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Clinical Drug Investigation

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https://www.readbyqxmd.com/read/29327219/pharmacological-insights-into-the-use-of-apomorphine-in-parkinson-s-disease-clinical-relevance
#1
REVIEW
Manon Auffret, Sophie Drapier, Marc Vérin
The present paper consists of a comprehensive review of the literature on apomorphine pharmacological properties and its usefulness in Parkinson's disease (PD). The chemistry, structure-activity relationship, pharmacokinetics and pharmacodynamics of apomorphine are described with regard to its effects on PD symptoms, drug interactions, interindividual variability and adverse events. Apomorphine chemical structure accounts for most of its beneficial and deleterious properties, both dopaminergic and non-dopaminergic...
January 11, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29302857/combination-of-omega-3-fatty-acids-and-valproic-acid-in-treatment-of-borderline-personality-disorder-a-follow-up-study
#2
Paola Bozzatello, Paola Rocca, Silvio Bellino
BACKGROUND AND OBJECTIVES: Some evidence of efficacy has been found for omega-3 fatty acids in patients with borderline personality disorder (BPD). In a previous 12-week randomized trial we assessed the efficacy of the combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) with valproic acid, in comparison with valproic acid monotherapy, in 43 BPD outpatients. Combined therapy was superior to valproic acid monotherapy (the control group) in the treatment of some BPD symptoms: impulsive-behavioral dyscontrol, outbursts of anger, and self-harm...
January 5, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29289999/author-correction-to-prevalence-of-use-and-cost-of-biological-drugs-for-cancer-treatment-a-5-year-picture-from-southern-italy
#3
Simona Lucchesi, Ilaria Marcianò, Paolo Panagia, Rosanna Intelisano, Maria Pia Randazzo, Carmela Sgroi, Giuseppe Altavilla, Mariacarmela Santarpia, Vincenzo Adamo, Tindara Franchina, Francesco Ferraù, Paolina Reitano, Gianluca Trifirò
Unfortunately, many errors were identified in the published article. The original article was corrected.
December 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29282676/surveillance-on-the-safety-and-efficacy-of-ambrisentan-volibris-tablet-2-5-mg-in-patients-with-pulmonary-arterial-hypertension-in-real-clinical-practice-post-marketing-surveillance-interim-analysis-report
#4
Tomohiko Takahashi, Satoru Hayata, Akihiro Kobayashi, Yuna Onaka, Takeshi Ebihara, Terufumi Hara
BACKGROUND AND OBJECTIVE: Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. METHODS: PAH patients aged 15 years or older were subjected to the analysis...
December 27, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29270790/budget-impact-analysis-of-brivaracetam-adjunctive-therapy-for-partial-onset-epileptic-seizures-in-valencia-community-spain
#5
Isabel Barrachina-Martínez, David Vivas-Consuelo, Anna Piera-Balbastre
BACKGROUND AND OBJECTIVE: More than 30% of patients with epilepsy have inadequate control of seizures with drug therapy. The goal of this study is to determine the budget impact (BI) of the introduction of brivaracetam to the portfolio of approved drugs in Spain as adjunctive therapy for the treatment of partial-onset epilepsy in patients over 16 years old with a 5-year time horizon in the Valencia Community, a Spanish region with a population of 5 million. METHODS: The BI model compares the pharmaceutical expenditure on antiepileptics in two scenarios: with and without brivaracetam...
December 21, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29264838/intentional-drug-overdose-involving-pregabalin-and-gabapentin-findings-from-the-national-self-harm-registry-ireland-2007-2015
#6
Caroline Daly, Eve Griffin, Darren M Ashcroft, Roger T Webb, Ivan J Perry, Ella Arensman
INTRODUCTION: Intentional drug overdose (IDO) is a significant public health problem. Concerns about the misuse of gabapentinoids, i.e. pregabalin and gabapentin, including their consumption in IDO have grown in recent years. This paper examines the trends in the prevalence of gabapentinoids taken in IDO, the profile of individuals taking them, and associated overdose characteristics. METHODS: Presentations to emergency departments involving IDO, recorded by the National Self-Harm Registry Ireland between 1 January 2007 and 31 December 2015 were examined...
December 20, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29256049/a-pilot-study-of-the-normative-range-of-overnight-urinary-free-cortisol-corrected-for-creatinine-in-children
#7
Ole D Wolthers, Sabine Mersmann, Sanjeeva Dissanayake
BACKGROUND: For more than a decade, urinary free cortisol corrected for creatinine (OUFCC) has been used to assess the systemic bioactivity of inhaled corticosteroids in children with asthma. Paediatric normative ranges, however, have not been established. The aim of the present study was to define a preliminary range for OUFCC in Tanner stage 1 children. METHODS: A post hoc analysis was performed of 26 Tanner stage one children (aged 5-11 years) with mild asthma only requiring prn (pro re nata) treatment with short-acting β2-agonists, who participated in a 3-way cross-over knemometry study...
December 18, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29249053/a-review-of-switching-biologic-agents-in-the-treatment-of-moderate-to-severe-plaque-psoriasis
#8
REVIEW
Yifan Hu, Zeyu Chen, Yu Gong, Yuling Shi
Psoriasis is an immune-mediated polygenic inherited skin disease. Many biologic agents have been approved for the treatment of moderate-to-severe plaque psoriasis. The most commonly utilized biologics include TNF-α antagonists (etanercept, infliximab, and adalimumab), IL-12/23P40 antagonist (ustekinumab), IL-23P19 antagonist (guselkumab), IL-17A antagonist (secukinumab and ixekizumab), and IL-17RA antagonist (brodalumab). However, some patients may fail to respond well to their first biologic agent. Reasons for failure include primary failure (lack of initial efficacy), secondary failure (loss of efficacy over time) or the development of adverse effects...
December 16, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29247383/adjusted-indirect-comparison-using-propensity-score-matching-of-osimertinib-to-platinum-based-doublet-chemotherapy-in-patients-with-egfrm-t790m-nsclc-who-have-progressed-after-egfr-tki
#9
Helen Mann, Frank Andersohn, Carolyn Bodnar, Tetsuya Mitsudomi, Tony S K Mok, James Chih-Hsin Yang, Christopher Hoyle
BACKGROUND AND OBJECTIVE: An adjusted indirect comparison was conducted to assess efficacy outcomes, particularly overall survival (OS), of osimertinib versus platinum-based doublet chemotherapy in patients with epidermal growth factor receptor-mutated (EGFRm) T790M mutation-positive non-small-cell lung cancer (NSCLC) who had progressed following an EGFR tyrosine kinase inhibitor (TKI). Analysis of treatment effect from two separate trials had the potential to more accurately estimate the magnitude of OS benefit due to absence of confounding due to treatment switching from the control arm to the osimertinib arm of the ongoing randomized control trial, AURA3...
December 15, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29236209/adverse-events-under-tacrolimus-and-cyclosporine-in-the-first-3-years-post-renal-transplantation-in-children
#10
Pauline Lancia, Beate Aurich, Phuong Ha, Anne Maisin, Véronique Baudouin, Evelyne Jacqz-Aigrain
BACKGROUND: Progress in immunosuppression has reduced acute rejection, graft loss and mortality after renal transplantation. Adverse drug reactions are well described in adults but few data are available in children. Our objectives were to analyse the adverse events reported in the first 3 years post-transplantation in children receiving tacrolimus or cyclosporine-based immunosuppression and compare them with the information of the Summary of Product Characteristics. METHODS: This retrospective study included all children who underwent a renal transplant at Hospital Robert Debré between 2002 and 2015...
December 13, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29214507/comparison-of-once-daily-bemiparin-with-twice-daily-enoxaparin-for-acute-deep-vein-thrombosis-a-multicenter-open-label-randomized-controlled-trial
#11
Igor A Suchkov, Javier Martinez-Gonzalez, Sebastian M Schellong, Toni Garbade, Michela Falciani
BACKGROUND: Individuals with deep vein thrombosis (DVT) have an increased risk of pulmonary embolism (PE), death, and long-term thrombotic complications. OBJECTIVES: To evaluate the efficacy and safety of bemiparin once daily versus enoxaparin twice daily in the treatment of acute DVT, and to establish therapeutic non-inferiority of bemiparin. PATIENTS AND METHODS: This multicenter, randomized, open-label, active-controlled phase III clinical trial enrolled patients with acute proximal DVT confirmed by complete compression ultrasound (CCUS)...
December 6, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29214506/pharmacokinetics-of-oral-and-intravenous-paracetamol-acetaminophen-when-co-administered-with-intravenous-morphine-in-healthy-adult-subjects
#12
Robert B Raffa, Jayne Pawasauskas, Joseph V Pergolizzi, Luke Lu, Yin Chen, Sutan Wu, Brant Jarrett, Randi Fain, Lawrence Hill, Krishna Devarakonda
BACKGROUND AND OBJECTIVE: Several features favor paracetamol (acetaminophen) administration by the intravenous rather than the oral route in the postoperative setting. This study compared the pharmacokinetics and bioavailability of oral and intravenous paracetamol when given with or without an opioid, morphine. METHODS: In this randomized, single-blind, parallel, repeat-dose study in healthy adults, subjects received four repeat doses of oral or intravenous 1000 mg paracetamol at 6-h intervals, and morphine infusions (0...
December 6, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29209982/adherence-to-inhaled-medications-and-its-effect-on-healthcare-utilization-and-costs-among-high-grade-chronic-obstructive-pulmonary-disease-patients
#13
Jee-Ae Kim, Min Kyoung Lim, Kunil Kim, JuHee Park, Chin Kook Rhee
BACKGROUND: Adherence to inhaled medication regimens affects chronic obstructive pulmonary disease (COPD) prognosis and quality of life, and reduces the use of healthcare services, resulting in cost savings. OBJECTIVES: To examine the effects of adherence to inhaled medication regimens on healthcare utilization and costs in high-grade COPD patients. METHODS: We performed an observational retrospective cohort study using a longitudinal data set from the Korean Health Insurance Review and Assessment Service (2008-2013) containing healthcare services' information for 50 million beneficiaries...
December 5, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29204958/pharmacokinetics-and-safety-of-ingenol-disoxate-gel-administered-under-maximum-use-conditions-to-patients-with-actinic-keratosis
#14
Edward Lain, Torsten Skov, Anders Hall
BACKGROUND AND OBJECTIVES: Ingenol disoxate (LEO 43204) is a field therapy in development for the treatment of actinic keratosis (AK) on areas between 25 and 250 cm2. We evaluated the systemic exposure and safety of ingenol disoxate under maximum-use conditions. METHODS: This was a phase I, open-label, non-randomized, multicenter trial. Patients ≥ 18 years of age with ≥ 15 clinically typical, visible, discrete AK lesions in a treatment area on the full face or approximately 250 cm2 on the arm or scalp were treated once-daily for 3 consecutive days with ingenol disoxate 0...
December 4, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29189921/lithium-toxicity-in-older-adults-a-systematic-review-of-case-reports
#15
REVIEW
Meng Sun, Nathan Herrmann, Kenneth I Shulman
BACKGROUND AND OBJECTIVES: Despite concerns regarding the vulnerability of older adults to lithium toxicity, this has not been well studied. This literature review aims to characterize the nature of lithium toxicity in older adults, the doses and serum lithium levels associated with toxicity, as well as its clinical and laboratory manifestations, precipitating factors, management and outcome. METHODS: A systematic 10-year search of English articles was conducted using Ovid Medline, Embase Classic + Embase, Cochrane Central Register of Controlled Trials and PsycINFO...
November 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29185238/agreement-among-different-scales-for-causality-assessment-in-drug-induced-liver-injury
#16
Saibal Das, Sapan K Behera, Alphienes S Xavier, Srinivas Velupula, Steven A Dkhar, Sandhiya Selvarajan
BACKGROUND AND OBJECTIVE: The causality assessment of drug-induced liver injury (DILI) remains a challenge and eagerly awaits the development of reliable hepatotoxicity biomarkers. None of the different available algorithms used for the causality assessment of DILI has been universally accepted as the gold standard. This study was conducted to examine the agreement among different causality assessment scales in reporting DILI. METHODS: The World Health Organization-Uppsala Monitoring Center (WHO-UMC), Naranjo, Roussel Uclaf Causality Assessment Method (RUCAM), Maria & Victorino (M & V) and Digestive Disease Week-Japan (DDW-J) assessment scales were used to compare the causalities in all the reported cases of DILI in our adverse drug reaction (ADR) monitoring centre from January 2014 to June 2017...
November 28, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29181714/discontinuation-of-efavirenz-in-paediatric-patients-why-do-children-switch
#17
Elke Wynberg, Eleri Williams, Gareth Tudor-Williams, Hermione Lyall, Caroline Foster
BACKGROUND: Efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI) is used globally as first-line antiretroviral therapy (ART) in combination with a dual nucleoside backbone in adults and children from 3 years of age. Up to 40% of adults taking efavirenz report central nervous system (CNS) adverse effects, and the rates of discontinuation of efavirenz-based treatment are higher than other first-line regimens. Data on efavirenz discontinuation are more limited for children and adolescents...
November 27, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29177645/ledipasvir-sofosbuvir-for-8%C3%A2-weeks-in-non-cirrhotic-patients-with-previously-untreated-genotype-1-hcv-infection%C3%A2-%C3%A2-%C3%A2-hiv-1-co-infection
#18
Vasily Isakov, Natalia Gankina, Viacheslav Morozov, Kathryn Kersey, Sophia Lu, Anu Osinusi, Evguenia Svarovskaia, Diana M Brainard, Riina Salupere, Elena Orlova-Morozova, Konstantin Zhdanov
BACKGROUND AND OBJECTIVES: The efficacy of < 12 weeks of hepatitis C virus (HCV) treatment in patients co-infected with HCV and human immunodeficiency virus type 1 (HIV-1) has not been established. We assessed the efficacy and safety of ledipasvir-sofosbuvir for 8 weeks in HCV mono-infected and HCV/HIV-1 co-infected patients. METHODS: We enrolled patients mono-infected with genotype 1 HCV or co-infected with HCV and HIV-1 who were HCV treatment-naive and did not have cirrhosis...
November 24, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29170983/correlation-of-age-and-metabolic-adverse-effects-of-antipsychotics
#19
LETTER
Eugene Y H Yeung, Kurt Buhagiar
No abstract text is available yet for this article.
November 23, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29159774/pharmacokinetics-pharmacodynamics-and-safety-of-rasagiline-transdermal-patch-a-preliminary-study-in-healthy-chinese-subjects
#20
Wenjia Zhou, Chengzhe Lv, Quanying Zhang, Shunlin Zong, Meng Wang
BACKGROUND AND OBJECTIVES: Rasagiline tablet is an oral MAO-B inhibitor applied in early or advanced Parkinson's disease (PD). However, when patients with PD cannot take their usual oral medications, a rasagiline transdermal patch can be used as a way to offer continuous rasagiline while avoiding plasma concentration peaks and troughs. The objectives of this study were to investigate the pharmacokinetics, pharmacodynamics, and safety of the rasagiline transdermal patch in healthy Chinese subjects...
November 20, 2017: Clinical Drug Investigation
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