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) in routine clinical practice. Subjects with IGT were included in analyses because acarbose has been approved for treatment of this condition since 2002. PATIENTS AND METHODS:A total of 2550 study participants were enrolled by 133 physicians throughout China. Efficacy parameters were the changes from initial visit to the end of study in glycosylated haemoglobin (HbA(1c)), fasting blood glucose (FBG), postprandial BG and bodyweight. RESULTS:The majority of study participants (74.7%) were newly diagnosed. Most (77.0%) were administered acarbose 50mg three times daily (the recommended standard dose in China) throughout the study and more than half (51.7%) received concomitant antihyperglycaemic treatment. Acarbose treatment reduced HbA(1c) by 1.4% to 6.7%, FBG by 38.5 mg/dL to 116.4 mg/dL, 2-hour postprandial BG by 92.2 mg/dL to 149.0 mg/dL and bodyweight by 0.4 kg to 67.5 kg. Subgroup analyses for type 2 diabetes and IGT populations were also conducted. In diabetic patients, HbA(1c) was reduced by 1.4%, FBG by 42.1 mg/dL and 2-hour postprandial BG by 98.9 mg/dL. Marked reductions were also achieved in the IGT population (0.9% for HbA(1c), 11.8 mg/dL for FBG and 42.9 mg/dL for 2-hour postprandial BG) despite lower baseline glucose levels in this group than in patients with type 2 diabetes. Bodyweight slightly increased in the IGT population. Only 12 acarbose-related adverse events, none of which was serious, were reported. The attending physicians assessed treatment efficacy as 'good' or 'very good' for 92.4%, tolerability as 'good' or 'very good' for 91.1%, and patient acceptance as 'good' or 'very good' for 89.8% of all study participants. CONCLUSION:Acarbose was efficacious, safe and well accepted by Chinese patients with type 2 diabetes and subjects with IGT under day-to-day treatment conditions, both as monotherapy and in combination with other antihyperglycaemic medication.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Pan CY,Landen Hdoi
10.2165/00044011-200727060-00003subject
Has Abstractpub_date
2007-01-01 00:00:00pages
397-405issue
6eissn
1173-2563issn
1179-1918pii
2763journal_volume
27pub_type
杂志文章,多中心研究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: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 OBJECTIVE:Recently the PatenT (Prevalence, awareness, treatment and control of hypertension in Turkey) study showed that while the prevalence of hypertension in Turkey is high, effective control of BP is infrequently achieved. This study investigated the efficacy and safety of quinapril (as monotherapy o...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200727090-00003
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Insulin degludec is a basal insulin with a slow and distinct absorption mechanism resulting in an ultra-long, flat, and stable pharmacokinetic profile in patients with diabetes mellitus. The aim of this study was to examine the effect of hepatic impairment on the single-dose pharmacokinetics of...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-013-0154-1
更新日期:2014-02-01 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:BACKGROUND AND OBJECTIVES:Despite the introduction of Medicare Part D (MPD) and 2012 Affordable Care Act (ACA), patients have a cost burden due to increases in drug prices. To overcome cost barriers, some patients purchase their medications from Canadian online pharmacies as Canadian prescription drug prices are believ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0556-6
更新日期:2017-10-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Cerebral vasospasm is a common and serious complication of aneurysmal subarachnoid haemorrhage (SAH). Many studies have revealed a role of inflammation in the development of cerebral vasospasm. This study aimed to investigate whether topically administered dexamethasone could attenuate vasospas...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/00044011-200727120-00004
更新日期:2007-01-01 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 AND OBJECTIVE:There is a risk that disturbances of activities of daily living (ADL) due to rheumatoid arthritis (RA) are increased by the occurrence of fractures, including vertebral compression fractures and femoral neck fractures, in RA patients receiving oral corticosteroid therapy. Bisphosphonates are mo...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200828030-00002
更新日期:2008-01-01 00:00:00
abstract:OBJECTIVE:This study aimed to investigate the relative bioavailability and bioequivalence of two omeprazole enteric-coated formulations following repeated doses (steady state) in healthy male and female adult volunteers. DESIGN AND STUDY PARTICIPANTS:The study formulation (Ompranyt® 20mg capsules, Bial-Industrial Farm...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200121030-00006
更新日期:2001-03-01 00:00:00
abstract:OBJECTIVES:This study investigated the pharmacokinetics and pharmacodynamics of a fixed-dose combination (FDC) tablet of olmesartan medoxomil 20 mg and amlodipine 5 mg (CS-8663) in healthy Chinese subjects. METHODS:This single-centre, open-label study was conducted in five healthy males and five females aged 18-45 yea...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-012-0026-0
更新日期:2012-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Several cases of facial paralysis have been reported following influenza vaccination; however, recent surveillance studies have not shown an increased risk. In this study, we analyzed the vaccine adverse event reporting system (VAERS) data to determine whether the facial paralysis reporting rat...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-020-00952-0
更新日期:2020-09-01 00:00:00
abstract:BACKGROUND:Rates and impacts of worsening symptoms in patients with psoriasis have not been well characterized. OBJECTIVES:To assess the risk of clinically relevant worsening of psoriasis symptoms in patients treated with adalimumab versus placebo and to determine the health-related quality-of-life (HRQOL) impacts of ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11539360-000000000-00000
更新日期:2011-01-01 00:00:00
abstract::The original version of this article unfortunately contained a mistake. The corresponding author was incorrect. ...
journal_title:Clinical drug investigation
pub_type: 已发布勘误
doi:10.1007/s40261-019-00817-1
更新日期:2019-07-01 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: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::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::Appropriate and successful management of pain with opioid analgesics is based on tailoring pharmacologic treatment to the individual and identifying the minimal effective dose at which pain is controlled with minimal adverse effects. Morphine and morphine-like-agonists exhibit similar pharmacodynamic profiles, but sub...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/0044011-200929001-00002
更新日期:2009-01-01 00:00:00
abstract::Intramuscular 17 α-hydroxyprogesterone caproate (Makena(®)), a synthetic progestin, is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of a singleton spontaneous preterm birth. Makena(®) reduces the risk of preterm birth in this patient population, and is associated...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-013-0060-6
更新日期:2013-03-01 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:BACKGROUND:The Benign Prostatic Hyperplasia-Patient Impact Measure (BPH-PIM) is a self-reported quality-of-life questionnaire for measuring the impact of urinary/prostate symptoms on the quality of life of patients with BPH. The aim of the present study was to adapt the original instrument to Spanish (for use in Spain)...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200626020-00005
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:As compared with individual tablets, saxagliptin/metformin extended-release (XR) fixed-dose combination (FDC) tablets offer potential for increased patient compliance with the convenience of once-daily dosing. Two bioequivalence studies assessed the fed-state bioequivalence of saxagliptin/metf...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11590290-000000000-00000
更新日期:2011-01-01 00:00:00
abstract::West syndrome (WS), also known as infantile spasms, occurs in infancy with a peak between 4 and 7 months. Spasms, neurodevelopmental regression and hypsarrhythmia on electroencephalogram (EEG) basically define WS. The International League Against Epilepsy commission classifies the aetiologies of WS into genetic, struc...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-017-0595-z
更新日期:2018-02-01 00:00:00
abstract::Mecapegfilgrastim (HHPG-19K) is a long-acting pegylated recombinant human granulocyte-colony stimulating factor (rhG-CSF) that is administered subcutaneously as prophylaxis once per chemotherapy cycle as a weight-adjusted dose of 100 µg/kg or as a 6 mg fixed dose. It is approved in China to reduce the incidence of inf...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-019-00836-y
更新日期:2019-10-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Olanzapine is an atypical antipsychotic indicated for the treatment of schizophrenia and, either as monotherapy or as an adjunct to lithium or valproate, for bipolar I disorder. Multiple daily doses of olanzapine do not affect the pharmacokinetics of lithium or valproate; therefore, concomitant...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-019-00860-y
更新日期:2020-01-01 00:00:00
abstract::Despite the availability of effective pain treatments, there are numerous barriers to effective management resulting in a large proportion of patients not achieving optimal pain control. Chronic pain is inadequately treated because of a combination of cultural, societal, educational, political and religious constraint...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/11630040-000000000-00000
更新日期:2012-02-22 00:00:00
abstract:BACKGROUND:NSAIDs are widely used for patients presenting with low back pain. A quick-release formulation of lornoxicam, a potent NSAID from the chemical class of oxicams, offers a faster onset of pain relief compared with the standard tablet formulation. METHODS:Time to onset of pain relief with lornoxicam was compar...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200626050-00004
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years since the invention of lasers. The HairMax LaserComb is a hand-held Class 3R...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200929050-00001
更新日期:2009-01-01 00:00:00
abstract:OBJECTIVE:This study aimed to compare the systemic bioavailability of two aciclovir tablets, Rouz-Aciclovir (test) and Zovirax (reference), in 12 healthy volunteers. METHODS:In a crossover design, each subject received a single oral dose of aciclovir 400 mg followed by a 7-day washout period. Plasma concentrations of ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200828010-00006
更新日期:2008-01-01 00:00:00
abstract:OBJECTIVE:To evaluate the efficacy and safety of the natural platelet-activating factor receptor antagonist, BN 52021 (ginkgolide B) in the treatment of patients with severe sepsis related to Gram-negative and mixed bacterial infection. DESIGN AND SETTING:Prospective, randomised, double-blind, placebo-controlled, mult...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200424030-00002
更新日期:2004-01-01 00:00:00