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Expert Review of Clinical Pharmacology

Giovanni Di Perri, Andrea Calcagno, Alice Trentalange, Stefano Bonora
Treatment of HIV infection has consistently evolved in the last three decades. A steady improvement in efficacy tolerability, safety and practical aspects of treatment intake has made HIV infection much easier to manage over the long term, and in optimal treatment conditions the life expectancy of persons living with HIV infection now approaches the values of the general population. The last category of antiretrovirals to be fully developed for clinical use is the one of strand-transfer integrase inhibitors (INSTIs)...
December 4, 2018: Expert Review of Clinical Pharmacology
Jingbo Hu, Yongzhong Du
During the years, while treatment strategy for diabetes mellitus has improved, the incidence of diabetes worldwide increases continuously. Chronic kidney disease (CKD) is one of the major diabetic microvascular complications, and a primary cause leading to end-stage renal disease (ESRD). The progression to ESRD, affected by hyperglycemia and hypertension, is characterized by microalbuminuria and macroalbuminuria. With advances in understanding the pathogenesis of CKD in diabetic patients, many novel therapeutic targets have been proposed, and the corresponding agents are being developed continually to prevent the progression of CKD...
December 3, 2018: Expert Review of Clinical Pharmacology
Sherifa A Hamed
Uremic syndrome of chronic kidney disease (CKD) is a term used to describe clinical, metabolic and hormonal abnormalities associated with progressive kidney failure. It is a rapidly growing public health problem worldwide. Nervous system complications occur in every patient with uremic syndrome of CKD. Areas covered: This review summarized central and peripheral nervous system complications of uremic syndrome of CKD and their pathogenic mechanisms. They include cognitive deterioration, encephalopathy, seizures, asterixis, myoclonus, restless leg syndrome, central pontine myelinosis, stroke, extrapyramidal movement disorders, neuropathies and myopathy...
December 2, 2018: Expert Review of Clinical Pharmacology
Syed Raza Shah, Sana Muhammad Iqbal, Richard Alweis, Steven Roark
Type 2 diabetes (T2D) is an independent risk factor for Heart Failure (HF). With concomitant T2D and HF, recent data suggests an incremental risk of cardiovascular death and hospitalization for HF, as compared to patients with HF without T2D. Areas covered: Management of these two diseases has been a challenge for physicians. The treatment goals for HF patients in T2D are very important. They serve as the end-point in using a specific treatment for management and treatment of T2D patients hence, decreasing mortality rates...
November 29, 2018: Expert Review of Clinical Pharmacology
Patricia Daliu, Antonello Santini, Ettore Novellino
Nutraceuticals, up today, do not have a specific definition distinct from those of other food-derived categories, e.g. food supplements, herbal products, pre- and pro- biotics, functional foods, etc.. They have, however, a pharmacological beneficial effect on health. Many studies have been recently addressed to assess their safety, efficacy, and regulation since they are getting growing attention by market and research, with the aim to clear the difference between them and other market available food derived products that claim beneficial effect on health...
November 28, 2018: Expert Review of Clinical Pharmacology
Fiona V Cresswell, Lindsey Te Brake, Rachel Atherton, Rovina Ruslami, Kelly E Dooley, Rob Aarnoutse, Reinout van Crevel
Meningitis is the most severe manifestation of tuberculosis, resulting in death or disability in over 30% of those affected, with even higher morbidity and mortality among patients with HIV or drug resistance. Antimicrobial treatment of Tuberculous meningitis (TBM) is similar to treatment of pulmonary tuberculosis, although some drugs show poor central nervous system penetration. Therefore, intensification of antibiotic treatment may improve TBM treatment outcome. Areas covered: In this review we address three main areas: available data for old and new anti-tuberculous agents; intensified treatment in specific patient groups like HIV co-infection, drug-resistance and children; and optimal research strategies...
November 24, 2018: Expert Review of Clinical Pharmacology
Angela Esposito, Giulia Viale, Carmen Criscitiello, Giuseppe Curigliano
Patients with early HER2-positive breast cancer (BC) benefit from HER2-targeted systemic therapy. The endorsed standard adjuvant treatment for patients with early HER2-positive breast cancer is chemotherapy plus trastuzumab administered for 1 year. Areas covered: Several trials have investigated modifications of the standard treatment in terms of de-escalation by either shortening the duration or giving less resource-demanding regimens and in terms of escalation by either adding a second anti-HER2 agent or extending the duration of HER2-targeted treatment for more than 12 months...
November 22, 2018: Expert Review of Clinical Pharmacology
Jasper Shen, Kevin Welch, Robert Kern
Chronic rhinosinusitis (CRS) is a broad heterogeneous inflammatory disorder of the nose and paranasal sinuses, resulting from the dysfunctional interplay between host immunity, defective epithelial barrier, and environmental factors. CRS with nasal polyps (CRSwNP) is considered a more severe clinical phenotype with greater burden of symptoms and higher relapse rate, especially with comorbid asthma or aspirin sensitivity. Available treatment options after endoscopic sinus surgery (ESS) - systemic corticosteroids or revision surgery - have significant risks and limitations...
November 20, 2018: Expert Review of Clinical Pharmacology
Joseph O Fadare, Olayinka Ogunleye, Reginald Obiako, Samuel Orubu, Okezie Enwere, Adetutu A Ajemigbitse, Johanna C Meyer, Ehijie Enato, Amos Massele, Brian Godman, Lars Gustafsson
Inappropriate use of medicines remains a problem, with consequences including increasing adverse drug reactions (ADRs) and prolonged hospitalizations. The Essential Medicines List and Drug and Therapeutics Committees (DTCs) are accepted initiatives to promote the rational use of medicines. However, little is known about DTC activities in Nigeria, the most populous African country. Areas covered: A cross-sectional questionnaire-based study was conducted among senior pharmacists, consultant physicians and clinical pharmacologists in 12 leading tertiary healthcare facilities across Nigeria...
November 17, 2018: Expert Review of Clinical Pharmacology
Katherine M Stiff, Katelyn R Glines, Caroline L Porter, Abigail Cline, Steven R Feldman
Psoriasis is a common chronic skin condition that is prevalent worldwide. Despite the numerous treatment options available, discrepancies exist between international guidelines. Areas Covered: This review aims to evaluate the current international guidelines for the systemic treatment of psoriasis and psoriatic arthritis. Expert Commentary: Most guidelines are unanimous on medication dosing and laboratory monitoring. However, even the most up to date guidelines do not include many of the new biologic medications...
November 17, 2018: Expert Review of Clinical Pharmacology
Georgios Schoretsanitis, Edoardo Spina, Christoph Hiemke, Jose de Leon
This is a combined analysis of therapeutic drug monitoring (TDM) studies of long-acting injectable paliperidone formulations: monthly (PP1M) and three-month (PP3M) injections. Areas covered: Fourteen PP1M articles and one PP3M article were identified. Using the paliperidone concentration/dose (C/D) ratio as a measure of clearance provided a weighted mean of 7.7 ng/ml per mg/day among 69 patients from 3 steady-state PP1M studies (twice as high as oral paliperidone). C/D ratios were: 1) higher by a factor of 1...
November 17, 2018: Expert Review of Clinical Pharmacology
Giovanni Guaraldi, Ines Pintassilgo, Jovana Milic, Cristina Mussini
Owing to more effective and less toxic antiretroviral therapy (ART), people living with HIV (PLWH) live longer, a phenomenon expected to grow in the next decades. With advancing age, effectively treated PLWH experience not only a heightened risk for non-infective comorbidities and multimorbidity, but also for geriatric syndromes and frailty. In addition, older adults living with HIV (OALWH) have a higher prevalence of so-called iatrogenic triad described as polypharmacy (PP), potentially inappropriate medication use, and drug-drug interactions...
November 16, 2018: Expert Review of Clinical Pharmacology
Punita Gupta, Gregory Pastores
Gaucher disease is an autosomal recessive disorder resulting from the deficiency of the lysosomal enzyme glucocerebrosidase (b-glucosidase), associated with varying degrees of visceral, bone and central nervous system pathology, leading to wide phenotypic diversity. Response to therapy and clinical outcomes are very different between the three clinical subtypes - non-neuronopathic, acute neuronopathic and chronic neuronopathic forms; hence a definitive clinical diagnosis is essential. The availability of two therapeutic options, i...
November 16, 2018: Expert Review of Clinical Pharmacology
Daniele Roberto Giacobbe, Malgorzata Mikulska, Claudio Viscoli
The emergence and diffusion of multidrug resistant Gram-negative bacteria (MDR-GNB) is an unprecedented threat, with prevalences as high as 10-50% being reported in many countries. Areas covered: In the present review we discuss the management of infections due to MDR-GNB, focusing in particular on current strategies and novel agents with already available results from phase 3 randomized controlled trials. Expert commentary: Some new drugs, such as ceftolozane/tazobactam, ceftazidime/avibactam, and meropenem/vaborbactam, which have become available in the past months, have increased our chance of improving survival in severe carbapenem-resistant Pseudomonas aeruginosa and carbapenem-resistant Enterobacteriaceae infections; while others, with potent activity against carbapenem-resistant Acinetobacter baumannii which is currently the highest priority regarding the need for novel agents, will become available in the near future...
November 16, 2018: Expert Review of Clinical Pharmacology
Abhinav Kanwal
No abstract text is available yet for this article.
November 14, 2018: Expert Review of Clinical Pharmacology
Tsakane P Mashaba, Moliehi Matlala, Brian Godman, Johanna C Meyer
The National Drug Policy in South Africa has achieved its objective in establishing and strengthening Pharmacy and Therapeutics Committees (PTCs) in all hospitals. However, little is known about the implementation of decisions by PTCs and the monitoring thereof. Consequently, there is a need to investigate this. Areas covered: We sought to address this via an online survey distributed to pharmacists working in public sector hospitals across South Africa with perceived functioning PTCs, with a 32.3% response rate to the survey...
November 8, 2018: Expert Review of Clinical Pharmacology
Andrea Fanelli, Maria Cristina Sorella, Daniela Ghisi
Abuse-deterrent formulations have been developed to reduce inappropriate opioid use. The aim of this paper is to review existing literature about currently available morphine abuse deterrent formulations. Areas covered: The US FDA has currently attributed an 'abuse deterrent formulation' label to two different morphine compounds: an agonist/antagonist combination, and a morphine formulation with physical barrier. The combination of morphine sulfate and naltrexone showed bioequivalence with extended release morphine...
November 7, 2018: Expert Review of Clinical Pharmacology
Pamela D Browne, Sjoerd C J Nagelkerke, Faridi S van Etten-Jamaludin, Marc A Benninga, Merit M Tabbers
Chronic idiopathic nausea (CIN) and functional dyspepsia (FD) cause considerable strain on many children's lives and their families. Areas Covered: This study aims to systematically assess the evidence on efficacy and safety of pharmacological treatments for CIN or FD in children. CENTRAL, EMBASE and Medline were searched for Randomized Controlled Trials (RCTs) investigating pharmacological treatments of CIN and FD in children (4-18 years). Cochrane risk of bias tool was used to assess methodological quality of the included articles...
October 25, 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
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