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Review: Testosterone therapy does not elevate CV event risk
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A review of various meta-analyses and randomized controlled trials conducted in middle-aged and older men did not link testosterone therapy with elevated risk for cardiovascular events.
Cardiovascular risk has been a topic of concern for elderly men taking testosterone therapy. To evaluate the link, Culley C. Carson, III, MD, of the University of North Carolina School of Medicine, and Giuseppe Rosano, MD, of San Raffaele Pisana, Rome, Italy, conducted the review of trials examining testosterone administration in men aged 45 years and older.
“In clinical trials where testosterone has been used in patients with pre-existing CV conditions, the effect on disease symptoms has typically been either neutral or beneficial,” the researchers wrote. According to results of the review, testosterone treatment significantly improved exercise performance in hypogonadal and eugonadal men with heart failure. Therapy also had no significant effect on serum lipid profiles or C-reactive protein in hypogonadal men with HF and physiologic levels of testosterone; however, therapy did produce small increases in total body mass and reductions in body fat percentage.
Several meta-analyses also linked testosterone treatment with better metabolic parameters, including decreases in fasting plasma glucose, HbA1c, fat mass and plasma triglycerides in patients with type 2 diabetes. In addition, the researchers found that testosterone therapy had no impact or slightly beneficial effects on CV risk factors in hypogonadal men with diabetes or metabolic syndrome. The treatment appeared to improve insulin sensitivity, decreased central adiposity and did not negatively affect inflammation.
An exception was an increase in hematocrit in this patient population using testosterone therapy, the researchers said.
“Although an increase in hematocrit may be of concern in some conditions, patients with [HF] are often anemic; therefore, the effect of testosterone on [hemoglobin] levels may be regarded as beneficial,” the researchers wrote.
In patients with angina or coronary artery disease, hematocrit increased with testosterone treatment, but the therapy had no effect on C-reactive protein, plasminogen activator inhibitor-1 and fibrogen, and antithrombotic factor tissue plasminogen activator.
Although testosterone therapy did not have an effect on LDL and triglyceride levels, the treatment either did not change or considerably reduced total and HDL cholesterol, according to the results. The researchers noted, however, that decreases in total and HDL cholesterol were an inconsistent response among study participants.
Despite these encouraging conclusions, the researchers acknowledged the limitations of the studies analyzed.
“The majority of the randomized, blinded, placebo-controlled clinical trials of testosterone included in this analysis were small and of short duration,” the researchers wrote. “Obviously, outcomes of large, well-designed, prospective trials would be a more compelling proof of the benefit (or otherwise) of testosterone treatment in terms of CV safety.”
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Disclosure: Drs. Carson and Rosano are consultants for Auxilium Pharmaceuticals.
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