Impact of combination therapy 5-alpha reductase inhibitors (5-ARI) plus alpha-blockers (AB) on erectile dysfunction and decrease of libido in patients with LUTS/BPH: a systematic review with meta-analysis

Favilla,; Gi, Russo; Privitera, Salvatore; Castelli, Tommaso; Giardina, Raimondo; Ae, Calogero; Condorelli, Rosita A.; Vignera, Sandro La; Cimino, Silvia; Morgia, Giuseppe

doi:10.1080/13685538.2016.1195361

Cited by 54 publications

(19 citation statements)

References 26 publications

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“…Generally, the incidence of libido‐related SexAEs in patients on 5ARIs is low. In fact, in a previous study, the risk of libido alteration was comparable for both patients treated with 5ARI monotherapy and those treated with combination therapy . Therefore, in this study, the MSHQ tool did not correlate well with libido‐related SexAEs.…”

Section: Discussioncontrasting

confidence: 72%

“…Generally, the incidence of libido-related SexAEs in patients on 5ARIs is low. In fact, in a previous study, the risk of libido alteration was comparable for both patients treated with 5ARI monotherapy and those treated with combination therapy 16. Therefore, in this study, the MSHQ tool did not correlate well with libido-related SexAEs.Our observation of a clear discrepancy between the directionality of MSHQ sexual desire (libido) domain scores and the likelihood of patients reporting libido-related SexAE is thought-provoking.…”

contrasting

confidence: 72%

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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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Section: Discussioncontrasting

confidence: 72%

contrasting

confidence: 72%

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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“…However, the potential for sexual dysfunction with 5ARI‐α 1 ‐blocker combination therapies can limit their use in clinical practice, despite patient satisfaction with treatment and clinical studies indicating efficacy in reducing symptoms, clinical progression, and the risk of surgery . A systematic review and meta‐analysis revealed that erectile dysfunction (ED) and libido alteration were notably more prevalent in patients treated with combination therapy compared with those treated with α 1‐ blocker monotherapy alone . The risk of ED was higher in those treated with combination therapy but the risk of libido alteration was the same for both patients treated with 5ARI monotherapy and those treated with combination therapy …”

Section: Introductionmentioning

confidence: 99%

“…A systematic review and meta‐analysis revealed that erectile dysfunction (ED) and libido alteration were notably more prevalent in patients treated with combination therapy compared with those treated with α 1‐ blocker monotherapy alone . The risk of ED was higher in those treated with combination therapy but the risk of libido alteration was the same for both patients treated with 5ARI monotherapy and those treated with combination therapy …”

Section: Introductionmentioning

confidence: 99%

Evaluation of the impact of dutasteride/tamsulosin combination therapy on libido in sexually active men with lower urinary tract symptoms ( LUTS ) secondary to benign prostatic hyperplasia ( BPH ): A post hoc analysis of a prospective randomised placebo‐controlled study

Rosen

Roehrborn

Manyak³

et al. 2018

Int J Clin Pract

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Summary Aims Five‐α reductase inhibitor (5ARI) therapy has been associated with sexual dysfunction in some patients. This study assessed the impact of a fixed‐dose combination of the 5ARI dutasteride 0.5 mg and the α1‐adrenoceptor antagonist tamsulosin 0.4 mg (DUT‐TAM FDC) on Men's Sexual Health Questionnaire (MSHQ) domain scores in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH). Methods This was a post hoc analysis of a double‐blind, randomised, placebo‐controlled, parallel‐group, multicentre study in sexually active patients, aged ≥50 years, with a confirmed clinical diagnosis of BPH. Sexual activity, sexual desire, and bother domain scores of the MSHQ were assessed at baseline and at Months 1, 3, 6, 9, and 12. Correlation between MSHQ sexual activity/desire scores and ejaculation, erection, and satisfaction domains at baseline was also evaluated. Results In the intent‐to‐treat population (N = 489), 243 and 246 patients were randomised to DUT‐TAM FDC and placebo groups, respectively. Compared with placebo, DUT‐TAM FDC therapy resulted in statistically significant reductions (worsening) from baseline in adjusted mean MSHQ sexual activity and bother domain scores at Months 1, 3, 6, 9, and 12 (all P < 0.05) and in adjusted mean MSHQ sexual desire domain scores at Months 6, 9, and 12 (all P < 0.05). Significant moderate correlations in the expected direction were observed at baseline between the sexual activity/desire domains and the ejaculation, erection, and satisfaction domains (P < 0.0001). Conclusions These findings help clarify the degree and impact of libido changes in sexually active men treated with DUT‐TAM FDC and may support clinical decision‐making.

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“…Whereby, several drug combinations, such as ABs and 5alpha reductase inhibitors (5ARIs), have been well established and are currently reported in the major urological guidelines as standard therapies. However, despite their efficacy in treating LUTS, their side effects, above all on sexual function, are mainly detrimental [ 2 , 38 ••, 40 – 42 ].…”

Section: Discussionmentioning

confidence: 99%

Tadalafil Alone or in Combination with Tamsulosin for the Management for LUTS/BPH and ED

et al. 2020

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Purpose of Review Aim of our systematic review is to evaluate and summarize the efficacy and safety of tadalafil alone or in combination with tamsulosin for the management of lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). Recent Findings Daily tadalafil, in particular 5 mg, according to retrieved studies, appears to be both safe and effective in treating LUTS/BPH and ED, compared with placebo or tamsulosin. The combination of daily tadalafil 5 mg and tamsulosin 0.4 mg allows a better improvement of LUTS compared with both the monotherapies, even if with an increased, but acceptable and tolerated, adverse events rate. After discontinuation of tamsulosin or tadalafil in patients previously treated with their combination, the improvement of LUTS retains significance compared with baseline. Summary Tadalafil 5 mg should be considered a primary treatment option for patients with LUTS/BPH and ED. Evidence highlight an excellent tolerability, safety, and effectiveness profile, both alone or in combination with tamsulosin 0.4 mg. A better efficacy on LUTS relief has been observed for combination therapy, preserving also sexual function. The further switch to monotherapy allows to preserve LUTS relief, but tadalafil only is able to retain ED improvement. Our results support the evidence for a more and more tailored and modular LUTS treatment.

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Impact of combination therapy 5-alpha reductase inhibitors (5-ARI) plus alpha-blockers (AB) on erectile dysfunction and decrease of libido in patients with LUTS/BPH: a systematic review with meta-analysis

Cited by 54 publications

References 26 publications

Evaluation of the impact of dutasteride/tamsulosin combination therapy on libido in sexually active men with lower urinary tract symptoms ( LUTS ) secondary to benign prostatic hyperplasia ( BPH ): A post hoc analysis of a prospective randomised placebo‐controlled study

Tadalafil Alone or in Combination with Tamsulosin for the Management for LUTS/BPH and ED

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