Supplement Table 2. Categorization of Statin Intensity Based on Potential Low-Density Lipoprotein Cholesterol Reduction
|
|
|
- Lucinda Ross
- 5 years ago
- Views:
Transcription
1 Supplement: Tables Supplement Table 1. Study Eligibility Criteria Supplement Table 2. Categorization of Statin Intensity Based on Potential Low-Density Lipoprotein Cholesterol Reduction Supplement Table 3. Index of Included Trials by Combination Therapy Agent Supplement Table 4. All Adverse Events Reported in Included Trials by Combination Therapy Agent
2 Supplement Table 1. Study Eligibility Criteria Population and condition of interest Interventions and approaches Comparisons of interest Outcomes and Timing Adults at high-risk for ASCVD including those with preexisting ASCVD (acute coronary syndromes, or a history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin), baseline LDL-c 190 mg/dl (4.91 mmol/l) or trial inclusion criteria LDL-c 190 mg/dl (4.91 mmol/l), preexisting diabetes mellitus. Excluded studies if they included only adults with low or moderate ASCVD risk Excluded studies that included only patients with homozygous familial hypercholesterolemia (FH) Studies must have evaluated a combination regimen of interest Included studies of bile acid sequestrants + statin Included studies of ezetimibe + statin Included studies of fibrates + statin Included studies of niacin + statin Included studies of omega-3 fatty acids + statin Excluded studies of lifestyle modifications Excluded studies of drugs approved only for the treatment of homozygous FH Excluded studies of drugs not approved by the FDA or investigational drugs Excluded studies of prepackaged medications that contained non lipid-lowering medications Included comparisons of higher intensity statin monotherapy Excluded studies if a study statin monotherapy was of the same or lower intensity than combination arm Excluded studies if there was no comparison or only placebo comparison Clinical outcomes including mortality, acute coronary events, cerebrovascular events, revascularization procedures at any time point Surrogate outcomes including LDL-c at any time point Adherence (investigator defined) at any time point Harms outcomes (investigator defined) including serious adverse events, withdrawal due to adverse events at any time point Type of study Included studies from the prior report that met all other criteria Included randomized controlled trials Included non-randomized extension of clinical trial over 24 weeks duration (clinical outcomes, SAE and harms only) Included FDA reports (SAE and harms only) Excluded studies with other observational designs Excluded studies with no original data (e.g., reviews, editorials, comments, letters) Excluded studies published only as abstracts Excluded qualitative studies Excluded crossover trials with fewer than 4 weeks washout and/or lacking paired observation, within person differences, or pre-crossover data Excluded non-english publications Abbreviations: ASCVD atherosclerotic cardiovascular disease; FH familial hypercholesterolemia; FDA Food and Drug Administration; LDL-c low-density lipoprotein cholesterol; RCT randomized controlled trial; SAE serious adverse event.
3 Supplement Table 2. Categorization of Statin Intensity Based on Potential Low-Density Lipoprotein Cholesterol Reduction Statin Low Intensity (<30% LDL-c reduction) Mid Intensity (30-40% LDL-c reduction) High Intensity (>40% LDL-c reduction) Atorvastatin Fluvastatin Fluvastatin XL 5 20 and/or Lovastatin 5 and/or 10 and/or 20 Pitavastatin 1 Pravastatin 10 and/or 20 and/or 40 Rosuvastatin Simvastatin and/or 80 2 and/or and/or 40 and/or and/or 10 and/or 20 and/or 40 Abbreviations: LDL-c low-density lipoprotein cholesterol. *Studies that use simvastatin 80mg in statin naïve patients were excluded. 40 and/or 80*
4 Supplement Table 3. Index of Included Trials by Combination Therapy Agent Author, Year (Reference) Bile acid sequestrants Ismail, 1990 (30) Barbi, 1992 (31) Johansson, 1995 (28) Knapp, 2001 (29) Pravastatin Multicenter Study Group II, 1993 (32) Schrott, 1995 (33) Ezetimibe Araujo, 2010 (34) McKenney, 2007 (36) Averna, 2010 (19) Bardini, 2010 (38)*** Barrios, 2005 (39) Cho, 2011 (40) Hamdan, 2011 (43) Matsue, 2012 (44) Okada, 2011 (45) Therapeutic Regimen (Intensity) in Eligible Arms M: PRV 80mg (mid) C: Cholestyramine 24g + PRV 40mg (low) C1: Colestipol 5g + SMV 20g (mid) C2: Colestipol 10g + SMV 20mg (mid) M: SMV 20mg (mid) C: Colesevelam 3.8g + SMV 10mg (low) M: PRV 80mg (mid) C: Cholestyramine 24g + PRV 40mg (low) M: LOV 40mg (mid) C1: Colestipol 5g + LOV 20mg (low) C2: Colestipol 10g + LOV 20mg (low) M: SMV 80mg (high) C: Ezetimibe 10mg + SMV 10mg (low) M: RSV 20mg (high) M1: RSV 5mg (high) M2: ATV 20mg (high) C1: Ezetimibe 10mg + RSV 2.5mg (mid) C2: Ezetimibe 10mg + ATV 10mg (mid) Baseline N in Eligible Arms by Population Outcome(s) Reported HLD CVD DM Clinical* LDL-c Adherence Harms 18 X 83 X 73 X X 127 X 70 X X 23 X 145 X X X 112 X X X X X X 435 NR** X X 85 X X X 93 X X 243 X 165 X
5 Ostad, 2009 (20) Pesaro, 2012 (41) Pesaro, 2013 (42) Piorkowski, 2007 (37) Roeters van Lennep, 2007 (21) Yamazaki, 2013 (46) Zieve, 2010 (47) Ben-Yehuda, 2011 (48) Bays, 2013 (49) Constance, 2007 (22) Foody, 2010 (53) Gaudiani, 2005 (56) Goldberg, 2006 (50) Guyton, 2007 (51) Tomassini, 2009 (52) Kawagoe, 2011 (57) Lee, 2013 (54) Rosen, 2013 (23) Jimenez, 2013 (24) Rosen, 2013 (25) Rudofsky, 2012 (35) Torimoto, 2013 (55) M: ATV 80mg (high) M: SMV 80mg (high) M: ATV 40mg (high) M1: ATV 20mg (high) M: RSV 10mg (high) C: Ezetimibe 10mg + RSV 2.5mg (mid) M1: RSV 10 mg (high) M2: ATV 20mg (high) M1: ATV 40mg (high) M2: ATV 20mg (high) C1: Ezetimibe 10mg + SMV 20mg (mid) M1: ATV 40mg (high) M2: ATV 20mg (high) M: FLV 60mg (mid) C: Ezetimibe 10mg + FLV 20mg (low) M1: RSV 10mg (high) M3: ATV 20mg (high) M: SMV 80mg (high) C: Ezetimibe 10mg + SMV 10mg (low) M: RSV 5mg (high) C: Ezetimibe 10mg + RSV 2.5mg (mid) 49 X X X 78 X X 51 X 367 X 46 X 891** 223** X 733** X 439 X X X X NR** X 214 X X 737 X 24 X 132 X X 808 X X X 21 X 75 X Fibrates Athyros, 2002 (58) 654 X X
6 Shah, 2007 (59) Farnier, 2011 (26) Niacin C1: Gemfibrozil 1200mg + SMV 20mg (mid) C2: Ciprofibrate 100mg + SMV 20mg (mid) C3: Gemfibrozil 1200mg + PRV 20mg (low) C4: Ciprofibrate 100mg + PRV 20mg (low) M1: ATV 20mg (high) C1: Fenofibrate 200mg + ATV 10mg (mid) C2: Fenofibrate 200mg + SMV 20mg (mid) M: SMV 20mg (mid) C: Fenofibrate 160mg + PRV 40mg (low) 102 X X 291 X X X X Bays, 2003 (60) M1: ATV 40mg (high) C1: Niacin-ER 1g + LOV 40mg (mid) C2: Niacin-ER 2g + LOV 40mg (mid) 315 X X X Hunninghake, 2003 (27) M: LOV 40mg (mid) C: Niacin-ER 1g + LOV 20mg (low) 118 X X X M: LOV 40mg (mid) Insull, 2004 (61) C1: Niacin-ER 2.5g + LOV 10mg (low) C2: Niacin-ER 2.5g + LOV 20mg (low) 101 X X X Abbreviations: ATV atorvastatin; C combination therapy; CVD population with preexisting atherosclerotic cardiovascular disease; DM population with diabetes mellitus; FLV fluvastatin; HLD population with LDL-c>= 190 mg/dl; LDL-c low-density lipoprotein cholesterol; LOV lovastatin; M monotherapy; NR not reported; PRV pravastatin; RSV rosuvastatin; SMV simvastatin. *Clinical outcomes include mortality, acute coronary events, cerebrovascular events, and/or revascularization procedures. **Indicates this population was included as part of a subgroup analysis in this trial. ***Inclusion criteria for this trial included CHD and DM.
7 Supplement Table 4. All Adverse Events Reported in Included Trials by Combination Therapy Agent Author, Year (Reference) Bile acid sequestrants Knapp, 2001 (29) Ezetimibe Averna, 2010 (19) Bardini, 2010 (38) Barrios, 2005 (39) Cho, 2011 (40) Therapeutic Regimen (Intensity) in Eligible Arms M: SMV 20mg (mid) C: Colesevelam 3.8g + SMV 10mg (low) Time Point (Population) (HLD) (CVD, DM) Adverse Event and/or hepatitis Elevation in CPK 10 times ULN and/or hepatitis Elevation in CPK 10 times ULN Elevation in CPK 10 times ULN and/or hepatitis Events Reported (%) C: 1 (3%) M: 1 (2%) M: 1 (2%) M: 13 (22%) C: 13 (22%) C: 1 (2%) M: 2 (4%) C: 1 (3%) M: 10 (20%) C: 5 (12%) M: 2 (1%) C: 5 (2%) M: 8 (4%) C: 5 (2%) M: 51 (24%) C: 44 (20%) C: 1 (<1%) M: 1 (3%) Between Group Difference p=0.47 p=0.45 p=0.40 p=0.45 p=0.41 p=0.35
8 Constance, 2007 (22) Gaudiani, 2005 (56) Hamdan, 2011 (43) Lee, 2013 (54) McKenney, 2007 (36) Ostad, 2009 (20) Pesaro, 2012 (41) Pesaro, 2013 (42) Rosen, 2013 (23) Jimenez, 2013 (24) M: RSV 20mg (high) M: ATV 80mg (high) M: SMV 80mg (high) M1: RSV 10mg (high) (DM) 24 weeks (DM) 12 weeks 12 weeks (DM) 12 weeks (HLD) 8 weeks (DM) Elevation in CPK 10 times ULN CPK >10 times ULN and/or hepatitis Elevation in AST/ALT >3 times ULN Elevation in CPK>10 times ULN and/or hepatitis M: 5 (2%) C: 1 (<1%) M: 2 (1%) C: 3 (1%) M: 42 (19%) C: 51 (23%) C: 1 (<1%) M: 1 (1%) C: 5 (5%) M: 5 (5%) C: 2 (2%) M: 11 (10%) C: 19 (18%) C: 1 (1%) M: 10 (22%) C: 2 (4%) M: 1 (2%) C: 3 (5%) M: 1 (1%) M: 5 C: 2 M1: 2 (1%) M2/3: 1 (1%) p=0.12 p=0.40 p=0.11 p=0.45 p=0.11 p=0.48 p=0.01 p=0.62 p=0.42 M1 vs c: M2/3 vs C:
9 Rosen, 2013 (25) Fibrates Athyros, 2002 (58) Farnier, 2011 (26) Shah, 2007 (59) Niacin Bays, 2003 (60) M3: ATV 20mg (high) C1: Gemfibrozil 1200mg + SMV 20mg (mid) C2: Ciprofibrate 100mg + SMV 20mg (mid) C3: Gemfibrozil 1200mg + PRV 20mg (low) C4: Ciprofibrate 100mg + PRV 20mg (low) M: SMV 20mg (mid) C: Fenofibrate 160mg + PRV 40mg (low) M1: ATV 20mg (high) C1: Fenofibrate 200mg + ATV 10mg (mid) C2: Fenofibrate 200mg + SMV 20mg (mid) M1: ATV 40mg (high) 52 weeks (HLD) 12 weeks (DM) 13 weeks 1 (HLD) Elevation in CPK>10 times ULN Elevation in AST and/or ALT > 3 times ULN Elevation in CPK Elevation in CPK > 5 times ULN Change in Cr > 20 mg/ml or CrCl<50 ml/min Elevation in AST or ALT > 3 times ULN C: 2 (1%) M1: 1 (<1%) M2/3: 3 (2%) C: 7 (2%) M1: 28 (9%) M2/3: 13 (9%) C: 33 (10%) M1: 1 (<1%) M2/3: 0 M1: 0 M2/3: 0 C1: 3 (2%) C2: 3 (2%) C3: 1 (1%) C4: 0 C1: 1 (1%) C2: 0 C3: 1 (15) C4: 0 M: 1 (1%) C: 1 (1%) M: 22 (15%) C: 25 (17%) M1: 0 M2: 2 (9%) C1: 0 C2: 0 M1: 0 M2: 0 M1 vs C: p=0.06 M2/3 vs C: M1 vs C: p=0.48 M2/3 vs C: p=0.42 M1 vs c: M2/3 vs C: p=0.84 p=0.29 p=0.73 p=0.89
10 C1: Niacin-ER 1g + LOV 40mg (mid) C2: Niacin-ER 2g + LOV 40mg (mid) C1: 0 C2: 0 Elevation in CPK > 5 times ULN M1: 0 M2: 0 C1: 0 C2: 0 M: (19%) C: (10%) p=0.06 Elevation in AST or ALT >3 times ULN M: 1 NR Hunninghake, 2003 M: LOV 40mg (mid) 28 weeks Elevation in CPK > 10 times ULN (27) C: Niacin-ER 1g + LOV 20mg (low) (HLD) M: 4 (7%) C: 2 (4%) p=0.68 Elevation in fasting glucose > 1.3 times ULN M: (7%) C (4%) p=0.68 M: 17 (52%) C1: 15 (44%) C2: 21 (62%) p=0.84 Insull, 2004 (61) Elevation in AST or ALT > 3 times ULN C1: 1 (3%) M: LOV 40mg (mid) 20 weeks C2: 1 (3%) C1: Niacin-ER 2.5g + LOV 10mg (low) (HLD) C2: Niacin-ER 2.5g + LOV 20mg (low) Elevation in CPK > 3 times ULN C1: 0 C2: 0 Hyperglycemia C1: 2 (6%) C2: 1 (3%) p=0.77 Abbreviations: AE adverse event; ALT alanine aminotransferase; AST aspartate aminotransferase; ATV atorvastatin; C combination therapy; CVD population with preexisting atherosclerotic cardiovascular disease; CI confidence interval; CPK creatinine phosphokinase; Cr creatinine; CrCl creatinine clearance; DM population with diabetes mellitus; FLV fluvastatin; HLD population with LDL-c >=190 mg/dl; LOV lovastatin; M monotherapy; not applicable; NR not reported and unable to calculate from information provided; NS not significant; PRV pravastatin; RSV rosuvastatin; SMV simvastatin; ULN upper limit of normal.
What do the guidelines say about combination therapy?
What do the guidelines say about combination therapy? Christie M. Ballantyne, MD Center for Cardiovascular Disease Prevention Methodist DeBakey Heart & Vascular Center Baylor College of Medicine Houston,
Learning Objectives. Patient Case
Joseph Saseen, Pharm.D., FASHP, FCCP, BCPS Professor and Vice Chair, Department of Clinical Pharmacy University of Colorado Anschutz Medical Campus Learning Objectives Identify the 4 patient populations
Disclosures No relationships (not even to an employer) No off-label uses. Cholesterol Lowering Guidelines: What now?
Disclosures No relationships (not even to an employer) No off-label uses Cholesterol Lowering Guidelines: What now?, FACP 1 2 65-year-old white woman Total cholesterol 175mg/dL HDL 54 mg/dl LDL 96 mg/dl
Dyslipidemia in the light of Current Guidelines - Do we change our Practice?
Dyslipidemia in the light of Current Guidelines - Do we change our Practice? Dato Dr. David Chew Soon Ping Senior Consultant Cardiologist Institut Jantung Negara Atherosclerotic Cardiovascular Disease
Cholesterol Management Roy Gandolfi, MD
Cholesterol Management 2017 Roy Gandolfi, MD Goals Interpreting cholesterol guidelines Cholesterol treatment in diabetics Statin use and side effects therapy Reporting- Comparison data among physicians
ATP IV: Predicting Guideline Updates
Disclosures ATP IV: Predicting Guideline Updates Daniel M. Riche, Pharm.D., BCPS, CDE Speaker s Bureau Merck Janssen Boehringer-Ingelheim Learning Objectives Describe at least two evidence-based recommendations
Drug Class Monograph
Drug Class Monograph Class: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Drugs: Praluent (alirocumab), Repatha (evolocumab) Line of Business: Medi-Cal Effective Date: February 17, 2016
Drug Class Review HMG-CoA Reductase Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin
Drug Class Review HMG-CoA Reductase Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin Final Report Update 5 November 2009 This report reviews information about the comparative
How to Handle Statin Intolerance in the High Risk Patient
How to Handle Statin Intolerance in the High Risk Patient Thomas D. Conley, MD FACC FSCAI Disclosures: None 1 Definition of High Risk Primary Prevention ASCVD Risk Calculator Adults >21 yrs, LDL 190 mg/dl
Repatha. Repatha (evolocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.16.08 Subject: Repatha Page: 1 of 8 Last Review Date: September 18, 2015 Repatha Description Repatha
Lipid Therapy: Statins and Beyond. Ivan Anderson, MD RIHVH Cardiology
Lipid Therapy: Statins and Beyond Ivan Anderson, MD RIHVH Cardiology Outline The cholesterol hypothesis and lipid metabolism The Guidelines 4 Groups that Benefit from Lipid therapy Initiation and monitoring
2013 ACC AHA LIPID GUIDELINE JAY S. FONTE, MD
2013 ACC AHA LIPID GUIDELINE JAY S. FONTE, MD How do you interpret my blood test results? What are our targets for these tests? Before the ACC/AHA Lipid Guidelines A1c:
Repatha. Repatha (evolocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.08 Subject: Repatha Page: 1 of 8 Last Review Date: December 2, 2016 Repatha Description Repatha (evolocumab)
How would you manage Ms. Gold
How would you manage Ms. Gold 32 yo Asian woman with dyslipidemia Current medications: Simvastatin 20mg QD Most recent lipid profile: TC = 246, TG = 100, LDL = 176, HDL = 50 What about Mr. Williams? 56
PCSK9 Agents Drug Class Prior Authorization Protocol
PCSK9 Agents Drug Class Prior Authorization Protocol Line of Business: Medicaid P & T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review of medical
CLINICAL OUTCOME Vs SURROGATE MARKER
CLINICAL OUTCOME Vs SURROGATE MARKER Statin Real Experience Dr. Mostafa Sherif Senior Medical Manager Pfizer Egypt & Sudan Objective Difference between Clinical outcome and surrogate marker Proper Clinical
Lipid Panel Management Refresher Course for the Family Physician
Lipid Panel Management Refresher Course for the Family Physician Objectives Understand the evidence that was evaluated to develop the 2013 ACC/AHA guidelines Discuss the utility and accuracy of the new
Atherosclerotic cardiovascular disease (ASCVD) affects. Review
Review Annals of Internal Medicine Effectiveness of Combination Therapy With Statin and Another Lipid-Modifying Agent Compared With Intensified Statin Monotherapy A Systematic Review Kimberly A. Gudzune,
Lipid Management 2013 Statin Benefit Groups
Clinical Integration Steering Committee Clinical Integration Chronic Disease Management Work Group Lipid Management 2013 Statin Benefit Groups Approved by Board Chair Signature Name (Please Print) Date
( Diabetes mellitus, DM ) ( Hyperlipidemia ) ( Cardiovascular disease, CVD )
005 6 69-74 40 mg/dl > 50 mg/dl) (00 mg/dl < 00 mg/dl(.6 mmol/l) 30-40% < 70 mg/dl 40 mg/dl 00 9 mg/dl fibric acid derivative niacin statin fibrate statin niacin ( ) ( Diabetes mellitus,
Pharmacy Drug Class Review
Pharmacy Drug Class Review January 22, 2014 Authored By: Christina Manciocchi, Pharm.D. BCACP Disclaimer: Specific agents may have variations Edited By: Richard J. Kraft, Pharm.D.BCPS NEW CHOLESTEROL GUIDELINES
High ( 50%) Restrictions mg 20-40mg PA; TS ⱡ 15 ⱡ
MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY: Cholesterol P&T DATE: 5/9/2017 THERAPEUTIC CLASS: Cardiovascular REVIEW HISTORY: 5/16, 5/15, 2/14, 5/12, LOB AFFECTED: Medi-Cal
New Guidelines in Dyslipidemia Management
The Third IAS-OSLA Course on Lipid Metabolism and Cardiovascular Risk Muscat, Oman, February 2017 New Guidelines in Dyslipidemia Management Dr. Khalid Al-Waili, MD, FRCPC, DABCL Senior Consultant Medical
Non-Statin Lipid-Lowering Agents M Holler - Last updated: 10/2016
Drug/Class Cholestyramine (Questran) Bile acid sequestrant Generic? Lipid Effects Y/N (monotherapy) Y LDL : 9% (4 g to 8 ; 21% (16 g to 20 ; 23% to 28% (>20 HDL : 4% to 8% (16 to 24 TG : 11% to 28% (4
PCSK9 Inhibitors Praluent (Alirocumab) and Repatha (Evolocumab) For the Treatment of Familial Hypercholesterolemia
PCSK9 Inhibitors Praluent (Alirocumab) and Repatha (Evolocumab) For the Treatment of Familial Hypercholesterolemia Policy Number: Original Effective Date: MM.04.037 08/01/2016 Line(s) of Business: HMO;
No relevant financial relationships
MANAGEMENT OF LIPID DISORDERS Balancing Benefits and harms Disclosure Robert B. Baron, MD MS Professor and Associate Dean UCSF School of Medicine No relevant financial relationships baron@medicine.ucsf.edu
Long-Term Complications of Diabetes Mellitus Macrovascular Complication
Long-Term Complications of Diabetes Mellitus Macrovascular Complication Sung Hee Choi MD, PhD Professor, Seoul National University College of Medicine, SNUBH, Bundang Hospital Diabetes = CVD equivalent
Common Repatha Documentation Requirements for Patients With Primary Hyperlipidemia and Established CVD 1,2
Established CVD Common Repatha Documentation Requirements for Patients With Primary Hyperlipidemia and Established CVD 1,2 Primary and Secondary Diagnosis Codes Primary Diagnosis: Primary hyperlipidemia
Diabetes: Use of Adjunctive Therapy ACEs, ARBs, ASA & STATINs --Oh My! Veronica J. Brady, PhD, FNP-BC, BC-ADM, CDE Project ECHO April 19, 2018
Diabetes: Use of Adjunctive Therapy ACEs, ARBs, ASA & STATINs --Oh My! Veronica J. Brady, PhD, FNP-BC, BC-ADM, CDE Project ECHO April 19, 2018 Points to Ponder ASCVD is the leading cause of morbidity
Introduction. Objective. Critical Questions Addressed
Introduction Objective To provide a strong evidence-based foundation for the treatment of cholesterol for the primary and secondary prevention of ASCVD in women and men Critical Questions Addressed CQ1:
PIEDMONT ACCESS TO HEALTH SERVICES, INC. Guidelines for Screening and Management of Dyslipidemia
PIEDMONT ACCESS TO HEALTH SERVICES, INC. Policy Number: 01-09-021 SUBJECT: Guidelines for Screening and Management of Dyslipidemia EFFECTIVE DATE: 04/2008 REVIEWED/REVISED: 04/12/10, 03/17/2011, 4/10/2012,
UnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2063-8 Program Prior Authorization/Medical Necessity Medication Repatha (evolocumab) P&T Approval Date 5/2015, 9/2015, 11/2015,
4/24/15. AHA/ACC 2013 Guideline Key Points
Review of the ACC/AHA 2013 Guidelines Anita Ralstin, MS, CNS, CNP Next Step Health Consultant, LLC 1! Discuss the rationale for the change in lipid guidelines and how that affects the decision to implement
Repatha. Repatha (evolocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.08 Subject: Repatha Page: 1 of 9 Last Review Date: September 15, 2017 Repatha Description Repatha
Conflicts of interest. What's the Skinny on the Lipid Guidelines? Key Differences. Are you applying the new ACC/AHA Lipid guidelines in your practice?
Conflicts of interest What's the Skinny on the Lipid Guidelines? The presenter has no relevant conflicts of interest to disclose. Kathleen Vest, PharmD, CDE, BCACP At the end of this presentation, pharmacist
Repatha. Repatha (evolocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.08 Subject: Repatha Page: 1 of 9 Last Review Date: November 30, 2018 Repatha Description Repatha (evolocumab)
Request for Prior Authorization for PCSK9 inhibitor therapy Website Form Submit request via: Fax
Request for Prior Authorization for PCSK9 inhibitor therapy Website Form www.highmarkhealthoptions.com Submit request via: Fax - 1-855-476-4158 PCSK9 is a protein that reduces the hepatic removal of low-density
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Repatha) Reference Number: HIM.PA.SP46 Effective Date: 01.01.18 Last Review Date: Line of Business: Health Insurance Marketplace Revision Log See Important Reminder at the end of this
Disclosure. No relevant financial relationships. Placebo-Controlled Statin Trials
MANAGEMENT OF HYPERLIPIDEMIA AND CARDIOVASCULAR RISK IN WOMEN: Balancing Benefits and Harms Disclosure Robert B. Baron, MD MS Professor and Associate Dean UCSF School of Medicine No relevant financial
Clinical Policy: Evolocumab (Repatha) Reference Number: ERX.SPMN.184 Effective Date: 01/2017
Clinical Policy: (Repatha) Reference Number: ERX.SPMN.184 Effective Date: 01/2017 Last Review Date: Revision Log See Important Reminder at the end of this policy for important regulatory and legal information.
2013 ACC/AHA Cholesterol Guidelines JULIE HAMMOND, D.O. PGY-2 MATTHEW PAOLI, D.O. PGY-2
2013 ACC/AHA Cholesterol Guidelines JULIE HAMMOND, D.O. PGY-2 MATTHEW PAOLI, D.O. PGY-2 GOALS ACC/AHA as publisher of guidelines Determining which patients are appropriate for statin therapy The treatment
PCSK9 Inhibitors: Promise or Pitfall?
PCSK9 Inhibitors: Promise or Pitfall? Tracy Harlan, PharmD PGY2 Ambulatory Care Resident University of Iowa Hospitals and Clinics tracy harlan@uiowa.edu Tracy Harlan does not have any actual or potential
Antihyperlipidemic Drugs
Antihyperlipidemic Drugs Hyperlipidemias. Hyperlipoproteinemias. Hyperlipemia. Hypercholestrolemia. Direct relationship with acute pancreatitis and atherosclerosis Structure Lipoprotein Particles Types
CPE Session 7. Update on Clinical Practice Guidelines and Best Evidence in the Management of Hyperlipidemia and Cardiovascular Risk Reduction
CPE Session 7 Update on Clinical Practice Guidelines and Best Evidence in the Management of Hyperlipidemia and Cardiovascular Risk Reduction Saturday, April 25, 2015 ACPE UAN 0128-0000-15-027-L01-P 1.0
Management of Post-transplant hyperlipidemia
Management of Post-transplant hyperlipidemia B. Gisella Carranza Leon, MD Assistant Professor of Medicine Lipid Clinic - Vanderbilt Heart and Vascular Institute Division of Diabetes, Endocrinology and
No relevant financial relationships
MANAGEMENT OF LIPID DISORDERS: WHERE DO WE STAND WITH THE NEW PRACTICE GUIDELINES? Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine Disclosure No relevant financial relationships
Quality ID #438: Statin Therapy for the Prevention and Treatment of Cardiovascular Disease National Quality Strategy Domain: Effective Clinical Care
Quality ID #438: Statin Therapy for the Prevention and Treatment of Cardiovascular Disease National Quality Strategy Domain: Effective Clinical Care 2018 OPTIONS F INDIVIDUAL MEASURES: REGISTRY ONLY MEASURE
Dyslipedemia New Guidelines
Dyslipedemia New Guidelines New ACC/AHA Prevention Guidelines on Blood Cholesterol November 12, 2013 Mohammed M Abd El Ghany Professor of Cardiology Cairo Universlty 1 1 0 Cholesterol Management Pharmacotherapy
B. Patient has not reached the percentage reduction goal with statin therapy
Managing Cardiovascular Risk: The Importance of Lowering LDL Cholesterol and Reaching Treatment Goals for LDL Cholesterol The Role of the Pharmacist Learning Objectives 1. Review the role of lipid levels
Landmark Clinical Trials.
Landmark Clinical Trials 1 Learning Objectives Discuss clinical trials and their role in lipid and lipoprotein treatment in cardiovascular prevention. Review the clinical trials of lipid-altering drug
New Guidelines in Dyslipidemia Management
The Fourth IAS-OSLA Course on Lipid Metabolism and Cardiovascular Risk Muscat, Oman, February 2018 New Guidelines in Dyslipidemia Management Dr. Khalid Al-Waili, MD, FRCPC, DABCL Senior Consultant Medical
Hae Sun Suh, B.Pharm., Ph.D. Jason N. Doctor, Ph.D.
Podium Presentation, May 18, 2009 Comparison of Cardiovascular Event Rates in Subjects with Type II Diabetes Mellitus who Augmented from Statin Monotherapy to Statin Plus Fibrate Combination Therapy with
Effective Health Care Program
Comparative Effectiveness Review Number 132 Effective Health Care Program Therapy Versus Intensification of Statin Monotherapy: An Update Executive Summary Background Cardiovascular disease (CVD) includes
Proprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization with Quantity Limit Program Summary
Proprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization with Quantity Limit Program Summary Proprotein Convertase Subtilisin/Kexin type 9(PCSK9) Inhibitors Prior Authorization
MOLINA HEALTHCARE OF CALIFORNIA
MOLINA HEALTHCARE OF CALIFORNIA HIGH BLOOD CHOLESTEROL IN ADULTS GUIDELINE Molina Healthcare of California has adopted the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel
Placebo-Controlled Statin Trials EXPLAINING THE DECREASE IN DEATHS FROM CHD! PREVENTION OF CARDIOVASCULAR DISEASE IN WOMEN EXPLAINING THE DECREASE IN
PREVENTION OF CARDIOVASCULAR DISEASE IN WOMEN Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine Declaration of full disclosure: No conflict of interest EXPLAINING THE DECREASE
Lipids & Hypertension Update
Lipids & Hypertension Update No financial disclosures Michael W. Cullen, MD, FACC Senior Associate Consultant, Assistant Professor of Medicine Mayo Clinic Department of Cardiovascular Diseases 34 th Annual
Praluent. Praluent (alirocumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.06 Subject: Praluent Page: 1 of 10 Last Review Date: September 20, 2018 Praluent Description Praluent
STATIN UTILIZATION MANAGEMENT CRITERIA
STATIN UTILIZATION MANAGEMENT CRITERIA DRUG CLASS: HMG Co-A Reductase Inhibitors & Combinations Agents which require prior review: Advicor (niacin extended-release/lovastatin) Crestor (rosuvastatin)(5mg,10mg,
UnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2062-8 Program Prior Authorization/Medical Necessity Medication Praluent (alirocumab) P&T Approval Date 5/2015, 8/2015, 9/2015,
Highlights of the new blood pressure and cholesterol guidelines: A whole new philosophy. Jeremy L. Johnson, PharmD, BCACP, CDE, BC-ADM
Highlights of the new blood pressure and cholesterol guidelines: A whole new philosophy Jeremy L. Johnson, PharmD, BCACP, CDE, BC-ADM OSHP 2014 Annual Meeting Oklahoma City, OK April 4, 2014 1 Objectives
Chapter 2: Pharmacological cholesterol-lowering treatment in adults Kidney International Supplements (2013) 3, ; doi: /kisup.2013.
http://www.kidney-international.org chapter & 3 KDIGO Chapter : Pharmacological cholesterol-lowering treatment in adults Kidney International Supplements (3) 3, 7 79; doi:.38/kisup.3.34 INTRODUCTION Therapeutic
Disclosures. Pediatric Dyslipidemia Casey Elkins, DNP, NP C, CLS, FNLA. Learning Objectives. Atherogenesis. Acceptable Values
39 th National Conference on Pediatric Health Care Pediatric Dyslipidemia Casey Elkins, DNP, NP C, CLS, FNLA March 19-22, 2018 CHICAGO Disclosures Speakers Bureau Sanofi and Regeneron Learning Objectives
NCEP Report. Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines
NCEP Report Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines Scott M. Grundy; James I. Cleeman; C. Noel Bairey Merz; H. Bryan Brewer,
High ( 50%) Restrictions mg 20-40mg Simvastatin (Zocor) 10mg 20-40mg $1.66 Pravastatin (Pravachol) mg $6.
MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY: Cholesterol P&T DATE: 5/8/2018 THERAPEUTIC CLASS: Cardiovascular REVIEW HISTORY: 5/17, 5/16, 5/15, 2/14, LOB AFFECTED: Medi-Cal
REPATHA (PCSK9 INHIBITORS)
REPATHA (PCSK9 INHIBITS) Indications: PCSK9 Inhibitors are indicated for treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease as
Hyperlipidemia: Past and Present. Rebecca Khaimova, PharmD The Brooklyn Hospital Center
Hyperlipidemia: Past and Present Rebecca Khaimova, PharmD The Brooklyn Hospital Center Rkhaimova@tbh.org Conflicts of Interest None to disclose Learning Objectives for Pharmacist Describe the pathophysiology
Drug Prior Authorization Guideline PCSK9 Inhibitors -
Drug Prior Authorization Guideline PCSK9 Inhibitors - REPATHA (evolocumab) PRALUENT (alirocumab) PA9911 Covered Service: Yes when meets criteria below Prior Authorization Required: Yes-as shown below Additional
Diabetes and Cardiovascular Risk Management Denise M. Kolanczyk, PharmD, BCPS-AQ Cardiology
Diabetes and Cardiovascular Risk Management Denise M. Kolanczyk, PharmD, BCPS-AQ Cardiology Disclosures In compliance with the accrediting board policies, the American Diabetes Association requires the
Drug Class Prior Authorization Criteria PCSK9 Inhibitors
Drug Class Prior Authorization Criteria PCSK9 Inhibitors Line of Business: Medicaid P & T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review of
Lipid Guidelines Who, What, and How Low. Anita Ralstin, MS, CNP Next Step Health Consultant, LLC New Mexico Heart Institute
Lipid Guidelines Who, What, and How Low Anita Ralstin, MS, CNP Next Step Health Consultant, LLC New Mexico Heart Institute Disclosures! None Objectives! List factors used in screening for dyslipidemia
In the Know: Canadian Guidelines for Dyslipidemia, 2003
In the Know: Canadian Guidelines for Dyslipidemia, 2003 In his reviews of Canadian dyslipidemia guidelines, Dr. Curnew explores the impact of major trials, the assessment and categories of risk, and both
Andrew Cohen, MD and Neil S. Skolnik, MD INTRODUCTION
2 Hyperlipidemia Andrew Cohen, MD and Neil S. Skolnik, MD CONTENTS INTRODUCTION RISK CATEGORIES AND TARGET LDL-CHOLESTEROL TREATMENT OF LDL-CHOLESTEROL SPECIAL CONSIDERATIONS OLDER AND YOUNGER ADULTS ADDITIONAL
Advances in Lipid Management
Advances in Lipid Management Kavita Sharma, MD Assistant Professor of Medicine, Division of Cardiology Clinical Director of the Lipid Management Clinics, The Ohio State University Wexner Medical Center
Clinical Policy: Evolocumab (Repatha) Reference Number: CP.CPA.269 Effective Date: Last Review Date: Line of Business: Commercial
Clinical Policy: (Repatha) Reference Number: CP.CPA.269 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
Cholesterol lowering intervention for cardiovascular prevention in high risk patients with or without LDL cholesterol elevation
TrialResults-center.org www.trialresultscenter.org Cholesterol lowering intervention for cardiovascular prevention in high risk patients with or without LDL cholesterol elevation A systematic review and
Conflict of Interest Disclosure. Learning Objectives. Learning Objectives. Guidelines. Update on Lifestyle Guidelines
Conflict of Interest Disclosure Updates for the Ambulatory Care Pharmacist: Dyslipidemia and CV Risk Assessment No conflicts of interest to disclose 2014 Updates to the Updates in Ambulatory Care Pharmacy
Confusion about guidelines: How should we treat lipids?
Confusion about guidelines: How should we treat lipids? Anne Carol Goldberg, MD, FACP, FAHA, FNLA Professor of Medicine Washington University School of Medicine American College of Physicians Missouri
Clinical Policy: Evolocumab (Repatha) Reference Number: ERX.SPA.169 Effective Date:
Clinical Policy: (Repatha) Reference Number: ERX.SPA.169 Effective Date: 01.11.17 Last Review Date: 11.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Inhibitors: PRALUENT (alirocumab) subcutaneous injection REPATHA (evolocumab) subcutaneous injection
REPATHA (evolocumab) subcutaneous injection Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy
Index. cardiology.theclinics.com. Note: Page numbers of article titles are in boldface type.
Index Note: Page numbers of article titles are in boldface type. A ACC/AHA. See American College of Cardiology/ ACE inhibitors. See Angiotensin-converting enzyme (ACE) inhibitors American College of Cardiology/American
Purpose: To establish a guideline in order to reduce ASCVD risk based the four identified statin benefit groups
Title: Algorithm Based on AHA-13 Report on Lipids Date Created: 11/30/2015 Date Modified: N/A Date Approved by Board of Directors: 12/08/2015 Clinical Guideline # CGC-CG-12 Purpose: To establish a guideline
The TNT Trial Is It Time to Shift Our Goals in Clinical
The TNT Trial Is It Time to Shift Our Goals in Clinical Angioplasty Summit Luncheon Symposium Korea Assoc Prof David Colquhoun 29 April 2005 University of Queensland, Wesley Hospital, Brisbane, Australia
10/4/2016. Similarities between the ACC/AHA Guidelines and the NLA Recommendations
Lipid Management CoxHealth Heart and Vascular Summit Oct 15, 2016 DISCLOSURES I have no potential conflicts of interest and nothing relevant to this lecture to disclose Learning Objectives Develop an evidence-based
Novel Therapeutic Strategies in Lipid Management: Lowering LDL C to Improve Patient Outcomes
Novel Therapeutic Strategies in Lipid Management: Lowering LDL C to Improve Patient Outcomes Rajat Deo, MD, MTR Assistant Professor of Medicine Division of Cardiology University of Pennsylvania April 25,
Safety profile of atorvastatin-treated patients with low LDL-cholesterol levels
Atherosclerosis 149 (2000) 123 129 www.elsevier.com/locate/atherosclerosis Safety profile of atorvastatin-treated patients with low LDL-cholesterol levels Rebecca G. Bakker-Arkema *, James W. Nawrocki,
Prevention of Heart Disease: The New Guidelines
Prevention of Heart Disease: The New Guidelines Nisha I. Parikh MD MPH Assistant Professor of Medicine Division of Cardiology Department of Medicine University of California San Francisco May 18 th 2015
DYSLIPIDEMIA PHARMACOLOGY. University of Hawai i Hilo Pre- Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D
DYSLIPIDEMIA PHARMACOLOGY University of Hawai i Hilo Pre- Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D 1 LEARNING OBJECTIVES Know normal cholesterol levels Understand what the role
Young high risk patients the role of statins Dr. Mohamed Jeilan
Young high risk patients the role of statins Dr. Mohamed Jeilan KCS Congress: Impact through collaboration CONTACT: Tel. +254 735 833 803 Email: kcardiacs@gmail.com Web: www.kenyacardiacs.org Disclosures
Current and Emerging Therapies in Hypercholesterolemia: Focus on Colesevelam
Clinical Medicine Reviews in Vascular Health R e v i e w Current and Emerging Therapies in Hypercholesterolemia: Focus on Colesevelam Nkechinyere Ijioma 1 and Jennifer G. Robinson 2 1 Department of Medicine,
PCSK9 Inhibitors DRUG POLICY BENEFIT APPLICATION
DRUG POLICY BENEFIT APPLICATION PCSK9 Inhibitors Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions
Death is inevitable but premature death is not. Sir Richard Doll
Welcome to the Diabetes Care for You webinar Please log onto the conference call so you can hear our presenter From any SCFT Cisco phone dial 800800 From a mobile phone or any other phone dial 01273 242
The new guidelines issued in PRESENTATIONS... Future Outlook: Changing Perspectives on Best Practice
... PRESENTATIONS... Future Outlook: Changing Perspectives on Best Practice Based on a presentation by Daniel J. Rader, MD Presentation Summary The guidelines recently released by the National Cholesterol
Pharmaceutical Help to Control Cholesterol
Pharmaceutical Help to Control Cholesterol Catherine E. Cooke, PharmD, BCPS, PAHM President, PosiHealth, Inc. Clinical Associate Professor, Univ. of Maryland This program has been brought to you by PharmCon
Approach to Dyslipidemia among diabetic patients
Approach to Dyslipidemia among diabetic patients Farzad Hadaegh, MD, Professor of Internal Medicine & Endocrinology Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences
Cardiovascular Risk Reduction and Other Co-Morbidities in Type 2 Diabetes
Cardiovascular Risk Reduction and Other Co-Morbidities in Type 2 Diabetes Following this presentation, you will be able to: Describe the relationship between major CV risk factors and CVD outcomes Select
Medical Policy An independent licensee of the Blue Cross Blue Shield Association
Proprotein Convertase Subtilisin/kexin type 9 Page 1 of 24 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Proprotein Convertase Subtilisin/kexin type 9 (PCSK9)
Supplementary Online Content
Supplementary Online Content Leibowitz M, Karpati T, Cohen-Stavi CJ, et al. Association between achieved low-density lipoprotein levels and major adverse cardiac events in patients with stable ischemic
Doctor discussion guide:
Bring this printout to your next doctor s appointment. It will help you and your doctor work together to set goals for treatment, evaluate the success of your treatment, and reduce your risk of side effects.