Abstract:
BACKGROUND:Dutasteride is a dual inhibitor of type I and type II 5α-reductases and provides nearly complete suppression of dihydrotestosterone, which plays a key role in the aetiology and development of benign prostatic hyperplasia (BPH). Most knowledge about the efficacy and safety of dutasteride in BPH derives from three pivotal phase III studies conducted primarily in Caucasian populations. OBJECTIVE:This study aimed to evaluate the efficacy and safety of dutasteride in Chinese adults with symptomatic BPH. METHODS:This was a randomized, double-blind, parallel-group, placebo-controlled study conducted over 6 months, followed by an open-label extension of 12 months. A total of 253 BPH subjects with a total prostate volume (TPV) of ≥30 cm3, a maximal urinary flow rate (Q(max)) between 5 and 15 mL/s, and an American Urology Association Symptom Index (AUA-SI) score of ≥12 units were randomized to dutasteride 0.5 mg/day orally or matching placebo treatment in a 1:1 ratio. After 6 months, eligible subjects who volunteered to enter the open-label extension received dutasteride 0.5 mg/day orally. Changes in TPV, Q(max) and AUA-SI as well as drug safety were evaluated. RESULTS:Dutasteride significantly reduced mean TPV compared with placebo at 3 and 6 months (both p < 0.05). At 6 months, mean TPV decreased by 17.14% versus 3.71% in the dutasteride and placebo groups, respectively. Numerically higher improvements in Q(max) and AUA-SI were observed in the dutasteride group at 3 and 6 months, but there was no statistically significant difference between treatment groups. However, ad hoc analysis indicated that, at 6 months, significantly higher proportions of subjects in the dutasteride group experienced a Q(max) improvement of ≥3 mL/s, or an AUA-SI improvement of ≥1 unit, compared with the placebo group (both p < 0.05). According to these criteria, the Q(max) responder rates were 33.63% and 19.83% in the dutasteride- and placebo-treated groups, respectively, and the AUA-SI responder rates were 87.61% and 76.92%, respectively. During the open-label extension, continuous improvements in TPV, Q(max) and AUA-SI were noted in both groups. Dutasteride was well tolerated with a low incidence of treatment-related adverse events over 18 months. CONCLUSION:Dutasteride was effective compared with placebo in the treatment of symptomatic BPH among Chinese patients. The efficacy data from trials involving subjects of different ethnic origins showed some similarities. Dutasteride was generally well tolerated during the study period.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Na Y,Ye Z,Zhang S,Chinese Dutasteride Phase III Trial (ARIA108898) Study Group.doi
10.2165/11593750-000000000-00000subject
Has Abstractpub_date
2012-01-01 00:00:00pages
29-39issue
1eissn
1173-2563issn
1179-1918journal_volume
32pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND AND OBJECTIVES:Vedolizumab, a humanized monoclonal antibody against the α4β7 integrin, is indicated for treatment of moderately to severely active ulcerative colitis or Crohn's disease. In this placebo-controlled, double-blind, randomized, single ascending-dose study, the pharmacokinetics, pharmacodynamics, ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-016-0437-4
更新日期:2016-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Hypertension, one of the major treatable cardiovascular (CV) risk factors, usually occurs in association with other major risk factors. As well as providing rapid blood pressure (BP) goal attainment, antihypertensive therapy should also provide reductions in CV events and mortality in a wide r...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
doi:10.2165/00044011-200828110-00001
更新日期:2008-01-01 00:00:00
abstract::Page 806, column 1, line 3: The text, which previously read. ...
journal_title:Clinical drug investigation
pub_type: 已发布勘误
doi:10.1007/s40261-020-00892-9
更新日期:2020-03-01 00:00:00
abstract:BACKGROUND:Recent data suggest that P-glycoprotein may be involved in cellular transport of lacosamide. OBJECTIVE:To investigate potential drug-drug interactions (DDIs) between lacosamide and digoxin, this phase I, multiple-dose, randomised, double-blind, placebo-controlled, crossover trial assessed the pharmacokineti...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-014-0180-7
更新日期:2014-05-01 00:00:00
abstract::Psychotropic medications and alcohol are potential risk factors for falls in older adults. However, there has been no appraisal of the literature on whether these medications, both singly and in combination with alcohol, are associated with falls in community dwelling older adults (those aged 60 years and older living...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-018-0721-6
更新日期:2019-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Baicalein, a flavonoid isolated from the root of Scutellaria baicalensis Georgi, is a neuroprotective agent under development to treat Parkinson's disease. This study investigated the pharmacokinetics, safety and tolerability of baicalein after a multiple-ascending-dose protocol in healthy Chi...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-016-0418-7
更新日期:2016-09-01 00:00:00
abstract:BACKGROUND:Recent clinical studies have documented the analgesic, anti-inflammatory, antioxidative and anxiolytic effects of exogenous melatonin. The pharmacokinetic properties of melatonin have primarily been investigated in experimental studies. OBJECTIVE:The aim of this study was to estimate the pharmacokinetics of...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-016-0452-5
更新日期:2016-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Oxycodone tamper resistant (OTR) is a new extended-release abuse-deterrent formulation providing improvements in the tamper resistant characteristics. This study aimed to investigate the pharmacokinetic properties of the new OTR tablets and evaluate the bioequivalence of oxycodone from OTR and...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-019-00870-w
更新日期:2020-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:This study was performed in healthy Chinese subjects to evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of a novel injection formulation of dexlansoprazole in the context of single and multiple administration, compared with the original lansoprazole injection. METHODS:H...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.1007/s40261-019-00824-2
更新日期:2019-10-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The implementation of chronic obstructive pulmonary disease (COPD) guidelines in the real-world setting remains low. Pulmonologists should participate in the new paradigms of chronicity of COPD, by providing their knowledge, expertise, innovation and research. The objective of this study was to...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-019-00787-4
更新日期:2019-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Schizophrenia is a severe public health problem and one of the top ten causes of disability, affecting about 1.1% of the world's population. Paliperidone is a new atypical antipsychotic used to treat schizophrenia. Several case reports about unexpected adverse drug reactions of paliperidone ha...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-020-00945-z
更新日期:2020-09-01 00:00:00
abstract::Heart rate is an established prognostic marker for longevity and is an important contributor in the pathophysiology of various cardiovascular diseases, including ischemic heart disease and heart failure. Most ischemic episodes are triggered by an increase in heart rate, which causes an imbalance between myocardial oxy...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-016-0472-1
更新日期:2017-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Statin-induced changes in high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) are unrelated. Many patients initiated on statins experience a paradoxical decrease in HDL-C. The aim of this study was to evaluate the association between a decrease in HDL-C...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-015-0372-9
更新日期:2016-03-01 00:00:00
abstract:OBJECTIVE:To compare the efficacy and safety of single doses of quinfamide and secnidazole in the treatment of amoebic non-dysenteric colitis in children. DESIGN:This was a prospective, longitudinal, double-blind, randomised, comparative study. SETTING:The participants were students or relatives of students at two ur...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200020020-00003
更新日期:2000-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The new oral anticoagulants (NOACs) are used for the prevention of thromboembolic complications in patients with non-valvular atrial fibrillation (AF) and those at risk of deep venous thrombosis. Their rapid onset of action and predictable pharmacokinetic and pharmacodynamic profiles make them...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-016-0436-5
更新日期:2016-10-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Following oral administration of abiraterone acetate, the parent compound abiraterone acetate is rapidly metabolized to abiraterone. To our knowledge, bioanalytical methods to date have not been able to detect the parent compound in human plasma, and bioassay was only performed on the metabolit...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.1007/s40261-019-00752-1
更新日期:2019-03-01 00:00:00
abstract:OBJECTIVE:Central nervous effects of oral anticholinergics may limit the success of incontinence therapy and patient compliance. Only a few studies investigating this topic are available. This study was conducted to determine whether oral anticholinergics alter sleep and psychometric test parameters. DESIGN:Randomised...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323060-00003
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:α(1)-Antitrypsin deficiency (α-ATD) is a disorder inherited in an autosomal recessive pattern, with co-dominant alleles known as the protease inhibitor system (Pi). The main function of α(1)-antitrypsin (α-AT) is to protect the lungs against a powerful elastase released from neutrophil leucocytes. α-ATD typi...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11631920-000000000-00000
更新日期:2012-05-01 00:00:00
abstract::A specific beta(2)-adrenoceptor-mediated effect, hypokalaemia, was studied in healthy volunteers after single as well as multiple dosages of the long-acting agonist formoterol and the short-acting agent salbutamol. The purpose of the study was to test with simple methodologies if rapidly induced tachyphylaxis for this...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199815060-00009
更新日期:1998-01-01 00:00:00
abstract::Cytochrome P450 (CYP) 3A4 has been considered to be the most important enzyme system for metabolism of lopinavir/ritonavir (LPV/r), a widely used HIV protease inhibitor (PI) recommended during pregnancy. Herein we present a clinical case of a pregnant HIV-infected woman who was taking standard doses of LPV/r, 400/100 ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-014-0245-7
更新日期:2015-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Cancer pain affects patients at all stages of the disease and there are clear guidelines for its management. Morphine is considered the first-choice strong opioid in the treatment of moderate-to-severe pain; however, numerous studies have shown that oxycodone controlled-release (CR) has a simi...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章,多中心研究
doi:10.2165/00044011-200828070-00001
更新日期:2008-01-01 00:00:00
abstract::Iobitridol is a water-soluble, non-ionic, monomeric, low-osmolar, iodine-based contrast medium in which the potential for interaction with membrane proteins in the body has been minimized by stable masking of the molecule's lipophilic tri-iodinated benzene ring. It is approved in various countries worldwide for use as...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-013-0055-3
更新日期:2013-02-01 00:00:00
abstract:OBJECTIVES:This paper aimed to provide an overview from published randomised clinical trials of the efficacy and tolerability of lamotrigine monotherapy compared with carbamazepine and phenytoin when initiated in adult patients with newly diagnosed epilepsy. DESIGN:The review included two double-blind, randomised tria...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199816020-00005
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Matrix metalloproteinases (MMPs) are proteases with different biological and pathological activities, and many have been linked to several diseases. Targeting individual MMPs may offer a safer therapeutic potential for several diseases. We assessed the safety, tolerability, and pharmacokinetic...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-020-00981-9
更新日期:2021-01-01 00:00:00
abstract::This article discusses current practice in the treatment of conjunctivitis and how the use of topical moxifloxacin can increase therapeutic effectiveness, reduce treatment failures and, consequently, be cost effective and reduce the societal burden of the disorder. Current practice and effectiveness data were derived ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11589020-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Polypharmacy, regarded as an indicator of potentially inappropriate medications (PIMs), may lead to a higher risk of serious health consequences in elderly patients with osteoporosis. Thus, this study aimed to analyze the association between polypharmacy and hip fracture in patients with osteop...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0716-3
更新日期:2019-01-01 00:00:00
abstract:BACKGROUND:Propofol is approved both for anaesthesia and sedation during intensive care. Serious adverse reactions with propofol have recently been reported, but patient exposure to the drug is unknown. OBJECTIVE:To investigate the consumption of propofol in Finnish hospitals and to develop a denominator to estimate p...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323010-00003
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:Post-marketing surveillance studies can provide supplemental data on the safety of medications in the general population. OBJECTIVE:This study aimed to evaluate the safety of analgesic regimens including the NSAID lornoxicam in the short-term treatment of postoperative pain in a clinically relevant populati...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/11538860-000000000-00000
更新日期:2010-01-01 00:00:00
abstract::Elbasvir/grazoprevir demonstrated high sustained virologic response rates 12 weeks after the end of treatment (SVR12) across five clinical trials in subjects infected with chronic hepatitis C virus (HCV) genotype 1, including those with advanced chronic kidney disease (CKD), and GT4. Despite favorable results overall,...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0492-5
更新日期:2017-04-01 00:00:00
abstract:BACKGROUND:Aliskiren is the first oral direct renin inhibitor to be approved for the treatment of hypertension. The pharmacokinetic and pharmacodynamic profile of aliskiren has been extensively characterized in Caucasian individuals; however, drug disposition, treatment response and tolerability can vary among ethnic g...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11533050-000000000-00000
更新日期:2010-01-01 00:00:00