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Expert Review of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28715945/methodological-issues-associated-with-clinical-trials-in-epilepsy
#1
Edoardo Ferlazzo, Chiara Sueri, Sara Gasparini, Emilio Russo, Vittoria Cianci, Michele Ascoli, Giovambattista De Sarro, Umberto Aguglia
despite methodological advances in epilepsy clinical trials, the proportion of patients reaching seizure-freedom has not substantially changed over the years. We review the main methodological limitations of current trials, the possible strategies to overcome these limits, and the issues that need to be addressed in next future. Area covered: references were identified by PubMed search until March 2017 and unpublished literature was searched on ClinicalTrials.gov. Add-on trials mainly involve refractory epilepsy subjects, reducing overall response to the investigational drug...
July 18, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28715943/introducing-treat-to-target-strategies-of-autoimmune-extrahepatic-manifestations-of-chronic-hepatitis-c-virus-infection
#2
Soledad Retamozo, Pilar Brito-Zeron, Luca Quartuccio, Salvatore De Vita, Manuel Ramos-Casals
The hepatitis C virus (HCV) is recognized as one of the hepatic viruses most often associated with extrahepatic manifestations (EHMs). It is currently accepted that cryoglobulinemic vasculitis (CV) is the key autoimmune extrahepatic disease associated with HCV infection. Therapeutic approaches have mainly been based on the use of old antiviral interferon (IFN)-based regimens and immunosuppressive therapies, often with an inadequate balance between therapeutic benefits and excess side effects. AREAS COVERED...
July 18, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28715916/drug-management-of-neutrophilic-dermatoses
#3
Simone Garcovich, Clara De Simone, Emilio Berti, Angelo Valerio Marzano
Neutrophilic dermatoses are a heterogenous group of chronic, cutaneous inflammatory conditions characterized by the accumulation of neutrophils in the skin and by systemic inflammation. Neutrophilic dermatoses can be idiopathic or associated with other inflammatory or systemic diseases, including the group of the hereditary, autoinflammatory syndromes. Clinical management is challenging, due to limited clinical evidence and lack of clinical practice guidelines. Areas covered: This review provides an overview of current therapeutic management of the three prototypical neutrophilic dermatoses, aseptic pustulosis of the folds, Sweet syndrome and pyoderma gangrenosum...
July 18, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28714780/atezolizumab-for-the-treatment-of-non-small-cell-lung-cancer
#4
Fernando C Santini, Charles M Rudin
The immune system can restrain or promote cancer development and growth. Antibodies targeting immune checkpoints have revolutionized cancer treatment. Among the best responses have been in non-small cell lung cancer (NSCLC) which is largely caused by chronic exposure to carcinogens; associated with high neoantigen creation and sensitization to immune recognition. Atezolizumab was the first approved antibody that targets the PD-1 ligand (PD-L1). Areas Covered: This drug profile article covers the basics of the cancer-immunity cycle and reviews some aspects of innate and adaptive immunology...
July 17, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28712325/pharmacodynamics-of-combined-estrogen-progestin-oral-contraceptives-2-effects-on-hemostasis
#5
Manuela Farris, Carlo Bastianelli, Elena Rosato, Ivo Brosens, Giuseppe Benagiano
The pharmacodynamic effects of various combined oral estrogen-progestin combinations (COC) are examined for their components alone or in the various combined formulations. Special emphasis is given to products containing natural estrogens. Areas covered: Recent information on the effect of androgens, estrogens, progestins, as well as various COC combinations on the coagulation cascade will be reviewed aiming at providing an updated picture. The present article reviews hemostatic changes occurring during use of classic and modern combinations of estrogens (ethinyl estradiol, estradiol, estradiol valerate and estetrol) and new progestins (desogestrel, gestodene, dienogest, drospirenone, nomegestrol acetate), compared to classic compounds, such as levonorgestrel...
July 17, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28699847/a-systematic-review-and-combined-analysis-of-therapeutic-drug-monitoring-studies-for-long-acting-risperidone
#6
Georgios Schoretsanitis, Edoardo Spina, Christoph Hiemke, Jose de Leon
This systematic review of therapeutic drug monitoring (TDM) identifies three long-acting injectable (LAI) risperidone formulations. Areas covered: Limited data is available on two formulations (RBP-7000 and in Situ Microparticle), but 20 TDM articles on the microsphere formulation were found. Risperidone TDM includes the serum concentrations of risperidone and its active metabolite, 9-hydroxyrisperidone, used for calculating: 1) the risperidone/9-hydroxyrisperidone (R/9-OH-R) ratio (a measure of CYP2D6; values >1 are indicative of a CYP2D6 poor metabolizer) and 2) the total risperidone concentration-to-dose (C/D) ratio (a measure of risperidone clearance with a normal value around 7 in oral risperidone)...
July 12, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28689437/the-effect-of-antiepileptic-drugs-on-the-kidney-function-and-structure
#7
S Hamed
Abtract Introduction: Long-term use of antiepileptic drugs (AEDs) is associated with number of somatic conditions. Data from experimental, cross-sectional and prospective studies have evidence for the deleterious effect of some AEDs on the kidney. Areas Covered: This review summarized the current knowledge of the effect of AEDs on the kidney including evidence and mechanisms. Fanconi syndrome was reported with valproate (VPA) therapy in severely disabled children with epilepsy. Renal tubular acidosis and urolithiasis were reported with acetazolamide, topirmate and zonisamide, drugs with carbonic anhydrase inhibition properties...
July 10, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28689434/role-of-genetic-testing-in-patients-undergoing-percutaneous-coronary-intervention
#8
Jae Youn Moon, Francesco Franchi, Fabiana Rollini, Jose R Rivas Rios, Megha Kureti, Larisa H Cavallari, Dominick J Angiolillo
Variability in individual response profiles to antiplatelet therapy, in particular clopidogrel, is a well-established phenomenon. Genetic variations of the cytochrome P450 (CYP) 2C19 enzyme, a key determinant in clopidogrel metabolism, have been associated with clopidogrel response profiles. Moreover, the presence of a CYP2C19 loss-of-function allele is associated with an increased risk of atherothrombotic events among clopidogrel-treated patients undergoing percutaneous coronary interventions (PCI), prompting studies evaluating the use of genetic tests to identify patients who may be potential candidates for alternative platelet P2Y12 receptor inhibiting therapies (prasugrel or ticagrelor)...
July 10, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28691537/pharmacological-management-of-dermatomyositis
#9
Zoltán Griger, Melinda Nagy-Vincze, Katalin Dankó
Dermatomyositis is a rare heterogeneous systemic autoimmune disease with multiple organ involvement which can result in significant disability and mortality. Despite the lack of placebo-controlled trials, glucocorticoids are considered to be the mainstay of initial management. Treatment strategies are mainly based on uncontrolled studies, evidence based guidelines for treatments do not exist. Areas covered: This review provides an overview of the currently available pharmacological treatments in the field of dermatomyositis including conventional immunosuppressants, biologics and topical agents...
July 8, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28631514/pharmacokinetics-and-dosing-requirements-of-digoxin-in-pregnant-women-treated-for-fetal-supraventricular-tachycardia
#10
Ana Martin-Suarez, J German Sanchez-Hernandez, Fabiola Medina-Barajas, J Samuel Pérez-Blanco, Jose M Lanao, Luisa Garcia-Cuenllas Alvarez, M Victoria Calvo
BACKGROUND: The objective of this study was to characterize the pharmacokinetics (PK) of digoxin in pregnant women and its potential implications for drug dosing. METHODS: Serum digoxin concentrations (SDCs) obtained in pregnant women treated for fetal supraventricular tachycardia (SVT) was retrospectively collected. PK analysis was comparatively performed using a two-stage approach (PKS™) and a Population PK approach (NONMEM™). As clinical outcome the fetal heart rate was recorded...
July 6, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28649898/a-review-of-body-composition-and-pharmacokinetics-in-oncology
#11
Jessica J Hopkins, Michael B Sawyer
Body surface area dosing of chemotherapeutic agents is based on limited scientific data, and often results in unpredictable plasma drug levels. Cross-sectional computed tomography (CT) imaging provides an accurate measurement of lean mass. This review summarizes emerging roles of lean mass in predicting pharmacokinetics and drug toxicities in cancer patients. Areas covered: A concise review of body composition measurement with CT cross-sectional imaging and its relationship to drug pharmacokinetics and toxicities...
July 5, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28649893/radium-223-dichloride-for-the-treatment-of-castration-resistant-prostate-cancer-with-symptomatic-bone-metastases
#12
Nicholas J Vogelzang
Castration-resistant prostate cancer (CRPC) is associated with the development of bone metastases, increased mortality, and a reduction in the patient's quality of life (QOL). The management of metastatic CRPC (mCRPC) has rapidly evolved over the past decade, with a number of available therapeutic agents improving overall survival. Radium-223 dichloride (radium-223), the first targeted alpha therapy, improves survival accompanied by QOL benefits with a favorable safety profile. It is approved in over 40 countries for the treatment of patients with CRPC with symptomatic bone metastases and no known visceral metastatic disease...
July 3, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28605258/avp-825-a-novel-intranasal-delivery-system-for-low-dose-sumatriptan-powder-in-the-treatment-of-acute-migraine
#13
Stephen Silberstein
Migraine is a common, disabling disorder, and many patients remain dissatisfied with existing treatments. AVP-825 (ONZETRA® Xsail®) is a Breath Powered® exhalation delivery system for low-dose sumatriptan nasal powder (22 mg) that has been recently approved for use in the treatment of acute migraine with or without aura in adults. AVP-825 takes advantage of unique features of nasal anatomy and physiology to avoid limitations typically seen with other types of intranasal medication delivery. Areas covered: This review provides a summary of the pharmacology, clinical efficacy and tolerability of AVP-825 in clinical studies to date and also provides an overview of the unique aspects of the delivery system...
July 3, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28656793/regulatory-framework-on-bioequivalence-criteria-for-locally-acting-gastrointestinal-drugs-the-case-for-oral-modified-release-mesalamine-formulations
#14
Gianluca Sferrazza, Paolo D Siviero, Giuseppe Nicotera, Paola Turella, Annalucia Serafino, Corrado Blandizzi, Pasquale Pierimarchi
Bioequivalence testing for locally acting gastrointestinal drugs is a challenging issue for both regulatory authorities and pharmaceutical industries. The international regulatory framework has been characterized by the lack of specific bioequivalence tests that has generated a negative impact on the market competition and drug use in clinical practice. Areas covered: This review article provides an overview of the European Union and United States regulatory frameworks on bioequivalence criteria for locally acting gastrointestinal drugs, also discussing the most prominent scientific issues and advances that has been made in this field...
June 28, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28649875/potential-benefits-of-zolpidem-in-disorders-of-consciousness
#15
Afsaneh Noormandi, Maryam Shahrokhi, Hossein Khalili
It has been suggested that zolpidem may arouse patients with decreased level of consciousness. Zolpidem may partially or even completely reverse abnormal cell metabolism following brain damage. In this article, available evidences regarding effects of zolpidem on disorders of consciousnesswere reviewed. Areas covered: A literature review was conducted using PubMed, Scopus, Medline, Cochrane central register of controlled trials, Cochrane database systematic reviews and Google scholar as online databases. Search Keywords were 'vegetative state','minimally conscious state','semi-comatose', 'arousal', 'zolpidem', 'wakefulness', 'awareness', and 'loss of consciousness'...
June 26, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28635328/dietary-implications-for-patients-receiving-long-term-oral-anticoagulation-therapy-for-treatment-and-prevention-of-thromboembolic-disease
#16
Emmanouela Kampouraki, Farhad Kamali
The effectiveness of oral anticoagulation therapy with warfarin (a vitamin K antagonist) in the treatment of thromboembolic disease, including stroke prophylaxis in patients with atrial fibrillation is well recognised. However, warfarin has a narrow therapeutic window and an unpredictable anticoagulation response, which make it difficult to achieve and maintain optimal anticoagulation. Various dietary factors, including sudden changes in eating patterns, can significantly alter anticoagulation control, thereby potentially exposing patients to the risk of bleeding or thromboembolic complications...
June 26, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28571505/buprenorphine-implants-in-medical-treatment-of-opioid-addiction
#17
Steven Chavoustie, Michael Frost, Ole Snyder, Joel Owen, Mona Darwish, Ryan Dammerman, Victoria Sanjurjo
Opioid use disorder is a chronic, relapsing disease that encompasses use of both prescription opioids and heroin and is associated with a high annual rate of overdose deaths. Medical treatment has proven more successful than placebo treatment or psychosocial intervention, and the partial µ-opioid receptor agonist and κ-opioid receptor antagonist buprenorphine is similar in efficacy to methadone while offering lower risk of respiratory depression. However, frequent dosing requirements and potential for misuse and drug diversion contribute to significant complications with treatment adherence for available formulations...
June 21, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28586272/pharmacological-treatment-options-for-cryopyrin-associated-periodic-syndromes
#18
Emmanuelle C Landmann, Ulrich A Walker
Cryopyrin-associated periodic syndromes (CAPS) are rare monogenic autoinflammatory diseases, comprising a spectrum of phenotypes of varying severity. CAPS are associated with gain-of-function mutations in the NLRP3 inflammasome, a multiprotein complex critical for the activation of IL-1ß, and are characterized by episodes of fever, urticaria-like rash, musculoskeletal, ocular, and neurological symptoms. Areas covered: Accounting for the pivotal role of IL-1ß in the pathogenesis of CAPS, three therapeutic options, all blocking the action of IL-1ß, are currently approved: anakinra, a recombinant IL-1 receptor antagonist, the IL-1 trap rilonacept and canakinumab, a monoclonal anti-IL-1ß antibody...
June 20, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28617060/levonorgestrel-releasing-intrauterine-system-lng-ius-12-for-prevention-of-pregnancy-for-up-to-five-years
#19
Anita L Nelson
A new five-year low dose, smaller-framed, levonorgestrel-releasing intrauterine contraceptive system (LNG-IUS 12) has been introduced to complement the currently available systems. Areas Covered: This article will provide an overview of this new intrauterine system - its composition and its mechanisms of action as well as the results of the Phase II and III clinical trials of its efficacy, safety and tolerability. Expert Commentary: This new LNG-IUS 12 provides five-year contraceptive protection a pregnancy rate (less than 1%) in first year of use, which puts it into the top tier with the existing LNG-IUS 20 products; however, the LNG-IUS 12 does not have the high rates of amenorrhea often seen with the higher dose devices...
June 19, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28597699/chelation-therapy-in-cardiovascular-disease-an-update
#20
Sulaiman Sultan, Shishir Murarka, Ahad Jahangir, Farouk Mookadam, A Jamil Tajik, Arshad Jahangir
The off-label use of chelation therapy (disodium edetate or EDTA) for prevention of cardiovascular disease (CVD) is widespread, despite the lack of convincing evidence for efficacy or approval from the Food and Drug Administration. After the publication of results from the National Institute of Health-sponsored Trial to Assess Chelation Therapy (TACT), a randomized controlled trial (RCT) in patients after myocardial infarction (MI), there is a renewed interest in clarifying the role of this treatment modality for patients with coronary artery disease...
June 19, 2017: Expert Review of Clinical Pharmacology
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