18 th Controversies-Advances:N ovem ber15,2018. U pdateonp CS K-9 Inhibition
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1 18 th Controversies-Advances:N ovem ber15,2018 U pdateonp CS K-9 Inhibition P.K.S hah,m D,M ACC S hapeland W ebb ChairinClinicalCardiology, Director,O ppenheim eratherosclerosisr esearchcenter, S m idtheartinstitute,cedarss inaim edicalcenter P rofessorofm edicine,u CL A and CS M C Disclosure Investigator,P CS K9 Inhibitors,R ecipientofr esearchgrantsfrom Am genand S anofi
2 P CS K-9 InhibitionforHyperlipidem iaand CAD W hatisp CS K-9 and w hatisitsbiologicalaction? DoesInhibitionofP CS K-9 affectcirculatingl ipid L evels? DoesP CS K-9 Inhibitionaffectatherosclerosis? DoesP CS K9 inhibition affectcardiovascularevents? W hataretheadverseeffectsofp CS K-9 Inhibition? DoesP CS K-9 Inhibitionrepresent agam echangeroram odestincrem ent? P KS hah-cs M C
3 P CS K9 (proproteinconvertasesubtilisin kexin9) GeneDiscovered in2003 (S aidah:p N AS ) Genelocated onchr1p32.3 Gainoffunctionm utations (Abifadel:N atgen2003) HighL DL from birthand highcvd risk P CS K9 P KS hah-cs M C L ossoffunctionm utations (Cohen:N atgen2005) L ow L DL from birthand L ow CVD risk
4 P KS hah-cs M C
5 P ost-transcriptionalr egulation ofl DL R eceptorby P CS K9 P arks W etal:jbc 2004 P KS hah-cs M C KaraN.M axw elland JanL.Breslow :P N AS 2004
6 P CS K-9 InhibitionforHyperlipidem iaand CAD W hatisp CS K-9 and w hatisitsbiologicalaction? DoesInhibition ofp CS K-9 affectcirculatingl ipid L evels? DoesP CS K-9 Inhibition affectatherosclerosis? DoesP CS K9 inhibition affectcardiovascularevents? W hataretheadverseeffectsofp CS K-9 Inhibition? DoesP CS K-9 inhib represent agam echangerorasm allincrem ent? P KS hah-cs M C
7 Monoclonal Antibody Inhibitors Evolocumab- REPATHA ( fully human) Alirocumab- PRALUENT ( fully human) Bococizumab ( Abandoned) (humanized) PCSK 9 PKShah-CSMC
8 Sustained LDL-C reduction with SC Injectable (q2-4wks) PCSK9 Inhibitors: Monoclonal Antibodies: Alirocumab( Praluent) and Evolocumab(Repatha) Robinson JG: NEJM 2015 Sabatine M: NEJM 2015 Standard Rx Alirocumab * 20-30% reduction in Lpa; no major effect on HDL or TG *Generally well tolerated; mostly injection site side effects * Effects incremental to placebo, Statins and or Ezetimibe PKShah 8
9 P CS K-9 InhibitionforHyperlipidem iaand CAD W hatisp CS K-9 and w hatisitsbiologicalaction? DoesInhibition ofp CS K-9 affectcirculatingl ipid L evels? DoesP CS K-9 Inhibition affectatherosclerosis? DoesP CS K9 inhibition affectcardiovascularevents? W hataretheadverseeffectsofp CS K-9 Inhibition? DoesP CS K-9 inhib represent agam echangerorasm allincrem ent? P KS hah-cs M C
10 GLAGOV Trial of Effect of Evolocumab on coronary atheroma by IVUS Nissen S et al : JAMA 2016 Principal Findings: Change in Coronary Atheroma Volume: LDL cholesterol at 76 weeks: Placebo Evolocumab % -0.95% 93 mg/dl p< mg/dl Secondary outcomes: Patients with plaque regression: 47.3% 64.3 % Major adverse cardiac events: % p< PKShah
11 P CS K-9 InhibitionforHyperlipidem iaand CAD W hatisp CS K-9 and w hatisitsbiologicalaction? DoesInhibition ofp CS K-9 affectcirculatingl ipid L evels? DoesP CS K-9 Inhibition affectatherosclerosis? DoesP CS K9 inhibition affectcardiovascularevents? W hataretheadverseeffectsofp CS K-9 Inhibition? DoesP CS K-9 inhib represent agam echangeroram odestincrem ent? P KS hah-cs M C
12 EffectofEvolocum ab oncardiovascularo utcom esinfouriert rial Cardiac death: 1.8 vs 1.7 ( p=ns) Death from any cause: 3.2 vs 3.1( p=ns) Myocardial infarction: 3.4 vs 4.6 (p<.001) Absolute RR=1.2% Stroke: 1.5 vs 1.9 (p=0.01) Absolute RR= 0.4% Revasc: 5.5 vs 7.0 ( p=.001)absolute RR= 1.5% N N N N P KS hah-cs M C oeffectonhem orrhagicstroke oeffectonnew onsetdiabetes-caveat oeffectoncognitivefunction-caveat oeffectoncataractrisk-caveat S abatinem etal:n EJM 2017
13 Evolocumab and Clinical Events: Fourier Trial Sabbatine NEJM 2017 Subset Analysis Shows Benefits Substantially Greater in High Risk Subjects *Patients with Symptomatic PAD *Patients with prior MI *Patients with elevated hs-crp *Patients with Diabetes *Patients with high Lpa. Circulation 2017;Nov 13:[Epub ahead of print]. Circulation2018;Mar 12:[Epub ahead of print]. Circulation 2018;Apr 6:[Epub ahead of print] (ARR 2.4) (ARR ) (ARR 2.7) ( ARR 2.7) (ARR 2.8)
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16 IndicationsofP CS K9 Inhibitors *S tatinintolerantp atients *S tatin+ezetem ibeinsufficientp atients M ajorp otentialdraw backs *Highcost-m odestefficacy (Benefitsgreaterinhighrisksubsetsand recentbig pricereductionareencouraging) *S C-Injectionsq2-4 w eeks * R esidualr iskr em ains * Ineffectiveinsom e
17 Future Prospects for Anti-PCSK9 Therapy *Inhibition of Synthesis: RNAi ( Inclisiran) *PCSK9 Vaccine *Genome editing using CRISPR-Cas9 17
18 Sustained Reduction in LDL-C with Single injection of Inclisiran (sirna against PCSK 9) Ray KK ; NEJM 2017 Placebo 200 mg Inclisiran 300 mg 500 mg SC Injection 18
19 AT04A Vaccine against PCSK9 Reduces Atherosclerosis in ApoE3Leiden.CETP Mice Landlinger C et al : EHJ 2017 Cholesterol level Atherosclerotic Plaque
20 Permanent Hepatic PCSK-9 Gene Editing With CRISPR-Cas9 Reduces Cholesterol Levels in Mice Qiurong D et al: Circ Res 2014 CRISPR-Cas9
21 Best Way to Reduce your Risk of CHD Choose Your Parents Wisely Preferably choose those with PCSK9 loss of function mutation 21
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