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Testosterone No Help for Viagra Response

Sildenafil plus testosterone was not superior to sildenafil plus placebo in improving erectile function.

By Crystal Phend, MedPage Today

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MONDAY, Nov. 19, 2012 (MedPage Today) —Testosterone therapy doesn't make erectile dysfunction drugs more effective for men with low hormone levels, a randomized trial showed.

Optimized doses of sildenafil (Viagra) boosted erectile function scores by 7.7 points from a baseline of less than 25 for men with erectile dysfunction and low testosterone levels, Matthew Spitzer, MD, of Boston University, and colleagues found.

But the addition of daily doses of transdermal testosterone gel only tended to further improve scores by 2.2 points compared with placebo, which didn't reach statistical significance or the minimum 4-point change considered clinically meaningful, the investigators wrote in the Nov. 20 issue of theAnnals of Internal Medicine.

Combination treatment has become increasingly common for such men, the group pointed out.

"Because ED and low testosterone levels often coexist in men, several expert panels and professional societies have suggested that men with ED should have their testosterone levels checked and that testosterone supplementation should be considered if levels are low," they explained.

However, the trial results suggest that this practice should not be routine, Spitzer's group concluded.

On the other hand, the findings shouldn't "be extrapolated to imply that testosterone has no beneficial effect in men with ED who have low testosterone levels," they added. "Testosterone is an approved drug for the treatment of hypogonadism in men and may have other beneficial effects on body composition, muscle strength, physical performance, cognition, and metabolism, which were not investigated in this trial."

The study couldn't answer whether testosterone alone, without a phosphodiesterase type 5 (PDE5) inhibitor such as sildenafil, would work to improve sexual function in this population.

The trial included 140 men ages 40 to 70 with erectile dysfunction marked by erectile function scores of 25 or less on the International Index of Erectile Function, as well as low testosterone.

After optimizing sildenafil dose, the men were randomized to the addition of double-blind treatment with daily transdermal gel containing 5 to 15 g testosterone (dose adjusted based on serum levels at week 2) or placebo for 14 weeks.

As expected, testosterone levels rose for the intervention group but not the placebo group.

Most participants reported an improvement in sexual function overall due to improvements on sildenafil, but the improvement did not significantly differ between the two groups.

Similar to the primary endpoint of 14-week change in erectile function domain score after randomization, other domains on the scale showed no advantage of testosterone treatment. Those included:

  • Sexual desire
  • Intercourse satisfaction
  • Overall satisfaction
  • Orgasmic function
  • Frequency of sexual encounter attempts
  • Vaginal penetration
  • Ejaculation

Nor were there any greater improvements with testosterone therapy in quality of life related to erectile dysfunction or in vitality or marital intimacy. Adverse events, though, weren't more common with the hormone therapy overall.

The effects didn't differ by age or testosterone levels or response to sildenafil alone during the run-in phase.

There were more men with prostate-specific antigen (PSA) above 4 μg/L in the testosterone group (4 versus 0), but change in PSA didn't differ between the groups.

Hematocrit levels did increase significantly more in the testosterone treatment group.

The researchers drew attention to the high-quality trial design and similar sildenafil usage and dose between groups.

While the failure of testosterone to improve erectile response to sildenafil in the trial might be surprising, they offered a possible explanation: Sildenafil improved testosterone levels by about 100 ng/dL on its own during the run-in period.

"Sildenafil may have increased testosterone levels higher than the upper limit of the dose–response relationship of testosterone for erectile function," Spitzer's group suggested. "Testosterone and sildenafil may share common mechanistic pathways; the optimized dose of sildenafil may have maximally induced these pathways such that no further induction could be expected from addition of testosterone."

Comorbidities were unlikely to have been the reason, given the "robust" response to sildenafil. The trial duration also was probably not the culprit, since most testosterone trials in hypogonadism have shown a response in 4 to 14 weeks.






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Date: 12.12.2018, 15:50 / Views: 72334


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