Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study.

The objective of this subset analysis was to evaluate and compare the efficacy and tolerability of two combination treatments for men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Data were from a real-world, open-label, prospective, and multicenter study performed in outpatient urology clinics. Men with moderate-to-severe LUTS/BPH received 6-month treatment with tamsulosin (TAM) in combination with either the hexanic extract of S. repens (HESr) or a 5-alpha-reductase inhibitor (5ARI). Changes in urinary symptoms and quality of life were measured using the IPSS and BII questionnaires, respectively. Treatment tolerability was assessed by recording adverse effects (AEs). Patients in the two study groups were matched using iterative and propensity score matching approaches. After iterative matching, data were available from 136 patients (n = 68 treated with TAM + 5ARI, n = 68 with TAM + HESr). After 6 months of treatment, mean (SD) IPSS total score improved by 7.7 (6.3) and 6.7 (5.0) points in the TAM + 5ARI and TAM + HESr groups, respectively (p = 0.272); mean BII total scores improved by 3.1 (2.9) and 2.9 (2.4) points (p = 0.751), respectively. AEs were reported by 26.5% and 10.3% of patients in the same groups, mostly affecting sexual function (p < 0.027). When used in a real-world setting to treat patients with moderate-severe LUTS/BPH, 6-month treatment with TAM + HESr was as effective as TAM + 5ARI, but with better tolerability.

Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients.

In a subset analysis of data from a 6-month, multicenter, non-interventional study, we compared change in symptoms and quality of life (QoL), and treatment tolerability, in men with moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving tamsulosin (TAM, 0.4 mg/day) or the hexanic extract of Serenoa repens (HESr, 320 mg/day) as monotherapy. Symptoms and QoL were assessed using the IPSS and BII questionnaires, respectively. Patients in the treatment groups were matched using two statistical approaches (iterative and propensity score matching). Within the iterative matching approach, data was available from a total of 737 patients (353 TAM, 384 HESr). After 6 months, IPSS scores improved by a mean (SD) of 5.0 (4.3) points in the TAM group and 4.5 (4.7) points in the HESr group (p = 0.117, not significant). Improvements in QoL were equivalent in the two groups. TAM patients reported significantly more adverse effects than HESr patients (14.7% vs 2.1%; p < 0.001), particularly ejaculation dysfunction and orthostatic hypotension. These results show that HESr is a valid treatment option for men with moderate/severe LUTS/BPH; improvements in urinary symptoms and QoL were similar to those observed for tamsulosin, but with considerably fewer adverse effects.

Quality of life in patients with lower urinary tract symptoms associated with BPH: change over time in real-life practice according to treatment--the QUALIPROST study.

PURPOSE: To evaluate change in quality of life (QoL) and symptoms in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) in conditions of current clinical practice. METHODS: Prospective, longitudinal, multicenter open-label study was carried out in urology outpatient clinics. Patients were ≥40 years of age with an International Prostate Symptom Score (IPSS) score ≥ 8. QoL and symptoms were measured at baseline and 6 months using the Benign Prostatic Hyperplasia Impact Index (BII) and the IPSS. RESULTS: 1713 patients were included for analysis. Mean (SD) IPSS and BII scores at baseline were 16.8 (5.4) and 6.8 (2.6), respectively. 8.9 % (n = 153) of study participants did not receive treatment (watchful waiting, WW), 70.3 % (n = 1204) were prescribed monotherapy (alpha-adrenergic blockers [AB]; phytotherapy [PT, of which 95.2 % was the hexanic extract of Serenoa repens, HESr]; or 5-alpha-reductase inhibitors [5ARI]), and 20.8 % (n = 356) received combined treatment (AB + 5ARI; AB + HESr; others). At 6 months, improvements in QoL were similar across the different medical treatment (MT) groups, both for monotherapy (AB: mean improvement [SD] of 2.4 points [2.4]; PT: 1.9 [2.4]; 5ARI: 2.5 [2.3]) and combined therapy (AB + 5ARI: 3.1 [2.9]; AB + PT: 3.1 [2.5]). There were no clinically significant differences between MT groups and all showed significant improvement over WW (p < 0.05). HESr showed similar efficacy to AB and 5ARI both as monotherapy and in combination with AB. Results on the IPSS were similar. CONCLUSIONS: Improvements in QoL and symptoms were equivalent across the medical treatments most widely used in real-life practice to manage patients with moderate or severe LUTS. HESr showed an equivalent efficacy to AB and 5ARI with fewer side effects.

Efficacy and Safety of Hexanic Lipidosterolic Extract of Serenoa repens (Permixon) in the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Systematic Review and Meta-analysis of Randomized Controlled Trials.

CONTEXT: A recent Cochrane Collaboration meta-analysis of randomized controlled trials (RCTs) evaluating the efficacy of different extracts of Serenoa repens in relieving lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) concluded that these extracts were no more effective than placebo. However, among all Serenoa repens extracts, Permixon (Pierre Fabre Medicament, Paris, France) has the highest activity and the most accurate standards of drug preparation and extraction. OBJECTIVE: To evaluate the efficacy and safety of Permixon in the treatment of LUTS/BPH. EVIDENCE ACQUISITION: A systematic review and meta-analysis of the literature was performed in January 2016 using the Medline, Scopus, and Web of Science databases, searching for the term Serenoa repens in all fields of the records. Only RCTs reporting on efficacy and safety of Permixon in the treatment of LUTS/BPH were selected. EVIDENCE SYNTHESIS: The systematic search identified 12 RCTs: 7 compared Permixon with placebo; 2 compared Permixon with tamsulosin; 2 compared Permixon plus tamsulosin with, respectively, placebo plus tamsulosin and tamsulosin alone; and 1 compared Permixon with finasteride. Permixon was significantly more effective than placebo in reducing the number of nocturnal voids (weighted mean difference [WMD] -0.31; p=0.03) and increasing maximum flow rate (Qmax; WMD 3.37; p<0.0001). The rates of overall adverse events (odds ratio [OR] 1.12; p=0.92) and withdrawal (OR 1.52; p=0.60) were similar for Permixon and placebo. Permixon was as effective as tamsulosin monotherapy and short-term therapy with finasteride in improving International Prostate Symptom Score (WMD 1.15; 95% confidence interval [CI], -1.11 to 3.40; p=0.32) and Qmax (WMD -0.16; 95% CI, -0.60 to 0.28; p=0.48). The combination of Permixon and tamsulosin was more effective than Permixon alone for relieving LUTS (WMD 0.31; 95% CI, 0.13-0.48; p<0.01) but not for improving Qmax (WMD 0.10; 95% CI -0.02 to 0.21; p=0.10). Permixon had a favorable safety profile, with a very limited impact with regard to ejaculatory dysfunction compared with tamsulosin (0.5% vs 4%; p=0.007) and with regard to decreased libido and impotence compared with short-term finasteride (2.2% and 1.5% vs 3% and 2.8%, respectively). CONCLUSIONS: The conclusions of the recent Cochrane meta-analysis on Serenoa repens in the treatment of LUTS/BPH apparently do not apply to Permixon. Our meta-analysis showed that Permixon decreased nocturnal voids and Qmax compared with placebo and had efficacy in relieving LUTS similar to tamsulosin and short-term finasteride. Moreover, Permixon had a favorable safety profile with a very limited impact on sexual function, which is significantly affected by all other drugs used to treat LUTS/BPH. PATIENT SUMMARY: A systematic review of the literature showed that Permixon was effective for relieving urinary symptoms due to prostate enlargement and improving urinary flow compared with placebo. Permixon had efficacy similar to tamsulosin and short-term finasteride in relieving urinary symptoms. Permixon was well tolerated and had a very limited impact on sexual function.

[Renal cell carcinoma with vena cava involvement: update and review of our series]. / Carcinoma de células renales con extensión a vena cava: puesta al día y revisión de nuestra casuística.

OBJECTIVE: To assess current management of renal cell carcinoma (RCC) extending into the inferior vena cava (IVC): staging, diagnosis, surgical approach, adjuvant therapy, prognostic factors and survival rate. MATERIALS AND METHODS: Nineteen cases of RCC extending into the IVC undergoing surgical resection from January 1988 to August 2008 were reviewed. TNM staging and Neves-Zincke grading of the tumor were also assessed. Surgical approach depended on thrombus level. RESULTS: With a perioperative mortality rate of 10.5% and a mean follow-up of 22.65 months (range 2-79), 5 patients are still alive, while 11 patients died from the disease, 1 from an unrelated cause, and 2 were lost to follow-up. Patients with metastatic disease received adjuvant treatment with immunotherapy or kinase inhibitors. Mean survival was 15.1 months. Significant differences were found in 3- and 5-year survival rates in patients staged as N0M0 as compared to all other stages (N+M0, N0M+, N+M+). No differences were found depending on thrombus level. CONCLUSIONS: RCC with thrombus in the IVC is a tumor with a high mortality rate. Surgery continues to be the best option, and requires adequate preoperative evaluation and the support of an experienced and well trained multidisciplinary team. Survival depends on disease extension.

Carcinoma de células renales con extensión a vena cava: puesta al día y revisión de nuestra casuística / Renal cell carcinoma with vena cava involvement: update and review of our series

Objetivo: Valorar la situación actual en el tratamiento del carcinoma renal con extensión a vena cava inferior (VCI): Clasificación, diagnóstico, abordaje quirúrgico, terapia adyuvante, factores de pronóstico y supervivencia. Materiales y Métodos: Se revisan 19 casos de carcinomas renales con extensión a VCI intervenidos entre enero de 1988 y agosto de 2008. Se valoran la edad, el sexo, lateralidad y función renal de los pacientes. Con respecto al tumor se valoran: estadio según TNM y la clasificación de Neves-Zincke. Se describe el abordaje quirúrgico según el nivel del trombo. Resultados: Con una tasa de mortalidad perioperatoria del 10.5% y una media de seguimiento de 22,65 meses (rango 2-79), sobreviven 5 pacientes; 11 han fallecido por la enfermedad; uno por otra causa y 2 se han perdido. Los pacientes metastásicos han recibido tratamiento adyuvante con Inmunoterapia o inhibidores de las kinasas. La supervivencia media es de 15,1 meses. Existen diferencias significativas a tres y cinco años en la supervivencia de los pacientes estadiados como N0M0 vs resto (N+M0, N0M+, N+M+). No hay diferencias en función del nivel del trombo. Conclusiones: El carcinoma renal con trombo en VCI es un tumor con alta mortalidad. El abordaje quirúrgico del mismo es la opción más valida y precisa una correcta valoración prequirúrgica y el apoyo de un equipo multidisciplinar preparado y con experiencia. La supervivencia depende de la extensión de la enfermedad (AU)

Objective: To assess current management of renal cell carcinoma (RCC) extending into the inferior vena cava (IVC): staging, diagnosis, surgical approach, adjuvant therapy, prognostic factors and survival rate. Materials and Methods: Nineteen cases of RCC extending into the IVC undergoing surgical resection from January 1988to August 2008 were reviewed. TNM staging and Neves-Zincke grading of the tumor were also assessed. Surgical approach depended on thrombus level. Results: With a perioperative mortality rate of 10.5% and a mean follow-up of 22.65 months (range 2-79), 5 patients are still alive, while 11 patients died from the disease, 1 from an unrelated cause, and 2 were lost to follow-up. Patients with metastatic disease received adjuvant treatment with immunotherapy or kinase inhibitors. Mean survival was 15.1 months. Significant differences were found in 3- and 5-year survival rates in patients staged as N0M0 as compared to all other stages (N+M0, N0M+, N+M+). No differences were found depending on thrombus level. Conclusions: RCC with thrombus in the IVC is a tumor with a high mortality rate. Surgery continues to be the best option, and requires adequate preoperative evaluation and the support of an experienced and well trained multidisciplinary team. Survival depends on disease extension (AU)