Copanlisib for the treatment of adults with relapsed follicular lymphoma.
Authors: Magagnoli M, Carlo-Stella C, Santoro A Abstract INTRODUCTION: Follicular lymphoma (FL) is the second most common histotype of lymphoma and is considered an incurable disease. The need for new treatment options has led to the development of innovative targeted agents, including inhibitors of the phosphatidylinositol-3-kinase (PI3K) pathway. AREAS COVERED: Copanlisib, an intravenous pan-class I PI3K inhibitor, has been approved by the US Food and Drug Administration (FDA) for the treatment of relapsed FL in patients who have received at least two prior systemic therapies. In this article, we critically r...
Source: Expert Review of Clinical Pharmacology - June 25, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Clozapine-related drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome: a systematic review.
Authors: de Filippis R, Soldevila-Matías P, De Fazio P, Guinart D, Fuentes-Durá I, Rubio JM, Kane JM, Schoretsanitis G Abstract INTRODUCTION: The Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome is a severe, multiorganic and potentially life-threatening drug-induced hypersensitivity reaction, linked to several common drugs, including antiepileptics, antibiotics and several psychotropic drugs, including clozapine. Due to the importance of clozapine in the management of treatment-resistant schizophrenia, a systematic review and characterization of clozapine-related DRESS syndrome i...
Source: Expert Review of Clinical Pharmacology - June 25, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Impact of pharmaceutical price controls on the cost of cardiovascular drugs: does essentiality matter?
CONCLUSIONS: Our analyses demonstrate considerable cost variations for essential cardiovascular medicines. Given the need for prolonged and often, lifelong-treatment, there is significant potential for cost savings based on chosen brand, highlighting the need for patient as well as prescriber education. PMID: 32552127 [PubMed - as supplied by publisher] (Source: Expert Review of Clinical Pharmacology)
Source: Expert Review of Clinical Pharmacology - June 21, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Contraception and reproductive planning during the COVID-19 pandemic.
Authors: Ferreira-Filho ES, de Melo NR, Sorpreso ICE, Bahamondes L, Simões RDS, Soares-Júnior JM, Baracat EC Abstract INTRODUCTION: The coronavirus disease (COVID-19) is a global health emergency. Major disruption to healthcare services during the current COVID 19 pandemic will last even after its peak. Sexual and reproductive health (SRH), specially contraception, needs to be understood as an essential service. AREAS COVERED: This paper is a narrative review. Data from PubMed/MEDLINE, Scopus, and websites of scientific societies were screened during the months of April and May 2020. It addresses ...
Source: Expert Review of Clinical Pharmacology - June 18, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Drospirenone 4 mg-only pill (DOP) in 24+4 regimen: a new option for oral contraception.
Authors: Chiara Del Savio M, De Fata R, Facchinetti F, Grandi G Abstract INTRODUCTION: Although progestin-only pills (POPs) are effective methods of hormonal contraception, their use is still relatively infrequent, mainly for their unpredictable effect on menstrual bleeding. A new oestrogen-free contraceptive consisting of 4 mg drospirenone (DRSP) for 24 days with a 4-day hormone-free interval has been developed to address this need, named the DRSP-only pill. DRSP is a potent progestin analogue of spironolactone, with antiandrogenic and antimineralocorticoid properties. AREAS COVERED: This is a narrative review...
Source: Expert Review of Clinical Pharmacology - June 18, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

The crosstalk between antiretrovirals pharmacology and HIV drug resistance.
Authors: Giacomelli A, Pezzati L, Rusconi S Abstract INTRODUCTION: The clinical development of antiretroviral drugs has been followed by a rapid and concomitant development of HIV drug resistance. The development and spread of HIV drug resistance is due on the one hand to the within-host intrinsic HIV evolutionary rate and on the other to the wide use of low genetic barrier antiretrovirals. AREAS COVERED: We searched PubMed and Embase on January 31, 2020, for studies reporting antiretroviral resistance and pharmacology. In this review we assessed the molecular target and mechanism of drug resistance development...
Source: Expert Review of Clinical Pharmacology - June 18, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

The availability of new drugs for hemophilia treatment.
Authors: Morfini M, Marchesini E Abstract INTRODUCTION: A number of new FVIII/IX concentrates enriched the portfolio of products available for the treatment of hemophilia A/B patients. Due to the large inter-patient variability, accurate tailoring of the therapy became essential to improve patients' adherence, clinical outcomes, and cost/effectiveness ratio. Recently, non-replacement therapies have taken the limelight and succeeded in decreasing the bleedings of patients. AREAS COVERED: The PK characteristics, efficacy, and safety of the new rFVIII and rFIX concentrates and of non-replacement therapy, are repor...
Source: Expert Review of Clinical Pharmacology - June 11, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

A spotlight on the treatment of intraabdominal infections.
Authors: Montravers P, Yung S, Tran-Dinh A PMID: 32511038 [PubMed - as supplied by publisher] (Source: Expert Review of Clinical Pharmacology)
Source: Expert Review of Clinical Pharmacology - June 10, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Patiromer for the treatment of hyperkalemia.
Authors: Colbert GB, Patel D, Lerma EV Abstract INTRODUCTION: Hyperkalemia is a chronic and life-threatening electrolyte disorder that affects millions of patients around the world with decreased kidney function, hypertension, and heart failure. Recently newer oral potassium-binding agents have been approved for clinical use, as an alternative to the decades long use of sodium polystyrene sulfonate. This review will focus on the patiromer and its use in reducing hyperkalemia. AREAS COVERED: Pubmed was used to search from 1960 to 2020 on free subject terms: Hyperkalemia, Potassium, Patiromer, Veltassa, Kayexalat...
Source: Expert Review of Clinical Pharmacology - June 10, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Cluster headache therapies: pharmacology and mode of action.
This article reviews acute and preventive substances for the pharmacological treatment of CH with a focus on the mode of action of these drugs. We also summarized the clinical trial evidence and discuss future research directions. EXPERT OPINION: Recommendations for current pharmacological CH therapies, in particular for CH prevention, are often based on small open label studies with inconclusive results. Larger trials are missing. A shared pathophysiological mechanism of action of these preventatives does not exist. Future studies with CGRP(R) antibodies and novel substances with specific actions are needed and will t...
Source: Expert Review of Clinical Pharmacology - June 10, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Modern approaches for the phenotyping of cytochrome P450 enzymes in children.
Authors: Magliocco G, Daali Y PMID: 32500746 [PubMed - as supplied by publisher] (Source: Expert Review of Clinical Pharmacology)
Source: Expert Review of Clinical Pharmacology - June 7, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

The clinical pharmacology of the medical treatment for overactive bladder in adults.
Authors: Mostafaei H, Shariat SF, Salehi-Pourmehr H, Janisch F, Mori K, Quhal F, Hajebrahimi S Abstract INTRODUCTION: Overactive bladder is a prevalent symptom complex that affects the patient's quality of life. Any disruption between the neuronal micturition pathway can lead to bladder overactivity. Neurogenic causes, myogenic causes, aging, bladder outlet obstruction, sex and psychological factors are some of the factors contributing to bladder overactivity. The complaint of any symptoms of OAB, which is highly prevalent and affects overall QOL, often needs therapeutic interventions. When conservative therapy met...
Source: Expert Review of Clinical Pharmacology - June 7, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Correction.
Authors: PMID: 32501733 [PubMed - as supplied by publisher] (Source: Expert Review of Clinical Pharmacology)
Source: Expert Review of Clinical Pharmacology - June 7, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Thromboembolic risk of complement 1 esterase inhibitors: a systematic review on current evidence.
Authors: Burnham K, Reinert JP Abstract INTRODUCTION: The exact risk of developing a thromboembolic event (TEE) while using complement 1 esterase inhibitors (C1-INH) is currently undetermined for patients with hereditary angioedema (HAE). This systematic review aimed to define the potential risk of TEEs from these agents. AREAS COVERED: This evaluation covers publications examining or mentioning the risk of TEEs in association with C1-INHs. A systematic literature search was conducted utilizing PubMed, Scopus, and ProQuest. This review utilized search results through January 2020 and followed the PRISMA recomme...
Source: Expert Review of Clinical Pharmacology - June 2, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Semaglutide injection for the treatment of adults with type 2 diabetes.
This article examines the use of injectable semaglutide in the treatment of type 2 diabetes. AREAS COVERED: We will describe the global problem posed by type 2 diabetes followed by consideration of the glucagon-like peptide 1 receptor agonist class of glucose lowering therapies. The focus is then shifted to semaglutide and a description of the large phase 3 pre-approval trial programme known as SUSTAIN. There is consideration of glucose control, the primary end-point of the phase 3 programme, as well as secondary end-points such as weight and blood pressure. There follows a précis of the cardiovascular outcomes ...
Source: Expert Review of Clinical Pharmacology - June 2, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Pexidartinib for the treatment of adult symptomatic patients with tenosynovial giant cell tumors.
Authors: Baldi GG, Gronchi A, Stacchiotti S Abstract INTRODUCTION: Tenosynovial giant cell tumor (TGCT) is a benign mesenchymal tumor arising from the synovium of tendon sheats and joints, driven by colony-stimulating factor 1 (CSF1) over-expression. Standard treatment is surgery, but local recurrences are frequent, especially in diffuse TGCT subtype, rarely cured with surgery. When TGCT becomes a chronic condition, which may severely compromise joint function and quality of life, patients may need a systemic therapy. Areas covered: We reviewed the drugs on clinical development in TGCT, focusing on the pharmacodyna...
Source: Expert Review of Clinical Pharmacology - June 2, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Integrating psychotherapy and psychopharmacology: psychedelic-assisted psychotherapy and other combined treatments.
Authors: Greenway KT, Garel N, Jerome L, Feduccia AA Abstract INTRODUCTION: Combinations of psychotherapy with antidepressants are gold-standard psychiatric treatments. They operate through complex and interactional mechanisms, not unlike the reemergent paradigm of psychedelic-assisted psychotherapy, which promising research suggests may also be highly effective in even challenging populations. AREAS COVERED: We review the therapeutic mechanisms behind both conventional and psychedelic paradigms, including the evolution of this knowledge and the associated explanatory frameworks. We explore how psychedelics hav...
Source: Expert Review of Clinical Pharmacology - June 2, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Tenapanor for the treatment of irritable bowel syndrome with constipation.
Authors: Sinagra E, Rossi F, Raimondo D, Conoscenti G, Anderloni A, Guarnotta V, Maida M Abstract INTRODUCTION: Irritable bowel syndrome with constipation is associated with higher rates of functional impairment, as compared to other subtypes of the syndrome. Conventional laxative-based pharmacologic therapy of IBS-C, which is mostly symptom-based, is often unsatisfactory. Tenapanor represents a first-in-class orally available inhibitor of NHE3, which is minimally absorbed in the GI tract, what constitutes a significant therapeutic benefit, as it may act on the drug target. AREAS COVERED: Aim of this article is...
Source: Expert Review of Clinical Pharmacology - June 2, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Current perspective on fibrinogen concentrate in critical bleeding.
Authors: Leal-Noval SR, Fernández Pacheco J, Casado Méndez M, Cuenca-Apolo D, Múñoz-Gómez M Abstract INTRODUCTION: . Massive hemorrhage continues to be a treatable cause of death. Its management varies from prefixed ratio-driven administration of blood components to goal-directed therapy based on point-of-care testing and administration of coagulation factor concentrates. AREAS COVERED: . We review the current role of fibrinogen concentrate (FC) for the management of massive hemorrhage, either administered without coagulation testing in life-threatening hemorrhage, or within a...
Source: Expert Review of Clinical Pharmacology - June 2, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Initial dosage optimization of tacrolimus in Chinese pediatric patients undergoing kidney transplantation based on population pharmacokinetics and pharmacogenetics.
CONCLUSIONS: The initial dosage recommendations in the tacrolimus instructions were not individualized, and we have developed more accurate initial doses based on weight and the CYP3A5 genotype. In addition, lower initial doses are recommended with concurrent use of WZ. PMID: 32452705 [PubMed - as supplied by publisher] (Source: Expert Review of Clinical Pharmacology)
Source: Expert Review of Clinical Pharmacology - May 28, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Tedizolid (torezolid) for the treatment of complicated skin and skin structure infections.
Authors: Carena AA, Stryjewski ME Abstract INTRODUCTION: Acute bacterial skin and skin structure infections (ABSSSI) are among the most frequent infectious diseases. Recently, several new antibiotics with activity against MRSA have been approved. Tedizolid, a second generation oxazolidinone approved for ABSSSI offers theoretical advantages over first generation oxazolidinones. AREAS COVERED: A comprehensive online search of Medline, ClinicalTrials.gov, and conference presentations was made, selecting articles between January 2000 and April 2020. In this review, the authors discuss the chemical and microbiologic...
Source: Expert Review of Clinical Pharmacology - May 26, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Pharmacological management of cardiovascular risk in chronic inflammatory rheumatic diseases.
Authors: Panoulas V, Kitas GD Abstract Introduction: Cardiovascular comorbidity is a major burden in patients with chronic inflammatory rheumatic diseases and a significant determinant of their outcome. In addition to optimal management of the underlying inflammatory condition according to current guidelines, individual cardiovascular risk factors, particularly dyslipidaemia, hypertension, and impaired glucose tolerance should be assessed regularly and guide risk stratification and requirement for treatment.Areas discussed: We critically reviewed manuscripts and guidelines on the pharmacological management of dysli...
Source: Expert Review of Clinical Pharmacology - May 23, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Cabozantinib as a second-line treatment option in hepatocellular carcinoma.
Authors: D'Angelo A, Sobhani N, Bagby S, Casadei-Gardini A, Roviello G Abstract Introduction: Hepatocellular carcinoma (HCC) is one of the most frequent tumours affecting the gastrointestinal tract and a universal cause of morbidity and mortality. Cabozantinib is a strong multi-inhibitor of receptor tyrosine kinases approved for renal cell carcinoma that could be useful also for the treatment of HCC.Areas covered: This review describes the chemical structure, the pharmacologic properties and current knowledge of the efficacy of cabozantinib in the treatment of HCC based on data available from first phase and later ...
Source: Expert Review of Clinical Pharmacology - May 13, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Switching biologics in psoriasis - practical guidance and evidence to support.
Authors: Tsai YC, Tsai TF Abstract Introduction: Advances of biologic agents have changed the treatment paradigm of psoriasis to higher efficacy and better quality of life. However, the demand of biologic switch is increasing due to patient's greater expectation and decreasing efficacy in long-term use. Also, biologic-induced adverse effects necessitate the switching of biologics.Areas covered: This review article was divided into two parts. The first part focused on the biologic switch due to lack of efficacy. The second part provided switching suggestions related to adverse effects.Expert opinion: Biologic switch...
Source: Expert Review of Clinical Pharmacology - May 13, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

The management of anti-infective agents in intensive care units: the potential role of a "fast" pharmacology.
The management of anti-infective agents in intensive care units: the potential role of a "fast" pharmacology. Expert Rev Clin Pharmacol. 2020 Apr 22;: Authors: Cattaneo D, Corona A, De Rosa FG, Gervasoni C, Kocic D, Marriott DJ Abstract Introduction: Patients in intensive care units (ICU) are often develop severe infections in which are associated with significant mortality rates. A number of novel technologies for the rapid microbiological diagnosis of these infections have been developed, introducing the era of 'fast microbiology'. Treatment of bacterial and fungal infections in ICU is howe...
Source: Expert Review of Clinical Pharmacology - April 23, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

The potential role of interventions impacting on gut-microbiota in epilepsy.
Authors: Iannone LF, Gómez-Eguílaz M, Citaro R, Russo E Abstract Introduction: The gut microbiota seems to be implicated in the functioning and development of basic physiological processes and might also influence central neural processes, through the microbiota-gut-brain (MGB) axis. Pre- and clinical studies support the role of the microbiome in seizure modulation and in the pathogenesis of epilepsy. Acting through different interventions (e.g. diet, supplementations, drugs) could perturb directly and indirectly the MGB axis. Investigating the effects of these interventions might possibly allow bette...
Source: Expert Review of Clinical Pharmacology - April 23, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

A dermatologist perspective in the pharmacological treatment of patients with psoriasis and psoriatic arthritis.
Authors: Francesco B, Paolo G, Giampiero G Abstract INTRODUCTION: Psoriatic arthritis (PsA) is chronic inflammatory disease associated with psoriasis in 20-30% of patients. PsA presents as a heterogeneous disease involving different domains and burdened by an important impact on function and quality of life.Areas covered: Dermatologists play an important role in the early detection of PsA because in most patients PsA develop after cutaneous psoriasis. The ideal goal of treating patients with PsA is to optimize the controls of symptoms, improve quality of life, and prevent structural damage and disability. The choic...
Source: Expert Review of Clinical Pharmacology - April 23, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Estetrol (E4): the new estrogenic component of combined oral contraceptives.
Authors: Grandi G, Chiara Del Savio M, Lopes da Silva-Filho A, Facchinetti F PMID: 32238069 [PubMed - as supplied by publisher] (Source: Expert Review of Clinical Pharmacology)
Source: Expert Review of Clinical Pharmacology - April 3, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

The potential role of big data in the detection of adverse drug reactions.
Authors: Sultana J, Trifirò G PMID: 32176553 [PubMed - as supplied by publisher] (Source: Expert Review of Clinical Pharmacology)
Source: Expert Review of Clinical Pharmacology - March 17, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Evolution of the inclusion/exclusion criteria and primary endpoints in pivotal trials of biologics and small oral molecules for the treatment of psoriasis.
Authors: Hsu SH, Tsai TF Abstract Introduction: Primary endpoints and inclusion/exclusion criteria of biologics and small oral molecules for psoriasis treatment have been evolving due to the better understanding of the pathogenesis and potential risks.Areas covered: We analyzed the designs of key phase 3 pivotal trials of all biologics and small oral molecules approved for moderate to severe plaque psoriasis from published data on the ClinicalTrials.gov website and literature in the PubMed database. Alefacept, efalizumab, anti-tumor necrosis factors, anti-interleukin (IL)-12/IL-23, anti-IL-17 and anti-IL-23 inhibit...
Source: Expert Review of Clinical Pharmacology - March 14, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Cancer prevention and treatment using combination therapy with natural compounds.
Authors: Sauter ER Abstract Introduction: Naturally occurring compounds play an essential role in the prevention and treatment of various cancers. There are more than 100 plant and animal based natural compoundscurrently in clinical use. Areas covered: 1) The importance of natural products combinations in the prevention and treatment of cancer, 2) the need to maximize efficacy while minimizing side effects when using natural product combinations, and 3) specifics related to plant and animal derived natural products, as well as agents derived from natural products. Therapies using natural compounds that have been in...
Source: Expert Review of Clinical Pharmacology - March 12, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Spotlight on experiences of medicine unavailability: Access to medicines challenges for NCDs and NTDs - The contrasting cases of Insulin and Praziquantel.
Authors: Wells N, Chappuis F, Beran D Abstract Introduction: Effective medicines exist to address leading global health challenges including Neglected Tropical Diseases (NTD) and Noncommunicable Diseases (NCD) however these are often unavailable and unaffordable. To date little literature exists comparing medicine unavailability across broad disease areas.Areas covered: Using insulin and praziquantel as useful tracer medicines this review aims to demonstrate that separating global health governance agendas for NCDs and NTDs ultimately impacts the effectiveness of coalitions for access for the poorest populations. E...
Source: Expert Review of Clinical Pharmacology - March 12, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Risk of acute pancreatitis with incretin-based therapy: a systematic review and updated meta-analysis of cardiovascular outcomes trials.
Conclusions: This meta-analysis revealed a significant association between pancreatitis and DPP-4 inhibitors; however, no such association was observed for GLP-1RAs. PMID: 32129106 [PubMed - as supplied by publisher] (Source: Expert Review of Clinical Pharmacology)
Source: Expert Review of Clinical Pharmacology - March 6, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

The role of xenobiotic-metabolizing enzymes in the placenta: a growing research field.
Authors: Blanco-Castañeda R, Galaviz-Hernández C, Souto PCS, Lima VV, Giachini FR, Escudero C, Damiano AE, Barragán-Zúñiga LJ, Martínez-Aguilar G, Sosa-Macías M Abstract Introduction: The placenta is a temporary and unique organ that allows for the physical connection between a mother and fetus; this organ regulates the transport of gases and nutrients mediating the elimination of waste products contained in the fetal circulation. The placenta performs metabolic and excretion functions, on the basis of multiple enzymatic systems responsible for the oxidation, reducti...
Source: Expert Review of Clinical Pharmacology - March 6, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

The 'entourage effect' or 'hodge-podge hashish': the questionable rebranding, marketing, and expectations of cannabis polypharmacy.
Authors: Cogan PS Abstract Introduction: The concept of a cannabis 'entourage effect' was first coined as a hypothetical afterthought in 1998. Since then, multiple scientific reviews, lay articles, and marketing campaigns have promoted the effect as a wholly beneficial manifestation of polypharmacy expected to modulate the therapeutic effects of cannabis and its derivatives. There is reason to wonder at the authenticity of such claims.Areas covered: A broad definition of the entourage effect is presented, followed by brief summaries of the nature of cannabis polypharmacy and the commonly cited contributing phytoche...
Source: Expert Review of Clinical Pharmacology - March 4, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Participants' written informed consent in low-risk pragmatic clinical trials with medicines.
Authors: Dal-Ré R Abstract Introduction: An important gap within modern medicine is the lack of enough comparative effectiveness research of marketed medicines. Low-risk pragmatic randomized controlled trials (pRCTs) are those conducted resembling usual clinical practice that pose no or minimal incremental risk compared with normal clinical practice.Areas covered: This review addresses one important hurdle in the conduct of low-risk pRCTs: the need to seek participants' written informed consent.Expert opinion: The CIOMS ethical guidelines consider that any research that a) would not be feasible or practicabl...
Source: Expert Review of Clinical Pharmacology - February 21, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Association between the membrane transporter proteins and type 2 diabetes mellitus.
Authors: Saha S Abstract Introduction: The prevalence rate of diabetes is increasing day by day and the current scenario of the available agents for its treatment has given rise to stimulation in the search for new therapeutic targets and agents. Therefore the present review will examine the role of membrane composition in the pathophysiology of Type 2 Diabetes and the possible therapeutic approaches for this.Areas covered: Glucose transporter proteins (GLUTs) are integral membrane proteins which are responsible for facilitated glucose transport over the plasma membrane into cells. Thus, this chapter is an attempt ...
Source: Expert Review of Clinical Pharmacology - February 19, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Emerging concepts on the use of ketamine for chronic pain.
Authors: Yang Y, Maher DP, Cohen SP Abstract Introduction: The use of ketamine infusions for chronic pain has surged, with utilization exceeding the proliferation of knowledge. A proposed mechanism for the long-term benefit in chronic pain is that ketamine may alter the affective-motivational component of pain.Areas covered: In this review, we discuss the classification and various dimensions of pain, and explore the effects of ketamine on different pain categories and components. The relationship between ketamine's action at the NMDA receptor, the development of chronic pain, and the its possible role in preventin...
Source: Expert Review of Clinical Pharmacology - January 30, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Nocebo effects and psychotropic drug action - an update.
Authors: Amanzio M, Palermo S PMID: 31995411 [PubMed - as supplied by publisher] (Source: Expert Review of Clinical Pharmacology)
Source: Expert Review of Clinical Pharmacology - January 30, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

The interpretation of China national essential medicines list 2018.
Conclusion: China has a large population and the territorial development is uneven. Although the essence of EMLs is a limited list, NEML should enlarge the choices properly. 2018 NEML provides a comprehensive coverage of diseases. Some of the medicines, including high-priced medicines that were not recommended by WHO. PMID: 31914825 [PubMed - as supplied by publisher] (Source: Expert Review of Clinical Pharmacology)
Source: Expert Review of Clinical Pharmacology - January 10, 2020 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Diagnosis and novel clinical treatment strategies for pyoderma gangrenosum.
Authors: Goldust M, Hagstrom EL, Rathod D, Ortega-Loayza AG Abstract Introduction: Pyoderma gangrenosum (PG) is a non-infectious, reactive inflammatory neutrophilic dermatosis that is commonly associated with autoimmune and neoplastic disorders. There are emerging diagnostic tools and treatment options for PG.Area covered: The diagnosis of PG should be seriously considered when managing ulcers to avoid unnecessary medical and surgical complications with prompt and suitable treatment. There are no standardized treatment guidelines for PG, and current therapy largely depends on severity and progression of disease. Sy...
Source: Expert Review of Clinical Pharmacology - December 27, 2019 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

JAK inhibition in the treatment of alopecia areata - a promising new dawn?
Authors: Ismail FF, Sinclair R Abstract Introduction: Alopecia areata (AA) is a T-cell-mediated disease which produces circular patches of non-scarring hair loss and nail dystrophy. Current treatment options for AA are limited and often yield unsatisfactory results. Pharmacologic inhibition of the Janus kinase (JAK) enzyme family is regrowing hair and reversing nail dystrophy in a number of patients with hitherto refractory AA. The six JAK inhibitors which have been successful in treating AA are tofacitinib, ruxolitinib, baricitinib, CTP-543, PF-06651600 and PF-06700841.Areas covered: This review reports randomized...
Source: Expert Review of Clinical Pharmacology - December 24, 2019 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Steroid-resistant nephrotic syndrome: pharmacogenetics and epigenetics points and views.
Authors: Hejazian SM, Zununi Vahed S, Moghaddas Sani H, Nariman-Saleh-Fam Z, Bastami M, Hosseiniyan Khatibi SM, Ardalan M, Samadi N Abstract Introduction: Nephrotic syndrome (NS) is a common glomerular disease. Glucocorticoids (GCs) as the first-line therapy for NS, cause complete remission in most patients. Although standardized guidelines to treat NS were provided, the therapeutic response varies among these patients. In response to the treatment, NS patients are divided into glucocorticoid-sensitive and -resistant. This variation is due to the differences in pharmacokinetics and pharmacodynamics of GCs in each p...
Source: Expert Review of Clinical Pharmacology - December 20, 2019 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Netarsudil and latanoprost ophthalmic solution for the reduction of intraocular pressure in open-angle glaucoma or ocular hypertension.
This article will cover Phase II-III clinical efficacy and safety data as well as basic science literature pertaining to the agent's mechanism of action and pharmacodynamics. In selecting articles for inclusion in this review, a literature search using the PubMed database was carried out. Cross-referencing was carried out where applicable. We did not use any date or language restrictions in electronic searches.Expert opinion: Netarsudil and latanoprost ophthalmic solution plays a pivotal role in management of individuals with OAG and OHTN. The agent may be used as first-line therapy to provide substantial IOP-lowering or w...
Source: Expert Review of Clinical Pharmacology - December 18, 2019 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Efficacy and Safety of Lorcaserin in Obesity: A Systematic Review and Meta-analysis of Randomized Controlled Trials.
Authors: Singh AK, Singh R Abstract BACKGROUND: Lorcaserin is a novel, selective 5-hydroxytryptamine 2C serotonin receptor agonist, approved for the treatment of obesity. Several phase 3 randomized controlled trials (RCTs) trials have shown a significant reduction in body weight with lorcaserin. RESEARCH DESIGN AND METHODS: We systematically searched the database of PubMed, Embase, The Cochrane Library and ClinicalTrials.gov up to July 31, 2019 and retrieved all the studies conducted with lorcaserin for ≥ 1-year that have explicitly reported the efficacy and safety outcomes versus placebo. Subsequently, we s...
Source: Expert Review of Clinical Pharmacology - December 11, 2019 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Erdafitinib for the treatment of metastatic bladder cancer.
Authors: Montazeri K, Bellmunt J Abstract Introduction: Since the approval of immune checkpoint inhibitors (ICIs), there has been continuing and significant progress in urothelial cancer (UC) treatment. However, only about one fifth of UC patients respond to ICI. Recently, erdafitinib was developed for treating locally advanced or metastatic UC (mUC) with FGFR3 or FGFR2 alterations, accounting for 15-20% of patients. Erdafitinib is the first targeted therapy ever approved for mUC.Areas covered: This review summarizes the preclinical and clinical data on erdafitinib for UC. PubMed search and relevant articles presen...
Source: Expert Review of Clinical Pharmacology - December 8, 2019 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

HCV-infected solid organ donors, direct-acting antivirals and the current challenges.
Authors: Fabrizi F, Cerutti R, Silva M Abstract Introduction: The introduction of direct-acting antiviral therapy has generated tremendous interest in transplanting organs from HCV-infected donors, an option which has the potential to lower waiting times for solid organ transplantation (including kidneys). Safe, effective and pangenotypic direct-acting antiviral agents are currently available.Areas covered: We have identified studies from PubMed, EMBASE, and the Cochrane database to review risks and benefits on solid organ transplantation from HCV exposed donors in uninfected recipients.Expert opinion: The transmis...
Source: Expert Review of Clinical Pharmacology - December 4, 2019 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

STOPP/START criteria for potentially inappropriate medications/potential prescribing omissions in older people: origin and progress.
Authors: O'Mahony D Abstract Introduction: STOPP (Screening Tool of Older Persons' Prescriptions) and START (Screening Tool to Alert to Right Treatment) are explicit criteria that facilitate medication review in multi-morbid older people in most clinical settings. This review examines the clinical trial evidence pertaining to STOPP/START criteria as an intervention.Areas covered: The literature was searched for registered clinical trials that used STOPP/START criteria as an intervention. In single-center trials, applying STOPP/START criteria improved medication appropriateness, reduced polypharmacy, reduced adverse...
Source: Expert Review of Clinical Pharmacology - December 4, 2019 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Adjunctive therapy to treat neonatal sepsis.
Authors: Esposito S, Principi N Abstract Introduction: Neonatal sepsis (NS) is a very severe condition that causes significant morbidity and mortality. The approach to NS is based on measures that can eliminate pathogens and overcome clinical manifestations derived from the immune process that follows pathogen invasion.Areas covered: To overcome the limits of antibiotic therapy and improve NS outcomes, measures chosen among those theoretically able to improve host defences or positively interfere with deleterious immune responses could be suggested. This paper discusses the mechanisms of action of these measures, w...
Source: Expert Review of Clinical Pharmacology - December 4, 2019 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research

Cognitive impairment with diabetes mellitus and metabolic disease: innovative insights with the mechanistic target of rapamycin and circadian clock gene pathways.
Authors: Maiese K Abstract Introduction: Dementia is the 7th leading cause of death that imposes a significant financial and service burden on the global population. Presently, only symptomatic care exists for cognitive loss, such as Alzheimer's disease.Areas Covered: Given the advancing age of the global population, it becomes imperative to develop innovative therapeutic strategies for cognitive loss. New studies provide insight to the association of cognitive loss with metabolic disorders, such as diabetes mellitus.Expert Opinion: Diabetes mellitus is increasing in incidence throughout the world and affects 350 m...
Source: Expert Review of Clinical Pharmacology - December 4, 2019 Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research