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Clinical Drug Investigation

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https://www.readbyqxmd.com/read/28643178/economic-evaluation-of-tobramycin-inhalation-powder-for-the-treatment-of-chronic-pulmonary-pseudomonas-aeruginosa-infection-in-patients-with-cystic-fibrosis
#1
Srilekha Panguluri, Praveen Gunda, Laurie Debonnett, Kamal Hamed
BACKGROUND: Chronic lung infection with Pseudomonas aeruginosa occurs in approximately 50% of patients with cystic fibrosis (CF). This infection further compromises lung function, and significantly contributes to the increased healthcare costs. OBJECTIVES: Inhaled tobramycin, used to manage P. aeruginosa infection in CF patients, is available as powder (tobramycin inhalation powder, TIP) and solution (tobramycin inhalation solution, TIS). Evidence suggests increased adherence with the use of TIP over TIS...
June 22, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28624930/basal-and-bolus-insulin-dose-changes-after-switching-basal-insulin-to-insulin-degludec-in-patients-with-type-1-diabetes%C3%A2-mellitus-a-pilot-study
#2
Yoshiyuki Hamamoto, Sachiko Honjo, Kanta Fujimoto, Shinsuke Tokumoto, Hiroki Ikeda, Yoshiharu Wada, Hiroyuki Koshiyama
BACKGROUND AND OBJECTIVES: Ultra-long-acting insulin degludec (DEG) has a longer duration of action and less daily variability relative to other basal insulin (BI), and thus may benefit patients with type 1 diabetes mellitus (T1DM). We examined the impact of switching BI to DEG on glycemic control and insulin dose in T1DM. METHODS: T1DM patients (n = 22; six male; mean age: 64.5 ± 12.6 years) receiving basal-bolus insulin therapy were included. Initially, the BI dose was replaced with DEG in a 1:1 ratio; 80-100% of the total dose was replaced with DEG for multiple basal insulin injections...
June 17, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28612237/assessment-of-the-impact-of-l-thyroxine-therapy-on-bleeding-risk-in-patients-receiving-vitamin-k-antagonists
#3
Farès Moustafa, Rémi Malhomme, Bruno Pereira, Alain Barres, Jennifer Saint-Denis, Frederic Dutheil, Marie Batisse, Jeannot Schmidt
BACKGROUND: Several studies have suggested a link exists between L-thyroxine and the coagulation system, and, according to some drug interaction studies, L-thyroxine can potentiate the effect of warfarin. This study sought to assess whether thyroid hormone therapy could impact the risk of bleeding in patients receiving vitamin K antagonists (VKAs). METHODS: We conducted a monocentric, retrospective study on prospectively collected data from consecutive patients enrolled in the Registry of patient with AntiThrombotic agents admitted to an Emergency Department (RATED) database, and compared the hemorrhage rates (both major and nonmajor) of patients receiving treatment with and without L-thyroxine...
June 13, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28608312/cost-effectiveness-analysis-of-rivaroxaban-for-treatment-of-deep-vein-thrombosis-and-pulmonary-embolism-in-greece
#4
George Gourzoulidis, Georgia Kourlaba, John Kakisis, Mitiadis Matsagkas, George Giannakoulas, Konstantinos I Gourgoulianis, Theodoros Vassilakopoulos, Nikos Maniadakis
BACKGROUND AND OBJECTIVE: Venous thromboembolism (VTE), comprising deep-vein thrombosis (DVT) and pulmonary embolism (PE), is a major healthcare concern that results in substantial morbidity and mortality with great economic burden for healthcare systems. Hence, the need for effective and efficient treatment of patients with VTE is important for both clinical and economic reasons. The objective of this study was to evaluate the cost effectiveness of rivaroxaban compared to standard of care (SoC) with enoxaparin followed by dose-adjusted vitamin-K antagonists for the treatment of DVT and PE in Greece...
June 12, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28608311/potential-role-of-allopurinol-in-preventing-contrast-induced-nephropathy-in-patients-undergoing-percutaneous-coronary-intervention-a-randomized-placebo-controlled-trial
#5
Zahra Ghelich Khan, Azita Hajhossein Talasaz, Hamidreza Pourhosseini, Kianoush Hosseini, Mohammad Javad Alemzadeh Ansari, Arash Jalali
BACKGROUND: Contrast-induced nephropathy (CIN) is a major drawback in percutaneous coronary intervention (PCI). Significant uricosuria has been reported following contrast exposure. Allopurinol-a xanthine oxidase inhibitor-has been suggested to prevent the formation of oxygen-free radicals, which may contribute to CIN. The aim of the present study was to evaluate the possible efficacy of allopurinol in preventing CIN. METHODS: In this double-blind placebo-controlled trial, patients with an estimated glomerular filtration rate ≥60 mL/min who were admitted for elective PCI, were randomized to receive either allopurinol 600 mg or a placebo administered 24 h before the procedure, and again immediately before the procedure...
June 12, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28597216/pharmacokinetic-properties-of-fast-acting-insulin-aspart-administered-in-different-subcutaneous-injection-regions-response-to-the-commentary-by-nuggehally-r-srinivas
#6
LETTER
Tim Heise, Ulrike Hövelmann, Leszek Nosek, Bettina Sassenfeld, Karen Margrete Due Thomsen, Hanne Haahr
No abstract text is available yet for this article.
June 8, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28597215/pharmacodynamics-of-insulin-preparations-administered-in-different-subcutaneous-injection-sites-are-there-differences-between-healthy-subjects-versus-diabetic-patients
#7
LETTER
Nuggehally R Srinivas
No abstract text is available yet for this article.
June 8, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28589372/erratum-to-surfactants-in-acute-respiratory-distress-syndrome-in-infants-and-children-past-present-and-future
#8
Angela Amigoni, Andrea Pettenazzo, Valentina Stritoni, Maria Circelli
No abstract text is available yet for this article.
June 6, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28577220/response-to-sharma-et-al-long-pulmonary-residence-time-and-plasma-half-life-of-tiotropium-implications-for-pharmacokinetic-bioequivalence-studies
#9
LETTER
Jaime Algorta
No abstract text is available yet for this article.
June 2, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28573499/effectiveness-of-lipid-lowering-statin-therapy-in-patients-with-and-without-psoriasis
#10
William C Ports, Rana Fayyad, David A DeMicco, Rachel Laskey, Robert Wolk
BACKGROUND: Psoriasis is associated with dyslipidemia and metabolic syndrome, and has been linked to an increased cardiovascular risk. The aim of this study was to compare baseline characteristics and effects of statin therapy on lipid levels and cardiovascular outcomes in patients with and without psoriasis. METHODS: This post-hoc analysis assessed patients from one primary cardiovascular prevention statin trial (Collaborative AtoRvastatin Diabetes Study [CARDS]) and two secondary cardiovascular prevention statin trials (Treating to New Targets [TNT] and Incremental Decrease in End Points Through Aggressive Lipid Lowering [IDEAL])...
June 1, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28567596/long-pulmonary-residence-time-and-plasma-half-life-of-tiotropium-implications-for-pharmacokinetic-bioequivalence-studies
#11
LETTER
Ashish Sharma, Benjamin Weber, Bernd Meibohm
No abstract text is available yet for this article.
June 1, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28547741/decrease-in-switches-to-unsafe-proton-pump-inhibitors-after-communications-about-interactions-with-clopidogrel
#12
Willemien J Kruik-Kollöffel, Job van der Palen, Myrthe P P van Herk-Sukel, H Joost Kruik, Kris L L Movig
BACKGROUND: In 2009 and 2010 medicines regulatory agencies published official safety statements regarding the concomitant use of proton pump inhibitors and clopidogrel. We wanted to investigate a change in prescription behaviour in prevalent gastroprotective drug users (2008-2011). METHODS: Data on drug use were retrieved from the Out-patient Pharmacy Database of the PHARMO Database Network. We used interrupted time series analyses (ITS) to estimate the impact of each safety statement on the number of gastroprotective drug switches around the start of clopidogrel and during clopidogrel use...
May 25, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28510235/surfactants-in-acute-respiratory-distress-syndrome-in-infants-and-children-past-present-and-future
#13
REVIEW
Angela Amigoni, Andrea Pettenazzo, Valentina Stritoni, Maria Circelli
There is a lack of definitive data on the effective management of acute respiratory distress syndrome (ARDS) in infants and children. The development and validation of the Berlin definition (BD) for ARDS and the Pediatric Acute Lung Injury Consensus Conference (PALICC) recommendations in children represented a major advance in optimizing research and treatment, mainly due to the introduction of a severe ARDS category. Proposed reasons for the lack of consistent results with surfactants in children and infants compared with neonates include different causes, type of lung damage (direct or indirect), timing and mode of administration as well as the type of surfactant used...
May 16, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28477315/treatment-of-bipolar-disorder-in-a-lifetime-perspective-is-lithium-still-the-best-choice
#14
REVIEW
Gabriele Sani, Giulio Perugi, Leonardo Tondo
Lithium preparations have been successfully used to treat bipolar disorder (BD), and remain the best established long-term treatment for the disorder. In fact, lithium is a cornerstone of treatment to minimize the risk of recurrences and improve inter-episodic symptomatology. We reviewed the available evidence for the use of lithium in the treatment of BD, including its efficacy, limitations, and potential benefits also in consideration of the different formulations available. We also overviewed salient comparative aspects regarding the long-term alternative use of anticonvulsants, antidepressants, and antipsychotics in BD patients...
May 5, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28451875/prevalence-of-gabapentin-abuse-comparison-with-agents-with-known-abuse-potential-in-a-commercially-insured-us-population
#15
Alyssa M Peckham, Kathleen A Fairman, David A Sclar
BACKGROUND: Despite international calls to make gabapentin a controlled substance, studies of gabapentin use/abuse patterns are limited to small/high-risk samples and adverse event reports. OBJECTIVE: The aim of this study was to conduct a systematic assessment of the abuse potential/prevalence of gabapentin in a large sample. DATA SOURCE: Truven Health MarketScan(®) Commercial Claims and Encounters database, years 2013-2015. ELIGIBILITY CRITERIA: Patients with two or more claims for one or more abusable drugs and ≥12 months' continuous enrollment were sampled for Lorenz curve analysis...
April 27, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28434141/prescription-appropriateness-of-cyproterone-acetate-ethinylestradiol-in-primary-care-a-population-based-study-in-italy
#16
Francesco Lapi, Monica Simonetti, Iacopo Cricelli, Claudio Cricelli, Nicoletta Cassano, Gino A Vena
BACKGROUND AND OBJECTIVE: We evaluated the prescription appropriateness of cyproterone acetate in combination with ethinylestradiol (CPA/EE) in a primary care setting before and after the 2013 European Medicines Agency's (EMA) recommendation relating to the risk profile of CPA/EE. METHODS: Data were obtained from the Health Search IMS Health Longitudinal Patient Database (HSD). We compared the results from 2011 to 2012 with the results of 2014, namely before and after the 2013 EMA recommendation, and investigated the burden of concurrent use of CPA/EE and other hormonal contraceptives (HCs) and the reported indication at the time of CPA/EE prescription...
April 22, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28432583/can-long-term-pharmacotherapy-prevent-relapses-in-generalized-anxiety-disorder-a-systematic-review
#17
REVIEW
Marina Dyskant Mochcovitch, Rafael Christophe da Rocha Freire, Rafael Ferreira Garcia, Antonio Egidio Nardi
BACKGROUND AND OBJECTIVES: Generalized anxiety disorder (GAD) is a persistent anxiety disorder with a high rate of relapse. While several trials have demonstrated the efficacy of pharmacotherapy for GAD treatment, fewer studies have investigated its efficacy in preventing symptom relapse in long-term treatment. The aim of this study is to evaluate if long-term pharmacotherapy may prevent relapses in GAD patients. METHODS: This is a systematic review of the relapse prevention trials with GAD patients...
April 21, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28421383/pharmacokinetics-safety-and-tolerability-of-single-and-multiple-doses-of-guanfacine-extended-release-formulation-in-healthy-japanese-and-caucasian-male-adults
#18
Yumiko Matsuo, Masafumi Okita, James Ermer, Toshihiro Wajima
BACKGROUND AND OBJECTIVE: Guanfacine extended-release (guanfacine XR) could be a useful treatment option for children and adolescent patients with attention-deficit/hyperactivity disorder (ADHD). As an initial step in the development in Japan, the pharmacokinetics, safety and tolerability were assessed in healthy Japanese and non-Hispanic Caucasian adults. METHODS: A Phase 1, double-blind, randomized, placebo-controlled, single- and multiple-oral dose escalation study of guanfacine XR was conducted...
April 18, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28421382/relationship-between-the-expression-of-o-6-methylguanine-dna-methyltransferase-mgmt-and-p53-and-the-clinical-response-in-metastatic-pancreatic-adenocarcinoma-treated-with-folfirinox
#19
Carole Vitellius, Caroline Eymerit-Morin, Dominique Luet, Lionel Fizanne, Fanny Foubert, Sandrine Bertrais, Marie-Christine Rousselet, François-Xavier Caroli-Bosc
BACKGROUND: To date, no predictive biomarker for the efficacy of FOLFIRINOX in metastatic pancreatic adenocarcinoma has been demonstrated. Deficiency in O(6)-methylguanine-DNA methyltransferase (MGMT) has been associated with a therapeutic response in endocrine tumors of the pancreas and the lack of expression of protein 53 (p53) could interfere with the action of MGMT. OBJECTIVE: The aim of our study was to assess the prevalence of MGMT and p53 in patients with metastatic pancreatic adenocarcinoma treated with FOLFIRINOX as a first-line treatment and to investigate their association with therapeutic response and survival...
April 18, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28417436/evaluation-of-the-pharmacokinetics-and-pharmacodynamics-of-prasugrel-in-japanese-elderly-subjects
#20
Tomoko Hasunuma, Hiroyuki Fukase, Atsuhiro Miyazaki, Yasuhiro Nishikawa
BACKGROUND AND OBJECTIVE: An increased incidence in bleeding events has been reported in Western elderly patients receiving prasugrel. Therefore, doses in Japanese elderly subjects need to be carefully determined. We assessed the pharmacokinetic and pharmacodynamic effects of prasugrel at the clinical dose used in Japan in healthy Japanese elderly subjects compared with non-elderly subjects. METHODS: In an open-label parallel-group study conducted in Japan, two groups (elderly, aged >75 years; non-elderly, aged 45-65 years) received a 20-mg loading dose and a 3...
April 17, 2017: Clinical Drug Investigation
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