Hemodynamic Effects of Once-daily Tadalafil in Men With Signs and Symptoms of Benign Prostatic Hyperplasia on Concomitant α1-Adrenergic Antagonist Therapy: Results of a Multicenter Randomized, Double-Blind, Placebo-controlled Trial

Goldfischer, Evan R.; Kowalczyk, John J.; Clark, William R.; Brady, Erin; Shane, Michael A.; Dgetluck, Nancy; Klise, Suzanne

doi:10.1016/j.urology.2011.11.040

Cited by 27 publications

(16 citation statements)

References 20 publications

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“…However, results of a 12–week randomized, double–blind study (N = 318) found similar changes in hemodynamic signs and symptoms in men receiving tadalafil 5 mg or placebo in combination with stable alpha–blocker therapy [52]. The proportion of patients who reported treatment–emergent dizziness was not significantly different (tadalafil/alpha–blocker 7.0%; placebo/alpha–blocker 5.7%; P = .403).…”

Section: Introductionmentioning

confidence: 99%

Tadalafil in the management of lower urinary tract symptoms: a review of the literature and current practices in Russia

Govorov¹,

Kasyan²,

Priymak³

et al. 2014

CEJU

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IntroductionStrong epidemiologic evidence supports correlation between lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH) and erectile dysfunction (ED). The link has biologic plausibility given phosphodiesterase type 5 (PDE5) expression in pelvic structures. PDE5 inhibitors target pathophysiologic processes implicated in LUTS/BPH.Material and methodsThis review highlights the efficacy and safety of the daily use of a PDE5 inhibitor tadalafil in LUTS/BPH, with a focus on LUTS/BPH medical management in Russia.ResultsAlpha–blockers and phytotherapy are major components of the current LUTS/BPH therapy in Russia. Russian regulatory authorities granted approval for once–daily tadalafil for treatment of LUTS/BPH in January 2012. In a pivotal study, tadalafil 5 mg once–daily significantly improved International Prostate Symptom Score (IPSS) over 12 weeks vs. placebo (P = .004) regardless of baseline ED severity. IPSS improvement was maintained at 12 weeks. Integrated analysis of randomized studies showed that tadalafil 5 mg once–daily resulted in significant symptom improvements across a range of men with LUTS/BPH. Relief of LUTS due to tadalafil was independent of improvement in ED; improvements in IPSS and erectile function were only weakly correlated (r = –0.229). Another pooled analysis found similar improvement in LUTS/BPH between men with or without ED, with non–significant P values for treatment–by–ED–status interactions for total IPSS ( P = .73). Non–registration studies of tadalafil and alpha–blocker co–therapy in LUTS/BPH suggest an additive effect, but co–therapy is not recommended in current tadalafil prescribing instructions.ConclusionsTadalafil results in symptom improvements across a range of men with LUTS/BPH and represents a new treatment option for patients in Russia with LUTS/BPH.

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Section: Introductionmentioning

confidence: 99%

Tadalafil in the management of lower urinary tract symptoms: a review of the literature and current practices in Russia

Govorov¹,

Kasyan²,

Priymak³

et al. 2014

CEJU

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“…Also, as in the study by Liguori et al , myalgia was the commonest AE leading to discontinuation of therapy. Studies have shown the combination of α‐blockers and PDE5i to be haemodynamically safe . Further, PDE5i is safe in the treatment of LUTS irrespective of age and pre‐existing co‐morbidities .…”

Section: Discussionmentioning

confidence: 99%

Tamsulosin and placebo vs tamsulosin and tadalafil in male lower urinary tract symptoms: a double‐blinded, randomised controlled trial

et al. 2020

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ObjectiveTo compare the efficacy and safety of tamsulosin vs the combination of tamsulosin and tadalafil in male lower urinary tract symptoms (LUTS). Patients and MethodsThis was a double-blinded, parallel-arm randomised controlled trial. Men aged >45 years with moderate LUTS and a maximum urinary flow rate (Q max ) of 5-15 mL/s were included. One arm received 0.4 mg tamsulosin only (Group-A), while the second received 5 mg tadalafil with tamsulosin (Group-B). The primary outcome was the International Prostate Symptom Score (IPSS). Secondary outcomes were IPSS quality of life (QoL) score, five-item version of the International Index of Erectile Function (IIEF-5) score, Q max , and post-void residual urine (PVR). Block randomisation was used. Placebo was used for blinding and allocation concealment. Intention-totreat analysis was used for outcome measures. ResultsOf the 183 men screened, 140 were randomised (71 in Group-A, 69 in Group-B); 116 (82.85%) (61 in Group-A, 55in Group-B) completed the study. Baseline characteristics were comparable. The improvements in the IPSS, IPSS QoL score, IIEF score and Q max were À1.69 (95% confidence interval [CI] À1.4 to À2.0), À0.70 (95% CI À0.60 to À0.80), 3.8 (95% CI 3.4-4.2) and 1.8 mL/s (95% CI 1.1-2.4) respectively, in favour of the combination group. The difference in PVR was not significant. There were no serious adverse events (AEs). The dropout rate due to AEs was 2.85%. Myalgia (five patients) was the commonest AE in the combination group. ConclusionThe combination of tamsulosin and tadalafil produced significantly better improvements in LUTS, QoL, erectile function and Q max compared to monotherapy with tamsulosin, without an increase in AEs.

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“…Safety assessments from several clinical studies, including a large randomized placebo-controlled study, showed that although tadalafil combined with tamsulosin or other a 1 -blockers does not decrease BP, combining tadalafil with a non-uroselective a 1 -blocker, such as doxazosin, enhances the hypotensive effect of tadalfil. [7][8][9] The possible hypotensive-enhancing effect of the combination of tadalafil with an a 1 -blocker, however, is still a clinical concern for physicians and needs to be better clarified. Furthermore, although several studies have suggested that combination therapy of a PDE5 inhibitor with an a 1 -blocker has an additive effect, the results are inconclusive, largely because few randomized, double-blinded, placebo-controlled studies with a large sample size have been carried out.…”

Section: Medicines Development Unit Eli Lilly and Company Indianapomentioning

confidence: 99%

“…Although the effectiveness and safety of tadalafil combined with various α 1 ‐blockers has not yet been established, several studies have reported the effectiveness and safety of this combination therapy. Safety assessments from several clinical studies, including a large randomized placebo‐controlled study, showed that although tadalafil combined with tamsulosin or other α 1 ‐blockers does not decrease BP, combining tadalafil with a non‐uroselective α 1 ‐blocker, such as doxazosin, enhances the hypotensive effect of tadalfil . The possible hypotensive‐enhancing effect of the combination of tadalafil with an α 1 ‐blocker, however, is still a clinical concern for physicians and needs to be better clarified.…”

Section: Introductionmentioning

confidence: 99%

Safety and efficacy of the combination of once‐daily tadalafil and alpha‐1 blocker in Japanese men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A randomized, placebo‐controlled, cross‐over study

et al. 2017

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Concurrent treatment with tadalafil and an α -blocker seems to be safe and well tolerated in Japanese patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Adding tadalafil to baseline α -blocker therapy does not translate in adverse effects on the blood pressure. Patients tend to prefer combination therapy over monotherapy, and there seems to be a clinical benefit when using combination therapy.

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Hemodynamic Effects of Once-daily Tadalafil in Men With Signs and Symptoms of Benign Prostatic Hyperplasia on Concomitant α1-Adrenergic Antagonist Therapy: Results of a Multicenter Randomized, Double-Blind, Placebo-controlled Trial

Cited by 27 publications

References 20 publications

Tadalafil in the management of lower urinary tract symptoms: a review of the literature and current practices in Russia

Tadalafil in the management of lower urinary tract symptoms: a review of the literature and current practices in Russia

Tamsulosin and placebo vs tamsulosin and tadalafil in male lower urinary tract symptoms: a double‐blinded, randomised controlled trial

Safety and efficacy of the combination of once‐daily tadalafil and alpha‐1 blocker in Japanese men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A randomized, placebo‐controlled, cross‐over study

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