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AceFrehley
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ediatric Asthma, Allergy and Immunology, 1999, 13 (4) 189-193.
Successful Use of Oxandrolone in the Prophylaxis of
Hereditary Angioedema: A Case Report
Because of its weak androgenic properties, it would appear that oxandrolone could be better tolerated than the other widely used prophylactic agents, particularly by women. Data compiled by the drug's US manufacturer indicate very few untoward side effects; out of over 400 patients (both males and females) taking oxandrolone doses ranging from 5 to 10 mg/day, three reported acne and 2 showed signs of hirsutism. In contrast, long-term studies that evaluated danazol and stanozolol have reported a high incidence of side effects in women, including menstrual abnormalities, weight gain myalgias and transaminase elevations.
All of the 17 alpha alkylated androgens carry warnings about hepatotoxicity, peliosis, and liver cell tumors. While the tumors are mostly benign, fatal malignant tumors have been reported. Withdrawal of the drug results in complete disappearance of the peliosis and regression or cessation of progression of benign tumors. It would appear that these complications occur to a lesser extent with oxandrolone than with other drugs in the class which are almost completely metabolized in the liver. In contrast, one third of oxandrolone is excreted unchanged in the urine and the rest undergoes considerably less metabolic transformation in the liver. (15) Patients on long-term androgen therapy should receive the lowest dose possible and should have annual liver ultrasonography. Androgens are contraindicated in patients with pre-existing cardiac, renal, or hepatic disease. In children, careful monitoring is required because androgen therapy may accelerate bone maturation without producing compensatory gain in linear growth. The presence of this adverse effect results in compromised adult height. Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, and clitoromegaly). Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization.
We know of another 38-year-old patient with Type 2 HAE who was experiencing regular severe attacks of gastrointestinal and extremity edema despite treatment with 800 mg/day of danazol. This patient was free from major attacks for 3 months on oxandrolone 20mg/day and experienced no untoward side effects.
CONCLUSION
There is currently no approved treatment for children with severe HAE symptoms, although the literature indicates that antifibrinolytics should be the first therapy attempted. Long term prophylaxis for patients with HAE has been successfully achieved by the use of androgens and antifibrinolytics. In this paper, we report the use of oxandrolone for the first time in the prophylaxis of HAE. In our opinion, oxandrolone could have a role in the prophylactic therapy of certain severely affected children and adults with HAE who cannot tolerate, or do not respond to antifibrinolytics and other attenuated androgens. Compared to other attenuated androgens, oxandrolone has comparatively milder side effects and less potential for hepatotoxicity and virilization even at doses as high as 20-40 mg/day.
ediatric Asthma, Allergy and Immunology, 1999, 13 (4) 189-193. Successful Use of Oxandrolone in the Prophylaxis of
Hereditary Angioedema: A Case Report
Because of its weak androgenic properties, it would appear that oxandrolone could be better tolerated than the other widely used prophylactic agents, particularly by women. Data compiled by the drug's US manufacturer indicate very few untoward side effects; out of over 400 patients (both males and females) taking oxandrolone doses ranging from 5 to 10 mg/day, three reported acne and 2 showed signs of hirsutism. In contrast, long-term studies that evaluated danazol and stanozolol have reported a high incidence of side effects in women, including menstrual abnormalities, weight gain myalgias and transaminase elevations.
All of the 17 alpha alkylated androgens carry warnings about hepatotoxicity, peliosis, and liver cell tumors. While the tumors are mostly benign, fatal malignant tumors have been reported. Withdrawal of the drug results in complete disappearance of the peliosis and regression or cessation of progression of benign tumors. It would appear that these complications occur to a lesser extent with oxandrolone than with other drugs in the class which are almost completely metabolized in the liver. In contrast, one third of oxandrolone is excreted unchanged in the urine and the rest undergoes considerably less metabolic transformation in the liver. (15) Patients on long-term androgen therapy should receive the lowest dose possible and should have annual liver ultrasonography. Androgens are contraindicated in patients with pre-existing cardiac, renal, or hepatic disease. In children, careful monitoring is required because androgen therapy may accelerate bone maturation without producing compensatory gain in linear growth. The presence of this adverse effect results in compromised adult height. Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, and clitoromegaly). Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization.
We know of another 38-year-old patient with Type 2 HAE who was experiencing regular severe attacks of gastrointestinal and extremity edema despite treatment with 800 mg/day of danazol. This patient was free from major attacks for 3 months on oxandrolone 20mg/day and experienced no untoward side effects.
CONCLUSION
There is currently no approved treatment for children with severe HAE symptoms, although the literature indicates that antifibrinolytics should be the first therapy attempted. Long term prophylaxis for patients with HAE has been successfully achieved by the use of androgens and antifibrinolytics. In this paper, we report the use of oxandrolone for the first time in the prophylaxis of HAE. In our opinion, oxandrolone could have a role in the prophylactic therapy of certain severely affected children and adults with HAE who cannot tolerate, or do not respond to antifibrinolytics and other attenuated androgens. Compared to other attenuated androgens, oxandrolone has comparatively milder side effects and less potential for hepatotoxicity and virilization even at doses as high as 20-40 mg/day.
