Evaluation of Tadalafil effect on lower urinary tract symptoms of benign prostatic hyperplasia in patients treated with standard medication

Abstract

Benign Prostatic Hyperplasia (BPH) is a pathological process responsible for the majority of lower urinary tract symptoms (LUTS) in elderly men (1). In addition, erectile dysfunction (ED), which has negative effect on quality of life (QoL), is another major problem of this age group (2).The incidence of BPH increases with age. It is observed in about 50% of men over 50 year with prevalence increasing up to 90% in those older than 80 year. Moreover, 25% to 50% of men with histological confirmed BPH have LUTS (3).The α-blockers and/or 5-α reductase inhibitors are used for the treatment of BPH frequently. The phosphodiesterase inhibitors are Objectives: To evaluate safety and efficacy of tadalafil on lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in patients treated with standard medication. Materials and Methods:In this case-controlled randomized clinical trial, from november 2008 to August 2009, 132 patients with obstructive and irritative urinary tract symptoms due to BPH, IPSS ≥ 8, no indication for surgical intervention and that reached plateau levels of response to treatment were selected. These patients were randomly allocated in two groups (each containing 66 patients). The treatment group received standard treatment of BPH and tadalafil (10 mg nightly); the placebo group received only standard treatment of BPH. IPSS, maximum urinary flow rate (Q max ) and quality of life were assessed before and after a 3-month period of study. Results: Before treatment, mean IPSS, Q max and quality of life values in the treatment and placebo groups were 13.06 ± 4.37 and 13.66 ± 4.25, 8.92 ± 2.96 mL/s and 9.09 ± 2.91 mL/s, 2.93 ± 0.86 and 2.66 ± 0.78, respectively. After treatment, mean IPSS, Q max , and quality of life values in treatment group were 7.66 ± 3.99, 9.99 ± 4.76 mL/s and 1.80 ± 0.98, respectively. These findings were compared to corresponding values of the placebo group (11.37 ± 3.64, 8.73 ± 2.22 mL/s and 2.19 ± 0.53, respectively): IPSS and quality of life were significantly different but Q max didn't show a significant change. Conclusions: Tadalafil improves quality of life and urinary symptoms in patients with LUTS suggestive of BPH, but doesn't have any significant effect on Qmax. Therefore, this drug may be effectively used in combination with standard medical therapies for BPH. Evaluation of

Comparative Effectiveness of Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis

“…The evidence from a single trial of tadalafil 5-ARI combination versus 5-ARI monotherapy [53] as well as that from a single trial comparing tadalafil versus 5-ARI/AB combination [54] was insufficient for both comparative effectiveness and safety.…”

Efficacy of tamsulosin and tadalafil in relieving benign prostatic hyperplasia related symptoms: A randomized double blind placebo controlled cross-over study

“…Alfa blockers, which are the standard of care for BPH related urinary symptoms, have not shown consistent improvement in the erectile function, though there are some studies that report improvement. [ 19 20 21 ] PDEI, which are the standard of care for ED, have been shown to cause a significant improvement in LUTS in patients with BPH in various studies, along with a remarkable effect on erectile function[ 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 22 23 ] which has led to the US-FDA approval of tadalafil (2.5 and 5 mg) for treatment of LUTS consistent with BPH with or without ED.…”

“…This is the clinical response criteria as per the AUA guidelines which suggests a >3 point decrease in total IPSS score from the baseline is indicative of a clinically meaningful improvement and this change is also consistent with that observed in other published tamsulosin and tadalafil studies. [ 9 10 12 13 14 15 17 18 ]…”

“…[ 3 ] Several studies have been conducted in men presenting with LUTS consistent with benign prostatic hyperplasia (BPH-LUTS) with and without concomitant ED to determine whether phosphodiesterase type 5 inhibitors (PDEIs) are effective for the treatment of symptomatic BPH. [ 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 ] They demonstrated that PDE-5 inhibitors are efficacious both alone and in combination with an alfa blocker in treating LUTS. [ 7 8 9 10 11 12 ] The current scientific evidence is insufficient to predict the differential response of either of the drugs and response of one of the agents when there is no response to the other for the treatment of LUTS.…”

Does sildenafil enhance the effect of tamsulosin in relieving acute urinary retention?

“…Sairam et al described that inhibition of 5-phosphodiesterase enzyme may increase the urinary flow rate by decreasing the smooth muscle tone of the prostate (27) but Madani et al indicated that tadalafil improves quality of life and obstructive urinary symptoms (mean 4 scores drop after treatment) but has no significant effect on Q max (28).…”