Efficacy and Safety of Combined Oral Therapy with Tadalafil and Alfuzosin: An Integrated Approach to the Management of Patients with Lower Urinary Tract Symptoms and Erectile Dysfunction. Preliminary Report

Abstract

Introduction Alpha1-blockers (AB) are the first-line monotherapy for lower urinary tract symptoms (LUTS). Phosphodiesterase type 5 (PDE5) inhibitors are the first-line treatment for erectile dysfunction (ED). Numerous studies have supposed a significant association between ED and LUTS, but a causal relationship cannot be established. Aim The aim was to evaluate the efficacy of a combined therapy with an AB (alfuzosin) and PDE5 inhibitors (tadalafil) in patients with LUTS and ED. Methods This was a randomized, open-label, three-arm study. A total of 66 men complaining of ED and LUTS were included in the study. Patients were assessed at baseline and after 12 weeks of study treatment, and then underwent randomized allocation to either alfuzosin 10 mg once a day (22 patients) or tadalafil 20 mg on alternative days (21 patients), or a combination of both (23 patients). Main Outcome Measures All participants completed the erectile function domain of the International Index of Erectile Function (IIEF-EF) and the International Prostatic Symptom Score (IPSS). Other efficacy variables included maximum urinary flow rate (Qmax) and medium urinary flow rate (Qave). Results IIEF-EF tended to improve with alfuzosin alone (+15%), while it was clearly improved with tadalafil alone (+36.3%). The greatest improvement was experienced with the combination therapy (+37.6%). Improvement in Qmax was observed in all groups, but patients receiving combination therapy had greater improvement (29.6%) than patients receiving either only alfuzosin (21.7%) or only tadalafil (9.5%). IPSS was significantly improved in alfuzosin group (27.2%), was more marked with the combination therapy (41.6%), and a small increase, although not significant, was also observed with tadalafil (8.4%). Conclusions Combined therapy improved ED and LUTS as demonstrated by the significant improvement in uroflowmetry measures and in IPSS and IIEF-EF scores. A significant improvement was also observed in quality of life assessments. The beneficial effects of tadalafil on LUTS similar to the benefits of alfuzosin on ED, although present, were smaller.

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

“…29 Supporting this is that the baseline Qmax of 14.54 ± 3.26 ml s À1 in the present study is high compared with those recorded in previous studies. [23][24][25][26] In comparison with Kaplan et al and Tuncel et al, the full dose of mirodenafil, which we used might result in similar outcomes of improvement for LUTS despite only two times per week. In addition, we investigated two groups to examine correlation on improvement of IIEF-5 and IPSS.…”

“…In addition, only the combination therapy was associated with a significant improvement in the IIEF (Po0.001). Moreover, when Liguori et al 25 conducted a study with 66 BPH patients who had had LUTS for at least 6 months to determine the efficacy of alfuzosin 10 mg OAD and/or tadalafil 20 mg every other day, they found that while the IPSS was significantly improved in the alfuzosin monotherapy group (27.2%), it was even better in the combination therapy group Combination therapy with mirodenafil and a 1 -blocker JY Lee et al (41.6%). Qmax was also improved in all three groups (21.7%, P ¼ 0.006 for alfuzosin; 9.5%, P ¼ 0.044 for tadalafil; 29.6%, Po0.001 for combination), with the combination group showing the best improvement.…”

Association of lower urinary tract symptoms and erectile dysfunction: pathophysiological aspects and implications for clinical management

“…94 Two more studies investigating the combination of a-blocker and PDE-5 inhibitor to treat LUTS and ED concluded that the combination of the two drugs is safe and more effective than monotherapy with either agent to improve both voiding and sexual dysfunction in men with LUTS suggestive of BPH. 95,96 Effects of testosterone used for treatment of hypogonadism on LUTS A number of studies involving the use of testo sterone for ED or late onset hypogonadism, investigated the effects of testosterone administration to elderly men on symptoms of LUTS. Saad et al 97 described the effects of administration of parenteral testosterone undecanaote over 12 months.…”

Combination therapy for erectile dysfunction: an update review

“…Also, relative international prostate symptom scores (IPSS) were the lowest in the combination arm (a 24% decrease from baseline), which supports other clinical studies showing sildenafil's independent positive effect on IPSS reduction in men with benign prostatic hyperplasia. 32,33 Liguori et al 34 examined tadalafil and alfuzosin in 66 men with LUTS and ED. As seen in earlier studies, combination therapy again showed benefits in comparison to monotherapy in treating both of these disease processes.…”