Side Effects of 5‐Alpha Reductase Inhibitors: A Comprehensive Review

Trost, Landon; Saitz, Theodore R.

doi:10.1002/smrj.3

Cited by 44 publications

(42 citation statements)

References 148 publications

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“…Sexual desire did not decrease significantly, as reported in major studies where administration of 5-ARI resulted in the loss of sexual desire in 2-10% and EjD in 0-8% 21 . Trost et al 22 note that sexual desire decreases in 1.5% and EjD in 3.4% with the use of 5-ARI compared to that of the placebo.…”

Section: Discussionmentioning

confidence: 99%

Impact of pharmacologic therapy for benign prostatic hyperplasia on prostate volume and free testosterone and consequently on urinary parameters and sexual desire in men

et al. 2017

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Background/Aim. Pharmacologic therapy for benign prostatic hyperplasia (BPH) relieves disease progression and affects the androgen hormone status. A decrease in the level of free testosterone (freeT) within total testosterone (totalT) leads to symptoms of sexual dysfunction. The aim of this study was to show the impact of pharmacological treatment for BPH on prostate volume (PV) and levels of freeT and, consequently, on urinary parameters and sexual desire in men during 6 months of administration. Methods. This clinical prospective study included 156 BPH patients with moderate urinary symptoms-International Prostate Symptom Score (IPSS) < 19, PV > 30 mL and prostate specific antigen (PSA) value < 4 ng/mL. The average age of patients was 61.16 ± 2.97 years. The performed tests included determination of tumor markers (PSA, free PSA), hormones (totalT, freeT, freeT/totalT ratio), trans abdominal ultrasonography and uroflowmetry. Urinary symptoms were measured by IPSS and the Quality of Life (QoL) questionnaire while the changes in sexual desire were measured using the International Index of Erectile Function (IIEF) questionnaire. Four groups were formed, 39 patients each. The group 1 received alpha1blocker (AB) tamsulosin, the group 2, 5 alpha-reductase inhibitor (5-ARI) finasteride, the group 3, combined therapy of both drugs (tamsulosin and finasteride), while the group 4 (control group) had no therapy. Follow-ups were performed every three and six months during therapy administration. Results. Prostate volume significantly decreased in the patients on combined therapy (-6.95 ± 2.00; p < 0.001) and finasteride (-6.67 ± 3.35). In the finasteride group, the levels of freeT (-4.23 ± 5.2; p < 0.001) and freeT/totalT ratio (-0.12 0.08; p < 0.001) significantly decreased as did the freeT (-2.64 ± 7.81) and freeT/totalT ratio (-0.09 ± 0.13) in the combined therapy group. Uroflowmetry showed a significant improvement in all parameters and all the therapy groups. Combined therapy provided the greatest improvement in the maximum flow rate (Qmax) (+4.06 ± 1.75; p < 0.001) and urinary symptoms (-10.95 ± 3.19). A significant improvement of sexual desire occurred in the patients on tamsulosin (+0.78 ± 1.00; p < 0.001), with a slight deterioration in the finasteride group, but without statistical significance. Conclusion. Hormonal component of pharmacologic therapy for BPH most effectively reduces PV and freeT levels, improves urinary symptoms with a slight decline of sexual desire in men on finasteride monotherapy.

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Section: Discussionmentioning

confidence: 99%

Impact of pharmacologic therapy for benign prostatic hyperplasia on prostate volume and free testosterone and consequently on urinary parameters and sexual desire in men

et al. 2017

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“…With regard to 5-ARIs, Gacci et al [20] found "an overall prevalence of ejaculation disorder as low as 3 %, although about 3-times higher than with placebo". In the review by Trost et al [67], a pooled summary of all randomized, placebo-controlled trials evaluating 5-ARIs revealed slightly increased rates over placebo Placebo effects in studies are shown in parenthesis. Data from Gur et al [66] we found 16 RCTs on tadalafil [184,185,187,188,[192][193][194][195][198][199][200][201][202][203][204][205], 3 RCTs on sildenafil [183,191,196], 2 RCTs on vardenafil [186,197] and 2 RCTs on UK-369,003 [189,190].…”

Section: Silodosinmentioning

confidence: 99%

“…The sexual adverse event profile of dutasteride appears to be similar to that of finasteride. Recent reports of persistent sexual dysfunction after discontinuation of treatment with finasteride require further studies to assess causality [67]. Further studies are also needed to assess the long-term role of combined therapy of phosphodiesterase type 5 inhibitors and α-blockers or 5-ARIs in the treatment LUTS/BPH [180,197].…”

Section: Conclusion ▼mentioning

confidence: 99%

Sexual Dysfunction Related to Drugs: a Critical Review. Part V: α-Blocker and 5-ARI Drugs

et al. 2015

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Sexual dysfunction is a potential side effect of BPH (benign prostatic hyperplasia) and LUTS (lower urinary tract symptoms) drugs: this article is a critical review of the current literature. Many studies have been published on this topic. Methodological flaws limit the conclusions of these studies, mainly because of the lack of diagnostic criteria for ejaculatory and sexual desire dysfunction. Few of these studies are RCTs. The ?-blocker (also called ?1-adrenergic antagonist, alpha-adrenoceptor antagonist, alpha-blocker or AB) and 5-ARI (also called 5?-reductase inhibitor or testosterone-5-alpha reductase inhibitor) drugs can in particular cause erectile dysfunction, ejaculatory disorders and reduction of sexual desire. The sexual side effect profile of these drugs is different. Among the ?-blockers, silodosin appears have the highest incidence of ejaculatory disorders. Persistent sexual side effects after discontinuation of finasteride has recently been reported, however further studies are needed to clarify the true incidence and the significance of this finding. It is desirable that future studies include validated tools to assess and diagnose sexual dysfunction induced by these medications, especially for ejaculation and sexual desire disorders. Only a small amount of research has intentionally set out to investigate sexual dysfunction caused by ?-blocker and 5-ARI drugs: studies to specifically assess sexual dysfunction induced by these drugs are needed. Further studies are also needed to assess in the long term the role of combined therapy of phosphodiesterase type 5 inhibitors and ?-blockers or 5-ARIs in treating LUTS/BPH. Methods: This study was conducted in 2014 using the paper and electronic resources of the library of the ?Azienda Provinciale per i Servizi Sanitari (APSS)? in Trento, Italy (http://atoz.ebsco.com/Titles/2793). The library has access to a wide range of databases including DYNAMED, MEDLINE Full Text, CINAHL Plus Full Text, The Cochrane Library, Micromedex healthcare series, BMJ Clinical Evidence. The full list of available journals can be viewed at http://atoz.ebsco.com/Titles/2793, or at the APSS web site (http://www.apss.tn.it). In completing this review, a literature search was conducted using the key words ?benign prostatic hyperplasia drugs?, ?lower urinary tract symptoms drugs?, ??-blockers?, ?5-ARIs?, ?sexual dysfunction?, ?sexual side effects?, ?treatment-emergent sexual dysfunction?, ?phosphodiesterase type 5 (PDE5) inhibitors?. All resulting listed articles were reviewed. Studies published between 2002 and December 2014 were included in the review. We included all studies that explicitly reported data on sexual dysfunction during treatment with ?-blockers and 5-ARIs. We also reviewed studies that have evaluated the use of phosphodiesterase type 5 (PDE5) inhibitors in combination with these drugs. The purpose was to identify possible intervention strategies for sexual dysfunction related to these drugs.

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“…The effects of 5ARIs and α‐blockers on sexual function are published in clinical trials, but these lack baseline assessments of sexual function. In addition, the mechanisms underlying these effects have not been fully elucidated . Our current knowledge of the clinical effects of 5ARIs and α‐blockers on sexual function is largely based on the spontaneous reporting of adverse events (AEs) in clinical trials and postmarketing studies as opposed to a quantitative, validated score of sexual dysfunction …”

Section: Introductionmentioning

confidence: 99%

“…In addition, the mechanisms underlying these effects have not been fully elucidated. 3,4 Our current knowledge of the clinical effects of 5ARIs and α-blockers on sexual function is largely based on the spontaneous reporting of adverse events (AEs) in clinical trials and postmarketing studies as opposed to a quantitative, validated score of sexual dysfunction. 1,[5][6][7] A validated scale, the Male Sexual Health Questionnaire (MSHQ), was developed for assessing specific aspects of male sexual dysfunction in patients from a BPH registry, 8 and is a valuable, freely available tool for assessing the impact of BPH treatment on sexual function.…”

Section: Introductionmentioning

confidence: 99%

Men’s Sexual Health Questionnaire score changes vs spontaneous sexual adverse event reporting in men treated with dutasteride/tamsulosin combination therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: A post hoc analysis of a prospective, randomised, placebo‐controlled study

Roehrborn

Rosen

Manyak³

et al. 2020

Int J Clin Pract

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Summary Aim To assess the impact of baseline characteristics on Men's Sexual Health Questionnaire (MSHQ) total scores and to evaluate the clinical relevance of MSHQ changes and their association with spontaneously reported sexual adverse events (SexAEs) in patients with benign prostatic hyperplasia. Methods This was a post hoc analysis of the Phase 4 FDC116115 study, in which patients aged ≥50 years were randomised 1:1 to receive a fixed‐dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg (DUT‐TAM FDC), or placebo. End‐points included: change in MSHQ total scores by baseline characteristics and SexAEs; cumulative distribution function for change from baseline to month 12 in MSHQ total score and the ejaculation, erection, satisfaction and sexual desire (libido) domain scores; and relationship between changes in MSHQ scores and SexAEs. Results The intent‐to‐treat population comprised 489 patients (DUT‐TAM FDC, n = 243; placebo, n = 246). The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs. Most patients reporting any SexAE (86% DUT‐TAM FDC, 67% placebo) had a worsening of the MSHQ total score at month 12 compared with baseline. Specifically, 90% (DUT‐TAM FDC) and 75% (placebo) of patients reporting an ejaculation SexAE and 73% (DUT‐TAM FDC) and 87% (placebo) of patients reporting an erection SexAE had a worsening of MSHQ ejaculation and erection domain scores, respectively, at month 12. A threshold effect for incident SexAE was observed; patients showing a decrease of approximately 6‐10 points in the total MSHQ score were more likely to report SexAEs. Conclusion Findings support the clinical utility of the MSHQ tool in assessing the impact of DUT‐TAM on sexual function by linking numerical changes in MSHQ scores to spontaneously reported SexAEs for the first time. The threshold effect for incidence of SexAEs warrants further investigation to determine its clinical relevance.

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Side Effects of 5‐Alpha Reductase Inhibitors: A Comprehensive Review

Cited by 44 publications

References 148 publications

Impact of pharmacologic therapy for benign prostatic hyperplasia on prostate volume and free testosterone and consequently on urinary parameters and sexual desire in men

Impact of pharmacologic therapy for benign prostatic hyperplasia on prostate volume and free testosterone and consequently on urinary parameters and sexual desire in men

Sexual Dysfunction Related to Drugs: a Critical Review. Part V: α-Blocker and 5-ARI Drugs

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