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Clinical Drug Investigation

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https://www.readbyqxmd.com/read/28074337/economic-burden-of-rheumatoid-arthritis-in-italy-possible-consequences-on-anti-citrullinated-protein-antibody-positive-patients
#1
Francesco Saverio Mennini, Andrea Marcellusi, Lara Gitto, Florenzo Iannone
BACKGROUND: Rheumatoid arthritis (RA) is an autoimmune disease with a substantial medical and economic burden. In Italy, it affects approximately 280,000 people, therefore representing the musculoskeletal disease with the highest economic impact in terms of costs for the National Health Service and the social security system. OBJECTIVE: The aim of this study was to estimate the annual economic burden of RA in Italy and determine the potential cost reduction considering the most effective biologic treatment for early rapidly progressing RA (ERPRA) patients...
January 10, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28066878/safety-and-effectiveness-of-sodium-stibogluconate-and-paromomycin-combination-for-the-treatment-of-visceral-leishmaniasis-in-eastern-africa-results-from-a-pharmacovigilance-programme
#2
Robert Kimutai, Ahmed M Musa, Simon Njoroge, Raymond Omollo, Fabiana Alves, Asrat Hailu, Eltahir A G Khalil, Ermias Diro, Peninah Soipei, Brima Musa, Khalid Salman, Koert Ritmeijer, Francois Chappuis, Juma Rashid, Rezika Mohammed, Asfaw Jameneh, Eyasu Makonnen, Joseph Olobo, Lawrence Okello, Patrick Sagaki, Nathalie Strub, Sally Ellis, Jorge Alvar, Manica Balasegaram, Emilie Alirol, Monique Wasunna
INTRODUCTION: In 2010, WHO recommended a new first-line treatment for visceral leishmaniasis (VL) in Eastern Africa. The new treatment, a combination of intravenous (IV) or intramuscular (IM) sodium stibogluconate (SSG) and IM paromomycin (PM) was an improvement over SSG monotherapy, the previous first-line VL treatment in the region. To monitor the new treatment's safety and effectiveness in routine clinical practice a pharmacovigilance (PV) programme was developed. METHODS: A prospective PV cohort was developed...
January 9, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28035616/effects-of-renal-function-on-crizotinib-pharmacokinetics-dose-recommendations-for-patients-with-alk-positive-non-small-cell-lung-cancer
#3
Weiwei Tan, Shinji Yamazaki, Theodore R Johnson, Rong Wang, Melissa T O'Gorman, Leonid Kirkovsky, Tanya Boutros, Nicoletta M Brega, Akintunde Bello
BACKGROUND AND OBJECTIVES: Crizotinib (250 mg twice daily) is the first anaplastic lymphoma kinase (ALK) inhibitor approved for treatment of ALK-positive non-small-cell lung cancer (NSCLC). The objectives of the current study were to evaluate the effects of mild, moderate, and severe renal impairment on crizotinib pharmacokinetics and to make crizotinib dosing recommendations for ALK-positive NSCLC patients with renal impairment on the basis of the findings. METHODS: The effects of varying degrees of renal impairment on crizotinib pharmacokinetics were evaluated by: (1) analysis of mild and moderate renal impairment on multiple-dose pharmacokinetics of crizotinib in ALK-positive NSCLC patients from the PROFILE 1001 and PROFILE 1005 trials; (2) analysis of severe renal impairment on single-dose pharmacokinetics of crizotinib in volunteers (Study 1020); and (3) prediction of the effect of severe renal impairment on multiple-dose crizotinib pharmacokinetics using a physiologically-based pharmacokinetic model of crizotinib...
December 29, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27995521/efficacy-and-safety-of-calcipotriol-plus-betamethasone-dipropionate-aerosol-foam-compared-with-betamethasone-17-valerate-medicated-plaster-for-the-treatment-of-psoriasis
#4
Catherine Queille-Roussel, Monika Rosen, Fabrice Clonier, Kasper Nørremark, Jean-Philippe Lacour
BACKGROUND: Fixed combination calcipotriol as hydrate (Cal) 50 µg/g plus betamethasone as dipropionate (BD) 0.5 mg/g aerosol foam is an alcohol-free treatment for psoriasis. Betamethasone 17-valerate 2.25 mg (BV)-medicated plasters are recommended for treating psoriasis plaques localized in difficult-to-treat (DTT; elbow, knee, anterior face of the tibia) areas. OBJECTIVE: The aim of this study was to compare the efficacy of Cal/BD foam with BV-medicated plaster in patients with plaque psoriasis...
December 19, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27988835/cost-effectiveness-analysis-of-apixaban-dabigatran-rivaroxaban-and-warfarin-for-stroke-prevention-in-atrial-fibrillation-in-taiwan
#5
Chieh-Yu Liu, Hui-Chun Chen
BACKGROUND AND OBJECTIVES: The aim of this study was to evaluate the cost effectiveness of novel oral anticoagulants (NOACs) for stroke prevention among atrial fibrillation (AF) patients by incorporating Taiwanese demographic information derived from a population-based database, the National Health Insurance Research Database (NHIRD), into cost-effectiveness analysis. METHODS: From 1 January to 31 December 2012, 98,213 AF patients were selected from the NHIRD database...
December 17, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27928739/cost-effectiveness-comparison-between-the-response-guided-therapies-and-monotherapies-of-nucleos-t-ide-analogues-for-chronic-hepatitis-b-patients-in-china
#6
Keng Lai, Chi Zhang, Weixia Ke, Yanhui Gao, Shudong Zhou, Li Liu, Yi Yang
BACKGROUND AND OBJECTIVE: Nucleos(t)ide analogue (NA) monotherapies are typically used as the primary treatment for chronic hepatitis B (CHB) patients, including lamivudine (LAM), telbivudine (TBV), adefovir (ADV), entecavir (ETV) and tenofovir (TDF). For high-resistance NAs (LAM, TBV, ADV), they can generate excellent clinical outcomes by using response-guided therapy; however, their pharmacoeconomic profiles remain unclear in China. We aimed to evaluate the cost effectiveness between response-guided therapies and monotherapies of NAs for Chinese hepatitis B e-antigen (HBeAg)-positive and -negative CHB patients...
December 7, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27928738/effect-of-multiple-oral-doses-of-the-potent-cyp3a4-inhibitor-clarithromycin-on-the-pharmacokinetics-of-a-single-oral-dose-of-vonoprazan-a-phase-i-open-label-sequential-design-study
#7
Helen Jenkins, Richard Jenkins, Alain Patat
BACKGROUND AND OBJECTIVES: This phase I, open-label, sequential design study assessed the effect of multiple oral doses of the potent cytochrome P450 (CYP) 3A4 inhibitor clarithromycin on the pharmacokinetics of a single oral dose of vonoprazan. METHODS: During the 10-day treatment period, 16 healthy male subjects received vonoprazan 40 mg on days 1 and 8, and clarithromycin 1000 mg on days 3-9, with the pharmacokinetics of both examined. Primary endpoints included the maximum observed plasma concentration (C max) and area under the plasma concentration-time curve (AUC) of vonoprazan and its major metabolites (M-I, M-II, M-III, and M-IV-Sul)...
December 7, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27910036/evaluation-of-the-pharmacokinetic-interaction-between-venetoclax-a-selective-bcl-2-inhibitor-and-warfarin-in-healthy-volunteers
#8
Ahmed Hamed Salem, Beibei Hu, Kevin J Freise, Suresh K Agarwal, Dilraj S Sidhu, Shekman L Wong
BACKGROUND AND OBJECTIVE: Venetoclax is a selective, B-cell lymphoma-2 inhibitor that has demonstrated clinical efficacy in a variety of hematological malignancies. In vitro data indicated weak cytochrome P450 (CYP) 2C9 inhibition by venetoclax; however, it is not predicted to cause clinically relevant inhibition due to high plasma protein binding. A Phase 1 study was conducted in healthy volunteers to evaluate the effect of venetoclax on warfarin pharmacokinetics. METHODS: Subjects received a single oral dose of 5 mg warfarin on day 1 of both periods 1 and 2, separated by a 14 days washout...
December 2, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27888448/a-randomized-single-blind-trial-of-clobetasol-propionate-0-05-cream-under-silicone-dressing-occlusion-versus-intra-lesional-triamcinolone-for-treatment-of-keloid
#9
Norazirah Md Nor, Rasimah Ismail, Adawiyah Jamil, Shamsul Azhar Shah, Farah Hani Imran
BACKGROUND AND OBJECTIVE: Keloid is conventionally treated with intra-lesional (IL) triamcinolone, which is highly operator dependent and has its own adverse effects. Topical steroid and silicone dressings are a patient friendly and non-invasive treatment alternative. We therefore sought to determine the efficacy and safety of topical clobetasol propionate (Dermovate(®)) 0.05% cream under occlusion with Mepiform(®) silicone dressing compared to IL triamcinolone in the treatment of keloid...
November 25, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27878562/full-dose-perindopril-indapamide-in-the-treatment-of-difficult-to-control-hypertension-the-fortissimo-study
#10
Yuri Aleksandrovich Karpov
BACKGROUND AND OBJECTIVE: Blood pressure (BP) control in hypertensive patients remains poor worldwide, particularly in high-risk patients with hypertension and diabetes. Guidelines recommend that such patients receive prompt pharmacological therapy at maximal doses to rapidly control BP. We aimed to evaluate efficacy and safety of single-pill combination (SPC) perindopril/indapamide (PER/IND) at full dose (10/2.5 mg) in hypertensive patients, including diabetics, with BP uncontrolled by previous medication...
November 22, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27858328/adverse-events-and-efficacy-of-cixutumumab-in-phase-ii-clinical-trials-a-systematic-review-and-meta-analysis
#11
REVIEW
Hongxin Cao, Lixuan Cui, Wei Ma, Linhai Zhu, Kai Wang, Yang Ni, Yibing Wang, Jiajun Du
BACKGROUND AND OBJECTIVES: Cixutumumab is a monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF1R). We sought to evaluate the efficacy of cixutumumab in the treatment of cancer, and to comprehensively assess the associated adverse events in phase II clinical trials. METHODS: Data were collected from PubMed, Embase, and Clinicaltrials.gov. The improvement on progression-free survival (PFS) was evaluated by hazard ratio (HR) and 95% confidence intervals (95% CIs)...
November 17, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27858327/erratum-to-methoxyflurane-a-review-in-trauma-pain
#12
Hannah A Blair, James E Frampton
No abstract text is available yet for this article.
November 17, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27853999/quantifying-the-exposure-of-tapentadol-extended-release-in-japanese-patients-with-cancer-pain-and-bridging-tapentadol-pharmacokinetics-across-populations-using-a-modeling-approach
#13
Liping Zhang, Xiaoyu Yan, Sayori Nobe, Peter Zannikos, Mila Etropolski, Partha Nandy
BACKGROUND AND OBJECTIVES: Tapentadol extended release (ER) is approved for the management of chronic and acute pain in adults. There has been no report of tapentadol ER pharmacokinetics in subjects with cancer pain. This analysis investigated tapentadol ER pharmacokinetics in Japanese patients with cancer pain and bridged it with the pharmacokinetics in Japanese healthy subjects and Caucasian patients with cancer pain. METHODS: Nonlinear mixed-effect pharmacokinetic modeling was conducted based on pooled tapentadol ER concentration data collected in five Phase 1 studies from 138 Japanese and Korean healthy subjects and in two Phase 3 studies from 215 Japanese and Korean subjects with cancer pain...
November 17, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27848150/factors-related-to-the-glucose-lowering-efficacy-of-dipeptidyl-peptidase-4-inhibitors-a-systematic-review-and-meta-analysis-focusing-on-ethnicity-and-study-regions
#14
REVIEW
Kayo Fujita, Masayuki Kaneko, Mamoru Narukawa
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 explored potential differences among ethnicities; in particular, Japanese subjects were dealt separately from other Asian subjects. METHODS: A systematic literature search was conducted using the MEDLINE, EMBASE, Cochrane Central Register, Japan Medical Abstracts Society, and ClinicalTrials...
November 16, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27830530/acknowledgement-to-referees
#15
(no author information available yet)
No abstract text is available yet for this article.
November 9, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27812971/efficacy-and-safety-of-dexmedetomidine-as-an-adjuvant-in-epidural-analgesia-and-anesthesia-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#16
REVIEW
Xu Zhang, Dong Wang, Min Shi, YuanGuo Luo
BACKGROUND AND OBJECTIVE: Several clinical trials have examined and indicated the usefulness of epidural dexmedetomidine therapy. However, there has been no systematic analysis of the findings of these trials to date. We undertook this systematic review and meta-analysis to investigate the efficacy and safety of epidural dexmedetomidine adjunctive therapy in different surgical procedures. MATERIALS AND METHODS: We searched EMBASE, PubMed, the Cochrane Library, and the Clinical Trials...
November 4, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27785737/pharmacokinetics-pharmacodynamics-and-safety-of-entospletinib-a-novel-psyk-inhibitor-following-single-and-multiple-oral-dosing-in-healthy-volunteers
#17
Srini Ramanathan, Julie A Di Paolo, Feng Jin, Lixin Shao, Shringi Sharma, Michelle Robeson, Brian P Kearney
BACKGROUND AND OBJECTIVES: Entospletinib is a selective, reversible, adenosine triphosphate-competitive small-molecule spleen tyrosine kinase (SYK) inhibitor that blocks B cell receptor-mediated signaling and proliferation in B lymphocytes. This study evaluated the safety, pharmacokinetics, and pharmacodynamics of entospletinib in a double-blind, single/multiple ascending dose study in healthy volunteers. METHODS: In sequential cohorts, 120 subjects received entospletinib (25-1200 mg; fasted) as single or twice-daily oral doses for 7 days...
October 26, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27785736/relationship-between-adverse-gastric-reactions-and-the-timing-of-enteric-coated-aspirin-administration
#18
Weijun Guo, Wenlin Lu, Yujun Xu, Liansheng Wang, Qin Wei, Qingyun Zhao
OBJECTIVE: This study aimed to elucidate the association between the adverse gastric effects of enteric-coated aspirin and the timing of its administration. METHODS: The study population comprised 572 patients (age range 45-84 years) admitted to Huaiyin Hospital between August 2012 and October 2014. Patients were administered a 100 mg enteric-coated aspirin tablet once daily: before a meal (30 min before a meal), during a meal, after a meal (30 min after a meal), or before sleep, and all patients were followed up for 6-9 months to observe for adverse gastric reactions and other side effects...
October 26, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27785735/real-world-outcomes-in-fingolimod-treated-patients-with-multiple-sclerosis-in-the-czech-republic-results-from-the-12-month-golems-study
#19
Veronika Tichá, Roman Kodým, Zuzana Počíková, Pavla Kadlecová
BACKGROUND AND OBJECTIVE: Once-daily oral fingolimod is approved in the EU as escalation treatment for adult patients with highly active relapsing multiple sclerosis (MS). The efficacy and safety profiles of fingolimod have been well established in a large clinical development programme and several papers reflecting the experience with fingolimod in real-world settings have been published to date. The GOLEMS study was designed to evaluate the efficacy, safety and tolerability of fingolimod and the impact of fingolimod treatment on disability progression and work capability in patients with MS in routine clinical practice in the Czech Republic...
October 26, 2016: Clinical Drug Investigation
https://www.readbyqxmd.com/read/27766511/the-efficacy-and-safety-of-tolvaptan-in-patients-with-hyponatremia-a-meta-analysis-of-randomized-controlled-trials
#20
Benlei Li, Dong Fang, Cheng Qian, Hongliang Feng, Yanggan Wang
BACKGROUND AND OBJECTIVES: Comprehensive evaluations regarding the benefits of tolvaptan in the treatment of hyponatremia are lacking. The objective of this meta-analysis was to assess the efficacy and safety of tolvaptan in patients with hyponatremia. METHODS: Pertinent studies were identified by searching PubMed, EMBASE, Web of Science, and the Cochrane Library for articles published between their respective inception dates and 31 April 2016. Summary relative risks (RRs) or weighted mean differences (WMDs) with their 95 % confidence intervals (CIs) were calculated using fixed-effects or randomized-effects models, depending on the degree of heterogeneity noted among the studies included in the analysis...
October 21, 2016: Clinical Drug Investigation
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