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At least 19 recordsLinked to original sources

PubMed1992

Immunosuppressive therapy of aplastic anemia: results of a prospective, randomized trial of antithymocyte globulin (ATG), methylprednisolone, and oxymetholone to ATG, very high-dose methylprednisolone, and oxymetholone.

Sixty-eight patients with moderate (n = 15) or severe (n = 53) aplastic anemia were entered into a prospective, randomized, two-arm treatment study comparing antihuman thymocyte globulin (ATG), lower-dose methylprednisolone (LDM) and oxymetholone to ATG, higher-dose methylprednisolone (HDM), and oxymetholone. There were no differences between the two groups when comparing age, sex, etiology of aplasia, disease duration, severity of aplasia, or pretherapy granulocyte counts. Side effects of LDM and HDM were similar. Of the 64 patients evaluable for response to therapy, 12 of 33 (36%) who received LDM had complete, partial, or minimal responses compared with 15 of 31 patients (48%) who received HDM (P = .33). Actuarial survival at 4 years is 43% for patients in the LDM group and 47% for patients in the HDM group (P = .99). Causes of death included hemorrhage, infection, evolution to acute leukemia, and complications of subsequent bone marrow transplantation. Long-term complications included paroxysmal nocturnal hemoglobinuria (n = 3), evolution to myelodysplasia or acute leukemia (n = 6), and recurrent aplasia (n = 6). We were unable to show a significant difference in toxicity, response rate, or survival for patients treated with ATG, oxymetholone, and LDM compared with patients who received ATG, oxymetholone, and HDM.

Adult↗

PubMed1983

Effect of lithium carbonate plus oxymetholone vs. lithium alone on chemotherapy-induced myelosuppression.

To evaluate the possible additive leukocyte count-enhancing properties of lithium and oxymetholone, patients (1-21 years old) were randomized to receive lithium or lithium plus oxymetholone after chemotherapy. Seventy-one trials with lithium, 63 with both drugs, and 79 in the control group, were compared. White blood cell count and neutrophil nadirs were better in both treatment groups than in the controls (p = 0.001) but an additive effect of oxymetholone above and over lithium alone was seen only in patients under 15 years old (p = 0.05). The median duration of severe neutropenia (absolute neutrophil count less than 1000/cm3) was 6.2 days/patient in the control group but only 4.5 days/patient and 3.8 days/patient in the lithium and lithium plus oxymetholone groups, respectively (p = 0.0001). Both the lithium and lithium plus oxymetholone treatments had a modest platelet-sparing effect (p = 0.03). No difference in the hemoglobin nadirs was observed in the three groups. While the majority of the patients lost weight in the control and lithium-treated group, the patients on oxymetholone gained weight (median 1.25 kg) p = 0.00001. Lithium reduces the period of neutropenia after chemotherapy during which the patients may acquire infection. The addition of oxymetholone does not substantially lessen myelosuppression in most patients but improves the patients' appetite and weight.

Adolescent↗

PubMed1981

Glucose intolerance and insulin resistance in aplastic anemia treated with oxymetholone.

Because of a suspected association between the drug oxymetholone and abnormal glucose metabolism, we determined immunoreactive insulin (IRI) and plasma glucose during oral glucose tolerance testing in seven patients with aplastic anemia, six of whom received oxymetholone therapy. All patients receiving oxymetholone therapy had abnormal glucose and/or IRI values. This finding was independent of GH, cortisol, and glucagon. In one patient, glucose and IRI levels were normal before oxymetholone but became abnormally elevated after the use of this drug. Furthermore, normal glucose and IRI values were present in the single patient not receiving oxymetholone. Thus, a positive relationship was demonstrated between oxymetholone administration and the presence of glucose intolerance and insulin resistance.

Adolescent↗

PubMed1988

Oxymetholone therapy in patients with familial antithrombin III deficiency.

Three patients with familial antithrombin III (ATIII) deficiency, who also have histories of thromboembolism, were treated with oxymetholone in combination with warfarin. Thrombolysis was observed in one patient with acute thrombosis of inferior vena cava during the oxymetholone and warfarin therapy. No further thromboembolic episodes occurred in these patients after initiation of warfarin with or without oxymetholone. The levels of plasma ATIII, alpha 1-antitrypsin, plasminogen and Cl-inactivator were significantly increased in all patients after the introduction of oxymetholone therapy. This suggests that oxymetholone augments anticoagulant and fibinolytic activity. Hence we consider that oxymetholone in combination with warfarin may be possible thrombolytic therapy in patients with familial ATIII deficiency.

Adolescent↗

PubMed1977

Oxymetholone and erythropoiesis: failure to detect an effect in fetal mouse liver cell cultures.

Oxymetholone, a steroid of proven clinical value in the treatment of refractory anemia, was without effect on endogenous or erythropoietin-mediated heme synthesis in fetal mouse liver cell cultures. This conclusion applied both when the cells were exposed to oxymetholone prior to culturing with erythropoietin and when the steroid was present in the cultures simultaneously with erythropoietin. Unlike those steroids having a direct effect on erythroid cells, oxymetholone also failed to increase the proportion of erythropoietin responsive cells in DNA synthesis. The relevance of these observations to the therapeutic benefit of oxymetholone is discussed. While the possibility that oxymetholone has to be metabolized to an active form cannot be excluded, the results suggest that oxymetholone does not seem to be erythropoietically active by a direct effect on erythroid cells. The fact that it is a successful therapeutic agent in some patients with aplastic anemia may be due to its proven ability to increase endogenous erythropoietin levels or to reduce ineffective erythropoiesis.

Animals↗

PubMed1996

Oxymetholone promotes weight gain in patients with advanced human immunodeficiency virus (HIV-1) infection.

The effect of the testosterone derivative oxymetholone alone or in combination with the H1-receptor antagonist ketotifen, which has recently been shown to block tumour necrosis factor alpha (TNF alpha), on weight gain and performance status in human immunodeficiency virus (HIV) patients with chronic cachexia was evaluated in a 30-week prospective pilot study. Thirty patients were randomly assigned to either oxymetholone monotherapy (n 14) or oxymetholone plus ketotifen (n 16). Patients receiving treatment were compared with a group of thirty untreated matched controls, who met the same inclusion criteria. Body weight and the Karnofsky index, which assesses the ability to perform activities of daily life, and several quality-of-life variables were measured to evaluate response to therapy. The average weight gain at peak was 8.2 (SD 6.2) kg (+ 14.5% of body weight at study entry) in the oxymetholone group (P < 0.001), and 6.1 (SD 4.6) kg (+10.9%) in the combination group (P < 0.005), compared with an average weight loss of 1.8 (SD 0.7) kg in the untreated controls. The mean time to peak weight was 19.6 weeks in the monotherapy group 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 variables (activities of daily life, and appetite/nutrition) improved in 68% (P < 0.05) and 91% (P < 0.01) of the treated patients 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 the need for a randomized, double-blind, placebo-controlled multicentre trial.

Acquired Immunodeficiency Syndrome↗

PubMed1992

Studies on anabolic steroids--8. GC/MS characterization of unusual seco acidic metabolites of oxymetholone in human urine.

One of the biotransformation routes of oxymetholone (17 beta-hydroxy-2-hydroxymethylene-17 alpha-methyl-5 alpha-androstan-3-one) in man leads to the formation of 17 beta-hydroxy-17 alpha-methyl-5 alpha-androstan-3-one (mestanolone). To demonstrate that this latter steroid may be formed by decarboxylation of an intermediate metabolite of oxymetholone bearing a 2-carboxylic group, we studied the urinary excretion of oxymetholone acidic metabolites. Five new acidic metabolites are reported here for the first time, among which four are unusual seco steroids resulting from the oxidative cleavage of the A-ring. The most abundant compound is 17 beta-hydroxy-17 alpha-methyl-2,3-seco-5 alpha-androstane-2,3-dioic acid 1, the cumulative excretion of which accounted for 1.52% of the dose. Three other seco diacids were produced in smaller amounts, namely 17 beta-hydroxy-17 alpha-methyl-2,3-seco-5 alpha-androstane-2,4- dicarboxylic acid 3, 17 beta-hydroxy-17 alpha-methyl-1,3-seco-5 alpha-androstane-1,3-dioic acid 4 and 17 beta-hydroxy-17 alpha-methyl-2,4-seco-5 alpha-androstane-2,4-dioic acid 5. The fifth acidic metabolite was identified as 3 alpha, 17 beta-dihydroxy-17 alpha-methyl-5 alpha-androstane-2 beta-carboxylic acid 2. The excretion in urine of these acidic metabolites suggests that the 2-hydroxymethylene group in oxymetholone is readily oxidized to yield the corresponding beta-keto acid which can be (1) decarboxylated to form mestanolone; (2) reduced at C-3 to give compound 2; and (3) further oxidized to afford the unexpected seco diacids 1, 3, 4 and 5. The identity of compounds 1 and 2 was ascertained by GC/MS and 1H and 13C-NMR analysis of reference compounds. The other metabolites were characterized by GC/MS analysis.

Adult↗

PubMed1997

Comparison of the effects of stanozolol, oxymetholone, and testosterone cypionate on the sexual behavior of castrated male rats.

In 3 experiments, adult male Long-Evans rats were castrated and treated daily with an anabolic-androgenic steroid (AAS) compound (either stanozolol, oxymetholone, or testosterone cypionate) for 6 weeks. Subjects were assigned to 5 groups that received injections of a high, medium, or low dose of the AAS, testosterone propionate, or the oil vehicle. Stanozolol failed to maintain ejaculation at any dose tested. Although some subjects receiving the low dose of oxymetholone ejaculated, oxymetholone generally failed to stimulate ejaculation above the levels of the oil group. Testosterone cypionate sustained ejaculation at all doses tested. The relative potency of the medium dose of each AAS in the sex accessory tissues was (from most potent to least potent): testosterone cypionate > stanozolol = oxymetholone = oil. Thus, these 3 AAS compounds produced a range of behavioral and endocrine responses in castrated male rats.

Anabolic Agents↗

PubMed1977

Fatal hepatic coma complicating oxymetholone therapy in multiple myeloma.

Two patients with multiple myeloma died in acute liver failure. Both had been treated with the anabolic steroid oxymetholone and both subsequently developed severe cholestatic hepatitis. In one the histological lesion progressed despite cessation of oxymetholone therapy. Myeloma infiltration of the liver and peliosis hepatis were not seen. As a fatal outcome from cholestatic hepatitis due to oxymetholone is rare it is possible that an unknown potentiating factor is present in multiple myeloma that can lead to a fatal outcome. If oxymetholone therapy is to be used in such patients then close clinical and laboratory assessment of liver function should be carried out in an attempt to prevent this unusual and fatal complication.

Cholestasis↗

PubMed1976

Oxymetholone effect of acute myeloblastic leukemia cells in vitro.

The possibility that oxymetholone might induce or enhance leukemia after androgen therapy for aplastic anemia prompted us to study the direct action of oxymetholone on the DNA synthesis of AML cells in vitro. The peripheral blasts of 10 patients, 8 with AML and 2 with CML in blast crisis have been studied. The DNA synthesis of the leukemic cells with and without oxymetholone was measured by the 3H-methyl-thymidine incorporation determined by liquid scintillation. The results have been shown a wide variation of DNA synthesis from patient to patient with a range from 2,000 to 40,000 cpm but no significant difference between test and control cultures. We may conclude that oxymetholone does not increase directly the proliferation capacity of the peripheral AML cells cultured in vitro.

Adolescent↗

PubMed1980

Fanconi anemia. Oxymetholone hepatic tumors, and chromosome aberrations associated with leukemic transition.

Jaundice and hepatomegaly developed in a boy with Fanconi anemia after he had undergone treatment with oxymetholone for nine years. A liver scan showed patchy uptake consistent with the presence of space-occupying lesions. After oxymetholone treatment was stopped, the jaundice resolved, the liver size decreased, and the filling defects were no longer detectable on the liver scan. A year later, 5% of his white blood cells showed a consistent chromosomal abnormality. His leukocyte count increased and 85% of these cells showed the same chromosomal abnormality. The rapid replication of this abnormal clone suggests that it was leukemic. The significance of oxymetholone therapy and the occurrence of hepatic tumors and leukemia is discussed.

Anemia, Aplastic↗

PubMed1982

A case of leukemic reticuloendotheliosis responding to oxymetholone.

A 63-year-old man presented with fever, easy bruisability, splenomegaly and pancytopenia. Bone marrow aspiration was unsuccessful, and marrow biopsy revealed crowding by sheets of mononuclear cells; a diagnosis of leukemic reticuloendotheliosis (LRE) was made and the patient underwent splenectomy. There was no hematologic improvement, and the patient continued to have a significant requirement for erythrocytes and platelet transfusions. Within two months of beginning oxymetholone therapy (50 mg orally three times a day) the patient's platelet count had normalized, followed by improved erythrocyte and leukocyte counts. When the drug was discontinued, the peripheral blood counts deteriorated drastically; he again demonstrated hematologic improvement when oxymetholone therapy was reinstated. We feel that by demonstrating a hematologic response to oxymetholone, relapse when it was withdrawn, and another remission upon readministration, that we have provided stronger evidence than previously reported for the efficacy of this drug in LRE.

Adult↗

PubMed1978

Oxymetholone treatment in myelofibrosis.

In order to study the effect of oxymetholone therapy in advanced myelofibrosis, 11 patients (4 females, 7 males) were given, 3--5 mg per kg body weight, long-term oxymetholone treatment in a prospective multicenter study. Five cases had previously had a diagnosis of polycythemia vera. All patients had anemia initially, 4 leukocytopenia and 10 thrombocytopenia in addition. Hepato-splenomegaly was present in all cases but in varying degree. Five patients required regular blood transfusions before treatment. In 9 of the 15 courses given, there was normalization of the peripheral blood or substantial improvement (better than 3 g hemoglobin/dl or 50 X 10(9) platelets/1) after androgens. Significant effects were noted both on hemoglobin values and platelet counts. The need for blood transfusions ceased completely in all 5 cases. When oxymetholone treatment was reduced or interrupted 4 patients relapsed; 2 of them responded to a renewed course. The red cell counts returned to previous polycythemic values in one patient and another died from acute leukemia. The results of this study suggest that androgens might be of value in advanced cases of myelofibrosis with transfusion-requiring anemia or severe thrombocytopenia.

Aged↗

PubMed1979

Clinical and biochemical effects of impeded androgen (oxymetholone) therapy of hereditary angioedema.

Daily therapy and alternate-day therapy with the attenuated androgen oxymetholone were compared in patients with hereditary angioedema (HAE). Fifteen of 16 patients who experienced at least monthly attacks of HAE without treatment were asymptomatic on administration of 5 mg oxymetholene daily. When 13 of the patients who had been maintained asymptomatically on 5 mg oxymetholone daily were advanced to a treatment schedule of 5 mg every other day, seven attacks occurred during a cummulative 50 mo of therapy. The adverse effects that occurred with daily oxymetholone therapy largely subsided when the patients received alternate-day therapy, while a significant mean rise in C4 protein and function occurred only on daily therapy. Statistically significant mean increases in serum levels of C1INH occurred with daily therapy and were maintained with alternate-day therapy. Clinical benefit can be obtained with a treatment program that does not produce a statistically significant rise in C4 protein or function and does not raise C1INH to the lower limit of normal. The finding that alternate-day therapy diminished the side effects of the drug while affording a substantial reduction in the incidence and severity of attacks indicates the feasibility of this therapeutic approach.

Adult↗

PubMed1998

Stanozolol, oxymetholone, and testosterone cypionate effects on the rat estrous cycle.

Anabolic-androgenic steroid (AAS) effects on the estrous cycle of adult Long-Evans rats were examined in four different experiments. Sexual receptivity, vaginal cytology, and body weight were monitored throughout two-week baseline, AAS treatment, and recovery periods. In Experiments 1-3, rats were administered stanozolol, oxymetholone, or testosterone cypionate within dose ranges selected to mimic the human abuse levels of each compound. In these studies, the highest doses of stanozolol (5 mg/kg), oxymetholone (12 mg/kg), or testosterone cypionate (7.5 mg/kg) disrupted the cyclical display of sexual receptivity and vaginal estrus. To compare effects on estrous cyclicity across AAS compounds, rats in Experiment 4 received a single dose (7.5 mg/kg) of each compound for 2 weeks. At the 7.5 mg/kg dose, all AAS compounds interfered with the cyclical display of vaginal estrus, although effects on sexual receptivity were not uniform. No striking AAS effects on body weight were seen in any experiment. The short-term administration of AAS compounds at high doses disrupts female neuroendocrine function in rats.

Anabolic Agents↗

PubMed1978

Effect of sodium fluoride, inorganic phosphate, and oxymetholone therapies in osteoporosis: a six-year progress report.

Elderly osteoporotic males treated with sodium fluoride or inorganic phosphate for 4 years plus 2 years of follow-up observations exhibited a mean but not significant decrease in the rate of bone mass loss in comparison with those receiving oxymetholone or a placebo. No hip fractures occurred in the patients who received fluoride, while 11 hip fractures occurred in the patients in the phosphate, oxymetholone, and control groups. Because the densitometric trends and fracture incidence are impressive, the progress of all subjects will be followed for an additional 4 years.

Aged↗

PubMedDate not supplied

Remission of pure red cell aplasia following oxymetholone therapy.

A 53-year-old male with a long-standing idiopathic pure red cell aplasia, refractory to testosterone cypionate, fluoxymesterone, and corticosteroid, was successfully treated with oxymetholone. Blood count, bone marrow, reticuloendothelial bone marrow scan, and ferrokinetic studies showed a marked increase of erythropoiesis in response to oxymetholone. The patient became hematologically normal within 12 weeks and has required no further transfusions. This observation suggests possible difference of mechanisms in the action of various androgenic drugs. It also suggests that failure of response to one androgenic agent does not necessarily mean the other androgenic agents will not be effective in cases of refractory idiopathic pure red cell aplasia.

Anemia, Aplastic↗

PubMed1980

Regression on oxymetholone-induced hepatic tumors after bone marrow transplantation in aplastic anemia.

Treatment of acquired aplastic anemia with androgens has been occasionally associated with the development of hepatic tumors. We have studied a 13-year-old boy with idiopathic aplastic anemia in whom oxymetholone treatment was associated with a partial hematological remission. Thirty-four months later, however, the patient developed multiple hepatic tumors. When oxymetholone therapy was discontinued, the aplastic anemia relapsed. He then underwent bone marrow transplantation from his HLA-A, B, and D-compatible sibling. This was followed by hematological and immunological reconstitution. The hepatic tumors underwent progressive regression after bone marrow transplantation. The patient is now 3 years post-bone marrow transplantation and is in complete remission of his aplastic anemia with no evidence of detectable liver tumors.

Adolescent↗