New Oral Testosterone Replacement Treatment is on the Horizon

We see a many men who develop testosterone deficiency. Testosterone is a hormone produced in both men and women which plays a tremendous part in our lean muscle mass, our sexuality and our energy levels. It is secreted into the blood and peaks between 8:00 – 10:00 each morning.

To determine whether you have a testosterone deficiency, your blood must be drawn during those hours for accuracy. If two tests show your level below 280 you may benefit from replacement therapy.

To replace testosterone we currently have had only three options. One option is by placing a gel preparation on your skin and allowing it to be absorbed each day. One preparation comes in a gel in a tube and you measure out a particular dosage and administer it to your skin. Another preparation comes in pre-measured transdermal patches which you apply to your skin.

Both skin applications are easy to use and are less likely to cause the adverse effects testosterone is sometimes associated with such as an increased blood thickness or secondary polycythemia. The drawback to these preparations is they cost anywhere from $500 to $1,000 per month. The only less expensive alternative has been the injectable testosterone cypionate which costs about $80 per month and requires an injection into your muscle every two weeks.

The injectable form, while far more affordable, results in more adverse events than the transdermal form. We usually prescribe the lowest dosage possible and then, seven days after your shot, measure your testosterone level with a blood test at any time of the day. Based on the results, we adjust the future dosage.

Marius Pharmaceutical submitted a new drug application to the Food and Drug Administration for an oral form of testosterone undeanoate taken in a gel capsule twice per day. It will be marketed under the name Kyzatrex.

In their initial studies, looking at six months of data, they were able to achieve average expected testosterone levels in 96% of the men who completed the 90-day treatment study. High blood pressure was the only true adverse effect reported. No mention was made of what a month’s supply will cost if the FDA approves the drug for use in primary and secondary testosterone deficiency.

Testosterone Therapy and Low T – “Does Anybody Really Know What Time It Is?”

Low T v2The Food and Drug Administration (FDA) will now be requiring pharmaceutical manufacturers to label testosterone products with a warning that says that the use of this product is associated with an increased risk of blood clots in the veins. These venous emboli can break off and travel downstream causing lung emboli (pulmonary emboli) and even strokes. It had long been known that in men with polycythemia, a thickening of the blood due to increased red blood cells which is a side effect of testosterone therapy, have an increased risk of venous thrombosis.

The study of the effect of testosterone on veins is independent of the current FDA evaluation of the effect of testosterone on arterial clots, coronary artery disease and stroke. A Veterans Affair (VA) study showed a 29% increased risk of those events in veterans taking testosterone. A 2.19 fold higher risk of heart attack in older men and a 2.90 fold elevated risk in younger men with pre-existing heart disease was noted in another VA study. This data was refuted by testosterone advocates in their industry in an observational study suggesting a decreased risk of heart disease in users.

Testosterone supplementation is clearly indicated in criteria outlined by the American College of Endocrinology for hypogonadism. This requires measurement of the patient’s early morning testosterone level on 2 separate occasions. If the value is below a certain level supplementation is appropriate to restore your testosterone to normal functional levels. The problem is that anti-aging advocates have created a fire storm of outpatient enhancement clinics blitzing neighborhoods with advertising that supplementing your low but within the normal range testosterone enhances your quality of life, reduces unwanted body fat and invigorates the patient. There have been insufficient randomized controlled trials to answer the question of whether this practice makes you feel better but is detrimental to your health or if this is something aging men need to think about trying. The FDA investigation is now being joined by the European Medicine Agency to try and assess benefits versus risk of this form of therapy. At the recent meeting of the American Academy of Urology a lively panel debate was held reviewing what is known about testosterone therapy and whether current usage had reached abusive levels? There was broad agreement that more research is needed and until then the guidelines of the American College of Endocrinology should be the gold standard for initiating testosterone therapy safely.

Testosterone Therapy in Low T Syndrome in Veteran’s tied To Higher Cardiovascular Risk.

Cardiovascular RiskMedPage Today is reporting a Veteran’s Affair study which indicates that men with and without coronary artery disease who received testosterone supplements had a higher risk of death, heart attack and stroke.  The current study looked at 8709 veterans who underwent coronary angiography between 2005 and 2011 and had a testosterone level less than 300 ng/dL.  These findings surprised researchers who had looked at a previous VA study that suggested that testosterone therapy reduced cardiovascular risk.

Steven Nissen, MD of the Cleveland Clinic, a world respected cardiologist felt the study was a “red flag” that “demands attention from not just physicians but also from regulators.”  He is concerned about the “increasingly commonly prescribed (testosterone replacement therapy) “practice which is largely “fueled by direct to consumer advertising that’s urging men to get tested for low testosterone and then to seek replacement.” Nissen pointed out that in both men and women a drop in hormone levels is a normal part of aging and it is not necessarily a disease. “Making it into a disease may end up causing more harm than good.”

Anne R. Coppola, MD of the University of Pennsylvania in an editorial noted that “what is missing from the literature are data from randomized trials that include a sufficient numbers of men for an adequate amount of time to assess the long term benefits and risks of testosterone therapy.”   She cited a small study called the Testosterone Trial in Older Men which had to be stopped early because of a higher rate of cardiovascular events “in the group taking testosterone.

In our market you cannot turn on a sports talk radio show or ride down an Interstate highway without seeing ads for “Low- T Syndrome.”  It is a highly profitable cash business being fueled by testimonials and word of mouth rather than well planned medical studies. Legitimate research is ongoing at Harvard Medical School but it is difficult for others to obtain funding when the producers of the product can make so much money based on here say and nothing else. The number of prescriptions for testosterone products has increased since 2000 from 5.3 million to 1.6 billion.  The American College of Endocrinology has clear and strict guidelines on when supplementation in young men is appropriate. There is a large anti-aging medical community who feel that even if you are older and have normal levels you will feel better and benefit from supplementation. This research questions that feeling and begs for regulators to step in and stop an unproven possibly dangerous practice until we have more data.