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Clinical Drug Investigation

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https://www.readbyqxmd.com/read/28434141/prescription-appropriateness-of-cyproterone-acetate-ethinylestradiol-in-primary-care-a-population-based-study-in-italy
#1
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
#2
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
#3
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
#4
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
#5
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
https://www.readbyqxmd.com/read/28409482/efficacy-of-interferon-free-therapies-for-chronic-hepatitis-c-a-systematic-review-of-all-randomized-clinical-trials
#6
REVIEW
Vinicius L Ferreira, Fernanda S Tonin, Nayara A Assis Jarek, Yohanna Ramires, Roberto Pontarolo
BACKGROUND AND OBJECTIVES: Second-generation direct-acting antivirals (DAAs) have recently arisen as more effective and safer treatments for chronic hepatitis C. These drugs can be combined into treatments without interferon (IFN), and are therefore called IFN-free therapies. OBJECTIVE: The objective of this study systematic review was to evaluate the efficacy of IFN-free therapies for the treatment of chronic hepatitis C, and thus increase the clinical evidence for these therapies...
April 13, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28386820/oral-teicoplanin-as-an-alternative-first-line-regimen-in-clostridium-difficile-infection-in-elderly-patients-a-case-series
#7
Benjamin Davido, Céline Leplay, Frédérique Bouchand, Aurélien Dinh, Maryvonne Villart, Jean-Laurent Le Quintrec, Laurent Teillet, Jérôme Salomon, Hugues Michelon
BACKGROUND: Elderly patients are more susceptible to Clostridium difficile infections (CDIs). Despite existing guidelines, there is no specific treatment for CDI in geriatrics. Vancomycin is commonly used in the treatment of CDI. Teicoplanin is an alternative glycopeptide which recently received marketing authorization approval for CDI in Europe. OBJECTIVES: Evaluate the potential interest of oral teicoplanin and assess whether such treatment could potentially become an alternative treatment in mild to severe CDIs in elderly patients...
April 6, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28386819/disease-burden-early-discontinuation-and-healthcare-costs-in-hepatitis-c-patients-with-and-without-chronic-kidney-disease-treated-with-interferon-free-direct-acting-antiviral-regimens
#8
Amy Puenpatom, Michael Hull, Jeffrey McPheeters, Kay Schwebke
BACKGROUND: Hepatitis C virus (HCV) is a risk factor for chronic kidney disease (CKD) and end-stage renal disease (ESRD). Direct-acting antiviral agents (DAAs) have improved HCV management in CKD patients, however real-world clinical practice data are limited. OBJECTIVE: This study examined the prevalence of CKD among HCV patients receiving oral DAAs in a real-world setting. Comorbidities, early discontinuation rates, and healthcare costs were compared between patients with and without CKD...
April 6, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28382572/current-clinical-trials-on-the-use-of-ceftaroline-in-the-pediatric-population
#9
REVIEW
Adam Corey, Tsz-Yin So
The rate of antibiotic resistance in children continues to rise requiring the use of new antibiotics. Ceftaroline fosamil, a newer-generation cephalosporin, was recently approved for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in children aged >2 months. Ceftaroline provides coverage against staphylococcal and streptococcal infections, including methicillin-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumoniae...
April 5, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28378135/exposure-safety-response-relationship-for-ombitasvir-paritaprevir-ritonavir-dasabuvir-and-ribavirin-in-patients-with-chronic-hepatitis-c-virus-genotype-1-infection-analysis-of-data-from-five-phase-ii-and-six-phase-iii-studies
#10
Chih-Wei Lin, Rajeev Menon, Wei Liu, Thomas Podsadecki, Nancy Shulman, Barbara DaSilva-Tillmann, Walid Awni, Sandeep Dutta
BACKGROUND AND OBJECTIVES: All-oral direct-acting antiviral regimens that include combinations of ombitasvir, paritaprevir, ritonavir, and dasabuvir with or without ribavirin were evaluated in hepatitis C virus-infected patients in phase II/III clinical studies. The objective of these analyses was to quantify the relationship between exposures of the components of the regimen and laboratory values and to determine covariates that could influence the relationship. METHODS: Exposure-safety response relationships between individual components of the direct-acting antiviral regimens and clinically important laboratory values were explored using data from 2998 patients from 11 phase II/III clinical studies...
April 4, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28361440/acid-suppressive-therapy-and-risk-of-infections-pros-and-cons
#11
REVIEW
Leon Fisher, Alexander Fisher
This narrative review summarises the benefits, risks and appropriate use of acid-suppressing drugs (ASDs), proton pump inhibitors and histamine-2 receptor antagonists, advocating a rationale balanced and individualised approach aimed to minimise any serious adverse consequences. It focuses on current controversies on the potential of ASDs to contribute to infections-bacterial, parasitic, fungal, protozoan and viral, particularly in the elderly, comprehensively and critically discusses the growing body of observational literature linking ASD use to a variety of enteric, respiratory, skin and systemic infectious diseases and complications (Clostridium difficile diarrhoea, pneumonia, spontaneous bacterial peritonitis, septicaemia and other)...
March 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28361439/cost-effectiveness-analysis-of-regorafenib-for-gastrointestinal-stromal-tumour-gist-in-germany
#12
David Tamoschus, Katja Draexler, Jane Chang, Christopher Ngai, Matthew Madin-Warburton, Ashley Pitcher
BACKGROUND: No study has compared the cost-effectiveness of active treatment options for unresectable or metastatic gastrointestinal stromal tumours in patients who progressed on or are intolerant to prior treatment with imatinib and sunitinib. The aim of this study was to estimate the cost-effectiveness of regorafenib compared to imatinib rechallenge in this setting in Germany. METHODS: Hazard ratios for progression-free (PFS) and overall survival (OS) with regorafenib versus imatinib rechallenge were estimated by indirect comparison...
March 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28361438/drug-utilization-of-japanese-patients-diagnosed-with-schizophrenia-an-administrative-database-analysis
#13
Stephane Cheung, Yukinobu Hamuro, Jörg Mahlich, Takanobu Nakahara, Rosarin Sruamsiri, Sunny Tsukazawa
BACKGROUND AND OBJECTIVE: Patient characteristics require consideration for optimal treatment in order to achieve clinical remission for an improved quality of life and social functioning. Prior evidence supports long-acting injectable antipsychotics (LAIs) in the relapse prevention of schizophrenia. This study aimed to characterize Japanese patients diagnosed with schizophrenia and to compare the outcomes of LAIs and oral antipsychotics (AP) in re-hospitalization or emergency room visit rates...
March 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28357813/rate-of-adverse-effects-of-medium-to-high-dose-glucocorticoid-therapy-in-systemic-lupus-erythematosus-a-systematic-review-of%C3%A2-randomized-control-trials
#14
REVIEW
Savino Sciascia, Elisa Mompean, Massimo Radin, Dario Roccatello, Maria J Cuadrado
BACKGROUND AND OBJECTIVES: The efficacy of glucocorticoids (GCs) in treating systemic lupus erythematosus (SLE) is beyond doubt. However, GCs-related adverse effects (AEs) are multiple and serious. Despite the current available evidence suggesting to reduce daily doses of prednisone <7.5 mg/day, or even to withdraw it, in the real-life practice, it is not uncommon to see patients receiving medium doses (up to 30 mg/day prednisone or equivalent) or high doses (≥30 mg/day). METHODS: We systematically reviewed the literature with a priori strategy, to assess the rate of AEs related to medium or high doses of GCs in patients with SLE, analyzing randomized control trials with at least one of the treatment groups including GCs alone at medium or high doses...
March 29, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28353169/the-effect-of-single-and-multiple-doses-of-rifampin-on-the-pharmacokinetics-of-doravirine-in-healthy-subjects
#15
Ka Lai Yee, Sauzanne G Khalilieh, Rosa I Sanchez, Rachael Liu, Matt S Anderson, Helen Manthos, Timothy Judge, John Brejda, Joan R Butterton
BACKGROUND AND OBJECTIVE: Doravirine is a novel, next-generation, non-nucleoside reverse transcriptase inhibitor in development for the treatment of human immunodeficiency virus-1 infection in combination with other antiretrovirals. Doravirine is a substrate for cytochrome P450 (CYP) 3A and P-glycoprotein. Rifampin (rifampicin) is used for treating tuberculosis in patients who are co-infected with human immunodeficiency virus. Rifampin demonstrates organic anion-transporting polypeptide 1B1 and P-glycoprotein inhibition after single-dose administration and CYP3A and P-glycoprotein induction after multiple-dose administration...
March 28, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28349329/efficacy-of-ripasudil-as-a-second-line-medication-in-addition-to-a-prostaglandin-analog-in-patients-with-exfoliation-glaucoma-a-pilot-study
#16
Riyo Matsumura, Toshihiro Inoue, Akira Matsumura, Hidenobu Tanihara
OBJECTIVE: This study aimed to assess the intraocular pressure (IOP)-lowering effects of ripasudil, a Rho kinase inhibitor, as a second-line medication in patients with exfoliation glaucoma. METHODS: This retrospective cohort study included patients with exfoliation glaucoma who received ripasudil as the second-line drug in addition to prostaglandin analogs, and were followed-up for at least 5 months. Twenty-seven eyes of 16 patients were enrolled; the mean (±standard deviation) age was 76...
March 27, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28349328/the-effect-of-food-on-doravirine-bioavailability-results-from-two-pharmacokinetic-studies-in-healthy-subjects
#17
Martin O Behm, Ka Lai Yee, Rachael Liu, Vanessa Levine, Deborah Panebianco, Paul Fackler
BACKGROUND AND OBJECTIVE: Doravirine is a novel non-nucleoside reverse transcriptase inhibitor being developed for the treatment of HIV-1. In two open-label, single-dose, randomized, two-period, crossover trials, the bioavailability of doravirine administered alone or in a fixed-dose combination (FDC) was determined under fed and fasted conditions. METHODS: Doravirine 100 mg alone or with lamivudine and tenofovir disoproxil fumarate (each 300 mg) were administered to healthy subjects fasted or 30 min after a high-fat, high-calorie breakfast...
March 27, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28326466/a-cost-minimisation-analysis-comparing-sublingual-immunotherapy-to-subcutaneous-immunotherapy-for-the-treatment-of-house-dust-mite-allergy-in-a-swedish-setting
#18
Åse Björstad, Lars-Olaf Cardell, Julie Hahn-Pedersen, Mikael Svärd
BACKGROUND AND OBJECTIVES: In Sweden, approximately 6% of children and 10% of adults suffer from house dust mite (HDM) allergy with symptoms of allergic rhinitis and allergic asthma. Treatment is aimed at reducing HDM exposure and to control the symptoms of allergic rhinitis and allergic asthma by symptom-relieving pharmacotherapy. This pharmacotherapy is often effective, but some patients remain inadequately controlled. For these patients, allergy immunotherapy (AIT, subcutaneous or sublingual) with repeated administration of HDM allergen should be considered...
March 22, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28303523/initiation-switching-and-cessation-of-psoriasis-treatments-among-patients-with-moderate-to-severe-psoriasis-in-the-united-states
#19
April W Armstrong, J Will Koning, Simon Rowse, Huaming Tan, Carla Mamolo, Mandeep Kaur
BACKGROUND: Psoriasis patients frequently switch among multiple therapies while managing their psoriasis. Determining treatment transitions is fundamental to understanding how patients access and use treatments. OBJECTIVE: We aimed to identify patterns of treatment transitions of US patients with moderate to severe psoriasis over 5 years. METHODS: This was a retrospective, longitudinal cohort study in which US patients aged ≥18 years who had at least one psoriasis claim (International Classification of Diseases, Ninth Revision [ICD-9] diagnosis) were continuously enrolled in a health plan between October 2007 and September 2012...
March 16, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28299582/complete-tumor-response-with-afatinib-20%C3%A2-mg-daily-in-egfr-mutated-non-small-cell-lung-cancer-a-case-report
#20
Raffaele Giusti, Marco Mazzotta, Daniela Iacono, Salvatore Lauro, Paolo Marchetti
Afatinib, a second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, is efficacious as first-line treatment in patients with EGFR-mutated non-small cell lung cancer (NSCLC). Dosage reduction is recommended in patients with intolerable adverse events; however, data regarding the efficacy of low-dose afatinib are limited. We report the case of a 71-year-old female patient who was diagnosed with advanced EGFR-mutated NSCLC and started treatment with oral afatinib 40 mg daily. The patient achieved partial tumor response on computed tomography imaging, but developed unacceptable skin-related toxicities requiring dosage reduction to 20 mg daily...
March 15, 2017: Clinical Drug Investigation
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