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Clinical Drug Investigation

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https://www.readbyqxmd.com/read/29098566/clinical-factors-associated-with-initial-decrease-in-body-fat-percentage-induced-by-add-on-sodium-glucose-co-transporter-2-inhibitors-in-patient-with-type-2-diabetes-mellitus
#1
Noboru Kurinami, Seigo Sugiyama, Hiroyuki Nishimura, Ayami Morita, Akira Yoshida, Kunio Hieshima, Fumio Miyamoto, Keizo Kajiwara, Katsunori Jinnouchi, Tomio Jinnouchi, Hideaki Jinnouchi
BACKGROUND AND OBJECTIVE: Obesity is globally recognized as an important clinical problem and sodium-glucose co-transporter 2 (SGLT2) inhibitors are considered a suitable therapy for obese patients with type 2 diabetes mellitus (T2DM). We examined the clinical factors associated with initial decrease in body-fat percentage (Fat %) induced by SGLT2 inhibitors in patients with T2DM. METHODS: We retrospectively enrolled patients newly treated with SGLT2 inhibitors in addition to ongoing medications at Jinnouchi Hospital between April 2014 and December 2015...
November 2, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29094282/tofacitinib-a-new-oral-therapy-for-psoriasis
#2
REVIEW
Alexandra Azevedo, Tiago Torres
Psoriasis is a common, chronic, immune-mediated disease associated with several comorbidities. Biologic therapy revolutionized the treatment of moderate-to-severe psoriasis, improving physical and emotional burden of the disease. Still, there are unmet needs in the treatment of psoriasis regarding long-term efficacy, tolerability, safety, route of administration, and cost. The increased knowledge of the pathogenesis of the intracellular metabolic pathways allowed the development of new compounds that inhibit certain intracellular proteins involved in the immune response...
November 1, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29094281/author-correction-to-in-vitro-drug-release-after-crushing-evaluation-of-xtampza-%C3%A2-er-and-other-er-opioid-formulations
#3
Stephen P Mayock, Said Saim, Alison B Fleming
Following correction should be noted.
November 1, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29086890/west-syndrome-a-review-and-guide-for-paediatricians
#4
REVIEW
Renato D'Alonzo, Donato Rigante, Elisabetta Mencaroni, Susanna Esposito
West syndrome (WS), also known as infantile spasms, occurs in infancy with a peak between 4 and 7 months. Spasms, neurodevelopmental regression and hypsarrhythmia on electroencephalogram (EEG) basically define WS. The International League Against Epilepsy commission classifies the aetiologies of WS into genetic, structural, metabolic and unknown. Early diagnosis and a shorter lag time to treatment are essential for the overall outcome of WS patients. These goals are feasible with the addition of brain magnetic resonance imaging (MRI) and genetic and metabolic testing...
October 31, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29086340/impact-of-herpes-zoster-and-post-herpetic-neuralgia-on-health-related-quality-of-life-in-japanese-adults-aged-60-years-or-older-results-from-a-prospective-observational-cohort-study
#5
Akiko Mizukami, Keiko Sato, Koichi Adachi, Sean Matthews, Katsiaryna Holl, Taizo Matsuki, Toshihiko Kaise, Desmond Curran
BACKGROUND AND OBJECTIVES: Herpes zoster (HZ) and its most frequent complication, post-herpetic neuralgia (PHN), have been shown to considerably impact quality of life (QoL). This has not yet been demonstrated in Japan. METHODS: QoL in HZ and PHN patients was evaluated using the Zoster Brief Pain Inventory (ZBPI), EuroQoL-5 Dimension (EQ-5D), Short-Form 12 version 2.0, and short-form McGill Pain Questionnaire up to 270 days after rash onset as part of a prospective, observational, cohort study conducted in Kushiro, Hokkaido, Japan...
October 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29081029/do-statins-increase-the-risk-of-esophageal-conditions-findings-from-four-propensity-score-matched-analyses
#6
Ioana Smith, Robert Schmidt, Ethan A Halm, Ishak A Mansi
BACKGROUND AND OBJECTIVE: Statins are commonly used medications. Whereas some observational studies suggested an association of statin use with Barrett's esophagus and some upper gastrointestinal symptoms, there is a dearth of data on the association of statins and common esophageal conditions such as gastroesophageal reflux disease and esophagitis. The aim of this study is to examine the association of statins with esophageal conditions. METHODS: This is a retrospective cohort study using regional military healthcare data (1 October, 2003 to 1 March, 2012)...
October 28, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29081028/burden-of-disease-of-human-papillomavirus-hpv-hospitalizations-in-the-marche-and-veneto-regions-an-observational-study
#7
Francesco Saverio Mennini, Gianluca Fabiano, Andrea Marcellusi, Paolo Sciattella, Mario Saia, Silvia Cocchio, Vincenzo Baldo
BACKGROUND AND OBJECTIVES: HPV (human papillomavirus) is the virus most often responsible for sexually transmitted infections. The burden of HPV-related diseases on hospital resources represents a major public health problem. The aim of this study was to assess the economic burden of HPV-related diseases (anal cancer, genital cancer, genital warts, oropharyngeal cancer) on hospital resources in two Italian regions. METHODS: A retrospective, non-randomized, observational study was developed in the Marche and Veneto Regions, based on patients receiving hospitalization between 2008 and 2011...
October 28, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29080210/cost-effectiveness-of-exenatide-once-weekly-versus-insulin-glargine-and-liraglutide-for-the-treatment-of-type-2-diabetes-mellitus-in-greece
#8
Charalampos Tzanetakos, Alexandra Bargiota, Georgia Kourlaba, George Gourzoulidis, Nikos Maniadakis
OBJECTIVE: The objective of this study was to evaluate the long-term cost effectiveness of exenatide once weekly (ExQW) versus insulin glargine (IG) or liraglutide 1.2 mg (Lira1.2mg) for the treatment of adult patients with type 2 diabetes mellitus (T2DM) not adequately controlled on oral antidiabetic drug (OAD) therapy in Greece. METHODS: The published and validated Cardiff Diabetes Model was used to project clinical and economic outcomes over a patient's lifetime...
October 27, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29080209/association-between-serum-amiodarone-and-n-desethylamiodarone-concentrations-and-development-of-thyroid-dysfunction
#9
Mikie Yamato, Kyoichi Wada, Tomohiro Hayashi, Mai Fujimoto, Kouichi Hosomi, Akira Oita, Mitsutaka Takada
OBJECTIVE: This retrospective cohort study was performed to examine the association between serum amiodarone (AMD) and N-desethylamiodarone (DEA) concentrations and the development of thyroid dysfunction. METHODS: Patients treated with AMD from January 2012 to April 2016 were identified from the computerized hospital information system database at the National Cerebral and Cardiovascular Center. Only patients whose serum AMD and DEA concentrations had been determined at least once were included in the study...
October 27, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29080208/who-receives-nalmefene-and-how-does-it-work-in-the-real-world-a-single-arm-phase-iv-study-of-nalmefene-in-alcohol-dependent-outpatients-baseline-and-1-month-results
#10
Pablo Barrio, Lluisa Ortega, Josep Guardia, Carlos Roncero, Lara Yuguero, Antoni Gual
BACKGROUND: Alcohol dependence remains a major health problem from both a public health and clinical perspective. Harm reduction strategies have been increasingly recognized as suitable treatment goals. Nalmefene has been recently approved for this precise therapeutic indication after completion of phase III trials. However, more data from routine practice settings are needed in order to obtain evidence with high external validity. The aim of this study was to conduct a single-arm, phase IV study with alcohol-dependent outpatients starting nalmefene for the first time...
October 27, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29076054/prevalence-of-use-and-cost-of-biological-drugs-for-cancer-treatment-a-5-year-picture-from-southern-italy
#11
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
BACKGROUND AND OBJECTIVES: Considering the clinical and economic burden of biological drugs in cancer treatment, it is necessary to explore how these drugs are used in routine care in Italy and how they affect the sustainability of the National Health Services. This study aimed to investigate the prevalence of use and costs of biological drugs for cancer treatment in a general population of Southern Italy in the years 2010-2014. METHODS: This was a retrospective, observational study using data from the healthcare administrative databases of Messina Province for the years 2010-2014...
October 26, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29071470/the-challenge-of-pharmacotherapy-in-children-and-adolescents-with-epilepsy-adhd-comorbidity
#12
REVIEW
Alberto Verrotti, Romina Moavero, Gianvito Panzarino, Claudia Di Paolantonio, Renata Rizzo, Paolo Curatolo
Epilepsy is common in children and adolescents where its prevalence is 3.2-5.5/1000. About one-third of patients also have attention deficit hyperactivity/impulsivity disorder (ADHD). The possible relationship between epilepsy and ADHD is still unclear, and ADHD symptoms (such as inattention, hyperactivity, behavioral disturbances) are frequently considered as adverse effects of antiepileptic drugs (AEDs). The literature was searched for data on the behavioral effects of AEDs. Phenobarbital is the most frequently reported medication to induce symptoms of ADHD, followed by topiramate and valproic acid...
October 25, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29067671/a-review-of-asenapine-in-the-treatment-of-bipolar-disorder
#13
REVIEW
Eduard Vieta, José Manuel Montes
Bipolar disorder places a significant burden on the affected individuals, their family, healthcare systems and the overall economy. More treatment options are needed, especially those with better efficacy and tolerability. Asenapine is a second-generation antipsychotic approved in Europe (brand name Sycrest(®)) for the treatment of moderate-to-severe manic episodes associated with bipolar I disorder in adults, and in the US (brand name Saphris(®)) for the treatment of manic or mixed episodes of bipolar I disorder in adults and children aged 10-17 years...
October 24, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29032438/improvements-in-quality-adjusted-life-years-and-cost-utility-after-pharmacotherapy-for-premenstrual-dysphoric-disorder-a-retrospective-study
#14
Eiichiro Kamagata, Kazuo Yamada
BACKGROUND AND OBJECTIVE: To investigate the cost-effectiveness of pharmacotherapy for premenstrual dysphoric disorder (PMDD), a relatively new classification of depressive disorder that is characterized by recurrent depression during the premenstrual phase of the menstrual cycle. METHODS: We performed a retrospective analysis of data from 49 previously untreated PMDD patients who visited our psychiatric department between October 2013 and February 2016 and received pharmacotherapy for 3 or 6 subsequent menstrual cycles...
October 14, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29027641/cost-effectiveness-of-imatinib-dasatinib-and-nilotinib-as-first-line-treatment-for-chronic-phase-chronic-myeloid-leukemia-in-china
#15
Na Li, Bin Zheng, Hong-Fu Cai, Jing Yang, Xiao-Feng Luo, Li-Zhu Weng, Feng-Mei Zhan, Mao-Bai Liu
BACKGROUND AND OBJECTIVE: Tyrosine kinase inhibitors (TKIs) have obvious effects on chronic myeloid leukemia (CML), but they are expensive in China. Moreover, the overall cost of treatment of CML is high and the medical economic burden of patients with CML on the government is heavy. This study tested the cost effectiveness of imatinib, nilotinib, and dasatinib as first-line treatment in Chinese patients who were first diagnosed with chronic myeloid leukemia in the chronic phase (CML-CP)...
October 13, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29022212/effect-of-food-on-the-pharmacokinetics-of-saroglitazar-magnesium-a-novel-dual-ppar%C3%AE-%C3%AE-agonist-in-healthy-adult-subjects
#16
Maulik R Patel, Kevinkumar A Kansagra, Devang P Parikh, Deven V Parmar, Hardik B Patel, Mayur M Soni, Uday S Patil, Harilal V Patel, Jaimik A Patel, Swagat S Gujarathi, Krupi V Parmar, Nuggehally R Srinivas
BACKGROUND AND OBJECTIVE: Peroxisome proliferator-activated receptors (PPARs) have recently become a focus of interest for their important roles in glucose and lipid metabolism. In humans, PPARα activation causes a decrease in plasma triglyceride (TG) levels, enhancement of high-density lipoprotein cholesterol (HDL-C) and simultaneous enhancement of very-low-density lipoprotein (VLDL) lipolysis, whereas PPARγ agonists act as insulin sensitizers and improve insulin resistance, which is very useful in patients with type 2 diabetes mellitus (T2DM)...
October 11, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28965312/a-comparison-of-adverse-drug-reaction-profiles-in-patients-on-antiretroviral-and-antitubercular-treatment-in-zimbabwe
#17
Josiah T Masuka, Precious Chipangura, Priscilla P Nyambayo, Andy Stergachis, Star Khoza
INTRODUCTION: Few studies describe the adverse drug event profiles in patients simultaneously receiving antiretroviral and anti-tubercular medicines in resource-limited countries. OBJECTIVES: To describe and compare the adverse drug reaction profiles in patients on highly active antiretroviral therapy only (HAART), HAART and isoniazid preventive therapy (HHART), and HAART and antitubercular treatment (ATTHAART). METHODS: We analysed individual case safety reports (ICSRs) for patients on antiretroviral therapy and antitubercular treatment submitted to the national pharmacovigilance centre during the targeted spontaneous reporting (TSR) programme from 1 September 2012 through 31 August 2016...
September 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28965280/acetazolamide-as-add-on-diuretic-therapy-in-exacerbations-of-chronic-heart-failure-a-pilot-study
#18
Tomasz Imiela, Andrzej Budaj
BACKGROUND: Congestion is the main cause of morbidity in patients with heart failure. Treatment of fluid overload is often challenging in everyday clinical practice. OBJECTIVE: The aim of this study was to determine the diuretic effect of acetazolamide in patients with exacerbations of chronic heart failure, in addition to their stable diuretic therapy. METHODS: This was a single-center, unblinded study. Patients hospitalized with chronic heart failure exacerbations, with left ventricular ejection fraction (EF) < 50% and signs of volume overload, with a stable dose of diuretics anticipated by the attending physician over the next 4 days, were considered eligible for the study...
September 30, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28940174/in-vitro-drug-release-after-crushing-evaluation-of-xtampza-%C3%A2-er-and-other-er-opioid-formulations
#19
Stephen P Mayock, Said Saim, Alison B Fleming
BACKGROUND AND OBJECTIVE: Extended-release (ER) opioids are associated with high rates of abuse. Recreational opioid users often manipulate ER formulations to achieve a high plasma concentration in a short amount of time, resulting in a more rapid and intense high. Patients may also manipulate ER tablets to facilitate swallowing, without recognizing that manipulation could increase release rate. The goal of this study was to assess the ability of oxycodone DETERx (Xtampza(®) ER, Collegium Pharmaceutical, Inc...
September 22, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29098567/oxycodone-naloxone-prolonged-release-a-review-in-severe-chronic-pain
#20
Esther S Kim
Oral oxycodone/naloxone prolonged release (PR) [Targin(®), Targinact(®), Targiniq(®)] is a 12-hourly opioid receptor agonist and opioid receptor antagonist fixed-dose combination product that is approved in countries in the EU for the management of severe pain (adequately manageable only with opioid analgesics) in adults. Oral naloxone prevents oxycodone from binding to μ-receptors in the gastrointestinal (GI) tract, thereby counteracting opioid-induced constipation (OIC). In short-term (5- to 12-week) clinical trials of adults with moderate to severe, chronic pain and OIC (OXN3001, OXN3006, OXN3506), oxycodone/naloxone PR significantly improved OIC while providing noninferior analgesia relative to oxycodone PR; results were consistent between cancer and non-cancer patients in OXN3506...
December 2017: Clinical Drug Investigation
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