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Clinical Drug Investigation

Ekaterini C Tampaki, Athanasios Tampakis, Constantinos E Alifieris, Dimitrios Krikelis, Anastasia Pazaiti, Michalis Kontos, Dimitrios T Trafalis
BACKGROUND: In the era of personalized therapy, targeted treatment in specific patient populations is mandated. OBJECTIVE: We evaluated the efficacy and safety of neoadjuvant treatment on locally advanced breast cancer (LABC) with a monoclonal agent against vascular endothelial growth factor (VEGF), bevacizumab plus chemotherapy combination of liposomal doxorubicin, cyclophosphamide and paclitaxel (PLAC-B). METHODS: Patients enrolled were at premenopausal status and characterized by human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor positive (estrogen receptor/progesterone receptor-positive [ER/PR+]) or triple-negative (TNBC), LABC (T > 3 cm), with high-grade ductal carcinoma...
May 9, 2018: Clinical Drug Investigation
Domenico Plantone, Tatiana Koudriavtseva
The process of finding new therapeutic indications for currently used drugs, defined as 'repurposing', is receiving growing attention. Chloroquine and hydroxychloroquine, with an original indication to prevent or cure malaria, have been successfully used to treat several infectious (HIV, Q fever, Whipple's disease, fungal infections), rheumatological (systemic lupus erythematosus, antiphospholipid antibody syndrome, rheumatoid arthritis, Sjögren's syndrome), and other immunological diseases. Indeed, they have anti-inflammatory, immunomodulating, anti-infective, antithrombotic, and metabolic effects...
May 8, 2018: Clinical Drug Investigation
Nevio Cimolai
No abstract text is available yet for this article.
May 7, 2018: Clinical Drug Investigation
Tomasz Imiela, Andrzej Budaj
No abstract text is available yet for this article.
May 7, 2018: Clinical Drug Investigation
Bin Wu, Ruoyan Gai Tobe, Yuchen Liu, Ben He
BACKGROUND AND OBJECTIVE: The economic outcomes of dual antiplatelet therapy in East Asian patients are still unclear. We aimed to evaluate the economic outcomes of ticagrelor versus clopidogrel for patients with acute coronary syndrome (ACS) in China, Japan, Korea, Taiwan and Hong Kong. METHODS: A two-phase model consisting of a 1-year decision tree and a lifetime Markov model was used to estimate the economic outcomes. The data from the East Asian subgroup of Platelet Inhibition and Patient Outcomes (PLATO) and PHILO studies were used for the calculation of the events rate for ticagrelor and clopidogrel in the first 12 months, whereas the costs were obtained from East Asian sources and utility from the published literature...
April 30, 2018: Clinical Drug Investigation
Ka Lai Yee, Jacqueline McCrea, Deborah Panebianco, Wen Liu, Nicole Lewis, Tamara Cabalu, Steven Ramael, Rebecca E Wrishko
BACKGROUND AND OBJECTIVES: Suvorexant (MK-4305) is an orexin receptor antagonist approved for the treatment of insomnia in the USA and other regions. This randomized, double-blind, placebo-controlled, sequential-panel, Phase 1 trial assessed the safety, tolerability, and pharmacokinetic data following single and multiple dosing of suvorexant in healthy men (aged 18-45 years). METHODS: Within allocated panels, subjects (n = 8) were randomized to receive nightly doses of suvorexant (10, 20, 40, 80, and 100 mg) administered orally for 14 days, or placebo...
April 28, 2018: Clinical Drug Investigation
Margarita Capel, María Mareque, Carlos José Álvarez, Leandro Lindner, Itziar Oyagüez
BACKGROUND AND OBJECTIVE: Chronic obstructive pulmonary disease (COPD), a progressive lung disorder associated with decline of respiratory function, affects 10.2% of Spanish adults (40-80 years of age). This study aimed to assess the cost-effectiveness of two fixed-dose combinations of long-acting muscarinic antagonist and long-acting β2-agonist therapies for COPD, with Spanish National Health System perspective. METHODS: A Markov model with five health states based on severity levels defined by GOLD 2010 criteria was used to simulate in monthly cycles the evolution along a 5-year period of a cohort of moderate-to-severe COPD patients, treated with aclidinium-formoterol (ACL/FF) 400/12 µg or tiotropium-olodaterol (TIO/OLO) 5/5 µg fixed-dose combinations...
April 13, 2018: Clinical Drug Investigation
Aaron J Salwan, Nicholas E Hagemeier, Sam Harirforoosh
The US Food and Drug Administration (FDA) is encouraging the innovation of long-acting opioid formulations that are manipulation-resistant. The purpose of this commentary is to assess the benefits and limitations of abuse-deterrent opioid formulations (ADFs) and discuss their role in mitigating the current opioid epidemic. ADFs have been created with chemical properties that make it difficult for people who non-medically use prescription drugs to crush and dissolve opioid tablets, as well as by combining opioids with antagonists such as naloxone or naltrexone, which are released only when the dosage form has been manipulated or the drug is taken by a non-intended route...
April 12, 2018: Clinical Drug Investigation
Chieh-Lin Jerry Teng, Kuang-Hsi Chang, I-Ju Tsai, Wen-Li Hwang, Chung Y Hsu, Wayne H-H Sheu
BACKGROUND AND OBJECTIVES: Although anthracyclines are effective chemotherapeutic agents for treating B-cell lymphoma, adverse effects, such as bone marrow suppression and cardiotoxicity, limit their clinical application. We assessed whether anthracycline treatment also increases the risk for diabetes mellitus in patients with B-cell lymphoma. METHODS: Using data obtained from the Taiwanese National Health Insurance Research Database from 2004 to 2011, we compared overall survival and clinical features for B-cell lymphoma patients administered anthracyclines (n = 3147) and those not administered anthracyclines (n = 837)...
April 9, 2018: Clinical Drug Investigation
Jaden Brandt, Wajd Alkabanni, Silvia Alessi-Severini, Christine Leong
Drug utilization research on benzodiazepines remains important for measuring trends in consumption within and across borders over time for the sake of monitoring prescribing patterns and identifying potential population safety concerns. The defined daily dose (DDD) system by the World Health Organization (WHO) remains the internationally accepted standard for measuring drug consumption; however, beyond consumption, DDD-based results are difficult to interpret when individual agents are compared with one another or are pooled into a total class-based estimate...
April 4, 2018: Clinical Drug Investigation
Annalisa Biffi, Lorenza Scotti, Federico Rea, Ersilia Lucenteforte, Alessandro Chinellato, Davide L Vetrano, Cristiana Vitale, Nera Agabiti, Janet Sultana, Giuseppe Roberto, Alessandro Mugelli, Giovanni Corrao
BACKGROUND AND OBJECTIVE: Conflicting findings from studies evaluating the association between use of antidepressant drugs and mortality have been reported. We tested the hypothesis that better adherence to antidepressant therapy may reduce mortality. METHODS: The cohort included 29,845 individuals aged ≥ 65 years from several Italian health units who were newly treated with antidepressant drugs after hospital discharge with a diagnosis for cardiovascular disease during 2008-2010...
March 27, 2018: Clinical Drug Investigation
Julia Paik, Lesley J Scott, Roy A Pleasants
The novel, easy-to-use, breath-actuated fluticasone propionate/salmeterol multidose dry powder inhaler (MDPI) (AirDuo RespiClick® ) was recently approved in the USA for twice-daily treatment of asthma in patients aged ≥ 12 years. This inhaled corticosteroid (ICS) and long-acting β2 -adrenoreceptor agonist (LABA) combination treatment is available in low-, mid- and high-dosage formulations (55/14, 113/14 and 232/14 μg, respectively). In 12-week, phase III trials in patients aged ≥ 12 years with persistent asthma, all three dosages of fluticasone propionate/salmeterol MDPI treatment produced significant improvements in lung function and other asthma symptoms compared with fluticasone propionate MDPI monotherapy or placebo MDPI...
March 26, 2018: Clinical Drug Investigation
Manabu Kato, Hidetoshi Furuie, Emi Kamiyama, Kazuhito Shiosakai, Kazutaka Yoshihara, Takashi Taguchi
BACKGROUND AND OBJECTIVES: G protein-coupled receptor 119 (GPR119) agonists reduce plasma glucose by promoting insulin secretion in a glucose-dependent manner. We evaluated the safety and pharmacokinetics of multiple oral doses of DS-8500a, a GPR119 agonist, under fed conditions in healthy adult Japanese male subjects. METHODS: In this Phase 1, randomized, placebo-controlled, double-blind, multiple oral dose study, participants were aged ≥ 20 and ≤ 45 years with a body mass index ≥ 18...
March 26, 2018: Clinical Drug Investigation
Siok Shen Ng, Nai Ming Lai, Surakit Nathisuwan, Nathorn Chaiyakunapruk
INTRODUCTION: Anticoagulation therapy is the fundamental approach for stroke prevention in atrial fibrillation (AF) patients. Numerous systematic reviews comparing anticoagulation strategies have been published. We aim to summarize the efficacy and safety evidence of these strategies in AF patients from previously published systematic reviews. METHODS: We searched PubMed, EMBASE and Cochrane library from inception to Feb 24th, 2017, to identify systematic reviews and meta-analyses of randomized controlled trials that assessed interventions or strategies to improve oral anticoagulant use in AF patients...
March 22, 2018: Clinical Drug Investigation
Rashmi Goyat, Pragya Rai, Jongwha Chang, Charles D Ponte, Xi Tan
BACKGROUND: Both diabetes and antidiabetic drugs (ADDs) increase the risk for cardiovascular (CV) diseases. Due to the increasing concern about CV safety associated with ADDs, the US FDA revised regulatory guidelines in 2008 to include CV safety as an endpoint. OBJECTIVE: The objective of the current study was to conduct a systematic review with meta-analysis to compare CV mortality of oral ADDs approved before and after the FDA's 2008 guidance. METHODS: Three electronic databases (PubMed, Scopus, and the Clinical Trial Registry) were searched to retrieve studies published up to 24 February 2017...
March 21, 2018: Clinical Drug Investigation
Ruth Pettengell, Bertrand Coiffier, Anton Egorov, Jack Singer, Lilia Sivcheva
BACKGROUND: Pixantrone is recommended in relapsed and refractory non-Hodgkin lymphoma (NHL) or heavily pretreated NHL patients. Its conditional approval in Europe was based on results from the open-label, randomized, phase 3 PIX301 study, comparing pixantrone monotherapy with physician's choice of treatment in 140 patients with relapsed or refractory aggressive NHL. METHODS: This post-hoc analysis of the PIX301 study investigated possible correlations between patient characteristics and clinical response in 17 patients (24%) treated with pixantrone who achieved a complete response (CR) or an unconfirmed complete response (CRu) at study end...
March 21, 2018: Clinical Drug Investigation
Jitendra K Sahu, Vamsi Krishna Vaddi, Sandeep Negi
No abstract text is available yet for this article.
March 19, 2018: Clinical Drug Investigation
Rieko Kikuchi, Junichiro Irie, Nobuko Yamada-Goto, Eri Kikkawa, Yosuke Seki, Kazunori Kasama, Hiroshi Itoh
BACKGROUND AND OBJECTIVES: Bariatric surgery improves metabolic diseases and alters the intestinal microbiota in animals and humans, but different procedures reportedly have different impacts on the intestinal microbiota. We developed laparoscopic sleeve gastrectomy with duodenojejunal bypass (LSG-DJB) as an alternative to laparoscopic Roux-en-Y gastric bypass (LRYGB) in addition to laparoscopic sleeve gastrectomy (LSG) for Japanese patients with obesity. We investigated the precise change in the intestinal microbiota induced by these procedures in the present study...
June 2018: Clinical Drug Investigation
Silvia L Nunes, Sune Forsberg, Hans Blomqvist, Lars Berggren, Mikael Sörberg, Toni Sarapohja, Carl-Johan Wickerts
BACKGROUND: Intensive care unit patients undergoing mechanical ventilation have traditionally been sedated to make them comfortable and to avoid pain and anxiety. However, this may lead to prolonged mechanical ventilation and a longer length of stay. OBJECTIVE: The aim of this retrospective study was to explore whether different sedation regimens influence the course and duration of the weaning process. PATIENTS AND METHODS: Intubated adult patients (n = 152) from 15 general intensive care units in Sweden were mechanically ventilated for ≥ 24 h...
June 2018: Clinical Drug Investigation
David Goldsmith, Frank Dellanna, Martin Schiestl, Andriy Krendyukov, Christian Combe
Biosimilars are biological medicines that are approved via stringently defined regulatory pathways on the basis that comparable safety, efficacy, and quality have been demonstrated to their reference medicine. The advantage of biosimilar drugs is that they may be less expensive than the reference medicine, allowing for greater patient access and cost savings in already stretched healthcare budgets. Biosimilar epoetins have been available in Europe for a decade. Complementing in vitro and preclinical characterization, and pharmacokinetic/pharmacodynamic studies, clinical trials provided the additional data needed to reassure European authorities that biosimilar epoetins were sufficiently similar to the reference epoetin to warrant approval...
June 2018: Clinical Drug Investigation
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