ACE inhibitors vs ARBs Myths and Facts

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1 ACE inhibitors vs ARBs Myths and Facts Prof. Dr. med. Frank Ruschitzka, FRCP (Edinburgh) Director Heart Failure/Transplantation Clinic University Clinic Zurich Switzerland Conflict of interest: Bayer, Biomarin, Biotronik, Cardiorentis, Merck, Pfizer, Novartis, Sanofi, St. Jude Medical Interest in Conflict: none

2 Blood Pressure Regulation ACE-Inhibitor Ang II -Blocker Calcium-Ant. Beta-Blocker Diuretic

3 Angiotensin II Plays a Central Role in Organ Damage

4 Renin-Angiotensin-Aldosterone System Vasoconstriction, Oxidative Stress, Cellular Growth BIRKENHÄGER LANCET 2007

5 ACE-inhibitors in high risk patients 55 years of age: HOPE trial - 9,297 patients - Documented CAD or DM + 1 RF CV death, AMI or stroke RRR 28% (14-30) - No history of CHF or LV dysfunction RR: 0.78 ( ) The HOPE investigators. N Engl J Med 2000 ; 342 :

6 EUROPA: results 14 CV death, AMI or resuscitated cardiac arrest patients with stable CAD no CHF Placebo Perindopril 8mg RRR: 20% [95% CI : 9-29] p = ans Annual event rate (placebo) : 2.4 % Lancet 2003; 362:

7 Meta-analysis of ACE inhibitor trials in CAD patients without HF or LV dysfunction % P< % P< % P< % P< % P= % P< % P<0.001 * End point not reported in QUIET ** End point not reported in PEACE and CAMELOT Danchin N et al. Arch Int Med. 2006;166:

8 All-cause mortality reduction in trials with Perindopril (n= patients) n HR ASCOT-BPLA ( ), P=0.025 amlodipine/perindopril HYPERTENSIVES HYVET ( ), P=0.02 indapamide/perindopril OLD HYPERTENSIVES ADVANCE ( ), P=0.025 perindopril/indapamide DIABETICS Total ( ) Active better Control better 0,5 0,75 1 1,25 1,5, P<0.001

9 ACE-Inhibitor is first choice-so what.s the ideal partner? ESC/ESH Guidelines for Management of Hypertension 2007

10 Give my Husband a Betablocker, please!

11 ASCOT: Benefit of Perindopril/Amlodipin over Atenolol/Diuretic 19,257 hypertensive patients P. Sever, Lancet 2005

12 New Treatment Algorhythm for Hypertension (British Hypertension Society) 2006

13 ACE-Inhibitors and Calciumantagonists Combination Therapy of First Choice ESC/ESH Guidelines for Management of Hypertension 2007

14 Is an ARB as good as an ACE-Inhibitor?

15 The Renin-Angiotensin System Bradykinin degradation Adrenalin release Selective AT 1 - receptor blockade Angiotensinogen Renin ACE Angiotensin I Angiotensin II AT 1 AT 2 Renin inhibition ACE inhibition Alternative pathways AT 3 AT 4 Inflammatory responses Aldosterone production Na +, H 2 O Vasopressin reabsorption release?

16 Does a class effect of ACE inhibitors and Sartans exist?

17 Does a class effect of ACE inhibitors and Sartans exist? Testosterone Estrogen

18 The Class Effect Myth Krum and Ruschitzka 2006

19 Are ACE inhibitors and Sartans created equal? N N CI COOH CH 3 N CH 3 O N CO 2 H N N N NH N N N O OH N N CH 3 Valsartan N N H Losartan (active form) Telmisartan N N O N S HOOC N NH N N N OCH 2 CH 3 N Candesartan (active form) N COCH COCH Eprosartan N N NH N Irbesartan

20 Are ACE inhibitors and Sartans created equal? N N CI COOH CH 3 N CH 3 O N CO 2 H N N N NH N N N O OH N N CH 3 Valsartan N N H Losartan (active form) Telmisartan Perindopril N N O N S HOOC N NH N N N OCH 2 CH 3 N Candesartan (active form) N COCH COCH Eprosartan N N NH N Irbesartan

21 Transcend (ACE-Inhibitor intolerant) Lancet 2008

22 Transcend: Telmisartan fails to prevent cardiovascular death, myocardial infarction,stroke, or heart failure hospitalisation Lancet 2008

23 Telmisartan Does Not Prevent Recurrent Stroke in ProFESS Yusuf NEJM Aug 28, 2008

24 Perindopril/Indapamid Prevent Stroke (PROGRESS) f/u 3.9 y RRR -28% ARR -3.7% NNT 27 Placebo (Perindopril ± Indapamide) Lancet 2001

25 Candesartan in Acute Stroke: SCAST Sandset, Lancet 2011

26 Candesartan in Acute Stroke: SCAST Sandset, Lancet 2011

27 Candesartan in Acute Stroke: SCAST Sandset, Lancet 2011

28 Candesartan in Acute Stroke: SCAST Sandset, Lancet 2011

29 Candesartan in Acute Stroke: SCAST Sandset, Lancet 2011

30 Navigator: Valsartan off-course Time to Rethink the Value of Sartans? Califf ACC NEJM 2010

31 ADVANCE: Perindopril reduces All-cause Mortality in Diabetes Lancet 2007

32 Renal Effects of Enalapril versus Losartan in Diabetes Maurer NEJM 2009

33 What.s the VALUE of Valsartan? Increased Risk of MI associated with Valsartan in VALUE VALUE Trial: Combined Primary Endpoint VALUE Trial: Myocardial Infarctions Julius Lancet 2004

34 Tendency Towards Increased Risk of Strokes associated with Valsartan in VALUE Julius Lancet 2004

35 OPTIMAAL: Crude rates and relative risks for prespecified endpoints Losartan Captopril Relative risk p (n=2744) (n=2733) (95% CI) All-cause mortality 499 (18 2%) 447 (16 4%) 1 13 ( ) SCD/RCA 239 (8 7%) 203 (7 4%) 1 19 ( ) Myocardial reinfarction (fatal/non-fatal)* 384 (14 0%) 379 (13 9%) 1 03 ( ) Other prespecified endpoints MI/total mortality 746 (27 2%) 689 (25 2%) 1 10 ( ) Cardiovascular death 420 (15 3%) 363 (13 3%) 1 17 ( ) Stroke (fatal/ non-fatal) 140 (5 1%) 132 (4 8%) 1 07 ( ) CABG 404 (14 7%) 375 (13 7%) 1 09 ( ) PTCA 466 (17 0%) 492 (18 0%) 0 94 ( ) Revascularisation 845 (30 8%) 827 (30 3%) 1 03 ( ) First all-cause admission 1806 (65 8%) 1774 (64 9%) 1 03 ( ) First admission for heart failure 306 (11 2%) 265 (9 7%) 1 16 ( ) Cardiovascular admission 1480 (53 9%) 1421 (52 0%) 1 06 ( ) Non-cardiovascular admission 885 (32 3%) 905 (33 1%) 0 98 ( ) Lancet 2002;360:752-60

36 Does the ARB paradox exist? Strauss and Hall Circulation 2006

37

38 ...but ARBs Fail to Prevent Myocardial Infarctions Messerli, Bangalore, Ruschitzka Eur Heart J 2009

39 ACTIVE 1 NEJM 2011

40 ACTIVE 1 NEJM 2011

41 ACTIVE 1 NEJM 2011

42 ACTIVE 1 NEJM 2011

43 NEJM 2011

44

45 ROADMAP NEJM 2011

46 ROADMAP - Occurrence of Microalbuminuria NEJM 2011

47 ROADMAP NEJM 2011

48 Cardiovascular Death Olmesartan and Cardiovascular Death Lessons from the ROADMAP and ORIENT Trials Roadmap Orient Olmesartan Placebo Olmesartan Placebo FDA 2010

49

50 Sartans may cause plaque rupture Strauss Circulation 2006

51

52 Discontinuation of study drugs in VALIANT NEJM 2003

53 Discontinuation of study drugs in VALIANT NEJM 2003

54 Discontinuation of study drugs in VALIANT NEJM 2003

55 Perception is reality

56

57 All-cause mortality reduction in trials with Perindopril (n= patients) n HR ASCOT-BPLA ( ), P=0.025 amlodipine/perindopril HYPERTENSIVES HYVET ( ), P=0.02 indapamide/perindopril OLD HYPERTENSIVES ADVANCE ( ), P=0.025 perindopril/indapamide DIABETICS Total ( ) Active better Control better 0,5 0,75 1 1,25 1,5, P<0.001

58 ACS: The Golden Rules of Hypertension ACE-Inhibitor or Sartan if ACE-I is not tolerated Ca-Antagonist Statin

59 Merci Frank Ruschitzka, MD, FRCP, FESC Professor of Cardiology University Hospital Zürich, Switzerland

60 Chutzpah The ARB a tale of overmarketing traditionally defined by the example of the young man who kills his parents, then pleads for mercy because he s an orphan PAUL KRUGMAN

61 Sartans - selective PPAR modulators Schupp Diabetes 2006

62 Telmisartan or TelmiGlitazone

63 Who tried to kill Bill?

64

65

66 Cardiovascular Risk Stratification Absolute risk in % of a fatal or non-fatal myocardial infarction or stroke over 10 years High Risk >20% 10-Jahresrisiko: >20% Intermediate Risk 10-20% 10-Jahresrisiko: 10 bis 20% Low Risk <10% 10-Jahresrisiko: <10% 28% 4%

67 Stratification of Risk to Quantify Prognosis

68 How would you treat Bill?

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