title: Liver enzymes and lipid levels in patients with lipodermatosclerosis and venous ulcers treated with a prototypic anabolic steroid (stanozolol): a prospective, randomized, double-blinded, placebo-controlled trial.
abstract: Anabolic steroids have been used to treat lower extremity ulcerations, including venous and cryofibrinogenemic ulcers and lipodermatosclerosis (LDS). Yet there have been no studies to determine the severity and reversibility of side effects of anabolic steroids on liver enzymes and lipid profiles in elderly patients. We therefore evaluated, in a prospective, randomized, double-blinded, placebo-controlled trial, the extent and reversibility of abnormal liver enzymes and lipid profiles in patients with LDS and venous leg ulcers treated with stanozolol at 2 mg twice daily for up to 6 months. Follow-up laboratory testing was done for 2 months after cessation of treatment. A total of 44 patients with LDS and venous ulcers were enrolled and treated with either leg compression alone (placebo) or leg compression plus oral stanozolol 2 mg twice daily (active). Baseline and follow-up laboratory testing of liver enzymes and lipid profiles were obtained. A total of 21 active and 23 placebo patients were treated and evaluated. We measured liver enzymes (aspartate aminotransferase [AST/SGOT], alanine aminotransferase [ALT/SGPT], γ-glutamyl transferase [GGT]) and lipid profile components (high-density lipoprotein [HDL], low-density lipoprotein [LDL], total cholesterol) before, during, and after the treatment period. We found that AST/SGOT and ALT/SGPT became significantly elevated in 29% (P = .0415 at 2 months) and 33% (P = .0182 at 1 month) of patients treated with stanozolol or placebo, respectively, with return to baseline in the posttreatment period. Unexpectedly, 91% of patients on stanozolol developed a significant (P < .0001) decrease in HDL levels, by as much as 37 U/L. All patients remained asymptomatic and levels returned to baseline after discontinuation of the drug. We conclude that low-dose stanozolol, 2 mg twice daily, produces asymptomatic and temporary elevation of liver transaminases and depression of the HDL level in a significant proportion of patients.
authors: Boston University School of Medicine, Boston, MA, USA.
authors: Polly
authors: P
authors: Carson
authors: Boston University School of Medicine, Boston, MA, USA.
authors: Christine J
authors: CJ
authors: Hong
authors: Boston University School of Medicine, Boston, MA, USA.
authors: Marta
authors: M
authors: Otero-Vinas
authors: Boston University School of Medicine, Boston, MA, USA.
authors: Emily Frances
authors: EF
authors: Arsenault
authors: Boston University School of Medicine, Boston, MA, USA vfalanga@bu.edu.
authors: Vincent
authors: V
authors: Falanga
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000378:metabolism*; D045930:Anabolic Agents / Q000627:therapeutic use; D001219:Aspartate Aminotransferases / Q000378:metabolism*; D003872:Dermatitis / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008055:Lipids / Q000032:analysis*; D008099:Liver / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012594:Scleroderma, Localized / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D013197:Stanozolol / Q000627:therapeutic use*; D014647:Varicose Ulcer / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism
chemical_list: D045930:Anabolic Agents; D008055:Lipids; D013197:Stanozolol; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase
keywords: high-density lipoprotein; leg ulcer; liver enzymes; reversible effects; stanozolol