The Most Exciting Time for Testosterone скачать в хорошем качестве

The Most Exciting Time for Testosterone

Primary care physicians may be more comfortable prescribing testosterone to men with low levels after hearing from these expert urologists. https://www.medscape.com/viewarticle/... TRANSCRIPT Rachel S. Rubin, MD: I am Dr Rachel Rubin, urologist and sexual medicine specialist in the Washington, DC, area. I am so blessed to have with me one of my favorite sexual medicine doctors on earth, Dr Mo Khera, professor of urology at Baylor College of Medicine. He's the president of the Sexual Medicine Society of North America and has been a part of a very big trial — the results of which just came out — all about testosterone, which is what we're going to talk about today. Mohit Khera, MD, MBA, MPH: Thank you, Rachel, for having me on. Rubin: We have some big news. We're talking about testosterone. Tell us about the very exciting findings that have just come out. Khera: This is probably the most exciting time for testosterone. We've published the largest randomized, placebo-controlled trial on testosterone and cardiovascular and prostate safety — a landmark trial. The genesis of this trial was cardiovascular concerns. Before 2010, the available studies suggested that testosterone may be protective against cardiovascular disease, with no increased risk for cardiovascular events. Then from 2010 to 2014, four studies came out suggesting an increased risk for cardiovascular events. There are a lot of limitations with these studies; they weren't randomized or placebo controlled. Still, in September of 2014, the FDA said they wanted to further investigate this. They convened, and two big things came out of that meeting. In 2015, they made a label change on all testosterone products saying that long-term clinical safety of testosterone cannot be assessed. We need larger trials, and it's inconclusive whether testosterone is safe against cardiovascular disease. The second big thing was that the FDA required that manufacturers of testosterone products conduct a large clinical trial to show that testosterone is safe. That's why the TRAVERSE trial started, in 2015. The placebo-controlled study involved more than 5200 men who were randomized to get testosterone gel or placebo. They had to have a low testosterone level ( 300 ng/dL), and they had to be symptomatic. The key point was that all of these men either had preexisting cardiovascular disease or at least three out of eight cardiovascular risk factors such as hypertension, diabetes, and metabolic syndrome. The study started in May 2018 and finished in February 2022. I'm very excited today to show you the results of four trials that have already been published. Rubin: Let's hear it. Start with the big one in The New England Journal of Medicine. Khera: The "big one" was about cardiovascular risk. The primary endpoint was time to cardiovascular events (myocardial infarction [MI] or stroke). The secondary outcome was risk for high-grade prostate cancer, and the tertiary outcome was any prostate cancer or intervention (medical or surgical) for BPH. All patients received an International Prostate Symptom Score (IPSS) to look for urinary symptoms. The benefit of this study was the other secondary outcomes, such as sexual activity and erectile dysfunction, anemia, diabetes, and bone fracture. Many of these study findings are yet to come out. Among the men who received testosterone gel, testosterone levels went up by about 148 ng/dL to about 400 ng/dL. Levels in the placebo group went up by about 14 ng/dL at the end — a small increase. The key message is that there was no increased risk in cardiovascular events. But three things surprised me. One, there was a slight increase in pulmonary embolism (PE) (0.5% in the placebo group vs 0.9% in the testosterone group). Two, men treated with testosterone had an increased risk for atrial fibrillation (2.54% with placebo vs 3.5% in the testosterone group). And three, an increased risk for acute kidney injury was seen (1.5% with placebo vs 2.3% with testosterone treatment). Remember, only the PE was adjudicated; the other outcomes were just self-reported. But it is what it is. That's the cardiovascular safety study. The second study was the sexual function study, with 1000 patients randomized to testosterone gel or placebo. The primary outcome was increase in sexual activity. Secondary outcomes were an increase in erectile function and libido. They found that testosterone as monotherapy did not improve erectile function. We already knew that; it's in the American Urological Association (AUA) guidelines. Testosterone as monotherapy does not improve erectile function, but it did significantly improve sexual activity and libido. What is very nice about the study is that testosterone improved libido, and it was sustained up to 24 months. https://www.medscape.com/viewarticle/...