Morning vs evening dosing with doxazosin in benign prostatic hyperplasia: efficacy and safety

Kirby, Roger; Chapple, Christopher R.; Sethia, Krishna; Flannigan, M.; Milroy, E. J. G.; Abrams, Paul

doi:10.1038/sj.pcan.4500220

Cited by 14 publications

(14 citation statements)

References 9 publications

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“…The α‐blockers doxazosin and terazosin can lower blood pressure and this may contribute to their side‐effects [1–8]. Despite inconclusive data for the comparison of doxazosin or terazosin with evening or morning dosing, because too few patients were included in the studies [9–11], it is recommended that patient take these drugs in the evening, to minimize side‐effects when treating LUTS suggestive of benign prostatic obstruction (BPO), particularly at the start of treatment.…”

Section: Introductionmentioning

confidence: 99%

Does the time of administration (morning or evening) affect the tolerability or efficacy of tamsulosin?

et al. 2001

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Objective To determine whether the time of dosing (morning or evening) affects the tolerability or ef®cacy of tamsulosin in the treatment of lower urinary tract symptoms. Patients and methods Data were analysed from an openlabel, observational study in which patients were treated with 0.4 mg tamsulosin once daily for 12 weeks. Treatment effects were determined using the Benign Prostatic Hyperplasia Impact Index, the quality-of-life question of the International Prostate Symptom Score, a similarly phrased question about sexual satisfaction, the maximum urinary¯ow rate, the postvoid residual urine volume, and the overall ef®cacy and tolerability. The results were analysed statistically for differences between dosing times, using analysis of covariance for the quantitative variables and logistic regression for the qualitative variables.Results While no speci®c recommendation about the dosing time was given in the trial, the retrospective analysis showed that 4420 and 2087 patients received tamsulosin in the morning and evening, respectively. Both groups had similar values for all variables before treatment. The ef®cacy and tolerability of tamsulosin treatment was also similar in both groups; there were small advantages for morning dosing, which were statistically signi®cant because there were many patients. Conclusion In contrast to other a-blockers, night-time dosing is not necessary to improve the tolerability or ef®cacy of tamsulosin.

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Section: Introductionmentioning

confidence: 99%

Does the time of administration (morning or evening) affect the tolerability or efficacy of tamsulosin?

et al. 2001

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“…For patients with hepatic impairment, the C max and t 1/2 are not significantly different, but the oral clearance has been shown to be 30% lower compared with healthy subjects [ 10]. Administration with a high‐fat meal does not significantly alter the pharmacokinetics of doxazosin [ 11]; and pharmacokinetics, efficacy, and safety are similar with morning or evening dosing [ 12, 13].…”

Section: Introductionmentioning

confidence: 99%

Clinical pharmacokinetics of doxazosin in a controlled‐release gastrointestinal therapeutic system (GITS) formulation

Chung

Vashi

Puente

et al. 1999

Brit J Clinical Pharma

113

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Aims A controlled-release gastrointestinal therapeutic system (GITS) formulation of doxazosin mesylate, a long-acting selective a 1 -adrenoceptor antagonist, was developed to enhance the pharmacokinetic profile and simplify the titration schedule by precisely controlling drug delivery rate, permitting an initial dose of 4 mg once daily, compared with standard doxazosin, which is initiated at 1 mg day −1 and titrated to a higher therapeutically effective dose. The aim of the present work was to evaluate the pharmacokinetics and bioavailability of doxazosin GITS with respect to the effect of food, age and gender, and multiple dosing. In addition, in vitro performance was assessed in conditions simulating the gastrointestinal environment. Methods A three-way crossover study in 24 subjects assessed the comparative bioavailability of doxazosin GITS under fed and fasting conditions and doxazosin standard under fasting condition. A multiple-dose, two-way crossover study in 35 subjects assessed the comparative pharmacokinetics and bioavailability of doxazosin GITS and doxazosin standard 4 and 8 mg upon multiple dosing. A multiple-dose, four-parallel-group study was conducted to determine the steady-state pharmacokinetics and bioavailability of doxazosin GITS 4 mg in 41 young and elderly male and female subjects. The release-rate profiles of doxazosin GITS were determined in artificial gastric fluid ( pH=1.2), intestinal fluid ( pH=7.5), and water. The effect of agitation on the dissolution characteristics of doxazosin GITS in artificial gastric fluid was studied at stirring rates of 50, 75, and 100 rev min −1 . ResultsIn vitro studies demonstrated that release rates for the GITS tablet are independent of pH in the range of 1.2 (gastric) to 7.5 (intestinal), and of stirring rates simulating gastrointestinal motility. Clinical pharmacology studies showed that doxazosin GITS had a lower maximum plasma concentration, prolonged time to reach maximum plasma concentration, and a higher minimum plasma concentration compared with doxazosin standard. Thus, the GITS formulation results in a more gradual absorption of doxazosin, and a reduced plasma doxazosin concentration peak-to-trough fluctuation ratio. The relative bioavailability of doxazosin GITS is approximately 60%. With a high-fat meal, the maximum plasma concentration and area under the concentration-time curve were 31% and 18% higher, respectively ( P<0.05). Bioequivalence was established between the dose strengths of two 4 mg doxazosin GITS tablets and one 8 mg doxazosin GITS tablet. For both young adult and elderly subjects, and males and females, the pharmacokinetics of doxazosin GITS once daily for 7 days were comparable. Doxazosin GITS was well tolerated in the subjects studied, including young and elderly males and females. Conclusions The GITS formulation of doxazosin enhances the pharmacokinetic profile compared with doxazosin standard, allowing more gradual absorption of doxazosin, and a reduced plasma doxazosin peak-to-trough concentration ratio. Thus, doxazosi...

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“…These compounds were nisoldipine [9], fluoxetine [10], doxazosin [11,12], ranitidine, famotidine [13], lansoprazole [14], fluvastatin [15], isradipine [16], trandolapril [17], ciclesonide [18], and diltiazem [19], for which the recommendation was 'morning or evening' administration. On the other hand for 64% (21/33) of the listed drugs the administration at a specific time of the day significantly improved the outcome.…”

Section: Analysis Of Clinical Trialsmentioning

confidence: 99%

Appropriateness of timing of drug administration in electronic prescriptions

Hassan

Haefeli

2010

Pharm World Sci

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Morning vs evening dosing with doxazosin in benign prostatic hyperplasia: efficacy and safety

Cited by 14 publications

References 9 publications

Does the time of administration (morning or evening) affect the tolerability or efficacy of tamsulosin?

Does the time of administration (morning or evening) affect the tolerability or efficacy of tamsulosin?

Clinical pharmacokinetics of doxazosin in a controlled‐release gastrointestinal therapeutic system (GITS) formulation

Appropriateness of timing of drug administration in electronic prescriptions

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