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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
Hannah A Blair, James E Frampton
Methoxyflurane (Penthrox(®)) is a halogenated ether first used clinically as a volatile inhalational anaesthetic. It has been used as an analgesic in Australia and New Zealand for the past 30 years. In the UK and Europe, methoxyflurane has been approved for the emergency relief of moderate to severe trauma pain in conscious adult patients. Methoxyflurane is self-administered using a hand-held inhaler. This article reviews the pharmacological properties of methoxyflurane and its clinical efficacy and tolerability in these patients...
October 13, 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
Andrea F D Di Stefano, Antonio Rusca, Milko M Radicioni, Luca Loprete, Daniela Binelli, Giorgio Caccia, Barbara Cometti
BACKGROUND AND OBJECTIVE: Highly purified human menotrophin and urofollitrophin preparations obtained from human urine via a novel patented purification method have been tested over a timeframe of 14 years in the studies presented in this article. The objective of the studies was to investigate the pharmacokinetics and the pharmacodynamics of follicle-stimulating hormone (FSH) after single subcutaneous and intramuscular doses and multiple subcutaneous doses of the tested preparations in healthy fertile pituitary-suppressed women...
September 15, 2016: Clinical Drug Investigation
Rezarta Cuni, Iris Parrini, Riccardo Asteggiano, Maria Rosa Conte
The care and treatment of cancer patients has significantly changed in the last decade with a remarkable shift towards novel targeted therapies. These promising new drugs may represent effective and potentially life-saving therapeutic options in cancer patients, but are also emerging in the cardiotoxicity scenario for their arrhythmogenic potential due to their QT-prolonging activity. In this article we review the mechanisms underlying drug-induced QT interval prolongation and the classes of anticancer-targeted therapies most frequently responsible for this adverse event, with a particular focus on tyrosine kinase-targeting molecules...
September 14, 2016: Clinical Drug Investigation
Yan Xue, Xianghong Qin, Liya Zhou, Sanren Lin, Ling Wang, Haitang Hu, Jielai Xia
BACKGROUND AND OBJECTIVE: Proton pump inhibitors (PPIs) are the main drugs for the treatment of reflux esophagitis. Previous studies have indicated ilaprazole to be safer and more effective in treating duodenal ulcers as compared with omeprazole. Being a novel PPI, ilaprazole may be used in the treatment of reflux esophagitis. The purpose of this study was to evaluate the safety and efficacy of ilaprazole tablets in the treatment of reflux esophagitis. METHODS: This study used a randomized, double-blind, multi-center, active-comparison design...
September 7, 2016: Clinical Drug Investigation
Paweł Moćko, Paweł Kawalec, Andrzej Pilc
BACKGROUND AND OBJECTIVES: Biologic drugs are used in innovative therapies for the management of inflammatory bowel diseases (IBDs). The aim of this study was to compare the safety profile of biologic drugs in patients with IBD. METHODS: A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, up to 22 August 2016. We included randomized, placebo-controlled, or head-to-head clinical trials that compared the safety of different biologics in patients with IBDs...
September 7, 2016: Clinical Drug Investigation
Brian L Erstad
The purpose of this paper is to provide clinicians with important considerations and caveats when evaluating published literature on medication dosing in obese subjects, since much of this literature involves short-term pharmacokinetic or pharmacodynamic studies that are not designed to look at clinically important outcomes. A secondary objective is to suggest improvements in the reporting of dosing information derived from clinical studies and incorporated into product information labeling that should help clinicians design medication-specific dosing regimens for patients with obesity...
September 7, 2016: Clinical Drug Investigation
Thomas Ward, Jason Gordon, Beverley Jones, Hayley Bennett, Samantha Webster, Anupama Kalsekar, Yong Yuan, Michael Brenner, Phil McEwan
BACKGROUND: Targeted intervention in patients with hepatitis C virus (HCV) closest to end-stage liver disease (ESLD) progression may offer an approach to treatment prioritisation whilst delivering benefits for patients and the healthcare system. In contrast to previous HCV economic analyses, this study aimed to estimate the health economic value of sustained virologic response (SVR) stratified by the patient's propensity to progress to ESLD. METHODS: An HCV natural history model was adapted to estimate the value of avoiding ESLD complications following SVR, assessed as cost offsets and quality-adjusted life year (QALY) gains, as a function of time to ESLD at treatment initiation...
September 1, 2016: Clinical Drug Investigation
Philip Lackey, Anthony Mills, Felix Carpio, Ricky Hsu, Edwin DeJesus, Gerald Pierone, Cassidy Henegar, Jennifer Fusco, Gregory Fusco, Mike Wohlfeiler
BACKGROUND AND OBJECTIVES: The standard of care for HIV treatment is a three-drug regimen consisting of two nucleoside reverse transcriptase inhibitors (NRTIs) and either a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor (PI) or an integrase strand transfer inhibitor. Darunavir boosted with ritonavir (DRV/r) is the only preferred PI in the US Department of Health and Human Services (DHHS) HIV treatment guidelines for antiretroviral-naïve patients, recommended in combination with tenofovir/emtricitabine for antiretroviral-naïve patients...
September 1, 2016: Clinical Drug Investigation
Alberto Castagna, Antonino Maria Cotroneo, Giovanni Ruotolo, Pietro Gareri
BACKGROUND: Acetylcholinesterase inhibitors (AchEIs), such as rivastigmine, coadministered with cholinergic precursors, such as citicoline, could be effective in Alzheimer's disease (AD) and in mixed dementia (MD), because they are able to increase the intrasynaptic levels of acetylcholine more than the single drugs given alone. OBJECTIVE: The aim of the present study was to show the effectiveness of oral citicoline plus rivastigmine in patients with AD and MD. METHODS: The CITIRIVAD study was a retrospective case-control study on 174 consecutive outpatients aged ≥65 years, affected with AD or MD, mean age 81...
September 1, 2016: Clinical Drug Investigation
Sherif Hanafy Mahmoud
Continuous renal replacement therapy (CRRT) is used for managing acute kidney injury in critically ill patients. Removal of antiepileptic drugs (AEDs) by CRRT could be significant and may complicate patients' intensive care unit stay. The objective of the current review was to summarize the available evidence for AED removal by CRRT. An electronic literature search of PubMed (1946 to May 2016), Medline (1946 to May 2016), and Embase (1974 to May 2016) databases for studies discussing AED removal by CRRT was conducted...
September 1, 2016: Clinical Drug Investigation
Yuuichi Sakurai, Madoka Shiino, Sayako Horii, Hiroyuki Okamoto, Koki Nakamura, Akira Nishimura, Yukikuni Sakata
BACKGROUND: Gastroprotective agents are recommended for patients receiving low-dose aspirin (LDA) or nonsteroidal anti-inflammatory drugs (NSAIDs). Vonoprazan is a potassium-competitive acid blocker recently approved for the prevention of peptic ulcer recurrence in patients receiving LDA or NSAIDs. METHODS: This phase 2, open-label, single-center study in healthy Japanese males evaluated drug-drug interactions between vonoprazan 40 mg and LDA (100 mg) or NSAIDs [loxoprofen sodium (60 mg), diclofenac sodium (25 mg), or meloxicam (10 mg)] and vice versa...
August 31, 2016: Clinical Drug Investigation
Carlos A Camargo, Kourtney J Davis, Elizabeth B Andrews, David A Stempel, Michael Schatz
RATIONALE: The increased risk of asthma mortality in association with long-acting β2-agonist (LABA) monotherapy is well documented but the risk associated with LABA plus inhaled corticosteroid (ICS) therapy remains unclear. OBJECTIVE: We assessed the feasibility of a large pharmacoepidemiological study to compare the effect of combined LABA + ICS therapy with non-LABA maintenance therapy on the risk of asthma mortality. METHODS: This observational retrospective study used electronic data from ten US data partners to construct a cohort of patients with persistent asthma (defined as: four or more asthma maintenance medication dispensings in 12 months and a code diagnosis of asthma)...
August 31, 2016: Clinical Drug Investigation
Xiaoyu Yan, Xiaohua Gu, Lei Zhou, Houweng Lin, Bin Wu
BACKGROUND AND OBJECTIVES: Apixaban and enoxaparin are indicated for preventing venous thromboembolism (VTE). The aim of this study was to evaluate the cost effectiveness of apixaban versus enoxaparin for the prophylaxis of VTE and associated long-term complications in Chinese patients after total knee replacement (TKR). METHODS: A decision model, which included both acute VTE (represented as a decision tree) and the long-term complications of VTE (represented as a Markov model), was developed to assess the economic outcomes of the two prophylactic strategies for Chinese patients after TKR...
August 31, 2016: Clinical Drug Investigation
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