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VA Educates Patients about Who Really Needs Testosterone Therapy

by U.S. Medicine

March 31, 2015

Veterans Increasingly Complain of ‘Low T’

By Annette M. Boyle

COLUMBIA, MO – Often spurred by advertising touting the benefits of testosterone supplementation for “low T,” veterans treated by the VA increasingly are requesting the replacement therapy.

Pitched toward men who may be experiencing reduced sex drive, lower energy, erectile dysfunction and other symptoms commonly associated with aging and certain medical conditions, the advertisements recommend use of testosterone patches or gels.

Warren Lockette, MD

Warren Lockette, MD

The VA has started pushing back against overuse of testosterone replacement therapy, however, especially now that the Food and Drug Administration (FDA) has changed labels on those products to caution about cardiovascular side effects as well as to emphasize the specific conditions testosterone is approved to treat.

“More and more of male patients, regardless of age, come to me and say, ‘I have low T,’” noted Warren Lockette, MD, former deputy assistant secretary of defense for health services policy and oversight and currently the senior associate dean for diversity and inclusion at the University of Missouri.

More than 85,000 veterans receive testosterone supplements through the VA.

Despite normal bloodwork, many patients still insist that their symptoms, such as lack of energy, fatigue, loss of strength, depression or erectile dysfunction are related to low testosterone levels, added Lockette added in his mil.health blog No Pablum Here. Yet, he writes, “most often, these symptoms are the result of the stresses of everyday life, not ‘low T.’”

Testosterone increases muscle mass and can boost mood and sexual functioning in individuals with underlying conditions that cause hypogonadism, but provides no significant benefit to others, according to Leonard Pogach, MD, national director of medicine at the VA.

Label Changes

In March, the FDA issued a safety announcement cautioning that prescription testosterone products are not approved for men who have low testosterone levels caused by aging and requiring manufacturers to note the approved uses on their labels. In addition, the FDA required the addition of label information regarding the possibility of increased risk of heart attacks and strokes in patients taking testosterone.

Further, the announcement advised healthcare providers to prescribe the therapy only for men who have disorders of the testicles, pituitary gland or brain that cause hypogonadism, as the benefits and risks in other populations have not been established. The FDA also required manufacturers to conduct a “well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products.”

Increasingly, there is evidence of significant risks from testosterone therapy for men who have age-related drops in the hormone or who have testosterone levels in the normal range, Pogach noted.

“Testosterone can lead to mood changes, an increase in red-cell production, a decrease in sperm production, enlargement of the prostate with symptoms and a possible risk of prostate cancer or in the growth of an undiagnosed cancer. Men may have an increase in PSA, leading to unnecessary testing,” he told U.S. Medicine in an email.

Testosterone therapy also has recently been associated with higher overall and cancer-specific mortality in men who started the therapy following a diagnosis of prostate cancer.1

Not all recent studies have detected a link between cardiovascular risk and testosterone therapy, but significant concerns have been raised by those which have found a link.

For example, a retrospective VA study of 8,709 men who had testosterone levels below 300 ng/dL and who underwent coronary angiography found a 29% increased risk of death, heart attack or stroke among those on testosterone therapy compared to those not receiving the hormone therapy over a 27-month period.2

That study followed a small National Institute on Aging trial looking at testosterone therapy in men with limited mobility, which was stopped because of high rate of cardiovascular events among participants using the hormone supplement.3

The VA study, which appeared in the Journal of the American Medical Association in 2013, generated considerable controversy in the field but was shortly followed by another conducted by researchers at the University of California, Los Angeles, which had similar findings. The UCLA team examined the healthcare records of 55,593 men receiving testosterone therapy, of whom 48,539 were under the age of 65 and 7,054 were 65 or older. Researchers found testosterone therapy doubled the risk of heart attack in men under age 65 with pre-existing cardiovascular disease. It also doubled the risk of a heart attack in men older than 65, regardless of whether they had heart disease. 4

Most recently, Elaine Wei-Yin Yu, MD, an assistant professor of medicine at Massachusetts General Hospital in Boston presented results of a study at the Endocrine Society’s 2015 meeting in March that found that higher testosterone levels in young men lower high-density lipids (HDL) and worsen other cardiovascular risk factors. In that study, 400 men between the ages of 20 and 50 suppressed their natural production of testosterone and estrogen. They then received either a placebo or one of four doses of testosterone gel daily. Half the group also blocked the conversion of testosterone to estrogen, so that the researchers could compare the effects of the two hormones. 5

Verify, Then Treat

The Endocrine Society advises physicians to consider treating men with symptoms and confirmed serum testosterone levels below 300 ng/dl. The American Association of Clinical Endocrinologists recommends physicians only consider treating symptomatic men with testosterone levels below 200 ng/dl.

Researchers at the University of Texas found that 20% of men receive testosterone prescriptions despite having normal testosterone levels. Almost 40% had not had a prostate cancer screen in the year before they initiated therapy, despite recommendations for screening prior to starting testosterone therapy. In the year following the start of therapy, 56% did not have prostate cancer screening. The study looked at insurance records for 61,474 men over a decade. 6

“Clinical practice guidelines make clear that no one should be treated with testosterone supplements unless they first have a test showing their testosterone level to be low, and then a search should be conducted for underlying disorders that may lead to such a test result,” according to Lockette.

Beyond verification, physicians and patients should consider the possible consequences of treatment, he urged. “You may feel better taking a testosterone supplement, but, given these new findings, do you want to take the risk?”

FACTS ABOUT TESTOSTERONE 

  • The Food and Drug Administration has approved testosterone products to replace testosterone in men who have low testosterone levels associated with certain medical conditions. Examples of these conditions include:
      • Failure of the testicles to produce testosterone because of genetic problems or because of damage from chemotherapy
      • Problems with the pituitary gland or part of the brain called the hypothalamus that control the production of testosterone by the testicles
  • FDA-approved testosterone formulations include gels, solution, skin patch, intramuscular injection, pellets implanted under the skin, and a buccal system applied to the upper gum or inner cheek.
  • In the past 5 years, the use of testosterone replacement therapy has increased significantly, from 1.3 million patients in 2009 to 2.3 million patients in 2013 receiving a prescription for a testosterone product. Currently, approximately 70%t of men who receive testosterone prescriptions through retail pharmacies are between 40 and 64 years old.
  • The most common diagnostic code associated with testosterone therapy is the non-specific diagnosis of “testicular hypofunction, not elsewhere classified.”2
  • A diagnosis of hypogonadism requires laboratory evidence of low testosterone levels measured on at least two separate mornings. However, in one health plan database, approximately 20% of men who received testosterone prescriptions had no insurance claims for laboratory testing of testosterone levels.

Source: The U.S. Food and Drug Administration 

1 Kaplan AL, Trinh QD, Sun M, Carter SC, Nguyen PL, Shih YC, Marks LS, Hu JC. Testosterone replacement therapy following the diagnosis of prostate cancer: outcomes and utilization trends. J Sex Med. 2014 Apr;11(4):1063-70.

2 Vigen R, O’Donnell CI, Barón AE, Grunwald GK, Maddox TM, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013 Nov 6;310(17):1829-36. doi: 10.1001/jama.2013.280386.

3 Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, et al. Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22.

4 Finkle WD, Greenland S, Ridgeway GK, Adams JL, Frasco MA, Cook MB, Fraumeni JF Jr, Hoover RN. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One. 2014 Jan 29;9(1):e85805.

5 Endocrine Society. Men’s Heart Disease Risk Linked to High Testosterone and Low Estrogen. Mar 7, 2015.

6 Baillargeon J, Urban RJ, Kuo YF, Holmes HM, Raji MA, Morgentaler A, Howrey BT,Lin YL, Ottenbacher KJ. Screening and monitoring in men prescribed testosterone therapy in the U.S., 2001-2010. Public Health Rep. 2015 Mar-Apr;130(2):143-52.

 

 


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