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Abstract:  As men age, testosterone levels progressively fall and inflammatory biomarkers increase. The gradual decline in testosterone production with aging, known as andropause, is common and may have deleterious effects on men including decreased overall well-being, increased sarcopenia, increased risk of cardiovascular disease, reduced sexual function, and bone loss. Therefore, it comes as no surprise that an increasing number of men worldwide have begun requesting testosterone replacement therapy from their physicians. Occasionally, physicians discourage male patients from getting testosterone replacement therapy based on a few recent studies indicating the therapy causes cardiovascular events, including myocardial infarctions. Yet, an extensive review of the testosterone replacement therapy literature reveals that the majority of clinical studies show that properly administered testosterone replacement therapy, in which estradiol and dihydrotestosterone levels are also controlled, has no adverse effects on myocardial infarction risk. The current state-of the- art in testosterone replacement therapy comprises compounded testosterone troches; an aromatase inhibitor, such as generic Anastrazole, to control estradiol levels; and a 5a-reductase inhibitor, such as generic Dutasteride or Finasteride, to control dihydrotestosterone. Compounded testosterone troches easily raise serum testosterone levels to the optimal range, are highly cost effective at $82 for a 180-day supply, and provide affordable access to testosterone replacement therapy to millions of men requesting it. Yet, the Blue Cross Blue Shield-associated firms have largely denied requests for coverage of compounded medications, including testosterone troches. Despite data demonstrating strong links between testosterone deficiency and significant comorbid conditions (including Type 2 diabetes and other metabolic syndrome diseases) as well as the health benefits of testosterone replacement therapy, some physicians have been swayed against prescribing testosterone replacement therapy to their aging male patients. The testosterone controversy stems largely from poorly designed clinical studies in which patients were subjected to testosterone replacement therapy without having their estradiol and dihydrotestosterone levels properly controlled.

Related Keywords: Michael A.S. Guth, PhD, JD, men, aging, andropause, androgen deficiency, cholesterol transport, testosterone replacement therapy, estradiol, aromatase inhibitor, dihydrotestosterone, 5-alpha reductase inhibitor, cardiovascular events, risk factors, insurance coverage, formulation, drug cost, dosage forms, controversy, therapeutic monitoring, Blue Cross Blue Shield, reimbursement

Related Categories: FORMULATIONS, HRT, CARDIOLOGY, DOSAGE FORMS/DRUG CARRIERS, ENDOCRINOLOGY/HORMONES/ MENOPAUSE/ANDROPAUSE, LITERATURE REVIEW

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