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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)

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.

A randomized crossover study comparing patient preference for tamsulosin and silodosin in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia. [2011]
Patient preference for benign prostatic hyperplasia (BPH) treatment with the alpha(1)-blockers, tamsulosin or silodosin, was compared using patient-reported outcomes. Japanese patients with lower urinary tract symptoms associated with BPH were randomly allocated to either the T-S group (tamsulosin 0.2 mg orally once daily for 4 weeks then silodosin 4 mg orally twice daily for 4 weeks) or the S-T group (silodosin 4 mg orally twice daily for 4 weeks then tamsulosin 0.2 mg orally once daily for 4 weeks)...

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Clinical Trials Related to Rapaflo (Silodosin)

A Dose-finding Study of Silodosin in Patients With Urinary Calculi [Recruiting]

Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy [Not yet recruiting]
Tamsulosin is an alpha blocker usually prescribed for urinary complaints that has been shown to have some benefit in allowing kidney stones to pass through the ureter. Silodosin is a new alpha blocker that acts more rapidly than tamsulosin and has been shown to have specific receptors on the ureter. The investigators would like to see if there is some benefit to taking silodosin over tamsulosin after extra-corporeal shock wave lithotripsy (ESWL) to break kidney stones in terms of allowing the ureteral fragments to pass through the ureter. Our hypothesis is that silodosin will be at least as effective as tamsulosin in terms of allowing stones to pass, but may allow them to pass more quickly because of the rapid onset of action.

The side effect profile for both drugs is quite similar and tolerable. Patients may experience some common side effects associated with tamsulosin, including abnormal ejaculation, dizziness, rhinitis (runny nose, sneezing), and somnolence (sleepiness). Serious reactions include orthostatic hypotension, syncope (fainting), and priapism (prolonged undesired erection).

Patients may experience some common side effects with both silodosin and tamsulosin including ejaculatory dysfunction, dizziness, postural hypotension, diarrhea, and headache. Serious side effects are rare and include orthostatic hypotension, intra-operative floppy iris syndrome, syncope, and priapism.

Patients will experience the discomfort normally associated with kidney stones. All efforts will be made to alleviate these discomforts, including the use of the study medications. Patients will be able to take their routine prescribed pain medications, and will be asked to keep a record of their pain medication use.

The investigators will be randomly enrolling patients from all racial backgrounds and of both genders. They must have kidney stones ranging in size from 4mm to 1. 0 cm and have no prior treatment for the study.

The primary endpoint of this study is the clearance rate of kidney stones. That is, in what period of time does the patient achieve clearance, is stone free and has all residual stones gone. The secondary endpoints of this study include analgesic use, residual stones remaining, need for re-treatment, need for intervention, steinstrasse clearance, and the need for hospitalization.

Study of Silodosin to Facilitate Passage of Urinary Stones [Recruiting]
The purpose of this study is to assess if patients treated with sildosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.

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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 >>


Page last updated: 2011-12-09

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