AVODART SUMMARY
AVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT.
Monotherapy
AVODART® (dutasteride) Soft Gelatin Capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
- improve symptoms,
- reduce the risk of acute urinary retention (AUR), and
- reduce the risk of the need for BPH-related surgery.
Combination With Alpha Adrenergic Antagonist
AVODART in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
Limitations of Use
AVODART is not approved for the prevention of prostate cancer.
|
|
NEWS HIGHLIGHTSMedia Articles Related to Avodart (Dutasteride)
Benign Prostatic Hyperplasia (Enlarged Prostate) Quiz
Source: MedicineNet Benign Prostatic Hyperplasia Specialty [2017.09.20]
Title: Benign Prostatic Hyperplasia (Enlarged Prostate) Quiz
Category: MedicineNet Quiz
Created: 2/7/2012 3:29:00 PM
Last Editorial Review: 9/20/2017 12:17:12 PM
Enlarged Prostate (BPH, Benign Prostatic Hyperplasia)
Source: MedicineNet Blood In Urine Specialty [2017.05.18]
Title: Enlarged Prostate (BPH, Benign Prostatic Hyperplasia)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 5/18/2017 12:00:00 AM
Published Studies Related to Avodart (Dutasteride)
Systematic review evaluating cardiovascular events of the 5-alpha reductase
inhibitor - Dutasteride. [2013]
dutasteride for the prevention or treatment of prostatic disease... CONCLUSION: We did not find consistent evidence of a significant
Efficacy and safety of dutasteride in chinese adults with symptomatic benign prostatic hyperplasia: a randomized, double-blind, parallel-group, placebo-controlled study with an open-label extension. [2012.01.01]
Background: Dutasteride is a dual inhibitor of type I and type II 5alpha-reductases and provides nearly complete suppression of dihydrotestosterone, which plays a key role in the aetiology and development of benign prostatic hyperplasia (BPH). Most knowledge about the efficacy and safety of dutasteride in BPH derives from three pivotal phase III studies conducted primarily in Caucasian populations...
Dutasteride reduces prostatitis symptoms compared with placebo in men enrolled in the REDUCE study. [2011.10]
PURPOSE: Men at risk for prostate cancer may concurrently experience chronic prostatitis or pelvic pain. We evaluated the effect of dutasteride on prostatitis-like symptoms in the REDUCE study population... CONCLUSIONS: Long-term dutasteride therapy resulted in improvement in prostatitis related symptoms in older men with an increased prostate specific antigen. Copyright (c) 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
Dutasteride improves outcomes of benign prostatic hyperplasia when evaluated for prostate cancer risk reduction: secondary analysis of the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial. [2011.09]
OBJECTIVE: To investigate the effect of dutasteride versus placebo on the symptoms and associated complications of male lower urinary tract symptoms and benign prostatic hyperplasia (BPH) across a range of prostate volumes and BPH symptoms in men evaluated for prostate cancer risk reduction in the 4-year REduction by DUtasteride of prostate Cancer Events (REDUCE) trial... CONCLUSION: During the 4-year study, dutasteride was associated with a decreased risk of BPH progression in men with mild-to-moderate symptoms and normal or enlarged prostates. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Comparison of dutasteride and finasteride for treating benign prostatic hyperplasia: the Enlarged Prostate International Comparator Study (EPICS). [2011.08]
OBJECTIVE: * To assess the efficacy and safety of dutasteride compared with finasteride in treating men with symptomatic benign prostatic hyperplasia (BPH) for 12 months... CONCLUSION: * Dutasteride and finasteride, when administered for 12 months, were similarly effective in reducing prostate volume and improving Q(max) and urinary symptoms associated with BPH in men with an enlarged prostate. (c) 2011 THE AUTHORS. BJU INTERNATIONAL (c) 2011 BJU INTERNATIONAL.
Clinical Trials Related to Avodart (Dutasteride)
Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation [Completed]
Avodart (dutasteride) reduces the male hormone (DHT) that leads to prostate growth and
stimulates cancerous growth. Avodart is currently approved by the FDA to treat men with
symptoms of an enlarged prostate. Avodart works by reducing DHT and prostate size;
therefore, the drug may be useful in improving lower urinary tract symptoms (LUTS) such as
frequency, urgency, weak stream, and urination difficulty (dysuria), among others, in men
with prostate cancer. Avodart may be effective in men with prostate cancer who are being
treated with hormonal therapy with one injection of Zolodex (goserelin) followed one month
later with a trans-urethral incision of the prostate (TUIP), and three months after that,
seed implantation (SI) of the prostate.
The purpose of this study is to test whether Avodart (dutasteride) is effective on LUTS and
dysuria in men with localized prostate cancer being treated with single-dose goserelin,
TUIP, and interval SI.
Bioequivalence - Duodart Against Avodart & Omnic [Completed]
Open-label, randomized, single dose, two-treatment, two-way crossover study
Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males. [Completed]
This study aims to determine the relative bioavailability of tamsulosin hydrochloride in a
fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0. 5 mg/0. 2 mg)
relative to co-administration of dutasteride 0. 5 mg capsules and tamsulosin hydrochloride
0. 2 mg tablets or capsules. Two fixed dose combination capsules will be tested; one will
contain tamsulosin hydrochloride pellets with a 15% enteric coating, and the other
tamsulosin hydrochloride pellets with a 10% enteric coat. In addition, two formulations of
tamsulosin hydrochloride will be tested in the co-administration with dutasteride 0. 5 mg; a
0. 2 mg oral disintegrating tablet and a 0. 2 mg hard shell capsule. This will be an
open-label, randomized, single dose, four-period crossover in healthy male subjects of North
East Asian ancestry. Subjects will receive single oral doses in four treatment periods, each
separated by a 5-10 day washout period. Blood samples for pharmacokinetic analysis will be
taken at regular intervals after dosing. Safety will be assessed by measurement of blood
pressure, heart rate and review of adverse events. The study will enrol approximately 30
healthy male subjects to ensure that 24 complete the study.
AVODART® Alopecia Post-marketing Surveillance (PMS) [Completed]
Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H) [Completed]
The study is to determine the safety and efficacy of Dutasteride in patients who have failed
Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H).
Reports of Suspected Avodart (Dutasteride) Side Effects
Drug Ineffective (34),
Erectile Dysfunction (20),
Gynaecomastia (18),
Dizziness (16),
Prostate Cancer (16),
Prostatic Specific Antigen Increased (16),
Breast Tenderness (15),
Breast Enlargement (14),
Product Quality Issue (14),
Pruritus (13), more >>
|
PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Avodart has an overall score of 7.50. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Avodart review by 35 year old male patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Alopecia |
| Dosage & duration: | | .5mg taken daily for the period of 3 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Hair maintainance. Without finasteried or dutasteride patient experienced prickly heat on scalp. With treament, the prickly heat stopped. Had previously taken finasteride and hair had regrown to some extent. |
| Side effects: | | Erections were less frequent and not as firm. Patient seemed to think that his personality was somewhat affected as well, becoming more timid. |
| Comments: | | Take one pill daily in the morning. Seldom skipped dosage. |
|
| | Avodart review by 37 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | hair loss |
| Dosage & duration: | | 0.5 mg taken 5 x per week for the period of 4 yrs + |
| Other conditions: | | None |
| Other drugs taken: | | Minoxidil | | |
Reported Results |
| Benefits: | | The treatment stopped hair loss and caused some regrowth. Some loss of effectiveness (I beieve due to worsening of underlying condition), but adding a topical solution corrected this. |
| Side effects: | | Difficult to know. May have been slight reduction in libido, and occasional mild depression/anxiety, but not sure about these. |
| Comments: | | 0.5mg taken 5 x per week in the morning. Started taking avodart but then moved onto generic ('Dutas') with no change in effectiveness. |
|
|
|
Page last updated: 2017-09-20
|
