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Journal of Clinical Pharmacology

Li-Ting Kao, Sudha Xirasagar, Herng-Ching Lin, Chao-Yuan Huang
To date, few epidemiologic studies have investigated the relationship between pioglitazone use and prostate cancer. The available studies show conflicting findings. This case-control study explored the association between prior pioglitazone usage and prostate cancer using a large, population-based data set. Data were derived from the Longitudinal Health Insurance Database 2005 in Taiwan, a population-based sample of National Health Insurance enrollees with longitudinal claims data since 1995. Cases were 3513 patients with prostate cancer aged over 40 years, and the controls were 3513 patients without prostate cancer, matched with prostate cancer cases on age, and having a medical care utilization episode in the year of the index prostate cancer (1 control per case)...
October 17, 2018: Journal of Clinical Pharmacology
Chao-Hung Chen, Cha-Ze Lee, Yi-Chun Lin, Li-Ting Kao, Herng-Ching Lin
Although current evidence suggests potential antitumor activity of proton pump inhibitors (PPIs), there is no population-based evidence of an association between PPI use and subsequent breast cancer risks. We used an observational case-control study to examine the association between prior PPI use and breast cancer occurrence. Additional analysis examined dose-response and age-stratified associations of PPIs with breast cancer. This study used data from the Taiwan National Health Insurance Research Dataset...
October 17, 2018: Journal of Clinical Pharmacology
Somayyeh Nasiripour, Maryam Saif, Maryam Farasatinasab, Sepide Emami, Atefeh Amouzegar, Ali Basi, Majid Mokhtari
Heparin-induced thrombocytopenia (HIT) is a potentially serious adverse drug reaction that can result in lethal vascular thrombosis. Dabigatran is a direct thrombin inhibitor that might be useful in the management of HIT. This study evaluated the efficacy and safety of dabigatran in patients with HIT. We included 43 patients in the study who received dabigatran for the management of suspected HIT, based on 4Ts (thrombocytopenia, timing of platelet count drop, thrombosis or other sequelae, and other causes of thrombocytopenia) scores...
October 4, 2018: Journal of Clinical Pharmacology
Dwain Tolbert, Frank Larsen
Clobazam (CLB) is a 1,5-benzodiazepine that has been widely used as an anxiolytic and antiseizure drug (ASD) since it was first synthesized over 50 years ago. CLB was approved in the United States in 2011 as adjunctive therapy for seizures in patients ≥2 years old with Lennox-Gastaut syndrome. CLB pharmacokinetics (PK) have been studied in single- and multiple-dose administrations in healthy subjects. Salient features include high bioavailability, linear PK, and negligible effects from coadministration of other ASDs...
October 4, 2018: Journal of Clinical Pharmacology
Sarah Cargnin, Michele Viana, Grazia Sances, Roberto Cantello, Cristina Tassorelli, Salvatore Terrazzino
A large meta-analysis of genome-wide association studies has recently identified a number of risk loci for migraine without aura (MwoA). In this study, we tested the hypothesis that a genetic risk score based on single-nucleotide polymorphisms (SNPs), previously reported to be associated with MwoA at genome-wide significance, may influence headache response to triptans in patients with migraine without aura. Genotyping of rs9349379, rs2078371, rs6478241, rs11172113, rs1024905, and rs6724624 was conducted with a real-time PCR allelic discrimination assay in 172 MwoA patients, of whom 36...
September 26, 2018: Journal of Clinical Pharmacology
Alice Damamme, Saïk Urien, Delphine Borgel, Dominique Lasne, Pauline Krug, Saoussen Krid, Marina Charbit, Rémi Salomon, Jean-Marc Treluyer, Olivia Boyer
Enoxaparin is commonly used in the prevention of renal allograft vascular thrombosis but off-label in children, and no consensus exists regarding the optimal dosing and dose adjustment. In this retrospective study, 444 anti-Xa levels were obtained from 30 pediatric renal transplant recipients in order to investigate enoxaparin population pharmacokinetics. The main results were (1) 25% of children achieved the target anti-Xa activity 36 hours after initiation of treatment, (2) anti-Xa time courses were best described by a 1-compartment open model with first-order absorption, (3) body weight but not renal function was the sole covariate influencing clearance and volume of distribution, and (4) large between-subject and between-occasion variabilities in anti-Xa activity were observed...
September 26, 2018: Journal of Clinical Pharmacology
Jincheng Yang, Mina Nikanjam, Brookie M Best, Jorge Pinto, Ellen G Chadwick, Eric S Daar, Peter L Havens, Natella Rakhmanina, Edmund V Capparelli
Lopinavir/ritonavir (LPV/r) is recommended by the World Health Organization as first-line treatment for HIV-infected infants and young children. We performed a composite population pharmacokinetic (PK) analysis on LPV plasma concentration data from 6 pediatric and adult studies to determine maturation and formulation effects from infancy to adulthood. Intensive PK data were available for infants, children, adolescents, and adults (297 intensive profiles/1662 LPV concentrations). LPV PK data included 1 adult, 1 combined pediatric-adult, and 4 pediatric studies (age 6 weeks to 63 years) with 3 formulations (gel-capsule, liquid, melt-extrusion tablets)...
September 25, 2018: Journal of Clinical Pharmacology
Xiaohui Li, Amit Roy, Bindu Murthy
Abatacept population pharmacokinetics (PK) and exposure-response (E-R) models for selective efficacy end points were developed using phase 2 and 3 study data in patients with rheumatoid arthritis treated with abatacept (intravenous [IV] or subcutaneous [SC]), followed by simulations. Two efficacy end points were assessed in the E-R analyses: Disease Activity Score in 28 joints (DAS28) and American College of Rheumatology response criteria for 20/50/70% improvement (ACR20/50/70). The analyses were performed with data from 11 clinical studies for the population PK analysis and from 3 clinical studies for the E-R analyses (DAS28 and ACR20/50/70)...
September 19, 2018: Journal of Clinical Pharmacology
Isabel Reinecke, Birte Hofmann, Emir Mesic, Henk-Jan Drenth, Dirk Garmann
To compare the pharmacokinetics (PK) of the progestin levonorgestrel for various routes of administration, an integrated population PK analysis was performed. This analysis integrated data from 10 clinical pharmacology studies and resulted in a single, comprehensive population PK model (and its applications) describing the PK of levonorgestrel and its variability for 6 levonorgestrel-containing contraceptives: 3 intrauterine systems (IUSs; levonorgestrel [LNG]-IUS 20 [Mirena® ], LNG-IUS 12 [Kyleena® ], and LNG-IUS 8 [Jaydess® /Skyla® ]); 2 oral contraceptives (the progestin-only pill [Microlut® /Norgeston® ] and the combined oral contraceptive [Miranova® ]); and a subdermal implant (Jadelle® )...
September 12, 2018: Journal of Clinical Pharmacology
Antonio Tello-Montoliu, Juan Miguel Ruiz-Nodar, María Asunción Esteve-Pastor, Andrea Véliz-Martínez, Esteban Orenes-Piñero, Manuel J Macías-Villanego, Teresa Lozano, Luna Carrillo-Alemán, Nuria Vicente-Ibarra, Vicente Pernias-Escrig, Juan G Martínez-Martínez, José Miguel Rivera-Caravaca, Francisco Marín
Chronic kidney disease (CKD) is associated with worse clinical outcomes in patients with acute coronary syndrome. However, they are underrepresented in clinical trials. We aimed to investigate differences in prognosis of acute coronary syndrome patients with and without CKD, focusing on the use of novel P2Y12 receptor inhibitors. This multicenter registry involved patients with acute coronary syndrome from 3 tertiary institutions. After excluding anticoagulated patients and patients on antiplatelet monotherapy, 1280 patients remained...
September 12, 2018: Journal of Clinical Pharmacology
Joshua C Euteneuer, Suyog Kamatkar, Tsuyoshi Fukuda, Alexander A Vinks, Henry T Akinbi
Evidence for dosing, efficacy, and safety of most medications used to treat neonates is sparse. Thus, dosing is usually derived by extrapolation from adult and pediatric pharmacologic data with scaling by body weight or body surface area. This may lead to drug dosing that is unsafe or ineffective. However, new strategies are being developed and studied to dose medications in critically ill neonates. Mass spectroscopy technology capable of quickly analyzing drug levels is readily available. Software that integrates population pharmacokinetics and pharmacodynamics with data from sparse samples from neonates allows for timely adjustments of dosing to achieve the desired effect while minimizing adverse outcomes...
September 11, 2018: Journal of Clinical Pharmacology
Luis Hermenegildo Martín Arias, Antonio Martín González, Rosario Sanz Fadrique, Esther Salgueiro Vazquez
The purpose of this study was to review the published evidence on the clinical use of nonsteroidal anti-inflammatory drugs (NSAIDs) and to assess the cardiovascular risk (CVR) of cyclooxygenase-2 inhibitors (coxibs), excluding aspirin, by means of a meta-analytic procedure. A search was conducted on MEDLINE and EMBASE databases between October 1999 and June 2018. Cohort and case-control studies showing CVR as relative risk (RR), odds ratio, hazard ratio, or incidence rate ratio associated with NSAIDs versus no treatment were selected...
September 11, 2018: Journal of Clinical Pharmacology
Manoli Vourvahis, Lynn McFadyen, Sunil Nepal, Srinivas Rao Valluri, Annie Fang, Gwendolyn D Fate, Linda S Wood, Jean-Claude Marshall, Phylinda L S Chan, Angus Nedderman, Julian Haynes, Mark E Savage, Andrew Clark, Kimberly Y Smith, Jayvant Heera
Maraviroc is a C-C chemokine receptor type-5 antagonist approved for the treatment of HIV-1. Previous studies show that cytochrome P450 3A5 (CYP3A5) plays a role in maraviroc metabolism. CYP3A5 is subject to a genetic polymorphism. The presence of 2 functional alleles (CYP3A5*1/*1) confers the extensive metabolism phenotype, which is rare in whites but common in blacks. The effect of CYP3A5 genotype on maraviroc and/or metabolite pharmacokinetics was evaluated in 2 clinical studies: a post hoc analysis from a phase 2b/3 study (NCT00098293) conducted in 494 HIV-1-infected subjects (study 1) in which the impact on maraviroc efficacy in 303 subjects was also assessed, and a study conducted in 47 healthy volunteers (study 2)...
September 7, 2018: Journal of Clinical Pharmacology
Yvonne Schuller, Christine Gispen-de Wied, Carla E M Hollak, Hubertus G M Leufkens, Violeta Stoyanova-Beninska
In the development process for new drugs, dose-finding studies are of major importance. Absence of these studies may lead to failed phase 3 trials and delayed marketing authorization. In our study we investigated to what extent dose-finding studies are performed in the case of orphan drugs for metabolic and oncologic indications. We identified all orphan drugs that were authorized until August 1, 2017. European Public Assessment Reports were used to extract the final dose used in the summary of product characteristics, involvement of healthy volunteers, study type, end points used, number of patients, number of doses, studies in special populations, and dose used for phase 3 studies...
September 7, 2018: Journal of Clinical Pharmacology
Marwa Ounissi, Christelle Rodrigues, Hugues Bienayme, Paul Duhamel, Gérard Pons, Olivier Dulac, Rima Nabbout, Catherine Chiron, Vincent Jullien
Vigabatrin is an antiepileptic drug indicated as monotherapy in infantile spasms. However, the pharmacokinetic profile of this compound in infants and young children is still poorly understood, as is the minimal effective dose, critical information given the risk of exposure-related retinal toxicity with vigabatrin. A reasonable approach to determining this minimal dose would be to identify the lowest dose providing a low risk of exposure overlap with the 36-mg/kg dose, which is the highest dose associated with an increased risk for treatment failure, based on randomized dose-ranging data...
September 7, 2018: Journal of Clinical Pharmacology
Kiyonori Kobayashi, Yasuo Suzuki, Kenji Watanabe, Kazunori Oda, Miyuki Mukae, Akihiro Yamada, Hirokazu Yamagami, Akira Nishimura, Hiroyuki Okamoto
Although previous studies have shown that patients with ulcerative colitis may benefit from treatment with vedolizumab, a humanized monoclonal antibody targeting the α4 β7 integrin heterodimer, no data exist in Japanese populations. The aim of this phase 1, open-label, multicenter study was to assess the pharmacokinetics, pharmacodynamics, efficacy, and safety of vedolizumab in Japanese patients with ulcerative colitis. Adult patients with confirmed ulcerative colitis received either 150 mg (step 1) or 300 mg (step 2) of intravenous (IV) vedolizumab on days 1, 15, and 43 of the study protocol...
September 7, 2018: Journal of Clinical Pharmacology
Iftekhar Mahmood, Million A Tegenge
The objective of this study was to compare the predictive performance of an allometric model with that of a physiologically based pharmacokinetic (PBPK) model to predict clearance or area under the concentration-time curve (AUC) of drugs in subjects from neonates to adolescents. From the literature, 10 studies were identified in which clearance or AUC of drugs from neonates to adolescents was predicted by PBPK models. In these published studies, drugs were given to children either by intravenous or oral route...
September 7, 2018: Journal of Clinical Pharmacology
Ryan L Crass, Manjunath P Pai
Renal function is the most commonly applied patient-specific quantitative variable used to determine drug doses. Measurement of renal function is not practical in most clinical settings; therefore, clinicians often rely on estimates when making dosing decisions. Similarly, renal function estimates are used to assign subjects in phase 1 pharmacokinetic studies, which inform dosing in late-phase clinical trials and ultimately the product label. The Cockcroft-Gault estimate of creatinine clearance has been the standard renal function metric; however, this paradigm is shifting toward the Modification of Diet in Renal Diseases (MDRD) estimate of the glomerular filtration rate (GFR)...
September 5, 2018: Journal of Clinical Pharmacology
Xianbin Tian, Hefei Zhang, Tycho Heimbach, Handan He, Aby Buchbinder, Mary Aghoghovbia, Florence Hourcade-Potelleret
Nilotinib, an oral inhibitor of the tyrosine kinase activity of Abelson protein, is approved for the treatment of patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase and patients with CML in chronic phase or accelerated phase resistant or intolerant to prior therapies. This review describes the pharmacokinetic and pharmacodynamic data of nilotinib in patients with CML and in healthy volunteers. Nilotinib is rapidly absorbed, with a peak serum concentration approximately 3 hours after dosing...
September 4, 2018: Journal of Clinical Pharmacology
Lotte Ramerman, Pieter J Hoekstra, Gerda de Kuijper
Health-related quality of life in people with intellectual disabilities can be affected by challenging behaviors and side effects of antipsychotics. The aim of this study was to evaluate the effect of discontinuation antipsychotic drugs on health-related quality of life, including data from 2 discontinuation trials: an open-label trial of various antipsychotic drugs and a double-blind trial of risperidone. In both studies, antipsychotics were discontinued in 14 weeks, with steps of 12.5% of the baseline dosage every 2 weeks...
August 30, 2018: Journal of Clinical Pharmacology
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