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Efficacy and safety of combination of tadalafil and aspirin versus tadalafil or aspirin alone in patients with vascular erectile dysfunction: a comparative randomized prospective study

  • Urology - Original Paper
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Abstract

Purpose

We aimed to investigate the efficacy and safety of tadalafil, aspirin, and tadalafil + aspirin combination therapy in vascular erectile dysfunction (VED).

Methods

A total of 336 patients were randomly divided into four groups (group 1, aspirin 100 mg/day, 126 patients; group 2, tadalafil 5 mg/day, 72 patients; group 3, tadalafil 5 mg + aspirin 100 mg, 72 patients; group 4, placebo, 66 patients). In all groups, the changes from baseline to end point in erectile function scores on the International Index of Erectile Function (IIEF-EF) and the number of patients who answered “yes” to questions 2 and 3 of the sexual encounter profile(SEP) were compared statistically.

Results

The changes in IIEF-EF scores after treatment were 7.2 ± 4.4, 7.3 ± 4.3, 7.5 ± 4.4, and 2.0 ± 4.6 for group 1 (p < 0.0001), group 2 (p < 0.0001), group 3 (p < 0.0001), and group 4 (p = 0.0204), respectively. The change in SEP-2 ratios after treatment were 36.6%, 36.9%, 41.7%, and 9.4% for group 1 (p < 0.0001), group 2 (p < 0.0001), group 3 (p < 0.0001), and group 4 (p = 0.2925), respectively. The change in SEP-3 ratios after treatment was 46.6%, 49.2%, 53.7%, and 12.5% for group 1 (p < 0.0001), group 2 (p < 0.0001), group 3 (p < 0.0001), and group 4 (p = 0.1456), respectively. In group 2, both the number of patients who reported side effects (p < 0.0001) and stopped using the drug due to side effects (p < 0.05) were significantly higher than the control and others groups.

Conclusions

Successful results were obtained by tadalafil and aspirin monotherapy and tadalafil + aspirin combination therapy in patients with VED. However, the least side effect was observed in the tadalafil + aspirin group. Aspirin can be used alone in the treatment of patients with VED, or combined with tadalafil to reduce side effects and increase success.

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Abbreviations

ASA:

Acetylsalicylic acid

CAD:

Coronary artery disease

cAMP:

Cyclic adenylate monophosphate

cGMP:

Cyclic guanylate monophosphate

COX:

Prostaglandin H synthase

DUS:

Doppler ultrasonography

IIEF:

International index of erectile function

MPV:

Mean platelet volume

NO:

Nitric oxide

PDE5i:

Phosphodiesterase type 5 inhibitors

PSV:

Peak systolic velocity

PAD:

Peripheric artery disease

PG:

Prostaglandin

SEP:

Sexual encounter profile

TxA2:

Thromboxane

VED:

Vascular erectile dysfunction

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Authors and Affiliations

  1. Department of Urology, School of Medicine, Istanbul Medipol University, Çamlık Mah, Piri Reis Cad, Papatya Sitesi No 48, Pendik, Istanbul, 34890, Turkey

    Zeki Bayraktar & Selami Albayrak

Authors
  1. Zeki Bayraktar
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  2. Selami Albayrak
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Correspondence to Zeki Bayraktar.

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Conflict of interest

There is no conflict of interest in the study. Zeki Bayraktar declares that he has no conflict of interest. Selami Albayrak declares that he has no conflict of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.

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Bayraktar, Z., Albayrak, S. Efficacy and safety of combination of tadalafil and aspirin versus tadalafil or aspirin alone in patients with vascular erectile dysfunction: a comparative randomized prospective study. Int Urol Nephrol 51, 1491–1499 (2019). https://doi.org/10.1007/s11255-019-02211-4

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