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Expert Review of Clinical Pharmacology

W Ennis James, Robert Baughman
Treatment of sarcoidosis recommendations are often based on clinical experience and expert opinion. However, there are an increasing number of studies which are providing evidence to support decisions regarding treatment. Areas covered: Several studies have identified factors associated with increased risk for organ failure or death ('danger'). There have been several studies focused on the role of treatment to improve quality of life for the patient. Sarcoidosis treatment often follows a progression, based on response...
June 18, 2018: Expert Review of Clinical Pharmacology
Ingrid Fricke-Galindo, Adrián LLerena, Helgi Jung-Cook, Marisol López-López
Carbamazepine (CBZ) is used for the treatment of epilepsy and other neurological and psychiatric disorders. The occurrence of adverse reactions (ADRs) to CBZ can negatively impact the quality of life of patients, as well as, increase health care costs. Thus, knowledge of CBZ-induced ADRs is important to achieve safer treatment outcomes. Areas covered. This review describes the clinical features, known mechanisms, and clinical management of the main CBZ-induced ADRs. In addition, pharmacogenetic studies focused on ADRs induced by CBZ are cited...
June 14, 2018: Expert Review of Clinical Pharmacology
Zhi-Shuai Hou, Alfredo Ulloa-Aguirre, Ya-Xiong Tao
Conformational diseases are caused by structurally abnormal proteins that cannot fold properly and achieve their native conformation. Misfolded proteins frequently originate from genetic mutations that may lead to loss-of-function diseases involving a variety of structurally diverse proteins including enzymes, ion channels, and membrane receptors. Pharmacoperones are small molecules that cross the cell surface plasma membrane and reach their target proteins within the cell, serving as molecular scaffolds to stabilize the native conformation of misfolded or well-folded but destabilized proteins, to prevent their degradation and promote correct trafficking to their functional site of action...
May 31, 2018: Expert Review of Clinical Pharmacology
Rabia Chaudry, Adie Viljoen, Anthony S Wierzbicki
A spectrum of disorders, ranging from rare severe cases of homozygous null lipoprotein lipase deficiency (LPLD) -familial chylomicronemia syndrome (FCS) to heterozygous missense LPLD or polygenic causes, result in hypertriglyceridemia and pancreatitis. The effects of mutations are exacerbated by environmental factors such as diet, pregnancy and insulin resistance. Areas covered: In this review, authors discuss chronic treatment of FCS by ultra-low fat diets allied with the use of fibrates, omega-3 fatty acids, niacin, statins and insulin-sensitising therapies depending on the extent of residual LPL activity; novel therapies in development target triglyceride-rich lipoprotein particle clearance...
May 29, 2018: Expert Review of Clinical Pharmacology
Jeffrey Baron, Eunice S Wang
Gemtuzumab ozogamicin (GO) is an antibody-drug conjugate consisting of a monoclonal antibody targeting CD33 linked to a cytotoxic derivative of calicheamicin. Despite the known clinical efficacy in relapsed/refractory acute myeloid leukemia (AML), GO was withdrawn from the market in 2010 due to increased early deaths seen in newly diagnosed AML patients receiving GO + intensive chemotherapy. In 2017, new data on the clinical efficacy and safety of GO administered on a fractionated dosing schedule led to re-approval for newly diagnosed and relapsed/refractory AML...
May 22, 2018: Expert Review of Clinical Pharmacology
Syed Raza Shah, David E Winchester
In the past few years, medical community, including doctors, have become increasingly aware of the fact that chronic kidney disease (CK) and heart failure (HF) have common risk factors which impacts one another in terms of choice of therapy. Areas covered: Management of these two diseases has been a challenge for physicians. The treatment goals for HF patients in CK are very important. They serve as the end-point in using a specific treatment for management and treatment of CK patients hence, decreasing mortality rates...
May 21, 2018: Expert Review of Clinical Pharmacology
Fabrizio Benedetti, Elisa Frisaldi, Aziz Shaibani
No abstract text is available yet for this article.
May 21, 2018: Expert Review of Clinical Pharmacology
Thomas Jouve, Johan Noble, Lionel Rostaing, Paolo Malvezzi
BACKGROUND: The prevalence of end-stage renal disease is increasing worldwide. The best treatment is kidney transplantation, although life-long immunosuppressive therapy is then mandatory. Currently, the cornerstone immunosuppressive therapy relies on tacrolimus, a calcineurin inhibitor that is nephrotoxic but whose exposition can be minimized in a delicate balance. Area covered: We addressed whether, in the setting of kidney transplantation, tacrolimus-based therapy can be tailored to medical needs: to achieve this, we searched for suitable articles in PubMed...
May 19, 2018: Expert Review of Clinical Pharmacology
Georgios Schoretsanitis, Edoardo Spina, Christoph Hiemke, Jose de Leon
This article includes a combined analysis of therapeutic drug monitoring (TDM) studies and a review of the marketer's data on pharmacological mechanisms. Areas covered: An article search led to the inclusion of 21 paliperidone studies in the systematic review plus 2 case reports. Paliperidone clearance was calculated from: 1) steady-state studies using concentration/dose (C/D) ratios, and 2) single-dose studies describing 24-hour area under the curve calculations. The marketed extended-release formulation has 28% bioavailability...
May 18, 2018: Expert Review of Clinical Pharmacology
Jose L Casado, Marta Monsalvo, Aurora M Rojo, María Fontecha, Miguel A Rodriguez-Sagrado
Triple combinations of antiretroviral (ART) drugs are the standard treatment for HIV infection, but the challenges include long-term side effects, high costs, and adherence. The recent advent of potent and well tolerated ART has renewed the interest for newer ART strategies. A dual regimen with the combination of dolutegravir (DTG) and rilpivirine (RPV), two well tolerated, metabolic-friendly, and potent drugs could offer additional benefits. Areas covered: A review of recent randomized trials and observational cohorts concerning the use of a dual therapy with DTG plus RPV as a switching strategy in patients with viral suppression...
May 18, 2018: Expert Review of Clinical Pharmacology
James Dugan, Daniel Pollyea
In August 2017 the United States Federal Drug Administration (FDA) approved enasidenib (Idhifa, Celgene/Agios) for adults with relapsed and refractory acute myelogenous leukemia (AML) with an IDH2 mutation. Enasidenib targets cells with mutant copies of isocitrate dehydrogenase-2 (IDH2), inhibiting the oncometabolite 2-hydroxyglutarte (2-HG) formed by the mutant IDH2. Areas covered: We review the studies leading to enasidenib's approval, as well as common side effects and safety issues experienced during the clinical trials...
May 17, 2018: Expert Review of Clinical Pharmacology
Anne Rodallec, Raphaelle Fanciullino, Bruno Lacarelle, Joseph Ciccolini
The Pharmacokinetics/pharmacodynamics (PK/PD) relationships with cytotoxics are usually based on a steepening concentration-effect relationship; the greater the drug amount, the greater the effect. The Maximum Tolerated Dose paradigm, finding the balance between efficacy while keeping toxicities at their manageable level, has been the rule of thumb over the last 50-years. Developing nanodrugs is an appealing strategy to help broaden this therapeutic window. The fact that efficacy and toxicity with cytotoxics are intricately linked is primarily due to the complete lack of specificity towards the tumor tissue during their distribution phase...
May 16, 2018: Expert Review of Clinical Pharmacology
Ronald G Hall, Eunice Yoo, Andrew Faust, Terri Smith, Edward Goodman, Eric M Mortensen, Victoria Felder, Carlos A Alvarez
BACKGROUND: The impact of total body weight (TBW) on the development of acute kidney injury (AKI) associated with gram-negative bacteremia has not been previously evaluated. METHODS: The cohort included 323 patients >/ = 18 years old with gram-negative bacteremia (1/1/2008-8/31/2011) who received >/ = 48 hours of antibiotics. We compared the incidence of AKI in patients with a TBW </ = 80kg vs. >80kg with a multivariable stepwise logistic regression adjusting for age >/ = 70 years, baseline serum creatinine of > 2...
May 10, 2018: Expert Review of Clinical Pharmacology
Kannan Sridharan, Gowri Sivaramakrishnan
BACKGROUND: To compare the efficacy and safety of desferrioxamine (DFO), deferiprone (DFP), deferasirox (DFX) and silymarin in patients with either thalassemia or sickle cell disorder through network meta-analysis. METHODS: Electronic databases were searched for appropriate randomized clinical trials comparing iron chelators in patients with iron overload. Random effects model was used to generate direct, indirect and mixed treatment comparison pooled estimates for the following outcomes: serum ferritin, liver iron concentration (LIC), changes in serum ferritin, mortality, urine iron excretion, adverse events, neutropenia, agranulocytosis and number of patients withdrawing the chelating therapy...
May 4, 2018: Expert Review of Clinical Pharmacology
Antonello Santini, Ettore Novellino
No abstract text is available yet for this article.
April 23, 2018: Expert Review of Clinical Pharmacology
Nikoleta Printza, Ireni Georeli, Stella Stabouli, John Dotis, Christina Sidira, Fotios Papachristou
No abstract text is available yet for this article.
May 2018: Expert Review of Clinical Pharmacology
Pedro Isaacsson Velho, Emmanuel S Antonarakis
Pharmacological inhibition of immune checkpoint receptors or their ligands represents a transformative breakthrough in the management of multiple cancers. However, immune checkpoint inhibitors have yet to be FDA-approved for the management of metastatic prostate cancer (PCa), the commonest non-cutaneous malignancy in men. Areas covered: We review our current understanding of the PD-1/PD-L1 pathway in cancer, the use of anti-PD-1/PD-L1 therapeutics in PCa, and potential subgroups of PCa patients who may derive the greatest benefit from these agents (such as men with tumors that have expression of PD-L1 and/or high mutational load)...
May 2018: Expert Review of Clinical Pharmacology
John J Knoedler, Jay D Raman
While radical nephroureterectomy remains the gold-standard for upper tract urothelial carcinoma (UTUC), there is a growing push for organ-sparing therapy in low-risk disease. Herein we review the use of intracavitary topical therapy for treatment of UTUC. Areas covered: A PubMed search was performed for studies pertaining to upper tract urothelial carcinoma, with 236 articles reviewed, and distilled for content pertinent to intracavitary therapy for UTUC. Topics discussed include agents used for management of UTUC, most commonly BCG, as well as techniques for administration...
May 2018: Expert Review of Clinical Pharmacology
Laura Benítez-Gutiérrez, Vicente Soriano, Silvia Requena, Ana Arias, Pablo Barreiro, Carmen de Mendoza
Current antiretroviral therapy allows to achieve and sustain maximal suppression of HIV replication in most treated patients. As result, the life expectancy of HIV-infected persons has improved dramatically and is nowadays similar to that of the HIV-negative population. However, oral antiretrovirals have to be taken daily and indefinitely to avoid resumption of HIV replication and selection of drug resistance. Unfortunately, drug adherence is often suboptimal and tends to decline over time. Areas covered: New drugs, formulations and delivery systems are being developed for extended-release of antiretrovirals...
May 2018: Expert Review of Clinical Pharmacology
Teruyuki Ogawa, Osamu Ishizuka, Tomohiro Ueda, Pradeep Tyagi, Michael B Chancellor, Naoki Yoshimura
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a symptomatic disorder characterized by pelvic pain and urinary frequency. Immunological responses are considered as one of the possible etiologies of IC/BPS. In this review, we focused on emerging targets, especially on those modulating immunological mechanisms for the treatments of IC/BPS. Area covered: This review was based on the literature search of PubMed/MEDLINE, for which key words following bladder pain syndrome, interstitial cystitis, and/or cyclosporine A (CyA) were used...
May 2018: Expert Review of Clinical Pharmacology
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