Standard imaging techniques in transcatheter aortic valve replacement.
Authors: Salemi A, Worku BM Abstract Transcatheter aortic valve replacement (TAVR) has become a widely accepted therapeutic option for patients with severe, symptomatic aortic stenosis at intermediate, high, or extreme risk for conventional surgery as determined through a heart team approach. Two valve prostheses are currently available and the Food and Drug Administration (FDA) approved in the United States for TAVR: the self-expandable Medtronic CoreValve (Medtronic, Inc., Minneapolis, MN, USA) and the balloon-expandable Edwards Sapien Valve (Edwards Lifesciences, Irvine CA, USA). The preoperative evaluation for ...
Source: Journal of Thoracic Disease - May 27, 2017 Category: Respiratory Medicine Tags: J Thorac Dis Source Type: research
Committee Opinion No. 704 Summary: Human Papillomavirus Vaccination.
Authors: Abstract Human papillomavirus (HPV) is associated with anogenital cancer (including cervical, vaginal, vulvar, penile, and anal), oropharyngeal cancer, and genital warts. The HPV vaccination significantly reduces the incidence of anogenital cancer and genital warts. Despite the benefits of HPV vaccines, only 41.9% of girls in the recommended age group, and only 28.1% of males in the recommended age group have received all recom-mended doses. Compared with many other countries, HPV vaccination rates in the United States are unacceptably low. The U.S. Food and Drug Administration has approved three vaccine...
Source: Obstetrics and Gynecology - May 27, 2017 Category: OBGYN Tags: Obstet Gynecol Source Type: research
Measuring the aggregation of CHO cells prior to single cell cloning allows a more accurate determination of the probability of clonality
This article is protected by copyright. All rights reserved. (Source: Biotechnology Progress)
Source: Biotechnology Progress - May 27, 2017 Category: Biotechnology Authors: Kerensa J. Klottrup, Guillermo Miro ‐Quesada, Layla Flack, Ivan Pereda, Pamela Hawley‐Nelson Tags: Cell Culture and Tissue Engineering Source Type: research
New Treatment for Duchenne Muscular Dystrophy
* Deflazacort (Emflaza) is the first corticosteroid approved by the Food and Drug Administration for the treatment of Duchenne muscular dystrophy. * Adverse effects of deflazacort include weight gain, Cushingoid appearance, and an increased risk of infections. (Source: AJN)
Source: AJN - May 26, 2017 Category: Nursing Tags: Drug Watch Source Type: research
New Injectable Drug Treats Moderate-To-Severe Plaque Psoriasis
* Injectable brodalumab (Siliq), a human monoclonal antibody that inhibits the release of inflammatory cytokines and chemokines, has been approved to treat moderate-to-severe plaque psoriasis. * Because brodalumab may increase the risk of suicidal ideation and behavior, it is only available for those in the Food and Drug Administration's Risk Evaluation and Mitigation Strategy program. (Source: AJN)
Source: AJN - May 26, 2017 Category: Nursing Tags: Drug Watch Source Type: research
A review on cardiovascular effects of newer hypoglycemic medications.
Authors: Cutshall BT, Twilla JD, Olinger AS, Oliphant CS Abstract Cardiovascular disease is the most prevalent cause of morbidity and mortality in diabetic patients. Improvement in cardiovascular complications with glycemic control and managing cardiovascular risk factors is well established. However, the impact of hypoglycemic medications on cardiovascular disease is of increasing importance. In 2008 the U.S. Food and Drug Administration issued study regulations for hypoglycemic agents after rosiglitazone was shown to increase the incidence of myocardial infarction, and the European Medicines Agency provided their...
Source: Annals of Medicine - May 26, 2017 Category: Internal Medicine Tags: Ann Med Source Type: research
Normal, Regular, and Standard: Scaling the Body through Fecal Microbial Transplants
In 2013, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) held a workshop to determine the risks and benefits associated with the experimental use of fecal microbial transplants to treat Clostridium difficile and other gastroenterological disorders. By focusing on the proceedings of the NIH–FDA workshop on the treatment of the human microbiome, the question of how medicine colonizes human bodies through microbial transplants raises questions about what an individual body is, how determinative of human health the microbiome is, and what the limits of molecular biomedicine are when the...
Source: Medical Anthropology Quarterly - May 25, 2017 Category: International Medicine & Public Health Authors: Matthew J. Wolf ‐Meyer Tags: Original Article Source Type: research
Warnings about certain lead tests for children and adults
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. The CDC recommends that parents of children younger than 6 years (72 months) of age and currently pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested. (Source: The Brown University Child and Adolescent Psychopharmacology Update)
Source: The Brown University Child and Adolescent Psychopharmacology Update - May 25, 2017 Category: Psychiatry Tags: From the FDA Source Type: research
Emerging Treatments in Eating Disorders
AbstractEating disorders (EDs), including anorexia nervosa, bulimia nervosa, and binge-eating disorder, constitute a class of common and deadly psychiatric disorders. While numerous studies in humans highlight the important role of neurobiological alterations in the development of ED-related behaviors, the precise neural substrate that mediates this risk is unknown. Historically, pharmacological interventions have played a limited role in the treatment of eating disorders, typically providing symptomatic relief of comorbid psychiatric issues, like depression and anxiety, in support of the standard nutritional and psycholog...
Source: Neurotherapeutics - May 25, 2017 Category: Neurology Source Type: research
Pain patients treated with ketamine less likely to experience depression
Large-scale data from the US Food and Drug Administration suggest that ketamine should be studied for use in patients suffering from depression. (Source: Clinical Pharmacist)
Source: Clinical Pharmacist - May 24, 2017 Category: Drugs & Pharmacology Source Type: research
What Does the Food and Drug Administration Do?
-- Read more on ScientificAmerican.com (Source: Scientific American)
Source: Scientific American - May 24, 2017 Category: Science Authors: Everyday Einstein Sabrina Stierwalt Tags: Health The Sciences Policy & Ethics Source Type: research
The Challenge of Treating Children With Hepatitis C Virus Infection
ABSTRACT: The development of oral hepatitis C virus (HCV) direct-acting antivirals (DAAs) has revolutionized the therapeutic field. Nowadays, multiple safe and highly effective antiviral regimens are commercially available to treat adults with hepatitis C infection. These new regimens for the first time genuinely raise the prospects of eradicating HCV. Many challenges, however, remain from identifying infected individuals to optimizing treatment and ensuring global access to antiviral therapy to all population groups, including children. Recently, in April 2017, the association of sofosbuvir with ribavirin and the fixed-do...
Source: Journal of Pediatric Gastroenterology and Nutrition - May 24, 2017 Category: Gastroenterology Tags: Topic of the Month Source Type: research
Pharmacokinetic, Pharmacodynamic, and Antihypertensive Effects of the Neprilysin Inhibitor LCZ-696: Sacubitril/Valsartan
LCZ-696: sacubitril/Valsartan is a dual-acting molecule consisting of the angiotensin II (Ang II) receptor blocker (ARB) valsartan and the neprisylin (neutral endopeptidase, NEP) inhibitor AHU-377 with significant beneficial effects in patients with hypertension and heart failure (HF). Several recent studies have demonstrated a higher effectiveness of LCZ-696 compared to valsartan in the treatment of hypertension and HF. The rationale for the development and the Food and Drug Administration (FDA) approval of LCZ-696 was based on the concept of an additive effect of the angiotensin II receptor blocker valsartan and the NEP ...
Source: Journal of the American Society of Hypertension - May 24, 2017 Category: Cardiology Authors: Steven G. Chrysant Tags: Review Article Source Type: research
Development of a clinical trials version of the Impact of Weight on Quality of Life ‐Lite questionnaire (IWQOL‐Lite Clinical Trials Version): results from two qualitative studies
Summary Existing measures of health‐related quality of life and patient functioning in obesity, such as the Impact of Weight on Quality of Life‐Lite (IWQOL‐Lite) questionnaire, lack the developmental rigour required by the Food and Drug Administration (FDA) to support product labelling. Two iterative qualitative studies informed development of a version of the IWQOL‐Lite questionnaire optimized for use in obesity clinical trials: the IWQOL‐Lite Clinical Trials Version. Study 1 included 42 patients with body mass index (BMI) ≥ 30 kg m−2 (obesity); and Study 2 included 29 patien...
Source: Clinical Obesity - May 23, 2017 Category: Eating Disorders & Weight Management Authors: R. L. Kolotkin, C. M. Ervin, H. H. Meincke, L. H øjbjerre, S. E. Fehnel Tags: Original Article Source Type: research
The regulation and adoption of health technologies under Brazil’s Unified Health System: barriers to access to medicines for diseases of poverty?
Resumo O presente trabalho buscou verificar os aspectos relacionados ao registro sanit ário e à incorporação de tecnologias no SUS para as doenças da pobreza. Trata-se de estudo exploratório, descritivo, desenvolvido entre janeiro e maio de 2016, em que foram realizados levantamentos e análises de documentos nos sítios eletrônicos da Anvisa, FDA, EMA, Conitec e Sistema Saúde Legis. Verificou-se um total de 132 medicamentos elencados na Rename 2014 para atendimento específico das doenças da pobreza, sendo que mais de um terço (49) poss...
Source: Ciencia e Saude Coletiva - May 23, 2017 Category: Occupational Health Source Type: research
Successful Treatment of Methicillin Susceptible Staphylococcus aureus Osteomyelitis with Oritavancin
This article is protected by copyright. All rights reserved. (Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy)
Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy - May 23, 2017 Category: Drugs & Pharmacology Authors: Dino J. Delaportas, Sandy J. Estrada, Matthew Darmelio Tags: Case Report Source Type: research
Etelcalcetide vs Cinacalcet for Hyperparathyroidism
In Reply Dr Hai and colleagues are concerned that the starting dose of etelcalcetide was 5 mg (not the lowest dose) whereas the starting dose of cinacalcet was 30 mg (the lowest dose). This clinical trial, using a double-dummy active control, dosed cinacalcet in strict accordance with the approved package insert and in a manner consistent with previous clinical trials of similar duration using similar biochemical end points. Our finding of a mean decrease in PTH of approximately 40% over 26 weeks in patients treated with cinacalcet is similar to findings of the phase 3 trials with cinacalcet (43% decrease in mean PTH over ...
Source: JAMA - May 23, 2017 Category: General Medicine Source Type: research
Fibromyalgia: Treating Pain in the Juvenile Patient
AbstractPresently, evidence for the efficacy of medications for the treatment of juvenile fibromyalgia syndrome (JFMS) is limited. While there are medications approved by the US Food and Drug Administration (duloxetine, milnacipran and pregabalin) for adults with fibromyalgia syndrome, there are none for the treatment of JFMS. A variety of medications have been prescribed for the treatment of JFMS, including (but not limited to) non-opioid analgesics, opioids, anticonvulsants, antidepressants, and muscle relaxants. Psychological therapies, most prominently cognitive behavioral therapy, are the most evidenced-based treatmen...
Source: Pediatric Drugs - May 23, 2017 Category: Pediatrics Source Type: research
Evaluating the Cardiovascular Safety of Nonsteroidal Anti-Inflammatory Drugs.
Abstract Some drugs used to treat noncardiovascular conditions may adversely impact the cardiovascular status of individuals both with and without known cardiovascular disease. When the US Food and Drug Administration judges the potential cardiovascular safety signal to be of sufficient concern, it may require the pharmaceutical manufacturer of the drug in question to conduct a postmarketing (phase 4) randomized controlled trial (RCT). Although historically many phase 4 RCTs focused on efficacy (using a superiority design), contemporary phase 4 RCTs often are focused on safety and use a noninferiority design. The ...
Source: Circulation - May 23, 2017 Category: Cardiology Authors: Antman EM Tags: Circulation Source Type: research
Fibromyalgia: Treating Pain in the Juvenile Patient.
Abstract Presently, evidence for the efficacy of medications for the treatment of juvenile fibromyalgia syndrome (JFMS) is limited. While there are medications approved by the US Food and Drug Administration (duloxetine, milnacipran and pregabalin) for adults with fibromyalgia syndrome, there are none for the treatment of JFMS. A variety of medications have been prescribed for the treatment of JFMS, including (but not limited to) non-opioid analgesics, opioids, anticonvulsants, antidepressants, and muscle relaxants. Psychological therapies, most prominently cognitive behavioral therapy, are the most evidenced-base...
Source: Paediatric Drugs - May 23, 2017 Category: Pediatrics Authors: Gmuca S, Sherry DD Tags: Paediatr Drugs Source Type: research
GLP-1R as a Target for the Treatment of Diabetic Retinopathy: Friend or Foe?
Glucagon-like peptide 1 receptor (GLP-1R) agonists are increasingly being used as treatment for type 2 diabetes. Since the U.S. Food and Drug Administration published recommendations about the cardiovascular safety of new antidiabetes therapies for treating type 2 diabetes in 2008, the results of two outstanding clinical trials using GLP-1R agonists addressing this issue (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results—A Long Term Evaluation [LEADER] and Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes [SUSTAIN-6]) ...
Source: Diabetes - May 22, 2017 Category: Endocrinology Authors: Simo, R.; Hernandez, C. Tags: Perspectives in Diabetes Source Type: research
No Smoke —Just Cancer-Causing Chemicals
Heat-not-burn tobacco products are for sale around the world. Although they are not yet on the market in the United States, Phillip Morris International has applied to the US Food and Drug Administration (FDA) to sell these products. These products threaten the progress that has been made on decreasing the harms of second-hand smoke because existing bans may not apply to these heat-not-burn products. However, as convincingly reported by Auer and colleagues, although these products may or may not produce smoke, they release cancer-causing chemicals. As shown in their table, heat-not-burn cigarettes release similar levels of...
Source: JAMA Internal Medicine - May 22, 2017 Category: Internal Medicine Source Type: research
Early Trifecta ™ Valve Failure — Report of a Cluster of Cases from a Tertiary Care Referral Center
We report a case series of 8 Trifecta™ valve failures, describin g patients’ clinical substrate and management, and the pathological characteristics of the explanted valves. (Source: The Journal of Thoracic and Cardiovascular Surgery)
Source: The Journal of Thoracic and Cardiovascular Surgery - May 22, 2017 Category: Cardiovascular & Thoracic Surgery Authors: Ankur Kalra, Hasan Rehman, Mahesh Ramchandani, Colin M. Barker, Gerald M. Lawrie, Ross M. Reul, Michael J. Reardon, Neal S. Kleiman Source Type: research
U.S. Food and Drug Administration Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy.
Abstract On August 5, 2016, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp., Kenilworth, NJ) for treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Approval was based on the objective response rate (ORR) and duration of response (DoR) in a cohort of patients in a nonrandomized multi-cohort trial (KEYNOTE-012) that included 174 patients with recurrent or metastatic HNSCC who had disease progression on or after plat...
Source: The Oncologist - May 22, 2017 Category: Cancer & Oncology Authors: Larkins E, Blumenthal GM, Yuan W, He K, Sridhara R, Subramaniam S, Zhao H, Liu C, Yu J, Goldberg KB, McKee AE, Keegan P, Pazdur R Tags: Oncologist Source Type: research
Thrombotic responses to coronary stents, bioresorbable scaffolds and the Kounis hypersensitivity-associated acute thrombotic syndrome.
Authors: Kounis NG, Koniari I, Roumeliotis A, Tsigas G, Soufras G, Grapsas N, Davlouros P, Hahalis G Abstract Percutaneous transluminal coronary angioplasty with coronary stent implantation is a life-saving medical procedure that has become, nowadays, the most frequent performed therapeutic procedure in medicine. Plain balloon angioplasty, bare metal stents, first and second generation drug-eluting stents, bioresorbable and bioabsorbable scaffolds have offered diachronically a great advance against coronary artery disease and have enriched our medical armamentarium. Stented areas constitute vulnerable sites for end...
Source: Journal of Thoracic Disease - May 21, 2017 Category: Respiratory Medicine Tags: J Thorac Dis Source Type: research
Cigarette Filter Ventilation and its Relationship to Increasing Rates of Lung Adenocarcinoma.
Abstract The 2014 Surgeon General's Report on smoking and health concluded that changing cigarette designs have caused an increase in lung adenocarcinomas, implicating cigarette filter ventilation that lowers smoking machine tar yields. The Food and Drug Administration (FDA) now has the authority to regulate cigarette design if doing so would improve public health. To support a potential regulatory action, two weight-of-evidence reviews were applied for causally relating filter ventilation to lung adenocarcinoma. Published scientific literature (3284 citations) and internal tobacco company documents contributed to...
Source: Cancer Control - May 20, 2017 Category: Cancer & Oncology Authors: Song MA, Benowitz NL, Berman M, Brasky TM, Cummings KM, Hatsukami DK, Marian C, O'Connor R, Rees VW, Woroszylo C, Shields PG Tags: J Natl Cancer Inst Source Type: research
Strategies to Improve Novel Drug Development in Kidney Transplantation Through the Clinical Trials Process.
Authors: Jordan SC, Choi J, Vo A Abstract Kidney transplantation has emerged as the preferred treatment for end-stage renal disease. Despite excellent short-term outcomes with standard T-cell centric immunosuppression, long-term outcomes have not improved. Indeed, approximately 5,000 renal allografts fail in the United States each year. Until recently, the focus on causes for late graft failures was on calcineurin inhibitor toxicity and the effects of primary co-morbid conditions (i.e., diabetes and hypertension) or recurrent glomerular diseases. However, several recent studies have identified donor-specific antibo...
Source: Clinical Transplants - May 20, 2017 Category: Transplant Surgery Tags: Clin Transpl Source Type: research
Stability of adhesive interfaces by stereocomplex formation of polylactides and hybridization with nanoparticles
Publication date: Available online 19 May 2017 Source:Polymer Degradation and Stability Author(s): Shinya Fujishiro, Kai Kan, Mitsuru Akashi, Hiroharu Ajiro In the creation of controllable selective adhesive materials, we have utilized a stereocomplex (SC) on an adhesive interface. We selected poly(L,L-lactide) (PLLA) and poly(D,D-lactide) (PDLA) initiated benzyl alcohol (PLLAb and PDLAb, respectively) as a substrate and gold nanoparticle-coated PLLA and PDLA (PLLA-Au and PDLA-Au, respectively) as an injection material. Before performing measurements, SC formation was examined via Fourier Transform Infrared Spectroscopy (...
Source: Polymer Degradation and Stability - May 20, 2017 Category: Chemistry Source Type: research
Efficacy of delayed brincidofovir treatment against a lethal rabbitpox virus challenge in New Zealand White rabbits
Publication date: July 2017 Source:Antiviral Research, Volume 143 Author(s): Irma M. Grossi, Scott A. Foster, Melicia R. Gainey, Robert T. Krile, John A. Dunn, Thomas Brundage, Jody M. Khouri In the event of a bioterror attack with variola virus (smallpox), exposure may only be identified following onset of fever. To determine if antiviral therapy with brincidofovir (BCV; CMX001) initiated at, or following, onset of fever could prevent severe illness and death, a lethal rabbitpox model was used. BCV is in advanced development as an antiviral for the treatment of smallpox under the US Food and Drug Administration's ‘...
Source: Antiviral Therapy - May 20, 2017 Category: Virology Source Type: research
Immunogenomics: using genomics to personalize cancer immunotherapy
AbstractWhile the use of genomic data has the potential to revolutionize patient care, there is still much work to be done with regard to the transformation of host-tumor interactions into favorable clinical outcomes for our patients. High-throughput technologies, such as next-generation sequencing (NGS), have rapidly advanced our understanding of oncology, and we are learning that most tumors do not simply possess consistently mutated genes that are responsible for tumorigenesis, facilitating the need for personalized cancer therapy. A T cell-dependent mechanism of cancer progression was discovered in 2012, providing a po...
Source: Virchows Archiv - May 20, 2017 Category: Pathology Source Type: research
Interaction of molecular alterations with immune response in melanoma
Major advances have been made in melanoma treatment with the use of molecularly targeted therapies and immunotherapies, and numerous regimens are now approved by the US Food and Drug Administration for patients with stage IV disease. However, therapeutic resistance remains an issue to both classes of agents, and reliable biomarkers of therapeutic response and resistance are lacking. Mechanistic insights are being gained through preclinical studies and translational research, offering potential strategies to enhance responses and survival in treated patients. A comprehensive understanding of the immune effects of common mut...
Source: Cancer - May 19, 2017 Category: Cancer & Oncology Authors: Robert A. Szczepaniak Sloane, Vancheswaran Gopalakrishnan, Sangeetha M. Reddy, Xue Zhang, Alexandre Reuben, Jennifer A. Wargo Tags: Review Article Source Type: research
Prevention of Sudden Cardiac Death in the Young: Developing a Rational, Reliable, and Sustainable National Health Care Resource
Publication date: Available online 18 May 2017 Source:American Heart Journal Author(s): Salim F. Idriss, Stuart Berger, Kimberly G. Harmon, Allen Kindman, Robert Kleiman, Martha Lopez-Anderson, Silvana Molossi, Tess (Elizabeth) Saarel, Colette Strnadova, Thomas Todaro, Kaori Shinagawa, Valarie Morrow, Mitchell Krucoff, Victoria Vetter, Theressa J. Wright This White Paper, prepared by members of the Cardiac Safety Research Consortium (CSRC), discusses important issues regarding sudden cardiac death in the young (SCDY), a problem that does not discriminate by gender, race, ethnicity, education, socioeconomic level, or athle...
Source: American Heart Journal - May 19, 2017 Category: Cardiology Source Type: research
Updated Recommendations for Use of MenB-FHbp Serogroup B Meningococcal Vaccine - Advisory Committee on Immunization Practices, 2016.
Abstract Two serogroup B meningococcal (MenB) vaccines are currently licensed for use in persons aged 10-25 years in the United States. The two vaccines are MenB-FHbp (Trumenba, Pfizer, Inc.) (1) and MenB-4C (Bexsero, GlaxoSmithKline Biologicals, Inc.) (2). In February 2015, the Advisory Committee on Immunization Practices (ACIP) recommended use of MenB vaccines among certain groups of persons aged ≥10 years who are at increased risk for serogroup B meningococcal disease* (Category A) (3), and in June 2015, ACIP recommended that adolescents and young adults aged 16-23 years may be vaccinated with MenB vaccines ...
Source: MMWR Morb Mortal Wkl... - May 19, 2017 Category: Epidemiology Authors: Patton ME, Stephens D, Moore K, MacNeil JR Tags: MMWR Morb Mortal Wkly Rep Source Type: research
Anesthetic Neurotoxicity Meets Big Data: Reasons to Be Cheerful?
(Anesthesiology. 2016;125(2):263–265) The potential risk to the developing human brain of general anesthetic exposure has been a topic of interest to both anesthesiologists and the public. Several research endeavors in addition to those by the public/private International Anesthesia Research Society/US Food and Drug Administration initiative SMARTTots (http://www.smarttots.org ) and the European Society of Anaesthesiology-sponsored (Brussels, Belgium) EuroStar” consortium (http//www.esahq.org/research/research-groups/eurostar ) have been undertaken in an attempt to elucidate the effects of anesthesia and keep ...
Source: Obstetric Anesthesia Digest - May 18, 2017 Category: Anesthesiology Tags: Mechanisms, Equipment, Hazards Source Type: research
Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary.
This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise t...
Source: Clinical Pharmacology and Therapeutics - May 18, 2017 Category: Drugs & Pharmacology Authors: Wang J, Johnson T, Sahin L, Tassinari MS, Anderson PO, Baker TE, Bucci-Rechtweg C, Burckart GJ, Chambers CD, Hale TW, Johnson-Lyles D, Nelson RM, Nguyen C, Pica-Branco D, Ren Z, Sachs H, Sauberan J, Zajicek A, Ito S, Yao LP Tags: Clin Pharmacol Ther Source Type: research
Balancing Low-density Lipoprotein Cholesterol Reduction and Hepatotoxicity With Lomitapide Mesylate and Mipomersen in Patients With Homozygous Familial Hypercholesterolemia.
Authors: Won JI, Zhang J, Tecson KM, McCullough PA Abstract Homozygous familial hypercholesterolemia (HoFH) is an autosomal codominant disorder manifested by high concentrations of total cholesterol and low-density lipoprotein (LDL) cholesterol, and premature cardiovascular disease. Despite conventional lipid-lowering therapy, LDL cholesterol levels remain elevated in patients with HoFH; these patients are considered to be at high risk for cardiovascular events. In 2012-2013, two drugs with novel mechanisms of action were approved by the US Food and Drug Administration for the treatment of HoFH: lomitapide mesylate...
Source: Reviews in Cardiovascular Medicine - May 18, 2017 Category: Cardiology Tags: Rev Cardiovasc Med Source Type: research
Paediatric Medicines: Regulatory and Scientific Issues
Drug Res (Stuttg) DOI: 10.1055/s-0043-109788In the past, dosage regimens authorized for adults were extrapolated to children relying mainly on empirical dosage adjustments. However, children are not small adults, but a distinct and heterogeneous group in terms of physiology, disease occurrence, pharmacokinetics, pharmacodynamics and also psychological, cognitive, and behavioral aspects. Even though it would be helpful to know the physiological changes and the special drug treatment needs in children, this task could not be performed due to ethical reasons. Important issues to consider for the development of paediatric drug...
Source: Drug Research - May 18, 2017 Category: Drugs & Pharmacology Authors: Daousani, Chrysa Karalis, Vangelis D. Tags: Review Source Type: research
Mechanisms of Resistance to FLT3 Inhibitors and the Role of the Bone Marrow Microenvironment
The presence of FLT3 mutations in acute myeloid leukemia (AML) carries a particularly poor prognosis, making the development of FLT3 inhibitors an imperative goal. The last decade has seen an abundance of clinical trials using these drugs alone or in combination with chemotherapy. This culminated with the recent approval by the US Food and Drug Administration of Midostaurin for the treatment of FLT3-mutated AML. Initial success has been followed by the emergence of clinical resistance. Although novel FLT3 inhibitors are being developed, studies into mechanisms of resistance raise hope of new strategies to prevent emergence...
Source: Hematology/Oncology Clinics of North America - May 18, 2017 Category: Cancer & Oncology Authors: Gabriel Ghiaur, Mark Levis Source Type: research
Targeting the Programmed Cell Death-1 Pathway in Genitourinary Tumors: Current Progress and Future Perspectives.
Abstract Immune checkpoint inhibitors have revolutionized the treatment many malignancies with over a dozen new United States Food and Drug Administration (FDA) approvals in the past six years. Due to the combination of potent treatment success and potentially deadly adverse effects from immune checkpoint inhibitors, gathering prognostic and predictive information about FDA-indicated tumors is prudent. PD-L1 expression is a poor prognostic factor and predictive of better responses from both PD-1 and PD-L1 inhibitors in a variety of tumor types including RCC and urothelial carcinoma. Each FDA-approved PD-1/PD-L1 dr...
Source: Current Drug Metabolism - May 18, 2017 Category: Drugs & Pharmacology Authors: Montironi R, Cheng L, Moch H, Lopez-Beltran A, Scarpelli M, Massari F, Fiorentino M, Ciccarese C, Koch M, Kaimakliotis HZ, Wang L, Pili R, Mann SA Tags: Curr Drug Metab Source Type: research
Induction of Proteotoxic Stress by the Mycotoxin Patulin.
Abstract Patulin is a naturally occurring mycotoxin produced by a number of molds and may contaminate a wide variety of food products. In practice, patulin's main societal relevance concerns apple juice and its products. Multiple advisory bodies, including the U.S. Food and Drug Administration and the World Health Organization, recommend that producers monitor and limit patulin levels in apple juice products. The mechanism of patulin toxicity remains largely unknown. Here we show that patulin induces proteotoxic stress in the yeast S. cerevisiae. The transcription factor Rpn4 controls the abundance of the proteaso...
Source: Toxicology Letters - May 18, 2017 Category: Toxicology Authors: Guerra-Moreno A, Hanna J Tags: Toxicol Lett Source Type: research
IP177. Drug-Coated Balloon Catheters: What Is Being Reported in the MAUDE Database?
The Manufacturer and User Facility Device Experience (MAUDE) Database was established by the United States Food and Drug Administration (FDA) to allow for voluntarily reporting of adverse outcomes with medical devices. There are two commercially available drug-coated balloons: IN.PACT Admiral (I-DCB; Medtronic, Inc; release date 1/5/2015) and Lutonix (L-DCB; C.R. Bard, Inc; release date 10/9/2014). We sought to examine MAUDE reporting of these two systems. (Source: Journal of Vascular Surgery)
Source: Journal of Vascular Surgery - May 17, 2017 Category: Surgery Authors: Michael F. Amendola, Ifechukwude Ikem, Gi-Ann Acosta Tags: IP: Interactive Poster Session Source Type: research
RS03. A Matched Cohort Comparison of Outcomes in Patients Who Underwent Fenestrated Endovascular Aortic Aneurysm Repair Using Physician-Modified Endovascular Grafts vs Company-Manufactured Devices
Fenestrated endografts are customized, patient-specific, endovascular devices with the potential to reduce morbidity and mortality of repair of complex aortic aneurysms. With approval from the United States Food and Drug Administration, our center began performing fenestrated endovascular aneurysm repair through a physician-sponsored investigational device exemption (IDE #G130210), using both physician-modified endografts (PMEG) and company manufactured devices (CMD). Because PMEG and CMD are each associated with specific advantages and disadvantages, we sought to investigate differences in outcomes between PMEG and CMD ca...
Source: Journal of Vascular Surgery - May 17, 2017 Category: Surgery Authors: Shernaz Dossabhoy, Andres Schanzer, Jessica Simons, Julie Flahive, Francesco Aiello, Parth Sheth, Edward Arous, Louis Messina Tags: S1: William J. von Liebig Forum Source Type: research
SS01. Characterization and Outcomes of Reinterventions Following EVAR
Published rates of reintervention after endovascular aneurysm repair (EVAR) range from 10% to 30%. We evaluated a single university center ’s experience with reinterventions in the context of trial and United States Food and Drug Administration (FDA)-approved devices. (Source: Journal of Vascular Surgery)
Source: Journal of Vascular Surgery - May 17, 2017 Category: Surgery Authors: Alexander S. Fairman, Grace J. Wang, Benjamin M. Jackson, Paul J. Foley, Scott M. Damrauer, Venkat Kalapatapu, Michael A. Golden, Ronald M. Fairman Tags: S1: William J. von Liebig Forum Source Type: research
VESS01. Real-World Experience With Gore IBE for Treatment of Bilateral Common Iliac Artery Aneurysms
The Gore (Flagstaff, Ariz) iliac branch endoprosthesis (IBE) has recently been United States (U.S.) Food and Drug Administration approved for treatment of common iliac artery (CIA) aneurysms. Despite excellent results in clinical trial, only four of 98 patients were treated for bilateral iliac aneurysms. The goal of this study was to examine real-world experience using the Gore IBE for bilateral CIA aneurysms. (Source: Journal of Vascular Surgery)
Source: Journal of Vascular Surgery - May 17, 2017 Category: Surgery Authors: Thomas Maldonado, Peter Lin, Frank J. Veith, Albeir Mousa, Robert Rhee, Ross Milner, Marc Schermerhorn, Michel Reijnen Tags: V1: VESS Paper Session 1 Source Type: research
PC058 What Is the Real Mode of Failure? Trends in Angio-Seal Adverse Events Reported to the MAUDE Database
The Manufacturer and User Facility Device Experience (MAUDE) Database was established by the United States Food and Drug Administration to allow for voluntary reporting of adverse outcomes of medical devices. The Angio-Seal device (St. Jude Medical, Minnetonka, Minn) closure device is one of many devices reported to the database. We set out to determine whether defined failure mode (DFM; collagen plug, device handle, footplate, and/or sheath) at index deployment vs an undefined failure mode (UFM) had differing outcomes in terms adverse patient consequences and/or returned devices (Table). (Source: Journal of Vascular Surgery)
Source: Journal of Vascular Surgery - May 17, 2017 Category: Surgery Authors: Meghan Reeves, Michael F. Amendola Tags: C10: Poster Competition Source Type: research
The Development and Use of Janus Kinase 2 Inhibitors for the Treatment of Myeloproliferative Neoplasms
Following the discovery of the JAK2V617F mutation, Janus kinase (JAK) 2 inhibitors were developed as rationally designed therapy in myeloproliferative neoplasms (MPNs). Although JAK2 inhibitors have clinical efficacy in MPN, they are not clonally selective for the JAK2V617F-mutant cells. Because activated JAK-signal transducer and activator of transcription (STAT) signaling is a common feature of MPN, JAK2 inhibitors are efficacious regardless of the specific MPN phenotypic driver mutation. The Food and Drug Administration approved the JAK1/JAK2 inhibitor, ruxolitinib, for the treatment of myelofibrosis and polycythemia ve...
Source: Hematology/Oncology Clinics of North America - May 17, 2017 Category: Cancer & Oncology Authors: Gabriela S. Hobbs, Sarah Rozelle, Ann Mullally Source Type: research
Considering the Role of the Laparoscopic Adjustable Gastric Band
Bariatric surgery as a discipline has evolved dramatically since the first procedure intended to induce weight loss was performed following World War II. In the past 60 years, procedures have come and gone, including the jejunalileal bypass, the horizontal gastroplasty, and the vertical-banded gastroplasty. The laparoscopic adjustable gastric band (LAGB) enjoyed a significant growth in popularity over the first 5 years following its approval from the US Food and Drug Administration. In the past 5 years, the use of the LAGB has seen a precipitous decline. In the United States, we may be close to saying goodbye to the LAGB. ...
Source: JAMA Surgery - May 17, 2017 Category: Sports Medicine Source Type: research
Injectable and topical neurotoxins in dermatology
Botulinum toxin is a potentially deadly anaerobic bacterial toxin that acts by inhibiting release of acetylcholine at the neuromuscular junction, thereby inhibiting contraction of the exposed striated muscle. There are currently 4 botulinum toxin preparations approved by the US Food and Drug Administration (FDA): onabotulinumtoxin, abobotulinumtoxin, incobotulinumtoxin and rimabotulinumtoxin. While significant overlap exists, each product has unique properties and specifications, including dosing, diffusion, and storage. (Source: Journal of the American Academy of Dermatology)
Source: Journal of the American Academy of Dermatology - May 16, 2017 Category: Dermatology Authors: Cerrene N. Giordano, Seth L. Matarasso, David M. Ozog Tags: Continuing medical education Source Type: research
Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study
In the primary analysis of the ERIVANCE BCC trial, vismodegib, the first US Food and Drug Administration –approved Hedgehog pathway inhibitor, showed objective response rates (ORRs) by independent review facili... (Source: BMC Cancer)
Source: BMC Cancer - May 16, 2017 Category: Cancer & Oncology Authors: Aleksandar Sekulic, Michael R. Migden, Nicole Basset-Seguin, Claus Garbe, Anja Gesierich, Christopher D. Lao, Chris Miller, Laurent Mortier, Dedee F. Murrell, Omid Hamid, Jorge F. Quevedo, Jeannie Hou, Edward McKenna, Natalie Dimier, Sarah Williams, Dirk Source Type: research
7,8-hydroxy-2'-deoxyguanosine/2'-deoxiguanosine ratio determined in hydrolysates of brain DNA by ultrachromatrography coupled to tandem mass spectrometry.
bar J Abstract 7,8-hydroxy-2'-deoxyguanosine (8-OHdG) is an abundant DNA lesion formed by oxidation of the nucleoside 2'-deoxyguanosine (2-dG) and one of the most studied and accepted oxidative stress biomarkers. 8-OHdG has a strong carcinogenic potential, and prolonged oxidative stress heightens pathological conditions and especially cancer risk. Our aim was to develop, validate and apply a reliable method to assess DNA oxidation in genomic cellular DNA of sensible target organs such as brain. A procedure to isolate and digest the DNA of brain tissue properly for further detection of 8-OHdG and 2-dG by Ultra Perf...
Source: Talanta - May 15, 2017 Category: Chemistry Authors: Torres-Cuevas I, Aupi M, Asensi MA, Vento M, Ortega Á, Escobar J Tags: Talanta Source Type: research