当前位置： SCI文献检索 > CLINICAL DRUG INVESTIGATION期刊下所有文献 > Effect of concomitant icosapent ethyl (eicosapentaenoic acid ethyl ester) on the pharmacokinetics of atorvastatin.

Effect of concomitant icosapent ethyl (eicosapentaenoic acid ethyl ester) on the pharmacokinetics of atorvastatin.

Abstract：

BACKGROUND AND OBJECTIVE:Icosapent ethyl is a high-purity prescription form of eicosapentaenoic acid ethyl ester approved as an adjunct to diet to reduce triglyceride levels in adult patients with triglyceride levels ≥500 mg/dL (≥5.65 mmol/L). The objective of this open-label, drug-drug interaction study was to examine the effects of icosapent ethyl on the steady-state pharmacokinetics of atorvastatin, a commonly prescribed medication in patients with dyslipidaemia. METHODS:Thirty healthy subjects received atorvastatin 80 mg/day on days 1-7, icosapent ethyl 4 g/day on days 8-28, and co-administration on days 29-35. Primary end-points were natural log-transformed maximum plasma concentration (C(max)) and area under the concentration-versus-time curve from 0 to 24 h (AUC(0-24)) for atorvastatin, 2-hydroxyatorvastatin, and 4-hydroxyatorvastatin with and without icosapent ethyl. RESULTS:Of the 30 subjects enrolled, 26 completed the study. The 90% confidence intervals for C(max) and AUC(0-24) least-squares geometric mean ratios were within the 0.80-1.25 bounds. Concomitant administration of icosapent ethyl and atorvastatin was safe and well tolerated and icosapent ethyl did not significantly change the steady state C(max) and AUC(0-24) of atorvastatin, 2-hydroxyatorvastatin, or 4-hydroxyatorvastatin. CONCLUSIONS:At steady-state concentrations, icosapent ethyl did not have an effect on the pharmacokinetics of atorvastatin. Co-administration of icosapent ethyl and atorvastatin was safe and well tolerated in healthy adult subjects.

journal_name

Clin Drug Investig

journal_title

Clinical drug investigation

authors

Braeckman RA,Stirtan WG,Soni PN

doi

10.1007/s40261-014-0252-8

subject

Has Abstract

pub_date

2015-01-01 00:00:00

pages

45-51

issue

1

eissn

1173-2563

issn

1179-1918

journal_volume

35

pub_type

杂志文章

相关文献

CLINICAL DRUG INVESTIGATION文献大全
  • Factors Related to the Glucose-Lowering Efficacy of Dipeptidyl Peptidase-4 Inhibitors: A Systematic Review and Meta-Analysis Focusing on Ethnicity and Study Regions.

    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

    authors： Fujita K,Kaneko M,Narukawa M

    更新日期：2017-03-01 00:00:00

  • Pharmacokinetic and pharmacodynamic profiles of a fixed-dose combination of olmesartan medoxomil and amlodipine in healthy Chinese males and females.

    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

    authors： Chen X,Hu P,Jiang J,Liu T,Zhong W,Liu H,Zhao Q

    更新日期：2012-12-01 00:00:00

  • Efficacy and Safety of the Platelet-Activating Factor Receptor Antagonist BN 52021 (Ginkgolide B) in Patients with Severe Sepsis : A Randomised, Double-Blind, Placebo-Controlled, Multicentre Trial.

    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

    authors： Albrecht DM,van Ackern K,Bender HJ,Hof H,Kox W,Victor N,Funk P,Kieser M,Köhler S,Krausch D,Marzi I,Menges T,Schmidt H

    更新日期：2004-01-01 00:00:00

  • Relative Bioavailability of Two Enteric-Coated Formulations of Omeprazole following Repeated Doses in Healthy Volunteers.

    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

    authors： Vaz-da-Silva M,Hainzl D,Almeida L,Dolgner A,Silveira P,Maia J,Soares-da-Silva P

    更新日期：2001-03-01 00:00:00

  • Effectiveness and Safety of Amlodipine in Newly Diagnosed Hypertensive Patients and in Previously Diagnosed Hypertensive Patients not Controlled with their Usual Treatment (NOTA Study).

    abstract：OBJECTIVE:To evaluate the effectiveness and safety of amlodipine in two cohorts of hypertensive patients, one newly diagnosed and the other previously diagnosed but not controlled with drug therapy, and to assess the risk factors for the entire sample at the outset of the study. PATIENTS AND DESIGN:We designed a postm...

    journal_title：Clinical drug investigation

    pub_type： 杂志文章

    doi：10.2165/00044011-200323120-00001

    authors： Valcárcel Y,Jiménez R,Arístegui R,Gil A,Nota Study Group.

    更新日期：2003-01-01 00:00:00

  • Pattern of Use and Long-Term Safety of Tyrosine Kinase Inhibitors: A Decade of Real-World Management of Chronic Myeloid Leukemia.

    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

    authors： Bettiol A,Marconi E,Lombardi N,Crescioli G,Gherlinzoni F,Walley T,Vannacci A,Chinellato A,Giusti P

    更新日期：2018-09-01 00:00:00

  • Diclofenac epolamine (Flector) patch: evidence for topical activity.

    abstract：:This review focuses on previously unpublished clinical and pharmacokinetic data with the diclofenac epolamine (diclofenac hydroxyethylpyrrolidine) patch supporting the hypothesis of a topical effect of this formulation. Previous studies have shown that 1 or 2 weeks of treatment with diclofenac epolamine provides pain ...

    journal_title：Clinical drug investigation

    pub_type： 杂志文章,评审

    doi：10.2165/0044011-200929010-00001

    authors： Petersen B,Rovati S

    更新日期：2009-01-01 00:00:00

  • Management of cognitive determinants in senile dementia of Alzheimer's type: therapeutic potential of a novel polyherbal drug product.

    abstract：BACKGROUND AND OBJECTIVE:The enigmatic etiology of neurodegenerative diseases poses a challenge for the development of novel and efficient drugs. The objective of the present study was to evaluate the efficacy of a polyherbal (test) formulation on cognitive functions, inflammatory markers and oxidative stress in health...

    journal_title：Clinical drug investigation

    pub_type： 杂志文章,随机对照试验

    doi：10.1007/s40261-014-0235-9

    authors： Sadhu A,Upadhyay P,Agrawal A,Ilango K,Karmakar D,Singh GP,Dubey GP

    更新日期：2014-12-01 00:00:00

  • Indinavir Pharmacokinetics during Different Phases of the Menstrual Cycle in HIV-Infected Women.

    abstract：OBJECTIVE:To characterise the pharmacokinetics of indinavir during different phases of the menstrual cycle in HIV-infected women. DESIGN:Open-label study. SETTING:The immunodeficiency clinic at Erie County Medical Center, Buffalo, New York. PATIENTS:Ten HIV-infected women were enrolled in the study. Eligibility crit...

    journal_title：Clinical drug investigation

    pub_type： 杂志文章

    doi：10.2165/00044011-200222020-00007

    authors： Frost CE,Adams J,Shelton M,Ebid AH,Gugino LJ,Hewitt R,Difrancesco R,Ingalls E,Cousins S,Hu J,Morse GD

    更新日期：2002-01-01 00:00:00

  • Reduction in opioid-related adverse events and improvement in function with parecoxib followed by valdecoxib treatment after non-cardiac surgery: a randomized, double-blind, placebo-controlled, parallel-group trial.

    abstract：BACKGROUND:Multimodal pain therapy including cyclo-oxygenase-2 inhibitors can result in optimal pain management with decreased opioid use and fewer opioid-related adverse events. Patient reported outcomes (PROs) help identify benefits in reduced opioid use and increased pain control. METHODS:In this randomized, double...

    journal_title：Clinical drug investigation

    pub_type： 杂志文章,多中心研究,随机对照试验

    doi：10.2165/11317570-000000000-00000

    authors： Langford RM,Joshi GP,Gan TJ,Mattera MS,Chen WH,Revicki DA,Chen C,Zlateva G

    更新日期：2009-01-01 00:00:00

  • Lack of bioequivalence between two aciclovir tablets in healthy subjects.

    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

    authors： Amini H,Javan M,Gazerani P,Ghaffari A,Ahmadiani A

    更新日期：2008-01-01 00:00:00

  • Pharmacokinetics, safety and tolerability of DA-6034, an anti-inflammatory agent, after single and multiple oral administrations in healthy volunteers.

    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

    authors： Lee J,Shin KH,Kim JR,Lim KS,Jang IJ,Chung JY

    更新日期：2014-01-01 00:00:00

  • A Literature Review of Psychotropic Medications and Alcohol as Risk Factors for Falls in Community Dwelling Older Adults.

    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

    authors： Laberge S,Crizzle AM

    更新日期：2019-02-01 00:00:00

  • Acid-Suppressive Therapy and Risk of Infections: Pros and Cons.

    abstract：:This narrative review summarises the benefits, risks and appropriate use of acid-suppressing drugs (ASDs), proton pump inhibitors and histamine-2 receptor antagonists, advocating a rationale balanced and individualised approach aimed to minimise any serious adverse consequences. It focuses on current controversies on ...

    journal_title：Clinical drug investigation

    pub_type： 杂志文章,评审

    doi：10.1007/s40261-017-0519-y

    authors： Fisher L,Fisher A

    更新日期：2017-07-01 00:00:00

  • Association Between Paradoxical HDL Cholesterol Decrease and Risk of Major Adverse Cardiovascular Events in Patients Initiated on Statin Treatment in a Primary Care Setting.

    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

    authors： Hasvold P,Thuresson M,Sundström J,Hammar N,Kjeldsen SE,Johansson G,Holme I,Bodegård J

    更新日期：2016-03-01 00:00:00

  • Insulin detemir results in less weight gain than NPH insulin when used in basal-bolus therapy for type 2 diabetes mellitus, and this advantage increases with baseline body mass index.

    abstract：OBJECTIVE:Weight gain during insulin therapy can be a challenging problem in already overweight type 2 diabetes mellitus patients, affecting treatment compliance and long-term prognosis. The analogue insulin detemir has been reported to have a weight-sparing effect compared with other basal insulins. This pooled analys...

    journal_title：Clinical drug investigation

    pub_type： 杂志文章,多中心研究,随机对照试验

    doi：10.2165/00044011-200727040-00007

    authors： Raslová K,Tamer SC,Clauson P,Karl D

    更新日期：2007-01-01 00:00:00

  • Hormonal Contraception and Depression: Updated Evidence and Implications in Clinical Practice.

    abstract：:Hormonal contraceptives are used worldwide by more than 100 million women. Some studies have been published about the possible appearance of depressive symptoms when using hormonal contraceptives, but this link is still a matter of debate. The purpose of this review is to provide an update of the literature on this is...

    journal_title：Clinical drug investigation

    pub_type： 杂志文章,评审

    doi：10.1007/s40261-020-00966-8

    authors： Fruzzetti F,Fidecicchi T

    更新日期：2020-12-01 00:00:00

  • Psychiatric symptoms induced by antiviral therapy in chronic hepatitis C: comparison between interferon-alpha-2a and interferon-alpha-2b.

    abstract：BACKGROUND AND OBJECTIVE:Interferon-alpha treatment is associated with a large number of adverse effects. Depressive symptoms are not unexpected, and potentially dangerous psychiatric adverse effects can induce life-threatening conditions. We compared the incidence of depressive symptoms in patients with chronic hepati...

    journal_title：Clinical drug investigation

    pub_type： 杂志文章,随机对照试验

    doi：10.2165/00044011-200626110-00005

    authors： Neri S,Pulvirenti D,Bertino G

    更新日期：2006-01-01 00:00:00

  • Risk Factors for and Incidence of Seizures in Metastatic Castration-Resistant Prostate Cancer: A Real-World Retrospective Cohort Study.

    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

    authors： Dharmani C,Bonafede M,Krivoshik A

    更新日期：2017-12-01 00:00:00

  • Immediate neurological recovery following perispinal etanercept years after brain injury.

    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

    authors： Tobinick E,Rodriguez-Romanacce H,Levine A,Ignatowski TA,Spengler RN

    更新日期：2014-05-01 00:00:00

  • Pharmacokinetic and pharmacodynamic interaction between gemigliptin and metformin in healthy subjects.

    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

    authors： Shin D,Cho YM,Lee S,Lim KS,Kim JA,Ahn JY,Cho JY,Lee H,Jang IJ,Yu KS

    更新日期：2014-06-01 00:00:00

  • Long-Term Cost Effectiveness of Interferon-beta-1a in the Treatment of Relapsing-Remitting Multiple Sclerosis : An Econometric Model.

    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

    authors： Lepen C,Coyle P,Vollmer T,Blumhardt L,Lilliu H,Beresniak A

    更新日期：2003-01-01 00:00:00

  • Evaluation of the Pharmacokinetics of Abiraterone Acetate and Abiraterone Following Single-Dose Administration of Abiraterone Acetate to Healthy Subjects.

    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

    authors： Bouhajib M,Tayab Z

    更新日期：2019-03-01 00:00:00

  • Pharmacokinetics, safety and tolerability of single and multiple oral doses of aliskiren in healthy Chinese subjects: a randomized, single-blind, parallel-group, placebo-controlled study.

    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

    authors： Hu P,Bartlett M,Karan RS,Jiang J,Zhang S,Zhang J,Howard D,Yeh CM,Al-Fayoumi S,Jarugula V,Dole WP

    更新日期：2010-01-01 00:00:00

  • Hypokalaemia in healthy volunteers after single and multiple doses of formoterol or salbutamol.

    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

    authors： van den Berg BT,Louwerse RT,Luiken GJ,Jonkers RE,van Boxtel CJ

    更新日期：1998-01-01 00:00:00

  • Oral Teicoplanin as an Alternative First-Line Regimen in Clostridium difficile Infection in Elderly Patients: A Case Series.

    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

    authors： Davido B,Leplay C,Bouchand F,Dinh A,Villart M,Le Quintrec JL,Teillet L,Salomon J,Michelon H

    更新日期：2017-07-01 00:00:00

  • High-dose N-acetylcysteine in patients with exacerbations of chronic obstructive pulmonary disease.

    abstract：OBJECTIVE:To investigate the efficacy and tolerability of high-dose N-acetylcysteine (NAC) in the treatment of patients with exacerbations of chronic obstructive pulmonary disease (COPD). DESIGN AND PATIENTS:Randomised, double-blind, double-dummy, placebo-controlled study in 123 patients experiencing an acute exacerba...

    journal_title：Clinical drug investigation

    pub_type： 杂志文章

    doi：10.2165/00044011-200525060-00005

    authors： Zuin R,Palamidese A,Negrin R,Catozzo L,Scarda A,Balbinot M

    更新日期：2005-01-01 00:00:00

  • Two cases of statin-induced rhabdomyolysis associated with mononeuropathy.

    abstract：:HMG-CoA reductase inhibitors (statins) are highly effective drugs for prevention of cardiovascular events in high-risk patients. Due to the widespread prescription of these agents, special attention should be given to their rare adverse effects when these may have severe outcomes. Here, we report two cases of localize...

    journal_title：Clinical drug investigation

    pub_type： 杂志文章

    doi：10.2165/11535470-000000000-00000

    authors： Fadini GP,Manzato E,Crepaldi C,de Kreutzenberg S,Tiengo A,Avogaro A

    更新日期：2010-01-01 00:00:00

  • Bemiparin versus unfractionated heparin as bridging therapy in the perioperative management of patients on vitamin K antagonists: the BERTA study.

    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

    authors： Santamaría A,Ugarriza A,Muñoz C,De Diego I,López-Chulia F,Benet C,Martínez-González J,Gómez N,Pina E,Ortín X,Marco P,Roncalés FJ,Fontcuberta J

    更新日期：2013-12-01 00:00:00

  • Oxycodone controlled-release as first-choice therapy for moderate-to-severe cancer pain in Italian patients: results of an open-label, multicentre, observational study.

    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

    authors： Silvestri B,Bandieri E,Del Prete S,Ianniello GP,Micheletto G,Dambrosio M,Sabbatini G,Endrizzi L,Marra A,Aitini E,Calorio A,Garetto F,Nastasi G,Piantedosi F,Sidoti V,Spanu P

    更新日期：2008-01-01 00:00:00