-
Analyzing the Efficacy of Isotretinoin in Treating Dissecting Cellulitis: A Literature Review and Meta-Analysis Drugs R D (IF 2.277) Pub Date : 2021-01-02 William Guo, Chencan Zhu, Gregg Stevens, David Silverstein
Background and Objective Dissecting cellulitis of the scalp is a primary scarring alopecia. Isotretinoin is commonly referenced in the literature as a treatment for dissecting cellulitis. The objective of this article was to conduct a review and meta-analysis to assess the efficacy of isotretinoin for treating dissecting cellulitis of the scalp. Methods The following databases were searched for articles
-
Effect of Preoperative Infusion of Levosimendan on Biomarkers of Myocardial Injury and Haemodynamics After Paediatric Cardiac Surgery: A Randomised Controlled Trial Drugs R D (IF 2.277) Pub Date : 2020-12-24 Ana Abril-Molina, Jose M. Gómez-Luque, Francesca Perin, María Esteban-Molina, Andrea Ferreiro-Marzal, Cristina Fernandez-Guerrero, Esther Ocete-Hita
Objective The aim was to test the hypothesis that preoperative infusion of levosimendan would decrease patients’ cardiac biomarker profiles during the immediate postoperative stage (troponin I and B-type natriuretic peptide levels) more efficiently than placebo after cardiopulmonary bypass. Methods In a randomised, placebo-controlled, double-blinded study, 30 paediatric patients were scheduled for
-
Standardization and Chemical Characterization of Intravenous Therapy in Adult Patients: A Step Further in Medication Safety Drugs R D (IF 2.277) Pub Date : 2020-12-21 Silvia Manrique-Rodríguez, Irene Heras-Hidalgo, M. Sagrario Pernia-López, Ana Herranz-Alonso, M. Camino del Río Pisabarro, M. Belén Suárez-Mier, M. Antonia Cubero-Pérez, Verónica Viera-Rodríguez, Noemí Cortés-Rey, Elizabeth Lafuente-Cabrero, M. Carmen Martínez-Ortega, Esther Bermejo-López, Cristina Díez-Sáenz, Piedad López-Sánchez, M. Luisa Gaspar-Carreño, Rubén Achau-Muñoz, Juan F. Márquez-Peiró,
Background Intravenous drug administration is associated with potential complications, such as phlebitis. The physiochemical characteristics of the infusate play a very important role in some of these problems. Aim The aim of this study was to standardize the dilutions of intravenous drugs most commonly used in hospitalized adult patients and to characterize their pH, osmolarity and cytotoxic nature
-
Recommendations for Dosing of Repurposed COVID-19 Medications in Patients with Renal and Hepatic Impairment Drugs R D (IF 2.277) Pub Date : 2020-12-17 Fiona Marra, Elise J. Smolders, Omar El-Sherif, Alison Boyle, Katherine Davidson, Andrew J. Sommerville, Catia Marzolini, Marco Siccardi, David Burger, Sara Gibbons, Saye Khoo, David Back
Introduction In December 2019, an outbreak of a novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began, resulting in a number of antivirals and immune modulators being repurposed to treat the associated coronavirus disease 2019 (COVID-19). Many patients requiring treatment for COVID-19 may have either pre-existing renal or hepatic disease or experience acute renal/hepatic injury as
-
Safety and Antitumor Activity of Repeated ASP3026 Administration in Japanese Patients with Solid Tumors: A Phase I Study Drugs R D (IF 2.277) Pub Date : 2020-12-17 Akira Ono, Haruyasu Murakami, Takashi Seto, Toshio Shimizu, Sawori Watanabe, Shigeru Takeshita, Kentaro Takeda, Junko Toyoshima, Itsuro Nagase, Erkut Bahceci, Maiko Morishita, Satoshi Morita, Masahiro Fukuoka, Kazuhiko Nakagawa
Background and Objective Anaplastic lymphoma kinase gene rearrangements (ALKr) resulting in EML4–ALK proteins occur in a subset of solid tumors and are targeted by ALK inhibitors. Given the development of drug resistance to ALK inhibitors, ALK inhibitors with different kinase selectivity are required. Methods This phase I, non-randomized, open-label study evaluated the dose-limiting toxicity (DLT)
-
Dosing Considerations for Antibodies Against COVID-19 Drugs R D (IF 2.277) Pub Date : 2020-12-01 Million A. Tegenge, Iftekhar Mahmood, Evi Struble, Basil Golding
At present, no cure is available for COVID-19 but vaccines, antiviral drugs, immunoglobulins, or the combination of immunoglobulins with antiviral drugs have been suggested and are in clinical trials. The purpose of this paper is to discuss the role of a pharmacokinetic and viral load analysis as a basis for adjusting immunoglobulin dosing to treat COVID-19. We reviewed the pre-clinical and clinical
-
Differences in In Vitro Properties of Pancreatin Preparations for Pancreatic Exocrine Insufficiency as Marketed in Russia and CIS Drugs R D (IF 2.277) Pub Date : 2020-11-19 Igor V. Maev, Yury A. Kucheryavyy, Natalya B. Gubergrits, Ingo Bonnacker, Ekaterina A. Shelest, Gwendolyn P. Janssen-van Solingen, J. Enrique Domínguez-Muñoz
Background Pancreatic enzyme-replacement therapy (PERT), provided as pancreatin to patients with pancreatic exocrine insufficiency (PEI), is considered an essential substitute for the pivotal physiological function the pancreas fulfills in digestion. PEI involves a reduction in the synthesis and secretion of pancreatic enzymes (lipase, protease, amylase), which leads to an inadequate enzymatic response
-
A GFR-Based Method to Predict the Effect of Renal Impairment on the Exposure or Clearance of Renally Excreted Drugs: A Comparative Study Between a Simple GFR Method and a Physiologically Based Pharmacokinetic Model Drugs R D (IF 2.277) Pub Date : 2020-11-04 Iftekhar Mahmood
Objective The objective of this study was to compare the predictive performances of a glomerular filtration rate (GFR) model with a physiologically based pharmacokinetic (PBPK) model to predict total or renal clearance or area under the curve of renally excreted drugs in subjects with varying degrees of renal impairment. Methods From the literature, 11 studies were randomly selected in which total
-
A Pharmacokinetic Bridging Study to Compare Systemic Exposure to Budesonide between Budesonide Oral Suspension and ENTOCORT EC in Healthy Individuals Drugs R D (IF 2.277) Pub Date : 2020-10-15 Ivy H. Song, Richard D. Finkelman, Lan Lan
Background and Objectives Currently, there are no US FDA-approved therapies for eosinophilic esophagitis (EoE). Budesonide oral suspension (BOS; SHP621, TAK-721) is a viscous, muco-adherent, oral formulation of budesonide that is in phase III development for the treatment of EoE. BOS 2 mg twice daily was studied in 12- and 36-week phase III studies for the induction and maintenance of clinical remission
-
Comparisons of Four Protein-Binding Models Characterizing the Pharmacokinetics of Unbound Phenytoin in Adult Patients Using Non-Linear Mixed-Effects Modeling Drugs R D (IF 2.277) Pub Date : 2020-10-07 Heajin Jun, Yan Rong, Catharina Yih, Jordan Ho, Wendy Cheng, Tony K. L. Kiang
Background and objective Phenytoin is extensively protein bound with a narrow therapeutic range. The unbound phenytoin is pharmacologically active, but total concentrations are routinely measured in clinical practice. The relationship between free and total phenytoin has been described by various binding models with inconsistent findings. Systematic comparison of these binding models in a single experimental
-
Population Pharmacokinetic Model of Plasma and Cellular Mycophenolic Acid in Kidney Transplant Patients from the CIMTRE Study Drugs R D (IF 2.277) Pub Date : 2020-10-06 François Riglet, Julie Bertrand, Aurélie Barrail-Tran, Céline Verstuyft, Hugues Michelon, Henri Benech, Antoine Durrbach, Valérie Furlan, Caroline Barau
Background and Objective Mycophenolate mofetil is widely used in kidney transplant recipients. Mycophenolate mofetil is hydrolysed by blood esterases to mycophenolic acid (MPA), the active drug. Although MPA therapeutic drug monitoring has been recommended to optimise the treatment efficacy by the area under the plasma concentration vs time curve, little is known regarding MPA concentrations in peripheral
-
Systematic Review: Monoclonal Antibody-Induced Subacute Cutaneous Lupus Erythematosus. Drugs R D (IF 2.277) Pub Date : 2020-09-22 Chrissy Bolton,Yifan Chen,Rachel Hawthorne,Ianthe R M Schepel,Elinor Harriss,Silke C Hofmann,Spencer Ellis,Alexander Clarke,Helena Wace,Blanca Martin,Joel Smith
Background Subacute cutaneous lupus erythematosus (SCLE) lacks consensus diagnostic criteria and the pathogenesis is poorly understood. There are increasing reports of SCLE induced by monoclonal antibodies (mAbs), but there are limited data on the aetiology, clinical characteristics and natural course of this disease. Methods We devised a set of diagnostic criteria for SCLE in collaboration with a
-
Comparability Considerations and Challenges for Expedited Development Programs for Biological Products. Drugs R D (IF 2.277) Pub Date : 2020-09-10 Sarah J Schrieber,Wendy S Putnam,Edwin Chiu Yuen Chow,Jacek Cieslak,Yanli Zhuang,Steven W Martin,Paul Hanson,Frank Maggio,Leslie A Rivera Rosado
Expedited development programs for biological products to be used in the treatment of serious conditions bring about challenges because of the compressed clinical development timeframes. As expedited development does not lessen the quality expectations, one challenge is providing adequate chemistry, manufacturing, and control (CMC) information required to support approval of a biological product. In
-
Nimodipine Pharmacokinetic Variability in Various Patient Populations. Drugs R D (IF 2.277) Pub Date : 2020-09-09 Sherif Hanafy Mahmoud,Xinqi Ji,Fadumo Ahmed Isse
Nimodipine has been shown to improve outcomes following aneurysmal subarachnoid hemorrhage. Guidelines recommend that all patients receive a fixed dose of oral nimodipine for 21 days. However, pharmacokinetic studies have suggested variability of nimodipine pharmacokinetics in subarachnoid hemorrhage and in other patient populations. The clinical relevance of such variability is unknown. Therefore
-
Remimazolam Has Low Oral Bioavailability and No Potential for Misuse in Drug-Facilitated Sexual Assaults, with or Without Alcohol: Results from Two Randomised Clinical Trials. Drugs R D (IF 2.277) Pub Date : 2020-08-05 Marija Pesic,Thomas Stöhr,Joachim Ossig,Keith Borkett,Martin Donsbach,Van-Anh Dao,Lynn Webster,Frank Schippers
Background and Objectives Remimazolam is a new ultra-short-acting benzodiazepine currently being developed for intravenous use in procedural sedation, general anaesthesia, and intensive care unit sedation. Benzodiazepines represent a drug class associated with drug-facilitated sexual assaults, especially in combination with alcohol. Two clinical trials were designed to evaluate the oral bioavailability
-
Combined Intravenous Sildenafil and L-Arginine Administration in a Porcine Animal Model: Hemodynamic Safety Profile and Effects on Coronary Blood Flow. Drugs R D (IF 2.277) Pub Date : 2020-07-27 Marek Brzezinski,Gabriela R Dincheva,Kelsey Alloo,Celeste Wong,Chun-Miao Feng,Wynnis L Tom,Ali Salahieh,Arthur W Wallace
Background Endothelial dysfunction in the nitric oxide-cyclic guanosine monophosphate pathway is a potential contributor to perioperative myocardial ischemia. The nitric oxide precursor, l-arginine, and the cyclic guanosine monophosphate degradation blocker, sildenafil, have vasodilatory effects under high dosage. Objective This study examined the hemodynamic safety and effect profiles of the combined
-
Fingolimod as a Treatment in Neurologic Disorders Beyond Multiple Sclerosis. Drugs R D (IF 2.277) Pub Date : 2020-07-22 Pablo Bascuñana,Luisa Möhle,Mirjam Brackhan,Jens Pahnke
Fingolimod is an approved treatment for relapsing–remitting multiple sclerosis (MS), and its properties in different pathways have raised interest in therapy research for other neurodegenerative diseases. Fingolimod is an agonist of sphingosine-1-phosphate (S1P) receptors. Its main pharmacologic effect is immunomodulation by lymphocyte homing, thereby reducing the numbers of T and B cells in circulation
-
Population Pharmacokinetics of Magnesium Sulfate in Preeclampsia and Associated Factors. Drugs R D (IF 2.277) Pub Date : 2020-07-08 Tatiana Xavier da Costa,Francine Johansson Azeredo,Marcela Abbott Galvão Ururahy,Miguel Adelino da Silva Filho,Rand Randall Martins,Antonio Gouveia Oliveira
Background and Objective The pharmacokinetic basis of magnesium sulphate (MgSO4) dosing regimens for preeclampsia (PE) prophylaxis and treatment is not clearly established. The aim of study is to develop a population pharmacokinetic (PK) model of MgSO4 in PE, and to determine key covariates having an effect in MgSO4 pharmacokinetics in preeclampsia (PE) and to determine key covariates having an effect
-
Pexidartinib (TURALIO™): The First FDA-Indicated Systemic Treatment for Tenosynovial Giant Cell Tumor. Drugs R D (IF 2.277) Pub Date : 2020-07-02 Shanada Monestime,Dovena Lazaridis
Tenosynovial giant cell tumor is a rare proliferative tumor that arises from the synovium, bursae, or tendon sheaths due to an overproduction of colony-stimulating factor 1. Historically, treatment options for patients with local or diffuse tenosynovial giant cell tumor have been limited to surgical interventions. However, for some patients, surgical resection could worsen functional limitations and/or
-
Identification of a Potential Peptide Inhibitor of SARS-CoV-2 Targeting its Entry into the Host Cells. Drugs R D (IF 2.277) Pub Date : 2020-06-26 Mirza S Baig,Manikandan Alagumuthu,Sajjan Rajpoot,Uzma Saqib
Background and objective Coronavirus disease (COVID-19) is an ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Due to the incessant spread of the disease with substantial morbidity and mortality rates, there is an urgent demand for effective therapeutics and vaccines to control and diminish this pandemic. A critical step in the crosstalk between the virus and
-
Ex-vivo Sensitivity of Plasmodium falciparum to Common Anti-malarial Drugs: The Case of Kéniéroba, a Malaria Endemic Village in Mali. Drugs R D (IF 2.277) Pub Date : 2020-06-18 Karim Traoré,Seidina A S Diakité,Sekou Bah,Drissa S Konaté,Djeneba Dabitao,Ibrahim Sanogo,Modibo Sangaré,Souleymane Dama,Bourama Keita,Mory Doumbouya,Merepen A Guindo,Seydou Doumbia,Mahamadou Diakité
Background In 2006, the National Malaria Control Program in Mali recommended artemisinin-based combination therapy as the first-line treatment for uncomplicated malaria. Since the introduction of artemisinin-based combination therapy, few reports are available on the level of resistance of Plasmodium falciparum to the most common anti-malarial drugs in Mali. Methods From 2016 to 2017, we assessed the
-
Cutaneous Adverse Events in Newly Approved FDA Non-cancer Drugs: A Systematic Review. Drugs R D (IF 2.277) Pub Date : 2020-06-17 Paul C Macklis,Brittany Dulmage,Brady Evans,Misha Rosenbach,Johann E Gudjonsson,Benjamin H Kaffenberger
The prevalence of cutaneous adverse events attributable to newly approved anti-cancer drugs has been well reviewed in the dermatologic literature. In contrast, over 75% of US Food and Drug Administration approvals in the past 5 years have been for non-cancer drugs and indications. This represents multiple other categories of approved medications associated with cutaneous adverse reactions. To investigate
-
Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study. Drugs R D (IF 2.277) Pub Date : 2020-06-06 David Kellstein,Rina Leyva
Introduction Ibuprofen and acetaminophen provide analgesia via different mechanisms of action and do not exhibit drug–drug interactions; therefore, combining low doses of each may provide greater efficacy without compromising safety. Objectives The present study assessed the analgesic efficacy of fixed-dose combinations (FDCs) of ibuprofen/acetaminophen (IBU/APAP) compared with ibuprofen 400 mg and
-
In-Vitro Sorbent-Mediated Removal of Edoxaban from Human Plasma and Albumin Solution. Drugs R D (IF 2.277) Pub Date : 2020-05-15 Alexandra A Angheloiu,Yanglan Tan,Cristian Ruse,Scott A Shaffer,George O Angheloiu
Background and Objective Based on previous experience of sorbent-mediated ticagrelor, dabigatran, and radiocontrast agent removal, we set out in this study to test the effect of two sorbents on the removal of edoxaban, a factor Xa antagonist direct oral anticoagulant. Methods We circulated 100 mL of edoxaban solution during six first-pass cycles through 40-mL sorbent columns (containing either CytoSorb
-
Intravenous Tramadol is Effective in the Management of Postoperative Pain Following Abdominoplasty: A Three-Arm Randomized Placebo- and Active-Controlled Trial. Drugs R D (IF 2.277) Pub Date : 2020-05-14 Harold Minkowitz,Hernan Salazar,David Leiman,Daneshvari Solanki,Lucy Lu,Scott Reines,Michael Ryan,Mark Harnett,Neil Singla
Background and Objective Oral tramadol, an atypical opioid approved in the United States (US) since 1995 and a Schedule IV controlled substance, has less abuse liability compared to Schedule II conventional opioids. Intravenous (IV) tramadol is not available in the US, but has the potential to fill a gap between non-opioid medications and conventional opioids for treatment of acute pain. This study
-
In Vitro Investigation of Auranofin as a Treatment for Clostridium difficile Infection. Drugs R D (IF 2.277) Pub Date : 2020-05-06 Christine Roder,Eugene Athan
Background Clostridium difficile infection is the leading cause of hospital-acquired gastrointestinal infection and incidence rates continue to rise. Clostridium difficile infection is becoming increasingly complex to treat owing to the rise in treatment failures and recurrent infections. There is a clear need for new therapeutic options for the management of this disease. Objective This study aimed
-
Public Health Outcomes May Differ After Switching from Brand-Name to Generic Angiotensin II Receptor Blockers. Drugs R D (IF 2.277) Pub Date : 2020-04-27 Jacinthe Leclerc,Claudia Blais,Louis Rochette,Denis Hamel,Line Guénette,Claudia Beaudoin,Paul Poirier
Background It is unclear whether generics are as safe as brand-name drugs in cardiology. For public health surveillance purposes, we evaluated if switching from the brand-name losartan, valsartan, or candesartan impacted the occurrence of the following outcomes: emergency room (ER) consultations, hospitalizations, or death. Study Design This was a retrospective cohort study. Methods This study was
-
Frequency and Types of Pathological Upper Gastrointestinal Endoscopy Findings in Clinically Healthy Individuals. Drugs R D (IF 2.277) Pub Date : 2020-04-25 Elisabeth Scheidl,Claus Benz,Peter Loeff,Volker Groneck,Andreas König,Alban Schulte-Fischedick,Hendrik Lück,Uwe Fuhr
Background and objective Beyond its application for diagnostics in patients, esophagogastroduodenoscopy (EGD) is used to assess gastrointestinal drug effects in clinical trials, where the interpretation of any pathological findings depends on the respective background variability. The objective of this analysis was to characterize the occurrence of pathological findings in the upper gastrointestinal
-
An Ex Vivo Evaluation of Cenobamate Administered via Enteral Tubes. Drugs R D (IF 2.277) Pub Date : 2020-04-23 Louis Ferrari,Arkady Nisman,Augustin Pegan,Jordan Ursino
Background Cenobamate is a new, Food and Drug Administration (FDA)-approved oral antiepileptic drug for treatment of focal seizures in adults. This study examined recovery of cenobamate from suspensions administered through ex vivo enteral feeding tubes. Methods Suspensions containing 100 and 200 mg of cenobamate were prepared (five duplicates for each dose), passed through five vertically standing
-
Combining Isotopic Tracer Techniques to Increase Efficiency of Clinical Pharmacokinetic Trials in Oncology. Drugs R D (IF 2.277) Pub Date : 2020-04-16 Jeroen Roosendaal,Hilde Rosing,Jos H Beijnen
With increasing numbers of drugs tested in oncology for smaller patient populations, fewer patients are available to answer important clinical pharmacological questions in the timeframe of clinical drug development. The quality and efficiency of trials to assess the pharmacokinetics of new drugs can be improved by making better use of available resources. One approach to do this is by making more effective
-
Assessment of Vancomycin Pharmacokinetics and Dose Regimen Optimisation in Preterm Neonates. Drugs R D (IF 2.277) Pub Date : 2020-04-08 Mwila Mulubwa,Heletje Aletta Griesel,Pierre Mugabo,Ricky Dippenaar,Lizelle van Wyk
Background The pharmacokinetics of vancomycin, a drug used for the treatment of methicillin-resistant Staphylococcus aureus (MRSA), varies between paediatric and adult patients. Objective The objective of this study was to assess the pharmacokinetics of vancomycin in preterm neonates and determine the optimum dose regimen. Methods This was a randomised double-blind study of preterm neonates admitted
-
Efficacy and Safety of VB-1953 Topical Gel in Non-Responder Acne Patients with Clindamycin-Resistant Cutibacterium acnes. Drugs R D (IF 2.277) Pub Date : 2020-03-28 Rohit Batra,Suresh Sadhasivam,Swamini Saini,Swati Gupta,Rahul Kumar Singh Bisen,Mau Sinha,Shamik Ghosh,Shilpi Jain
Background and Objectives The emergence of resistant strains of Cutibacterium acnes can limit the efficacy of currently approved antibiotics for acne. VB-1953 is a next-generation antibiotic that exerts a bactericidal effect on resistant C. acnes. In this study, we investigated the safety, tolerability, and efficacy of VB-1953 topical gel in patients with moderate to severe acne having clindamycin-resistant
-
Poly (ADP-Ribose) Polymerase Inhibitors: Talazoparib in Ovarian Cancer and Beyond. Drugs R D (IF 2.277) Pub Date : 2020-03-25 Stergios Boussios,Charlotte Abson,Michele Moschetta,Elie Rassy,Afroditi Karathanasi,Tahir Bhat,Faisal Ghumman,Matin Sheriff,Nicholas Pavlidis
Genetic complexity and DNA damage repair defects are common in different cancer types and can induce tumor-specific vulnerabilities. Poly(ADP-ribose) polymerase (PARP) inhibitors exploit defects in the DNA repair pathway through synthetic lethality and have emerged as promising anticancer therapies, especially in tumors harboring deleterious germline or somatic breast cancer susceptibility gene (BRCA)
-
Dolutegravir-Based Antiretroviral Regimens for HIV Liver Transplant Patients in Real-Life Settings. Drugs R D (IF 2.277) Pub Date : 2020-03-18 Dario Cattaneo,Salvatore Sollima,Paola Meraviglia,Laura Milazzo,Davide Minisci,Marta Fusi,Carlo Filice,Cristina Gervasoni
Background and Objectives Liver transplantation is now considered a safe procedure in patients with HIV because of the advent of potent antiretroviral therapies (ART). Objective We aimed to describe the use of dolutegravir-based maintenance ART in patients with HIV and liver transplant regularly followed in our hospital. Methods We searched the database of our Department of Infectious Diseases for
-
Concordance of Vancomycin Population-Predicted Pharmacokinetics with Patient-Specific Pharmacokinetics in Adult Hospitalized Patients: A Case Series. Drugs R D (IF 2.277) Pub Date : 2020-03-12 IfeanyiChukwu O Onor,Alison Neuliep,Kieu Anh Tran,Jennifer Lambert,Christopher J Gillard,Fatima Brakta,Michael C Ezebuenyi,Kirbie St James,John I Okogbaa,Robbie A Beyl
Background Vancomycin empiric therapy is commonly dosed using clinical algorithms adapted from population-predicted pharmacokinetic parameters. However, precise dosing of vancomycin can be designed using patient-specific pharmacokinetic calculations. Objective The objective of this study is to assess the correlational fit between vancomycin population-predicted and patient-specific pharmacokinetic
-
Plasma Polyethylene Glycol (PEG) Levels Reach Steady State Following Repeated Treatment with N8-GP (Turoctocog Alfa Pegol; Esperoct®). Drugs R D (IF 2.277) Pub Date : 2020-03-09 Inga Bjørnsdottir,Birgitte Støvring,Tue Søeborg,Helene Jacobsen,Ola Sternebring
Background Extended half-life (EHL) factor VIII (FVIII)-replacement therapies enable patients with haemophilia A to maintain higher activity levels with fewer injections. N8-GP (turoctocog alfa pegol; Esperoct®) is an EHL product derived from conjugation of polyethylene glycol (PEG) to a recombinant FVIII protein. Upon activation, PEG is released from the active protein and excreted in urine and faeces
-
Phase I Pharmacokinetic Study of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in Healthy Adult and Adolescent Populations Drugs R D (IF 2.277) Pub Date : 2020-03-04 Sanela Tarabar,Debra Kelsh,Bradley Vince,Rina Leyva,Dongweon Song,Kyle Matschke,David E. Kellstein,Suzanne Meeves,Mario Cruz-Rivera
Introduction A fixed-dose combination (FDC) of ibuprofen and acetaminophen has been developed that provides greater analgesic efficacy than either agent alone at the same doses without increasing the risk for adverse events. Methods We report three clinical phase I studies designed to assess the pharmacokinetics (PK) of the FDC of ibuprofen/acetaminophen 250/500 mg (administered as two tablets of ibuprofen
-
Intramuscular Clodronate in Long-Term Treatment of Symptomatic Knee Osteoarthritis: A Randomized Controlled Study. Drugs R D (IF 2.277) Pub Date : 2020-02-20 Bruno Frediani,Carmela Toscano,Paolo Falsetti,Antonella Nicosia,Serena Pierguidi,Alberto Migliore,Stefano Giannotti,Luca Cantarini,Edoardo Conticini
BACKGROUND AND OBJECTIVE Clodronate is a nitrogen-free bisphosphonate that is widely and effectively used in the treatment of many osteo-metabolic disorders. The objective of our study was to evaluate the effectiveness of clodronate in reducing pain and bone marrow edema in knee osteoarthritis. METHODS In total, 74 patients were included in the study. Group 1 received intramuscular clodronate 200 mg
-
Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome. Drugs R D (IF 2.277) Pub Date : 2020-02-19 Michael Rosenbloom,Terry Barclay,Justin Johnsen,Lauren Erickson,Aleta Svitak,Maria Pyle,William Frey,Leah R Hanson
BACKGROUND Individuals with Down syndrome are likely to develop clinical and neuropathological brain changes resembling Alzheimer's disease dementia by the ages of 35-40 years. Intranasal insulin is a potential treatment for neurodegenerative disease that has been shown to reduce amyloid plaque burden and improve verbal memory performance in normal as well as memory-impaired adults. Investigations
-
Prediction of Clearance in Children from Adults Following Drug-Drug Interaction Studies: Application of Age-Dependent Exponent Model. Drugs R D (IF 2.277) Pub Date : 2020-02-13 Iftekhar Mahmood
BACKGROUND AND OBJECTIVE Pharmacokinetic drug-drug interaction (DDI) studies are conducted in adult subjects during drug development but there are limited studies that have characterized pharmacokinetic DDI studies in children. The objective of this study was to evaluate if the DDI clearance values from adults can be allometrically extrapolated from adults to children. METHODS Fifteen drugs were included
-
Evaluation of Fosphenytoin Therapeutic Drug Monitoring in the Neurocritical Care Unit. Drugs R D (IF 2.277) Pub Date : 2020-01-10 Mandee Noval,Hyunuk Seung,Michael Armahizer
OBJECTIVE The aim of this study was to determine whether the current method of calculating a fosphenytoin reloading dose results in a therapeutic free phenytoin level on subsequent days. METHODS Medical records of patients receiving fosphenytoin in the neurocritical care unit between July 2017 and June 2018 were screened. Included patients were those who had received at least three doses of fosphenytoin
-
Extrapolation of Drug Clearance in Children ≤ 2 Years of Age from Empirical Models Using Data from Children (> 2 Years) and Adults Drugs R D (IF 2.277) Pub Date : 2019-12-09 Iftekhar Mahmood
Background The application of modeling and simulation approaches in clinical pharmacology studies has gained momentum over the last 20 years. Objectives The objective of this study was to develop six empirical models from clearance data obtained from children aged > 2 years and adults to evaluate the suitability of the models to predict drug clearance in children aged ≤ 2 years (preterm, term, and
-
The Effect of Fluctuating Temperature on the Stability of Turoctocog Alfa for Hemophilia A. Drugs R D (IF 2.277) Pub Date : 2019-12-01 Mariasanta Napolitano,Anne Mette Nøhr
BACKGROUND AND OBJECTIVE Factor VIII (FVIII) is indicated for the prevention or treatment of bleeding in patients with hemophilia A. FVIII product stability under high and fluctuating temperatures is important, particularly for patients who reside in, or travel to, regions with high ambient temperatures, as they may remove their product from the refrigerator and return it, unused, multiple times. We
-
Use of Selective Serotonin Reuptake Inhibitors and Outcomes in Stroke Rehabilitation: A Prospective Observational Pilot Cohort Study. Drugs R D (IF 2.277) Pub Date : 2019-12-01 See-Hwee Yeo,Keng He Kong,Derek Chi-Kien Lim,Wai-Ping Yau
PURPOSE The aim of this study was to examine the association between selective serotonin reuptake inhibitor (SSRI) therapy and rehabilitation outcomes, specifically disability and quality of life (QOL), in a real-world setting of multi-ethnic Asian patients with first-ever stroke. METHODS In this prospective observational pilot cohort study, we included patients with first-ever stroke admitted to two
-
A Clinician's Guide to the Recognition and Management of Dupilumab-Associated Conjunctivitis. Drugs R D (IF 2.277) Pub Date : 2019-12-01 Gaurav Agnihotri,Katherine Shi,Peter A Lio
Dupilumab, a monoclonal antibody that inhibits both interleukin (IL)-4 and IL-13 signaling, is an effective treatment option in moderate-to-severe atopic dermatitis (AD). Patients with AD are already at increased risk of developing conjunctivitis, and clinical trials and case reports have shown a greater incidence of conjunctivitis in individuals with AD treated with dupilumab. As this is one of the
-
The Selective Oral Immunomodulator Vidofludimus in Patients with Active Rheumatoid Arthritis: Safety Results from the COMPONENT Study. Drugs R D (IF 2.277) Pub Date : 2019-12-01 Andreas Muehler,Hella Kohlhof,Manfred Groeppel,Daniel Vitt
INTRODUCTION The dihydroorotate dehydrogenase (DHODH) inhibitors leflunomide and teriflunomide are immunomodulatory agents approved to treat rheumatoid arthritis (RA) and multiple sclerosis, respectively, and are actively being investigated as therapeutic agents for other immune-related diseases; however, both structurally related compounds have a number of potentially serious adverse effects. Vidofludimus
-
Are Standard Doses of Renally-Excreted Antiretrovirals in Older Patients Appropriate: A PBPK Study Comparing Exposures in the Elderly Population With Those in Renal Impairment. Drugs R D (IF 2.277) Pub Date : 2019-12-01 M De Sousa Mendes,Manoranjenni Chetty
BACKGROUND AND OBJECTIVES The elderly population receives the majority of prescription drugs but are usually excluded from Phase 1 clinical trials. Alternative approaches to estimate increases in toxicity risk or decreases in efficacy are therefore needed. This study predicted the pharmacokinetics (PK) of three renally excreted antiretroviral drugs in the elderly population and compared them with known
-
Apremilast Normalizes Gene Expression of Inflammatory Mediators in Human Keratinocytes and Reduces Antigen-Induced Atopic Dermatitis in Mice. Drugs R D (IF 2.277) Pub Date : 2019-12-01 Peter H Schafer,Mary Adams,Gerald Horan,Francesca Truzzi,Alessandra Marconi,Carlo Pincelli
BACKGROUND Apremilast, an oral phosphodiesterase (PDE) 4 inhibitor, has demonstrated efficacy in psoriasis, while its efficacy in atopic dermatitis (AD) was found to be modest. AD is a chronic inflammatory skin disease associated with activation of T helper (Th) 2 and Th17 immunity and a compromised epidermal barrier. OBJECTIVE The objectives of this study were to examine the expression of PDE4 isoforms
-
Vasodepressor Effects of Adenosine in the Cat are Independent of Cyclooxygenase, Potassium Channels, and Nitric Oxide Pathways. Drugs R D (IF 2.277) Pub Date : 2019-12-01 Alan David Kaye,Syed R Baber,Mohammed T Sharief,Rachel J Kaye,Elyse M Cornett
BACKGROUND Pulmonary arterial hypertension is a hemodynamic disorder. Signs and symptoms are generally difficult to recognize because they are non-specific. The current treatment for pulmonary arterial hypertension offers no cure or prevention; therefore, it is important to explore treatment avenues for novel pulmonary arterial hypertension treatments. In this study, we tested the hypothesis: pulmonary
-
Characterization of the Pharmacokinetics of Samidorphan in Healthy Volunteers: Absolute Bioavailability and the Effect of Food and Age. Drugs R D (IF 2.277) Pub Date : 2019-09-01 Vipul Kumar,Hong Lu,Marjie Hard,Lisa von Moltke
BACKGROUND AND OBJECTIVES Samidorphan (SAM) is a novel μ-opioid receptor antagonist. We report clinical pharmacokinetic (PK) properties of SAM following different routes of administration, and the effects of food and age on the PK of SAM following oral administration in healthy volunteers. METHODS An open-label, fixed-sequence study (study 1, N = 10) examined the PK parameters following intravenous
-
Prediction of Drug-Drug Interactions Between Opioids and Overdosed Benzodiazepines Using Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation. Drugs R D (IF 2.277) Pub Date : 2019-09-01 Beihong Ji,Shuhan Liu,Ying Xue,Xibing He,Viet Hoang Man,Xiang-Qun Xie,Junmei Wang
BACKGROUND Researchers have long been interested in the potential drug-drug interactions (DDIs) between opioids and benzodiazepines. However, much remains unknown concerning the interactions between these two drug classes. The objective of this work is to study the mechanism underlying the DDIs between opioids and benzodiazepines from the perspective of their pharmacokinetic (PK) interactions. A PK
-
Amount of Cycloserine Emanating from Terizidone Metabolism and Relationship with Hepatic Function in Patients with Drug-Resistant Tuberculosis. Drugs R D (IF 2.277) Pub Date : 2019-09-01 Mwila Mulubwa,Pierre Mugabo
BACKGROUND AND OBJECTIVES The dosing of cycloserine and terizidone is the same, as both drugs are considered equivalent or used interchangeably. Nevertheless, it is not certain from the literature that these drugs are interchangeable. Therefore, the amount of cycloserine resulting from the metabolism of terizidone and the relationship with hepatic function were determined. METHODS This prospective
-
Impact of Primary Tumour Location and Early Tumour Shrinkage on Outcomes in Patients with RAS Wild-Type Metastatic Colorectal Cancer Following First-Line FOLFIRI Plus Panitumumab. Drugs R D (IF 2.277) Pub Date : 2019-09-01 Claus-Henning Köhne,Meinolf Karthaus,Laurent Mineur,Josef Thaler,Marc Van den Eynde,Javier Gallego,Reija Koukakis,Marloes Berkhout,Ralf-Dieter Hofheinz
OBJECTIVE Data from a trial of first-line panitumumab plus FOLFIRI (folinic acid, infusional 5-fluorouracil and irinotecan) in metastatic colorectal cancer were retrospectively analysed to investigate the effects of primary tumour location and early tumour shrinkage on outcomes. METHODS Patients with RAS wild-type metastatic colorectal cancer from a single-arm, open-label phase II study (NCT00508404)
-
Pharmacokinetics of Sublingual Buprenorphine Tablets Following Single and Multiple Doses in Chinese Participants With and Without Opioid Use Disorder. Drugs R D (IF 2.277) Pub Date : 2019-09-01 Ruihua Dong,Hongyun Wang,Dandan Li,Liwei Lang,Frank Gray,Yongzhen Liu,Celine M Laffont,Malcolm Young,Ji Jiang,Zeyuan Liu,Susan M Learned
BACKGROUND Two phase I studies assessed the pharmacokinetics of buprenorphine, its metabolite norbuprenorphine, and naloxone following administration of buprenorphine/naloxone sublingual tablets in Chinese participants. METHODS In the first phase I, open-label, single ascending-dose (SAD) study, 82 opioid-naïve volunteers received a single buprenorphine/naloxone dose ranging from 2 mg/0.5 mg to 24
-
Effects of Age Among Elderly Cancer Patients on Breakthrough Pain Management with Sublingual Fentanyl Tablets. Drugs R D (IF 2.277) Pub Date : 2019-09-01 Jordi Guitart,María Isabel Vargas,Vicente De Sanctis,Jordi Folch,Rafael Salazar,José Fuentes,Joan Coma,Julia Ferreras,Jordi Moya,Albert Tomás,Pere Estivill,Francisco Rodelas,Antonio Javier Jiménez,Almudena Sanz
INTRODUCTION Sublingual fentanyl tablets (SFTs) have been shown to be a safe and effective option in controlling breakthrough cancer pain (BTcP). However, further examination is required to investigate the use of SFTs among the elderly. The aim of this study was to examine the influence of age in BTcP management with SFTs in the elderly population. METHODS We performed subgroup analyses of a recently
-
Elderly Bleeding Risk of Direct Oral Anticoagulants in Nonvalvular Atrial Fibrillation: A Systematic Review and Meta-Analysis of Cohort Studies. Drugs R D (IF 2.277) Pub Date : 2019-09-01 Jessika Lobraico-Fernandez,Salma Baksh,Eric Nemec
INTRODUCTION The 2014 American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines recommend anticoagulation to reduce clot formation and the risk of thromboembolic events in patients with atrial fibrillation but does not specify guidelines for the elderly population. Direct oral anticoagulants (DOACs) are newer US FDA-approved alternatives to warfarin
-
Correction to: Safety and Efficacy of 0.5% Carbomer 980 Gel for Treatment of Symptoms of Common Cold: Results of 2 Randomized Trials. Drugs R D (IF 2.277) Pub Date : 2019-07-22 Lara Dennie,Gilbert Shanga
The original publication of the article contained the following errors.
-
Timing of GLP-1 Receptor Agonist Initiation for Treatment of Type 2 Diabetes in the UK. Drugs R D (IF 2.277) Pub Date : 2019-05-23 Kristina S Boye,Dara Stein,Louis S Matza,Jessica Jordan,Ren Yu,Kirsi Norrbacka,Syed Wasi Hassan,Luis-Emilio García-Pérez
INTRODUCTION Patients with type 2 diabetes mellitus (T2DM) who fail to meet glycaemic control are at increased risk of diabetes complications. For patients who cannot maintain glycaemic control with oral medication, one recommended option is to add an injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA) to their treatment regimen. The purpose of this study was to examine time to treatment
-
Neuropsychiatric Symptoms in Dementia: Considerations for Pharmacotherapy in the USA. Drugs R D (IF 2.277) Pub Date : 2019-05-18 Stephanie V Phan,Sharmon Osae,John C Morgan,Mfon Inyang,Susan C Fagan
Dementia affects all domains of cognition. The relentless progression of the disease after diagnosis is associated with a 98% incidence of neuropsychiatric symptoms (NPS) at some point in the disease, including depression, psychosis, agitation, aggression, apathy, sleep disturbances, and disinhibition. These symptoms can be severe and lead to excess morbidity and mortality. The purpose of this article
-
Towards a Generic Tool for Prediction of Meropenem Systemic and Infection-Site Exposure: A Physiologically Based Pharmacokinetic Model for Adult Patients with Pneumonia. Drugs R D (IF 2.277) Pub Date : 2019-05-16 Pauline Thémans,Pierre Marquet,Joseph J Winkin,Flora T Musuamba
OBJECTIVE The objective of this study was to develop a physiologically based pharmacokinetic model for meropenem using a retrograde approach, which could serve as a basis for prediction of the systemic and infection-site drug exposures in different populations and indications. We intended this model to be a useful tool to inform (local) pharmacokinetic-based optimal dosing of meropenem in different
Contents have been reproduced by permission of the publishers.