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Young-A Heo, Emma D Deeks
A fixed-dose combination of the hepatitis C virus (HCV) NS5B polymerase inhibitor sofosbuvir, the HCV NS5A inhibitor velpatasvir and the HCV NS3/4A protease inhibitor voxilaprevir (sofosbuvir/velpatasvir/voxilaprevir; Vosevi® ) is approved in the EU for the treatment of chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection in adults. In the phase III POLARIS trials, in patients who had HCV genotype 1-6 infection with or without compensated cirrhosis, overall rates of sustained virological response at 12 weeks post-treatment (SVR12 ) with sofosbuvir/velpatasvir/voxilaprevir were high after 8 weeks of treatment in direct-acting antiviral (DAA)-naïve patients and 12 weeks of treatment in DAA-experienced patients...
March 15, 2018: Drugs
Wilbert S Aronow, William H Frishman
The 2017 American College of Cardiology/American Heart Association hypertension guidelines diagnose hypertension if systolic blood pressure (SBP) is ≥ 130 mmHg or diastolic blood pressure (DBP) is ≥ 80 mmHg. Increased BP is SBP 120-129 mmHg with DBP < 80 mmHg. Lifestyle measures should be used to treat individuals with increased BP. Lifestyle measures plus BP-lowering drugs should be used for secondary prevention of recurrent cardiovascular events in individuals with clinical cardiovascular disease (coronary heart disease, congestive heart failure, or stroke) and an average SBP ≥ 130 mmHg or an average DBP ≥ 80 mmHg...
March 13, 2018: Drugs
James E Frampton, Stephen Silberstein
An intramuscular formulation of onabotulinumtoxinA (onabotA; Botox® ) is currently the only therapy specifically approved for the prevention of headaches in adults with chronic migraine (CM) in the EU and North America. This article provides a narrative review of relevant data on the drug in this indication from an EU perspective. OnabotA was originally approved on the basis of pooled data from two phase III studies (PREEMPT 1 and 2). In these pivotal studies, injection of up to five cycles of onabotA (155-195 U/cycle) at 12-week intervals was generally well tolerated and effective in producing statistically significant and clinically meaningful improvements in headache symptoms, acute headache pain medication usage, headache impact and health-related quality of life in adults with CM, of whom approximately two-thirds were acute medication overusers and approximately one-third had failed to respond to ≥ 3 prior oral prophylactic therapies...
March 12, 2018: Drugs
Nicki Niemann, Joseph Jankovic
The dose (mg/day) for Clonazepam which reads.
March 10, 2018: Drugs
Sohita Dhillon
The article Eculizumab: A Review in Generalized Myasthenia Gravis, written by Sohita Dhillon, was originally published Online First without open access.
March 9, 2018: Drugs
Joshua J Gagne, Jennifer M Polinski, Wenlei Jiang, Sarah K Dutcher, Jing Xie, Joyce Lii, Lisa A Fulchino, Aaron S Kesselheim
Page 432, Fig. 2 Plots of model-based outcome incidence rates (per 100 person-years of exposure) before and after introduction of first generic versions of study and control drugs.
March 8, 2018: Drugs
Hannah A Blair
Brodalumab (Kyntheum® ) is a human anti-interleukin-17 receptor A (IL-17RA) monoclonal antibody available for use in patients with moderate to severe plaque psoriasis. In the phase III AMAGINE trials in this patient population, 12 weeks of induction therapy with subcutaneous brodalumab was superior to placebo in terms of the proportion of patients with ≥ 75% improvement in the Psoriasis Area and Severity Index score (PASI 75) and the proportion of patients with a static Physician Global Assessment score of 0 or 1...
March 8, 2018: Drugs
Zaina T Al-Salama, Lesley J Scott
The article Lonoctocog Alfa: A Review in Haemophilia A, written by Zaina T. Al-Salama and Lesley J. Scott, was originally published Online First without open access. After publication in volume 77, issue 15, pages 1677-1686 CSL Behring GmbH requested that the article be Open Choice to make the article an open access publication. Post-publication open access was funded by CSL Behring GmbH. Further details may be found at . The article is forthwith distributed under the terms of the Creative Commons Attribution-NonCommercial 4...
March 3, 2018: Drugs
Hillel P Cohen, Andrew Blauvelt, Robert M Rifkin, Silvio Danese, Sameer B Gokhale, Gillian Woollett
INTRODUCTION: To evaluate the possibility that switching from reference biologic medicines to biosimilars could lead to altered clinical outcomes, including enhanced immunogenicity, compromised safety, or diminished efficacy for patients, a systematic literature review was conducted of all switching studies between related biologics (including biosimilars). METHODS: A systematic search was conducted using the Medline® and Embase® databases up to 30 June 2017 employing specific medical subject heading terms...
March 3, 2018: Drugs
Jaquelyn N Sanchez, Ton Wang, Mark S Cohen
The mitogen activated protein kinase/extracellular signal-related kinase (MAPK/ERK) signaling pathway serves an integral role in growth, proliferation, differentiation, migration, and survival of all mammalian cells. Aberrant signaling of this pathway is often observed in several types of hematologic and solid malignancies. The most frequent insult to this signaling cascade, leading to its constitutive activation, is to the serine/threonine kinase rapidly accelerating fibrosarcoma (RAF). Considering this, the development and approval of various small-molecule inhibitors targeting the MAPK/ERK pathway has become a mainstay of treatment as either mono- or combination therapy in these cancers...
February 27, 2018: Drugs
Nicki Niemann, Joseph Jankovic
Tardive dyskinesia (TD) encompasses the spectrum of iatrogenic hyperkinetic movement disorders following exposure to dopamine receptor-blocking agents (DRBAs). Despite the advent of atypical or second- and third-generation antipsychotics with a presumably lower risk of complications, TD remains a persistent and challenging problem. Prevention is the first step in mitigating the risk of TD, but early recognition, gradual withdrawal of offending medications, and appropriate treatment are also critical. As TD is often a persistent and troublesome disorder, specific antidyskinetic therapies are often needed for symptomatic relief...
February 26, 2018: Drugs
Anouk E Muller, Benedikt Huttner, Angela Huttner
Antibiotics are among the medications most frequently administered to the critically ill, a population with high levels of intra- and inter-individual pharmacokinetic variability. Our knowledge of the relationships among antibiotic dosing, exposure and clinical effect in this population has increased in recent decades. Therapeutic drug monitoring (TDM) of serum antibiotic concentrations is the most practical means of assessing adequate antibiotic exposure, though until recently, it has been underutilised for this end...
February 23, 2018: Drugs
Anthony Markham
Ertugliflozin (Steglatro™) is an orally active sodium glucose co-transporter type 2 inhibitor being developed by Merck and Pfizer as a treatment for type 2 diabetes mellitus (T2DM). Ertugliflozin as monotherapy and in combination with various other antidiabetic drugs was associated with improvements in glycaemic control and secondary outcome measures in the VERTIS phase III clinical trial program. Ertugliflozin and fixed-dose combinations of ertugliflozin and metformin (Segluromet™) and ertugliflozin and sitagliptin (Steglujan™) have recently been approved by the US FDA as an adjunct to diet and exercise to improve glycaemic control in adults with T2DM...
February 23, 2018: Drugs
Sebastiano Mercadante
The aim of this review is to present the way in which episodic breathlessness (EB) has been recognized over the years, with regard to definition, characteristics, and management of these acute episodes that have serious consequences for patients. EB is characterized by a sudden increase in intensity of dyspnea over a short duration of time, leading to high levels of anxiety. A significant aggravation of dyspnea may occur in patients with a background of dyspnea or intermittently even without basal breathlessness...
February 22, 2018: Drugs
Yahiya Y Syed
Intravenous landiolol [Rapibloc® (EU)], an ultra short-acting highly cardioselective β1 -blocker, is approved in the EU for the rapid short-term control of tachyarrhythmias in the perioperative and intensive care settings. It has long been used in Japan to treat perioperative tachyarrhythmias. The efficacy of landiolol has been demonstrated in a large number of randomized controlled clinical trials. Landiolol significantly reduced heart rate in patients with postoperative or intraoperative supraventricular tachycardia relative to placebo and in those with atrial fibrillation/flutter and left ventricular dysfunction relative to digoxin...
February 22, 2018: Drugs
Antonello Di Paolo, Elena Arrigoni
Generic drugs are important components of measures introduced by healthcare regulatory authorities to reduce treatment costs. In most patients and conditions the switch from a branded drug to its generic counterpart is performed with no major complications. However, evidence from complex diseases suggests that generic substitution requires careful evaluation in some settings and that current bioequivalence criteria may not always be adequate for establishing the interchangeability of branded and generic products...
February 20, 2018: Drugs
A Markham
Kyowa Hakko Kirin, AstraZeneca and subsidiaries are developing benralizumab (Fasenra™)-a fully humanised anti-interleukin-5 receptor alpha chain (IL-5Rα) monoclonal antibody-as a treatment of severe eosinophilic asthma and chronic obstructive pulmonary disease (COPD). Eosinophilia is a characteristic of certain asthma and COPD phenotypes and depletion of eosinophils has demonstrated therapeutic benefit. Benralizumab was recently approved by the US FDA as add-on maintenance therapy for patients with severe asthma who have an eosinophilic phenotype...
February 20, 2018: Drugs
Sheridan M Hoy
Netarsudil ophthalmic solution 0.02% (hereafter referred to as netarsudil 0.02%) [Rhopressa ® ] is a Rho-associated protein kinase inhibitor that is thought to lower intraocular pressure (IOP) by increasing aqueous humour outflow through the trabecular meshwork. It has been developed by Aerie Pharmaceuticals and was recently approved in the USA for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. The recommended dosage is one drop in the affected eye(s) once daily in the evening...
February 16, 2018: Drugs
Jonathan Jia Yuan Ong, Diana Yi-Ting Wei, Peter J Goadsby
Migraine is a common and disabling neurological disorder, with a significant socioeconomic burden. Its pathophysiology involves abnormalities in complex neuronal networks, interacting at different levels of the central and peripheral nervous system, resulting in the constellation of symptoms characteristic of a migraine attack. Management of migraine is individualised and often necessitates the commencement of preventive medication. Recent advancements in the understanding of the neurobiology of migraine have begun to account for some parts of the symptomatology, which has led to the development of novel target-based therapies that may revolutionise how migraine is treated in the future...
February 2, 2018: Drugs
Hannah A Blair, Sean T Duggan
Belimumab (Benlysta®) is a human immunoglobulin G1λ monoclonal antibody that inhibits the binding of soluble B lymphocyte stimulator to B cells. It is the only biological agent currently approved for the treatment of non-renal systemic lupus erythematosus (SLE). Belimumab is approved in the EU, the USA and other countries as add-on therapy in adult patients with active, autoantibody-positive SLE despite standard therapy. In phase III trials, treatment with IV or SC belimumab plus standard therapy was effective in terms of reducing overall disease activity and reducing the incidence and severity of flares, without worsening of patients' overall condition or the development of significant disease activity in new organ systems...
February 2, 2018: Drugs
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