Content area
Full Text
About the Authors:
William D. Finkle
* E-mail: [email protected] (RNH); [email protected] (WDF)
Affiliation: Consolidated Research, Inc., Los Angeles, California, United States of America
Sander Greenland
Affiliation: Department of Epidemiology and Department of Statistics, University of California, Los Angeles, California, United States of America
Gregory K. Ridgeway
Affiliation: Consolidated Research, Inc., Los Angeles, California, United States of America
John L. Adams
Affiliation: Consolidated Research, Inc., Los Angeles, California, United States of America
Melissa A. Frasco
Affiliation: Consolidated Research, Inc., Los Angeles, California, United States of America
Michael B. Cook
Affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, United States of America
Joseph F. Fraumeni Jr
Affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, United States of America
Robert N. Hoover
* E-mail: [email protected] (RNH); [email protected] (WDF)
Affiliation: Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, United States of America
Introduction
Testosterone therapy (TT) has been used in healthy older men to treat diminished extremity strength and physical function associated an age-related decline in serum testosterone. [1] Recently TT has been increasing extraordinarily rapidly, including among younger men and among those without hormone measurement, suggesting that the indications for prescription have likely markedly expanded. [2], [3] Three recent studies have raised some concerns about possible adverse cardiovascular outcomes associated with TT. In 2010 a small randomized trial of testosterone gel on muscle function in men 65 years of age or older was discontinued due to an excess of a variety of cardiovascular events in the testosterone arm. [4] This was followed by a meta-analysis of a number of a number of very small trials in predominantly older men which also suggested excess cardiovascular risk. [5] Recently, a study in the Veteran’s Administration health care system of men average age over 60, 80% of whom had documented coronary disease, reported an excess of a category of events that included death and cardiovascular disease in those receiving TT. [6] In the two studies assessing timing of the increase, it was noted to appear very soon following initiation of therapy. [4], [5] While this has raised public health concerns [2], [5], [7], significant questions remain. In all 3 studies, combined cardiovascular disease endpoints were used since individual outcomes, particularly...