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Journal Cover Drugs
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   ISSN (Print) 0012-6667 - ISSN (Online) 1179-1950
   Published by Adis Homepage  [20 journals]
  • Contemporary Drug Treatment of Hypertension: Focus on Recent Guidelines
    • Abstract: 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. Lifestyle measures plus BP-lowering drugs should be used for primary prevention of cardiovascular disease in individuals with an estimated 10-year risk of atherosclerotic cardiovascular disease (ASCVD) ≥ 10% and an average SBP ≥ 130 mmHg or an average DBP ≥ 80 mmHg. Lifestyle measures plus BP-lowering drugs should be used for primary prevention of cardiovascular disease in individuals with an estimated 10-year risk of ASCVD < 10% and an average SBP ≥ 140 mmHg or an average DBP ≥ 90 mmHg. White coat hypertension must be excluded before starting antihypertensive drug treatment in individuals with hypertension with a low risk for ASCVD. BP should be lowered to < 130/80 mmHg in patients with coronary heart disease, heart failure, or chronic kidney disease; after renal transplantation; for secondary stroke prevention; in lacunar stroke, peripheral arterial disease, and diabetes mellitus; and in ambulatory community-dwelling adults aged > 65 years. The selection of antihypertensive drug treatment is discussed.
      PubDate: 2018-03-13
  • OnabotulinumtoxinA: A Review in the Prevention of Chronic Migraine
    • Abstract: 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. More recently, the efficacy and tolerability of onabotA over a period of 1 year in the PREEMPT programme has been substantiated and extended by the results of a long-term phase IV study (COMPEL), in which patients received up to nine treatment cycles over a period of 2 years, and by findings from several real-world clinical practice studies from Europe, including the prospective multinational REPOSE and CM-PASS studies. In conclusion, the totality of evidence from clinical trials and real-world studies indicates that onabotA is an effective and generally well tolerated option for the prevention of CM that may be particularly useful for patients who have previously failed to respond to or are intolerant of commonly prescribed oral prophylactics.
      PubDate: 2018-03-12
  • Ferric Carboxymaltose: A Review in Iron Deficiency
    • Abstract: Intravenous ferric carboxymaltose (Ferinject®; Injectafer®) is a colloidal solution of nanoparticles which consist of a polynuclear iron (III)-(oxyhydr)oxide core stabilized by carboxymaltose and may be given as a single high-dose, 15-min infusion. This article reviews the clinical use of ferric carboxymaltose in various patient populations with iron deficiency (ID) [± anaemia] and briefly summarizes its pharmacological properties. Based on extensive experience in the clinical trial and real-world settings, ferric carboxymaltose is an effective and generally well tolerated treatment for rapidly replenishing iron stores and correcting anaemia in patients with ID (± anaemia) of various aetiologies, including patients with chronic heart failure (CHF), chronic kidney disease, inflammatory bowel disease or perioperative anaemia, and women with ID during pregnancy, postpartum or associated with heavy uterine bleeding. As it may be given as a single high-dose infusion, ferric carboxymaltose has the potential to provide cost savings from a healthpayer perspective. Thus, ferric carboxymaltose remains an important option for the treatment of ID in adults and, where approved, children aged ≥ 14 years, when oral iron preparations are ineffective or cannot be used.
      PubDate: 2018-03-12
  • Correction to: Treatment of Tardive Dyskinesia: A General Overview with
           Focus on the Vesicular Monoamine Transporter 2 Inhibitors
    • Abstract: The dose (mg/day) for Clonazepam which reads:
      PubDate: 2018-03-10
  • Correction to: Eculizumab: A Review in Generalized Myasthenia Gravis
    • Abstract: The article Eculizumab: A Review in Generalized Myasthenia Gravis, written by Sohita Dhillon, was originally published Online First without open access
      PubDate: 2018-03-09
  • Correction to: Outcomes Associated with Generic Drugs Approved Using
           Product-Specific Determinations of Therapeutic Equivalence
    • Abstract: 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.
      PubDate: 2018-03-08
  • Brodalumab: A Review in Moderate to Severe Plaque Psoriasis
    • Abstract: 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. Brodalumab was also superior to ustekinumab for PASI 100 (i.e. complete skin clearance) at week 12. Health-related quality of life (HR-QOL) outcomes improved to a significantly greater extent with brodalumab than with placebo. Moreover, brodalumab was more effective than placebo in patients with difficult-to-treat nail or scalp psoriasis. Brodalumab was generally well tolerated, with low rates of immunogenicity. Efficacy was sustained and brodalumab remained well tolerated during up to 52 weeks of maintenance therapy. Thus, subcutaneous brodalumab is a useful addition to the treatment options currently available for patients with moderate to severe plaque psoriasis.
      PubDate: 2018-03-08
  • Correction to: Lonoctocog Alfa: A Review in Haemophilia A
    • Abstract: 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 4.0 International License (, which permits any noncommercial use, duplication, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made.
      PubDate: 2018-03-03
  • Switching Reference Medicines to Biosimilars: A Systematic Literature
           Review of Clinical Outcomes
    • Abstract: 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. Additionally, the snowball method and a hand search were also applied. Publications were considered if they contained efficacy or safety information related to a switch from a reference medicine to a biosimilar. Non-English, non-human studies, editorials, notes, and short surveys were excluded. Results Primary data were available from 90 studies that enrolled 14,225 unique individuals. They included protein medicines used in supportive care as well as those used as therapeutic agents. The medicines contained seven different molecular entities that were used to treat 14 diseases. The great majority of the publications did not report differences in immunogenicity, safety, or efficacy. The nature and intensity of safety signals reported after switching from reference medicines to biosimilars were the same as those already known from continued use of the reference medicines alone. Three large multiple switch studies with different biosimilars did not show differences in efficacy or safety after multiple switches between reference medicine and biosimilar. Two publications reported a loss of efficacy or increased dropout rates. Conclusions While use of each biologic must be assessed individually, these results provide reassurance to healthcare professionals and the public that the risk of immunogenicity-related safety concerns or diminished efficacy is unchanged after switching from a reference biologic to a biosimilar medicine.
      PubDate: 2018-03-03
  • Correction to: Daratumumab: A Review in Relapsed and/or Refractory
           Multiple Myeloma
    • Abstract: The author has alerted us to the following error in Sect., and the following correction should be noted:
      PubDate: 2018-03-01
  • Pharmacotherapy for Refractory and Super-Refractory Status Epilepticus in
    • Abstract: Patients with prolonged seizures that do not respond to intravenous benzodiazepines and a second-line anticonvulsant suffer from refractory status epilepticus and those with seizures that do not respond to continuous intravenous anesthetic anticonvulsants suffer from super-refractory status epilepticus. Both conditions are associated with significant morbidity and mortality. A strict pharmacological treatment regimen is urgently required, but the level of evidence for the available drugs is very low. Refractory complex focal status epilepticus generally does not require anesthetics, but all intravenous non-anesthetizing anticonvulsants may be used. Most descriptive data are available for levetiracetam, phenytoin and valproate. Refractory generalized convulsive status epilepticus is a life-threatening emergency, and long-term clinical consequences are eminent. Administration of intravenous anesthetics is mandatory, and drugs acting at the inhibitory gamma-aminobutyric acid (GABA)A receptor such as midazolam, propofol and thiopental/pentobarbital are recommended without preference for one of those. One in five patients with anesthetic treatment does not respond and has super-refractory status epilepticus. With sustained seizure activity, excitatory N-methyl-d-aspartate (NMDA) receptors are increasingly expressed post-synaptically. Ketamine is an antagonist at this receptor and may prove efficient in some patients at later stages. Neurosteroids such as allopregnanolone increase sensitivity at GABAA receptors; a Phase 1/2 trial demonstrated safety and tolerability, but randomized controlled data failed to demonstrate efficacy. Adjunct ketogenic diet may contribute to termination of difficult-to-treat status epilepticus. Randomized controlled trials are needed to increase evidence for treatment of refractory and super-refractory status epilepticus, but there are multiple obstacles for realization. Hitherto, prospective multicenter registries for pharmacological treatment may help to improve our knowledge.
      PubDate: 2018-03-01
  • Efficacy and Safety of Tiotropium in Children and Adolescents
    • Abstract: Asthma is one of the most common chronic diseases in children, with a high proportion of patients demonstrating poor control despite the availability of disease management guidelines. Global Initiative for Asthma guidelines include tiotropium as an add-on therapy option at Steps 4 and 5 in patients aged ≥ 12 years with a history of exacerbations, and tiotropium delivered via the Respimat® Soft Mist™ Inhaler has recently been approved for use as once-daily maintenance therapy for children with asthma over the age of 6 years in the USA. A large clinical trial program has been conducted in children, adolescents, and adults across the spectrum of asthma severity. Findings from these clinical studies and pooled analyses in children and adolescents with symptomatic moderate or severe asthma have demonstrated that tiotropium Respimat® as add-on to inhaled corticosteroids, with or without other maintenance therapies, is a well-tolerated and efficacious bronchodilator, showing improved lung function and trends towards improved asthma control, mirroring findings in adult studies. This review discusses the evidence to date for tiotropium Respimat® for the management of asthma in adolescents and children with symptomatic moderate and severe asthma, and considers the challenges of asthma management in these patients. Factors affecting this population group, such as poor adherence, underreporting of symptoms, and social and psychological issues, are highlighted, along with the need for active review and management of treatment to help achieve optimal control.
      PubDate: 2018-03-01
  • Landiolol: A Review in Tachyarrhythmias
    • Abstract: 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. It was more effective than diltiazem in converting postoperative atrial fibrillation (POAF) to normal sinus rhythm. Perioperative prophylactic administration of landiolol significantly reduced the incidence of POAF during the first week after cardiac and other surgeries, compared with diltiazem, placebo or no landiolol treatment. Landiolol also attenuated adverse haemodynamic and other responses to invasive procedures such as percutaneous coronary intervention, tracheal intubation, extubation and electroconvulsive therapy. Landiolol was generally well tolerated, with a relatively low risk of hypotension and bradycardia. Landiolol has more favourable pharmacological properties than esmolol, a short-acting β-blocker commonly used for the rapid control of heart rate. Although additional comparative studies are warranted to define the place of landiolol relative to esmolol, current evidence suggest that landiolol is a useful option for the rapid short-term control of tachyarrhythmias. Landiolol offers a simple dosage scheme and is available in two easy-to-use formulations (concentrate and powder).
      PubDate: 2018-03-01
  • BRAF and MEK Inhibitors: Use and Resistance in BRAF-Mutated Cancers
    • Abstract: 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. Although effective initially, a major clinical barrier with these inhibitors is the relapse of patients due to drug resistance. Knowledge of the mechanisms of resistance to these drugs is still premature, highlighting the need for a more in-depth understanding of how patients become insensitive to these pharmacologic interventions. Herein, we will succinctly summarize the milestones in the approval of select MAPK/ERK pathway inhibitors, their use in patients, and major modes of resistance.
      PubDate: 2018-02-27
  • Netarsudil Ophthalmic Solution 0.02%: First Global Approval
    • Abstract: 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. Phase III development in the EU and phase II development in Japan are underway for this indication. This article summarizes the milestones in the development of netarsudil 0.02% leading to this first approval for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.
      PubDate: 2018-02-16
  • Eculizumab: A Review in Generalized Myasthenia Gravis
    • Abstract: The humanized monoclonal antibody eculizumab (Soliris®) is a complement inhibitor indicated for use in anti-acetylcholine receptor (AChR) antibody-positive adults with generalized myasthenia gravis (gMG) in the USA, refractory gMG in the EU, or gMG with symptoms that are difficult to control with high-dose IVIg therapy or PLEX in Japan. It is the first complement inhibitor to be approved for use in these patients. In the well-designed, 26-week REGAIN study in patients with anti-AChR-positive refractory gMG, although a statistically significant benefit of eculizumab over placebo in the prespecified primary endpoint analysis (change from baseline in MG-activities of daily living (ADL) score assessed by worst-rank ANCOVA) was not formally demonstrated, preplanned and post hoc sensitivity analyses of this outcome, as well as other secondary outcomes supported the efficacy of eculizumab. Overall, patients receiving eculizumab experienced significant improvements in the ADL, muscle strength and health-related quality of life (HR-QOL) parameters relative to patients receiving placebo. Moreover, an ongoing extension of REGAIN showed that treatment benefits with eculizumab were sustained during continued therapy for at least 52 weeks. Eculizumab was generally well tolerated in these studies, with a tolerability profile similar to that reported previously in other indications. Although several questions remain, such as duration of treatment, cost effectiveness and long-term efficacy and tolerability, current evidence indicates that eculizumab is a valuable emerging therapy for patients with refractory gMG.
      PubDate: 2018-02-12
  • Outcomes, Access, and Cost Issues Involving PCSK9 Inhibitors to Lower
    • Abstract: The clinical importance and benefit of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors appears well established for the high-risk cardiovascular (CV) patient. This applies especially to the statin-intolerant patient or the patient who does not attain an appropriate low-density lipoprotein cholesterol (LDL-C) target. Therefore, the barriers to appropriate clinical use of the PCSK9 inhibitors involve cost and not the documented CV benefit or LDL-C lowering. Multiple roadblocks affect many high-risk CV patients in arranging approval of a PCSK9 inhibitor. Overcoming these roadblocks may require legal pressures, some increased regulation, and facilitation by competitive forces.
      PubDate: 2018-02-02
  • Belimumab: A Review in Systemic Lupus Erythematosus
    • Abstract: 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. Sustained disease control was maintained during longer-term (up to 10 years) treatment with IV belimumab. Belimumab also demonstrated steroid-sparing effects and was associated with clinically meaningful improvements in health-related quality of life and fatigue. Belimumab was generally well tolerated in clinical trials, with low rates of immunogenicity. In view of the flexibility regarding the route of administration and the convenience of the once-weekly, self-administered, SC regimen, add-on therapy with belimumab is a useful treatment option for patients with active, autoantibody-positive SLE despite standard therapy.
      PubDate: 2018-02-02
  • Prevention and Treatment of Chronic Postsurgical Pain: A Narrative Review
    • Abstract: Chronic postsurgical pain affects between 5 and 75% of patients, often with an adverse impact on quality of life. While the transition of acute to chronic pain is a complex process—involving multiple mechanisms at different levels—the current strategies for prevention have primarily been restricted to perioperative pharmacological interventions. In the present paper, we first present an up-to-date narrative literature review of these interventions. In the second section, we develop several ways by which we could overcome the limitations of the current approaches and enhance the outcome of our surgical patients, including the better identification of individual risk factors, tailoring treatment to individual patients, and improved acute and subacute pain evaluation and management. The third and final section covers the treatment of established CPSP. Given that evidence for the current therapeutic options is limited, we need high-quality trials studying multimodal interventions matched to pain characteristics.
      PubDate: 2018-01-29
  • Overview of Current Drugs and Molecules in Development for Spinal Muscular
           Atrophy Therapy
    • Abstract: Spinal muscular atrophy (SMA) is a neurodegenerative disease primarily characterized by a loss of spinal motor neurons, leading to progressive paralysis and premature death in the most severe cases. SMA is caused by homozygous deletion of the survival motor neuron 1 (SMN1) gene, leading to low levels of SMN protein. However, a second SMN gene (SMN2) exists, which can be therapeutically targeted to increase SMN levels. This has recently led to the first disease-modifying therapy for SMA gaining formal approval from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Spinraza (nusinersen) is a modified antisense oligonucleotide that targets the splicing of SMN2, leading to increased SMN protein levels, capable of improving clinical phenotypes in many patients. In addition to Spinraza, several other therapeutic approaches are currently in various stages of clinical development. These include SMN-dependent small molecule and gene therapy approaches along with SMN-independent strategies, such as general neuroprotective factors and muscle strength-enhancing compounds. For each therapy, we provide detailed information on clinical trial design and pharmacological/safety data where available. Previous clinical studies are also discussed to provide context on SMA clinical trial development and the insights these provided for the design of current studies.
      PubDate: 2018-01-29
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