PCSK9 Inhibitors: Promise or Pitfall?

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1 PCSK9 Inhibitors: Promise or Pitfall? Tracy Harlan, PharmD PGY2 Ambulatory Care Resident University of Iowa Hospitals and Clinics tracy Tracy Harlan does not have any actual or potential conflicts of interest to disclose Off label use of medications will not be discussed Objectives Pharmacists Summarize current evidence based guideline recommendations for treatment of hypercholesterolemia to reduce cardiovascular risk Review the role of the PCSK9 pathway in atherosclerosis Explore the novel mechanism of PCSK9 inhibitors and rationale for their use Evaluate evidence for treatment role of PCSK9 based therapies Review emerging evidence for PCSK9 inhibitors and cardiovascular outcomes Objectives Technicians Review the role of the PCSK9 pathway in atherosclerosis Explore the novel mechanism of PCSK9 inhibitors and rationale for their use Background Cardiovascular disease Leading cause of death in the United States 610,000 deaths annually 1 in every 4 deaths attributed to heart disease 2013 ACC/AHA Lipid Guidelines Statin Benefit Groups Clinical atherosclerotic cardiovascular disease (ASCVD) LDL C 190 mg/dl Age years with diabetes and LDL C mg/dl Age years without diabetes, LDL C mg/dl, and ASCVD risk 7.5% Stone NJ ACC/AHA Blood Cholesterol Guideline 1

2 Current Guideline Statin Regimens What s in the Toolbox Now? High Intensity Moderate Intensity Low Intensity Lowers LDL 50% Lowers LDL 30% to < 50% Lowers LDL <30% Atorvastatin mg Rosuvastatin mg Atorvastatin mg Rosuvastatin 5 10 mg Simvastatin mg Pravastatin mg Lovastatin 40 mg Fluvastatin XL 80 mg Fluvastatin 40 mg BID Pitavastatin 2 4 mg Simvastatin 10 mg Pravastatin mg Lovastatin 20 mg Fluvastatin mg Pitavastatin 1 mg Adapted from: Circulation. 2014;129:S1 S45 Familial Hypercholesterolemia Inherited condition that causes high levels of LDL Heterozygous (HeFH) (1 in 250 people) Homozygous (HoFH) (1 in 1 million people) thefhfoundation.org Treatment for Familial Hypercholesterolemia High intensity statin Ezetimibe Bile acid sequestrant Niacin Apheresis Lomitapide Mipomersen PCSK9 inhibitor Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Regulatory role in cholesterol homeostasis Expressed by liver and intestine Promotes intracellular degradation of LDL R Reduced LDL R on cell surface Reduces LDL clearance from circulation (results in elevated LDL C) Hall S. Nature 2013; 496:

3 Not on Lipid Lowering Therapy On Statin Therapy On PCSK9 Inhibitor Statin Therapy + PCSK9 Inhibitor Indications Adjunct to diet and maximally tolerated statin therapy for treatment of: Heterozygous familial hypercholesterolemia (HeFH) Clinical ASCVD requiring additional lowering of LDL C Dosage 75 mg (1 pen/syringe) subcutaneously every 2 weeks (may increase to 150 mg every 2 weeks) Storage Refrigerated Cost $14,600/year Monitoring LDL within 4 to 8 weeks after initiation/dose changes Hypersensitivity reactions Adverse Drug Reactions Injection site reaction (7%) Diarrhea (5%) Elevated LFTs (3%) Myalgia (4%) Confusion (<1%) Patient Counseling Let warm to room temperature for ~30 minutes Clean injection area (thighs, stomach, upper arms) Rotate injection sites Do not use if pen/syringe has been at room temp. for 24 hours or greater _75%20mg.pdf 3

4 Sawtoothing Clinical Trial Overview Population Key Characteristics Intervention ODYSSEY FH I (n=486) and FH II (n=249) ODYSSEY High FH (n=107) HeFH 46% history of CVD (FH I) 36% history of CVD (FH II) Over 80% on high dose statin ~50% on ezetemibe HeFH ~50% history of CVD 80% on high dose statin 27% on ezetemibe Alirocumab 75 mg every 2 weeks or placebo may to 150 mg Alirocumab 150 mg every 2 weeks or placebo ODYSSEY COMBO I (n=316) and II (N=720) High CVD risk ~80% history of CVD 62% (Combo I); 67% (Combo II) on high dose statin 8% on ezetemibe (Combo I) 42% on other lipid lowering therapy (Combo I) Alirocumab 75 mg every 2 weeks or placebo (Combo I) or ezetemibe (Combo II) may to 150 mg Ginsberg HN. Presented at AHA Scientific Sessions Nov Chicago, IL Kastelein JJ. Eu Heart J 2015; 36(43): Cannon CP. Eu Heart J 2015; 36: Kereiakes DJ. Am Heart J 2015; 169(6): ODYSSEY LONG TERM(n=2341) Population High risk for CV events with LDL 70 mg/dl On maximally tolerated statin therapy History of CVD/Statin Use 70% CVD 18% HeFH 40% CVD risk equivalent 50% on high dose statin 99% any statin Robinson JG. NEJM 2015; 372(16): Intervention Alirocumab 150 mg every 2 weeks or placebo Results 61% mean percentage change in LDL C from baseline to 6 months CV events in post hoc analysis 1.7% (alirocumab) versus 3.3% (placebo) {hazard ratio 0.52, CI } Indications Adjunct to diet and maximally tolerated statin therapy for treatment of HeFH Homozygous familial hypercholesterolemia (HoFH) Clinical ASCVD requiring additional LDL C lowering Dosage 140 mg subcutaneously every 2 weeks OR 420 mg once 140 mg prefilled syringe or autoinjector Storage Refrigerated Room temperature for 30 days Cost $14,100/year Monitoring LDL within 4 to 8 weeks after initiation/dose changes Hypersensitivity reactions multivu.com Clinical Trial Overview Adverse Reactions Nasopharyngitis (11%) Upper respiratory tract infection (9%) Influenza (8%) Injection site reaction (6%) Gastroenteritis (6%) Myalgia (4%) Patient Counseling Let warm to room temperature for ~30 minutes Clean injection area (thighs, stomach, upper arms) Rotate injection sites _english.pdf MENDEL 2 (n=614) LAPLACE 2 (n=2067) GAUSS 2 (n=307) RUTHERFORD 2 (n=331) DESCARTES (n=905) Population Key Characteristics Intervention LDL 100 and <190 Monotherapy Low CVD risk Primary hypercholesterolemia Koren MJ. J Am Coll Cardiol Jun 17; 63(23): Robinson JG. JAMA May 13; 311(18): Stroes E. J Am Coll Cardiol Jun 17; 63(23): % history of CVD Randomized to background statin Statin intolerant 56% history of CVD 30% on statin therapy HeFH 30% history of CVD 87% high intensity statin Hypercholesterolemia 15% history of CVD Randomized to background statin Evolocumab 420 mg Rall FJ. Lancet Jan 24; 385(9965): Blom DJ. NEJM May 8; 370(19):

5 OSLER 1 and OSLER 2 (n=4465) Population Patients who have completed one of the parent trials Intervention every 2 weeks or 420 mg plus standard therapy versus standard therapy alone Safety Data Results Similar rates of adverse events (69.2% in treatment group and 64.8% in standard therapy) Slightly more neurocognitive events in treatment group (0.9% ) versus standard therapy (0.3%) LDL reduced from median of 120 mg/dl to 48 mg/dl Lower rate of CV events shown in exploratory analysis at 1 year 29 (treatment) versus 31 (standard of care) {hazard ratio 0.47, CI } Sabatine MS. NEJM 2015; 372: WHAT ABOUT CARDIOVASCULAR OUTCOMES? ODYSSEY OUTCOMES Primary Objective Occurrence of CV events with alirocumab versus placebo in addition to evidence based medical and dietary management of dyslipidemia in patients with history of acute coronary syndrome Estimated Enrollment >18,000 patients Estimated completion: February FOURIER Primary Objective Time to cardiovascular death, myocardial infarction, or stroke in patients with history of CVD with evolocumab versus placebo in addition to effective statin therapy Estimated Enrollment >25,000 patients Estimated completion: February 2018 Summary PCSK9 inhibitors represent a novel mechanism in LDL lowering Specific patient groups that may benefit from use Overall, well tolerated with minimal adverse effects Clinical cardiovascular outcomes are highly anticipated in the next two years 5

6 Role of Pharmacist/Technician Provide thorough patient counseling Identification of appropriate utilization especially given high cost Ensure continued adherence to existing evidence based lipid lowering therapy Assess laboratory monitoring for safety and efficacy PCSK9 Inhibitors: Promise or Pitfall? Tracy Harlan, PharmD PGY2 Ambulatory Care Resident University of Iowa Hospitals and Clinics tracy 6

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