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The alpha 1-adrenoceptor antagonists doxazosin and terazosin and the 5 alpha-reductase inhibitor finasteride are used in the treatment of benign prostatic hyperplasia. The aim of this study was to assess the potential pharmacokinetic interaction of doxazosin or terazosin when coadministered with finasteride. This was a randomized, placebo-controlled, multi-center study. Ninety healthy men were assigned to one of six treatment groups: doxazosin; doxazosin plus finasteride; terazosin; terazosin plus finasteride; placebo; and placebo plus finasteride. Plasma concentrations, maximum plasma concentration (Cmax), time to maximum concentration (tmax), and area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) of doxazosin, terazosin, and finasteride were determined. Ratios of Cmax and AUC for doxazosin and terazosin were not significantly altered by coadministration with finasteride. The Cmax and AUC0-24 of finasteride were not significantly altered by coadministration with doxazosin. However, Cmax and AUC0-24 of finasteride were significantly higher after coadministration with terazosin. There is no statistically significant pharmacokinetic interaction between finasteride and doxazosin; however, there is a statistically significant interaction between finasteride and terazosin, which affects the pharmacokinetics of finasteride but not those of terazosin. The clinical significance of this interaction remains to be determined.
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In this study long-term doxazosin treatment was significantly effective and well tolerated for treating BPH in normotensive and hypertensive patients.
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An active component in the tablet Cardura XL is doxazosine. Doxazosine belongs to the third generation of alpha 1-adrenolytics. It is a blocker of post-synaptic alpha 1-receptors both in humans and in animals. It is a long acting preparation. A tablet cover of Cardura XL is built of two layers (GITS system). It has enabled administration of doxazosine once a day. A great advance of the GITS system is a verly slow and systematic release of the drug from the tablet. This release is independent of pH of gastro-intestinal content or peristalsis. After administration of the tablet of Cardura XL, over 85% of the drug is released after 12 hours and the release ends after 12-16 hours. Maximal serum drug level after administration of doxazosine GITS is observed after 14-16 hours. Higher maximal serum drug level is achieved when the drug is administered together with a meal. Using doxazosine in the GITS form, minimal and maximal serum drug levels during the whole 24 hours differ non significantly. GITS technology enabled achieving stable daily serum drug concentration. Introducing doxazosine GITS caused: 1. decrease of Cmax; 2. elongation of Tmax; and 3. decrease of Cmin compared to doxazosine. It became possible due to gradual absorption of the preparation from gastrointestinal tract and improved coefficient of the drug fluctuation. It should be stated that the described pharmacological differences of doxazosine GITS in younger and elderly, in female and male patients do not influence significantly initial dosing of the drug. Stenosis of the gastrointestinal tract or chronic diarrhea affecting bowel passage of the drug, change its therapeutic effect. An effect of doxazosine GITS, doxazosine and placebo on blood pressure was studied in 392 patients with mild and moderate hypertension (< or = 220/95-115 mm Hg). Doxazosine GITS similarly to doxazosine effectively decreases blood pressure. The value of diastolic blood pressure decrease increases together with the therapy duration. Use of the unique GITS technology assures stable daily serum drug concentration. It results in: mild but permanent decrease of the blood pressure, decreased risk of side-effects, including orthostatic hypotony. Based on the performed post-registration studies it should be stated that doxazosine GITS is not only a very effective but also a safe preparation, which may be administered once daily. The treatment should be initialized with a dose of 4 mg daily. In as much as 60% of the patients with mild or moderate arterial hypertension, an initial dose (4 mg of Cardura XL) effectively lowers blood pressure. Taking into consideration unique features of the described preparation, it is worth thinking of Cardura XL while initializing or switching therapy in hypertensive patients. Cardura XL, due to favourable metabolic effects as well as the unique GITS technology seems to be the drug particularly suitable in hypertensive patients with accompanying dyslipidaemia, diabetes mellitus type 2 and/or benign prostata hypertrophy.
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For various reasons, the alpha 1-receptor blocker prazosin has been used infrequently as initial therapy for hypertension. The introduction of additional agents of this class with properties different from prazosin provides slower onset of action, which should reduce the degree of first-dose and postural hypotension and a longer duration of action, which allows for once-a-day dosage. A summary of the published data on efficacy, side effects, and special properties of this class of agents indicates that they will probably be used more extensively, particularly because of their ability to improve lipid and glucose-insulin metabolism.
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During the past few years, several randomised trials have compared the effects of older blood-pressure lowering drugs (diuretics, beta-blockers) with those of newer ones (angiotensin converting enzyme (ACE) inhibitors, calcium entry blockers) on the long-term prognosis. In general, no significant differences were found between these regimes. Recently, the ALLHAT trial, which was the largest hypertension trial ever and in which over 40,000 patients with hypertension participated, was completed. The initial treatment consisted of either the diuretic chlorthalidone, the calcium entry blocker amlodipine, the ACE inhibitor lisinopril, or the alpha-blocker doxazosin. The latter arm was prematurely discontinued because of a higher incidence of the secondary endpoint heart failure and stroke. Based on an intention-to-treat analysis, the other types of treatment proved to be equivalent in terms of the primary endpoint, a composite of fatal coronary heart disease and non-fatal myocardial infarction. Although the investigators conclude that ALLHAT suggests that thiazide diuretics should be first choice in the treatment of hypertension, there are several caveats that tend to lessen the strength of this conclusion.
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Cases were defined as men, aged 40 years and older with a first diagnosis for hip/femur fracture. Controls were matched 1 : 1 on gender, year of birth and general practitioner-practice.
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A prospective study was conducted of 60 patients who were diagnosed with BPH. Patients were aged 45 years or older and had a prostate volume of 30 cc or more, International Prostate Symptom Score (IPSS) of 12 or above, maximal flow rate (Qmax) of 15 ml/s or less, and prostate-specific antigen (PSA) level of less than 10 ng/ml. The patients initially received a combination therapy of doxazosin 4 mg/day and finasteride 5 mg/day for 3 months and were then randomly assigned to receive monotherapy for 3 months. The factors were then compared.
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A cross-over study was done to compare the effects of doxazosin, moduretic and amlodipine on biochemical values in 9 hypertensive Nigerians aged 35 to 65 years. Doxazosin therapy was characterized by significant increase in the levels of mean plasma total protein and albumin, while moduretic therapy showed significant reduction in the mean values of plasma creatinine and calcium. All other parameters did not show any significant variation during doxazosin and moduretic treatment phases; and amlodipine therapy did not have any effect on the biochemical values of the hypertensive patients.
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To the best of our knowledge, there have been no published studies of doxazosin transfer into human milk. In rats, milk concentrations twentyfold higher than in plasma have been reported. Based on these animal data, some references advise to avoid breastfeeding during doxazosin therapy. However, the physicochemical properties of doxazosin suggest low transfer into human milk. A 37-year-old breastfeeding woman who was administered doxazosin 4 mg daily for 2 doses was studied. Doxazosin concentrations in milk and plasma were measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The milk/plasma area under the concentration-time curve (AUC0-18 hours) ratio was 0.1. This finding is consistent with what could be predicted based on the physicochemical properties of doxazosin. The average and maximum milk concentrations were 2.9 and 4.2 µg/L. These values correspond to estimated relative infant doses of 0.06% and 0.09%, respectively, assuming standard infant milk intake. These values are well below the generally accepted cutoff of 10% for predicting safety during breastfeeding. A low relative infant dose of < 0.1% suggests that maternal doxazosin therapy may be compatible with breastfeeding after careful individual risk-benefit analysis.
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Forty-seven patients with idiopathic dilated cardiomyopathy (left ventricular ejection fraction, 0.24±0.09) were randomized to the adrenergic-receptor blockers metoprolol (β1-selective), metoprolol+doxazosin (β1/α1), or carvedilol (β1/β2/α1). Serial radionuclide ventriculography and endomyocardial biopsies were performed at baseline, 3, and 12 months. Expression of 50 mRNA gene products was measured by quantitative polymerase chain reaction. Thirty-one patients achieved left ventricular ejection fraction reverse-remodeling response defined as improvement by ≥0.08 at 12 months or by ≥0.05 at 3 months (Δ left ventricular ejection fraction, 0.21±0.10). Changes in gene expression in responders versus nonresponders were decreases in NPPA and NPPB and increases in MYH6, ATP2A2, PLN, RYR2, ADRA1A, ADRB1, MYL3, PDFKM, PDHX, and CPT1B. All except PDHX involved increase in adult or decrease in fetal cardiac genes, but 100% were concordant with changes predicted by inhibition of β1-adrenergic signaling.
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In animals challenged systemically and intranasally with LPS, doxazosin inhibited TNF-α and MCP-1 production, respectively. In the delayed-type hypersensitivity model, footpad swelling was inhibited by doxazosin. Doxazosin decreased the level of MCP-1 release in the peritoneal cavity of thioglycollate-stimulated animals, though this effect was not statistically significant.
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A model for Q(max) improvement in BPH based on the receptor occupancy theory was able to describe the clinical effects of the alpha(1)-receptor antagonists. Receptor occupancy is a useful index for predicting the clinical effects of alpha(1)-receptor antagonists.
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Adherence to alpha-blockers was less than adherence to finasteride or multiple medications and nonadherence was significantly associated with a procedure. Interventions focused on improving adherence to benign prostatic hyperplasia medications are clearly needed.
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Increasing plasma estrogen (E) levels during the follicular phase of the estrous cycle trigger the pre-ovulatory surge of gonadotropin-releasing hormone (GnRH)/LH. Noradrenaline (NA)-producing cells of the brain stem are involved in regulating GnRH cells and project to the preoptic area (POA) and bed nucleus of stria terminalis (BnST). Input to GnRH cells may be direct or indirect, via relay neurons in the POA/BnST. To investigate this, we ascertained whether an alpha(1)-adrenergic antagonist would block/delay the LH surge in ovariectomised (OVX), E-treated ewes. E benzoate (EB) (50microg) was injected (i.m.) and Doxazosin (100nmol/h) or vehicle was infused into the third ventricle 2-26h after EB injection. Doxazosin reduced the magnitude of the LH surge, but did not affect timing. To determine if NA is released in the POA/BnST of cyclic ewes, we immunostained dopamine-beta-hydroxylase (DBH) in terminal fields. Reduced numbers of varicosities staining for DBH indicates release of NA. The number of varicosities immunostained for DBH was reduced in the dorsal and lateral BnST during the follicular phase and during the preovulatory LH surge compared to the luteal phase. These data suggest that noradrenergic mechanisms are involved in generation of the GnRH/LH surge via projections to the BnST and relay to GnRH cells. Since Doxasozin reduced the magnitude of the LH surge in the E-treated OVX ewe, and release of NA in cyclic ewes occurred during the follicular phase of the estrous cycle, we speculate that NA is a permissive factor in surge generation. Thus, increased noradrenergic activity is not a trigger mechanism for initiation of the surge.
In the total population, home/office SBP, UACR, and baPWV decreased significantly from the baseline. In multivariate regression analyses, DeltabaPWV was significantly associated with DeltaUACR, independent of Deltahome SBP (beta = 0.21, P < 0.001). When the patients were divided into a group with DeltabaPWV of at least 0 cm/s (positive DeltaPWV) and a group with DeltabaPWV of less than 0 cm/s (negative DeltaPWV), the reduction of UACR was greater in the latter group, even after adjustment for the covariates including the change in home SBP. These results were essentially the same when office SBP was entered in place of home SBP, and similar both in the active treatment group and the control group.