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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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This randomized, placebo-controlled, double-blind study was performed to evaluate the efficacy and safety of once-a-day terazosin (10 mg/day) in ambulatory patients (n = 57) with benign prostatic hyperplasia (BPH). After a 4-week placebo lead-in and a 24-week treatment period with terazosin (both single-blind), 30 patients who responded to terazosin were randomly assigned to either the terazosin or placebo treatment group for 12 weeks. During the single-blind treatment period, the peak urine flow rate increased 54% from a baseline average of 7.76 ml/sec to 11.92 ml/sec after terazosin; the mean flow rate increased 55% from a baseline of 4.90 ml/sec to 7.59 ml/sec; and the residual volume decreased 56% from 93.1 ml to 40.7 ml. The mean obstructive symptom score, irritative symptom score and physician's global assessment score improved by 68%, 34% and 27%, respectively. All these changes were significant (P less than 0.05) when compared to baseline values. During the double-blind period, the improvement in all the variables was sustained in the terazosin group but not in the placebo group. Peak and mean urinary flow rates, and physician's global assessment showed significant (P less than or equal to 0.05) differences at the end of the double-blind period. Adverse events occurred only during the single-blind period. The most frequent were headache (n = 6), asthenia (n = 3), and hypotension (n = 3). In summary, terazosin administered once-a-day improved the obstructive and irritative symptoms of BPH, urine flow rates and residual volume. Terazosin was well tolerated.
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The long-term treatment of essential hypertension with terazosin, a new once-a-day alpha 1-adrenergic blocking agent, was evaluated in 364 hypertensive patients who received total daily doses of 1 to 40 mg for 3 weeks to 56 months. Consistent mean decreases in supine and standing systolic and diastolic blood pressures were observed throughout the study for patients treated with terazosin as monotherapy (supine, 9 to 12/10 to 13 mm Hg; and standing, 12 to 18/11 to 14 mm Hg) or in combination with other antihypertensive agents (supine, 12 to 16/12 to 15 mm Hg; and standing, 16 to 22/13 to 19 mm Hg). The most commonly reported adverse experiences were dizziness, headache, asthenia, cold symptoms, and nasal congestion. Adverse effects and metabolic disorders often associated with diuretics and beta blockers such as sexual dysfunction, hyperglycemia, hyperuricemia, hypokalemia, or adverse lipid effects were seen infrequently during long-term treatment with terazosin as monotherapy. Overall, terazosin was shown to be effective, safe, and well tolerated by most patients.
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Benign prostatic hyperplasia (BPH) is a common disorder in older men and may be associated with lower urinary tract symptoms (LUTS) and sexual dysfunction. Men who present with symptomatic BPH and LUTS are at increased risk for sexual dysfunction, including erectile dysfunction (ED) and ejaculatory dysfunction (EjD).
The effects of i.v. infusion of the alpha1-adrenoceptor antagonists doxazosin and terazosin (2 mg kg-1 h-1) on spontaneous hypogastric, renal and inferior cardiac nerve activity, spontaneous bladder contractions, blood pressure, heart rate and femoral arterial flow were investigated separately in alpha-chloralose-anaesthetized cats. Both drugs caused a reduction in hypogastric nerve activity associated with no overt changes in spontaneous bladder contractions. Doxazosin was more potent than terazosin, in that there was a significant reduction in hypogastric nerve activity after 20 min (0.67 mg kg-1) of infusion, while for terazosin this occurred after 40 min (1.33 mg kg-1). Both drugs also caused significant falls in blood pressure of 34 +/- 3 mm Hg and 33 +/- 4 mm Hg after 60 min. This was associated with no change in heart rate for doxazosin while terazosin caused an initial and significant increase in heart rate of 20 +/- 3 beats min-1 by 5 min, declining by 30 min to 1 +/- 5 beats min-1. This terazosin-induced tachycardia was associated with a significant increase in cardiac nerve activity of 128 +/- 22%. Both drugs caused increases in renal nerve activity however only for doxazosin was this increase significant. Femoral arterial conductance was also increased by both drugs, however, for doxazosin this increase was immediate and larger over the infusion period. These results demonstrate that alpha1-adrenoceptor antagonists can reduce sympathetic drive to the bladder and related organs.
No evidence of heterogeneity was found in the estimated effects of terazosin on the change in peak flow rates in the studies. Terazosin treatment was associated with an increase in the peak flow rate of 1.4 mL/s (95% confidence interval [1.0, 1.7]) compared with placebo. Terazosin resulted in an average reduction of 2.2 points over placebo (95% confidence interval [1.6, 3.0]) regarding the common symptom score (range 0 to 36 points). A mild heterogeneity was found across the studies, with the decrease in symptom score slightly greater with longer treatment duration. No evidence was found that the baseline prostate volume influenced the effect of terazosin.
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Tadalafil augmented the hypotensive effects of doxazosin but had little hemodynamic interaction with tamsulosin. In patients taking tadalafil for ED, tamsulosin 0.4 mg may be given for the treatment of benign prostatic hyperplasia.
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Ninety-two male Sprague-Dawley rats were randomized to 1 of 5 groups: double-placebo control (n = 15), nicotine opposed by oral placebo (n = 26), nicotine opposed by subcutaneous placebo (n = 16), nicotine opposed by oral terazosin (n = 21), and nicotine opposed by subcutaneous terazosin (n = 14).
Symptomatic benign prostatic hyperplasia (BPH) is a common condition in older men and has a significant impact on their daily lives. Transurethral resection of the prostate is currently the most effective remedy for BPH but is not suitable for all patients. There is now clear evidence for the efficacy of alpha-adrenoceptor antagonists, particularly selective alpha 1-adrenoceptor antagonists, in the treatment of BPH. Inhibition of alpha-adrenoceptors significantly increases urinary flow and improves symptoms in BPH. alpha 1-Adrenoceptor antagonists have a place in the management of BPH patients with mild to moderate disease, who are bothered by their symptoms, or for those awaiting or wishing to delay surgery. Treatment with selective alpha 1-adrenoceptor antagonists is generally better tolerated than nonselective-alpha-blockers. alpha 1-Selective adrenoceptor antagonists with a long half-life such as terazosin, doxazosin and tamsulosin, as a modified release formulation, permit once-daily dosing. Tamsulosin is the first subtype-specific (cloned alpha 1c/functional alpha 1A) adrenoceptor antagonist in clinical practice. Initial reports suggest that it gives no clinically relevant lowering of blood pressure and that its (vasodilatory) side effect profile is minimal. The scientific rationale behind the therapeutic use of alpha-adrenergic blockade as treatment for BPH and the trials data relating to the various agents which are available for clinical use are reviewed in the context of the contemporary literature.
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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.
EjD related to medical treatments for LUTS.
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We investigated the frequency of prescription of alpha-blockers and PDE5Is from 3 general hospitals from January 1, 2007 to December 31, 2009. For alpha-blockers, data were collected from patients to whom alpha-blockers were prescribed from among patients recorded as having benign prostatic hyperplasia according to the 5th Korean Standard Classification of Diseases. For PDE5Is, data were collected from patients to whom PDE5Is were prescribed by the urology department and by other departments. Alpha-blockers were classified into tamsulosin, alfuzosin, doxazosin, and terazosin, whereas PDE5Is were classified into sildenafil, tadalafil, vardenafil, udenafil, and mirodenafil.
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alpha(1)-Adrenoceptors of the locus coeruleus (LC) have been implicated in behavioral activation in novel surroundings, but the endogenous agonist that activates these receptors has not been established. In addition to the canonical activation of alpha(1)-receptors by norepinephrine (NE), there is evidence that dopamine (DA) may also activate certain brain alpha(1)-receptors. This study examined the contribution of DA to exploratory activity in a novel cage by determining the effect of infusion of various dopaminergic and adrenergic drugs into the mouse LC. It was found that the D2/D3 agonist, quinpirole, which selectively blocks the release of CNS DA, produced a dose-dependent and virtually complete abolition of exploration and all movement in the novel cage test. The quinpirole-induced inactivity was significantly attenuated by coinfusion of DA but not by the D1 agonist, SKF38390. Furthermore, the DA attenuation of quinpirole inactivity was blocked by coinfusion of the alpha(1)-adrenergic receptor antagonist, terazosin, but not by the D1 receptor antagonist, SCH23390. LC infusions of either quinpirole or terazosin also produced profound inactivity in DA-beta-hydroxylase knockout (Dbh -/-) mice that lack NE, indicating that their behavioral effects were not due to an alteration of the release or action of LC NE. Measurement of endogenous DA, NE, and 5HT and their metabolites in the LC during exposure to the novel cage indicated an increase in the turnover of DA and NE but not 5HT. These results indicate that DA is a candidate as an endogenous agonist for behaviorally activating LC alpha(1)-receptors and may play a role in the activation of this nucleus by novel surroundings.
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This study was designed to evaluate the safety and efficacy of the selective alpha 1-adrenoceptor blocker terazosin in the treatment of benign prostatic hyperplasia (BPH).
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The incidence of heart attack and stroke undergo diurnal variation. Molecular clocks have been described in the heart and the vasculature; however it is largely unknown how the suprachiasmatic nucleus (SCN) entrains these peripheral oscillators.
The ability of the quinazoline derived alpha1-adrenoceptor antagonists doxazosin and terazosin to induce apoptosis in benign and malignant prostate cells has been established. In this study we investigated the effect of the 2 piperazidinyl quinazoline based alpha1-adrenoceptor antagonists and the methoxybenzene sulfonamide alpha1-antagonist tamsulosin on human prostate cancer cell adhesion.
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We determined if alpha1 receptor antagonism at the hypoglossal motor nucleus (HMN) decreases genioglossus (GG) activity consistent with a role for an endogenous noradrenergic drive contributing to GG activation across sleep-wake states. We also determined if alpha1 receptor stimulation could counteract reduced endogenous noradrenergic drive and increase sleeping GG activity.
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Relevant information was identified through a search of MEDLINE (1966-June 2010), International Pharmaceutical Abstracts (1970-June 2010), and EMBASE (1947-June 2010). Randomized, controlled trials that examined prostate cancer, benign prostatic hypertrophy, or procedures related to the prostate (ie, biopsies) were excluded.
We have previously demonstrated that low dose of inhaled dopamine (0.5-2 microg kg(-1) min(-1)) induces broncodilatacion in patients with acute asthma attack, suggesting that this dopamine effect is mediated by dopaminergic rather than by adrenergic receptors. To understand better these dopamine effect, rat tracheal smooth muscle was used as a model to evaluate the responses of beta2-, alpha1-, alpha2-adrenergic and DA1 and DA2 dopaminergic antagonists. Tracheal rings from male Sprague-Dawley rats (n = 90) were excised and placed in an organ bath containing modified Krebs-Ringer bicarbonate buffer at 37 degrees C, and gassed with O2 (95%) and CO2 (5%). Contractile responses were recorded with an isometric transducer in a polygraph (Letica, Spain). Contraction was induced by accumulative doses of acetylcholine (0.1, 0.3, 1, 3, 10 mM) or by electric field stimulation (10 Hz at 2 milliseconds), and accumulative doses of dopamine were added to the bath. Low concentration (0.1-0.3 mM) elicited a small initial contraction, followed by a marked relaxation. Cholinergic contraction was completely reversed at 6 mM of dopamine. This biphasic dopaminergic response was not blocked by incubation with beta2-adrenergic antagonist propranolol (0.1 microM), alpha1-antagonist, terazosin (0.1 mM), alpha2-antagonist, yohimbine (0.1 mM), or by DA2 antagonist metoclopramide (1-8 mM); DA1 antagonist SCH23390 (0.1 microM) produced a sustained increase of basal tone but did not block initial dopaminergic contraction and partially inhibited bronchodilator effect of dopamine. Dopaminergic relaxation in rat trachea is mediated by DA1 rather than by DA2 receptors; and adrenergic receptors are not involved in such dopamine-induced response. Finally, DA1 antagonist SCH23390 exerts intrinsic contractile activity on airway smooth muscle that deserves further research.
The phenomenon of polymorphism is prevalent in pharmaceuticals, yet it is unusual to identify more than three or four forms for any particular drug. Terazosin hydrochloride has been found to exist at room temperature in four solvent-free forms that can be isolated directly, one solvent-free form that can be prepared by desolvation of a methanolate, a methanol solvate, and a dihydrate. This study presents characterization and methods for preparation of each of these forms. Data are also presented demonstrating the relative stability of these forms.
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We analyzed the prescriptions of alpha-blockers and phosphodiesterase 5 inhibitors (PDE5Is) in the urology department as well as in other departments of the general hospital.
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Intraperitoneal epinephrine enhances the cerebral auditory evoked potential (AEP), an effect that is dependent on the basal forebrain cortical cholinergic system. The present study examined the hypothesis that ascending noradrenergic projections from brainstem autonomic substrates to the basal forebrain cholinergic system represent an essential component of the ascending pathway mediating this effect of epinephrine. Epinephrine again enhanced the AEP in rats, and this effect was attenuated by infusion of the selective alpha1 adrenergic antagonist terazosin into the basal forebrain. Moreover, infusions of the selective alpha1 adrenergic agonist phenylephrine into the basal forebrain mimicked the priming effects of epinephrine. Results support the hypothesis that noradrenergic afferents to the basal forebrain cholinergic system represent a component of an ascending visceral afferent system.
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Continuous cystometry was performed in conscious, freely moving rats with and without bladder outlet obstruction. Cystometric parameters were evaluated before and after intracerebroventricular drug administration.
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To investigate the effectiveness of terazosin, an alpha1-adrenoceptor blocking agent, on bladder neck obstruction (BNO), by assessing the urodynamic hydraulic energy profile. Patients, subjects and methods The study included 17 men (mean age 60.1 years, range 24-84), comprising 11 patients with BNO (mean age 66.5 years) and six normal volunteers (mean age 48.1 years). A five-transducer microtip catheter was used to measure the pressure in the bladder and at the bladder neck, and in the membranous and bulbous urethra during voiding. All the subjects then received terazosin, 1 mg/day orally for 2 weeks, and were re-assessed.
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The antihypertensive activity of terazosin, an investigational alpha 1-adrenergic-receptor blocker, and its effect on blood lipids were compared with placebo in a double-blind study. After a 3-week placebo baseline period, patients were randomized to receive terazosin (n = 22) or placebo (n = 16). The dose of terazosin was titrated over 2 weeks to a maintenance dosage of 10 mg once daily for 4 weeks. Antihypertensive efficacy was assessed: (1) at the end of the 24-hour dosing interval by comparing the average blood pressure (BP) after 3 and 4 weeks of maintenance therapy to the average BP after 2 and 3 weeks of placebo therapy, and (2) for 3 hours after drug ingestion at the final visit in comparison to the predose BP at that visit. At the end of the 24-hour dosing interval, 10 mg of terazosin reduced the mean supine systolic BP from 155.6 to 152.2 mm Hg and mean supine diastolic BP from 101.9 to 99.0 mm Hg (p less than 0.05). During the 3 hours after drug ingestion, mean supine systolic and diastolic pressures decreased maximally from 151.8 to 142.7 mm Hg (p less than 0.05) and from 99.5 to 91.0 mm Hg (p less than 0.05) respectively. No supine BP reduction differed significantly from the placebo response. During terazosin therapy there was a nonsignificant increase in mean body weight of 1.4 +/- 2.9 kg and no change in blood lipids. Thus the drug demonstrated greater antihypertensive activity 1-3 hours after ingestion than at the end of the 24-hour dosing interval.(ABSTRACT TRUNCATED AT 250 WORDS)
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Terazosin has been studied in a variety of clinical trials conducted in hypertensive patients with supine diastolic blood pressures of 95 mm Hg or greater before treatment. Blood pressure, pulse rate, body weight, clinical laboratory variables, and adverse experience data were evaluated periodically throughout each study. Patients generally were seen at weekly or biweekly intervals. Total daily doses of terazosin ranged from 1 to 40 mg. Terazosin was administered alone and in combination with other antihypertensive agents. Clinical trials consisted of double-blind, controlled studies and long-term, follow-up studies. The controlled clinical trials employed three principal designs: studies in which the dose was titrated according to blood pressure response; studies in which the dose was increased to a fixed level regardless of blood pressure response; and randomized withdrawal studies. Efficacy evaluations were based on mean blood pressure changes from baseline to the final visit and on the distribution of patient responses, which were categorized from excellent to inadequate. Safety evaluations were based principally on comparisons of specific safety parameters before and after the study.
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The total effective rate was 86.3% (69/80), 61.3% (49/80) and 17.5% (14/80) respectively in combined therapy group, medicine group I and medicine group II, indicating that the curative effect in combined therapy group was superior to that in other groups (P < 0.01, P < 0.05), and it in medicine group I was superior to that in medicine group II (P < 0.01). The Chinese medicine syndrome score was markedly reduced in combined therapy group (P < 0.01), and there was no obvious change in other groups (both P > 0.05). Urinary albumin (UMA) and urinary protein in 24 hours were notably reduced in combined therapy group and medicine group I (all P < 0.01), and it was more obviously in combined therapy group than that in other groups (P < 0.01, P < 0.05). The blood pressure was markedly reduced in all groups (all P < 0.05) after treatment, and there was no significant change in indices of liver and kidney functions (all P > 0.05).
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To determine the efficacy of an alpha-adrenoceptor antagonist, terazosin, in reducing nocturia in men with lower urinary tract symptoms (LUTS), and to identify the factors predicting treatment outcome.
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A total of 100 subjects, aged 20 to 50 years, who met the National Institutes of Health criteria for chronic prostatitis/chronic pelvic pain syndrome and had not previously been treated with alpha-blockers, were entered in a 14-week, double-blind comparison of terazosin or placebo therapy. Nonresponders and responders with subsequent relapse were treated with terazosin or other medications (open label). The criterion for response was a score of 0 to 2 on the National Institutes of Health Chronic Prostatitis Symptom Index quality-of-life item. The initial response was evaluated at week 14, and the long-term response was evaluated after a median of 38 weeks (range 34 to 42), regardless of any additional treatment. A durable response was defined as an initial response without additional treatment.