Real-world 5-ARI data shows increased sexual side effects with finasteride compared to dutasteride


Real-world data for patients treated with 5 alpha-reductase (5-ARI) inhibitors showed that sexual adverse events (AEs) occurred at higher rates in patients receiving finasteride compared to dutasteride. , according to a study presented at the European Association of Urology 2021. Annual Congress.1

The risk of ejaculation disorders was 8 times higher with finasteride compared to dutasteride, and the risk of erectile dysfunction and decreased libido was 5 times higher (P = .001).

“Clinicians should take this data into account when prescribing 5-ARIs,” said presenting author Antonio Franco, MD, Sant’Andrea Hospital, Sapienza University of Rome, Department of Urology, Rome, Italy.

The urological literature has established an increased risk of sexual AEs in patients with benign prostatic hyperplasia (BPH) treated with 5-ARI finasteride and dutasteride. Investigators initiated this study to compile and compare real-world data for these 5-ARIs.

For their study, the researchers used data from the Eudra-Vigilance (European Union Medicines Regulatory Authorities) database, a system created by the European Medicines Agency to manage and analyze information on effects. adverse reactions related to drugs approved or under review in clinical trials in the European Union. Economic area (EU countries, Iceland, Liechtenstein and Norway).

“We recorded the number of sexual AEs for dutasteride and finasteride by category and severity up to January 2021. The pooled relative risk was used to compare data between the 2 drugs,” Franco said.

Franco reported that real-world results showed an increased risk of sexual AEs in patients treated with 5-ARI, which is consistent with the literature. In all patients, 2748 sexual AEs were reported for dutasteride and 6099 sexual AEs for finasteride.

Rates were higher for finasteride for ejaculation disorders, erectile dysfunction, and decreased libido at 6.3% versus P <.05 vs.>P > .05), and 12% against 2.4% (P <.05 respectively.>

The rates of gynecomastia and hot flashes were comparable between the 2 arms. Gynecomastia occurred in 5.5% of the dutasteride arm and 7% of the finasteride arm. Hot flashes occurred in less than 1% of each group.

Franco noted that most AEs occurred in elderly patients (aged 65 to 85), with 62% in the finasteride and dutasteride arms (P > .05).

Franco explained that when interpreting the results of the study, the limitations of the EudraVigilance database should be noted, including the number of patients, the indication of the treatment itself and the combined therapy with the 5- ARI that the patient may have received.


1. From Nunzio C, Nacchia A, Lombardo R, et al. Sexual adverse reactions associated with dutasteride and finasteride: analysis of actual data from the EudraVigilance database. Presented at the 36th Annual UAE Congress (virtual). July 8-12, 2021. P0033.

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