Abstract:
BACKGROUND:The use of budesonide/formoterol as both maintenance and reliever therapy in asthma is recommended in many countries; however, there are limited data available for the Asian patient population. OBJECTIVE:This study aimed to evaluate the short-term safety and tolerability of a fixed high-dose combination of the inhaled corticosteroid budesonide and the long-acting β(2)-adrenoceptor agonist formoterol with that of the β(2)-agonist terbutaline for acute symptom relief in Japanese adults with persistent asthma who were already receiving a combination of budesonide/formoterol maintenance therapy. METHODS:This was a randomized, double-blind, crossover, active comparator-controlled, phase III study. Patients aged 16-65 years with persistent asthma received either budesonide/formoterol 160 μg/4.5 μg ten inhalations daily for 3 days via Turbuhaler® or terbutaline 0.4 mg ten inhalations daily for 3 days via Turbuhaler®, in addition to budesonide/formoterol 160 μg/4.5 μg one inhalation twice daily as maintenance treatment. After a 7- to 14-day washout period, patients crossed over to receive the other medication for a further 3 days. Adverse events (AEs), clinical laboratory variables, 12-lead electrocardiogram (ECG) and vital signs were assessed throughout. RESULTS:Twenty-five patients (mean age 44.3 years, 40% female) were randomized and received at least one dose of study medication. Overall, 14 AEs were reported in 12 out of 25 patients (48%) during high-dose budesonide/formoterol therapy and 24 AEs were reported in 14 out of 23 patients (61%) during terbutaline therapy. The majority of AEs were mild in intensity and no serious AEs were reported. The most common AEs were tremor (12%) during budesonide/formoterol therapy and tremor (17%), palpitations (13%), tachycardia (13%) and decreased serum potassium (13%) during terbutaline therapy. There were no clinically significant differences from baseline or between groups in laboratory values, vital signs or ECG recordings. conclusion: Budesonide/formoterol 160 μg/4.5 μg ten inhalations daily for 3 days in addition to ongoing budesonide/formoterol 160 μg/4.5 μg one inhalation twice daily maintenance therapy was well tolerated in Japanese adults with persistent asthma. TRIAL REGISTRATION:Clinicaltrials.gov identifier: NCT00837967; AstraZeneca study code: D589LC00003.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Saito T,Hasunuma Tdoi
10.2165/11595440-000000000-00000subject
Has Abstractpub_date
2012-01-01 00:00:00pages
51-61issue
1eissn
1173-2563issn
1179-1918journal_volume
32pub_type
杂志文章,随机对照试验abstract:BACKGROUND:Elderly patients are more susceptible to Clostridium difficile infections (CDIs). Despite existing guidelines, there is no specific treatment for CDI in geriatrics. Vancomycin is commonly used in the treatment of CDI. Teicoplanin is an alternative glycopeptide which recently received marketing authorization ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0524-1
更新日期:2017-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Nonsteroidal anti-inflammatory drugs are effective analgesics but their use during tonsillectomy is controversial because of the risk of postoperative bleeding. The aim of this study was to compare the analgesic efficacy and safety of nimesulide, a preferential cyclo-oxygenase type-2 inhibitor,...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323100-00004
更新日期:2003-01-01 00:00:00
abstract::None of the available antiemetics is entirely effective, perhaps because most of them act through the blockade of one receptor. There is a possibility that a combination of antiemetics with different sites of activity would be more effective than one drug alone for prophylaxis against postoperative nausea and vomiting...
journal_title:Clinical drug investigation
pub_type: 杂志文章,收录出版,评审
doi:10.2165/00044011-200222090-00001
更新日期:2002-09-01 00:00:00
abstract:OBJECTIVE:This open, prospective, non-interventional, non-randomised, multi-centre postmarketing surveillance study was conducted over a mean period of 13.9 weeks to assess the efficacy, safety and acceptance of acarbose in Chinese patients with type 2 diabetes mellitus and subjects with impaired glucose tolerance (IGT...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.2165/00044011-200727060-00003
更新日期:2007-01-01 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:OBJECTIVE:The efficacy and tolerability of acarbose were examined in a postmarketing surveillance study of 27 803 patients with diabetes mellitus (26 044 were diagnosed as having type 2 diabetes) over a 12-week treatment period. PATIENTS AND M ethods: Overall efficacy data were reported for type 1 and type 2 diabetes, ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200525100-00004
更新日期:2005-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The possible adverse or positive effects of levothyroxine treatment among patients with atrial fibrillation have been debated. Atrial fibrillation, levothyroxine treatment, and dementia are common among older adults, yet little is known about the effects of levothyroxine on the development of d...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0740-3
更新日期:2019-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Lenvatinib is an oral, multitargeted tyrosine kinase inhibitor under clinical investigation in solid tumours. This study evaluated the influence of P-glycoprotein (P-gp) inhibition (single-dose rifampicin) and simultaneous cytochrome P450 3A4 (CYP3A4)/P-gp induction (multiple-dose rifampicin) ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-014-0217-y
更新日期:2014-09-01 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
abstract:BACKGROUND AND OBJECTIVES:There is little information on the effects of trandolapril on renal function when used in Canadian general practice. We evaluated the use and blood pressure (BP) lowering effectiveness of trandolapril-based therapies in Canadian conditions of actual care and attempted to capture assessments of...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.1007/s40261-013-0092-y
更新日期:2013-08-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to confirm randomized clinical trial results showing that a fixed timolol/travoprost combination (TT; DuoTrav) controls intraocular pressure (IOP) better than a fixed timolol/latanoprost combination (TL; Xalacom) in everyday ophthalmic practice, when measured in the morning and >24 h...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/0044011-200828120-00004
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Fentanyl buccal soluble film (FBSF) is a small, bilayered, water-soluble polymer film (BioErodible MucoAdhesive; BEMA™) that adheres to the buccal mucosa and rapidly delivers fentanyl into the systemic circulation. It is approved for the treatment of cancer breakthrough pain in adult opioid-to...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11594670-000000000-00000
更新日期:2012-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:This real-world study assessed the prevalence, risk factors for, and incidence of seizures in patients with metastatic castration-resistant prostate cancer (mCRPC). METHODS:Patients with mCRPC were selected from MarketScan Commercial and Medicare Supplemental Databases between 1 January 2009 a...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0578-0
更新日期:2017-12-01 00:00:00
abstract:OBJECTIVE:To estimate the cost effectiveness of venlafaxine compared with generic fluoxetine and generic amitriptyline used in major depressive disorder in primary care in the UK. METHODS:A decision-tree model for the treatment of major depressive disorder was constructed using a Delphi panel. The tree was populated w...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200929030-00004
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:For patients with hypertension, effective 24-hour blood pressure (BP) control is vital to ensure protection against the early morning surge in BP and the associated increased risk of cardiovascular events. The aim of this analysis was to assess the 24-hour antihypertensive efficacy of olmesartan medoxomil (2...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200626040-00002
更新日期:2006-01-01 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:First-line treatment of chronic phase (CP) chronic myeloid leukemia (CML) is based on the first-generation tyrosine kinase inhibitor (TKI) imatinib or the second-generation TKIs dasatinib or nilotinib. Thanks to the efficacy of TKIs, CML has switched from a fatal to a 'chronic' pathology, and ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0676-7
更新日期:2018-09-01 00:00:00
abstract:BACKGROUND:Warfarin is a commonly used oral anticoagulant and its interaction with other drugs can result in serious thrombotic or bleeding events. Currently, there is no definitive evidence on the possibility of an interaction between warfarin and oseltamivir. OBJECTIVE:The objective of this study was to investigate ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11595860-000000000-00000
更新日期:2012-02-01 00:00:00
abstract::Positron emission tomographic brain imaging and pathological examination have revealed that a chronic, intracerebral neuroinflammatory response lasting for years after a single brain injury may occur in humans. Evidence suggests the immune signaling molecule, tumor necrosis factor (TNF), is centrally involved in this ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-014-0186-1
更新日期:2014-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Bilastine is a novel second-generation antihistamine for the symptomatic treatment of allergic rhinitis and urticaria. The objective of this study was to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of bilastine following single and multiple oral doses in healthy Japanese ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-016-0447-2
更新日期:2016-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The hematological side effects associated with mycophenolic acid (MPA) are relatively common and have severe consequences. The majority of literature data have not shown clear consistency in the MPA exposure-neutropenia relationship. We hypothesized that (i) adult de novo kidney transplant rec...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0694-5
更新日期:2018-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Golimumab is a fully human anti-tumor necrosis factor monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). This study estimated rates of prespecified outcomes in patients with RA, PsA or AS initiating golimumab ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-020-00959-7
更新日期:2020-11-01 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:BACKGROUND AND OBJECTIVE:Clinicians must choose between an increasing number of medications for the treatment of pulmonary arterial hypertension (PAH) with different routes of administration, adverse effects, costs and efficacies. We constructed a decision analysis to help inform treatment choices in PAH. METHODS:We c...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11317820-000000000-00000
更新日期:2009-01-01 00:00:00
abstract:OBJECTIVE:To compare the real-life treatment of acute exacerbations of chronic bronchitis (AECBs) using moxifloxacin tablets or one of the oral macrolides azithromycin, clarithromycin or roxithromycin in terms of symptom relief, time until improvement and cure, overall efficacy and tolerability. METHODS:This prospecti...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.2165/00044011-200626120-00007
更新日期:2006-01-01 00:00:00
abstract::The objective of the present study was to determine the frequency of adverse drug reactions (ADRs) in intensive care units (ICUs) and to evaluate their effect on the length of stay. We performed a prospective study to detect ADRs in 420 patients hospitalised in 10 predetermined beds in the ICU of our hospital between ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199815040-00011
更新日期:1998-01-01 00:00:00
abstract::Cefoperazone is a third-generation cefalosporin that contains the N-methyl- thio-tetrazole (NMTT) side chain, which inhibits vitamin K-dependent carboxylation. Administration of NMTT-containing cefalosporins can cause alterations in the hepatic glutathione redox state, resulting in a dose-related increase in oxidised ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200626080-00006
更新日期:2006-01-01 00:00:00
abstract:OBJECTIVE:To investigate prescribing trends of selective serotonin reuptake inhibitors (SSRIs) during the course of the Defeat Depression Campaign (1992 to 1996). METHODS:This study utilised cross-sectional data on the prescribing of SSRIs for the treatment of depression from a large primary care database for the 5 co...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199816060-00005
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND:As an increasing number of elderly are undergoing orthopaedic procedures, it is important to understand and evaluate postoperative pain management in this population, especially in regard to opioid use. Data in the literature pertaining to the very elderly remains scarce. OBJECTIVES:This study was conducted...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-00744-7
更新日期:2019-03-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Little is known about the effects of the calcium channel antagonist manidipine when it is added as a third drug in non-controlled hypertensive patients with diabetes mellitus receiving dual antihypertensive therapy. The aim of this study was to evaluate the response in terms of blood pressure (...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/11587400-000000000-00000
更新日期:2011-01-01 00:00:00