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International Journal of Clinical Pharmacology and Therapeutics

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https://www.readbyqxmd.com/read/28079518/angiotensin-receptor-blockers-and-the-risk-of-cancer-data-mining-of-a-spontaneous-reporting-database-and-a-claims-database%C3%A2
#1
Mai Fujimoto, Migiwa Kanou, Kouichi Hosomi, Mitsutaka Takada
OBJECTIVE: The aim of this study was to examine the associations between angiotensin receptor blockers (ARBs) and the risk of 10 major cancers by employing different pharmacoepidemiological assessments. MATERIALS AND METHODS: Data from the first quarter of 2004 through 2012 were downloaded from the US Food and Drug Administration Adverse Event Reporting System (FAERS). The reporting odds ratio (ROR) and information component (IC) were used to detect the signals...
January 12, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28079517/pharmacokinetic-and-bioequivalence-study-comparing-a-candesartan-cilexetil-rosuvastatin-calcium-fixed-dose-combination-with-the-concomitant-administration-of-candesartan-cilexetil-and-rosuvastatin-calcium-in-healthy-korean-subjects%C3%A2
#2
Dan-Bee Park, Kyungho Jang, Jae-Won Lee, Cheol-Won Park, Back-Hwan Lee, Min-Gul Kim, Ji-Young Jeon
CONTEXT: A fixed-dose combination (FDC) of candesartan and rosuvastatin was recently developed for the treatment of cardiovascular disease and expected to enhance patient compliance. OBJECTIVE: This study was performed to compare the single-dose pharmacokinetic properties and tolerability of DP-R208 (candesartan and rosuvastatin FDC) to those of each component administered alone in healthy Korean male volunteers. MATERIALS AND METHODS: A total of 40 healthy Korean volunteers were enrolled in this randomized, open-label, single-dose, two-treatment, two-way crossover study...
January 12, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28079516/adequate-exposure-to-tacrolimus-with-sublingual-administration-in-pediatric-liver-transplant-patients
#3
Natalia Riva, María E Galván, Paulo Cáceres-Guido, Marcelo Dip, Nieves Licciardone, Oscar Imventarza, Paula Schaiquevich, Daniel Buamscha
No abstract text is available yet for this article.
January 12, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28079515/efficacy-and-safety-of-subcutaneous-versus-intravenous-bortezomib-in-multiple-myeloma-a%C3%A2-meta-analysis%C3%A2
#4
Bin Hu, Quan Zhou, Tao Wu, Lan Zhuang, Liping Yi, Jinxia Cao, Xin Yang, Jun Wang
PURPOSE: We performed this meta-analysis to compare the efficacy and safety between two different administration routes of bortezomib, subcutaneous and intravenous. METHODS: Six retrospective studies and three randomized controlled trials (RCTs) were included in our study. Data from retrospective studies or RCTs were pooled and displayed in their corresponding subgroup, retrospective studies subgroup or RCTs subgroup. We comprehensively compared the overall response rate (ORR) and the incidence of adverse events between subcutaneous and intravenous bortezomib...
January 12, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28025969/quantitative-analysis-of-valsartan-by-two-dimensional-liquid-chromatography-2d-hplc-method-and-its-application-in-a-bioequivalence-study-in-chinese-volunteers%C3%A2
#5
Min Zhang, Yang Deng, Hua-Lin Cai, Ping-Fei Fang, Miao Yan, Bi-Kui Zhang, Yan-Qin Wu
PURPOSE: To develop a sensitive, two-dimensional liquid chromatography (2D-LC) method for determination of valsartan, applied to investigate bioequivalence of two valsartan tablets in Chinese volunteers under fasting condition. METHODS: A full automatic 2D-HPLC system was used to quantify valsartan in human plasma. The analytes were extracted by protein precipitation, using telmisartan as internal standard. The analytical method was applied in a randomized, crossover bioequivalence study of valsartan tablets; the study enrolled 18 Chinese volunteers (12 were men and 6 were women)...
December 27, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28025968/risk-of-dementia-in-german-patients-treated-with-antidepressants-in-general-or-psychiatric-practices%C3%A2
#6
Louis Jacob, Jens Bohlken, Karel Kostev
AIMS: To study the impact of the use of antidepressants on dementia in German patients with depression treated in general (GPs) or psychiatric practices (PPs). METHODS: Patients with a first-time documentation of depression with known severity level between 2010 and 2013 (index date) were identified by 1,126 general practitioners and 176 psychiatrists in the IMS Disease Analyzer database. We included patients between the ages of 60 and 80 years who had not previously received prescriptions for antidepressant drugs and had not been diagnosed with all-cause dementia prior to or on the index date...
December 27, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28025967/a-single-dose-randomized-open-label-cross-over-bioequivalence-study-of-sildenafil-citrate-tablets-in-healthy-chinese-volunteers%C3%A2
#7
Dai Li, Yu-Lu Wang, Su-Mei Xu, Dan Li, Xiao-Min Li, Jing Pan, Ping-Sheng Xu
OBJECTIVE: The present study was designed to evaluate the bioequivalence of a newly developed sildenafil citrate tablet 50 mg (Jinge®, Test) and a marketed counterpart (Viagra®, 100 mg, Reference) in healthy adult male Chinese volunteers. METHODS: This single-dose, randomized, open-label, four-period, and two-treatment self-crossover study included two parts: fasting and postprandial studies. In each part of the study, the subjects were randomly assigned to receive test or reference products (100 mg sildenafil) in a 1 : 1 ratio, and then received the alternative products, following a 1-week washout period...
December 27, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28025966/a-single-and-multiple-postprandial-dose-study-investigating-the-pharmacokinetics-and-pharmacodynamics-of-edoxaban-in-healthy-chinese-volunteers%C3%A2
#8
Xia Chen, Dongyang Liu, Yiwen Wu, Yang Liu, Hanlin Song, Ji Jiang, Pei Hu
AIMS: This study investigated the pharmacokinetics (PK) and pharmacodynamics (PD) of once-daily postprandial doses of edoxaban 60 mg in healthy Chinese subjects. METHODS: 6 male and 6 female healthy Chinese volunteers, aged 18 - 45 years, were enrolled into this open-label, phase-I trial. Subjects received single oral doses of edoxaban 60 mg after a meal, followed by successive once-daily doses for 7 days. Serial blood samples were taken pre- and postdose to measure plasma concentrations of edoxaban and its major active metabolite D21-2393 as well as prothrombin time (PT) and activated partialprothrombin time (aPTT)...
December 27, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28025965/pharmacokinetics-and-safety-of-nifedipine-gits-candesartan-fixed-dose-combination-in-subjects-with-hepatic-impairment%C3%A2
#9
Yuwang Liu, Michael-Friedrich Boettcher, Anja Schmidt, Sigrun Unger, Atef Halabi, Erich Brendel, Hartmut Blode
OBJECTIVE: To investigate the pharmacokinetic (PK) profiles and safety of nifedipine and candesartan after a single oral dose of nifedipine gastrointestinal therapeutic system (GITS) 30 mg/candesartan cilexetil 8 mg (N30/C8 mg) fixed-dose combination (FDC) in adults with mild to moderate hepatic impairment. METHODS: A phase I, single-center, non-randomized, non-controlled, non-blinded, observational study (N = 32). PK profiles for nifedipine and candesartan were assessed in patients with mild (Child-Pugh A; group 1) or moderate (Child-Pugh B; group 2) hepatic impairment and compared with age- and gender-matched healthy controls (groups 3 and 4) following a single dose of N30/C8 FDC...
December 27, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28025964/bioequivalence-of-two-formulations-of-pregabalin-150-mg-capsules-under-fasting-conditions-in-healthy-male-subjects%C3%A2
#10
Hyun Lee, SeungHwan Lee, Sung-Vin Yim, Bo-Hyung Kim
BACKGROUND: Pregabalin binds to the α2δ auxiliary subunit of voltage-gated calcium channels, which are widely distributed throughout the central and peripheral nervous systems and modulate calcium-dependent neurotransmitter release. Pregabalin is indicated for the treatment of peripheral and central neuropathic pain, partial seizures with or without secondary generalization, and treatment of generalized anxiety disorder (GAD). OBJECTIVE: The purpose of this study was to assess the bioequivalence of two different formulations of pregabalin 150-mg capsules in healthy Korean male subjects under fasting conditions...
December 27, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28025963/association-between-pioglitazone-use-and-the%C3%A2-risk-of-bladder-cancer-among-subjects-with%C3%A2-diabetes-mellitus-a-dose-response-meta-analysis%C3%A2
#11
Zhuyue Li, Min Sun, Feng Wang, Jia Shi, Kang Wang
PURPOSE: Previous epidemiological studies reported inconsistent results regarding the association between pioglitazone use and the risk of bladder cancer (BC). We conducted a dose-response meta-analysis to assess this association. METHODS: PUBMED and EMBASE databases were searched through August 2015. Pooled results derived from a random-effects model, and the dose-response analyses were conducted for the association between cumulative dose or duration of pioglitazone use and BC risk...
December 27, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28025962/the-cost-savings-of-newer-oral-anticoagulants-in-atrial-fibrillation-related-stroke-prevention%C3%A2
#12
Norliana Masbah, Mary Macleod
BACKGROUND: Newer oral anticoagulants (NOACs) are considered as better alternatives compared to warfarin for stroke prevention in atrial fibrillation (AF) in terms of clinical effectiveness although the drug acquisition cost is more substantial. AIM: This study determined the direct stroke costs based on inpatient hospitalization in a subgroup of the National Health Service (NHS) Grampian, Scotland, stroke patients, to evaluate the differences in costs related to AF stroke, and to ascertain whether the use of NOACs within this study population would produce greater cost savings...
December 27, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28025961/prevalence-of-aspirin-resistance-in-patients-with-type-ii-diabetes-a-descriptive-analytical-study%C3%A2
#13
Rahimeh Eskandarian, Mohammadreza Razavi, Abolfazal Fattah, Kamran Ghods, Mohammad Forozeshfard
BACKGROUND: Aspirin resistance is one of the most important factors for arterial thrombotic events in diabetic patients. This study aimed to evaluate aspirin resistance in diabetic patients. METHODS: In this cross-sectional study, 180 patients who received 80 mg of aspirin daily for at least 10 days were studied, and their urinary 11-DH-TXB2 was measured. Those with 11-dehydro-thromboxane B2 above 1,500 pg/mg creatinine were considered aspirin resistant. Data with significance level of 5% were analyzed in SPSS-16...
December 27, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27936527/individualized-dosing-of-enoxaparin-in-a-morbidly-obese-patient-by-monitoring-the-anti-factor-xa
#14
Faizan Mazhar, Yousif Ahmed
No abstract text is available yet for this article.
December 12, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27936526/diclofenac-systemic-bioavailability-of-a-topical-1-diclofenac-3-menthol-combination-gel-vs-an-oral-diclofenac-tablet-in-healthy-volunteers-a%C3%A2-randomized-open-label-crossover-study%C3%A2
#15
Sebastian Moreira, D Jeffery Liu
OBJECTIVE: Evaluate systemic exposure with repeated topical application of a fixed-combination topical gel product containing 1% diclofenac sodium and 3% menthol in either of 2 formulation packages relative to oral administration. METHODS: In this phase 1, single-center, 4-way crossover study, healthy volunteers aged 18 - 50 years underwent consecutive 3-day treatment regimens in a randomly assigned sequence with each of 4 treatment groups: 4 g of topical 1% diclofenac + 3% menthol gel administered via an aluminum tube or roll-on device applied 4 times daily; 4 g of topical 1% diclofenac sodium gel (Voltaren Gel) applied 4 times daily; and oral diclofenac sodium tablets 50 mg 3 times daily...
December 12, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27936525/a-case-of-multiple-vertebral-compression-fractures-due-to-glucocorticoid-induced-osteoporosis-in-a-pediatric-patient-with-nephrotic-syndrome%C3%A2
#16
Akira Ashida, Yuko Fujii, Hideki Matsumura, Hiroshi Tamai
INTRODUCTION: Glucocorticoid therapy has a number of adverse effects, among which osteoporosis and bone fracture can be major complications. Immunosuppressive therapy for nephrotic syndrome is effective and can help to reduce the cumulative dose of glucocorticoids. Therefore, for this reason, the number of patients with nephrotic syndrome who develop glucocorticoid-related osteoporotic compression fracture is decreasing. Here we describe a pediatric case of multiple vertebral compression fractures due to glucocorticoid-induced osteoporosis during treatment for nephrotic syndrome...
December 12, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27936524/comparative-pharmacodynamic-effects-of-two-clopidogrel-formulations-under-steady-state-conditions-in-healthy-thai-volunteers%C3%A2
#17
Nontaya Nakkam, Somsak Tiamkao, Sirimas Kanjanawart, Kutcharin Phunikhom, Siriporn Tiamkao, Suda Vannaprasaht, Wongwiwat Tassaneeyakul, Wichittra Tassaneeyakul
OBJECTIVE: Clopidogrel is a commonly used antiplatelet aggregation agent. Compared with the reference clopidogrel product, most commercially available generic clopidogrel products contain different crystalline forms of clopidogrel. This study was aimed to compare the pharmacodynamics of a commonly used generic clopidogrel product in Thailand with the reference clopidogrel product under steady state conditions. METHODS: A multiple-dose, randomized 2-way crossover study was conducted in 32 healthy male Thai volunteers...
December 12, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27936523/single-and-multiple-dose-pharmacokinetics-and-tolerability-of-paroxetine-controlled-release-tablet-in-healthy-chinese-subjects%C3%A2
#18
Rui Chen, Kai Shen, Pei Hu
OBJECTIVES: To evaluate the pharmacokinetics of paroxetine controlled-release (CR) tablets after single and multiple oral administrations and to evaluate its safety profile in healthy Chinese subjects. METHODS: This was a phase 1, open-label, single- and multiple-dose combined study. All 12 healthy subjects received a single oral dose of 25-mg paroxetine CR, followed by a washout period of 5 days. Then, the subjects received multiple oral doses of 25-mg paroxetine CR for 14 consecutive days...
December 12, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27936522/a-study-comparing-the-safety-and-efficacy-of-febuxostat-allopurinol-and-benzbromarone-in-chinese-gout-patients-a-retrospective-cohort-study%C3%A2
#19
Qiao Zhou, Jiang Su, Ting Zhou, Juan Tian, Xixi Chen, Jing Zhu
OBJECTIVE: To evaluate and compare the safety and efficacy of three urate lowering agents: febuxostat, allopurinol, and benzbromarone, when used to treat Chinese gout patients. METHODS: A total of 120 patients treated in our department from November 2011 to December 2014 were randomly selected and divided into four groups: febuxostat (40 mg per day), febuxostat (80 mg per day), allopurinol (100 mg, 3 × per day) or benzbromarone (50 mg per day), (n = 30 patients/group)...
December 12, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27900937/post-authorization-changes-in-the-safety-and-efficacy-assessment-recommended-indications-and-drug-quality-profile-of-adalimumab-a-chronological-overview
#20
Gergely Iványi, Romána Zelkó
OBJECTIVE: The intention of the present study was to demonstrate the postauthorization changes of adalimumab (European trade name: Humira), evaluating the variations in its safety, efficacy, and quality profile. METHODS: Type-II, major variations of the Summary of Product Characteristics (SmPC) from September 8, 2003 to November 19, 2015, were analyzed, which, according to Commission Regulation (EC) No. 1234/2008, have to reflect changes that may have a significant impact on the safety, efficacy, or quality profile of a medicinal product...
November 30, 2016: International Journal of Clinical Pharmacology and Therapeutics
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