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Clinical Drug Investigation

Yaqun Hong, Xiaofan Li, Bo Wan, Nainong Li, Yuanzhong Chen
BACKGROUND AND OBJECTIVES: Eltrombopag seems to be effective in treating patients with aplastic anemia in several clinical trials. This paper aims to perform the first meta-analysis analyzing the efficacy and safety of eltrombopag for aplastic anemia. METHODS: Literatures were retrieved from PubMed, EMBASE, OVID, Web of Science, Cochrane, Wanfang, and World Health Organization International Clinical Trials Registry Platform search portal from establishment to July 2018...
November 8, 2018: Clinical Drug Investigation
Rashid Kazerooni, Edward P Armstrong
No abstract text is available yet for this article.
November 3, 2018: Clinical Drug Investigation
Philippe Picaut
No abstract text is available yet for this article.
November 3, 2018: Clinical Drug Investigation
Zhihang Tao, Stanley Xiangyu Li, Kai Shen, Yunuo Zhao, Hao Zeng, Xuelei Ma
BACKGROUND: Neratinib is a novel pan-human epidermal growth factor receptor (HER) tyrosine kinase inhibitor that has shown promising activity against several types of malignancies, especially HER2-overexpressing breast cancer. OBJECTIVE: The objective of the current study was to provide a comprehensive insight into the efficacy and safety profiles of neratinib-based therapies. METHODS: Comprehensive literature searches of the PubMed, EMBASE, and Web of Science electronic databases were performed for all relevant clinical trials...
October 28, 2018: Clinical Drug Investigation
Sufeng Zhou, Yuanyuan Wang, Lu Wang, Lijun Xie, Juan Chen, Yun Liu, Hongwen Zhang, Yuqing Zhao, Ning Ou, Feng Shao
BACKGROUND AND OBJECTIVE: Tylerdipine hydrochloride (KBP-5660) is a novel L/T-type dual calcium channel blocker developed for the treatment of hypertension. We aimed to study the pharmacokinetics, safety and tolerability of tylerdipine in healthy Chinese subjects. METHODS: Two double-blind, randomized, dose-escalation studies were conducted that included a total of 88 healthy subjects: (1) a single-ascending dose (SAD) study; and (2) a multiple-ascending dose (MAD) study...
October 27, 2018: Clinical Drug Investigation
Catalano Antonino, Martino Gabriella, Bellone Federica, Papalia Maria, Lasco Carmen, Basile Giorgio, Sardella Alberto, Nicocia Giacomo, Morabito Nunziata, Lasco Antonino
BACKGROUND AND OBJECTIVE: Benign prostatic hyperplasia (BPH) is a common disease found in elderly men and 5α-reductase (5α-R) inhibitors are a commonly used treatment option. 5α-reduced steroids are compounds that play a role in several functions across different organs and systems. In the adult brain, 5α-R accounts for neuroactive steroid production. Whether neuropsychological impairment could be due to dutasteride treatment, a 5α-R inhibitor affecting the production of dihydrotestosterone (DHT), is still unknown...
October 26, 2018: Clinical Drug Investigation
Yi Shen, Jie Zhou, Sheng Zhang, Xu-Lin Wang, Yu-Long Jia, Shu He, Yuan-Yuan Wang, Wen-Chao Li, Jian-Guo Shao, Xun Zhuang, Yuan-Lin Liu, Gang Qin
BACKGROUND AND OBJECTIVE: Although many meta-analyses have evaluated the pharmacotherapy of intrahepatic cholestasis of pregnancy (ICP) and recommended ursodeoxycholic acid (UDCA) as an effective treatment, the defect of the pair-wise analyses and the mixture of the control group made the outcome uncertain and unclear. We aimed to employ Bayesian network meta-analysis (NMA) to compare the maternal and fetal outcomes after UDCA, S-adenosylmethionine (SAMe) mono-therapy or the combination treatment of these two drugs for ICP patients...
October 24, 2018: Clinical Drug Investigation
Jing Li, Jian Gu
BACKGROUND AND OBJECTIVE: Use of the vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) has led to considerable improvements in the clinical outcome of patients with various tumor types. However, VEGFR-TKIs may be associated with increased incidence of cardiovascular toxicities. We conducted this meta-analysis to systematically review the risk of cardiovascular toxicities with VEGFR-TKIs in cancer patients. METHODS: The relevant studies of the randomized controlled trials in cancer patients treated with VEGFR-TKIs were retrieved and a systematic evaluation was conducted...
October 16, 2018: Clinical Drug Investigation
Josep Franch-Nadal, Fermín García-Gollarte, Alfonso Pérez Del Molino, María L Orera-Peña, Marta Rodríguez de Miguel, Malena Melogno-Klinkas, Héctor D de Paz, Susana Aceituno, Patricia Rodríguez-Fortúnez
BACKGROUND: Management of elderly patients with type 2 diabetes mellitus (T2DM) is complex due to their age-related conditions. Several clinical guidelines provide specific recommendations for management of these patients but little is known about their implementation in clinical practice. OBJECTIVE: To describe physician and community pharmacist perceptions and routine clinical practice in the management of elderly T2DM patients. METHODS: Cross-sectional study...
October 12, 2018: Clinical Drug Investigation
Hae-Young Park, Suji Kim, Hyun Soon Sohn, Jin-Won Kwon
BACKGROUND AND OBJECTIVE: Polypharmacy, regarded as an indicator of potentially inappropriate medications (PIMs), may lead to a higher risk of serious health consequences in elderly patients with osteoporosis. Thus, this study aimed to analyze the association between polypharmacy and hip fracture in patients with osteoporosis because only a limited number of studies have reported on this association, with inconsistent results to date. METHODS: In this nested case-control study using a population-based sample cohort, the target cases were female patients with hip fracture diagnosed with osteoporosis and aged ≥ 50 years...
October 10, 2018: Clinical Drug Investigation
Hiroki Koshimichi, Toru Ishibashi, Nao Kawaguchi, Chisako Sato, Akira Kawasaki, Toshihiro Wajima
BACKGROUND AND OBJECTIVE: Baloxavir marboxil, a prodrug that is metabolized to baloxavir acid, suppresses viral replication by inhibiting cap-dependent endonuclease. This first-in-human phase I study evaluated the safety, tolerability, and pharmacokinetics of baloxavir marboxil/baloxavir acid in healthy Japanese volunteers (Study 1), while food effects were evaluated in a separate phase I, crossover study in healthy Japanese volunteers (Study 2). METHODS: Study 1 participants were randomized to single-dose oral baloxavir marboxil (6, 20, 40, 60, or 80 mg; n = 6 per dose) or placebo (n = 10), while Study 2 participants (n = 15) received single-dose oral baloxavir marboxil 20 mg in fasted, fed, and before-meal states...
October 4, 2018: Clinical Drug Investigation
Eriko Sumi, Takashi Nomura, Ryuta Asada, Ryuji Uozumi, Harue Tada, Yoko Amino, Teruo Sawada, Atsushi Yonezawa, Masatoshi Hagiwara, Kenji Kabashima
BACKGROUND: Cutaneous warts are caused by human papilloma virus (HPV) infection. FIT039, a specific inhibitor of CDK9, suppresses the proliferation of DNA viruses in vitro. PURPOSE: We evaluated the safety, plasma concentrations, and efficacy of FIT039 delivered by single application of an adhesive skin patch on normal back skin and cutaneous warts. PATIENTS AND METHODS: In this placebo-controlled, dose-escalation, open-label, two-cohort phase I/II clinical trial, after a single administration of a 1% FIT039 patch, 3% FIT039 patch, or placebo on back skin, patients with cutaneous warts were treated with cryotherapy followed by a 1% FIT039 patch for 24 h in the first cohort...
October 4, 2018: Clinical Drug Investigation
Yoshitaka Arase, Tatehiro Kagawa, Kota Tsuruya, Hirohiko Sato, Erika Teramura, Kazuya Anzai, Shunji Hirose, Ryuzo Deguchi, Koichi Shiraishi, Tetsuya Mine
BACKGROUND AND OBJECTIVE: Tolvaptan, an oral vasopressin V2 receptor antagonist, has been widely used for the treatment of patients with cirrhosis and ascites. However, its efficacy in patients with renal dysfunction remains unknown. The objective of this study was to investigate the efficacy and safety of tolvaptan in patients with decompensated cirrhosis and severe chronic kidney disease (s-CKD). METHODS: We studied 43 patients with liver cirrhosis who received tolvaptan (7...
October 4, 2018: Clinical Drug Investigation
Yeon-Hee Baek, Sang Jun Park, Sohyun Jeong, In-Sun Oh, Han Eol Jeong, Kyu Hyung Park, Ju-Young Shin
BACKGROUND AND OBJECTIVES: The association between fluoroquinolone and rhegmatogenous retinal detachment (RRD) has been controversial as a result of inconsistent findings. We set out to detect a possible association of fluoroquinolone use and risk of RRD, using sequence symmetry analysis (SSA). METHODS: We conducted an SSA, case-only design, using a Korean nationwide healthcare database between 2004 and 2015. Exposure was defined as new fluoroquinolone use and outcome as an incident RRD, defined by a diagnosis of RRD (ICD-10: "H33...
October 1, 2018: Clinical Drug Investigation
Sara Nazha, Simon Tanguay, Anil Kapoor, Michael Jewett, Christian Kollmannsberger, Lori Wood, G A Georg Bjarnason, Daniel Heng, Denis Soulières, Martin Neil Reaume, Naveen Basappa, Eric Lévesque, Alice Dragomir
BACKGROUND AND OBJECTIVE: The development of new targeted therapies in kidney cancer has shaped disease management in the metastatic phase. Our study aims to conduct a cost-utility analysis of sunitinib versus pazopanib in first-line setting in Canada for metastatic renal cell carcinoma (mRCC) patients using real-world data. METHODS: A Markov model with Monte-Carlo microsimulations was developed to estimate the clinical and economic outcomes of patients treated in first-line with sunitinib versus pazopanib...
September 28, 2018: Clinical Drug Investigation
Ya Luo, Kai Lu, Gang Liu, Jing Wang, Irakoze Laurent, Xiaoli Zhou
BACKGROUND AND OBJECTIVE: The effects of novel antidiabetic drugs, including sodium-glucose cotransporter 2 (SGLT-2) inhibitors, glucagon-like peptide 1 (GLP-1) receptor agonists, and dipeptidyl peptidase 4 (DPP-4) inhibitors, on albuminuria in patients with type 2 diabetes mellitus (T2DM) are still controversial. Therefore, we performed a meta-analysis to evaluate the effects of novel antidiabetic drugs on albuminuria in patients with T2DM. METHODS: We conducted a random-effects meta-analysis of randomized controlled trials (RCTs) by searching the MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials databases up to 16 August 2018...
September 25, 2018: Clinical Drug Investigation
Shijie Zhao, Zhaoshuang Zhong, Guoxian Qi, Liye Shi, Wen Tian
BACKGROUND AND OBJECTIVE: The results of studies on cilostazol-based triple antiplatelet therapy (TAT) after drug-eluting stent (DES) implantation were inconsistent. To assess the effects of TAT compared with dual antiplatelet therapy (DAT) after DES/second-generation DES implantation, we performed a meta-analysis of randomized controlled trials (RCTs). METHODS: All relevant studies evaluated were identified by searching the PubMed, EMBASE, Cochrane Library, and ISI Web of Science databases without time and language limitation...
September 24, 2018: Clinical Drug Investigation
Chaoying Hu, Xiao Hu, Chunhua Wang, Zirun Zhao, Dan Gao, Xiaoping Chen, Dongli Zhou, Yue Huang, Lin Li, Lan Zhang
BACKGROUND: The pharmacokinetics of bisoprolol and amlodipine administered as a fixed-dose combination (FDC) tablet have not been sufficiently studied in healthy Chinese subjects to support a medical need for using the FDC in hypertension. OBJECTIVE: This study was conducted to compare the pharmacokinetic profiles of the bisoprolol-amlodipine FDC tablet with the bisoprolol tablet and amlodipine tablet administered concomitantly under both fasting and fed conditions...
September 19, 2018: Clinical Drug Investigation
Jie Fu, Yuchen Liu, Houwen Lin, Bin Wu
OBJECTIVES: The objective of this systematic review was to conduct a comprehensive assessment of economic evaluations of tyrosine kinase inhibitors (TKIs) in patients with chronic myeloid leukemia (CML) in middle- and high-income countries. METHODS: A literature search was conducted in Embase, MEDLINE (via PubMed) and the Cochrane library on March 3, 2018 to identify economic evaluations of chronic myeloid leukemia that met the inclusion criteria. Data on such parameters as patient characteristics, cost components, and main outcomes were extracted from eligible studies...
September 19, 2018: Clinical Drug Investigation
Tatsuo Hosoya, Tomohiko Ishikawa, Yoshimi Ogawa, Ryusuke Sakamoto, Tetsuo Ohashi
BACKGROUND AND OBJECTIVES: Topiroxostat-a novel selective xanthine oxidoreductase inhibitor-has been reported to reduce serum urate levels. The purpose of this study was to assess the efficacy and safety of long-term topiroxostat administration in Japanese hyperuricemic patients with or without gout. METHODS: This multicenter, open-label study evaluated the efficacy and safety of long-term twice-daily oral topiroxostat administration in patients with or  without gout...
September 15, 2018: Clinical Drug Investigation
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