Novel Natriuretic Peptides
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1 Novel Natriuretic Peptides Frank Ruschitzka, MD, FRCP, FESC Professor of Cardiology Director, Heart Failure and Transplantation Clinic University Hospital Zürich, Switzerland Conflict of interest: Aventis, Bayer, Biotronik, Cardiorentis, Merck, Novartis, Pfizer Interest in Conflict: none
2 Natriuretic Peptides Cardiovasc Res 2006
3 Natriuretic Peptides Cardiovasc Res 2006
4 Natriuretic Peptide Receptors ANP BNP CNP Guanylins NPR/GC NPR-Bi NPR-C sgc E ECD TM KLD HR llllllllllllllllllll llllllllllllllllllll JD llllllllllllllllllll G-protein HBD DD FE 2+ Amino Terminal NO GC TK GC cgmp TyrP camp clearance cgmp Carboxy Terminal McKie, Burnett. Curr Heart Fail Rep 2009
5 Dickstein EHJ 2008
6 VMAC: Nesiritide vs Nitroglycerin JAMA 2002
7 VMAC: Nesiritide vs Nitroglycerin JAMA 2002
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16 Action of ANP at Target Cells Levin NEJM 1998
17 Effects of Carperitide on the Long-Term Prognosis of Patients With Acute Decompensated Chronic Heart Failure The PROTECT MulticenterRandomized Controlled Study Hata Circ J 2008
18 Mutant ANP (consisting of nativeanp (1-28) and a C-terminal Extension of 12 AA McKie JACC 2009
19 Renin-Angiotension-Aldosterone Response to High Dose ANP and Mutant ANP McKie JACC 2009
20 Urine Sodium Excretion and Distal Tubular Fractional Sodium Reabsorption in Response to ANP and Mutant ANP McKie JACC 2009
21 Diuretics and Aquaretics?? degoma JACC 2006
22 Natriuretic Peptides Cardiovasc Res 2006
23 Differential Processing of ANP and Urodilatin Cleavage of the signal peptide is different in heart and kidney mod. Forssmann CVR 2006 and Histochem Cell Biol 1998
24 Urodilatin Forssman CVR 2006
25 Urodilatin endogenous human natriuretic peptide synthesized in distal tubular cells regulates renal sodium/water excretion binds downstream in inner medullarcollecting duct to NPR-A and B acts via cgmp and induces vasodilation bronchodilation natriuresis diuresis
26 Safety and Efficacy of Intravenous Placebo-Controlled Randomised Infusion of Ularitide Study: SIRIUS II Mitrovic Eur Heart J 2006
27 SIRIUS II: Wedge Pressure Mitrovic Eur Heart J 2006
28 % patients SIRIUS II: Patient-assessed Dyspnea Moderately or Markedly Better Mitrovic Eur Heart J 2006
29 % of patients Outcome in SIRIUS-II Mortality in SIRIUS II Placebo Ularitide, ng/kg/min European Heart Journal (2006) 27,
30 SIRIUS II: Renal Safety of Urodilatin Mitrovic Eur Heart J 2006
31 EUROPA HF: EFFICACY AND SAFETY OF URODILATIN IN PATIENTS with ACUTE HEART FAILURE STUDY DESIGN Primary Efficacy: Global composite score (superiority) Primary Safety: All-cause mortality and cardiovascular rehospitalisation and other significant cardiovascular events at 30 days / 3 months (non-inferiority) Study Size: 1500 subjects FPFV: III/2011 Ruschitzka et al 2010
32 Natriuretic Peptides Cardiovasc Res 2006
33 Amino Acid Sequence and Structure of CD-NP Dendroaspis augusticeps McKie, Burnett. Curr Heart Fail Rep 2009
34 Renal Actions of Dendroaspis Natriuretic Peptide HS-142-1: NP receptor antagonist Burnett JACC 2002
35 Renal Actions of Dendroaspis Natriuretic Peptide Burnett JACC 2002
36 CD-NP Increases Natriuresis via cgmp While Maintaining MAP McKie, Burnett. Curr Heart Fail Rep 2009
37 Dickstein EHJ 2008
38 The absence of alternatives clears the mind marvelously Henry Kissinger ( )
39 Thank You Professor Frank Ruschitzka, FRCP, FESC Director, Heart Failure and Transplantation Clinic University Clinic Zürich
40 Amino Acid Sequence and Structure of CD-NP McKie, Burnett. Curr Heart Fail Rep 2009
41 Differential Processing of ANP and Urodilatin Cleavage of the signal peptide is different in heart and kidney McKie, Burnett. Curr Heart Fail Rep 2009
42 Action of ANP at Target Cells Levin NEJM 1998
43 Urodilatin: ANP ANP (Urodilatin) Thr Ala Pro Arg Ser Leu Arg Arg Gly Gly Arg Met Ser Asp Phe Ser Arg Cys Ile Cys Asn Ser Phe Arg Tyr HOO C Gly Leu Gly Ser Ala Gln Gly Ser Leu Arg Arg Gly Gly Arg Met Ser Asp Phe Ser Arg Cys Ile Cys Asn Ser Phe Arg Tyr HOO C ANP (ANP) Gly Leu Gly Ser Ala Gln Gly
44 Amino Acid Sequence and Structure of CD-NP McKie, Burnett. Curr Heart Fail Rep 2009
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47 Cinaciguat: Soluble Guanylate Cyclase Activation
48 Cinaciguat: Hemodynamics PCWP Cardiac Output Lapp, Mitrovic Circulation 2009
49 Relaxin Relaxin Peptide hormone Similar in size and shape to insulin (MW 5963) Found in men and women Normal hormone of pregnancy Women exposed for 9 months to increased plasma concentrations: ng/ml pregnancy* Benign safety profile *Szlachter et al, Obstet & Gynecol 1982;59: Stewart et al, J Clin Endocrinol Metab 1990;70:
50 Rapid Dyspnea Improvement through 24 hours (Likert Scale) Proportion of Patients with Moderate/Marked Improvement in Dyspnea at 6, 12 and 24 hr Teerlink Lancet 2009
51 Who needs Inotropes? Felker Cardiology 2009
52 Who needs Inotropes? Patients that during admission have nonresolving symptoms or heart failure recurrence (worsening HF) Cotter JCF 2009
53 So What's Wrong? 1. Some inotropes are also vasodilators - patients who need inotropes deteriorate when vasodilated. 2. Many inotropes increase oxygen demand leading to side effects 3. Inotropy leads to negative long term effects
54 Disadvantages of Current Inotropes camp/ Diastolic Calcium Heart Rate Blood Pressure Oxygen Demand Efficiency Arrhythmias Cardiac Sarcomere Mortality
55 Milrinone phase III - Optime No clinical efficacy with increased AEs (arrhythmia, hypotension), worsening HF And a trend to More death driven by significant increases of mortality in patients with Ischemic CM JAMA 2002
56 Long-Term Effects of Inotropes Optime
57 % Patients AHFS/LO TREATMENT REVIVE II: Primary Endpoint (n=600) Placebo Levosimendan % - 7% P = Improved Unchanged Worse Packer M, et al. Presented at AHA Scientific Sessions 2005 Data from Cleland et al., Eur J heart Fail 2006; 8:105
58 AHFS/LO TREATMENT Revive I LEVOSIMENDAN - MORTALITY Days Following Randomization Placebo Levosimendan Revive II Placebo Levosimendan Revive I + II Placebo Levosimendan Cleland et al., Eur J heart Fail 2006; 8:105
59 AHFS/LO TREATMENT INDICATIONS FOR INOTROPES USE These agents continue to be used owing to the lack of effective and safer alternatives There is an unmet need for developing new agents to safely improve cardiac performance in these patients
60 ISTAROXIME in AHF Mechanism of action Istaroxime is a new calcium cycling modulator with a dual mechanism of action From Opie LH: Heart Physiology: From Cell to Circulation. LWW 2004
61 ISTAROXIME in AHF Mechanism of action - Inotropism Inhibition of Na + /K + -ATPase with increased cytosolic Ca ++ Modified from Opie LH: Heart Physiology: From Cell to Circulation. LWW 2004
62 ISTAROXIME in AHF Mechanism of action Lusitropisdm Stimulation of SERCA-2a with increased Ca ++ uptake Modified from Opie LH: Heart Physiology: From Cell to Circulation. LWW 2004
63 HD effect by AUC
64 The absence of alternatives clears the mind marvelously Henry Kissinger ( )
65 1,162,309 hospital admissions associated with a firsttime diagnosis of HF, AMI and cancer Ekman Circ CV Outcomes 2010
66 Hospital Discharge for Heart Failure in the United States Circulation 2009
67 Rate of hospitalisation associated with a first-time diagnosis of HF, AMI and Cancer Ekman Circ CV Outcomes 2010
68 Impact on life-expectancy and quality adjusted life years (QALY) according to diagnosis Ekman Circ CV Outcomes 2010
69 Approach to Acute Therapy in Volume Overloaded Heart Failure Patients Clinical Congestion Adequate Perfusion Reduced Perfusion Cardiogenic Shock IV Diuretics IV Diuretics plus IV Vasodilators IV Diuretics plus IV Inotropes
70 Clinical Trials in ADHF Very few large-scale randomized controlled trials have prospectively evaluated the effects of ADHF treatments on clinical status and outcomes None have definitively demonstrated improved outcomes Retrospective analyses of smaller trials have raised concern about some agents
71 The Ideal Drug in Acute Heart Failure (1) symptom relief (2) decreases rehospitalization rate (3) improves survival (4) no safety concern (kidney) (5) be affordable for the millions of patients with heart failure throughout the world
72 old approved DRUGS in CHF new in research diuretics beta blockers ACE inhibitors AT-1 antagonists digitalis aldosterone antagonists natriuretic peptides (Nesiritide, Ularitide) Renin-Inhibitors (Aliskiren) ECE + NEP-inh. (Daglutril) Adenosine 1-Ant. (SLV 320, KW 9302) vasopresin-ant. (Tolvaptan) BAY ( , Cinaciguat)
73 Diuretics and Aquaretics degoma JACC 2006
74 Vasopressin Antagonists
75 EVEREST: Primary Endpoints Konstam JAMA 2007
76 In theory, theory and practice are the same. In practice, they are not. Albert Einstein
77 Adenosine Antagonists degoma JACC 2006
78 Rolofylline: Change in Serum Creatinine Gottlieb Circ 2002
79 Rolofylline: Fails to meet Primary Endpoint Massie NEJM 2010
80 Rolofylline: Fails to meet Primary Endpoint Massie NEJM 2010
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