Rapaflo (Silodosin) - Summary

RAPAFLO SUMMARY

RAPAFLO is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors.

RAPAFLO, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [ see Clinical Studies ]. RAPAFLO is not indicated for the treatment of hypertension.

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NEWS HIGHLIGHTS

Published Studies Related to Rapaflo (Silodosin)

A pooled analysis of individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). [2014]
comparing silodosin and placebo... CONCLUSIONS: Silodosin is an effective treatment for male lower urinary tract

Comparison of prophylactic naftopidil, tamsulosin, and silodosin for 125I brachytherapy-induced lower urinary tract symptoms in patients with prostate cancer: randomized controlled trial. [2011.11.15]
CONCLUSIONS: Silodosin has a greater impact on improving PI-induced lower urinary tract symptoms than the other two agents. Copyright (c) 2011 Elsevier Inc. All rights reserved.

Silodosin for men with chronic prostatitis/chronic pelvic pain syndrome: results of a phase II multicenter, double-blind, placebo controlled study. [2011.07]
PURPOSE: We evaluated the efficacy and safety of 2 doses of silodosin vs placebo in men with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome who had not been treated previously with alpha-blockers for chronic prostatitis/chronic pelvic pain syndrome... CONCLUSIONS: Silodosin 4 mg relieved symptoms and improved quality of life in men with chronic prostatitis/chronic pelvic pain syndrome but its efficacy requires confirmation in additional studies. Copyright (c) 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH. [2011.06]
Data from phase 3 studies (NCT00224107, NCT00224120) of silodosin for treatment of BPH symptoms were analyzed to examine the relationship between treatment efficacy and occurrence of abnormal ejaculation. Men aged >/=50 years with International Prostate Symptom Scores (IPSS) >/=13 and peak urinary flow rates (Qmax) of 4-15 ml s(-1) received placebo or silodosin 8 mg once daily for 12 weeks...

Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe. [2011.03]
BACKGROUND: Silodosin is a new selective therapy with a high pharmacologic selectivity for the alpha(1A)-adrenoreceptor. OBJECTIVE: Our aim was to test silodosin's superiority to placebo and noninferiority to tamsulosin and discuss the findings in the context of a comprehensive literature review of the new compound silodosin... CONCLUSIONS: Silodosin is an effective and well-tolerated treatment for the relief of both voiding and storage symptoms in patients with lower urinary tract symptoms suggestive of bladder outlet obstruction thought to be associated with benign prostatic hyperplasia. Its overall efficacy is not inferior to tamsulosin. Only silodosin showed a significant effect on nocturia over placebo. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00359905. Copyright (c) 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.

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Clinical Trials Related to Rapaflo (Silodosin)

Comparative Study of Use of Alpha-Blockers to Treat Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy [Not yet recruiting]
Approximately 50%-95% of prostate cancer patients undergoing radiation therapy (RT) develop symptomatic urinary problems .These symptoms can significantly diminish a patient's quality of life during and shortly after therapy. Alpha1-blockers, such as Rapaflo, act to decrease resistance to urinary flow. This multi-institutional phase III trial is designed to compare standard of care versus preventive treatment with Rapaflo for prostate cancer patients, regardless of risk group, whose treatment consists of radical radiation therapy. We plan to recruit 188 patients across Quebec who will be randomized into two arms: rapaflo prescribed at start of radiation therapy or if/when symptoms appear.

Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome. [Completed]
The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.

Silodosin Versus Tamsulosin for Treatment of Ureteral Stones [Terminated]
Ureteral calculi, commonly known as kidney stones, are a frequent cause of Emergency Department (ED) visits. These stones can get caught in the ureter (the tube connecting the kidney to the bladder) and cause symptoms including pain, nausea, and vomiting. As long as the obstructing stone meets certain conditions and the patient isn't too sick, the patient is usually sent home to try and pass the stone without surgery. This treatment is known as medical expulsive therapy (MET), and routinely involves the use of a drug called tamsulosin, which relaxes the smooth muscle of the urinary system to help the stone pass. Silodosin is a drug in the same class of tamsulosin, but which is thought to have a more selective action and a quicker onset, which would theoretically make it better for aiding in kidney stone passage. The purpose of this study is a head-to-head, blinded comparison of these two drugs to see how quickly they result in stone passage. Subjects are patients presenting to the ED with acute kidney stone shown by CT scan, and who are appropriate for MET. The main study intervention is randomization to receiving either tamsulosin or silodosin. The hypothesis is that silodosin will have decreased time to stone passage compared to tamsulosin. Subjects who qualify and consent are randomized to a two-week course of either silodosin or tamsulosin. They are also given prescriptions for standard of care medications for pain and nausea, as well as a pain diary. They receive a follow-up phone call after one week to remind them of their follow-up appointment, ask about adverse events, and determine if their stone has passed. They have a follow-up visit with study staff at the end of their two week treatment to collect their pain diary, pill count, adverse events, and to determine if their stone has passed. Study participation ends after this follow-up visit.

Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia [Completed]
The purpose of this study is to confirm in a larger population in Europe the effectiveness and safety observed with silodosin in previous clinical trials.

A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia [Completed]
Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

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Reports of Suspected Rapaflo (Silodosin) Side Effects

Loss of Consciousness (17),  Death (10),  Dizziness (9),  Syncope (9),  Liver Disorder (5),  Dyspnoea (5),  Sudden Hearing Loss (4),  Fall (4),  Diarrhoea (4),  Tachycardia (3), more >>