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The treatment of benign prostatic hyperplasia (BPH) has changed dramatically over the past 10 years. Phase 3 studies of the safety and effectiveness of alpha-blockers (eg, terazosin and doxazosin) and 5-alpha-reductase inhibitors (eg, finasteride) for the treatment of BPH began to appear in the literature in 1992. This article reviews the results of landmark studies of these agents, either separately as monotherapy or as combined therapy, for the treatment of BPH. The relationship between prostate size and lower urinary tract symptoms (LUTS) is discussed. Although prostate volume is not as strongly correlated with these symptoms as was once believed, it has been shown to be an important predictor of risk for developing acute urinary retention. alpha-Blockers represent an effective treatment for LUTS independent of prostate volume; the clinical benefit of finasteride for LUTS is limited primarily to men with large prostates. Finasteride decreases the risk of progression to acute urinary retention and the requirement for surgical intervention; this benefit is greatest in men with enlarged prostates.
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As an initial medical therapy for moderate BPH, tamsulosin is more effective than generic terazosin or doxazosin, with an incremental cost of about 203 dollars per year (or about 17 dollars per month) over 3 years.
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Tamsulosin-associated EjD, which was found in clinical studies, was reproduced in this analysis with markedly higher signal scores, and these results strongly suggest the necessity of well-organized clinical studies on A1B-associated adverse events.
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Lower urinary tract symp toms due to benign prostatic hyperplasia (LUTS/BPH) are common in aging men and can progress to acute urinary retention. Among the classes of agents recommended for patients with moderate to severe symptoms are α-adrenergic receptor (adrenoceptor) antagonists (α-blockers) and 5α-reductase inhibitors (5ARIs). This review provides a brief overview of the diagnosis and management of LUTS/BPH, focusing on the efficacy and tolerability of α-blockers approved for the treatment of LUTS/BPH, with particular emphasis on silodosin, a novel α-blocker. Of the older α1-blockers, alfuzosin, doxazosin and terazosin show little selectivity for the α1-adrenoceptor subtypes, while tamsulosin is moderately and silodosin is highly selective for the α1A subtype in preference to the α1B subtype. Highly selective α1A-receptor antagonists such as silodosin were developed specifically for the treatment of LUTS because non-selective antagonists were associated with cardiovascular adverse effects. Since α1A is predominantly expressed in the prostate, higher selectivity for α1A may account for lower blood pressure-related adverse effects. Silodosin is administered once daily and provides rapid improvements in the signs and symptoms of moderate to severe LUTS/BPH in male patients. As with other α-blockers, silodosin is generally well-tolerated and the most common adverse events seen are abnormal ejaculation, dizziness, headache, diarrhoea, nasal congestion and orthostatic hypotension. Unlike 5ARIs, α-blockers do not impair libido. Given the prevalence of LUTS/BPH and the efficacy and tolerability concerns with existing therapies, silodosin is a welcome addition to the pharmacological options for these patients.
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A total of 45 patients who participated in a multicenter trial was evaluated with urodynamic pressure-flow studies before and after 26 weeks of treatment.
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This study provides evidence that the alpha(1)-adrenoceptor antagonist terazosin may have therapeutic potential in the treatment of advanced hormone refractory prostate cancer.
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Benign prostatic hyperplasia (BPH), a common benign tumor in men has been attributed to age and male androgen functions. Of the various management options for treatment of BPH, medical therapy is the first line treatment modality involving either blockade of alpha adrenergic receptors or inhibition of 5-alpha reductase. Amongst these, the alpha-1 blockers are used most frequently. The association of numerous adverse effects with non selective and short acting alpha-1 blockers (like phenoxybenzamine, prazosin and alfuzosin) has led to the development of long acting alpha-1 adrenoceptor blockers (doxazosin, terazosin, tamulosin) which being uroselective significantly reduce the incidence of cardiovascular side effects and increase patient compliance. The review gives a brief account of pharmacological properties and efficacy of alpha adrenergic receptor blockers in the treatment of BPH.
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To investigate the effects of amlodipine, a dihydropyridine calcium-channel blocker, alone or combined with terazosin, on urodynamics in rats with benign prostatic hyperplasia (BPH) and in female rats with detrusor instability (DI).
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This study clarifies that tamsulosin 0.2 mg has similar efficacy and fewer adverse events compared with other alpha-blockers as an initial treatment strategy for men with lower urinary tract symptoms.
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In this study we test whether functional screening of compounds to adrenergic G protein-coupled receptors (GPCRs) would provide data that correlated significantly with radiolabeled binding data, thereby permitting researchers to replace expensive radioligand-binding experiments with non-radioactive screening. An increase in intracellular calcium levels represents an important second messenger signal for several recombinant GPCRs. In this study, we describe the affinities of three alpha adrenoceptor antagonists (terazosin, tamsulosin and alfuzosin), determined by monitoring the changes in intracellular calcium levels and comparing them with their radioligand-binding affinities. In addition to determining the functional affinities of the three alpha adrenoceptor antagonists, we evaluate their binding at two alpha adrenoceptor subtypes and optimized the assay for high-throughput screening.
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The purpose of this study is to investigate the penetration effects and mechanism of N-arginine chitosan (ACS). This novel transdermal enhancer with a mimetic structure of cell-penetration peptides was synthesized by introducing hydrophilic arginine groups to the amino-group on chitosan's side chain. The structure of ACS was confirmed by FT-IR, 1H NMR and element analysis. In addition, attenuated total reflection Fourier transform infrared spectroscopy (ATR-FTIR) was used to study the protein conformation and the water content of stratum corneum, and the result suggested that ACS can change the orderly arrangement of the molecules in the stratum corneum, making the stack structure of keratin become loose. And ACS can increase the water content of the stratum corneurn. Inverted fluorescence microscope and flow cytometry were used to examine penetration effect of ACS on Hacat cell. The result confirmed that the uptake of ACS was enhanced with increased substitution degree of arginine by 4-8 folds compared to chitosan. In vitro penetration studies on three electrical types of drugs were carried out using three model drugs of negatively charged aspirin, positively charged terazosin and neutral drug isosorbide mononitrate by the method of Franz diffusion cells. The results showed that ACS has obviously penetration of the negatively charged drug aspirin, and certain penetration of neutral drug issorbide mononitrate, but inhibition of positively charged terazosin. In vivo imaging technology research results show that the ACS can significantly enhance the fluorescence intensity of morin, which is the auto-fluorescence anionic drug. These obtained results suggested that ACS, as a promising transdermal enhancer, can change the structure of the keratinocytes and analog penetrating peptides promote absorption, but have certain selectivity for the drug.
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It has long been recognised that neural factors are of considerable importance in lower urinary tract function. Whilst reduction in the bulk of the human prostate is feasible, experience on this therapeutic approach proved to be disappointing. Existing trial data with the agent finasteride are reviewed. A number of formulations derived from plant extracts have been advocated but their mechanism of action remain largely obscure and there is a dearth of placebo controlled information to support their efficacy. Experience over the last 10 years has demonstrated efficacy with the use of alpha adrenoceptor blockade in the management of BPH. Alpha adrenoceptor antagonists relax the prostatic smooth muscle by interrupting the sympathetic pathway at the receptor level. Recent developments in this field include the recognition that there are alpha I adrenoceptor subtypes. The functional adrenoceptor in the human prostate is predominantly the alpha IA - subtype. Of the alpha 1-adrenoceptor antagonists only tamsulosin discriminates between the alpha 1-adrenoceptor subtypes. Alpha 1-blockers should be used in first-line medical therapy for BPH and 5-alpha-reductase inhibitors reserved for those patients in whom alpha-blocker therapy fails. Alpha I-blockers such as doxazosin, tamsulosin, terazosin, alfuzosin are effective in the treatment of BPH both in younger and in older men. The drugs are well tolerated. The majority of side effects were classified as minor and mild. The most common complaints, as with other alpha-blockers, are dizziness, fatigue and headache, and these are often transient. In contrast, finasteride can lead to impotence, reduced libido. gynaecomastia or ejaculatory disorders. Men with small prostates may not be suitable candidates for finasteride therapy.
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An open randomized comparative trial of setegis (terazosine) has shown good subjective and objective results in patients with chronic bacterial prostatitis. The drug is well tolerated and produces insignificant side effects. It is also demonstrated that combined therapy with alpha-adrenoblockers is more effective that monotherapy with antibacterial drugs in patients with bacterial prostatitis.
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Alpha1-adrenoceptor antagonists are clinically useful for the improvement of urinary obstruction due to benign prostatic hyperplasia (BPH), and their therapeutic effects are mediated through the blockade of prostatic alpha(1)-adrenoceptors. The present study was undertaken to predict the magnitude and duration of alpha(1)-adrenoceptor occupancy in the human prostate after oral alpha(1)-adrenoceptor antagonists. Prostatic alpha(1)-adrenoceptor-binding parameters of silodosin were estimated by measuring specific [(3)H]prazosin binding in rat prostate after oral administration of this drug. The plasma concentration of silodosin after oral administration in rats and healthy volunteers was measured using a high-performance liquid chromatographic method. The alpha(1)-adrenoceptor-binding affinities (K(i)) of silodosin, tamsulosin, and terazosin in the human prostate and plasma concentrations of tamsulosin and terazosin were obtained from the literature. Using the alpha(1)-adrenoceptor binding parameters of silodosin in rat prostate, alpha(1)-adrenoceptor occupancy in the human prostate was estimated to be around 60-70% at 1-6 h after oral administration of silodosin at doses of 3.0, 8.1, and 16.1 micromol. Thereafter, the receptor occupancy was periodically decreased, to 24% (8.1 micromol) and 54% (16.1 micromol) 24 h later. A similar magnitude and time course of alpha(1)-adrenoceptor occupancy by silodosin in the human prostate were estimated using alpha(1)-adrenoceptor-binding affinities (K(i)) in the human prostate. Despite about two orders of differences in the plasma unbound concentrations after clinically effective oral dosages of silodosin, tamsulosin, and terazosin, there was a comparable magnitude of prostatic alpha(1)-adrenoceptor occupancy by these drugs. In conclusion, the prediction of alpha(1)-adrenoceptor occupancy in the human prostate by alpha(1)-adrenoceptor antagonists may provide the rationale for the optimum dosage regimen of these drugs in the therapy of BPH.
Alpha1-AR antagonists are currently first-line therapy for lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). In this study, we report the synthesis of a new series of arylpiperazine derivatives containing acetophenone (3-17) which possess alpha1-adrenoreceptor blocking activity. The in vitro alpha1-adrenoreceptor blocking activity of each derivative was first screened using rabbit thoracic aortic rings by measuring the relaxation response (%) activated by (-)-noradrenaline (3 microM). Compounds 6 and 7 with 2,5-dimethoxy and 2-ethoxy substituent were found to have significant vasodilatory effect. Since the presence of a chiral carbon in the structure, 6 and 7 together with their enantiomers 14-17 were further evaluated by testing diastolic effect on rabbit thoracic aorta, prostate and bladder smooth muscle. The S-enantiomer was found to have more potent diastolic activity than the R-enantiomer and racemate, 17 being the most effective alpha1-adrenoreceptor antagonist. In order to assess tissue selectivity, the antagonistic effect of 17 on the (-)-noradrenaline induced contractile response of isolated rat vas deferens (alpha(1A)), spleen (alpha(1B)) and aorta (alpha(1D)) was characterized finally. Compared with naftopidil (1) and terazosin, compound 17 exhibited higher selectivity (18-fold) for the alpha(1D)-adrenoceptor subtype as compared to the alpha(1B)-adrenoceptor subtype, indicating less cardiovascular side effects for the treatment of LUTS/BPH. These data suggest that the acetophenone is a new effective adrenergic receptor ligand as well as incentivizes further research regarding pharmacological properties of chiral molecules.
TTD can improve the UFR, decrease the NIH-CPSI score, pH value and UA level in the EPS, is an effective recipe for treatment of CPS.
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The available data suggest that combination alpha(1)ARA/5ARI therapy is beneficial in the treatment of BPH and the associated symptoms. The greatest efficacy was evident in patients with an enlarged prostate, more severe symptoms, and higher PSA levels. There are limited data suggesting that the presence of prostatic inflammation may indicate a greater likelihood of treatment efficacy with combination therapy.
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To assess the effect of antihypertensive therapy on hemorheology in essential hypertension, blood viscosity and red blood cell deformability were examined in 45 patients with essential hypertension and 20 age-matched normotensive control subjects. Hypertensive patients were randomly assigned to monotherapy with five different antihypertensive drugs for 6 months and change of blood viscosity and red blood cell deformability were reexamined after the end of the monotherapy with each antihypertensive drug. Blood viscosity increased and red blood cell deformability decreased in hypertensive patients compared to normotensive control subjects. Monotherapy with each drug resulted in sufficient blood pressure control in all hypertensive patients. After the monotherapy with the alpha-blocker, terazosin, blood viscosity decreased significantly at shear rates from 22.5/sec to 450/sec, and red blood cell deformability, estimated by red blood cell filtration rate, increased by 15% (from 65 +/- 10 to 75 +/- 12 microL/sec, P < .05). The decrease in blood viscosity induced by alpha-blocker monotherapy may relate to an improvement of red blood cell deformability. It is possible that the treatment with alpha-blocker has a beneficial effect on the peripheral microcirculation due to an improvement of hemorheology in patients with essential hypertension.
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The authors describe a patient whose symptoms could not be controlled with commonly prescribed therapies, who obtained total relief of sympathetically maintained pain and vasospasm with terazosin, a new alpha 1 antagonist.
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Traditional Chinese medicine (TCM) has been proposed to prevent urolithiasis. In China, Flos carthami (FC, also known as Carthamus tinctorius) (Safflower; Chinese name: Hong Hua/) has been used to treat urological diseases for centuries. We previously performed a screening and confirmed the in vivo antilithic effect of FC extract. Here, ex vivo organ bath experiment was further performed to study the effect of FC extract on the inhibition of phenylepinephrine (PE) (10(-4) and 10(-3) M) ureteral peristalsis of porcine ureters with several α 1-adrenergic antagonists (doxazosin, tamsulosin, and terazosin) as experimental controls. The results showed that doxazosin, tamsulosin, and terazosin dose (approximately 4.5 × 10(-6) - 4.5 × 10(-1) μg/mL) dependently inhibited both 10(-4) and 10(-3) M PE-induced ureteral peristalsis. FC extract achieved 6.2% ± 10.1%, 21.8% ± 6.8%, and 24.0% ± 5.6% inhibitions of 10(-4) M PE-induced peristalsis at doses of 5 × 10(3), 1 × 10(4), and 2 × 10(4) μg/mL, respectively, since FC extract was unable to completely inhibit PE-induced ureteral peristalsis, suggesting the antilithic effect of FC extract is related to mechanisms other than modulation of ureteral peristalsis.
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Each drug observed in this study can improve the subjective and objective symptoms significantly for BPH patients, especially for patients with higher IPSS baseline. When using 5alpha-reductase inhibitor, prostatic volume can be decreased significantly and more obviously subjective and objective improvement can be found in the patients with TPV greater than 35.5 cm3.
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Safety data from a large, multinational study were analysed retrospectively. Normotensive and hypertensive patients received escalating dosages of terazosin for 10 weeks and were maintained on 5 or 10 mg daily doses for 16 weeks (single-blind period). After the initial treatment period, only men having sufficient improvements in International Prostate Symptom Score (> or = 30%) and in peak flow rate (> or = 10%) were randomly assigned to continue terazosin or to receive placebo for 24 weeks (double-blind period).
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Doxazosin effectively blocked PE-induced vascular and urethral changes over the dose range 1-16 mg. There was no evidence for target organ selectivity. The degree of blockade of the PE-induced responses by tamsulosin was highly dependent on the time of measurement, post drug administration. The degree of observed blockade with tamsulosin at 0.4 mg was substantially less than that observed at 0.8 mg tamsulosin and/or 1 mg doxazosin.
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We created partial bladder outlet obstruction in 5 groups of rabbits, each containing 8. Rabbits with sham operation (group 1) received no drug treatment. Similarly, animals in group 2 underwent partial bladder outlet obstruction and received no drug treatment. Rabbits in groups 3 were administered 5 mg/day oral terazosin, and rabbits in group 4 received 10 mg/kg/day melatonin intraperitoneally. Animals in group 5 received both terazosin and melatonin. We removed their bladders and performed histopathological and biochemical measurements. We assessed tissue malondialdehyde and antioxidant enzyme activity levels and recorded in vitro contractility response to KCl in isolated organ baths.
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To review the current diagnostic and treatment options of lower urinary tract symptom due to benign prostatic hyperplasia and to put data from real life practice into perspective.
This prospective randomized double-blinded clinical trial was designed to explore the effects of amlodipine and the combination of amlodipine with terazosin in improving postvoid residual (PVR) in patients with lower urinary tract symptoms (LUTS) and concomitant hypertension.
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A total of 713 patients with hypertension were evaluated in eight randomized, double-blind, placebo-controlled trials of terazosin administered in single daily doses ranging from 1 to 40 mg. In three of these studies, terazosin or placebo was added to ongoing antihypertensive drug therapy. Patient response was categorized (from excellent to inadequate) according to the change in supine diastolic blood pressure from baseline and the value at the final visit. The distribution of patients in these response categories differed significantly between patients treated with terazosin and those treated with placebo. Overall, 52 percent of terazosin-treated patients in these eight studies, compared with 30 percent of placebo-treated patients, had good to excellent responses. Subgroup analysis revealed that blood pressure response was not dependent on sex or age, although white patients appeared to achieve better responses to terazosin in comparison with placebo than did black patients. These studies demonstrate that terazosin administered once daily, either as monotherapy or in combination with other antihypertensive agents, effectively controls blood pressure in patients with mild to moderate hypertension.
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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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TUR of the prostatic gland for prostatic adenoma was made in 93 patients aged 54-81 years (mean age 64.4 +/- 7.5 years). The patients were divided into two groups. Patients of group 1 (n = 31) received no alpha-adrenoblockers, those of group 2 (n = 62) received terasosine in pre- and postoperative period. Group 2 patients demonstrated significant improvement in clinical parameters, postoperative hospital stay for them decreased by 11.3%, side effects were insignificant, their residual urine early after operation was 26.3 +/- 8.6 cm3 while 4 weeks after TUR it was 16.3 +/- 6.9 cm3. Thus, terasosine (setegis) can be recommended for use in early postoperative period after TUR of the prostate for prostatic adenoma as an effective and safe drug improving postoperative outcome.