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PubMed2006

BPH: costs and treatment outcomes.

The current treatments for benign prostatic hyperplasia (BPH) include pharmacotherapy with alpha1-selective adrenergic receptor (a1-AR) antagonists, 5-alpha-reductase inhibitors (5-aRIs), and a range of invasive and minimally invasive interventions, each of which is effective in the amelioration of lower urinary tract symptoms (LUTS) and the prevention of symptom progression and BPH-related complications. Pharmacotherapy is considered the mainstay of treatment for LUTS caused by BPH. The available a1-AR antagonists have comparable efficacy for the relief of LUTS and to enhance patients' quality of life. The use of nonsubtype-selective drugs in this class may precipitate vasodilatory adverse events such as dizziness, somnolence, and orthostatic hypotension. Based on current studies, a1-AR antagonists are more cost effective (particularly the subtype-selective a1-AR antagonist, tamsulosin) than the 5-aRIs (eg, finasteride) and comparable in cost to transurethral resection of the prostate and minimally invasive therapies. There are few cost-effectiveness studies comparing the various pharmacologic interventions for BPH. Only 1 cost-analysis model has addressed the impact of adverse events on the cost effectiveness of pharmacotherapy for BPH. The publication of additional analyses would contribute to the appropriate selection of therapy in patients with BPH.

5-alpha Reductase Inhibitors↗
PubMedDate not supplied

Association between nonsteroidal anti-inflammatory drugs and prostate cancer occurrence.

UNLABELLED: Prostate cancer is the most common malignancy among men in Western nations. Previous studies indicate that nonsteroidal anti-inflammatory drugs have an inhibitory effect on prostate cancer cells. We evaluated the association between frequent use of nonsteroidal anti-inflammatory drugs and prostate cancer occurrence. METHODS: We conducted a nested case-control study using medical administrative databases. All men older than 65 years of age who had filled at least one prescription for nonselective nonsteroidal anti-inflammatory drugs, cyclooxygenase-2 inhibitors (coxibs), aspirin, or acetaminophen between January 1999 and December 2002 were eligible. Among this group, we identified men who underwent prostate biopsy between January 2000 and June 2002 and did not have a diagnosis of any cancer in the preceding 2-year period. Cases were those with a diagnosis of prostate cancer. Controls were those who did not receive a diagnosis of any cancer. Logistic regression models were used to determine associations between prostate cancer occurrence and frequent exposure (more than 4 months) to nonsteroidal anti-inflammatory drugs/cyclooxygenase-2 inhibitors or aspirin during the prior 2 years in comparison with no exposure to any of these drugs, adjusting for age and prior finasteride use. RESULTS: We identified 2025 cases and 2150 controls. Older men were at greater risk for developing prostate cancer. Exposure to nonsteroidal anti-inflammatory drugs/cyclooxygenase-2 inhibitors was associated with a reduced likelihood of prostate cancer (odds ratio [OR], 0.71; 95% confidence interval [CI], 0.58-0.86) as was exposure to aspirin (OR, 0.84; 95% CI, 0.74-0.96). DISCUSSION: Our results suggest that among men 65 years of age or older, frequent use of nonsteroidal anti-inflammatory drugs/cyclooxygenase-2 inhibitors and use of aspirin are associated with a reduced risk of prostate cancer.

Age Factors↗
PubMed2001

[Changes in treatment and cost of benign prostatic hyperplasia in Iceland.].

OBJECTIVE: During the last eight years there has been a dramatic change in the treatment of patients with benign prostatic hyperplasia (BPH) in Iceland. The number of transurethral resection of the prostate (TURP) has decreased while at the same time there has been a growing tendency to treat patients with a1-blockers and finasteride. The purpose of this study was to obtain statistical information regarding these changes and to estimate alterations in the cost of the BPH treatment. Possible changes in indications for TURP were also looked at. MATERIAL AND METHODS: Information on the number of patients who underwent surgery since 1984 was gathered from Icelandic hospitals. Information on the use and cost of medical treatment was obtained from the Icelandic Social Security. Medical records of 587 men who underwent surgery in the years 1988-1989 and 1998-1999 were reviewed. RESULTS: Since 1992 the number of TURP operations per year has dropped from its peak of about 560 to around 270 in 1999. This is more than a 50% reduction in eight years. The number of patients being treated for BPH has multiplied since the introduction of drugs and the total cost of BPH treatment has doubled since 1984. There was a trend but not a significant change in indications for TURP when the two periods were compared. CONCLUSIONS: Increasing number of Icelandic men with BPH are now recieving treatment although the number of TURP operations has decreased. The total cost of treatment has doubled since 1984, mainly attributed to the advent of medical treatment.

English Abstract↗
PubMed2006

Hormonal status of male reproductive system: androgens and estrogens in the testis and epididymis. In vivo and in vitro approaches.

The purpose of this article was to summarize our results on the role of androgens and estrogens in human, rodent and equine testes and epididymides, in both, physiological and patological conditions, obtained in the space of the Solicited Project (084/PO6/2002) financially supported by the State Committee for Scientific Research during the last three years. Testosterone produced by Leydig cells of the testes is clearly the major androgen in the circulation of men and adult males of most mammalian species. However, androgen metabolites make up a significant fraction of total circulating steroids. Moreover, androgen metabolism may proceed to amplify the action of testosterone through its conversion to dihydrotestosterone (DHT) or its aromatization to estradiol. The distribution of androgen and estrogen receptors (ARs and ERs) within male reproductive tissues is important because of their crucial role in mediating androgen and/or estrogen action. Attempts were undertaken to discuss not only the role of aromatase and ERs in mediating the action of estrogens in the male, but also the importance of DHT in hormonal regulation of the epididymis. In the latter, alterations caused by finasteride treatment and lead-induced oxidative stress are described. Male reproductive function of the testis and epididymis reflected by the alterations in enzymatic activity, distribution of steroid hormone receptors, differences in steroid hormone levels and altered gene expression of antioxidant enzymes are also discussed.

Androgens↗
PubMed2006

Chemopreventive trials in urologic cancer.

Cancer prevention uses natural, synthetic, or biological chemical agents to reverse, suppress, or prevent carcinogenic progression. Chemoprevention trials are based on the hypothesis that interruption of the biological process involved in carcinogenesis will inhibit this process and, in turn, reduce cancer incidence. Bladder cancer chemoprevention trials demonstrate conflicting findings. Dietary fat, soy protein, garlic, and selenium have been reported to possess anticancer properties in the bladder, but they still remain largely unstudied in vivo. Regarding prostate cancer, vitamin D deficiency was reported to increase risk for the disease, and sunlight exposure is inversely proportional to prostate cancer mortality. The Prostate Cancer Prevention Trial reported a 24.4% prostate cancer incidence with placebo, compared with 18.4% with finasteride, and a reduction of 24.8% over 7 years. Dutasteride, a dual inhibitor of type 1 and type 2 5alpha-reductase, is the subject of the Reduction by Dutasteride of Prostate Cancer Events trial. Results are awaited from that study.

Journal Article↗
PubMed2001

Saw Palmetto Berry as a Treatment for BPH.

Phytotherapeutic agents are often prescribed in Europe for the treatment of benign prostatic hyperplasia with lower urinary tract symptoms and are commonly used in the United States in over-the-counter preparations. Saw palmetto berry is the most popular of these agents, and in vitro some studies suggest that liposterolic extract of the plant has antiandrogenic effects that inhibit the type 1 and type 2 isoenzymes of 5alpha-reductase; however there are no clinical studies that show any decrease in serum dihydrotestosterone or prostate-specific antigen. Its efficacy in the treatment of lower urinary tract symptoms has not been conclusively proven. Clinical efficacy was suggested by a meta-analysis of Permixon, a formulation of saw palmetto, but the meta-analysis was done on suboptimal studies. One trial supports the equivalency of Permixon to finasteride in treating moderate to severe symptoms of benign prostatic hyperplasia, with less decrease in sexual function. However, without a control/placebo arm, the actual efficacy of the agents cannot be determined. Other than occasional gastrointestinal upset, no other side effects have been reported.

Journal Article↗
PubMed2004

5alpha-reductase: history and clinical importance.

The treatment of men with symptomatic benign prostatic hyperplasia (BPH) has shifted dramatically from surgery to drug therapy over the past decade. The revolution in BPH treatment began with the discovery of congenital 5alpha-reductase (5AR) deficiency, leading to the appreciation of 2 different androgenic hormones: testosterone, which mediates overt masculinization in the adult male, and dihydrotestosterone (DHT), which mediates prostatic growth, acne, facial beard, and male pattern baldness. Inhibition of DHT in adults results in prostatic shrinkage and symptomatic relief in many men, without the side effects seen with conventional androgen-deprivation therapy. The 5AR inhibitor drugs (finasteride and the dual inhibitor, dutasteride) are able to ablate the accumulation of intraprostatic DHT, the mechanism most responsible for prostate growth and maintenance. Not only may these drugs relieve symptoms, but they may also alter the natural history of the BPH process. Future indications for the 5ARI drugs could include chemoprevention of prostate cancer, prophylaxis of BPH-related complications, and treatment of BPH-associated hematuria.

Journal Article↗
PubMed2005

Acute urinary retention: risks and management.

Acute urinary retention (AUR) secondary to benign prostatic hyperplasia has in the past represented an immediate indication for surgery, and today most patients failing to void after an attempt at catheter removal still undergo surgery. The concept that this disease is in fact progressive in nature is slowly being accepted. Descriptive and analytical epidemiological data have shown that the incidence rate per 1000 person-years is less variable in the community than previously assumed; however, the risk is cumulative and increases with advancing age. The risk for patients diagnosed with benign prostatic hyperplasia is naturally higher, and analytical epidemiology has identified several strong risk factors, the most important one being serum prostate-specific antigen (PSA). In addition, prostate volume, maximum flow rate, and symptom severity should be considered when counseling patients presenting with lower urinary tract symptoms and clinical benign prostatic hyperplasia who are considering a course of watchful waiting. Efforts toward primary prevention of AUR should be directed to patients at increased risk, ie, those who are older and have more severe symptoms, larger glands, and higher PSA values. Risk reduction with finasteride has been demonstrated, and alpha-blockers have been shown to aid patients in achieving spontaneous voiding after an episode of AUR.

Journal Article↗
PubMed2002

The potential for prostate cancer chemoprevention.

The dramatic international variation in prostate cancer incidence and mortality rates suggests that changeable environmental factors exert an influence. This has prompted a search for ways to prevent the disease. Epidemiologic studies suggest that dietary factors such as the carotenoid lycopene, selenium, vitamin E, and high intake of fat have roles in prostate cancer risk. Several studies show that impairment of androgen synthesis lowers the risk of prostate cancer. 5-alpha-reductase inhibitors such as finasteride have been shown to decrease prostate size by decreasing androgenic stimulation to the prostate. Other promising, but less developed, interventions include vitamin D supplements and modification of diet. Any manipulation to decrease one's relative risk of prostate cancer will by necessity have to be given to a large proportion of men who would never develop prostate cancer even without the intervention. To be acceptable, a successful preventive intervention should have few or no side effects; some additional benefits would be useful. All potential preventive interventions will need to be rigorously evaluated before they can be advocated for prostate cancer prevention.

Journal Article↗
PubMed2006

Prevention, complementary therapies, and new scientific developments in the field of prostate cancer.

Prostate cancer prevention and therapies were reviewed in a recent update. Finasteride, a 5alpha reductase inhibitor, shows promise as a preventative; however, it may increase the incidence of high-grade cancer. There are ongoing studies regarding the positive effects of antioxidant therapy (vitamin E, selenium, and lycopene) on the prevention of prostate cancer; initial results are promising. Lipid-lowering drugs are associated with a statistically significant reduction in prostate cancer incidence, a 46% reduction in risk of high-grade or high-stage prostate cancer, and a 66% reduction in mortality from prostate cancer. Overexpression of transcription factors is caused by translocation of the promoter of the TMPRSS2 gene, which may be a primary event in prostate cancer. Immunomic profiling with use of autoantibodies directed against prostate-specific antigens may be used to identify cases of prostate cancer.

Journal Article↗
PubMed1994

New use for alpha blockers: benign prostatic hyperplasia.

Treatment with alpha 1-adrenergic blockers can be a reasonable alternative to surgery for patients with symptomatic benign prostatic hypertrophy. Alpha blockers may also be useful as an adjunct to finasteride in the treatment of this disorder. Pretreatment evaluation is essential to ensure that the patient does not have an infection, prostate cancer or another serious cause of the prostatic symptoms. The patient should be monitored for side effects, and the dosage should be increased slowly. Side effects can be minimized by administering the medication at night and reversed by discontinuing the drug. In more than 50 percent of patients, treatment with alpha blockers results in objective and subjective symptomatic relief.

Adrenergic alpha-Antagonists↗
PubMed1994

Cost effectiveness in the management of benign prostatic hyperplasia: Italian data.

Several works in literature demonstrate that in some countries the economic considerations are as important as the clinical aspects of a disease; economic evaluation may be of help for decision making. The exact cost of the diagnosis and treatment of benign prostatic hypertrophy (BPH) patients is difficult to estimate. The total number of males in Italy is 27,982,144 (1991 data). In the last year 2,200,000 patients have been treated for BPH in Italy (surgically and pharmacologically); the overall cost for the therapy of BPH exceeded 46 million dollars per year. Currently surgery represents the standard treatment of BPH. In the USA alone over 350,000 surgical procedures are performed annually. In USA the cost per TURP is 12,000 dollars. In Italy the minimum direct cost is 3681 dollars; in most cases, however, the cost per TURP is over 5000 dollars. It is estimated that about 80% of patients with micturion problems prefer an alternative treatment before surgery. In our country 4,338,000 diagnoses of BPH have been performed in 1991. The number of prescriptions for BPH has been 4,867,000 and the number of drugs per prescription 1.16. It may be of interest to compare costs associated with different pharmacological therapies for BPH. Considering the direct costs, it has been estimated that the cost of 1 year's treatment with finasteride is 1833 dollars, while that of 1 year with plant extracts is 1151 dollars. The existing literature is deficient in defining the cost related to the therapeutical options for BPH.(ABSTRACT TRUNCATED AT 250 WORDS)

Cost-Benefit Analysis↗
PubMed1994

Benign prostatic hyperplasia.

Benign prostatic hyperplasia (BPH) is the most common cause of bladder outlet obstruction and voiding symptoms in elderly men. The pathogenesis is not fully determined but a combination of androgens and age are needed for development of BPH. Symptoms of BPH are divided into obstructive and irritative symptoms but large interpersonal variability is found and no specific BPH symptom exists. Treatment modalities include surgery (TURP, TUIP, open prostatectomy, laser ablation, balloon dilatation, hyperthermia and thermotherapy, and urethral stents) and medical therapy. TURP is the gold standard treatment and TUIP is a safe and effective alternative to TURP in patients with smaller prostates. Laser ablation, hyperthermia and thermotherapy, and urethral stents are at the present time under investigation. Balloon dilatation is FDA-approved but not often used because of low efficacy and poor long-term results. Medical treatment includes alpha-blocker or finasteride treatment and is indicated in patients with moderate to severe symptoms of BPH without a strong indication for surgery.

Humans↗
PubMed1995

In vitro metabolism of tirilazad mesylate in male and female rats. Contribution of cytochrome P4502C11 and delta 4-5 alpha-reductase.

Tirilazad mesylate, a potent inhibitor of membrane lipid peroxidation in vitro, is under clinical development for the treatment of subarachnoid hemorrhage and head injury. In rat, tirilazad seems to be highly extracted and is cleared almost exclusively via hepatic elimination. The biotransformation of tirilazad has been investigated in liver microsomal preparations from adult male and female Sprague-Dawley rats. Tirilazad metabolism in male rat liver microsomes resulted in the formation of two primary metabolites: M1 and M2. In incubations with female rat liver microsomes, M2 was the only primary metabolite detected. Structural characterization of M1 and M2 by mass spectrometry demonstrated that M2 was formed by reduction of the delta 4-double bond in the steroid A-ring, whereas M1 arose from oxidative desaturation of one pyrrolidine ring. Further structural analysis of M2 by proton NMR demonstrated that reduction at C-5 had occurred by addition of hydrogen in the alpha-configuration. Using metabolic probes and antibodies specific to individual hepatic microsomal enzymes, CYP2C11 and 3-oxo-5 alpha-steroid:NADP+ delta 4-oxidoreductase (5 alpha-reductase) were identified as responsible for the formation of M1 and M2, respectively. The formation of M1 was inhibited by testosterone, nicotine, cimetidine, and anti-CYP2C11 IgG. The formation of M2 was inhibited by finasteride, a potent inhibitor of 5 alpha-reductase. Kinetic analysis of CYP2C11-mediated M1 formation in male rat liver microsomal incubations revealed that M1 formation occurred through a low-affinity/low-capacity process (KM = 16.67 microM, Vmax = 0.978 nmol/mg microsomal protein/min); the formation of M2 was mediated by 5 alpha-reductase in a high-affinity/low-capacity process (KM = 3.07 microM, Vmax = 1.06 nmol/mg microsomal protein/min). In contrast, the formation of M2 in female rat liver microsomes was mediated by 5 alpha-reductase in a high-affinity/high-capacity process (KM = 2.72 microM, Vmax = 4.11 nmol/mg microsomal protein/min). Comparison of calculated intrinsic formation clearances (Vmax/KM) for M1 and M2 indicated that the female rat possessed a greater in vitro metabolic capacity for tirilazad biotransformation than the male rat. Therefore, the clearance of tirilazad mesylate in the rat is mediated primarily by rat liver 5 alpha-reductase, and the capacity in the female rat is 5-fold the capacity in the male. These observations correlate with documented differences in 5 alpha-reductase activity and predict a gender difference in tirilazad hepatic clearance in vivo.

3-Oxo-5-alpha-Steroid 4-Dehydrogenase↗
PubMed1994

5-Alpha-reductase inhibition and prostate cancer prevention.

Studies of prostate biology support the concept that dihydrotestosterone is the principal androgen responsible for normal and hyperplastic growth of the prostate gland. Cancer is a process of malignant transformation evolving over time, involving cellular growth and division. Therefore, an altered endocrine state, such as suppression of dihydrotestosterone activity, may have an impact on prostate cells inhibiting carcinogenic transformation. In vitro and in vivo preclinical observations support this hypothesis. A placebo-controlled randomized trial using finasteride, an inhibitor of the enzyme that converts testosterone to dihydrotestosterone, is planned. The endpoint of this trial will be reduction of prostate cancer incidence.

3-Oxo-5-alpha-Steroid 4-Dehydrogenase↗
PubMedDate not supplied

Chemopreventive drug development: perspectives and progress.

Chemoprevention drug development has the goal of identifying safe and effective chemopreventive agents for clinical use. Several distinctive strategies are pursued in developing chemopreventive agents: (a) identifying and validating predysplastic and early dysplastic lesions that can be used instead of cancers as endpoints for measuring chemopreventive activity; (b) identifying and testing candidate agents based on considerations of mechanisms of action; (c) evaluating combinations of agents with potential for maximizing efficacy and minimizing toxicity; and (d) applying a systematic methodology for identifying and ranking candidate agents at each stage of development to ensure discovery of the best agents and most effective use of available resources. This article discusses 22 drugs and three drug combinations which have reached an advanced stage of development as chemopreventive agents. The first generation of drugs are the most advanced, now being in Phase II and Phase III clinical trials. These drugs include several retinoids [vitamin A, 13-cis-retinoic acid, all-trans-N-(4-hydroxyphenyl)retinamide], calcium, beta-carotene, tamoxifen, and finasteride. The second generation drugs are those in Phase I clinical trials. From most to least advanced, these drugs are 2-difluoromethylornithine, sulindac, piroxicam, oltipraz, N-acetyl-I-cysteine, aspirin, ibuprofen, carbenoxolone, 18 beta-glycyrrhetinic acid, and the combination of 2-difluoromethylornithine with piroxicam. The third generation includes agents with significant evidence of chemopreventive activity in animal models. These agents are now in preclinical toxicity testing. They are S-allyl-I-cysteine, phenhexyl isothiocyanate, curcumin, ellagic acid, fumaric acid, fluasterone, and the combinations of all-trans-N-(4-hydroxyphenyl)retinamide with oltipraz and all-trans-N-(4-hydroxyphenyl) retinamide with tamoxifen.

Animals↗
PubMed1995

Advances in the diagnosis and treatment of the hirsute patient.

Most patients with hirsutism demonstrate hyperandrogenemia, which may be caused by polycystic ovary syndrome, nonclassic congenital adrenal hyperplasia, insulin resistance and, occasionally, neoplasms. In this review, current methods of diagnosis and recent advances in the medical treatment of hirsutism and hyperandrogenemia are discussed, including the use of gonadotropin-releasing hormone analogs, flutamide, spironolactone, finasteride, and ketoconazole.

Hirsutism↗
PubMed1996

Histopathological effects of androgen deprivation in prostatic cancer.

Thanks to earlier detection of clinically significant prostatic adenocarcinoma by measurement of serum prostate-specific antigen (PSA) levels, increasing numbers of patients are undergoing radical prostatectomy. However, the curative potential of this procedure is seriously limited by clinical understaging, which results in positive surgical margins and a marked increase in disease progression. In a multicenter study, histopathologic evaluation of radical prostatectomy specimens showed that presurgical androgen deprivation with leuprolide plus flutamide reduced the incidence of surgical margin involvement by 62%. In patients who received androgen deprivation therapy, characteristic and recognizable histopathologic changes in nontumor glands included atrophy, basal cell prominence, vacuolated luminal cell layers, and squamous and transitional cell metaplasia. Androgen deprivation markedly reduced the incidence of prostatic intraepithelial neoplasia (PIN) to 35%. The effects of androgen deprivation on prostatic carcinoma included smaller tumor glands, pyknosis and empty glandular spaces, and vacuolization and degeneration of tumor cells with an inflammatory response. Similar but less pronounced changes with no decrease in PIN were observed in finasteride-treated patients. It is important for pathologists to be aware of these histological changes and process tissue appropriately, because the changes affect the recognition and histological grading of tumors in radical prostatectomy specimens.

Adenocarcinoma↗