Efficacy of TRT plus alternate-day tadalafil for patients with LOH

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madman

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Efficacy of testosterone replacement therapy plus alternate-day tadalafil for patients with late-onset hypogonadism: An open-label, a randomized, crossover study

Objective:
To examine the efficacy and safety of combination treatment with testosterone replacement therapy plus alternate-day tadalafil (10 mg) in patients with late-onset hypogonadism.

Methods: In this open-label, randomized, crossover study, 29 patients with late-onset hypogonadism were randomly assigned to receive testosterone replacement therapy for 12 weeks followed by combination treatment for 12 weeks (Group 1) or combination treatment for 12 weeks followed by testosterone replacement therapy (Group 2). Symptom questionnaires were administered and blood tests were performed prior to and following each treatment to assess safety and efficacy. At the end of the study, participants were asked about their treatment preferences.

Results: An adverse effect, a rheum symptom, occurred in only one participant, and 26 participants completed the study without any toxicity. Scores on the Aging Male Symptoms scale and the modified short version of the International Index of Erectile Function and Overactive Bladder Symptom Score were significantly improved in the combination treatment phase of Group 2, whereas no significant difference between the phases was observed in Group 1. In total, 12 out of the 14 participants in Group 1 and 11 out of the 12 participants in Group 2 preferred combination treatment, which reached statistical significance (P = 0.008 and 0.004 for Groups 1 and 2, respectively).

Conclusions: Testosterone replacement therapy with add-on alternate-day tadalafil is a safe and satisfactory treatment for patients with late-onset hypogonadism.




Introduction

Patients with LOH display reduced sexual desire, dysuria, ED, and urinary frequency.1–3
The main treatment for LOH is TRT. Meanwhile, PDE5 inhibitors, such as sildenafil and tadalafil, are employed extensively for treating ED,4,5 and daily tadalafil (5 mg) is a primary therapeutic approach for LUTS in patients with BPH in Japan.6,7 PDE5 inhibitors cause smooth muscle cell relaxation in the prostate, urethra, bladder neck, and blood vessels,8 and daily tadalafil therapy is reported to improve vascular endothelial function,9 suggesting its utility as an antiaging agent in older men.10 In addition, previous reports have shown that daily tadalafil treatment increased serum testosterone levels,11 and the combination of daily tadalafil and injectable testosterone undecanoate improved erectile function.12 Thus, tadalafil can potentially increase the efficacy of TRT, thereby enhancing patient satisfaction. The aim of the present study was to investigate the efficiency and safety of CoT with alternate-day tadalafil (10 mg) and TRT in comparison with TRT alone.




In conclusion, TRT plus add-on tadalafil is safe and improves treatment satisfaction in patients with LOH.
 

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madman

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Table 1 Baseline clinical characteristics of patients in Groups 1 and 2
Screenshot (3001).png
 

madman

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Fig. 3 The sequential changes of symptom questionnaire scores and total testosterone or free testosterone level in each group. The questionnaires included the AMS, m-IIEF-5, IPSS, and OABSS. Data are presented as median (IQR).
Screenshot (3003).png
 
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