Tadalafil 5 mg Alone or in Combination with Tamsulosin 0.4 mg for the Management of Men with Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Prospective Observational Trial

Abstract

Tadalafil 5 mg represents the standard for men with Erectile dysfunction (ED) and lower urinary tract symptoms (LUTS)/benign prostatic enlargement (BPE). We carried out an observational trial aiming to assess the efficacy and safety of Tadalafil compared with Tadalafil plus Tamsulosin. Seventy-five patients complaining of ED and LUTS were treated for 12-weeks with Tadalafil plus placebo (TAD+PLA-group) or with combination therapy tadalafil plus tamsulosin (TAD+TAM-group). Efficacy variables were: International Index of Erectile Function (IIEF), International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax) and safety assessments. Data were evaluated using paired samples T-test (baseline vs. 12-weeks) and analysis of variance (Δgroup-TAD+PLA vs. Δgroup-TAD+TAM). At baseline, both groups presented similar characteristics and symptoms scores (all: p > 0.05). From baseline to 12-weeks, all the subjects showed a significant improvement of IIEF, total-IPSS, storage-IPSS, Qmax (all: p < 0.001). Conversely, a significant improvement of voiding-IPSS was observed in TAD+TAM-group (−3.5 points, p < 0.001). Indeed, TAD+PLA-group showed a not significant improvement of voiding-IPSS (−2.0 points, p = 0.074). When we compared between-groups differences at 12-weeks, IIEF (p = 0.255), total-IPSS (p = 0.084) and storage-IPSS (p = 0.08) did not show any statistically significant differences, whereas, voiding-IPSS and Qmax were significantly better in TAD+TAM-group (p = 0.006 and p = 0.027, respectively). No severe treatment adverse events (TAEs) were reported in both groups. Tadalafil achieved the same improvements of IIEF, total-IPSS, storage-IPSS when compared to combination therapy. Instead, Qmax and voiding-IPSS were better managed with combination therapy, without change of TAEs.

Evaluation of combined therapeutic effects of hydrogen sulfide donor sodium hydrogen sulfide and phosphodiesterase type‐5 inhibitor tadalafil on erectile dysfunction in a partially bladder outlet obstructed rat model

“…Interestingly, combined treatment with NaHS and tadalafil induced significantly higher levels of cGMP than controls. Previous data showed that the tadalafil augmented NO/cGMP pathway 1 . Also, a recent study has indicated that NaHS and l ‐cysteine increased cGMP accumulation and potentiated vasodilatory capacity of sildenafil in human CC and penile arteries 10 .…”

“…Lower urinary tract symptoms (LUTS) are often concurrent with benign prostatic hyperplasia (BPH) in older men 1 . The pharmacological management of BPH is primarily based on the use of 5‐alpha reductase inhibitors and alpha‐blockers.…”

“…The pharmacological management of BPH is primarily based on the use of 5‐alpha reductase inhibitors and alpha‐blockers. However, there are several sexual adverse effects such as erectile dysfunction (ED) that decreases the quality of life in aged men receiving LUTS/BPH treatment 1 …”

“…A phosphodiesterase type‐5 inhibitor (PDE5i), tadalafil (5 mg once daily), has been approved for the treatment of moderate to severe LUTS/BPH with or without ED by the US Food and Drug Administration in 2011. Tadalafil improved smooth muscle relaxation through activating the NO/cyclic guanosine monophosphate (cGMP) pathway and decreased inflammatory action, oxidative stress, hypoxia, and ischemia via improvement of vascular endothelial function and resulted in amelioration of LUTS/BPH symptoms 1 …”

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

“…No one experienced severe TEAEs. Headache, nasopharyngitis, back pain, and dizziness were the most frequent TEAEs [ 37 ••].…”