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Product Monograph of Avodart dutasteride. GlaxoSmithKline Inc. September Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 dutasteride in men with benign prostatic hyperplasia. Urology ; Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5-alpha-reductase inhibitor dutasteride. Eur Urol ; Improvements in benign prostatic hyperplasia-specific quality of life with dutasteride, the novel dual 5-alpha-reductase inhibitor.
BJU International ; AUA guideline on management of benign prostatic hyperplasia Chapter 1: Diagnosis and treatment recommendations. J Urol ; Summary of outcomes with dutasteride for the treatment of benign prostatic hyperplasia BPH ; safety and tolerability. These studies show that the incidence of general adverse events with dutasteride was similar to that with placebo. The exception was an elevated incidence of sexually-related adverse events which were seen more commonly with dutasteride in the first 6 months of treatment compared with placebo; impotence 4.
The incidence of these events except impotence, 1. The adverse event profile with clinically used doses of dutasteride 0. Medical treatment for BPH requires lifetime medication. In comparison, surgery is generally a one-off event which can be costly due to the requirement for a stay in the hospital.
Data obtained with dutasteride have provided evidence that indicates both surgery and AUR can be avoided. At the very least the patient will present in pain with the inability to urinate and will probably require catheterization in the emergency room. Follow-up visits, catheter removal, and then surgery are the likely costly sequelae of AUR. Clearly a treatment that ultimately avoids, rather than just delays, the need for managing AUR and surgery can have important implications in resource utilization.
Hospital resources are under greater pressure as the population ages and so any treatment that can reduce this burden is appealing. Although dutasteride is effective in reducing the signs and symptoms of BPH there is a delay in the onset of statistically significant symptom relief of at least 3 months Roehrborn et al.
This delay may be reduced by the short-term combination of dutasteride with an alfa blocker. So far only the effects of combining tamsulosin with dutasteride have been reported Barkin et al. Nevertheless it is possible that other alfa blockers may be used in combination. For example, doxazosin has been used in combination with finasteride for the generation of rapid symptom relief. The AUA guidelines note that the combination of an alfa blocker and a 5ARI is an appropriate and effective treatment for patients with LUTS associated with demonstrable prostatic enlargement Roehrborn et al.
The optimal period for continuing with an alfa blocker in combination therapy is unclear. Whether it can be withdrawn after short-term symptom relief has been achieved or continued treatment is necessary remains to be determined. It is also unclear as to whether or not combination therapy would lead to improved compliance with drug treatment due to patients perceiving improvements in treatment effects.
Dutasteride and finasteride have been recommended as appropriate and effective treatments for patients with LUTS associated with demonstrable prostatic enlargement Roehrborn et al. This is because they affect the natural history of the disease and affect its progression by limiting prostate enlargement. The benefits of this may be seen in the reduced occurrence of AUR and avoidance of surgery. Because 5ARIs are not as effective as alfa blockers and have a slower onset of action for symptom relief they are not recommended for the treatment of LUTS alone in men with no prostatic enlargement.
In this case alfa blockers are an appropriate treatment option to manage troublesome symptoms through the dynamic component of bladder outlet obstruction. In addition to the demonstrable presence of an enlarged prostate gland other factors may influence the choice of dutasteride for the treatment of BPH for specific patient groups. Younger patients with moderate or severe BPH may wish to avoid surgery yet achieve symptom relief.
Avoidance of troublesome side effects and the maintenance of libido and sexual function are also factors which will influence the choice of appropriate therapy.
It is contraindicated for use in women and children and for patients with known hypersensitivity to dutasteride, other 5ARIs, or any component of the preparation. The recommended dose is one capsule 0. There is now a range of options for the treatment of BPH, including watchful waiting through to medical treatments, minimally invasive therapies, and surgery. Men with mild BPH symptoms as determined by AUA-SI that are not bothersome may undergo watchful waiting in order to monitor any change in the condition.
If there is progression to moderate or severe symptoms then any of the current treatment options may be considered. However, it is important for the physician and patient to discuss the various options together so that an appropriate treatment may be selected. During clinical development, dutasteride has been shown to improve BPH symptoms and is also well tolerated.
These observational studies have extended the findings that dutasteride reduces the risk of the most serious complications associated with BPH, i.
AUR and the need for surgery. This is achieved by dutasteride altering the natural history of BPH progression through significant reductions in prostate volume achieved by rapid and near maximal suppression of circulating DHT levels.
Because dutasteride acts on the static component of bladder outlet obstruction, there is a delay in onset of symptom relief of up to 6 months. The combination of dutasteride and an alfa blocker tamsulosin has overcome this delay while limiting disease progression.
Clearly this approach has advantages in the management of BPH. Recent treatment guidelines have used these findings to recommend that combination therapy with 5ARIs and alfa blockers are more beneficial than monotherapy Roehrborn et al.
In conclusion, dutasteride has a place in therapy for those patients with a demonstrable prostate enlargement and the presence of LUTS. For rapid symptom relief, combination with an alfa blocker may be appropriate. There is strong evidence that dutasteride has a positive effect not only on disease-oriented outcomes e. National Center for Biotechnology Information , U.
Journal List Core Evid v. Core Evid. Andrew Thomson. Author information Copyright and License information Disclaimer.
All rights reserved. This article has been cited by other articles in PMC. Aims: The objective of this article is to review the evidence for the treatment of BPH with dutasteride. Clinical value: In conclusion, dutasteride is a valuable treatment option in men with moderate to severe BPH. Keywords: dutasteride, evidence-based review, benign prostatic hyperplasia BPH , 5-alfa-reductase inhibitor.
Core evidence clinical impact summary for dutasteride in benign prostatic hyperplasia. Outcome measure Evidence Implications Patient-oriented evidence Detectable symptom relief Substantial Effective treatment; delay in onset of action may be reduced by short-term combination with an alfa blocker Avoidance of surgery Clear Avoidance of one of the most costly complications associated with the progression of benign prostatic hyperplasia Reducing the risk of acute urinary retention Clear Avoidance of a serious acute complication of benign prostatic hyperplasia which requires prompt medical intervention Tolerability Substantial Adverse events are few and reversible.
Open in a separate window. Scope, aims, and objectives Benign prostatic hyperplasia BPH is a common condition in older men. Methods Medical literature databases were searched for appropriate articles relating to dutasteride for the treatment of BPH. Table 1 Evidence base included in the review. Disease overview BPH is a common age-related condition in men.
Diagnosis of BPH An early accurate diagnosis of BPH is important for determining the most appropriate treatment option and maximizing the treatment outcomes. Symptom score Symptom severity 0—7 Mild 8—19 Moderate 20—35 Severe. Table 3 Summary of medical options for the treatment of benign prostatic hyperplasia. Medical therapy Medical therapies can provide significant relief from symptoms with less trauma compared with surgical treatment. Surgical treatment The most well-established treatment option for BPH is surgery.
Table 4 Summary of outcomes with dutasteride for the treatment of benign prostatic hyperplasia BPH ; avoidance of BPH-related surgical interventions and episodes of acute urinary retention AUR. Symptom relief There is evidence from pooled data from three studies that dutasteride provides relief from the symptoms of BPH Table 5.
Table 5 Summary of outcomes with dutasteride for the treatment of benign prostatic hyperplasia BPH ; effect on BPH symptoms and uroflowmetry. Reduction in androgen levels and prostate gland size There is good evidence that dutasteride reduces the disease-oriented outcome of prostate volume in men with BPH, as measured by total prostate volume TPV and transition zone volume TZV Table 6. Table 6 Summary of outcomes with dutasteride for the treatment of benign prostatic hyperplasia BPH ; effect on prostate size and androgen levels.
Table 7 Summary of the outcomes associated with dutasteride and prostate-specific antigen PSA. Safety and tolerability Results from observational studies provide good evidence of the safety and tolerability of dutasteride in a large number of patients treated over a long period of up to 4 years Roehrborn et al. Table 8 Summary of outcomes with dutasteride for the treatment of benign prostatic hyperplasia BPH ; safety and tolerability. Resource utilization Medical treatment for BPH requires lifetime medication.
Clinical value There is now a range of options for the treatment of BPH, including watchful waiting through to medical treatments, minimally invasive therapies, and surgery. Eur Urol. Treatment with finasteride preserves usefulness of prostate-specific antigen in the detection of prostate cancer: results of a randomized, double-blind, placebo-controlled clinical trial. J Urol. The impact of dutasteride, a novel dual 5a-reductase inhibitor, on both serum and intraprostatic androgens.
Eur Urol Suppl. Dutasteride provides sustained symptom relief following short term combination treatment with tamsulosin. Benign prostatic hyperplasia specific health measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients?
Progression and outcomes. Effect of dutasteride on the risk of acute urinary retention and the need for surgical treatment. Early use of dutasteride arrests prostate growth, improves clinical parameters and prevents complications in men with benign prostatic hyperplasia. Unique preclinical characteristics of GG, a potent dual inhibitor of 5AR. J Pharm Exp Ther. Effect of maximal dihydrotestosterone suppression with dutasteride on sexual function and gynecomastia. J Clin Endocrinol Metab. Long-term risk of retreatment of patients using alpha-blockers for lower urinary tract symptoms.
Benign prostatic hyperplasia: where do we stand in the new millennium. Curr Opin Urol. Managing benign prostatic hyperplasia.
Am Fam Phys. Abstract U A prospective, comparative study of the onset of symptomatic benefit of dutasteride versus finasteride in men with benign prostatic hyperplasia in everyday clinical practice.
Rev Urol. EAU guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction BPH guidelines Eur Urol.
The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia.
N Engl J Med. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. BJU Int. Benign prostatic hyperplasia: medical and minimally invasive treatment options. The management of men with acute urinary retention. Br J Urol. The epidemiology of acute urinary retention in benign prostatic hyperplasia. Clinical predictors of spontaneous acute urinary retention in men with LUTS and clinical BPH: a comprehensive analysis of the pooled placebo groups of several large clinical trials.
Effect of the dual 5 alpha-reductase inhibitor dutasteride on endocrine parameters and prostate volume. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 dutasteride in men with benign prostatic hyperplasia. Dutasteride provides sustained and continued improvement in BPH-related symptoms over 4 years. The utility of serial PSA measurements for the diagnosis of prostate cancer is preserved in men treated with the dual 5-alpha reductase inhibitor dutasteride.
Efficacy and safety of dutasteride in the four-year treatment of men with benign prostatic hyperplasia. Long-term dutasteride therapy results in sustained reductions in total prostate volume in men with symptomatic benign prostatic hyperplasia. Eliciting preferences for drug treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia.
Minimally invasive therapies for benign prostatic hyperplasia in the new millennium: long-term data. Articles from Core Evidence are provided here courtesy of Dove Press. Support Center Support Center. External link. Please review our privacy policy. Effective treatment; delay in onset of action may be reduced by short-term combination with an alfa blocker. Avoidance of one of the most costly complications associated with the progression of benign prostatic hyperplasia.
Avoidance of a serious acute complication of benign prostatic hyperplasia which requires prompt medical intervention. Adverse events are few and reversible. Fundamental outcome in treating the disease rather than just providing symptomatic relief. Reduced levels of the principal androgen responsible for prostatic growth.
Risk of dizziness, postural hypotension, and abnormal ejaculation. No effect on PSA Titration required at start of therapy. Rapid symptom relief Low acquisition cost. Risk of abnormal ejaculation High acquisition cost. Gradual onset of action Reversible impotence; decreased libido and ejaculation. Reduces PSA levels prostate cancer detection unaffected Generally well tolerated.
Roehrborn et al. Boyle et al. Debruyne et al. Emberton Clinically relevant improvement in BPH health status from 6 mo. Improvement of 2.
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