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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
Kimihiro Okubo, Yoichi Inoue, Hirotaka Numaguchi, Kumi Tanaka, Itori Saito, Nobuyuki Oshima, Yuki Matsumoto, Marita Prohn, Anish Mehta, Chisato Nishida, George Philip
Background: This study was conducted to evaluate the safety and tolerability, and population pharmacokinetics (PPK) of montelukast as well as efficacy in the treatment of perennial allergic rhinitis (PAR) in paediatric Japanese patients aged between 1 and 15 years. Methods: In this multi-centre, open-label trial, 87 paediatric Japanese patients with PAR received montelukast 4 mg oral granules (OG) for 4 weeks (1-5-year-olds, N = 15), 4 mg OG for 12 weeks (1-5-year-olds, N = 36), 5 mg chewable tablets (CT) for 12 weeks (6-9-year-olds, N = 18), or 5 mg CT for12 weeks (10-15-year-olds, N = 18)...
2016: Journal of Drug Assessment
Mauro Geller, Marco Antonio Mibielli, Carlos Pereira Nunes, Adenilson de Souza da Fonseca, Stephanie Wrobel Goldberg, Lisa Oliveira
Objective : To assess results of the finger-to-floor distance (FFD) and the Schober test performed during the DOLOR study, and to verify correlation between Visual Analog Pain Scale scores (VAS) with these measures. Research design and methods : Previously tabulated data from the Clinical Research Forms of the DOLOR study were analyzed (statistical significance defined with a two-tailed p value < 0.05 and confidence interval of 95%). For continuous variables, the Student's T - test or analysis of variance (ANOVA) was used, and differences between pre-treatment and Visits 2, 3, and 4 in the absolute number and percentage of patients with no change, improvement, or worsening of the Schober test and the FFD test scores were calculated, and the results were analyzed with the Chi-squared test...
2016: Journal of Drug Assessment
Vasilios G Athyros, Niki Katsiki, Asterios Karagiannis
No abstract text is available yet for this article.
2016: Journal of Drug Assessment
Michael J Fossler, David A Collins, Hiroko Ino, Nobuaki Sarai, Ramiya Ravindranath, Chester L Bowen, Olivia Burns
OBJECTIVE: To evaluate the bioequivalence of five 0.1 mg dutasteride capsules to one 0.5 mg dutasteride capsule in healthy adult male subjects under fasting conditions. METHODS: This was a single-center, open-label, randomized, single dose, two-way cross-over study ( identifier NCT01929330). Thirty-six healthy male subjects aged 18-65 years received 5 × 0.1 mg dutasteride softgel capsules and 1 × 0.5 mg dutasteride softgel capsule in a randomized order, with a minimum washout of 28 days between each drug administration...
2015: Journal of Drug Assessment
Thirumurugan Gunasekaran, Natsanet Dejene, Vanapalli V Satyaveni, Magharla Dasaratha Dhanaraju
OBJECTIVE: Many medications have potential interactions with other drugs or substances when prescribed together. This study was intended to investigate the extent of poly-pharmacy, event of drug-drug interactions and associated ADRs in Adama Referral Hospital, Oromia regional State, Ethiopia to create awareness of potential drug interactions and for development of clinical strategies to prevent the occurrence of DDIs. METHODS: A retrospective study was done at Adama Referral hospital, Adama city, Ethiopia during March-May 2014...
2015: Journal of Drug Assessment
Reza Tahvilian, Ali Ebrahimi, Omid Beiki, Hoshang Nemati, Sahar Masoud
OBJECTIVE: Hirsutism is the presence of excess terminal hairs in females in a male-like pattern. The most accepted hypothesis for the development of hirsutism is increased 5α-reductase activity in hair follicles of hirsute women. Finasteride partially blocks the conversion of testosterone to dihydrotestosterone through inhibition of 5α-reductase in hair follicles. This study was designed to determine the efficacy of finasteride gel 0.25% in management of idiopathic hirsutism and treatment of hirsutism with topical finasteride to lessen the side-effects...
2015: Journal of Drug Assessment
Rashid Kazerooni, Jane Lim
BACKGROUND: Cardiovascular diseases are among the leading causes of death worldwide and studies have found a direct relationship between levels of low-density lipoprotein cholesterol and coronary heart disease. Statins are the most commonly prescribed medications to lower cholesterol, a major controllable risk factor for coronary heart disease. OBJECTIVE: This study aims to find what factors in the first year of statin therapy are predictive of long-term all-cause mortality...
2015: Journal of Drug Assessment
Stanley Cohan, Chiayi Chen, Elizabeth Baraban, Tamela Stuchiner, Lois Grote, Monica Rodriguez
BACKGROUND: Few studies have evaluated long-term efficacy of interferon beta-1a in large community-based cohorts. OBJECTIVE: Evaluate time to relapse, relapse rate, and disability progression in patients treated with intramuscular interferon beta-1a. METHODS: A retrospective review of medical records from 2000-2010 was performed. Adult patients with relapsing-remitting MS or clinically isolated syndrome treated with interferon beta-1a were included...
2015: Journal of Drug Assessment
Kei Hosoya, Satoru Masuno, Kazuhiro Hashiguchi, Kimihiro Okubo
OBJECTIVE: This double-blind, placebo-controlled comparative study was designed to investigate whether pranlukast dry syrup, a leukotriene receptor antagonist, has a protective effect against priming, controlled pollen exposure, and natural pollen exposure in children with Japanese cedar pollinosis. RESEARCH DESIGN AND METHODS: Thirty children aged 12-15 years with Japanese cedar pollinosis (positive skin test for Japanese cedar pollen), who had suffered from pollinosis for at least 2 years and developed severe nasal obstruction when exposed to Japanese cedar pollen, were enrolled in this study...
2014: Journal of Drug Assessment
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