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Clinical Drug Investigation

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
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
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
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 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
Hannah A Blair, James E Frampton
No abstract text is available yet for this article.
November 17, 2016: Clinical Drug Investigation
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
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
(no author information available yet)
No abstract text is available yet for this article.
November 9, 2016: Clinical Drug Investigation
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
Frank R Ernst, Peri Barr, Riad Elmor, Walter Sandulli, Lionel Thevathasan, Arnold B Sterman, Jessica Goldenberg, Kevin Vora
BACKGROUND: In general, hypothyroidism can be adequately treated with a consistent daily dose of levothyroxine. However, the need for levothyroxine dose adjustments is frequent in clinical practice. The extent to which levothyroxine dose adjustments increase the utilization of healthcare resources has not previously been described in the clinical literature. OBJECTIVE: The primary objective of our study was to measure the effect of levothyroxine dose adjustments in terms of their utilization of healthcare resources including direct and indirect costs...
October 31, 2016: Clinical Drug Investigation
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
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
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
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
Cosmo Godino, Antonio Colombo, Alberto Margonato
Heart rate is an established prognostic marker for longevity and is an important contributor in the pathophysiology of various cardiovascular diseases, including ischemic heart disease and heart failure. Most ischemic episodes are triggered by an increase in heart rate, which causes an imbalance between myocardial oxygen delivery and consumption. In addition, increased heart rate is a modifiable risk factor for chronic heart failure. Ivabradine, an inhibitor of If ion channels, is an approved second-line anti-ischemic drug for the treatment of angina...
October 21, 2016: Clinical Drug Investigation
Nuggehally R Srinivas
No abstract text is available yet for this article.
October 12, 2016: Clinical Drug Investigation
Hui Liu, Rong Fu, Lijuan Li, Guojin Wang, Jia Song, Erbao Ruan, Huaquan Wang, Yuhong Wu, Xiaoming Wang, Kai Ding, Zonghong Shao
BACKGROUND AND OBJECTIVES: The therapy in elderly patients with acute myeloid leukemia (AML) is a big challenge because of poor risk factors and inferior tolerance to intensive chemotherapy. This study aims to compare the efficacy between reduced-intensity idarubicin plus cytarabine and daunorubicin plus cytarabine (IA regimen and DA regimen, respectively) in elderly patients with newly diagnosed AML. METHODS: We retrospectively investigated 74 patients with newly diagnosed non-M3 AML aged >60 years, where 33 patients received IA regimen, 30 patients received DA regimen, while 11 patients received supportive treatment...
October 8, 2016: Clinical Drug Investigation
Virginie Nerich, Camille Fleck, Loïc Chaigneau, Nicolas Isambert, Christophe Borg, Elsa Kalbacher, Marine Jary, Pauline Simon, Xavier Pivot, Jean-Yves Blay, Samuel Limat
INTRODUCTION: The management of advanced gastrointestinal stromal tumors (GISTs) has been modified considerably by the availability of costly tyrosine kinase inhibitors (TKIs); however, the best therapeutic sequence in terms of cost and effectiveness remains unknown. OBJECTIVE: The aim of this study was to compare four potential strategies (reflecting the potential daily practice), each including imatinib 400 mg/day, as first-line treatment: S1 (imatinib400/best supportive care [BSC]); S2 (imatinib400/imatinib800/BSC); S3 (imatinib400/sunitinib/BSC); and S4 (imatinib400/imatinib800/sunitinib/BSC)...
September 24, 2016: Clinical Drug Investigation
Wei Xu, Yang Gong, Meng Kuang, Peng Wu, Chunxiang Cao, Jinfei Chen, Cuiju Tang
BACKGROUND: Recently, the need for maintenance chemotherapy arose as a result of the significantly improved survival of patients with metastatic colorectal cancer (mCRC) without increasing adverse events. Currently used maintenance regimens are fluoropyrimidines, bevacizumab, and the combination of fluoropyrimidine with bevacizumab. A new combination with bevacizumab and erlotinib, a tyrosine kinase inhibitor of the epithelial growth factor receptor, has shown synergistic effects in preclinical tests and promising results in some clinical trials...
September 24, 2016: Clinical Drug Investigation
Tomoyasu Otsuki, Terumi Higuchi, Toshio Yamazaki, Erina Okawa, Kazuyoshi Okada, Masanori Abe
OBJECTIVE: Pregabalin is a gamma aminobutyric acid derivative administered for neuropathic pain. It binds to α2δ subunits of voltage-dependent calcium channels, and inhibits calcium inflow of synapses and the release of excitatory neurotransmitters. This study investigated the efficacy and safety of pregabalin in patients with peripheral neuropathic pain undergoing maintenance hemodialysis. METHODS: This study was a prospective, open-label, single-arm, multi-center trial...
September 23, 2016: Clinical Drug Investigation
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