Of the 6,458 year 2 and 4,777 year 4 biopsies, 26 biopsies reflecting 13 sample handling errors at year 2 (0.4%) and one biopsy reflecting one sample handling error at year 4 (0.02%) were confirmed to be mismatched to the patient for whom they were originally submitted. Of 6,733 reference blood samples profiled, 31 (0.5%) were found to be mismatched to the patient's verified identity profile. Sample identification errors occurred at local research sites and central laboratories.
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Phosphodiesterase type 5 inhibitor was not associated with prostate cancer diagnosis (OR 0.90, 95% CI 0.68-1.20, p = 0.476), low grade disease (OR 0.93, 95% CI 0.67-1.27, p = 0.632) or high grade disease (OR 0.85, 95% CI 0.51-1.39, p = 0.508). An inverse trend was seen between phosphodiesterase type 5 inhibitor and prostate cancer diagnosis in North American men but this was not statistically significant (OR 0.67, 95% CI 0.42-1.07, p = 0.091).
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Most men who live to middle age and beyond will ultimately develop lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), and many will also experience sexual dysfunction. Clinical studies indicate that most patients will experience improvement in BPH-related LUTS with alpha-adrenergic blockade or 5alpha-reductase inhibition. Recent studies suggest that alpha-blockers and 5alpha-reductase inhibitors may help to slow the progression of LUTS; 5alpha-reductase inhibitors reduce the need for surgery and complications, such as acute urinary retention. Third-generation alpha-blockers (alfuzosin, tamsulosin) are infrequently associated with cardiovascular side effects, in contrast to their predecessors (doxazosin, terazosin, prazosin). This may provide an advantage for consideration as firstline therapy. alpha-Blocker therapy may also improve sexual functioning, with the exception of ejaculation disorders, predominantly associated with subtypeselective alpha-blockers. By contrast, 5alpha-reductase inhibition is not recommended for men without demonstrable prostatic enlargement, may be associated with a long delay between treatment initiation and LUTS improvement, and is clearly associated with sexual side effects, including decreased libido, ejaculatory dysfunction, and erectile dysfunction. When choosing appropriate pharmacotherapy, the clinician should consider not only the expeditious relief of the presenting symptoms but also the patient's quality of life, including sexual function and potential long-term outcomes, such as acute urinary retention and the need for surgical intervention.
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Although the etiology of lower urinary tract symptoms (LUTS) is often multifactorial, a significant proportion of men over the age of 50 suffer from benign prostatic obstruction (BPO) secondary to benign prostatic hyperplasia. Prostate, being an androgen responsive organ is dependent on the male sex hormone, testosterone, for growth. Thus, treatment strategies that manipulate the levels of circulating hormones that influence the level of testosterone and/or prostatic growth represent an important potential option for patients suffering with troublesome LUTS due to BPO. Despite this, the only hormonal treatment that is currently used in daily clinical practice is the 5-alpha reductase inhibitor. In this article, we review the current evidence on the use of the 5-alpha reductase inhibitors finasteride and dutasteride. We also discuss new emerging hormonal manipulation strategies for patients with LUTS secondary to BPO.
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The meta-analysis demonstrated that in a population with symptomatic BPH and/or at increased risk of prostate cancer, a statistically significant lower number of detectable prostate cancers was found in men taking dutasteride compared to control groups (MHRR: 0.66, 95% CI 0.52-0.85). In our analysis, there was no increased risk for Gleason 7-10 (MHRR: 0.83, 95% CI 0.56-1.21) or Gleason 8-10 prostate cancers (MHRR: 0.99, 95% CI 0.39-2.53) in men taking dutasteride over control groups. There were several limitations that need to be considered when interpreting these results.
Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery. Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression. Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr. Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies, with the exception of an imbalance in the composite term of cardiac failure among the three study arms. The lack of placebo control is a study limitation.
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Knowledge of baseline factors that influence outcomes for men with benign prostatic hyperplasia (BPH) receiving medical therapy may help to improve outcomes and cost effectiveness.
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This is a prospective, placebo-controlled, randomized, double-blind study. A total of 59 patients were randomized to either dutasteride 0.5 mg or placebo for 3 months before and 12 months after PV. Surgical time, joules used, estimated blood loss, and ease of the procedure were compared. Other clinical end points investigated include postsurgical catheter time, hematuria, dysuria, urinary flow parameters, American Urological Association symptom score, benign prostatic hyperplasia quality of life score, prostate volume, and prostate-specific antigen level.
To assess the association between use of 5-alpha reductase inhibitors (eg, finasteride) for BPH and occurrence of hip fracture.
To further investigate the mechanisms of erectile dysfunction (ED) related to 5ARI therapy using a rat model.
Dutasteride is a new 5-alpha reductase inhibitor for the treatment of men with moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia. It has been available in the UK since March 2003. It is a competitive inhibitor of both type I and type II isoforms of the 5-alpha reductase enzyme that converts testosterone to the more potent androgen, dihydrotestosterone. Randomised controlled studies have shown dutasteride to be statistically more effective than placebo in reducing lower urinary tract symptoms and increasing maximum urinary flow rates. This is a consequence of a reduction in serum dihydrotestosterone and hormone dependent prostate volume. Dutasteride has also been shown to decrease the absolute risk of urinary retention and the need for prostate-related surgery when compared to placebo taken over a 24-month period. In this review article we discuss the pharmacology and clinical effects of dutasteride, a new dual-acting 5-alpha reductase inhibitor.
We identified 339 breast cancer cases matched to 6,780 controls. No statistically significant associations were observed between 5α-reductase inhibitors and breast cancer regardless of exposure assessment before the index date (1 year or more-RR 0.70, 95% CI 0.34-1.45; 2 years or more-RR 0.59, 95% CI 0.24-1.48; or 3 years or more-RR 0.75, 95% CI 0.27-2.10). Each subsequent 180 days (RR 1.02, 95% CI 0.67-1.53) and 365 days (RR 1.03, 95% CI 0.45-2.37) of cumulative 5α-reductase inhibitor therapy and period specific rate ratios also showed null associations.
AE data reported from available trials were summarized and reviewed.