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testosterone increased VTE risk in men

a recent article tied testosterone therapy with increased risk of venous thromboembolism (VTE) in men, both those with and without hypogonadism ( testosterone and VTE jamaintmed2019 in dropbox, or doi:10.1001/jamainternmed.2019.5135 ) Details: -- 39,622 men with documented VTE , from the IBM MarketScan Commercial Claims and Encounter Database and the Medicare Supplemental Database, from 2011-2018. These databases contain claims information from US employers, health plans, hospitals, and Medicare -- these men had 12 months of continuous enrollment prior to VTE event, were followed at least 12 months, and were initially free of cancer at baseline -- mean age 57, 75% <65 years old, testosterone route: intramuscular 28%/transdermal 68% -- each man with VTE was matched with himself as his own control, assessing the times 6 months, 3 months, and one month prior to the VTE, and comparing that to similar time periods 6 months before each of  these, assessing the pre...

testosterone, again

there have been a couple of recent articles on testosterone, though please note the older blog from 4/3/14, appended below.  1. article in j clin endocrinology and metabolism on testosterone therapy for men with type 2 diabetes (T2D) and low testosterone levels (see  dm testosterone not help sex jcem 2014​ in dropbox, or doi: 10.1210/jc.2014-1872). 88 men aged 35-70 (ave age 62) with A1c <8.5%, total testosterone (TT) < 346 ng/dl (they specifically were looking for men with low normal testosterone levels, and excluded those with TT < 144), with mild to moderate"aging male symptoms" and erectile dysfunction, randomized to 40 weeks of IM testosterone undecanoate 1000 mg or placebo, assessing their AMS (aging male symptoms score, a validated 17-item scale to assess 3 domains: somatovegetative, psychological, and sexual), as well as sexual desire and erectile function. this analysis was a secondary one, with the primary...

FDA testosterone alert

here is the Jan 31 FDA alert about testosterone (also see link:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm384225.htm ): AUDIENCE : Cardiology, Urology, Family Practice ISSUE : FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete. BACKGROUND : Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or h...

testosterone and MI

there seems to be much more demand for testosterone (i assume promoted by advertising and men's magazines), even in inner city Boston.  there have been a couple of cautionary articles in the past year or so (small RCT in 2010 of testosterone gel in men with  decreased muscle function, stopped because of excess cardiovasc events; VA study of men>60yo most with CAD found increase in cardiovasc outcomes).  the open access journal PLOS ONE published an article today funded by the national cancer institute -- and not pharma  (see  testosterone and nonfatal MI pLos 2014 , or  DOI: 10.1371/journal.pone.0085805), a cohort study of 56K men prescribed testosterone therapy (TT) from a large health-care database (representing men from around the US) and looked at the incidence of MI in the 90 days following the initial prescription (earlier studies found excess cardiovasc risk occurred soon after starting TT). they compared this rate to  167K men  men rec...