Abstract:
BACKGROUND:Physiologic changes of aging may affect processes of drug absorption and distribution, in some cases necessitating age-dependent dose adjustment. OBJECTIVE:The possibility of age dependence in the pharmacokinetic behavior and tolerability of levormeloxifene was investigated in a single-center, open-label study. METHODS:The study comprised 2 groups of healthy postmenopausal women: group A included younger subjects (50-60 years) and group B included elderly subjects (> or = 66 years). All subjects received a single 40-mg tablet of levormeloxifene base. Blood samples were collected immediately before drug intake and at several points after administration, through day 34. Peak plasma concentration, time to maximum plasma concentration, area under the plasma concentration-time curves from zero to the last quantifiable value and to infinity, and terminal half-life were calculated for levormeloxifene and compared between age groups. RESULTS:Of 29 subjects enrolled, 28 (15 group A, 13 group B) completed the study. The ages of the women in group A ranged from 50 to 58 years and in group B from 66 to 79 years. No serious adverse events were reported. Ten subjects experienced 17 adverse events, of which 2 (abdominal pain and vaginal hemorrhage) were judged to be possibly related to study drug. There was no noticeable difference between age groups in the frequency of adverse events or laboratory abnormalities. The plasma concentration-time curves of levormeloxifene were indistinguishable between age groups up to 48 hours after dosing. From 72 hours onward, the mean plasma concentration-time curve was approximately 20% higher and the area under the curve was approximately 19% greater in the older subjects compared with the younger subjects. However, no statistically significant differences were observed between groups in any of the pharmacokinetic parameters, except for the elimination rate constant. The difference in mean elimination half-life was 25 hours (group A, 126 hours; group B, 151 hours). CONCLUSION:The findings suggest that it is not necessary to adjust the dose of levormeloxifene on the basis of age in postmenopausal women. However, these results need confirmation in a multiple-dose setting under steady-state conditions--that is, as the drug is intended to be used clinically.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Kiehr B,Skrumsager BK,Müller M,Pedersen PCdoi
10.1016/s0149-2918(01)80030-8subject
Has Abstractpub_date
2001-01-01 00:00:00pages
62-71issue
1eissn
0149-2918issn
1879-114Xpii
S0149-2918(01)80030-8journal_volume
23pub_type
杂志文章abstract:BACKGROUND:Cytochrome P450-related drug interactions can lead to adverse effects that may affect health care resource utilization. OBJECTIVE:The purpose of this study was to quantify the impact of drug interactions involving hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) on health care resource utiliz...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(02)80102-3
更新日期:2002-12-01 00:00:00
abstract:OBJECTIVE:This meta-analysis was performed to assess the possible prophylactic benefit of prolonged treatment with oral N-acetylcysteine (NAC) in chronic bronchitis (CB) based on qualifying clinical trials. Treatment of acute exacerbations with NAC was not investigated. BACKGROUND:Prolonged treatment with oral NAC has...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析
doi:10.1016/S0149-2918(00)88479-9
更新日期:2000-02-01 00:00:00
abstract::This pilot study was conducted to compare both the clinical effectiveness and the treatment costs of newer (atypical) antipsychotic medications (clozapine and risperidone) with those of older (classic) neuroleptic medications (chlorpromazine and haloperidol) for psychosis in a community mental health care setting. The...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:10.1016/s0149-2918(99)80028-9
更新日期:1999-06-01 00:00:00
abstract:BACKGROUND:The continuing increase in the rate of penicillin and cephalosporin resistance among respiratory pathogens and of cross-resistance to macrolide antibiotics has led to the recommendation that fluoroquinolone antibiotics be used to treat high-risk patients with community-acquired pneumonia (CAP) and acute bact...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/S0149-2918(00)89007-4
更新日期:2000-04-01 00:00:00
abstract:BACKGROUND:Mitoxantrone, an intravenously administered immunosuppressant that inhibits T-cell, B-cell, and macrophage proliferation, is indicated for reducing neurologic disability and relapse frequency in patients with secondary progressive multiple sclerosis (SPMS), progressive relapsing MS, or worsening relapsing-re...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
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更新日期:2006-04-01 00:00:00
abstract:BACKGROUND:Coronary heart disease (CHD) is the leading cause of death in men and women in the United States, with a higher mortality in women, despite a lower prevalence. Statins effectively treat dyslipidemia and reduce the risk of CHD mortality. OBJECTIVE:The objective of this study was to evaluate the treatment of ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2006.04.012
更新日期:2006-04-01 00:00:00
abstract::The antiemetic efficacy and tolerability of four different oral doses of granisetron (0.25, 0.5, 1, and 2 mg twice daily [BID]) were compared in a randomized, double-blind, parallel-group, multicenter study involving 930 patients with malignant disease receiving moderately emetogenic chemotherapy over a 7- or 14-day p...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/0149-2918(95)80005-0
更新日期:1995-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(01)80132-6
更新日期:2001-10-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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更新日期:1996-07-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.04.015
更新日期:2011-05-01 00:00:00
abstract:BACKGROUND:Metastatic bone disease is a serious clinical problem in patients with advanced cancer. Bisphosphonates inhibit the activity of osteoclasts and are the treatment of choice for bone metastases. OBJECTIVE:This article reviews the efficacy and safety data from Phase III trials of ibandronate in metastatic bone...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2004.12.010
更新日期:2004-12-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2006.05.010
更新日期:2006-05-01 00:00:00
abstract:BACKGROUND:Patients and physicians consider rapid onset of pain relief and pain freedom among the most important attributes of migraine therapy. OBJECTIVE:This study compared the effectiveness of rizatriptan 10 mg and usual-care oral migraine medications in everyday clinical practice settings. METHODS:This was a mult...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
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更新日期:2006-06-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(00)89019-0
更新日期:2000-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.11.019
更新日期:2011-12-01 00:00:00
abstract:BACKGROUND:Telbivudine (LdT) is an L-nucleoside that is structurally related to lamivudine. It is highly selective for hepatitis B virus (HBV) and inhibits viral DNA synthesis. LdT was approved by the US Food and Drug Administration on October 25, 2006, for the treatment of chronic HBV infection in adults who have acti...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2007.12.032
更新日期:2007-12-01 00:00:00
abstract::The pharmacokinetics of cimetidine were studied in three newborn infants with reflux esophagitis or stress ulcer. One infant was given 5 mg/kg intravenously (IV), one was given 10 mg/kg IV, and one was given 10 mg orally. Serum concentrations 30 minutes after administration were 1.2 micrograms/ml, 5 micrograms/ml, and...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1985-01-01 00:00:00
abstract:BACKGROUND:Oral bisphosphonates are well established for the treatment and prevention of postmenopausal osteoporosis; however, they are poorly absorbed from the gastrointestinal (GI) tract and have been associated with GI adverse events. Thus, current dosing guidelines recommend that the patient not eat or lie down for...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(03)90005-1
更新日期:2003-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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更新日期:2004-04-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1993-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
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更新日期:2017-11-01 00:00:00
abstract::Cisapride is a substituted piperidinyl benzamide. It is chemically related to metoclopramide but lacks the antidopaminergic properties of metoclopramide that affect the central nervous system and cause extrapyramidal side effects. Cisapride is indicated for the symptomatic treatment of patients with nocturnal heartbur...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
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更新日期:1998-03-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2010.02.013
更新日期:2010-02-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2007.09.012
更新日期:2007-09-01 00:00:00
abstract:BACKGROUND:Trials of monotherapy with alpha(1)-adrenergic-receptor antagonists (alpha(1)ARAs) and 5 alpha-reductase inhibitors (5ARIs) have found that the former drug class is effective in managing benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS) and improving the maximal urinary flow rate...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(07)80077-4
更新日期:2007-03-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1981-01-01 00:00:00
abstract:BACKGROUND:Mirodenafil is a phosphodiesterase type 5 (PDE-5) inhibitor developed for the treatment of erectile dysfunction. Mirodenafil has the possibility of being administered with alcohol. OBJECTIVE:This study assessed the hemodynamic effects and pharmacokinetic properties of mirodenafil administered with alcohol. ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2009.06.008
更新日期:2009-06-01 00:00:00
abstract:PURPOSE:The purposes of this review are to describe the pathogenesis of mucormycosis and to address recent research advances in understanding the mechanisms of fungal invasion and dissemination. METHODS:Studies and reviews published in the PubMed and ClinicalTrials.gov databases until December 2017 that explored or re...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2018.03.009
更新日期:2018-06-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1986-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
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更新日期:2015-09-01 00:00:00