.0005). Importantly, statistically significant increases versus placebo were observed in body cell mass (30.6 before versus 32.5 after therapy), lean body mass (56.3 before versus 59.0 after therapy in the twice daily group) and body mass index (21.4 before versus 22.1 after therapy) exclusively in oxymetholone treated patients. The extracellular mass to body cell mass ratio, an indicator of body composition, significantly improved from 0.87 to 0.80 (P<0.0001).Total body fat was unchanged by oxymetholone treatment. Adverse events were mainly hepatic occurring in 14% of oxymetholone-treated patients with significant elevations of AST, ALT and GGT; two patients (7.4%) in the twice daily arm experienced grade 3 and 4 liver toxicity compared with six (21.4%) in the three times daily arm. Oxymetholone was found to have true anabolic effects in a double-blind, placebo-controlled Phase III trial. The twice daily (100 mg/day) regimen appeared equally effective to three times daily (150 mg/day) dosing while displaying reduced liver toxicity. Due to its favorable protein anabolism, it may be recommended for therapy of wasting and lipodystrophy in HIV-infected subjects.
