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Expert Review of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28531360/omega-3-polyunsaturated-fatty-acids-for-cardiovascular-diseases-present-past-and-future
#1
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 20, 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
#2
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...
May 19, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28460547/tenofovir-alafenamide-for-the-treatment-of-chronic-hepatitis-b-virus-infection
#3
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...
May 17, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28490202/tumor-necrosis-factor-inhibitors-in-psoriatic-arthritis
#4
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 11, 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
#5
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. RESEARCH DESIGN AND 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...
May 8, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28447475/olaratumab-for-advanced-soft-tissue-sarcoma
#6
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...
May 5, 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
#7
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...
May 2, 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
#8
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...
May 2, 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
#9
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...
May 2, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28434260/dapsone-associated-fixed-drug-eruption
#10
Daniel Garcia, Philip R Cohen
Dapsone is a sulfone drug used to treat infectious conditions and also numerous dermatologic diseases. Fixed drug eruption is a distinctive adverse cutaneous reaction associated with the initial administration and subsequent delivery of a specific agent. Areas covered: The authors preformed a literature search using the following keywords: dapsone, fixed drug eruption, and adverse cutaneous drug reaction. Bibliographies were also reviewed for pertinent articles. The results were combed for relevant papers and reviewed...
April 28, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28447486/guidance-to-develop-individual-dose-recommendations-for-patients-on-chronic-hemodialysis
#11
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...
April 27, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28434375/the-role-of-adaptive-trial-designs-in-drug-development
#12
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...
April 24, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28431476/a-consensus-statement-for-the-clinical-use-of-the-renal-sodium-glucose-co-transporter-2-inhibitor-dapagliflozin-in-patients-with-type-2-diabetes-mellitus
#13
A Avogaro, A Giaccari, P Fioretto, S Genovese, F Purrello, F Giorgino, S Del Prato
The present review developed a clinical consensus based on a Delphi method on Dapagliflozin, a selective inhibitor of the renal sodium-glucose co-transporter-2 (SGLT2-I) in the treatment of patients with Type 2 diabetes mellitus. Areas covered: Panel members, using a 5-point scale, were asked to rate 9 statements on pharmakodinamic, mode of action on glycaemic and extra-glycaemic effects, and safety of dapaglifozin, Members also aimed to identify the patient most susceptible to the treatment with dapagliflozin ...
April 21, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28475384/optimizing-pharmacologic-management-of-inflammatory-bowel-disease
#14
Shannon Chang, Stephen Hanauer
As our medical armamentarium for IBD continues to expand, it is essential that clinicians understand both optimizing and sequencing of individual and combination therapeutic approaches with available medications. Areas covered: This review summarizes dosing strategies and therapeutic drug monitoring for pharmacologic optimization in IBD. Aminosalicylates remain first-line therapies for mild-to-moderate UC but have limited evidence of efficacy in CD. Budesonide provides an alternative to aminosalicylates when targeted to appropriate sites in the distal small bowel and colon, as do conventional corticosteroids when applied rectally...
June 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28475378/clinical-development-of-biologicals-and-biosimilars-safety-concerns
#15
Stefanos Bonovas, Laurent Peyrin-Biroulet, Silvio Danese
No abstract text is available yet for this article.
June 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28395555/alirocumab-for-the-treatment-of-hypercholesterolaemia
#16
Giuseppe Della Pepa, Lutgarda Bozzetto, Giovanni Annuzzi, Angela Albarosa Rivellese
Prescription of statins for low-density lipoprotein cholesterol (LDL-C) reduction is the standard of care in primary and secondary prevention of cardiovascular disease; nevertheless, a large number of patients treated with statins are unable to reach the recommended LDL-C targets. Therefore, there is need for safe and effective novel therapies for the pharmacological management of hypercholesterolaemia, in addition or as alternative to lipid-lowering therapies (LLT) currently in use. Areas covered: In 2015, the Food and Drug Administration and the European Medicines Agency approved alirocumab (Praluent®; Sanofi), a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), for the treatment of hypercholesterolaemic patients unable to meet LDL-C targets, as an adjunct to diet in addition/alternative to LLT...
June 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28393583/spotlight-on-canagliflozin-300-review-of-its-efficacy-and-an-indirect-comparison-to-other-sglt-2-inhibitors-and-long-acting-glp-1-receptor-agonists
#17
Awadhesh Kumar Singh, Ritu Singh
Both sodium-glucose co-transporter-2 inhibitors (SGLT-2Is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) have been consistently found to lower blood glucose, body weight and systolic blood pressure (SBP) in patients with type 2 diabetes mellitus (T2DM). While all the SGLT-2Is inhibit glucose reabsorption by blocking SGLT-2 receptor in kidney, dose-dependently, the highest licensed dose of canagliflozin 300-mg has an additional ability to inhibit SGLT-1 receptor in intestine transiently, that may lead to additional inhibition of prandial glucose absorption, unlike other approved highly selective SGLT-2Is...
June 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28375040/evolution-of-diagnostic-approaches-in-betalactam-hypersensitivity
#18
Tahia D Fernandez, Cristobalina Mayorga, Maria Salas, Esther Barrionuevo, Teresa Posadas, Adriana Ariza, Jose J Laguna, Esther Moreno, Maria J Torres, Inmaculada Doña, Maria I Montañez
Betalactams are the most widely used drugs against infections and the primary cause of antibiotic hypersensitivity reactions. Reaction patterns for different betalactams have been changing in accordance with consumption trends, and vary among countries. As a consequence, in vivo and in vitro tests have had to change with to keep up with new tendencies. Areas covered: This review is focused on advances in betalactam hypersensitivity diagnosis. Changes in in vivo methods have been limited to the inclusion of new haptens...
June 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28374641/why-highly-effective-drugs-are-not-enough-the-need-for-an-affordable-solution-to-eliminating-hcv
#19
C Nelson Hayes, Kazuaki Chayama
Because of the rapid pace of development of new direct-acting antiviral (DAA) drugs, chronic hepatitis C virus (HCV) infection is now increasingly considered curable. However, the emphasis on DAA therapies disregards key issues related to cost, availability, and antiviral resistance. Areas covered: This perspective provides an overview of current HCV therapies and the development of DAAs, followed by a discussion of the limitations of DAA therapy. A literature search was used to select relevant studies, and a web search for relevant news articles and press releases was conducted...
June 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28349740/immunotherapy-for-gastric-cancers-emerging-role-and-future-perspectives
#20
Marta Bonotto, Silvio Ken Garattini, Debora Basile, Elena Ongaro, Valentina Fanotto, Monica Cattaneo, Francesco Cortiula, Donatella Iacono, Giovanni Gerardo Cardellino, Nicoletta Pella, Gianpiero Fasola, Lorenzo Antonuzzo, Nicola Silvestris, Giuseppe Aprile
The broad use of immunotherapy is revolutionizing the treatment paradigms of many solid tumors. Although chemotherapy remains the treatment backbone for advanced gastric cancer, improvements in its molecular characterization and progresses in understanding its underpinning biology have supported clinical development of novel immunotherapies. However, the results of recent trials testing these new agents raise the question on how to identify the patients that could greatly benefit. Areas covered: This article summarizes the current understanding on the biology and the mechanisms underlying different clinical features of gastric cancers...
June 2017: Expert Review of Clinical Pharmacology
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