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International Journal of Clinical Pharmacology and Therapeutics

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https://www.readbyqxmd.com/read/29974857/review-of-baclofen-induced-neurotoxicity-in-patients-with-compromised-renal-function
#1
Sohail Abdul Salim, Litty Thomas, Anand Achanti, Monika Beck Gööz, Jorge Castaneda, István Arany, Albert W Dreisbach, Tibor Fülöp
Baclofen is a centrally-acting γ-amino butyric acid agonist used mainly in the symptomatic management of spasticity originating from the spinal cord. It is absorbed completely from the gastrointestinal tract, metabolized by the liver to a minor degree, and excreted unchanged by the kidneys. Baclofen is moderately lipophilic and can cross the blood-brain barrier easily. At the usual dosage, it acts mainly at the spinal level without central nervous system (CNS) side effects. During renal failure, however, the elimination of the drug will decrease with a prolonged half-life, resulting in a larger area-under-the-curve exposure and disproportionate CNS toxicity...
July 5, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29956648/a-randomized-open-label-crossover-study-evaluating-bioequivalence-of-two-n-acetylcysteine-2-oral-solution-formulations-in-healthy-subjects
#2
Frank Donath, Marianna Armogida, Lucy Shneyer
OBJECTIVE: N-acetylcysteine is a mucolytic agent used to treat bronchopulmonary diseases associated with airway mucus hypersecretion. The bioequivalence of a new oral N-acetylcysteine 2% formulation was evaluated relative to an appropriate reference product. MATERIALS AND METHODS: This open-label, randomized, crossover study assessed the bioequivalence of a new N-acetylcysteine 2% oral solution compared to an approved reference N-acetylcysteine 2% oral solution in healthy subjects in terms of pharmacokinetics, including area under the plasma concentration vs...
June 29, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29932416/bioequivalence-assessment-of-tulobuterol-transdermal-delivery-system-in-healthy-subjects
#3
Sang-In Park, Bo-Hyung Kim
OBJECTIVE: The purpose of this study was to evaluate the bioequivalence in the pharmacokinetics of two 2-mg tulobuterol transdermal delivery systems (TDSs) in healthy subjects. MATERIALS AND METHODS: The pharmacokinetic (PK) analysis was performed using data from a randomized, open-label, single-dose, two-way, two-period, crossover study. Eligible subjects received either the Bretol® patch (test drug) or Hokunalin® patch (reference drug) in sequence according to their allocated group...
June 22, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29932415/platelet-rich-plasma-injection-in-the-treatment-of-frozen-shoulder-a-randomized-controlled-trial-with-6-month-follow-up
#4
Junhong Lin
PURPOSE: Platelet-rich plasma (PRP) has been utilized in the treatment of chronic injuries. The current study aimed to evaluate the efficiency of PRP in the treatment of frozen shoulder compared to procaine. MATERIALS AND METHODS: 60 patients with frozen shoulder were randomly divided into two groups. The PRP group was injected with 2 mL prepared PRP, while in the control group procaine was used. The stretching and formal strengthening exercises were carried out in both groups during the 6-month follow-up...
June 22, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29932414/effects-of-food-and-gender-on-pharmacokinetics-of-ticagrelor-and-its-main-active-metabolite-ar-c124910xx-in-healthy-chinese-subjects
#5
Wanke Feng, Dongbo Liu, Yiya Wang, Xin Shi, Fang Liu, Luning Sun, Li Ding
OBJECTIVES: The manuscript was mainly aimed to evaluate effects of food and gender on the pharmacokinetics of ticagrelor and its main active metabolite AR-C124910XX in healthy Chinese subjects observed in the bioequivalence studies of the two formulations of ticagrelor tablets. MATERIALS AND METHODS: The single-dose, two-sequence, two-period and crossover studies were respectively conducted under fasting and fed conditions. Plasma samples were analyzed by an HPLC-MS/MS method...
June 22, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29932413/pharmacokinetics-and-bioequivalence-of-0-5-mg-lobeglitazone-tablets-in-healthy-male-subjects
#6
So Jin Lee, Min-Gul Kim, Shin-Jung Park, Ji-Young Jeon
OBJECTIVE: This study was conducted to evaluate the pharmacokinetics and bioequivalence of two formulations of -DuvieTM (0.5-mg lobeglitazone sulfate). MATERIALS AND METHODS: This study was designed as an open-label, randomized, single-dose, crossover bioequivalence study in healthy male subjects. A total of 28 subjects were randomized into two groups: one group received the test drug, 0.5-mg DuvieTM tablets, which have formulations available on the global market; and the other group received the reference drug, the initially-approved 0...
June 22, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29882510/pharmacokinetics-and-bioequivalence-study-of-tetramethylpyrazine-phosphate-tablets-after-single-dose-administration-in-healthy-chinese-male-subjects
#7
Houli Li, Benjie Wang, Guiyan Yuan, Ruichen Guo
BACKGROUND: Tetramethylpyrazine, isolated from <i>Ligusticum wallichii</i> Franch., is widely used for the treatment of cerebrovascular and cardiovascular diseases in China. OBJECTIVE: To assess and compare the pharmacokinetic characteristics and bioequivalence of two tetramethylpyrazine phosphate (TMPP) tablets in healthy Chinese male subjects. MATERIALS AND METHODS: 20 healthy male subjects were randomly divided into two groups according to a two-period crossover design test...
June 8, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29882509/evaluation-of-medication-dosing-errors-in-elderly-patients-with-renal-impairment
#8
Hyo-Joong Won, Gokyung Chung, Kyeong Ju Lee, Eunkyung Lee, Soonjoo Son, Soyoung Choi, Seon Cheol Park, Yu Jeung Lee
OBJECTIVE: The administration of the usual dosage of medication in elderly patients with renal impairment can cause adverse drug reactions due to patients' decreased renal function. Using retrospective prescription analysis, in a teaching hospital, this study aimed to evaluate medication dosing errors in elderly patients with renal impairment and the risk factors for these dosing errors. MATERIALS AND METHODS: This retrospective study included elderly patients with a creatinine clearance of 59 mL/min or less who were hospitalized in a teaching hospital between July 1, 2015, and September 30, 2015...
June 8, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29809132/effect-of-perindopril-and-bisoprolol-on-il-2-inf-%C3%AE-hs-crp-and-t-cell-stimulation-and-its-correlations-with-blood-pressure-in-mild-and-moderate-hypertension
#9
Andrzej Madej, Józefa Dąbek, Michał Majewski, Justyna Szuta
INTRODUCTION: Cardiovascular disease is the leading global cause of death. Its development is largely determined by lifestyle and cardiovascular risk factors, among which arterial hypertension (HT) plays a key role. Available data indicate a significant role of inflammation in the pathophysiology of HT. OBJECTIVES: The aim of this study was to assess concentrations of mediators of inflammation in patients with mild and moderate HT and its modulation with antihypertensive treatment...
May 29, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29792395/how-are-patients-with-heart-failure-treated-in-primary-care
#10
Hélène Vaillant-Roussel, Bruno Pereira, Sylvaine Gibot-Boeuf, Romain Eschalier, Claude Dubray, Rémy Boussageon, Philippe Vorilhon
OBJECTIVE: The aim of this study was to assess the adherence of general practitioners (GPs) to guidelines in patients with heart failure with reduced ejection fraction (HFrEF) and to describe GPs' prescribing behavior regarding patients with heart failure with preserved ejection fraction (HFpEF). MATERIALS AND METHODS: Cross-sectional study as part of the ETIC trial. Five classes of drugs were described: angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs); β-blockers (BBs); mineralocorticoid receptor antagonists (MRAs); diuretics (thiazide or loop diuretics); and digoxin...
May 24, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29701171/risk-factors-for-rhabdomyolysis-with-hmg-coa-reductase-inhibitors-identified-using-a-postmarketing-surveillance-database-in-japan
#11
Masayuki Hashiguchi, Jun Hakamata, Mikiko Shimizu, Junya Maruyama, Tsuyoshi Shiga, Mayumi Mochizuki
OBJECTIVE: To investigate quantitatively the risk factors for rhabdomyolysis or related symptoms associated with HMG-CoA reductase inhibitors (statins), we used the lipid-lowering drug database (32,157 patients) developed by the RAD-AR Council, Japan, based on the postmarketing surveillance (PMS) data of pharmaceutical companies to perform a nested case-control study. MATERIALS AND METHODS: Of 26,849 patients taking statins, the case group was composed of 51 patients who experienced rhabdomyolysis or related symptoms while taking statins, and the control group was 1,020 patients randomly selected from patients who did not experience rhabdomyolysis or related symptoms while taking statins...
April 27, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29701170/diagnosing-and-treating-dementia-in-german-primary-and-specialized-care-between-2011-and-2015
#12
Bernhard Michalowsky, Karel Kostev, Steve Iliffe, Wolfgang Hoffmann, Jens Bohlken
BACKGROUND: Whilst there was no upturn in detection rate of persons with dementia (PwD) in German general practitioner (GP) practices before 2012, dementia diagnoses markedly increased in 2013 and 2014. OBJECTIVE: (1) Verify the increase of dementia diagnoses in GP practices and neurologist/psychiatrist (NP) practices; (2) examine the subsequent prescription of antidementia drugs. MATERIALS AND METHODS: We performed a retrospective, longitudinal analysis of 874 GP and 141 NP practices collecting clinical data about 220,213 patients who received a dementia diagnosis (ICD-10: G30, F01, F03) between 2011 and 2015...
April 27, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29792394/concomitant-administration-of-candesartan-cilexetil-in-patients-on-paclitaxel-and-carboplatin-combination-therapy-increases-risk-of-severe-neutropenia
#13
Yurie Katsube, Daiki Hira, Masayuki Tsujimoto, Hiroyoshi Koide, Tetsuya Minegaki, Yoshito Ikeda, Shin-Ya Morita, Kohshi Nishiguchi, Tomohiro Terada
OBJECTIVE: Angiotensin receptor blockers (ARBs) are often used in patients on paclitaxel (PTX) and carboplatin combination (TC) therapy to treat hypertension caused by the co-administration of bevacizumab. The aim of this retrospective study was to analyze the association between co-administration of ARBs and the development of severe neutropenia in patients on TC therapy. MATERIALS AND METHODS: In this study, 211 concomitant medications were prescribed to 173 patients on TC therapy...
July 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29750634/effectiveness-of-febuxostat-in-patients-with-allopurinol-refractory-hyperuricemic-chronic-kidney-disease
#14
Chae Hee Kwak, Minji Sohn, Nayoung Han, Yoon-Sook Cho, Yon Su Kim, Jung Mi Oh
OBJECTIVE: As uncontrolled hyperuricemia has been associated with an increased risk of cardiovascular disease and the progression of chronic kidney disease (CKD), management of serum uric acid levels is important. The aim of this study was to evaluate the effectiveness of febuxostat in regulating uncontrolled hyperuricemia in patients with renal dysfunction. MATERIALS AND METHODS: We included patients with CKD and persistent uncontrolled hyperuricemia despite treatment with allopurinol...
July 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29648533/effect-of-fluconazole-on-the-pharmacokinetics-of-everolimus-and-tacrolimus-in-a-heart-transplant-recipient-case-report
#15
Kazuki Nakagita, Kyoichi Wada, Yuka Terada, Sachi Matsuda, Nobue Terakawa, Akira Oita, Mitsutaka Takada
OBJECTIVE: Everolimus is an inhibitor of the mammalian target of rapamycin (mTOR) and has been used in combination with calcineurin inhibitors (tacrolimus and cyclosporine) to prevent allograft rejection following organ transplantation. In heart transplant recipients, everolimus should be maintained at a target blood concentration of 3 - 8 ng/mL, in combination with reduced-dose calcineurin inhibitors and therefore, requires strict monitoring. Fluconazole, an azole antifungal agent, affects blood concentration of tacrolimus by inhibiting the cytochromes P450 (CYP) 3A4 and 3A5...
June 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29648532/bioequivalence-of-a-fixed-dose-repaglinide-metformin-combination-tablet-and-equivalent-doses-of-repaglinide-and-metformin-tablets
#16
Hea-Young Cho, Lien Ngo, Sang-Ki Kim, Yoonho Choi, Yong-Bok Lee
OBJECTIVE: This study was conducted to determine whether a fixed-dose combination (FDC) tablet of repaglinide/metformin (2/500 mg) is equivalent to coadministration of equivalent doses of individual (EDI) tablets of repaglinide (2 mg) and metformin (500 mg) in healthy Korean male subjects. MATERIALS AND METHODS: This study was conducted as an open-label, randomized, single-dose, two-period, two-sequence crossover design in 50 healthy Korean male subjects who received an FDC tablet or EDI tablets...
June 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29648531/propafenone-quantification-in-human-plasma-by-high-performance-liquid-chromatography-coupled-with-electrospray-tandem-mass-spectrometry-in-a-bioequivalence-study
#17
Beatrice Severino, Giancarlo Luisi, Renan Donomae Iwamoto, Ronilson Agnaldo Moreno, Victor Perez Teixeira, Paola Di Vaio, Irene Saccone, Elisa Magli, Vincenzo Santagada, Giuseppe Caliendo, Gustavo D Mendes, Gilberto De Nucci
Propafenone is an antiarrhythmic drug applied to ventricular arrhythmias, initially recognized as a sodium channel blocker. This study aims to evaluate the bioequivalence of two propafenone formulations (300 mg tablet) in healthy subjects under non-fasting conditions. The study was conducted as an open, randomized, 2-period design with a 2-sequence (RT, TR) with a 1-week washout interval. The subjects were selected for the study after having their health status previously assessed by a clinical evaluation and laboratory tests (biochemical and hematological parameters, and urinalysis)...
June 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29628023/effects-of-erythropoietin-on-the-clinical-outcomes-of-patients-with-acute-st-segment-elevation-myocardial-infarction-after-percutaneous-coronary-intervention-a-meta-analysis
#18
Hai-Tao Yang, Wen-Juan Xiu, Ying-Ying Zheng, Yi-Tong Ma, Xiang Xie
AIMS: To investigate the effects of erythropoietin (EPO) on the clinical outcomes of patients with acute ST segment elevation myocardial infarction (STEMI) after percutaneous coronary intervention (PCI). MATERIAL AND METHODS: We collected randomized controlled studies conducted before April 15, 2017, and performed a meta-analysis using RevMan5.3 software. RESULTS: Compared with the conventional revascularization group, mortality (RR = 0...
June 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29595122/population-pharmacokinetics-and-pharmacodynamics-of-fondaparinux-in-japanese-patients-after-artificial-total-knee-replacement
#19
Kazuhiko Hanada, Soichi Shibata, Yuki Takashima, Takuma Matsuo, Keisuke Iwa, Hajime Matsubara, Yasunori Tsukimura, Harumi Takahashi
OBJECTIVE: This study was designed to clarify the factors affecting the efficacy, adverse events, and pharmacokinetics of fondaparinux in Japanese patients undergoing artificial knee replacement surgery. MATERIALS AND METHODS: Fondaparinux (1.5 mg/d) was administered subcutaneously to patients (n = 30) at 24 hours after surgery, and blood samples were taken at various time points thereafter. Venous thromboembolism (VTE), presence of bleeding, and pharmacokinetics were evaluated...
June 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29578394/comparative-efficacy-and-safety-of-tnf-inhibitor-plus-methotrexate-versus-oral-triple-therapy-in-patients-with-active-rheumatoid-arthritis-inadequately-responding-to-methotrexate-a-meta-analysis-of-randomized-controlled-trials
#20
Sang-Cheol Bae, Young Ho Lee
AIMS: The study aimed to assess the efficacy and safety of tumor necrosis factor inhibitor (TNFI) with methotrexate (MTX) vs. oral triple therapy in patients with active rheumatoid arthritis (RA), showing inadequate response to MTX. MATERIALS AND METHODS: We performed a meta-analysis of three randomized controlled trials (RCTs) (913 MTX-resistant RA patients) to examine the relative efficacy and safety of TNFI+MTX compared to triple therapy (hydroxychloroquine, sulfasalazine, MTX) in patients with RA responding inadequately to MTX...
June 2018: International Journal of Clinical Pharmacology and Therapeutics
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