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Expert Review of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28635328/dietary-implications-for-patients-receiving-long-term-oral-anticoagulation-therapy-for-treatment-and-prevention-of-thromboembolic-disease
#1
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 21, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28571505/buprenorphine-implants-in-medical-treatment-of-opioid-addiction
#2
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 2, 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
#3
Ana Martin-Suarez, Jose German Sanchez-Hernandez, Fabiola Medina-Barajas, Jonas Samuel Perez 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...
June 20, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28586272/pharmacological-treatment-options-for-cryopyrin-associated-periodic-syndromes
#4
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
#5
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
#6
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
https://www.readbyqxmd.com/read/28463532/aspirin-and-omeprazole-for-secondary-prevention-of-cardiovascular-disease-in-patients-at-risk-for-aspirin-associated-gastric-ulcers
#7
Guillermo García-Rayado, Carlos Sostres, Angel Lanas
Cardiovascular disease is the most important cause of morbidity and mortality in the world and low-dose aspirin is considered the cornerstone of the cardiovascular disease prevention. However, low-dose aspirin use is associated with gastrointestinal adverse effects in the whole gastrointestinal tract. In this setting, co-therapy with a proton pump inhibitor is the most accepted strategy to reduce aspirin related upper gastrointestinal damage. In addition, some adverse effects have been described with proton pump inhibitors long term use...
June 19, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28590144/pharmacological-treatment-of-depression-in-geriatric-chronic-pain-patients-a-biopsychosocial-approach-integrating-functional-restoration
#8
Peter Polatin, Kelley Bevers, Robert J Gatchel
A recent literature review concluded that the comorbidity of chronic pain and depression in adults is approximately 50%-65%. Physical and cognitive declines, concurrent multiple health conditions, and complex medication regimens add to the unique and complex challenges of effectively treating pain in particularly geriatric populations. Interdisciplinary medical intervention and monitoring for psychiatric sequelae, such as depression, cognitive change, and synergistic physical side effects are necessary. Areas covered: This review covers an extensive multi-database wide search of the pharmacotherapy of pain and depression in older adults, including biopsychosocial approaches...
June 14, 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
#9
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...
June 12, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28573914/treatment-strategies-for-dna-repair-deficient-prostate-cancer
#10
Benjamin A Teply, Emmanuel S Antonarakis
Common recurrent genetic alterations have been identified in prostate cancer through comprehensive sequencing efforts, and the prevalence of mutations in DNA repair pathway genes in patients with advanced and metastatic disease approaches 20-25%. Identification of these underlying DNA repair defects may present unique treatment opportunities for patients, both in terms of standard-of-care treatments and selected investigational agents. Areas covered: We review our current understanding of the genomic landscape of prostate cancer, with special attention to alterations in DNA repair pathway genes in metastatic castration-resistant disease...
June 12, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28531360/omega-3-polyunsaturated-fatty-acids-for-cardiovascular-diseases-present-past-and-future
#11
Yasuhiro Watanabe, Ichiro Tatsuno
Large-scale epidemiological studies on Greenlandic, Canadian and Alaskan Eskimos have examined the health benefits of omega-3 fatty acids consumed as part of the diet, and found statistically significant relative reduction in cardiovascular risk in people consuming omega-3 fatty acids. Areas covered: This article reviews studies on omega-3 fatty acids during the last 50 years, and identifies issues relevant to future studies on cardiovascular (CV) risk. Expert commentary: Although a meta-analysis of large-scale prospective cohort studies and randomized studies reported that fish and fish oil consumption reduced coronary heart disease-related mortality and sudden cardiac death, omega-3 fatty acids have not yet been shown to be effective in secondary prevention trials on patients with multiple cardiovascular disease (CVD) risk factors...
May 29, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28490202/tumor-necrosis-factor-inhibitors-in-psoriatic-arthritis
#12
Santhi Mantravadi, Alexis Ogdie, Walter K Kraft
Psoriatic arthritis (PsA) is a chronic inflammatory disease that can result in significant disability. With the emergence of tumor necrosis factor inhibitors (TNFi), therapeutic outcomes in PsA have improved substantially. The clinical efficacy and the inhibition of radiographic progression demonstrated by TNFi have transformed the management of PsA. However, there is still an unmet need for a subset of patients who do not respond adequately to TNFi. Areas covered: This review provides an overview of the pharmacokinetics of TNFi, the efficacy of TNFi in PsA, and the role of immunogenicity of TNFi in the treatment of PsA...
May 22, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28524738/selexipag-a-selective-prostacyclin-receptor-agonist-in-pulmonary-arterial-hypertension-a-pharmacology-review
#13
Jesús Honorato Pérez
Pulmonary hypertension is defined by a mean pulmonary artery pressure ≥25 mm Hg at rest. Management of pulmonary arterial hypertension (PAH) includes specific drug therapy with calcium channel blockers in vasoreactive patients, or drugs approved for PAH in non-reactive patients that target the endothelin, nitric-oxide and prostacyclin pathways. Areas covered: The review covers receptor selectivity, pharmacokinetics, pharmacodynamics and adverse effects (AEs) of intravenous (IV) epoprostenol (synthetic prostacyclin); the prostacyclin analogs iloprost, beraprost, and treprostinil administered by IV, subcutaneous, inhaled or oral routes; and the oral selective prostacyclin receptor agonist selexipag...
July 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28480762/steady-state-pharmacokinetics-of-tenofovir-disoproxil-fumarate-in-human-immunodeficiency-virus-infected-chinese-patients
#14
Xiaoli Du, Huijuan Kou, Qiang Fu, Yanling Li, Zhu Zhu, Taisheng Li
BACKGROUND: The pharmacokinetic (PK) profile of tenofovir disoproxil fumarate in Chinese adults infected with HIV is unknown. METHODS: A pilot, prospective, open-label study was performed to investigate the steady-state PK profile of tenofovir disoproxil fumarate in 15 Chinese HIV-infected patients among whom eight patients were treated with 300 mg tenofovir disoproxil fumarate, 300 mg lamivudine and 400/100 mg lopinavir/ritonavir, and seven with 300 mg tenofovir disoproxil fumarate, 300 mg lamivudine and 400 mg nevirapine...
July 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28463572/nanoparticles-as-potential-clinical-therapeutic-agents-in-alzheimer-s-disease-focus-on-selenium-nanoparticles
#15
Mustafa Nazıroğlu, Salina Muhamad, Laszlo Pecze
In etiology of Alzheimer's disease (AD), involvement of amyloid β (Aβ) plaque accumulation and oxidative stress in the brain have important roles. Several nanoparticles such as titanium dioxide, silica dioxide, silver and zinc oxide have been experimentally using for treatment of neurological disease. In the last decade, there has been a great interest on combination of antioxidant bioactive compounds such as selenium (Se) and flavonoids with the oxidant nanoparticles in AD. We evaluated the most current data available on the physiological effects of oxidant and antioxidant nanoparticles...
July 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28460547/tenofovir-alafenamide-for-the-treatment-of-chronic-hepatitis-b-virus-infection
#16
Syed Abdul Basit, Altaf Dawood, John Ryan, Robert Gish
In April 2017 tenofovir alafenamide (TAF) was added to the list of first-line therapies recommended for chronic hepatitis B (CHB). TAF has pharmacology similar to tenofovir disoproxil fumarate (TDF) with higher cell delivery to the hepatocytes but less systemic exposure. Areas covered: We review here studies leading to TAF's approval and comparing it to TDF. In two major clinical trials, TAF was non-inferior to TDF in achieving HBV DNA levels below 29 IU/ml. TAF-treated patients had significantly smaller decreases in bone mineral density (BMD) at the hip and spine in both HBeAg-positive and HBeAg-negative patients, and smaller mean increases in serum creatinine, although the difference was only statistically significant in HBeAg-positive patients...
July 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28447486/guidance-to-develop-individual-dose-recommendations-for-patients-on-chronic-hemodialysis
#17
Verena Gotta, Kim Dao, Frédérique Rodieux, Thierry Buclin, Françoise Livio, Marc Pfister
In addition to tailored clinical trials in patients on chronic hemodialysis (HD) during drug development, clinician-initiated post-marketing studies and case reports on individual pharmacokinetic (PK) assessments provide an important source of information about drug dialysability and individualized dose recommendations in this vulnerable population. Areas covered: First, factors that may alter drug exposure in HD patients are explained. Second, available regulatory and methodological guidelines for PK assessments in this population are summarized...
July 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28447475/olaratumab-for-advanced-soft-tissue-sarcoma
#18
Alexander Tobias, Michael P O'brien, Mark Agulnik
Olaratumab is a humanized IgG1 monoclonal antibody that blocks the platelet-derived growth factor receptor alpha (PDGFRα). Its antagonistic behavior inhibits the receptor's tyrosine kinase activity, thereby, turning off the downstream signaling cascades responsible for soft tissue sarcoma tumorigenesis. In October 2016, olaratumab received Food and Drug Administration (FDA) approval for its use in combination with doxorubicin for treatment of advanced soft tissue sarcoma. Areas covered: This drug profile takes a comprehensive look at the clinical studies leading to FDA approval of olaratumab as well as its safety and efficacy as a front-line treatment option for sarcoma patients...
July 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28443352/gff-mdi-for-the-improvement-of-lung-function-in-copd-a-look-at-the-pinnacle-1-and-pinnacle-2-data-and-beyond
#19
Klaus F Rabe
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death globally and incidence rates are continuing to rise. Long-acting bronchodilators are the foundation on which current pharmacological approaches to COPD management are built, with long-acting muscarinic antagonists (LAMAs) and long-acting β2-agonists (LABAs) recommended across the spectrum of the disease continuum. Combining LAMAs and LABAs provides additional lung function improvements and relief of patient symptoms compared with either therapy alone...
July 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28434375/the-role-of-adaptive-trial-designs-in-drug-development
#20
François Curtin, Stephane Heritier
Clinical development of new drugs is a long and costly process. There is a need to find solutions which can improve and shorten this process. By introducing flexibility in to the design of clinical trials, adaptive design contributes to this improvement and allows to reach drug development decisions in a quicker way. Areas covered: We review the main methodological approaches to adaptive trial design, introducing key statistical concepts. For each phase of the clinical development, different uses and implementations of adaptive trial (AD) design are presented and examples of recent clinical trials are given...
July 2017: Expert Review of Clinical Pharmacology
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