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Clinical Drug Investigation

Shinichi Komiyama, Masaru Nagashima, Tomoko Taniguchi, Takayuki Rikitake, Mineto Morita
BACKGROUND AND OBJECTIVE: Administration of bevacizumab to ovarian cancer patients with distal deep vein thrombosis (DVT) is problematic because of lack of evidence about the likely outcomes. We conducted a preliminary study in ovarian cancer patients with DVT who received bevacizumab combined with a direct oral anticoagulant (DOAC). METHODS: We retrospectively investigated patients with advanced or recurrent epithelial ovarian cancer and distal DVT diagnosed by ultrasonography who underwent chemotherapy containing bevacizumab (15 mg/kg every 3 weeks) combined with DOAC therapy...
February 8, 2019: Clinical Drug Investigation
Dongbao Zhao, Zhiwei Chen, Shaoxian Hu, Jianhao Lin, Zengwu Shao, Guochun Wang, Weiguo Xiao, Yi Zheng, Zhiyi Zhang, Yeqing Shi, Zhanguo Li
BACKGROUND AND OBJECTIVE: Loxoprofen (LOX) is a nonsteroidal anti-inflammatory drug (NSAID). Although oral administration of LOX has been widely prescribed, clinical guidelines for osteoarthritis generally recommend topical rather than oral NSAIDs in specific patients. However, there is limited information on the effects of loxoprofen sodium oral (LOX-O) versus loxoprofen sodium hydrogel transdermal patch (LOX-T) in myalgia patients. Hence, this non-inferiority study was designed to compare the efficacy and safety of LOX-O versus LOX-T in Chinese patients with myalgia...
February 6, 2019: Clinical Drug Investigation
Sohita Dhillon
An Online First version of this article was made available online at.
February 6, 2019: Clinical Drug Investigation
Daniel R Morales, Jim Slattery, Alexandra Pacurariu, Luis Pinheiro, Patricia McGettigan, Xavier Kurz
The article Relative and Absolute Risk of Tendon Rupture with Fluoroquinolone and Concomitant Fluoroquinolone/Corticosteroid Therapy: Population-Based Nested Case-Control Study, written by Morales DR, Slattery J, Pacurariu A, Pinheiro L, McGettigan P, Kurz X, was originally published Online First without open access.
February 6, 2019: Clinical Drug Investigation
Mauro Molteni, Matteo Crippa, Annalisa Orenti, Hernan Polo Friz, Anna Menghini, Pierluigi Tramacere, Giuseppe Marano, Claudio Cimminiello, Patrizia Boracchi
BACKGROUND AND OBJECTIVES: Warfarin-related nephropathy is an unexplained acute kidney injury, and may occur in patients with supratherapeutic INR, in the absence of overt bleeding. Similar findings have been observed in rats treated with dabigatran etexilate. We conducted a prospective study in dabigatran etexilate-treated patients to assess the incidence of dabigatran-related nephropathy and to investigate the possible correlation between dabigatran plasma concentration (DPC) and worsening renal function...
January 29, 2019: Clinical Drug Investigation
Keiko Hosohata, Ayaka Inada, Saki Oyama, Iku Niinomi, Tomohito Wakabayashi, Kazunori Iwanaga
BACKGROUND AND OBJECTIVE: Adverse cutaneous drug reactions associated with antiepileptic drugs (AEDs) are a serious problem in the clinical setting. New-generation AEDs have been reported to be better tolerated than old-generation forms; however, information about the risks of adverse cutaneous drug reactions to new-generation AEDs is limited. OBJECTIVE: The purpose of this study was to clarify the association of AEDs with adverse cutaneous drug reactions using a spontaneous reporting database...
January 28, 2019: Clinical Drug Investigation
Yan Xu, Ningying Mao, Viktor Chirikov, Fen Du, Yu-Chen Yeh, Li Liu, Ruiqi Liu, Xin Gao
BACKGROUND AND OBJECTIVE: Teriflunomide is a once-daily oral immunomodulatory agent approved in 80 countries for the treatment of patients with relapsing multiple sclerosis (RMS). The study objective was to estimate the cost effectiveness of teriflunomide (14 mg tablet, daily) versus interferon beta-1b (250 mcg subcutaneous injection, every other day) among RMS patients from the Chinese healthcare system perspective. METHODS: A Markov model with annual cycles and a lifetime horizon was utilized to assess cost-effectiveness of teriflunomide in comparison with interferon beta-1b in RMS patients...
January 25, 2019: Clinical Drug Investigation
Kurt Buhagiar, Farid Jabbar
BACKGROUND AND OBJECTIVE: Individuals with severe mental illness experience increased morbidity and mortality as a result of metabolic problems that may partly be related to the adverse effects of antipsychotics. Compared with first-generation antipsychotics, second-generation antipsychotics collectively are considered to have stronger associations with lipid abnormalities, but evidence for this specific claim has not been systematically reviewed. The objective of this review was to evaluate the risk of dyslipidaemia with second-generation versus first-generation antipsychotics amongst individuals with severe mental illness...
January 24, 2019: Clinical Drug Investigation
Huan-Huan Ji, Xue-Wen Tang, Zhi Dong, Lin Song, Yun-Tao Jia
BACKGROUND AND OBJECTIVE: Immune checkpoint inhibitors (ICIs)-cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed death receptor-1 (PD-1) monoclonal antibodies (mAbs)-either as single agents or in combination have become the standard of care for an increasing number of indications. Understanding both the ICI-associated adverse events (AEs) and the possible rank-order of these drugs in terms of susceptibility is essential if we are to improve the curative effect and reduce toxicity...
January 23, 2019: Clinical Drug Investigation
Mohammed Bouhajib, Zia Tayab
BACKGROUND AND OBJECTIVE: Following oral administration of abiraterone acetate, the parent compound abiraterone acetate is rapidly metabolized to abiraterone. To our knowledge, bioanalytical methods to date have not been able to detect the parent compound in human plasma, and bioassay was only performed on the metabolite. A highly sensitive bioanalytical method was developed and validated to measure plasma concentrations of the parent compound. In this study, both analytes were assayed and used to evaluate the full pharmacokinetic profile of abiraterone acetate tablets...
January 22, 2019: Clinical Drug Investigation
Sermsiri Sangroongruangsri, Usa Chaikledkaew, Suthasinee Kumluang, Olivia Wu, Claudia Geue, Tanapat Ratanapakorn, Pattara Leelahavarong, Lily Ingsrisawang, Paisan Ruamviboonsuk, Wongsiri Taweebanjongsin, Janejit Choovuthayakorn, Apichart Singalavanija, Prut Hanutsaha, Kittisak Kulvichit, Thitiporn Ratanapojnard, Warapat Wongsawad, Yot Teerawattananon
The Open Access license, which previously read.
January 19, 2019: Clinical Drug Investigation
Aditya K Gupta, Rachel R Mays, Sarah G Versteeg, Neil H Shear, Vincent Piguet, Bianca Maria Piraccini
Androgenetic alopecia (AGA) is characterized by non-scarring follicle miniaturization. Despite the success of approved therapies, commonly reported side effects and the need for continual use has led to the investigation of alternative therapies. The aim of this paper is to critically review the success of off-label, topical monotherapies for treatment of AGA in men. A literature search was conducted to obtain randomized, controlled and blinded studies that investigated off-label, topical, monotherapies in male patients...
January 17, 2019: Clinical Drug Investigation
Griet Hoste, Laurence Slembrouck, Lynn Jongen, Kevin Punie, Tom Matton, Sara Vander Borght, Isabelle Vanden Bempt, Johan Menten, Hans Wildiers, Giuseppe Floris, Carlos Arteaga, Patrick Neven
Dr. Arteaga serves on an Advisory Board for Novartis and was a consultant for AstraZeneca from 2015 to 2016. All other authors declare that they have no competing interests.
January 12, 2019: Clinical Drug Investigation
Vincent Dagenais-Beaulé, Jean-François Tourigny, Louise Papillon-Ferland
BACKGROUND: As an increasing number of elderly are undergoing orthopaedic procedures, it is important to understand and evaluate postoperative pain management in this population, especially in regard to opioid use. Data in the literature pertaining to the very elderly remains scarce. OBJECTIVES: This study was conducted to evaluate whether older patients require lower opioid doses than their younger counterparts after undergoing an elective or urgent orthopaedic procedure, and to assess the cumulative incidence of adverse events and length of stay for each age group...
January 10, 2019: Clinical Drug Investigation
Toshiyuki Yamamoto
Palmoplantar pustulosis (PPP) is a chronic inflammatory disorder characterized by sterile pustules predominantly involving the palms and soles. The purpose of this review was to describe the characteristics of Japanese PPP patients as PPP is frequently observed within the Japanese population. Most Japanese dermatologists consider PPP a distinct entity, and co-existence of PPP and psoriasis is rare; however, outside Japan, PPP is often considered to be palmoplantar psoriasis, and an extra-palmoplantar lesion associated with PPP is considered to be psoriasis...
January 10, 2019: Clinical Drug Investigation
Nuggehally R Srinivas
No abstract text is available yet for this article.
January 10, 2019: Clinical Drug Investigation
Tadao Akizawa, Ryutaro Shimazaki, Masanari Shiramoto, Masafumi Fukagawa
No abstract text is available yet for this article.
January 10, 2019: Clinical Drug Investigation
Luna Carrillo-Aleman, Francisco Marín, José M Rivera-Caravaca, Nuria Vicente-Ibarra, Elena Candela-Sanchez, Maria A Esteve-Pastor, Teresa Lozano, Miriam Sandín-Rollan, Vicente Pernias-Escrig, Manuel Macías, Miriam Quintana-Giner, Andrea Veliz, Esteban Orenes-Piñero, Juan G Martínez-Martínez, Juan M Ruiz-Nodar
BACKGROUND AND OBJECTIVE: Dual antiplatelet therapy is one of the main treatments in acute coronary syndrome (ACS). Switching antiplatelet agents may be necessary in some patients to improve efficacy or safety. The objective of this study was to determine the prevalence, predictors, and implications of clinical switching in patients during hospital admission and 1-year follow-up at discharge. METHODS: Observational, prospective, multicenter registry study in patients discharged following an admission for ACS and followed up for 1 year...
January 8, 2019: Clinical Drug Investigation
Derek E Murrell, David B Cluck, Jonathan P Moorman, Stacy D Brown, Ke-Sheng Wang, Michelle M Duffourc, Sam Harirforoosh
BACKGROUND AND OBJECTIVES: Integrase strand transfer inhibitors (INSTIs), dolutegravir, elvitegravir, and raltegravir, have become integral in the treatment of HIV, with close monitoring of continued efficacy and tolerability. As side effect occurrence varies among subjects receiving these drugs, we sought to perform an exploratory analysis examining the role of several single-nucleotide polymorphisms (SNPs) on drug concentration changes, selected clinical outcomes, and the occurrence of subject-reported adverse events...
January 8, 2019: Clinical Drug Investigation
Sohita Dhillon
Neratinib (Nerlynx® ) is an oral, irreversible pan-human epidermal growth factor receptor (HER) tyrosine kinase inhibitor of HER1, HER2 and HER4. Neratinib therapy for 12 months significantly reduced the risk of invasive disease recurrence or death relative to placebo at both 2 and 5 years post-randomization in the pivotal ExteNET trial in women with early-stage HER2-positive breast cancer who had completed adjuvant trastuzumab. Subgroup analyses showed that patients with hormone receptor (HRc)-positive disease derived greater benefit with neratinib than patients with HRc-negative disease, and patients who initiated neratinib within 1 year of completing trastuzumab had better outcomes than those who started treatment 1-2 years after trastuzumab...
January 3, 2019: Clinical Drug Investigation
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