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Defined daily doses

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https://www.readbyqxmd.com/read/29453947/evaluation-of-the-effects-of-rp5063-a-novel-multimodal-serotonin-receptor-modulator-as-single-agent-therapy-and-co-administrated-with-sildenafil-bosentan-and-treprostinil-in-a-monocrotaline-induced-pulmonary-arterial-hypertension-rat-model
#1
Laxminarayan Bhat, Jon Hawkinson, Marc Cantillon, Dasharatha G Reddy, Seema R Bhat, Charles-E Laurent, Annie Bouchard, Marzena Biernat, Dany Salvail
Pulmonary arterial hypertension (PAH), a condition that is defined by pulmonary vasculature constriction and remodeling, involves dysfunctional signaling of the serotonin (5-HT) receptors, 5-HT 2/2B/7 . In a rat model of monocrotaline (MCT)-induced PAH, the effectiveness of RP5063 (RP), a dopamine and 5-HT receptor modulator, was evaluated as monotherapy and as an adjunct to standard PAH treatments. After a single 60mg/kg dose of MCT, rats received vehicle (MCT+Veh; gavage twice-daily [b.i.d.]), RP (10mg/kg; gavage b...
February 14, 2018: European Journal of Pharmacology
https://www.readbyqxmd.com/read/29451701/phase-1b-study-of-pasireotide-everolimus-and-selective-internal-radioembolization-therapy-for-unresectable-neuroendocrine-tumors-with-hepatic-metastases
#2
Hyun S Kim, Walid L Shaib, Chao Zhang, Ganji Purnachandra Nagaraju, Christina Wu, Olatunji B Alese, Zhengjia Chen, Edith Brutcher, Meredith Renfroe, Bassel F El-Rayes
BACKGROUND: Neuroendocrine tumors (NETs) metastasize to the liver. Everolimus and selective internal radioembolization (SIRT) are approved treatments. Pasireotide is a somatostatin analogue with an affinity for somatostatin receptors 1, 2, 3, and 5. Everolimus and pasireotide may potentiate SIRT radiosensitization and inhibit rebound angiogenesis. This study evaluated the safety of pasireotide, everolimus, and SIRT. METHODS: This 3 + 3 phase 1 trial evaluated 3 dose levels of everolimus (2...
February 16, 2018: Cancer
https://www.readbyqxmd.com/read/29449894/personalization-of-regorafenib-treatment-in-metastatic-gastrointestinal-stromal-tumours-in-real-life-clinical-practice
#3
Margherita Nannini, Maria Concetta Nigro, Bruno Vincenzi, Elena Fumagalli, Giovanni Grignani, Lorenzo D'Ambrosio, Giuseppe Badalamenti, Lorena Incorvaia, Raffaella Bracci, Silvia Gasperoni, Maristella Saponara, Lidia Gatto, Valentina Indio, Annalisa Astolfi, Valerio Di Scioscio, Paolo G Casali, Giuseppe Tonini, Massimo Aglietta, Antonio Russo, Guido Biasco, Maria A Pantaleo
Background: Regorafenib (REG) has now been approved as the standard third-line therapy in metastatic gastrointestinal stromal tumour (GIST) patients at the recommended dose and schedule of 160 mg once daily for the first 3 weeks of each 4-week cycle. However, it has a relevant toxicity profile that mainly occurs within the first cycles of therapy, and dose and schedule adjustments are often required to reduce the frequency or severity of adverse events and to avoid early treatment discontinuation...
December 2017: Therapeutic Advances in Medical Oncology
https://www.readbyqxmd.com/read/29448243/impact-of-health-authority-control-measures-aimed-at-reducing-the-illicit-use-of-anabolic-androgenic-steroids
#4
Raquel Vázquez-Mourelle, Eduardo Carracedo-Martinez, Adolfo Figueiras
OBJECTIVE: To evaluate two interventions on anabolic-androgenic-steroids (AAS) dispensation in retail pharmacies. MATERIAL AND METHODS: The study was conducted in a north-western region of Spain. Data were the AAS supplied by wholesale drug distributors to retail pharmacies over a period of 102 months. It is designed as an ecological time-series study; the dependent variables were daily defined doses per 1,000 inhabitants per day of each drug. The two interventions evaluated were: (1) an inspection program intended for those retail pharmacies where there was an irregular dispensation and (2) a regulation put forth forcing these pharmacies to carry out additional registers...
February 15, 2018: European Addiction Research
https://www.readbyqxmd.com/read/29439697/trajectories-of-antidepressant-medication-use-in-individuals-before-and-after-being-granted-disability-pension-due-to-common-mental-disorders-a-nationwide-register-based-study
#5
Syed Rahman, Michael Wiberg, Kristina Alexanderson, Jussi Jokinen, Antti Tanskanen, Ellenor Mittendorfer-Rutz
BACKGROUND: Early retirement caused by disability pension (DP) due to common mental disorders (CMDs) is frequent in European countries. Inadequate treatment, e.g., suboptimal antidepressant (AD) medication before DP can be crucial in such DP. This explorative study aimed to disentangle trajectories of AD based on defined daily dose (DDD) before and after granted DP, and to characterize the trajectories by socio-demographics and medical factors. METHODS: All 4642 individuals in Sweden aged 19-64 with incident DP due to CMD in 2009-2010 were included...
February 13, 2018: BMC Psychiatry
https://www.readbyqxmd.com/read/29434990/abiraterone-acetate-withdrawal-syndrome-speculations-on-the-underlying-mechanisms
#6
Tomonori Kato, Akira Komiya, Joji Yuasa, Kanya Kaga, Mayuko Kaga, Satoko Kojima, Yukio Naya, Shigeo Isaka
A 72-year-old man initially presented with lumbar and right chest pain, but was later found out to also have an elevated prostate-specific antigen (PSA) level at 2,000.0 ng/ml. Further evaluation disclosed metastatic prostate cancer involving the bones and lymph nodes. The patient was initially treated with combined androgen blockade (CAB) with leuprolide acetate and bicalutamide. After 6 months of CAB, the patient's PSA level began to rise from the nadir (85.1 ng/ml) to 113.3 ng/ml. Bicalutamide was withdrawn in anticipation of anti-androgen withdrawal syndrome and the PSA level declined temporally...
February 2018: Oncology Letters
https://www.readbyqxmd.com/read/29432959/impact-of-adverse-event-solicitation-on-the-safety-profile-of-sq-house-dust-mite-sublingual-immunotherapy-tablet
#7
Hendrik Nolte, David I Bernstein, Gordon L Sussman, Bodil Svanholm Fogh, Susan Lu, Bernt Husøy, Harold S Nelson
BACKGROUND: It has been recommended that sublingual immunotherapy (SLIT) safety be assessed using solicited adverse event (AE) collection methods. OBJECTIVES: To describe the impact on the safety profile of SQ house dust mite (HDM) SLIT-tablet (12 SQ-HDM dose) when pre-specified local application site reactions were solicited vs unsolicited, and discuss ramifications of AE solicitation. METHODS: Subjects were randomized to daily 12 SQ-HDM or placebo for up to 52 weeks in 4 double-blinded, multicenter trials...
February 9, 2018: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/29430641/comparative-effect-of-antipsychotics-on-risk-of-self-harm-among-patients-with-schizophrenia
#8
C-H Ma, S-S Chang, H-J Tsai, S S-F Gau, I-M Chen, S-C Liao, Y-L Chien, M H Hsieh, C-S Wu
OBJECTIVE: To investigate the association of different antipsychotic treatments with hospitalization due to self-harm among patients with schizophrenia. METHOD: This retrospective cohort study was based on Taiwan's universal health insurance database. Patients aged 15-45 years with a newly diagnosed schizophrenic disorder in 2001-2012 were included. The study outcome was the first hospitalization due to self-harm or undetermined injury after the diagnosis of schizophrenic disorders...
February 11, 2018: Acta Psychiatrica Scandinavica
https://www.readbyqxmd.com/read/29429975/teratogenicity-of-antiepileptic-dual-therapy-dose-dependent-drug-specific-or-both
#9
Ravish R Keni, Manna Jose, Prabhakaran Sankara Sarma, Sanjeev V Thomas
OBJECTIVE: To determine the relative risk (RR) of major congenital malformations (MCMs) in infants with antenatal exposure to antiepileptic drug (AED) dual therapy and to explore the influence of specific AEDs vs dose. METHODS: All completed pregnancies prospectively enrolled in the Kerala Registry of Epilepsy and Pregnancy from 1998 until December 2013 on AED dual therapy exposure during the first trimester were analyzed for the outcome, MCMs. Dose was expressed as ratio of prescribed to daily defined dose (PDD/DDD), and the RR for malformation was referenced to lamotrigine monotherapy...
February 2, 2018: Neurology
https://www.readbyqxmd.com/read/29428566/trends-and-patterns-of-national-antimicrobial-consumption-in-japan-from-2004-to-2016
#10
Atsuko Tsutsui, Koji Yahara, Keigo Shibayama
Frequent use of broad-spectrum antimicrobial classes has been reported in Japan; however, little is known about the long-term trend of national antimicrobial consumption, and that of individual agents. This study analyzed the national sales data of systemic antimicrobials from 2004 to 2016, derived from the IMS Japan Pharmaceutical Market database, to assess the consumption patterns of antimicrobial classes and agents in Japan. The number of defined daily doses per 1000 inhabitants per day (DID) was calculated for each antimicrobial agent...
February 7, 2018: Journal of Infection and Chemotherapy: Official Journal of the Japan Society of Chemotherapy
https://www.readbyqxmd.com/read/29426752/increased-dose-and-duration-of-statin-use-is-associated-with-decreased-asthma-related-emergency-department-visits-and-hospitalizations
#11
Jiu-Yao Wang, Tsung-Chieh Yao, Yu-Ting Tsai, Ann Chen Wu, Hui-Ju Tsai
BACKGROUND: Statins have pleiotropic anti-inflammatory and immunomodulatory effects, yet the effect of statin use on asthma-related emergency department (ED) visits and hospitalizations has remained unclear, especially in Asian populations. OBJECTIVE: We sought to examine the effect of statin therapy on asthma-related ED visits and/or hospitalizations. METHODS: A cohort study was conducted using data from Taiwan's National Health Insurance Research Database from 2001 to 2013...
February 6, 2018: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/29423910/kidney-function-monitoring-and-non-vitamin-k-oral-anticoagulant-dosage-in-atrial-fibrillation
#12
Jose Manuel Andreu Cayuelas, Cesar Caro Martínez, Pedro Jose Flores Blanco, Gines Elvira Ruiz, Helena Albendin Iglesias, Juan Jose Cerezo Manchado, Jose Luis Bailen Lorenzo, James Louis Januzzi, Arcadio García Alberola, Sergio Manzano-Fernández
BACKGROUND: Clinical practice guidelines recommend regular kidney function monitoring in atrial fibrillation patients on non-vitamin K oral anticoagulants (NOAC), however information regarding compliance with these recommendations in daily life conditions is scarce. We sought to determine the compliance with kidney function monitoring recommendations in nonvalvular atrial fibrillation (NVAF) patients starting NOAC and its implication on the appropriateness of NOAC dosage. MATERIAL AND METHODS: Retrospective analysis of a multicentre registry including consecutive NVAF patients who started NOAC (n = 692)...
February 9, 2018: European Journal of Clinical Investigation
https://www.readbyqxmd.com/read/29423683/a-phase-i-study-of-afatinib-for-patients-aged-75-or-older-with-advanced-non-small-cell-lung-cancer-harboring-egfr-mutations
#13
Hisashi Tanaka, Kageaki Taima, Yoshihito Tanaka, Masamichi Itoga, Yoshiko Ishioka, Hideyuki Nakagawa, Keisuke Baba, Yukihiro Hasegawa, Shingo Takanashi, Sadatomo Tasaka
This phase I trial was conducted to determine the maximum tolerated dose (MTD) and recommended dose of afatinib for phase II trial in elderly patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. The study used a standard 3 + 3 dose escalation design. Patients aged 75 years or older with advanced NSCLC harboring EGFR mutations were enrolled. The doses of afatinib, which were given once daily, were planned as follows: level 1, 20 mg/day; level 2, 30 mg/day; level 3, 40 mg/day...
February 8, 2018: Medical Oncology
https://www.readbyqxmd.com/read/29421002/evaluation-of-the-safety-and-efficacy-of-an-edoxaban-based-antithrombotic-regimen-in-patients-with-atrial-fibrillation-following-successful-percutaneous-coronary-intervention-pci-with-stent-placement-rationale-and-design-of-the-entrust-af-pci-trial
#14
Pascal Vranckx, Thorsten Lewalter, Marco Valgimigli, Jan G Tijssen, Paul-Egbert Reimitz, Lars Eckardt, Hans-Joachim Lanz, Wolfgang Zierhut, Rüdiger Smolnik, Andreas Goette
BACKGROUND: The optimal antithrombotic treatment after percutaneous coronary intervention (PCI) with stenting in patients with atrial fibrillation (AF) is unknown. In the ENGAGE AF-TIMI 48 trial, edoxaban was noninferior to a vitamin K antagonist (VKA) with respect to the prevention of stroke or systemic embolism and was associated with significantly lower rates of bleeding and cardiovascular death in patients with nonvalvular AF. The effects of edoxaban in combination with single- or dual-antiplatelet therapy in the setting of PCI are unexplored...
February 2018: American Heart Journal
https://www.readbyqxmd.com/read/29420395/ulipristal-acetate-for-treatment-of-symptomatic-uterine-leiomyomas-a-randomized-controlled-trial
#15
James A Simon, William Catherino, James H Segars, Rick E Blakesley, Anna Chan, Vilma Sniukiene, Ayman Al-Hendy
OBJECTIVE: To assess efficacy and tolerability of ulipristal acetate, a selective progesterone receptor modulator, for treatment of symptomatic uterine leiomyomas. METHODS: This phase 3, double-blind, placebo-controlled study enrolled premenopausal women (aged 18-50 years) with abnormal uterine bleeding, one or more discrete leiomyomas, and uterine size 20 weeks of gestation or less. Patients were randomized 1:1:1 to 5 mg ulipristal, 10 mg ulipristal, or placebo once daily for 12 weeks followed by 12-week drug-free follow-up...
February 5, 2018: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/29420185/landscape-of-antimicrobial-stewardship-programs-in-ontario-a-survey-of-hospitals
#16
Valerie Leung, Julie Hui-Chih Wu, Bradley J Langford, Gary Garber
BACKGROUND: Antimicrobial resistance is an important public health issue globally and in Canada. To understand the current state of antimicrobial stewardship programs in Ontario health care facilities, Public Health Ontario conducted a voluntary survey of hospitals in the province. METHODS: The Ontario Antimicrobial Stewardship Program Landscape Survey was distributed online to hospitals, targeting front-line antimicrobial stewardship clinicians. The survey was open for 5 weeks in fall 2016...
February 2, 2018: CMAJ Open
https://www.readbyqxmd.com/read/29414538/antiepileptic-drug-reduction-and-increased-risk-of-stimulation-evoked-focal-to-bilateral-tonic-clonic-seizure-during-cortical-stimulation-in-patients-with-focal-epilepsy
#17
Kevin G Hampel, Asier Gómez-Ibáñez, Mercedes Garcés-Sánchez, David Hervás-Marín, Irene Cano-López, Esperanza González-Bono, Rebeca Conde-Sardón, Antonio Gutiérrez-Martín, Vicente Villanueva
INTRODUCTION: Stimulation-evoked focal to bilateral tonic-clonic seizure (FBTCS) can be a stressful and possibly harmful adverse event for patients during cortical stimulation (CS). We evaluated if drug load reduction of antiepileptic drugs (AEDs) during CS increases the risk of stimulation-evoked FBTCS. MATERIAL AND METHODS: In this retrospective cohort study, we searched our local database for patients with drug-resistant epilepsy who underwent invasive video-EEG monitoring and CS in the University Hospital la Fe Valencia from January 2006 to November 2016...
February 1, 2018: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/29410796/environmental-and-social-factors-impacting-on-epidemic-and-endemic-tuberculosis-a-modelling-analysis
#18
Chacha M Issarow, Nicola Mulder, Robin Wood
Tuberculosis (TB) transmission results from the interaction between infective sources and susceptible individuals within enabling socio-environmental conditions. As TB is an airborne pathogen, the transmission probability is determined by the volume of air inhaled from an infected source and the concentration of Mycobacterium tuberculosis containing respirable particles (doses) per volume of air. In this study, we model the contributions of infectious dose production, prevalence of infectious cases and daily rebreathed air volume (RAV) for defining the boundary conditions necessary to sustain endemic TB transmission at the population level...
January 2018: Royal Society Open Science
https://www.readbyqxmd.com/read/29408938/cost-effectiveness-of-liraglutide-versus-lixisenatide-as-add-on-therapies-to-basal-insulin-in-type-2-diabetes
#19
Åsa Ericsson, Divina Glah, Maria Lorenzi, Jeroen P Jansen, Adam Fridhammar
BACKGROUND: We assessed the cost-effectiveness of the glucagon-like peptide 1 receptor agonists liraglutide 1.8 mg and lixisenatide 20 μg (both added to basal insulin) in patients with type 2 diabetes (T2D) in Sweden. METHODS: The Swedish Institute for Health Economics cohort model for T2D was used to compare liraglutide and lixisenatide (both added to basal insulin), with a societal perspective and with comparative treatment effects derived by indirect treatment comparison (ITC)...
2018: PloS One
https://www.readbyqxmd.com/read/29408293/potential-impurities-in-drug-substances-compound-specific-toxicology-limits-for-20-synthetic-reagents-and-by-products-and-a-class-specific-toxicology-limit-for-alkyl-bromides
#20
J P Bercu, S M Galloway, P Parris, A Teasdale, M Masuda-Herrera, K Dobo, P Heard, M Kenyon, J Nicolette, E Vock, W Ku, J Harvey, A White, S Glowienke, E A Martin, L Custer, R A Jolly, V Thybaud
This paper provides compound-specific toxicology limits for 20 widely used synthetic reagents and common by-products that are potential impurities in drug substances. In addition, a 15 μg/day class-specific limit was developed for monofunctional alkyl bromides, aligning this with the class-specific limit previously defined for monofunctional alkyl chlorides. Both the compound- and class-specific toxicology limits assume a lifetime chronic exposure for the general population (including sensitive subpopulations) by all routes of exposure for pharmaceuticals...
February 2, 2018: Regulatory Toxicology and Pharmacology: RTP
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