Hemodynamic interaction study between the alpha1-blocker alfuzosin and the phosphodiesterase-5 inhibitor tadalafil in middle-aged healthy male subjects

Giuliano, François; Kaplan, Steven A.; Cabanis, Marie-Josée; Astruc, B

doi:10.1016/j.urology.2006.01.001

Cited by 57 publications

(31 citation statements)

References 23 publications

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“…Similarly, when Giuliano et al conducted the study of healthy men who were administered alfuzosin 10 mg daily for 7 days and tadalafil 20 mg or a placebo on the seventh day, it was concluded that a combination of alfuzosin 10 mg and tadalafil 20 mg does not induce hemodynamic interactions in middle-aged healthy men. 21 However, one study reported that PDE5i/a 1 -blocker combination therapy does induce hemodynamic interactions. This study by Nieminen et al 22 involved 16 patients with enlarged prostates and LUTS who were treated with tamsulosin 0.4 mg and/or sildenafil 100 mg. On their own, tamsulosin did not affect the hemodynamics but sidenafil decreased blood pressure in the supine position.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of combination therapy with mirodenafil and α1-blocker for benign prostatic hyperplasia-induced lower urinary tract symptoms accompanied by erectile dysfunction: a multicenter, open-label, prospective study

Lee

Cho

et al. 2011

Int J Impot Res

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This study was conducted to determine whether mirodenafil 100 mg, when administered on demand to patients with benign prostatic hyperplasia (BPH) who are receiving a 1 -blocker therapy, is safe with regard to the cardiovascular system and whether it improves lower urinary tract symptoms (LUTS) and sexual function. The study involved 121 LUTS/BPH patients who had been treated for at least 3 months with a 1 -blockers before being administered with mirodenafil 100 mg on demand. Before the start of mirodenafil administration, the blood pressure, heart rate, international prostate symptom score (IPSS)/quality of life (QoL), peak urine flow rate (Qmax), post-voiding residual urine volume (PVR), and international index of erectile function-5 (IIEF-5) of each patient were measured. At 4 and 8 weeks after commencing mirodenafil administration, the blood pressure and heart rate were measured again, any adverse effects of mirodenafil were assessed, and sexual function and voiding symptoms were re-evaluated. Of the 121 patients, 73 (60.3%) completed the 8-week clinical trial. Significant changes in blood pressure and heart rate were not observed during the study. Significant improvements in the IIEF-5 and the IPSS/QoL, but not the Qmax or PVR, were observed. The results of this study suggest that the administration of mirodenafil 100 mg on demand may induce few hypotensive interactions and may be acceptably effective with regard to improving LUTS and sexual function.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of combination therapy with mirodenafil and α1-blocker for benign prostatic hyperplasia-induced lower urinary tract symptoms accompanied by erectile dysfunction: a multicenter, open-label, prospective study

Lee

Cho

et al. 2011

Int J Impot Res

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“…34 Furthermore, it seems to be noteworthy to mention that the administration of a PDE-5 inhibitor in addition to any a1-blocker was not reported to induce clinically significant hypotension in treated men and therefore has to be considered to be a safe 'combination'. 35,36 Impact of BPH surgery on male sexual function Open and transurethral surgery Retrograde ejaculation and ED are the main potential sexual side effects that have to be discussed with the patient before surgery.…”

Section: Combination Therapymentioning

confidence: 99%

Lower urinary tract symptoms and erectile dysfunction; links for diagnosis, management and treatment

Ponholzer

Madersbacher

2007

Int J Impot Res

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Recent large-scale epidemiological studies have documented a strong association between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). This observation has two important scientific and clinical aspects: (i) to reveal the pathomechanism linking LUTS and ED and (ii) to consider this fact in the individual approach for diagnosis and management of these two disorders. The following hypotheses are under investigation to explain the relation between LUTS and ED: (i) an increased Rho-kinase activation, (ii) an a-adrenergic receptor imbalance, (iii) a decrease of NOS/ NO in the endothelium, (iv) atherosclerosis affecting the small pelvis and (v) an autonomic hyperactivity, each affecting simultaneously bladder, prostate and penis. According to a recent randomized trial, sildenafil has a positive effect on LUTS yet not on uroflowmetry in men with LUTS and ED. Although further trials are mandatory, phosphodiesterase-5 inhibitors might play a role in the management of LUTS in the future. a-Blockers have no relevant effect on erectile function, tamsulosin leads to retrograde ejaculation in up to 10%. 5a-Reductase inhibitors are associated with ED, loss of libido and reduction of ejaculate volume in up to 10%. Transurethral and open prostatectomy induce retrograde ejaculation in up to 90% of patients while their impact on erectile function is still controversially discussed. Minimal invasive treatment options (laser prostatectomy, transurethral microwave thermotherapy) have a lower rate of retrograde ejaculation in the range of 20-70%. LUTS and ED are strongly linked although the exact mechanism is poorly understood. Men seeking for help for LUTS/benign prostatic hyperplasia should be assessed for different aspects of sexual dysfunction and informed regarding the impact of medication and surgery on sexual health.

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“…45 When coadministration of tadalafil and alfuzosin (uroselective) was evaluated, the change in standing SBP was not statistically significant from tadalafil and placebo (Table 4). 41 Although 1 asymptomatic man had a standing SBP of 83 mm Hg, no man had a supine SBP Ͻ85 mm Hg, a Ͼ30-mm Hg decrease in SBP, or a diastolic BP Ͻ45 mm Hg.…”

Section: Uroselective ␣-Blockersmentioning

confidence: 99%

Drug Interactions With Phosphodiesterase-5 Inhibitors Used for the Treatment of Erectile Dysfunction or Pulmonary Hypertension

2010

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Hemodynamic interaction study between the alpha1-blocker alfuzosin and the phosphodiesterase-5 inhibitor tadalafil in middle-aged healthy male subjects

Cited by 57 publications

References 23 publications

Efficacy and safety of combination therapy with mirodenafil and α1-blocker for benign prostatic hyperplasia-induced lower urinary tract symptoms accompanied by erectile dysfunction: a multicenter, open-label, prospective study

Efficacy and safety of combination therapy with mirodenafil and α1-blocker for benign prostatic hyperplasia-induced lower urinary tract symptoms accompanied by erectile dysfunction: a multicenter, open-label, prospective study

Lower urinary tract symptoms and erectile dysfunction; links for diagnosis, management and treatment

Drug Interactions With Phosphodiesterase-5 Inhibitors Used for the Treatment of Erectile Dysfunction or Pulmonary Hypertension

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