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Prostatodynia is a clinical entity associated with voiding symptoms and pelvic pain suggestive of prostatitis but with a normal prostate examination and without evidence of inflammation or infection in expressed prostatic secretions. The problem tends to be chronic and is vexing in its management. Although thought to be a common condition, prevalence data are generally lacking. From June to October 1995, the U.S. Army's 86th Combat Support Hospital provided medical support to a multinational United Nations peacekeeping force in Haiti. Patients diagnosed with prostatodynia were more common (13 cases) than men with other urologic problems (urolithiasis, 6 cases; urinary tract infection, 6 cases; scrotal abscess/mass, 2 cases; epididymitis, 1 case). Patients tended to be young (mean age 29.8), had multiple visits, failed to respond to multiple courses of antibiotics for presumed "prostatitis," and denied recent sexual relations. Some patients reported having had similar symptoms on prolonged separation from their spouses in the past that resolved with resumption of normal intercourse. Masturbation, however, had no impact on symptoms and was painful in some individuals. Terazosin, an alpha-antagonist, and stress-reduction therapy led to improvement in some patients' symptoms. A discussion of these retrospective findings in light of what is known about the possible etiologies and treatment of prostatodynia is presented. Prostatodynia appears to be a common problem in deployed troops and can lead to frequent use of medical services. Physicians supporting long deployments need to be aware of this entity.
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The development of finasteride (PROSCAR, Merck & Co., Whitehouse Station, NJ) for the treatment of benign prostatic hyperplasia (BPH) has had variable results. Numerous short-term and long-term studies comparing finasteride with placebo have been reported. The results suggest that, physiologically, treatment with finasteride significantly decreases levels of both serum and intraprostatic dihydrotestosterone about 70% to 80% from baseline. In addition, total gland size decreases significantly-about 15% to 25% from baseline-particularly in the area of the periurethral zone of the prostate after finasteride treatment. Baseline prostate size has been found to have a relation to efficacy of finasteride treatment. The larger the prostate at baseline, the greater the urinary flow rate increase and symptom score decrease compared with placebo. Health-related quality-of-life parameters improved in those taking finasteride. In studies evaluating combination therapy, no significant differences were noted between those treated with an alpha blocker, such as terazosin or doxazosin in combination with finasteride, and those receiving an alpha blocker alone. Long-term finasteride versus placebo studies, such as the PROSCAR Long-Term Efficacy and Safety Study (PLESS), suggest that long-term medical therapy with finasteride affects the natural history of the disease as manifested by the decrease in rates of acute urinary retention and surgery. In patients who are "therapeutic responders," the degree of symptomatic improvement in those treated with finasteride appears to be equal to that seen in patients receiving alpha blockers. Prostate cancer detection rates did not differ between those treated with finasteride and those receiving a placebo. The results of these studies suggest that physicians must evaluate what role finasteride plays in the spectrum of available options for the treatment of BPH and lower urinary tract symptoms. Baseline parameters, such as prostate volume, prostate-specific antigen values, and whether to administer finasteride in combination with alpha blockers, are among the factors that will determine the appropriateness of such therapy.
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Chi-square test was used to determine the statistical significance of resolution of upper tract stasis. Student's t test for 2-paired samples was used to evaluate whether urodynamic parameters differed significantly before and after treatment with alpha1-blockers.
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Pharmacologic strategies for the treatment of BPH are at present directed toward relaxing prostate smooth muscle and reducing prostate volume. Historically, the primary limitation of pharmacotherapy for BPH has been that the symptomatic improvement achieved was overshadowed by the morbidity of treatment. However, the morbidity has been markedly diminished based on a more precise understanding of the embryology, physiology, and pharmacology of the prostate. The origins and pharmacologic properties of the smooth musculature of the prostate and bladder are unique. Therefore, drugs such as alpha blockers may relax the prostate selectively without altering bladder function. Although phenoxybenzamine, a nonselective alpha blocker, relieves infravesical obstruction secondary to BPH, the severity of the adverse reactions limits the use of this drug. The contractile properties of the prostate smooth muscle are mediated by alpha-1 adrenoceptors. The effectiveness of phenoxybenzamine and selective alpha-1 blockers such as prazosin and terazosin are similar. The side effects of the selective alpha-1 blockers are negligible. Androgen suppression, which lowers testosterone, produces intolerable side effects such as gynecomastia, erectile dysfunction, and impaired libido. The androgen dependency of the prostate provides the rationale for using 5 alpha-reductase inhibitors for the treatment of BPH. Reduction of prostate volume can be achieved by blocking the action or synthesis of dihydrotestosterone without impotence, gynecomastia, and hot flashes. These recent advances in pharmacotherapy for BPH are based on understanding of the fundamental developmental properties of the prostate.
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Reversal of left ventricular (LV) hypertrophy is an important goal of antihypertensive therapy. This phase 3b study compared the ability of the angiotensin receptor blocker olmesartan medoxomil with the calcium channel blocker amlodipine besylate to induce regression of LV hypertrophy and vascular hypertrophy after achieving blood pressure (BP) goal. After a washout phase, 102 patients with hypertension and LV hypertrophy were randomized to olmesartan medoxomil 20 mg/day, up titrated to 40 mg/day, or amlodipine 5 mg/day, up titrated to 10 mg/day, for up to 4 weeks until a BP goal of <140/90 mm Hg (<130/85 mm Hg for diabetes) was achieved (hydrochlorothiazide 25 mg/day and terazosin 1 to 5 mg/day 2 times/day could be added if needed). Upon achieving the BP goal or by week 8, and again at weeks 26 and 52, assessments of LV mass and compliance and arterial structure and function were performed by echocardiography, Doppler flow, and arterial ultrasonography, respectively. There was no statistically significant percent change in LV mass at 52 weeks in either treatment group (11.6% with olmesartan medoxomil vs 2.9% with amlodipine) and no statistically significant difference between treatment groups. There were no significant changes in LV compliance or carotid or femoral artery wall-to-lumen ratios in either treatment group at 52 weeks. In conclusion, there did not appear to be a clinically significant BP-independent effect with olmesartan medoxomil or amlodipine on LV mass decrease, diastolic function or vascular structure, and compliance in patients with hypertension and LV hypertrophy.
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Among insured patients diagnosed with BPH, our study suggests that the overall use of new agents is rising. In particular, urologists were more likely to prescribe newer selective α-1 blockers compared with PCPs.
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Six placebo-controlled trials (including two unpublished series) involving 996 patients provide the database for this evaluation. Six hundred thirty-six patients received terazosin from 1 to 20 mg daily for a total of 229 patient-years of exposure to terazosin. The most common final dose of terazosin was 10 mg once daily.
The baseline characteristics for age, peak flow rate and average flow rate did not vary between the 3 groups, however, the pretreatment volume of residual urine was greater in patients with large prostate adenomas. Terazosin treatment resulted in significant changes in flow rate and residual urine, however, changes in flow rates were not influenced by prostate size, while a marked decrease in residual urine was found in patients with large prostates.
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This article attempts to put into clinical context the recently described effects of certain alpha(1)-AR on prostate cell dynamics (i.e., proliferation and apoptosis). RESULTS AND CONCLUSIONS There is good evidence that certain alpha(1)-AR antagonists, in addition to affecting stromal smooth muscle, have effects on prostatic apoptosis that contribute to the overall clinical profile. Furthermore, this is not a class effect and may be restricted to balanced quinazoline alpha blockers (BQABs), such as terazosin.
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To evaluate the efficacy and safety of α-adrenergic blockers in the treatment of female lower-urinary-tract symptoms and dysfunction.
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This article reviews the rationale and data supporting alpha blocker therapy for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), the most common and difficult prostatitis syndrome.
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Benign prostatic hyperplasia (BPH), common in aging males is often treated with alpha1-adrenoceptor (AR) antagonists. In view of known hypotensive effect of most of the alpha1-AR antagonists, this work examined the effect of a selected alpha1-AR antagonist, terazosin on the baroreceptor mediated regulation of blood pressure. The three doses of terazosin (10, 100, 300 microg/kg body weight) used in anesthetized dogs inhibited in a dose-dependent manner the prostatic contractions and rise in blood pressure induced by phenylphrine. Impairment of arterial baroreflex, an important neural regulatory mechanism for the maintenance of normal arterial pressure, by alpha1-AR antagonist (prazosin) has been suggested in an earlier study. Hence, the effects of terazosin in doses 10, 100 and 300 microg/kg on baroreflex sensitivity (calculated as the ratio of heart rate change to acute increase in blood pressure by phenylephrine) were investigated. Terazocin did not produce any change in the baroreflex sensitivity. Therefore, in the absence of any adverse effect on the baroreceptor mediated regulation of the blood pressure, terazosin can be treated as a safer drug for the symptomatic treatment of BPH.
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This study suggests that terazosin is well tolerated and effective in longterm treatment of patients with BPH.
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A new sensitive and selective preconcentration-fluorimetric method for determination of terazosin based on its native fluorescence was developed. The analyte, initially present in aqueous matrix, was treated with an extractive non-ionic surfactant solution and separated by the clouding phenomenon. The optimum analytical conditions for terazosin assay were established. Under these conditions, linear calibration curves were obtained over the range of 1x10(-5) to 7.0 microg mL(-1) with detection and quantification limits of 1.11x10(-5) and 3.7x10(-5)microg mL(-1), respectively. Additionally, the binding constant (K(B)) for the terazosin-PONPE 7.5 system was determined given a value of 1028 L mol(-1). The developed coupled methodology, which thoroughly satisfies the typical requirements for pharmaceutical control processes, was proved to be appropriate for monitoring terazosin in actual pharmaceutical formulations and biological fluid sample. The results were validated by recovery test and by comparison with other reported methods, being highly satisfactory.
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In this large cohort, we observed no association between the use of thiazolidinediones or metformin and new medical or surgical treatment for BPH compared to sulfonylureas.
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To evaluate the effects of terazosin and tolterodine on ureteral stent discomfort.
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A total of 505 individual patients attended the clinic during the study period, and 342 patients fit the inclusion criteria. About 189 of these patients (55%) had OH. Among patients with OH, 61 patients (33%) were symptomatic, including 52 patients who had falls. The prevalence of OH in patients receiving zero, one, two, and three or more potentially causative medications was 35, 58, 60 and 65% respectively. Receiving hydrochlorothiazide was associated with the highest prevalence of OH (65%), followed by receiving lisinopril (60%), trazodone (58%), furosemide (56%) and terazosin (54%).
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Retrospective analysis of anonymized patient longitudinal prescription reimbursement claims data. All patients who had claims for any of four alpha blocker medications and six AM agents during an index period from April 1, 2011 to March 31, 2012 were included. For the combination therapy group, the effect of adherence with the AM medication on persistence to the alpha blocker was examined.
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In naive, acute pudendal nerve transection (PNT) and 4 weeks after PNT (PNT-4w) female rats, leak point pressures (LPPs) during bladder compression were measured before and after the application of hexamethonium (C6), propranolol, and N (ω)-nitro-L: -arginine-methyl ester (L: -NAME), or terazosin and atropine. Responses to carbachol and phenylephrine of proximal and middle urethral muscle strips from naive and PNT-4w rats were also examined.
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Retrospective drug utilization analysis of electronic patient prescription data.
To evaluate the clinical role of an alpha(1a-1d)-specific blocker in the medical expulsive therapy of symptomatic lower ureteral stones.
The influence of various alpha-adrenoceptor antagonists (phentolamine, yohimbine, R 28935, prazosine, terazosine) on clonidine's blood pressure effects at different steady state plasma concentrations was investigated in awake spontaneous hypertensive rats. Clonidine's threshold (greater than 10 mmHg, less than 20 mmHg) antihypertensive effect was potentiated by phentolamine but opposed by centrally acting antagonists as was the maximal antihypertensive effect. The pressor response on the other hand was blocked by peripherally acting alpha-1- and alpha 2-antagonists. The effect of clonidine on blood pressure thus seems a consequence of both the tissue distribution and the alpha-adrenoceptor affinity. At low steady state plasma concentrations of clonidine a peripheral action could be a part of the antihypertensive mechanism.
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The available evidence indicates that terazosin improves the symptoms and flow rates associated with BPO; it was more effective than placebo or finasteride and similar to other alpha-antagonists. Adverse effects were generally mild but more frequent than with other alpha-antagonists and associated with a two- to four-fold increase in treatment discontinuation.
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The implication of a single adrenoceptor subtype in the contractility of prostatic and urethral smooth muscle cells led to the concept that drugs with selectivity for this subtype may exhibit functional uroselectivity. Comparison of the affinities of the alpha1-adrenoceptor antagonists revealed that few compounds show selectivity for one of the three cloned alpha1-adrenoceptor subtypes (alpha1a/A, alpha1b/B, alpha1d/D) whereas most of them had a similar affinity for the three subtypes. Moreover, data supporting a relationship between selectivity for the alpha1a/A-adrenoceptor subtype and functional uroselectivity are still lacking and recent data challenged the relevance of the selectivity for a given cloned alpha1-adrenoceptor subtype in predicting functional uroselectivity. In vivo data showed that alpha1-adrenoceptor antagonists without adrenoceptor subtype selectivity, like alfuzosin or to a minor extent doxazosin, showed functional uroselectivity whereas prazosin and terazosin were not shown to be uroselective. Compounds considered to be selective for the alpha1a/A-adrenoceptor, like tamsulosin or 5-Me-urapidil, did not show functional uroselectivity since they modified urethral and blood pressures in a manner which was not correlated to their selectivity for the cloned alpha1-adrenoceptor subtypes. Meanwhile, the identification in prostatic tissue, of a new sub-family of alpha1-adrenoceptors with low affinity for prazosin and denominated alpha1L gave rise to numerous studies. However, its functional role as well as the affinity of the known antagonists for this receptor subtype remains to be clarified. In conclusion, the existing alpha1-adrenoceptor antagonists have different pharmacological profiles in vivo which are yet not predictable from their receptor pharmacology based on the actual state of knowledge of the alpha1-adrenoceptor classification.
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During reflex bladder contractions streptozotocin induced diabetic rats showed smooth and striated muscle dysfunctions of the urethra. The inhibition of alpha1-adrenoceptors, which decreased the UPP nadir and UPP fluctuation, may be useful for treating urethral dysfunction in DM.
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The present paper describes development of stability-indicating high-performance liquid chromatographic (HPLC) assay methods for three alpha-adrenergic-blocker drug substances, namely, prazosin, terazosin and doxazosin, in the presence of degradation products generated from forced decomposition studies. Resolution of drugs from degradation products was obtained using a reversed-phase C-18 column using water/acetonitrile/methanol/glacial acetic acid/diethylamine (25:35:40:1:0.017) as mobile phase for prazosin and terazosin and acetonitrile/water/glacial acetic acid/diethylamine (65:35:1:0.02) for doxazosin. The detection was done at 254 nm. The methods were validated with respect to linearity, precision, accuracy, specificity and robustness.
Blood pressure was similar after 12 weeks of treatment (atenolol: 129 (9)/75 (7) mm Hg; terazosin: 128 (11)/75 (9) mm Hg) and total cholesterol was significantly reduced after 12 weeks of treatment (atenolol: Diff 0-12 weeks: 7.29 (1.32) versus 6.62 (1.14 mmol/L, p = 0.006; terazosin: 7.34 (0.93) versus 6.67 (0.85) mmol/L, p = 0.002). In the terazosin group, HDL-cholesterol increased and triglycerides decreased significantly (Diff 0-12 weeks: HDL-chol: 1.55 (0.31) versus 1.63 (0.44) mmol/L, p = 0.04; TG: 1.93 (1.17) versus 1.34 (0.64) mmol/L, p = 0.03). Comparing both groups a significant difference was found with regard to HDL-cholesterol and triglycerides (atenolol versus terazosin: HDL-chol: -0.05 (0.12) versus +0.08 (0.1) mmol/L, p = 0.04; TG: -0.18 (0.61) versus--0.59 (0.6), p = 0.03).
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A total of 103 studies (102 RCTs, 65 from reviews) were included. RCTs were available for all interventions except yoga. The following interventions demonstrated significant improvements (p < 0.05) in arithmetic mean difference in IELT compared with placebo: topical anaesthetics - eutectic mixture of local anaesthetics (EMLA(®), AstraZeneca), topical eutectic mixture for PE (Plethora Solutions Ltd) spray; selective serotonin reuptake inhibitors (SSRIs) - citalopram (Cipramil(®), Lundbeck), escitalopram (Cipralex(®), Lundbeck), fluoxetine, paroxetine, sertraline, dapoxetine (Priligy(®), Menarini), 30 mg or 60 mg; serotonin-noradrenaline reuptake inhibitors - duloxetine (Cymbalta(®), Eli Lilly & Co Ltd); tricyclic antidepressants - inhaled clomipramine 4 mg; phosphodiesterase-5 (PDE5) inhibitors - vardenafil (Levitra(®), Bayer), tadalafil (Cialis(®), Eli Lilly & Co Ltd); opioid analgesics - tramadol (Zydol SR(®), Grünenthal). Improvements in sexual satisfaction and other outcomes compared with placebo were evident for SSRIs, PDE5 inhibitors and tramadol. Outcomes for interventions not compared with placebo were as follows: behavioural therapies - improvements over wait list control in IELT and other outcomes, behavioural therapy plus pharmacotherapy better than either therapy alone; alpha blockers - terazosin (Hytrin(®), AMCO) not significantly different to antidepressants in ejaculation control; acupuncture - improvements over sham acupuncture in IELT, conflicting results for comparisons with SSRIs; Chinese medicine - improvements over treatment as usual; delay device - improvements in IELT when added to stop-start technique; yoga - improved IELT over baseline, fluoxetine better than yoga. Treatment-related AEs were evident with most pharmacological interventions.