A low testosterone trial stopped after adverse cardiovascular events were reported during the trial in 2009. The reason the low testosterone trial stopped was bacause the researchers found a higher rate of adverse cardiovascular events, such as heart attacks and elevated blood pressure, in a group of older men receiving testosterone gel compared to those receiving placebo.
It appears that the treatment phase of the trial was stopped on Dec. 31, 2009, following a review by the study’s Data and Safety Monitoring Board (DSMB) (an independent panel of medical and statistical experts set up from the start of the trial to check regularly for the occurrence of adverse health events in participants and to detect any possible risks from treatment). The board found:
- that 23 of the 106 men who had received testosterone experienced adverse cardiovascular-related events during the study, compared to five of the 103 men who received placebo.
- the cardiovascular-related events included heart attack, heart rhythm disturbances and elevated blood pressure, and one death from a suspected heart attack.
- and weighed the severity of the adverse events in relation to the potential benefits and recommended that participants stop taking study medications and that enrollment be stopped.
Recently, the Endocrine Society called for more low testosterone studies to be conducted in low T or low testosterone therapy because it may be causing problems in men.
The call for more low T or more low testosterone studies is based on the recent studies (see Low T Lawsuit) published by NIH and the VA.
These low testosterone studies raised concerns that low T therapy or low testosterone therapy may possibly be linked to cardiovascular events in men.
Some of the potential problems that may be caused by low T or low testosterone therapy may include:
- Stroke, which occurs when a blood clot reaches the brain and restricts oxygen supply
- Pulmonary embolism, which happens when a blood clot lodges in the lungs
- Blood Clot in the Deep Veins (Deep Vein Thrombosis or DVT)
- Myocardial infarction (Heart Attack), commonly known as a heart attack – a sudden loss of blood flow in the heart
- Arrhythmia, an irregular heartbeat
- Transient ischemic attacks, or “mini-strokes,” as they are commonly called
- Death
If you or your loved one has suffered a heart attack or stroke while on Androgel®, Androderm®, Fortesta®, Axiron®, Testim®, Bio-T-Gel®, Delatestryl®, Depo-Testosterone®, Striant®, and Testopel®– and you have any of these symptoms while on low testosterone or low t therapy and want to talk to a Low T lawyer and/or file a low testosterone lawsuit or low t lawsuit, contact us.
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At the Gooch Law Firm, we pride ourselves on providing our clients reliable representation for even the most challenging cases. If you or a man you know suffered a stroke, pulmonary embolism, heart attack, stroke, death or another serious cardiac event while undergoing low testosterone therapy or low T therapy (e.g., androgel et al.) and would like your case evaluated, contact our office at 1.844.329.5955.
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