Long-Acting Beta-Agonists in the Management of Chronic Obstructive Pulmonary Disease: Current and Future Agents
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
1 Effect of Indacaterol, a Novel Long-Acting Beta 2
ERJ Express. Published on November 29, 2006 as doi: 10.1183/09031936.00032806 EFFECT OF INDACATEROL, A NOVEL LONG-ACTING BETA 2-AGONIST, ON HUMAN ISOLATED BRONCHI Emmanuel Naline (1), Alexandre Trifilieff (2), Robin A. Fairhurst (2), Charles Advenier (1), Mathieu Molimard (3) (1) Research Unit EA220, Université de Versailles, Faculté de Médecine, Pharmacology, Hôpital Foch, 40 rue Worth, 92150 Suresnes, France (2) Novartis Institute for BioMedical Research, Horsham, England (3) Département de Pharmacologie, Université Victor Segalen Bordeaux 2; CHU Pellegrin; INSERM U657, Bordeaux, France Correspondence: Mathieu Molimard Département de Pharmacologie CHU de Bordeaux - Université Victor Segalen-INSERM U657 33076 Bordeaux cedex, France Phone: 33 (0)5 57 57 15 60 Fax: 33 (0)5 57 57 46 71 E-mail: [email protected] Short title: Indacaterol effect on isolated human bronchi 1 Copyright 2006 by the European Respiratory Society. Abstract Indacaterol is a novel β2-adrenoceptor agonist in development for the once-daily treatment of asthma and COPD. This study evaluated the relaxant effect of indacaterol on isolated human bronchi obtained from lungs of patients undergoing surgery for lung carcinoma. Potency (-logEC50), intrinsic efficacy (Emax) and onset of action were determined at resting tone. Duration of action was determined against cholinergic neural contraction induced by electrical field stimulation (EFS). At resting tone, -logEC50 and Emax values were, respectively, 8.82±0.41 and 77±5% for indacaterol, 9.84±0.22 and 94±1% for formoterol, 8.36±0.16 and 74±4% for salmeterol, and 8.43±0.22 and 84±4% for salbutamol. In contrast to salmeterol, indacaterol did not antagonize the isoprenaline response. -
Medicaid Policy Change
MEDICAID POLICY CHANGE IMMINENT PERIL JUSTIFICATION September 25, 2019 ADVAIR: POLICY CHANGE: LDH is changing the preferred drug list to switch the diskus inhaled powder from preferred to non-preferred and adding the HFA inhaler to the preferred list instead. JUSTIFICATION: This product is used to control symptoms and prevent complications caused by asthma or chronic obstructive pulmonary disease. This change is necessary to make an easier delivery device available for recipients to aid with treatment. Without preferred status, recipients would be required to obtain prior authorization which could delay necessary treatment. This change is needed by 10/1/19 due to the coming seasonal change in weather, including influenza and allergy season, that can significantly exacerbate chronic lung diseases, and so this presents an imminent peril to public health. EFFECTIVE DATE: October 1, 2019 LA Medicaid Preferred Drug List (PDL)/Non-Preferred Drug List (NPDL) Effective Date: July 15October 1, 2019 AG – Authorized Generic DR – Concurrent Prescriptions Must Be Written by Same Prescriber PU – Prior Use of Other Medication is Required AL – Age Limits DS – Maximum Days’ Supply Allowed QL – Quantity Limits BH – Behavioral Health Clinical Authorization Required for Children Younger Than 6 DT – Duration of Therapy Limit RX – Specific Prescription Requirements Years Old BY – Diagnosis Codes Bypass Some Requirements DX – Diagnosis Code Requirements TD – Therapeutic Duplication UN – Drug Use Not Warranted (Needs Appropriate CL – More Detailed Clinical Information -
Study Protocol and Statistical Analysis Plan
Propranolol and Gene Expression in HCT Protocol v3.0, January 15, 2016 RANDOMIZED CONTROLLED PILOT STUDY USING PROPRANOLOL TO DECREASE GENE EXPRESSION OF STRESS-MEDIATED BETA- ADRENERGIC PATHWAYS IN HEMATOPOIETIC STEM CELL TRANSPLANT RECIPIENTS Version 3.0 Principal Investigator: Jennifer M. Knight, MD Medical College of Wisconsin 8701 Watertown Plank Road Milwaukee, WI 53226 Telephone: 414-955-8908 Fax: 414-955-6285 Email: [email protected] Co-Investigator: J. Douglas Rizzo, MD, MS CIBMTR Froedtert and the Medical College of Wisconsin Clinical Cancer Center 9200 W. Wisconsin Avenue Suite C5500 Milwaukee, WI 53226 Telephone: 414-805-0700 Fax: 414-805-0714 Email: [email protected] Co-Investigator: Parameswaran Hari, MD, MS Froedtert and the Medical College of Wisconsin Clinical Cancer Center 9200 W. Wisconsin Avenue Suite C5500 Milwaukee, WI 53226 Telephone: 414-805-4600 Fax: 414-805-4606 Email: [email protected] Consultant Steve W. Cole, PhD and Statistician: UCLA-David Geffen School of Medicine 10833 LeConte Ave 11-934 Factor Bldg Los Angeles, CA 90095-1678 Telephone: 310-267-4243 Email: [email protected] 1 Propranolol and Gene Expression in HCT Protocol v3.0, January 15, 2016 Sponsor: Medical College of Wisconsin Funding Sponsor: This project has an offer of sponsorship from the National Cancer Institute, National Institutes of Health, under Contract No. HHSN261200800001E. 2 Propranolol and Gene Expression in HCT Protocol v3.0, January 15, 2016 PROTOCOL SYNOPSIS Randomized Controlled Pilot Study Using Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in Hematopoietic Stem Cell Transplant Recipients Principal Investigator: Jennifer M. Knight, MD Study Design: This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic antagonist propranolol is effective in decreasing gene expression of stress-mediated beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic stem cell transplant (HCT) for multiple myeloma. -
Therapeutic Class Overview Inhaled Anticholinergics
Therapeutic Class Overview Inhaled Anticholinergics Therapeutic Class Overview/Summary: The inhaled anticholinergics are a class of bronchodilators primarily used in the management of chronic obstructive pulmonary disease (COPD), a condition characterized by progressive airflow restrictions that are not fully reversible.1-3 Symptoms associated with COPD typically include dyspnea, cough, sputum production, wheezing and chest tightness. Specifically, inhaled anticholinergics work via the inhibition of acetylcholine at parasympathetic sites in bronchial smooth muscle causing bronchodilation. Meaningful increases in lung function can be achieved with the use of inhaled anticholinergics in patients with COPD.1-3 The available single-entity inhaled anticholinergics include aclidinium (Tudorza® Pressair), glycopyrrolate (Seebri Neohaler®), ipratropium (Atrovent®, Atrovent® HFA), tiotropium (Spiriva®, Spiriva Respimat®) and umeclidinium (Incruse Ellipta®) with the combination products including glycopyrrolate/indacaterol (Utibron Neohaler®), umeclidinium/vilanterol (Anoro Ellipta®), tiotropium/olodaterol (Stiolto Respimat®) and ipratropium/albuterol, formulated as either an inhaler (Combivent Respimat®) or nebulizer solution (DuoNeb).4-15 Ipratropium, a short-acting bronchodilator, has a duration of action of six to eight hours and requires administration four times daily. Aclidinium, glycopyrrolate, tiotropium and umeclidinium are considered long-acting bronchodilators. Aclidinium is dosed twice daily, while glycopyrrolate, tiotropium and umeclidinium -
Us Anti-Doping Agency
2019U.S. ANTI-DOPING AGENCY WALLET CARDEXAMPLES OF PROHIBITED AND PERMITTED SUBSTANCES AND METHODS Effective Jan. 1 – Dec. 31, 2019 CATEGORIES OF SUBSTANCES PROHIBITED AT ALL TIMES (IN AND OUT-OF-COMPETITION) • Non-Approved Substances: investigational drugs and pharmaceuticals with no approval by a governmental regulatory health authority for human therapeutic use. • Anabolic Agents: androstenediol, androstenedione, bolasterone, boldenone, clenbuterol, danazol, desoxymethyltestosterone (madol), dehydrochlormethyltestosterone (DHCMT), Prasterone (dehydroepiandrosterone, DHEA , Intrarosa) and its prohormones, drostanolone, epitestosterone, methasterone, methyl-1-testosterone, methyltestosterone (Covaryx, EEMT, Est Estrogens-methyltest DS, Methitest), nandrolone, oxandrolone, prostanozol, Selective Androgen Receptor Modulators (enobosarm, (ostarine, MK-2866), andarine, LGD-4033, RAD-140). stanozolol, testosterone and its metabolites or isomers (Androgel), THG, tibolone, trenbolone, zeranol, zilpaterol, and similar substances. • Beta-2 Agonists: All selective and non-selective beta-2 agonists, including all optical isomers, are prohibited. Most inhaled beta-2 agonists are prohibited, including arformoterol (Brovana), fenoterol, higenamine (norcoclaurine, Tinospora crispa), indacaterol (Arcapta), levalbuterol (Xopenex), metaproternol (Alupent), orciprenaline, olodaterol (Striverdi), pirbuterol (Maxair), terbutaline (Brethaire), vilanterol (Breo). The only exceptions are albuterol, formoterol, and salmeterol by a metered-dose inhaler when used -
COPD Agents Review – October 2020 Page 2 | Proprietary Information
COPD Agents Therapeutic Class Review (TCR) October 1, 2020 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. October 2020 -
Arformoterol Tartrate) Inhalation Solution 3 15 Mcg*/2 Ml 4 *Potency Expressed As Arformoterol 5 6 for Oral Inhalation Only 7 8 WARNING: ASTHMA RELATED DEATH
® 1 BROVANA 2 (arformoterol tartrate) Inhalation Solution 3 15 mcg*/2 mL 4 *potency expressed as arformoterol 5 6 For oral inhalation only 7 8 WARNING: ASTHMA RELATED DEATH 9 Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related 10 death. Data from a large placebo-controlled US study that compared the safety of 11 another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual 12 asthma therapy showed an increase in asthma-related deaths in patients receiving 13 salmeterol. This finding with salmeterol is considered a class effect of LABA, 14 including arformoterol, the active ingredient in BROVANA (see WARNINGS). The 15 safety and efficacy of BROVANA in patients with asthma have not been established. 16 All LABA, including BROVANA, are contraindicated in patients with asthma 17 without use of a long-term asthma control medication (see 18 CONTRAINDICATIONS). 19 20 DESCRIPTION 21 BROVANA (arformoterol tartrate) Inhalation Solution is a sterile, clear, colorless, 22 aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. 23 Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for 24 arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2 25 (4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-, (2R,3R)-2,3 26 dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows: OH H N . HO OH CH3 HO OCH3 HOOC COOH HN H 27 O 28 The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula ٠C4H6O6 (1:1 salt). -
Olodaterol Monograph
Olodaterol Monograph Olodaterol (Striverdi Respimat) National Drug Monograph VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. Updates will be made when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current. FDA Approval Information Description/Mechan Olodaterol is a long-acting beta2-adrenergic agonist (LABA). Binding to and activating ism of Action beta2-adrenoceptors in the airways results in stimulation of intracellular adenyl cyclase, an enzyme that mediates the synthesis of cyclic-3’, 5’ adenosine monophosphate (cAMP). Elevated levels of cAMP induce bronchodilation by relaxation of airway smooth muscle cells. Indication(s) Under Long-term once daily maintenance bronchodilator treatment of airflow obstruction in Review patients with COPD including chronic bronchitis and/or emphysema Dosage Form(s) Inhalation spray for oral inhalation via Respimat (a soft-mist inhaler) Under Review The soft-mist inhalers (SMI) provide multi-dose medication using liquid formulations similar to that used in nebulizers and are propellant-free. Presently, Respimat is the only SMI commercially available for clinical use. The soft mist is released at a slower velocity and has more prolonged spray duration than the mist produced from pressurized metered dose inhalers (pMDIs). Pressurized MDIs require coordination of actuation with inhalation which may be difficult for some patients partly due to the rapid speed at which the drug is delivered and the short duration of the mist. -
Analysis of the Indacaterol-Regulated Transcriptome in Human Airway
Supplemental material to this article can be found at: http://jpet.aspetjournals.org/content/suppl/2018/04/13/jpet.118.249292.DC1 1521-0103/366/1/220–236$35.00 https://doi.org/10.1124/jpet.118.249292 THE JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS J Pharmacol Exp Ther 366:220–236, July 2018 Copyright ª 2018 by The American Society for Pharmacology and Experimental Therapeutics Analysis of the Indacaterol-Regulated Transcriptome in Human Airway Epithelial Cells Implicates Gene Expression Changes in the s Adverse and Therapeutic Effects of b2-Adrenoceptor Agonists Dong Yan, Omar Hamed, Taruna Joshi,1 Mahmoud M. Mostafa, Kyla C. Jamieson, Radhika Joshi, Robert Newton, and Mark A. Giembycz Departments of Physiology and Pharmacology (D.Y., O.H., T.J., K.C.J., R.J., M.A.G.) and Cell Biology and Anatomy (M.M.M., R.N.), Snyder Institute for Chronic Diseases, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada Received March 22, 2018; accepted April 11, 2018 Downloaded from ABSTRACT The contribution of gene expression changes to the adverse and activity, and positive regulation of neutrophil chemotaxis. The therapeutic effects of b2-adrenoceptor agonists in asthma was general enriched GO term extracellular space was also associ- investigated using human airway epithelial cells as a therapeu- ated with indacaterol-induced genes, and many of those, in- tically relevant target. Operational model-fitting established that cluding CRISPLD2, DMBT1, GAS1, and SOCS3, have putative jpet.aspetjournals.org the long-acting b2-adrenoceptor agonists (LABA) indacaterol, anti-inflammatory, antibacterial, and/or antiviral activity. Numer- salmeterol, formoterol, and picumeterol were full agonists on ous indacaterol-regulated genes were also induced or repressed BEAS-2B cells transfected with a cAMP-response element in BEAS-2B cells and human primary bronchial epithelial cells by reporter but differed in efficacy (indacaterol $ formoterol . -
HIM.PA.153 Inhaled Agents for Asthma and COPD
Clinical Policy: Inhaled Agents for Asthma and COPD Reference Number: HIM.PA.153 Effective Date: 03.01.21 Last Review Date: 02.21 Line of Business: HIM Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description The following are inhaled agents for asthma and/or chronic obstructive pulmonary disease (COPD) requiring prior authorization: • Short acting beta-2 agonist (SABA): albuterol (ProAir® Digihaler®), levalbuterol (Xopenex® HFA, Xopenex® inhalation solution) • Inhaled corticosteroid (ICS): budesonide (Pulmicort Respules®)*, ciclesonide (Alvesco®), fluticasone (Armonair® Digihaler™), mometasone (Asmanex® HFA, Asmanex® Twisthaler®) • Long acting beta-2 agonist (LABA): arformoterol (Brovana®), formoterol (Perforormist) • Long acting muscarinic antagonist (LAMA): aclidinium bromide (Tudorza® Pressair®), glycopyrrolate (Seebri™ Neohaler®, Lonhala® Magnair®), revefenacin (Yupelri®) • Combination ICS/LABA: budesonide/formoterol (Symbicort®)*, fluticasone/salmeterol (Advair Diskus®*, AirDuo® Digihaler™, AirDuo® RespiClick®), mometasone/formoterol (Dulera®) • Combination LABA/LAMA: aclidnium/formoterol (Duaklir® Pressair®), indacaterol/glycopyrrolate (Utibron™ Neohaler®), tiotropium/olodaterol (Stiolto® Respimat®) • Combination ICS/LAMA/LABA: budesonide/glycopyrrolate/formoterol (Breztri Aerosphere™) _______________ *Generic agents do not require prior authorization. FDA Approved Indication(s) ProAir Digihaler and Xopenex are indicated for the treatment or prevention of bronchospasm -
Beta Adrenergic Agents
Beta2 Adrenergic Agents –Long Acting Review 04/10/2008 Copyright © 2007 - 2008 by Provider Synergies, L.L.C. All rights reserved. Printed in the United States of America. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage and retrieval system without the express written consent of Provider Synergies, L.L.C. All requests for permission should be mailed to: Attention: Copyright Administrator Intellectual Property Department Provider Synergies, L.L.C. 5181 Natorp Blvd., Suite 205 Mason, Ohio 45040 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Comments and suggestions may be sent to [email protected]. -
The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances
WHO/PSM/QSM/2006.3 The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances 2006 Programme on International Nonproprietary Names (INN) Quality Assurance and Safety: Medicines Medicines Policy and Standards The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 © World Health Organization 2006 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.