Abstract:
INTRODUCTION:More and more evidence suggests that the density of calcification plays an important role in the plaque stability. However, few studies have investigated the statin treatment on the density of plaque calcification in patients with both coronary artery disease (CAD) and type 2 diabetes mellitus. METHODS:One hundred and twenty-two CAD patients with type 2 diabetes with confirmed coronary artery calcification (CAC) will be recruited consecutively in a 12-month period. These patients will receive rosuvastatin (20 mg/day) therapy in the next 24 months. Blood tests and adverse events will be collected at routine follow-up of 1, 3, 6, 12, 18 and 24 months. The primary endpoint will be the change of CAC density score measured by coronary CT angiography after 24 months' treatment of rosuvastatin (20 mg/day) compared with baseline. The secondary endpoints will be the change of serum sclerostin and the effect on the volume score of CAC in those patients. RESULTS:We expect that rosuvastatin could both increase the density of CAC to improve plaque stability and up-regulate serum sclerostin, which would suggest the underlying mechanism of the plaque stabilization by a statin. CONCLUSION:This study would be the first to demonstrate the impact of rosuvastatin on the density score of coronary artery calcification in CAD patients with type 2 diabetes. This study has been registered in ClinicalTrials.gov (NCT02418884).
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Zhang W,Luan Y,Jin C,Xu S,Bi X,Zhao Y,Qiu F,Fu G,Wang Mdoi
10.1007/s40261-016-0445-4subject
Has Abstractpub_date
2016-12-01 00:00:00pages
1023-1029issue
12eissn
1173-2563issn
1179-1918pii
10.1007/s40261-016-0445-4journal_volume
36pub_type
临床试验,杂志文章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:The management of patients on vitamin K antagonist therapy who require an invasive procedure is problematic. A randomised, controlled, double-blind clinical trial was designed to compare the efficacy and safety of bemiparin, a low molecular weight heparin (LMWH), with unfractionated heparin (UF...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-013-0141-6
更新日期:2013-12-01 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 AND OBJECTIVE:Gemigliptin is a novel dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes mellitus. This study evaluated possible pharmacodynamic and pharmacokinetic interactions between gemigliptin and metformin and investigated their tolerability. METHODS:A randomized, open-la...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-014-0184-3
更新日期:2014-06-01 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::Early initiation of rational and effective combination therapy consisting of antihypertensive drugs with two different and complementary mechanisms of actions is increasingly becoming accepted in clinical practice and by guidelines as a first-line approach to control blood pressure (BP) and prevent cardiovascular outc...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/11538440-000000000-00000
更新日期:2010-01-01 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: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::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: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 OBJECTIVES:Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract. DA-6034 has been shown to be effective in an IBD model and has demonstrated a good toxicological profile in preclinical studies. This study evaluated the tolerability, safety and pharmacokinetics...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-013-0147-0
更新日期:2014-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The time-course when changes in glycemic control and body weight were first manifest in patients with type 2 diabetes mellitus (T2DM) treated with a combination of insulin degludec and liraglutide (IDegLira) was assessed, comparing IDegLira to its individual components. METHODS:Data from week...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-016-0376-0
更新日期:2016-04-01 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:NSAIDs are widely used to treat fever and pain in children, but their possible role in the progression of some bacterial infections is controversial. OBJECTIVE:This study was performed to analyse reported cases of severe bacterial infection associated with NSAID exposure in children admitted for this reason...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11532890-000000000-00000
更新日期:2010-01-01 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: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 AND OBJECTIVE:Several systematic reviews and meta-analyses have been conducted including an analysis to investigate the difference between ethnic groups in the glucose-lowering efficacy of dipeptidyl peptidase-4 (DPP-4) inhibitors. This study assessed the factors related to the glucose-lowering efficacy and ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,meta分析,评审
doi:10.1007/s40261-016-0478-8
更新日期:2017-03-01 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:BACKGROUND AND OBJECTIVE:Schizophrenia treatment has been shifting to resocialization by efficacious antipsychotic drugs. However, even some of the pivotal studies of approved new antipsychotic drugs with proven efficacy had failed due to high placebo response. The aim of this study was to identify the potential factor...
journal_title:Clinical drug investigation
pub_type: 杂志文章,meta分析
doi:10.1007/s40261-018-0661-1
更新日期:2018-08-01 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:OBJECTIVE:To evaluate the cost effectiveness of subcutaneous interferon-beta-1a (IFNbeta-1a) 44mug three times weekly in relapsing-remitting multiple sclerosis (RRMS) using an econometric model. METHODS:Data on RRMS patients treated with IFNbeta-1a 22 or 44mug subcutaneously three times weekly or placebo for up to 4 y...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323090-00003
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Warfarin-related nephropathy is an unexplained acute kidney injury, and may occur in patients with supratherapeutic INR, in the absence of overt bleeding. Similar findings have been observed in rats treated with dabigatran etexilate. We conducted a prospective study in dabigatran etexilate-tre...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0742-1
更新日期:2019-04-01 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: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 AND OBJECTIVES:Currently evidence about clinical and demographic predictors of response to newer antidepressants such as duloxetine is limited. This study aimed to investigate whether a number of predictors, particularly co-morbid anxiety disorders and anxious depression, are associated with clinical improve...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/11588800-000000000-00000
更新日期:2011-01-01 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:BACKGROUND:Indacaterol is a novel, inhaled, once-daily, ultra-long-acting β2-adrenoceptor agonist that has been approved in the EU for the treatment of chronic obstructive pulmonary disease (COPD). Ethnic differences may influence the pharmacokinetics and pharmacodynamics of a drug, and it is therefore important to com...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11586520-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Patients with cancer are at high risk of major depressive disorder (MDD), but little is known about their MDD treatment. We investigated the use of antidepressants and other drugs for MDD after cancer diagnosis, and patient characteristics associated with their use. METHODS:Adults with a new c...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-020-00976-6
更新日期:2020-12-01 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:BACKGROUND AND OBJECTIVE:TZP-101 is a selective, small molecule ghrelin receptor agonist in clinical development for the treatment of gastric motility disorders. The objectives of this study was to assess pharmacokinetic parameters of TZP-101 after multiple- and single-dose administration to healthy subjects and patien...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200929060-00004
更新日期:2009-01-01 00:00:00