Cholesterol Medication Fact Sheets
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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. -
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. -
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. -
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. -
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. -
Pharmaceutical Appendix to the Harmonized Tariff Schedule
Harmonized Tariff Schedule of the United States Basic Revision 3 (2021) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States Basic Revision 3 (2021) 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. -
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 -
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 -
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 -
Medical Necessity Criteria for Welchol (Colesevelam)
Medical Necessity Criteria for Welchol (colesevelam) Background – The antilipidemics II drug class includes three types of medications that affect cholesterol levels: the fibric acid derivatives (gemfibrozil and fenofibrate), the bile acid sequestrants (cholestyramine, colesevelam, and colestipol), and prescription omega-3 fatty acids (Lovaza, formerly Omacor). After evaluating the relative clinical and cost effectiveness of the bile acid subclass, the DoD P&T Committee recommended that Welchol (colesevelam) be designated as non-formulary. This recommendation has been approved by the Director, TMA. Effective Date: 13 July 2011 Patients currently using Welchol (colesevelam) may wish to ask their doctor to consider a formulary alternative. Notes: * Active duty cost share always $0 in all points of service for all three tiers; active duty service members may not fill prescriptions for a non-formulary medication unless it is determined to be medically necessary. ** MTFs will be able to fill non-formulary requests for non-formulary medications only if both of the following conditions are met: 1) a MTF provider writes the prescription, and 2) medical necessity is established for the non-formulary medication. MTFs may (but are not required to) fill a prescription for a non-formulary medication written by a non-MTF provider to whom the patient was referred, as long as medical necessity has been established. Medical Necessity Criteria for Welchol (colesevelam)® 1. The formulary medication is contraindicated (e.g., due to hypersensitivity). 2. The patient has experienced or is likely to experience significant adverse effects with the formulary medication. 3. The formulary medication resulted in therapeutic failure. 4. The patient has a history of GI obstruction and requires treatment with a bile acid sequestrant. -
2 12/ 35 74Al
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 22 March 2012 (22.03.2012) 2 12/ 35 74 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 9/16 (2006.01) A61K 9/51 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 9/14 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (21) International Application Number: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/EP201 1/065959 HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (22) International Filing Date: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, 14 September 201 1 (14.09.201 1) ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, (25) Filing Language: English RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, (26) Publication Language: English TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 61/382,653 14 September 2010 (14.09.2010) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except US): GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, NANOLOGICA AB [SE/SE]; P.O Box 8182, S-104 20 ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, Stockholm (SE). -
Atorvastatin Calcium)
PRODUCT INFORMATION LIPITOR® (atorvastatin calcium) NAME OF THE MEDICINE LIPITOR atorvastatin (as calcium) 10 mg, 20 mg, 40 mg and 80 mg tablets. LIPITOR contains the active ingredient atorvastatin calcium. The structural formula of atorvastatin calcium is shown below: CH3 CH3 CH OH OH O O CH CH CH C NHC 2 - N CH2 CH2 CH2 O •Ca 2+ •3H2 O F 2 Chemical name: [R-(R*,R*)]-2-(4-fluorophenyl)-ß,-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino) carbonyl] -1H-pyrrole -1-heptanoic acid, calcium salt (2:1) Molecular formula: (C33H34FN2O5)2Ca.3H2O Molecular weight: 1209.42 CAS registry number: 134523-03-8. DESCRIPTION Atorvastatin calcium is a white to off-white crystalline powder that is practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile, slightly soluble in ethanol and freely soluble in methanol. LIPITOR tablets contain atorvastatin calcium equivalent to 10, 20, 40 and 80 mg atorvastatin. The tablets also contain the following inactive ingredients: calcium carbonate, microcrystalline cellulose, lactose, croscarmellose sodium, polysorbate 80, hydroxypropylcellulose, magnesium stearate, Opadry White YS-1-7040 and Simethicone Emulsion. Version: pfplipit10613 Supersedes: pfplipit10512 Page 1 of 20 PHARMACOLOGY Mechanism of Action Atorvastatin is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl-glutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Triglycerides (TG) and cholesterol in the liver are incorporated into very low density lipoprotein (VLDL) and released into the plasma for delivery to peripheral tissues.