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Journal of Drug Assessment

Müberra Devrim Güner, Perihan Elif Ekmekci
Background: Spontaneous adverse drug reaction (ADR) reports prepared by healthcare professionals (HCPs) are the backbone of collecting post-marketing safety data. However, underreporting is a global problem creating health, economic, and ethical burden. Objectives: To determine the factors limiting ADR reporting rates from the HCPs' point of view. Methods: A questionnaire containing 43 questions evaluating sociodemographic characteristics, pharmacovigilance knowledge and activities, and prescription behaviors was prepared on "surveymonkey...
2019: Journal of Drug Assessment
Alessandro Battaggia, Andrea Scalisi, Bruno Franco Novelletto, Massimo Fusello, Raffaella Michieli, Maurizio Cancian
Context: Both frailty and multimorbidity are strong predictors of clinical endpoints for older people. In Italy, the interventions targeting chronicity are mainly based on the treatment of diseases: sufficient epidemiological literature is available about these strategies. Less is known about the territorial distribution of the frailty status. Aims: To estimate the prevalence of frailty in older people (65+) and to evaluate the relationship between frailty and multimorbidity. Methods and material: A group of general practitioners working in Veneto (Italy) was enrolled on a voluntary basis...
2019: Journal of Drug Assessment
Stephen Youngberg, Erin Brandt, Avantika Barve, Surendra Machineni, Christopher T Jones, Kristina Dabovic, Catherine L Jones, Richard A Colvin
Objective: Infection with hepatitis C virus is the leading indication for liver transplantation and most common cause of infectious disease-related mortality in the United States. BZF961 is a novel inhibitor of the hepatitis C virus NS3-4A protease. Methods: This sequential, three part exploratory first-in-human study investigated the safety and pharmacokinetics of single and multiple ascending oral doses of BZF961 in healthy subjects. The first two parts were randomized, double-blind, placebo-controlled, time-lagged, single and multiple ascending oral dose segments...
2018: Journal of Drug Assessment
Bouchra Bakr Mouhtadi, Malak M Alame, Bassem Malaeb, Souheil Hallit, Pascale Salameh, Diana Malaeb
Background: Attaining therapeutic goals in diabetes mellitus (DM) is often suboptimal due to disease complexity, poor adherence and inadequate patient counseling. Aim: This study evaluated the effectiveness of the collaboration between the physicians and pharmacists in DM management. Design and setting: A pilot study was conducted between January 2015 and December 2015 in diabetic patients from four districts of Lebanon. Methods: A total of 200 patients with type 2 DM were recruited with 12 months of follow-up...
2018: Journal of Drug Assessment
Hiroyuki Ito, Emiko Tsugami, Shigenori Ando, Rie Araki, Suzuko Matsumoto, Kosuke Uemura, Shinya Nishio, Shinichi Antoku, Tomoko Yamasaki, Toshiko Mori, Michiko Togane
Objective: We compared the clinical course of type 2 diabetic patients whose basal insulin preparations were replaced from insulin glargine (IGlar) 100 units/mL (U100) to IGlar biosimilar or IGlar 300 units/mL (U300). Methods: After propensity score matching, 34 patients whose basal insulin preparation was switched from IGlar U100 to IGlar biosimilar and 102 switched to IGlar U300 were observed for 6 months. Results: The HbA1c level and body weight did not change significantly after the replacement in the IGlar biosimilar or IGlar U300 groups...
2018: Journal of Drug Assessment
Utkarsh H Acharya, Anna B Halpern, Qian Vicky Wu, Jenna M Voutsinas, Roland B Walter, Seongseok Yun, Mohammed Kanaan, Elihu H Estey
Aim: Acute myeloid leukemia (AML) is an aggressive hematopoietic clonal disorder characterized by the increased blasts and poor survival outcome, which is mainly driven by cytogenetic and molecular abnormalities. Here, we investigated the prognostic impact of other demographic parameters on the survival outcomes in AML patients. Method: We reviewed the Surveillance, Epidemiology, and End Result (SEER) database to collect demographic information, including age, diagnosis, gender, race, and geographic region in patients with non-acute promyelocytic leukemia AML, between 2004-2008...
2018: Journal of Drug Assessment
Shankar Raman, Mayin Lin, Nivedita Krishnan
Objective: The objective of the study was to systematically investigate the outcomes of Liposomal Bupivacaine following major colorectal resections. Patients and methods: We conducted a comprehensive literature search of PubMed, Medline, Google scholar, Cochrane Central Registry and clinical databases through May 2017 for studies published regarding liposomal bupivacaine. Studies were filtered based on relevance to perioperative analgesia in colorectal resections. Data comparing type of study, techniques of resection, mode of administration of liposomal bupivacaine, details of control group, outcomes were collected...
2018: Journal of Drug Assessment
Preetam B Mahajan, Somnath Mukherjee
Objectives: To study the accuracy and reliability of two point of care devices (Hemocue 201 [HC201 ]) and Hemoglobin Colour Scale (HCS) with reference to automated laboratory analyser Sysmex XP 100 (LabSXP ) and determine factors influencing their performances. To discuss certain design issues while ascertaining these parameters for its judicious use in both clinical context and disease burden studies. Methods: Reliability and accuracy statistics were calculated for four population subgroups that were selected randomly using cluster sampling in a rural community of eastern India...
2018: Journal of Drug Assessment
Pieter-Jan Cuyle, Anke Engelen, Veerle Moons, Tim Tollens, Saskia Carton
Objective: Patients with stage III and high-risk stage II colorectal cancer (CRC) are advised to initiate adjuvant treatment as soon as feasible and certainly before 8 to 12 weeks after resection of the tumor. A protective ileostomy is often constructed during surgery to protect a primary anastomosis "at risk", especially in rectal cancer surgery. However, up to 17% of patients with a stoma suffer from high output, a major complication that can prevent adjuvant treatment implementation or completion...
2018: Journal of Drug Assessment
Anand A Dalal, Annie Guerin, Alex Mutebi, Kenneth W Culver
Objective: To describe patient characteristics, treatment patterns, healthcare resource utilization (HRU), and costs among patients with anaplastic lymphoma kinase ( ALK )-positive non-small cell lung cancer (NSCLC) receiving ceritinib in second or later line of therapy. Methods: Adult patients with NSCLC receiving ceritinib were identified from two large US claims databases (2006-2015). Patient characteristics, comorbidity profile, treatment patterns prior to ceritinib, and ceritinib dosing patterns were described...
2018: Journal of Drug Assessment
Rattanachai Chanchai, Rungsrit Kanjanavanit, Krit Leemasawat, Anong Amarittakomol, Paleerat Topaiboon, Arintaya Phrommintikul
Background: Beta-blockers have been shown to decrease mortality and morbidity in heart failure with reduced ejection fraction (HFrEF) patients. However, the side effects are also dose-related, leading to the underdosing. Cost constraint may be one of the limitations of appropriate beta-blocker use; this can be improved with generic drugs. However, the effects in real life practice have not been investigated. Methods and results: This study aimed to compare the efficacy and safety of generic and brand beta-blockers in HFrEF patients...
2018: Journal of Drug Assessment
Tamar Lin, Yulia Mayzel, Karnit Bahartan
Objective: GlucoTrack is a non-invasive device that indirectly measures glucose fluctuation in the earlobe tissue. Thus, its accuracy may be subjected to a time lag between glucose concentration in blood and tissue. This time lag was shown to depend on individual characteristics related to microvascular complications, such as diabetes duration, HbA1c level, and smoking history. Therefore, the current study investigated the effects of these factors on GlucoTrack performance. Research design and methods: Clinical trials were conducted on 114 people with type 2 diabetes...
2018: Journal of Drug Assessment
Ashish Agrawal, Shibnath Kamila, Aditya Donepudi, Rajendra Premchand
Background: Thrombolytics are recommended in high risk patients with massive pulmonary embolism (PE). However, clinical practice seems to be far different and questions related to its utility in less severely affected patients remain the subject of investigation. The objective of this observational study was to compare the efficacy and safety of tenecteplase with streptokinase and heparin. Method: A total of 103 patients (tenecteplase: 62, streptokinase: 17, heparin: 24) diagnosed with PE (massive: 33 [32.04%], submassive: 50 [48...
2017: Journal of Drug Assessment
Boulenouar Mesraoua, Dirk Deleu, Hassan Al Hail, Faisal Ibrahim, Gayane Melikyan, Hassan Al Hussein, Rajvir Singh, Basim Uthman, Leopold Streletz, Peter W Kaplan, Heinz Gregor Wieser
Objective: This study reports the prevalence of Nonconvulsive Status Epilepticus (NCSE) in patients with altered mental status (AMS), and describes the clinical presentation, etiology, neurophysiological findings, neuroimaging, treatment, and outcome of NCSE in Qatar. Recording duration of continuous EEG monitoring was also discussed. Methods: This was a 3-year, prospective, hospital-based study involving patients with AMS and continuous EEG monitoring admitted to the Emergency and ICUs of Hamad Hospital, Qatar...
2017: Journal of Drug Assessment
Randeep Sangha, Andrew Davies, Nam H Dang, Michinori Ogura, David A MacDonald, Revathi Ananthakrishnan, M Luisa Paccagnella, Erik Vandendries, Joseph Boni, Yeow Tee Goh
Objective : To evaluate safety, tolerability, and preliminary activity of inotuzumab ozogamicin (InO) plus rituximab, gemcitabine, dexamethasone, and cisplatin (R-GDP) in patients with relapsed/refractory CD22+ B-cell non-Hodgkin lymphoma (NHL). Methods : Patients received InO plus R-GDP (21-day cycle; six-cycle maximum) using up-and-down dose-escalation schema for gemcitabine and cisplatin to define the highest dosage regimen(s) with acceptable toxicity (Part 1; n  = 27). Part 2 ( n  = 10) confirmed safety and tolerability; Part 3 ( n  = 18) evaluated preliminary efficacy...
2017: Journal of drug assessment
Neil A Roe, Sami Sakaan, Heather Swanson, Jennifer D Twilla
Background/Aim: Hospitalizations due to gastroparesis have increased in the last 20 years with limited advancements in pharmacologic therapy. Although therapy primarily consists of prokinetic agents, little is known about their effects on hospital outcomes. The aim of our study was to determine whether common prokinetic therapies (metoclopramide and erythromycin) improve outcomes in gastroparesis patients. Methods: A retrospective review of adult patients admitted with a primary diagnosis of gastroparesis between 7 January 2011 and 7 January 2014 was conducted...
2017: Journal of Drug Assessment
Robin Moorman Li, Brian Gilbert, Anna Orman, Petra Aldridge, Sue Leger-Krall, Clare Anderson, Juan Hincapie Castillo
Objectives: To evaluate the effects of diffused lavender on the frequency of behavioral issues [BIs], defined as a composite of restlessness/wandering [RW], agitation [AGT], anger [ANG], and anxiety [ANX] in an adult day care center. Secondary objectives evaluate systematic differences on the frequency of BIs between age cohorts, gender, and individual behaviors. Design: Pre-post quasi-experimental study. Setting: Private nonprofit adult day care center for patients with dementia. Participants: Elderly patients older than 65 years of age with a clinical diagnosis of dementia, who require daytime monitoring...
2017: Journal of Drug Assessment
Mousa Al Omari, Yousef Khader, Ali Shakir Dauod, Othman Ahmed Beni Yonis, Adi Harbi Mohammad Khassawneh
Objective : To assess the efficacy and safety of vildagliptin added to metformin in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin monotherapy. Methods: This was a 12-week prospective observational study where vildagliptin 50 mg twice daily was added to patients with T2DM inadequately controlled (glycosylated hemoglobin type A1c (Hba1c) 7-10%) by a daily dose of metformin ≥1700 mg between June 2012 and May 2013. Efficacy was assessed by change in Hba1c and fasting plasma glucose (FPG) levels, and safety was assessed by reported adverse events (AEs)...
2016: Journal of Drug Assessment
Ashish Agrawal, Shibnath Kamila, Swetha Reddy, Joyal Lilly, Ms Sadhguna Mariyala
Background: Globally the burden of chronic kidney disease (CKD) is rising, an important cause of death and loss of disability-adjusted life years. Activation of the renin-angiotensin-aldosterone system is involved in its pathogenesis. The aim of the present study was to examine the effects of telmisartan (40 mg/day), an angiotensin receptor blocker (ARB) in Indian patients with CKD in real-life setting. Method: This was a prospective observational study. Fifty-six patients (>18 years) diagnosed with CKD were enrolled into the study...
2016: Journal of drug assessment
Sho Kanzaki, Kazuhiro Hashiguchi, Ken-Ichiro Wakabayashi, Kiyochika Suematsu, Kimihiro Okubo
Objective: To determine the efficacy of the antihistamine bepotastine on treating nasal symptoms in patients with Japanese cedar and cypress pollinosis, based on two previous studies that looked at bepotastine OD's inhibitory effect on symptom onset after exposure. Design and methods: Randomized double-blind placebo controlled, parallel study. Twenty-eight volunteers with Japanese cedar and cypress pollinosis were randomly assigned into two experimental groups: a bepotastine-treated or a placebo control group...
2016: Journal of Drug Assessment
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