DOCSLIB.ORG

Lowering LDL Cholesterol with Nonstatin Treatments

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Lowering LDL Cholesterol with Nonstatin Treatments CONTINUING EDUCATION THIS ACTIVITY IS SUPPORTED BY AN EDUCATIONAL GRANT FROM ESPERION THERAPEUTICS, INC. Lowering LDL Cholesterol With Nonstatin Treatments FACULTY EDUCATIONAL OBJECTIVES Craig J. Beavers, PharmD, FACC, FAHA, At the completion of this activity, the participant will be able to: FCCP, BCCP, BCPS-AQ Cardiology, • Examine the most recent cholesterol guidelines and the ongoing cardiovascular disease burden, CACP particularly with patients on maximally tolerated statins Director, Cardiovascular Services Baptist Health Paducah • Investigate the nonstatin options currently available including emerging therapies Paducah, Kentucky • Identify appropriate patients who may require an additional reduction in LDL cholesterol • Integrate the novel LDL-lowering medications into clinical decision making for at-risk patients Cardiovascular Clinical Pharmacist TARGET AUDIENCE: Retail pharmacists University of Kentucky HealthCare ACTIVITY TYPE: Application Lexington, Kentucky RELEASE DATE: November 16, 2020 Adjunct Assistant Professor EXPIRATION DATE: November 16, 2021 University of Kentucky College of ESTIMATED TIME TO COMPLETE ACTIVITY: 2.0 hours Pharmacy FEE: This lesson is offered for free at www.pharmacytimes.org. Lexington, Kentucky DISCLOSURES The following contributors have no relevant financial relationships with Introduction with a diagnosis of ASCVD.3 Beyond the commercial interests to disclose: Cardiovascular disease (CVD) is the mortality and morbidity associated with FACULTY Craig J. Beavers, PharmD, FACC, FAHA, leading cause of death both worldwide ASCVD, the burden on health care utiliza- FCCP, BCCP, BCPS-AQ Cardiology, and in the United States. Due to concerted tion and cost is excessive. The AHA data CACP public health efforts and therapeutic reveal estimates of annual and direct cost PHARMACY TIMES CONTINUING advances, mortality had declined from of ASCVD to be $351.3 billion. Further- EDUCATION™ PLANNING STAFF the 1990s into the early 2010s; however, more, it is estimated that by the year 2035, Jim Palatine, RPh, MBA; Maryjo Dixon, it appears mortality rates due to CVD are more than 45% of the US population will RPh; Rose Namissa, PharmD, BCPS; Kelly McCormick; Susan Pordon; and increasing again. The most recent American have some form of ASCVD, and total cost Brianna Winters Heart Association (AHA) disease statistics is projected to be $1.1 trillion.1 PHARMACY TIMES® EDITORIAL STAFF approximate 647,000 people in the United Davy James States, or 1 of 4, will die of CVD.1 Athero- CVD and the Role of Blood An anonymous peer reviewer was part of the content validation and conflict sclerotic cardiovascular disease (ASCVD) Cholesterol resolution and has no relevant financial is defined as stroke, transient ischemic There are 5 major modifiable risk factors relationships with commercial interests to disclose. attack (TIA), documented coronary artery for ASCVD, with blood pressure, lipids, disease (CAD) with stable angina, acute diabetes, smoking, and overweight/obesity coronary syndrome (ACS), coronary or responsible for more than half of cardio- other arterial revascularization, peripheral vascular mortality.4 More importantly, 90% vascular disease with or without claudi- of myocardial infarction (MI) events occur cation, and aortic aneurysm.2 Of these, in individuals with at least 1 risk factor.5 CAD is the most common type of CVD In terms of lipids, serum cholesterol and and contributes to half of the deaths each associated lipoproteins (low-density lipo- year. The Centers for Disease Control and protein [LDL], very low-density lipopro- Prevention estimates there are more than tein, high-density lipoprotein [HDL], etc) 18 million adults aged 20 years and older are clearly documented in a variety of data Pharmacy Times Continuing Education™ is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity is approved for 2.0 contact hours (0.20 CEU) under the ACPE universal activity number 0290-0000-20-317-H01-P. The activity is available for CE credit through November 16, 2021. PHARMACYTIMES.ORG 62 NOVEMBER 2020 www.pharmacytimes.org TABLE 1. STATIN THERAPY INTENSITIES7,a High intensity Moderate intensity Low intensity (lowers LDL, on average, by ≥50%) (lowers LDL, on average, by 30%-50%) (lowers LDL, on average, by <30%) Atorvastatin (Lipitor) 40-80 mg daily Atorvastatin 10-20 mg daily Fluvastatin 20-40 mg daily Rosuvastatin (Crestor) 20-40 mg daily Fluvastatin (Lescol) 40 mg twice daily Lovastatin 20 mg daily Fluvastatin XL 80 mg daily Pitavastatin 1 mg daily Lovastatin (Mevacor) 40 mg daily Pravastatin 10-20 mg daily Pitavastatin (Livalo, Zypitamag) 2-4 mg Simvastatin 10 mg daily daily Pravastatin (Pravachol) 40-80 mg daily Rosuvastatin 5-10 mg daily Simvastatin (Zocor) 20-40 mg daily Adapted from Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. J Am Coll Cardiol. 2017;70(14):1785-1822. aBolded agents and doses indicate statins and doses that were evaluated in randomized, controlled trials included in the guideline decision-making process. sources, from animal studies to randomized controlled trials, approval of the proprotein convertase subtilisin/kexin type 9 as contributing to ASCVD.2 Specifically, LDL plays a key (PCSK9) inhibitors, positive data from the Improved Reduction role in the pathogenesis and perpetuation of ASCVD, and of Outcomes: Vytorin Efficacy International Trial (IMPROVE- elevations of these levels above 100 mg/dL are associated IT) with ezetimibe and consensus that achieving the lowest with this heightened risk; aggressive lowering of these levels threshold of LDL possible would reduce ASCVD risk. This led produces a marked reduction in ASCVD events.2 to the development of the 2018 ACC/AHA blood cholesterol In 2013, the American College of Cardiology (ACC) and AHA guidelines. This version of the guidelines still focuses on the released their first set of cholesterol guidelines, taking over from importance of lifestyle changes and the use of moderate- or high- the National Heart, Lung, and Blood Institute of the National intensity fixed-dose statins, but there were significant departures Institutes of Health.6 In these guidelines, the ACC/AHA focused from the 2013 document, such as endorsements for monitoring on the reduction of ASCVD versus coronary heart disease alone for LDL response to a threshold, additional recommendations to embody entities such as carotid artery disease, peripheral for each of the 4 statin benefit groups, and considerations for vascular disease, and stroke. Based on the available clinical special populations not included in previous guidelines.2,6 In evidence related to ASCVD risk reduction, these guidelines addition, the ACC/AHA used the recommendations of the removed historical LDL treatment targets, focused treatment on guidelines related to non-ASCVD cholesterol management and statin therapy, provided limited recommendations for nonstatin integrated them into the 2019 ACC primary prevention guide- treatment, and devised the 4 major statin treatment groups. lines.8 It should be noted the history of cholesterol guideline These groups are (1) patients with clinical ASCVD; (2) patients development is rich, and other organizations besides ACC/ with LDL 190 mg/dL and greater; (3) patients aged 40 to 75 AHA produce cholesterol management recommendations; a full years with diabetes and with an LDL of 70 mg/dL to 189 mg/ discussion encompassing these documents is beyond the scope dL who were not classified in groups 1 or 2; (4) patients aged 40 of this activity. to 75 years with LDL of 70 mg/dL to 189 mg/dL and a 10-year In addition to the aforementioned new recommendations in ASCVD risk of at least 7.5%. This risk was calculated via the the 2018 guidelines, there are also new recommendations for pooled cohort risk equation (see ADDITIONAL RESOURCES for LDL thresholds at which to consider adding nonstatins as well link to pooled cohort calculator smartphone app). Furthermore, as recommendations for those nonstatin agents. In the most group 4 consists of primary prevention patients. As alluded recent version of the guidelines, the authors acknowledge that above, the recommendations primarily focused on statin some patients experience intolerance, which ranges from 10% to treatment, with preference toward moderate to high intensity 25% and most commonly presents as muscle symptoms. Addi- (TABLE 17), given their robust data in reducing ASCVD events. tionally, patients are concerned about adverse effects (AEs), After the 2013 guideline publication, much changed in the such as development of diabetes or memory impairment.2,9 They field of cholesterol management, including the introduction and also recognized that patients may have variable responses to PHARMACYTIMES.ORG NOVEMBER 2020 63 FIGURE. GUIDELINE RECOMMENDATIONS FOR SECONDARY PREVENTION OF ASCVD2 Clinical ASCVD Healthy Lifestyle ASCVD not at very high-risk* Very high-risk* ASCVD Age <75 y Age >75 y High-intensity or maximal statin (Class I) High-intensity statin (Goal: LDL-C >50% (Class I) If on maximal If PCSK9-I is Dashed statin and considered, arrow LDL-C >70 add ezetimibe indicates mg/dL (>1.8 to maximal RCT- If high- If on maximal Initiation of mmol/L), statin before supported intensity statin therapy Continuation of moderate- or adding adding efficacy, but statin not and LDL-C high-intensity high-intensity ezetimibe is PCSK9-I is less cost tolerated, >70 mg/dL statin is statin is reasonable (Class I) effective use (>1.8 reasonable reasonable
Load more

Recommended publications
  • Role of Colesevelam in Combination Lipid-Lowering Therapy
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Springer - Publisher Connector Am J Cardiovasc Drugs (2013) 13:315–323 DOI 10.1007/s40256-013-0037-0 REVIEW ARTICLE Role of Colesevelam in Combination Lipid-Lowering Therapy Michael R. Jones • Oliseyenum M. Nwose Published online: 3 August 2013 Ó The Author(s) 2013. This article is published with open access at Springerlink.com Abstract Hyperlipidemia is associated with an increased ezetimibe, statin plus niacin, or statin plus ezetimibe) and risk of cardiovascular events; reducing low-density lipo- high-sensitivity C-reactive protein (with statins), and protein cholesterol (LDL-C), the primary target for cho- increases in apo A-I (with statins, ezetimibe, or statins plus lesterol-lowering therapy, lowers the risk for such events. niacin). Triglyceride levels remained relatively unchanged Although bile acid sequestrants were the first class of drugs when colesevelam was combined with statins, fibrates, to show a mortality benefit related to LDL-C lowering, ezetimibe, or statin plus ezetimibe, and decreased with the statins are now considered first-line pharmacological ther- triple combination of colesevelam, statin, and niacin. apy for reducing LDL-C levels because of their potency Colesevelam offset the negative glycemic effects of statins and their remarkable record of successful outcomes studies. and niacin in subjects with insulin resistance or impaired Nevertheless, a substantial proportion of patients do not glucose tolerance. Colesevelam was generally well toler- achieve LDL-C goals with statin monotherapy. In addition, ated when added to other lipid-lowering therapies in clin- because of adverse effects (primarily myopathy), some ical trials, with gastrointestinal effects such as constipation patients may be unwilling to use or unable to tolerate statin being the predominant adverse events.
    [Show full text]
  • Download This PDF File
    Journal of Cardiology and Therapy Online Submissions: http: //www.ghrnet.org/index./jct/ Journal of Cardiol Ther 2021 January; 8(1): 967-970 DOI: 10.17554/j.issn.2309-6861.2021.08.183 ISSN 2309-6861(print), ISSN 2312-122X(online) REVIEW The Role of Non-statin Therapy to Improve Cardiovascular Outcomes Abdulhalim Jamal Kinsara1, FRCP, FACC,FESC; Domenico Galzerano2, FESC; Olga Vriz2, MD 1 Ministry of National Guard-Health Affairs, King Saud Bin Ab- disease risk, while other therapy are showing less evidence. The dulaziz University for Health Sciences, COM-WR, King Abdullah current review highlights the evidence related to non-statins in the International Medical Research Center, Jeddah, Saudi Arabia; reduction of CV outcomes. 2 King Faisal Specialist Hospital and Research Centre and Alfaisal University. Key words: Ezetimibe; Proprotein convertase subtilisin kexin type 9 Inhibitor; Lomitapide; Mipomersen; Inclisiran; Bempedoic acid; Conflict-of-interest statement: The author(s) declare(s) that there Nexletol & Nexlizet; Bile acid sequestrants; Fibrates; Nicotinic acid; is no conflict of interest regarding the publication of this paper. Plasmapheresis Open-Access: This article is an open-access article which was © 2021 The Author(s). Published by ACT Publishing Group Ltd. All selected by an in-house editor and fully peer-reviewed by external rights reserved. reviewers. It is distributed in accordance with the Creative Com- mons Attribution Non Commercial (CC BY-NC 4.0) license, which Kinsara AJ, Galzerano D, Vriz O. The Role of Non-statin Therapy permits others to distribute, remix, adapt, build upon this work non- to Improve Cardiovascular Outcomes. Journal of Cardiology and commercially, and license their derivative works on different terms, Therapy 2021; 8(1): 967-970 Available from: URL: http://www.
    [Show full text]
  • Cholestagel®) Combination and Monotherapy for Familial Hypercholesterolaemia
    New Medicine Recommendation Colesevelam (Cholestagel®) Combination and monotherapy for familial hypercholesterolaemia Recommendation: Black - NOT recommended for use by the NHS in Lancashire. Colesevelam (Cholestagel®) is NOT recommended as combination or monotherapy for familial hypercholesterolaemia. Clinical evidence indicates that the drug is poorly tolerated and the trials were weak in significant areas such as the inclusion of small numbers of patients, only demonstrating surrogate endpoints or being conducted using nonstandard co-administered drugs. There are similar, established drugs for the treatment of the condition for which there were no head to head trials with Colesevalam therefore relative clinical efficacy cannot be directly demonstrated. Summary of supporting evidence: Primary dyslipidaemias, including familial hypercholesterolaemia (FH), are lipid disorders that are genetic in origin. FH is the most common inherited lipid metabolism disorder in its heterozygous form. In the UK heterozygous FH affects 1 in 500 of the UK population. [1] Statin therapy is the first-line treatment for patients with the vast majority of dyslipidaemias. NICE CG 71 recommends the prescribing of a high-intensity statin at the maximum licensed dose or at the maximum tolerated dose to achieve a reduction in LDL cholesterol concentration of greater than 50% from baseline. [2] Colesevelam is a lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption. [3] Colesevelam is a third-line agent, behind statins and ezetimibe. [2] The main body of evidence for the use of colesevelam in familial hypercholesterolaemia comes from the European Public Assessment Reports (EPAR). Study GTC-48-301 was a randomised, double-blind, parallel design, placebo-controlled pivotal phase III dose-response study.
    [Show full text]
  • PHARMACEUTICAL APPENDIX to the TARIFF SCHEDULE 2 Table 1
    Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names INN which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service CAS registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known.
    [Show full text]
  • Does Your Patient Have Bile Acid Malabsorption?
    NUTRITION ISSUES IN GASTROENTEROLOGY, SERIES #198 NUTRITION ISSUES IN GASTROENTEROLOGY, SERIES #198 Carol Rees Parrish, MS, RDN, Series Editor Does Your Patient Have Bile Acid Malabsorption? John K. DiBaise Bile acid malabsorption is a common but underrecognized cause of chronic watery diarrhea, resulting in an incorrect diagnosis in many patients and interfering and delaying proper treatment. In this review, the synthesis, enterohepatic circulation, and function of bile acids are briefly reviewed followed by a discussion of bile acid malabsorption. Diagnostic and treatment options are also provided. INTRODUCTION n 1967, diarrhea caused by bile acids was We will first describe bile acid synthesis and first recognized and described as cholerhetic enterohepatic circulation, followed by a discussion (‘promoting bile secretion by the liver’) of disorders causing bile acid malabsorption I 1 enteropathy. Despite more than 50 years since (BAM) including their diagnosis and treatment. the initial report, bile acid diarrhea remains an underrecognized and underappreciated cause of Bile Acid Synthesis chronic diarrhea. One report found that only 6% Bile acids are produced in the liver as end products of of British gastroenterologists investigate for bile cholesterol metabolism. Bile acid synthesis occurs acid malabsorption (BAM) as part of the first-line by two pathways: the classical (neutral) pathway testing in patients with chronic diarrhea, while 61% via microsomal cholesterol 7α-hydroxylase consider the diagnosis only in selected patients (CYP7A1), or the alternative (acidic) pathway via or not at all.2 As a consequence, many patients mitochondrial sterol 27-hydroxylase (CYP27A1). are diagnosed with other causes of diarrhea or The classical pathway, which is responsible for are considered to have irritable bowel syndrome 90-95% of bile acid synthesis in humans, begins (IBS) or functional diarrhea by exclusion, thereby with 7α-hydroxylation of cholesterol catalyzed interfering with and delaying proper treatment.
    [Show full text]
  • Intervention to Improve LDL Receptor Function Emerging Therapies
    Intervention to improve LDL receptor function Emerging Therapies Marina Cuchel, MD, PhD Perelman School of Medicine University of Pennsylvania Most Lipid Lowering Drugs Affect LDL-C Levels By Up-Regulating the LDLR B100 apoB MTP VLDL TG TG statins ezetimibe bile acid sequestrants IDL PCSK9 -inhibitors LDL TG Cuchel NLA 2017 Do we really need more LDL-C lowering drugs? • LDL-C still not a goal with existing LLTs in a significant portion of subjects • Drug intolerance (statins) • Cost of new treatments • Other reasons Cuchel NLA 2017 Outline • PCSK9 – beyond monoclonal antibodies • ETC-1002 – inhibiting upstream HMGCoAR • Replacing LDLR - Gene therapy • ANGPTL3 inhibitors and other drug affecting LDL production Cuchel NLA 2017 PCSK9 enhances LDLR degradation Cuchel NLA 2017 Use of PCSK9i is complementary to that of statins PCSK9i evolucumab alirocumab [other monoclonal ABs] statins HMG-CoA ↑LDLR ↑PCSK9 ↓LDL-C ↓Cholesterol Cuchel NLA 2017 PCSK9 inhibition is very effective in lowering LDL-C Sabatine MS et al. N Engl J Med 2017. DOI: 10.1056/NEJMoa1615664 Cuchel NLA 2017 PCSK9 – beyond monoclonal Antibodies • Monoclonal PCSK9i are expensive • Require high doses • Are injectable • ?May lose responsiveness over time? Cuchel NLA 2017 Targeting PCSK9 with novel strategies • Vaccines • siRNA • Small molecules Cuchel NLA 2017 Targeting PCSK9 with novel strategies Vaccines antibodies response SREBP-2 pathway ↑ HMGCoA Red ↑ LDL-R Target protein ↑Epitope PCSK9 identification Conjugation with Administration Antibodies foreign peptide production Clinicaltrials.gov NCT02508896 Cuchel NLA 2017 Vaccine against PCSK9 lowers LDL-C in primates Crossey E. Vaccine, 2015 , 33, 5747–5755 Cuchel NLA 2017 Targeting PCSK9 with novel strategies siRNA SREBP-2 pathway ↑ HMGCoA Red ↑ LDL-R ↓PCSK9 Gene silencing Clinicaltrials.gov NCT02597127, NCT02314442 Cuchel NLA 2017 The RNAi inhibitor of PCSK9 - inclisiran - lowers PCSK9 and LDL-C levels in humans Ray KK et al.
    [Show full text]
  • Role of Colesevelam in Combination Lipid-Lowering Therapy
    Am J Cardiovasc Drugs DOI 10.1007/s40256-013-0037-0 REVIEW ARTICLE Role of Colesevelam in Combination Lipid-Lowering Therapy Michael R. Jones • Oliseyenum M. Nwose Ó The Author(s) 2013. This article is published with open access at Springerlink.com Abstract Hyperlipidemia is associated with an increased ezetimibe, statin plus niacin, or statin plus ezetimibe) and risk of cardiovascular events; reducing low-density lipo- high-sensitivity C-reactive protein (with statins), and protein cholesterol (LDL-C), the primary target for cho- increases in apo A-I (with statins, ezetimibe, or statins plus lesterol-lowering therapy, lowers the risk for such events. niacin). Triglyceride levels remained relatively unchanged Although bile acid sequestrants were the first class of drugs when colesevelam was combined with statins, fibrates, to show a mortality benefit related to LDL-C lowering, ezetimibe, or statin plus ezetimibe, and decreased with the statins are now considered first-line pharmacological ther- triple combination of colesevelam, statin, and niacin. apy for reducing LDL-C levels because of their potency Colesevelam offset the negative glycemic effects of statins and their remarkable record of successful outcomes studies. and niacin in subjects with insulin resistance or impaired Nevertheless, a substantial proportion of patients do not glucose tolerance. Colesevelam was generally well toler- achieve LDL-C goals with statin monotherapy. In addition, ated when added to other lipid-lowering therapies in clin- because of adverse effects (primarily myopathy), some ical trials, with gastrointestinal effects such as constipation patients may be unwilling to use or unable to tolerate statin being the predominant adverse events.
    [Show full text]
  • Bempedoic Acid and Inclisiran for Patients with Heterozygous Familial Hypercholesterolemia and for Secondary Prevention of ASCVD: Effectiveness and Value
    Bempedoic Acid and Inclisiran for Patients with Heterozygous Familial Hypercholesterolemia and for Secondary Prevention of ASCVD: Effectiveness and Value Draft Evidence Report November 12, 2020 Prepared for ©Institute for Clinical and Economic Review, 2020 ICER Staff and Consultants Modeling Team Grace A. Lin, MD, MAS Dhruv S. Kazi, MD, MSc, MS Associate Professor of Medicine and Health Policy Associate Director, Smith Center for Outcomes University of California, San Francisco Research in Cardiology Director, Cardiac Critical Care Unit Jane Jih, MD, MPH Beth Israel Deaconess Medical Center Assistant Professor, Division of General Internal Associate Professor, Harvard Medical School Medicine University of California, San Francisco Foluso Agboola, MBBS, MPH Director, Evidence Synthesis Dr. Kazi was responsible for the development of the ICER cost-effectiveness model, interpretation of results, and drafting of the economic sections of this report; the Rick Chapman, PhD, MS resulting ICER reports do not necessarily represent the Director of Health Economics views of Beth Israel Deaconess Medical Center or ICER Harvard Medical School. Steven D. Pearson, MD, MSc President ICER DATE OF PUBLICATION: November 12, 2020 How to cite this document: Lin GA, Kazi DS, Jih J, Agboola F, Chapman R, Pearson SD. Inclisiran and Bempedoic Acid for Patients with Heterozygous Familial Hypercholesterolemia and for Secondary Prevention of ASCVD: Effectiveness and Value; Draft Evidence Report. Institute for Clinical and Economic Review, November 12, 2020. https://icer-review.org/material/high-cholesterol-update- draft-evidence-report/ Grace Lin served as the lead author for the report and wrote the background, other benefits, and contextual considerations sections of the report, with Jane Jih serving as a co-author.
    [Show full text]
  • Assessment Report
    15 October 2020 EMA/696912/2020 Committee for Medicinal Products for Human Use (CHMP) Assessment report Leqvio International non-proprietary name: inclisiran Procedure No. EMEA/H/C/005333/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us An agency of the European Union Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. Administrative information Name of the medicinal product: Leqvio applicant: Novartis Europharm Limited Vista Building Elm Park Merrion Road Dublin 4 IRELAND Active substance: INCLISIRAN International Non-proprietary Name/Common inclisiran Name: Pharmaco-therapeutic group lipid modifying agents, plain, other lipid (ATC Code): modifying agents (C10AX) treatment for primary hypercholesterolaemia Therapeutic indication(s): or mixed dyslipidaemia Pharmaceutical form(s): Solution for injection Strength(s): 284 mg Route(s) of administration: Subcutaneous use Packaging: pre-filled syringe (glass) Package size(s): 1 pre-filled syringe Assessment report EMA/696912/2020 Page 2/143 Table of contents 1. Background information on the procedure ............................................ 12 1.1. Submission of the dossier ...................................................................................
    [Show full text]
  • WELCHOL (Colesevelam Hydrochloride) Pancreatitis
    HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------WARNINGS AND PRECAUTIONS--------------------- These highlights do not include all the information needed to use • The effect of WELCHOL on cardiovascular morbidity and WELCHOL safely and effectively. See full prescribing information mortality has not been determined (5.1). for WELCHOL. • WELCHOL can increase TG, particularly when used with insulin or sulfonylureas. Marked hypertriglyceridemia can cause acute WELCHOL (colesevelam hydrochloride) pancreatitis. The effect of hypertriglyceridemia on the risk of Initial U.S. Approval: 2000 coronary artery disease is uncertain. Monitor lipids, including TG and non-high density lipoprotein cholesterol (non-HDL-C) (5.2). ----------------------RECENT MAJOR CHANGES----------------------- • Bile acid sequestrants may decrease absorption of fat-soluble Dosage and Administration (2) xx/2011 vitamins. Use caution in patients susceptible to fat-soluble vitamin Warnings and Precautions (5.4) xx/2011 deficiencies (5.3). -----------------------INDICATIONS AND USAGE------------------------ • Because of its constipating effects, WELCHOL is not WELCHOL is a bile acid sequestrant indicated as an adjunct to diet recommended in patients at risk of bowel obstruction (e.g., patients and exercise to with gastroparesis, other gastrointestinal motility disorders or a • reduce elevated low-density lipoprotein cholesterol (LDL-C) in history of major gastrointestinal surgery) (5.4). adults with primary hyperlipidemia as monotherapy or in • WELCHOL reduces gastrointestinal
    [Show full text]
  • Bempedoic Acid
    Drug and Biologic Coverage Policy Effective Date ............................................. 7/15/2020 Next Review Date ......................................... 7/1/2021 Coverage Policy Number .................................. 2015 Bempedoic acid Table of Contents Related Coverage Resources Coverage Policy ................................................... 1 Genetic Testing of Heritable Disorders FDA Approved Indications ................................... 4 Recommended Dosing ........................................ 4 General Background ............................................ 4 Coding/Billing Information .................................... 7 References .......................................................... 7 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit
    [Show full text]
  • MPS 2742 To: All Community Pharmacists 15 December 2020 Dear Colleague
    MPS 2742 Pharmaceutical Services, 2 Franklin Street, Belfast BT2 8DQ Telephone No. 028 95 36 0333 To: All Community Pharmacists 15th December 2020 Dear colleague Re: Bile acid sequestrants- colestyramine powder for oral suspension 4g (Questran and Questran Light), colesevelam (Cholestagel) and colestipol (Colestid) Description of product affected Colestyramine is licensed for use in the following indications1,2: Primary prevention of coronary heart disease in men between 35 and 59 years of age and with primary hypercholesterolaemia who have not responded to diet and other appropriate measures. Reduction of plasma cholesterol in hypercholesterolaemia, particularly in those patients who have been diagnosed as Fredrickson's Type II (high plasma cholesterol with normal or slightly elevated triglycerides). Relief of pruritus associated with partial biliary obstruction and primary biliary cirrhosis. Relief of diarrhoea associated with ileal resection, Crohn's disease, vagotomy and diabetic vagal neuropathy. Management of radiation-induced diarrhoea The dose used varies between 4g and 36g daily according to the indication.1,2 MPS 2742 Pharmaceutical Services, 2 Franklin Street, Belfast BT2 8DQ Telephone No. 028 95 36 0333 For relief of diarrhoea, it is common practice to use colestyramine off-label to treat “bile acid diarrhoea” where considered clinically appropriate. This condition may be diagnosed using a radionucleotide SeHCAT test.3 Colestyramine is also used to help reduce the volume of jejunal and ileostomy outputs as a consequence
    [Show full text]