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Expert Review of Clinical Pharmacology

Emma M Y Tay, Darren M Roberts
No abstract text is available yet for this article.
October 19, 2018: Expert Review of Clinical Pharmacology
Bogusław Okopień, Łukasz Bułdak, Aleksandra Bołdys
The need to reduce residual cardiovascular risk led to the development of novel therapeutic strategies to improve patients' outcomes. The residual risk in people with atherogenic dyslipidemia, despite LDL reduction obtained mainly by statins, remains high. Fibrates in those patients lead to significant clinical improvements. Those include reduction in the progression of atherosclerosis, which translates into decrease in cardiovascular events and improvements in microvascular diabetic complications. Furthermore there are other clinical and biochemical benefits connected with fibrate therapy (e...
October 17, 2018: Expert Review of Clinical Pharmacology
Carlo Bastianelli, Manuela Farris, Elena Rosato, Ivo Brosens, Giuseppe Benagiano
Following a historical overview, the ovulation-inhibiting effect of various orally-administered estrogen-progestin combinations (COCs) are examined for their components alone or in the various combined formulations. Special emphasis is given to products containing natural estrogens. Areas covered: Inhibition of ovulation with progestins alone; estrogens alone; various progestins in combination with ethinyl estradiol, various progestins in combination with natural estrogens (estradiol, estradiol valerate and estetrol) Expert commentary: The original idea to achieve ovulation blockage through the administration of steroid hormones involved the use a progestogen (both progesterone and its synthetic homologous)...
October 16, 2018: Expert Review of Clinical Pharmacology
Fabrizio Fabrizi, Piergiorgio Messa
Hepatitis C virus (HCV) infection leads to important morbidity and mortality through liver disease and extra-hepatic manifestations. Recent evidence suggests the role of HCV in developing chronic kidney disease (CKD); also, HCV adversely affects cardiovascular (CV) disease both in the general population and in patients with CKD. Areas covered: All-oral, interferon-free direct-acting antiviral agents (DAAs) are currently available; anti-HCV regimens based on DAAs are provided with high efficacy and safety and short treatment duration...
October 12, 2018: Expert Review of Clinical Pharmacology
Scott A Coon, Erica F Crannage, Lara C Kerwin, Justinne E Guyton
Semaglutide once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) injection has been approved as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus (T2DM). Areas Covered: The safety and efficacy of the semaglutide once-weekly injection are reviewed using results from preliminary pharmacology studies and later-phase randomized control trials (RCTs) and meta-analyses. Semaglutide once-weekly is compared to placebo and active comparators for T2DM in the SUSTAIN clinical trial series, with outcomes of: glycemic control, weight loss, major adverse cardiovascular events, and adverse effects...
October 8, 2018: Expert Review of Clinical Pharmacology
Vincenzo Savarino, Elisa Marabotto, Patrizia Zentilin, Manuele Furnari, Giorgia Bodini, Costanza De Maria, Gaia Pellegatta, Claudia Coppo, Edoardo Savarino
The introduction of proton pump inhibitors (PPIs) into clinical practice has greatly improved our therapeutic approach to acid-related diseases for their efficacy and safety. Areas Covered: The following evidence-based indications for PPI use are acknowledged by many scientific societies: treatment of the various forms and complications of gastroesophageal reflux disease, eradication of H. pylori infection in combination with two or more antibiotics, short- and long-term therapy of H. pylori-negative peptic ulcers, healing, and prevention of NSAID/COXIB-associated gastric ulcers, co-therapy with endoscopic procedures to control upper digestive bleeding and medical treatment of Zollinger Ellison syndrome...
October 8, 2018: Expert Review of Clinical Pharmacology
Sarah N Hilmer
No abstract text is available yet for this article.
September 29, 2018: Expert Review of Clinical Pharmacology
Kannan Sridharan, Gowri Sivaramakrishnan
INTRODUCTION: Several drugs were explored for their utility in treating nausea and vomiting in pregnancy (NVP). The present study is a network meta-analysis of such drugs. METHODS: Electronic databases were searched for randomized clinical trials that have compared active interventions (with placebo or other active interventions) for treating NVP. Nausea scores were the primary outcome and changes in nausea scores, emetic episodes, adverse events, and vomiting control were the key secondary outcomes...
September 27, 2018: Expert Review of Clinical Pharmacology
Andrea Farcaş, Andreea Măhălean, Noémi Beátrix Bulik, Daniel Leucuta, Cristina Mogoșan
BACKGROUND: Safety monitoring of all drugs throughout their entire life cycle is mandatory in order to protect the public health. Our objective was to describe all new safety signals assessed at EU level by the Pharmacovigilance Risk Assessment Committee (PRAC). METHODS: Publicly available data on signals assessment from PRAC meeting minutes for the period January 2014-November 2017 were analyzed and classified. RESULTS: A total of 239 new signals for 194 drugs/drug combinations/therapeutic classes were evaluated by PRAC...
October 2018: Expert Review of Clinical Pharmacology
Maria Gerosa, Lorenza Maria Argolini, Carolina Artusi, Cecilia Beatrice Chighizola
Biological agents have radically changed the prognosis of rheumatic patients. Current evidence demonstrates that tight disease control during pregnancy is mandatory to minimize adverse outcome risk. As the new therapeutic tools are pivotal to maintain appropriate disease activity, it is timely to review available evidence about the safety of biologics and small molecules in pregnancy. Areas covered: A comprehensive literature review has been performed, reporting available data about the passage into breast milk, rate of pregnancy loss and fetal malformations, and long-term complications due to in utero exposure to biological agents and small molecules...
October 2018: Expert Review of Clinical Pharmacology
Jochen G Mainz, Anke Jaudszus, Mathias W Pletz
No abstract text is available yet for this article.
October 2018: Expert Review of Clinical Pharmacology
Carlos Roncero, Jose Luis Villegas, Maria Martínez-Rebollar, Maria Buti
Most direct-acting antivirals (DAAs) and psychotropic drugs are metabolized by or induct/inhibit CYP enzymes and drug transporters. Although they are frequently coadministered, the drug-drug interactions (DDIs) have been little studied. Therefore, the aim of this review is to describe the interactions between the approved DAA or combination regimens and the main psychoactive substances, including legal and illegal drugs of abuse. Areas covered: We performed a literature search on PubMed database on drug interactions with the currently available antivirals for hepatitis C and a review of the information on pharmacokinetics, metabolism, and drug interactions from www...
October 2018: Expert Review of Clinical Pharmacology
Uffe Ravnskov, Michel de Lorgeril, David M Diamond, Rokuro Hama, Tomohito Hamazaki, Björn Hammarskjöld, Niamh Hynes, Malcolm Kendrick, Peter H Langsjoen, Luca Mascitelli, Kilmer S McCully, Harumi Okuyama, Paul J Rosch, Tore Schersten, Sherif Sultan, Ralf Sundberg
For half a century, a high level of total cholesterol (TC) or low-density lipoprotein cholesterol (LDL-C) has been considered to be the major cause of atherosclerosis and cardiovascular disease (CVD), and statin treatment has been widely promoted for cardiovascular prevention. However, there is an increasing understanding that the mechanisms are more complicated and that statin treatment, in particular when used as primary prevention, is of doubtful benefit. Areas covered: The authors of three large reviews recently published by statin advocates have attempted to validate the current dogma...
October 2018: Expert Review of Clinical Pharmacology
Lucia Festino, Vito Vanella, Claudia Trojaniello, Paolo A Ascierto
Checkpoint inhibitor immunotherapy has revolutionized the treatment of many advanced stage cancers. Preexisting immunity is necessary for a response to these agents, which are most effective in inflamed tumors since they principally act by reinforcing preexisting antitumor T-cell responses. An important goal of therapy is to convert the tumor environment from non-inflamed to inflamed in order to facilitate subsequent response to checkpoint inhibitors. Clinical trials are underway to identify checkpoint inhibitor-based combination approaches, which may help to achieve this goal...
October 2018: Expert Review of Clinical Pharmacology
Guillermo García-Rayado, Mercedes Navarro, Angel Lanas
NSAIDs are widely used to treat pain and rheumatic conditions, but they induce adverse events in different body systems, although the major, most frequent events occur in the upper and lower gastrointestinal (GI) tracts. Areas covered: This review is focused on damage caused by NSAIDs in the upper and lower GI tracts, the different mechanisms of damage and the GI-sparing NSAIDs designed to minimize adverse events based on understanding of these mechanisms. Expert commentary: Among the new NSAIDs, COX-2 selective inhibitors have been extensively investigated, and some were approved for human use...
October 2018: Expert Review of Clinical Pharmacology
Mina Tadrous
No abstract text is available yet for this article.
October 2018: Expert Review of Clinical Pharmacology
Jadel Müller Kratz, Facundo Garcia Bournissen, Colin J Forsyth, Sergio Sosa-Estani
Chagas disease (CD) is one of the most neglected public health problems in the Americas, where <1% of the estimated 6 million people with the infection have been diagnosed and treated. The goal of treatment is to eliminate the parasite, decrease the probability of cardiomyopathy and other complications during the chronic stage of infection, and interrupt the cycle of disease transmission by preventing congenital infection. Currently, only benznidazole (BZN) and nifurtimox are recognized by the World Health Organization as effective drugs for treatment of CD...
October 2018: Expert Review of Clinical Pharmacology
Farnaz Foolad, Samuel L Aitken, Roy F Chemaly
Allogeneic hematopoietic cell transplants (allo-HCT) recipients are at the high-risk of reactivation of cytomegalovirus (CMV), and reactivation is associated with significant morbidity and mortality. Although available anti-CMV therapies may be effective for the prevention of CMV, they are plagued by unacceptable toxicities that prohibit their use in the post-transplant period. Recently studied CMV-active agents, such as maribavir and brincidofovir, failed to reduce the incidence of CMV infection in HCT recipients...
October 2018: Expert Review of Clinical Pharmacology
Claudio Marasca, Maria Carmela Annunziata, Maddalena Napolitano, Gabriella Fabbrocini
Hidradenitis suppurativa (HS) is a chronic, inflammatory, and debilitating skin disease, which usually occurs after puberty with painful, deep-seated, inflammatory lesions in the apocrine gland-bearing areas of the body. Several pharmacologic agents have been described to reduce lesion activity and inflammation in HS. However, conventional treatment may not always get the desired results. Therefore, unconventional therapies must be taken into account. Areas covered: Recently, the better understanding of HS pathogenesis has been used to improve treatment strategies with many emerging conventional and unconventional therapeutics options...
September 2018: Expert Review of Clinical Pharmacology
Dan Le, Karen A Gelmon
Germ line BRCA mutations (gBRCAm) are diagnosed in approximately 5% of unselected breast cancer patients. Olaparib is a new treatment option for patients with a gBRCAm who have metastatic HER2-negative breast cancer. Areas covered: Olaparib is an oral poly (ADP-ribose) polymerase inhibitor that has been shown in phase I-III clinical trials to have single-agent efficacy in breast cancer patients with gBRCAm. The recent phase III OlympiAD study demonstrated a statistically significant progression-free survival benefit compared with the chemotherapy control arm, although an overall survival benefit has not been demonstrated...
September 2018: Expert Review of Clinical Pharmacology
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