Clinically Meaningful Improvements in LUTS/BPH Severity in Men Treated with Silodosin Plus Hexanic Extract of Serenoa Repens or Silodosin Alone

Abstract

To assess the rate and predictors of clinically meaningful improvements (CMI) in patients with lower urinary tract symptoms (LUTS) treated with either silodosin (SIL) alone or with a combination of SIL+ serenoa repens (Ser) hexanic lipidosterolic extract for ≥12 months. Data from 186 patients were collected. Patients completed the International Prostatic Symptoms Score (IPSS) at baseline and at follow-up assessment. Descriptive statistics and logistic regression models tested rates and predictors of CMI. Two CMI were assessed: 1) >3 points improvement in total IPSS from baseline to end (CMI#1); 2) >25% IPSS improvement from baseline to end (CMI#2). Overall, 93 (50%) patients were treated with SIL and SIL+ Ser, respectively. At a mean 13.5-mos follow-up [range: 12–20], mean IPSS scores were significantly lower in patients treated with SIL + Ser compared to those after SIL (p = 0.002). SIL + Ser patients more frequently achieved CMI#1 (69.9% vs. 30.1%, p = 0.001) and CMI#2 (68.8% vs. 31.2%, p < 0.001) compared SIL men. At multivariable analyses, younger age, IPSS severity and SIL + Ser (all p < 0.03) were independent predictors of CMI#1 and CMI#2. In conclusion, SIL + Ser therapy was more effective than SIL alone in improving IPSS scores in men with LUTS. SIL + Ser treatment led to CMIs in up to seven out of ten men.

Clinical Benefit of Tamsulosin and the Hexanic Extract of Serenoa Repens, in Combination or as Monotherapy, in Patients with Moderate/Severe LUTS-BPH: A Subset Analysis of the QUALIPROST Study

“…The improvement of 7.2 points in mean IPSS score observed in our combination arm was also similar to the 6.4 point improvement reported for silodosin plus HESr [23] and to results reported in different RCTs which evaluated the effect of combining an alpha-blocker and a 5ARI to treat LUTS/BPH [6,[32][33][34]. The enhanced effectiveness achieved with a combination of tamsulosin and HESr over the HESr alone has also been reported in a recent meta-analysis [19].…”

“…This hypothesis is further supported by the results of a study which found that storage symptoms improved significantly more with TAM + HESr vs TAM alone after 12 months of treatment [22], which may be due to the HESr's anti-inflammatory action. In another study comparing the efficacy of silodosin versus silodosin plus HESr over a mean follow-up period of 13.5 months, combined therapy showed significantly more improvement from baseline on the IPSS score than silodosin alone, without any increase in adverse effects [23]. The proportion of patients showing clinically meaningful improvement (>3 IPSS points) was also higher for combination treatment (69.9% vs. 30.1% for silodosin alone; p = 0.001).…”

“…Combined treatment with an alpha-blocker and a plant extract has been reported to represent 49.7% of all combination therapies used to manage LUTS/BPH in general practice [21]. While previous studies have reported on the experience of using HESr in combination with alpha-blockers [22,23], with positive results for the combination treatment over alpha-blocker monotherapy, no study to date has simultaneously evaluated and compared the combined therapy and both constituent treatments separately in conditions of real-world practice.…”

The Clinical Impact of Hexanic Extract of Serenoa repens in Men with Prostatic Inflammation: A Post Hoc Analysis of a Randomized Biopsy Study

“…In addition, a higher than 25% improvement in IPSS was found in 68.8% and 31.2% of the patients in the combination and the monotherapy groups, respectively (p < 0.001). These data suggest that combination of a1-blocker with HESr results in greater clinically meaningful improvements in LUTS compared to monotherapy with an a-blocker [16].…”

“…A cross-sectional study compared the combination of HESr with silodosin to silodosin as monotherapy in patients treated for at least for 12 months (mean duration 13.5 months) [16]. It was reported that 69.9% of the combination therapy patients achieved the predefined clinically meaningful improvement (improvement more than three points in baseline IPSS) compared to 30.1% of patients treated only with silodosin (p = 0.001).…”