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Title: Topical Testosterone Gel Appears to Benefit Patients Awaiting Liver Transplant: Presented at AASLD

"Topical Testosterone Gel Appears to Benefit Patients Awaiting Liver Transplant: Presented at AASLD"

By Ed Susman BOSTON, MA -- October 29, 2003 -- Men who are awaiting a liver transplant but who are exhibiting deteriorating health may benefit from topical testosterone replacement therapy, researchers said here October 25th at the 54th Annual Meeting of the American Association for the Study of Liver Diseases. "Our preliminary data suggest that topical testosterone replacement increases muscle strength, stimulates albumin synthesis and improves the outcome of orthotopic liver transplantation," said Guy Neff, MD, an assistant professor of medicine, University of Miami, Florida, United States. Thus, testosterone gel 1% appears to be of great benefit in patients with end-stage liver disease and muscle wasting." Dr. Neff cautioned, however, that further studies are needed to determine the efficacy and safety of topical testosterone replacement in these patients. There have been anecdotal reports that use of topical testosterone gel reduced wasting and improved quality of life in patients with human immunodeficiency virus. However, its use in patients with liver disease was not known. "Everyone with HIV-infection was getting testosterone and they seemed to benefit," Dr. Neff said at his poster presentation of his open-label study that involved 13 patients awaiting liver transplantation. "Men with end stage liver disease develop a plethora of debilitating symptoms, including severe muscle wasting, that render many of these patients non-suitable for liver transplantation," Dr. Neff explained. He said that end-stage liver disease-associated testosterone deficiency may be responsible for the development and progression of many of these incapacitating symptoms. "In general, hypogonadism can be effectively treated with topical testosterone replacement, which avoids the first pass effect via the hepatic system in contrast to oral anabolic steroids," he said. Dr. Neff and colleagues retrospectively reviewed records of liver transplant patients treated for at least 3 months with 5 g a day of testosterone gel 1% therapy for muscle wasting from January 2002 to March 2003. The doctors collected demographic and clinical data. Tumour marker and imaging studies were used to rule out malignancy. Thirteen patients were identified with end stage liver disease and muscle wasting. Eight of the patients received testosterone gel; five did not. Most of the patients receiving testosterone -- generally applied to the chest -- reported a subjective improvement in muscle strength and in overall wellbeing. Serum albumin levels increased in the patients on the active treatment (P=0.0002). Of the eight people on the transplant list who were getting testosterone, seven received a new liver and another patient remains on the list. After transplantation, no patient in either group suffered from rejection or graft failure. Ascites accumulation, as assessed by abdominal ultrasound imaging, appeared to be less common in patients who received testosterone therapy. All patients who did not receive testosterone had persistent ascites, Dr. Neff said. [Study title: Beneficial Effects of Topical Testosterone Replacement in Patients With End Stage Liver Disease. Abstract 446]

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