DECLARATION OF CONFLICT OF INTEREST
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1 DECLARATION OF CONFLICT OF INTEREST
2 Novel approaches in hypertension Aldosterone-synthase inhibitors. Faiez Zannad Nancy, France
3 Disclosures Dr Zannad reports receiving Speaker/consultant honoraria from Alere, AstraZeneca, BG Medicine, Boston Scientific, Novartis, Pfizer, Resmed, Servier and Takeda.
4 Rationale to investigate aldosterone-synthase inhibition 1. Pathophysiological role of Aldosterone 2. Limitations of MR antagonists 3. Aldosterone synthase implication in blood pressure levels
5 Rationale to investigate aldosterone-synthase inhibition 1. Patho physiological role of Aldosterone BP independent pro-inflammatory and/or profibrotic effect on end organ damage Cardiovascular and renal diseases patho physiology and prognosis Association of serum aldosterone with incidence of hypertension and resistance to therapy
6 The higher the Serum Aldosterone the Higher is the Incidence of Hypertension in Non-hypertensive Subjects at 4 years in the Framingham Offspring Study Serum aldosterone Baseline BP HTN Men Women SBP/DBP Aldo quartiles ng/dl ng/dl mmhg % % First 5.6 ( ) 5.5 ( ) 120/ Second 8.5 ( ) 8.5 ( ) 119/ Third 11.2 ( ) 11.5 ( ) 119/ Fourth 19.1 ( ) 18.9 ( ) 117/ An increase in BP was defined as an increment of at least one BP category (JNC). Hypertension (HTN): 140/90 mm Hg or the use of antihypertensive medications. Vasan R.S. et al. N. Engl. J. Med. 2004, 351:33
7 Aldosterone antagonists, blockers, inhibitors? Aldosterone Cortisol MRA MR MR antagonists Steroidal Spironolactone Poatssium canrenone Eplerenone Non steroidal Bay
8 Mean percent change in SA and AR Eplerenone dose response of mean change from baseline at final visit of serum aldosterone and active renin Serum Aldosterone (177, 257) (-4, 16) (4, 23) (104, 151) (72, 107) (38, 76) (49, 75) (64, 116) (43, 80) (36, 67) (22, 37) (4, 36) PBO 25mg/d 50mg/d 100mg/d 200mg/d 400mg/d EPL dose Active Renin
9 Rationale to investigate aldosterone-synthase inhibition 2. Limitations of MR antagonists Aldosterone and renin increase during MR blockade But should we care? MRA are life saving agents in HF Nongenomic effects of aldosterone, not necessarily blocked by MR antagonism But pathophysiological relevance is uncertain Spironolactone: sexual side effects, menstrual irregularities But, now we have eplerenone, a more selective MRA without such adverse effects
10 Aldosterone antagonists, blockers, inhibitors? Aldosterone Cortisol Aldo Synthase Inhibitors LCI MSD ASI MR MR antagonists Steroidal Spironolactone Poatssium canrenone Eplerenone Non steroidal Bay MRA
11 Biosynthetic Pathway of Aldosterone Side chain cleavage enzyme (CYP11A) Cholesterol Pregnenolone 17 -Hydroxylase (CYP17) 3 -Hydroxysteroid dehydrogenase 3 -HSD Progesterone 21-Hydroxylase (CYP21) 17-OH-Pregnenolone 11-Deoxycorticosterone Corticosterone 11 β - Hydroxylase (CYP11B2) 18 - Hydroxylase (CYP11B2) 18-OH-corticosterone Aldosterone 18 Oxidase (CYP11B2) Aldosterone synthase - 11 β - Hydroxylase (CYP11B1) 17-OH-Progesterone 11-Deoxycortisol Cortisol
12 Fadrozole 1) a non-steroidal aromatase inhibitor effective in the treatment of advanced breast cancer 2) An anecdotal observation of hyperkaliemia in a treated breast cancer patient has stimulated the in-depth investigation of fadrozole effects on aldosterone in normal male volunteers 3) Non selective for Aldosterone synthase (CYP11B)
13 Ideal properties for aldosterone synthase inhibitors 1.High potency toward aldosterone synthase 2. High specificity, with no effect on other cytochrome P450 enzymes, including CYP11B1 3. Good pharmacokinetic and pharmacodynamic profiles, allowing adequate delivery to the target organ following oral administration 4. An acceptable tolerability and toxicity profile. Jansen PM et al. Curr Opin Invest Drugs :2040
14 First in class aldo synthase inhibitor Amar L. Hypertension 2009
15 Proof of concept Pts with Primary Hyperladosteronism 11-Deoxycorticosterone Corticosterone CYP11B2 11-Deoxycortisol 18-OH-corticosterone LCI 699 Aldosterone CYP11B1 Cortisol ACTH Test Amar L. Hypertension 2009
16 Proof of concept Pts with Primary Hyperladosteronism 11-Deoxycorticosterone ACTH Corticosterone CYP11B2 11-Deoxycortisol 18-OH-corticosterone LCI 699 Aldosterone CYP11B1 Cortisol Amar L. Hypertension 2009
17 Effects of LCI699 on plasma potassium levels Placebo LCI mg bid LCI699 1 mg bid Placebo Plasma potassium, mmol/l * * * * 3.0 Global time effect: p < Days * adjusted P< vs Day 1 Oral KCl : 5g/d (range: 4-6 g). The oral KCl dose was kept constant until Day 15 On day 15 oral KCl was stopped in 13/14 patients Amar L, et al. Hypertension published online Sep 13, 2010
18 Changes from baseline in mean ambulatory SBP/DBP at week 4 Mean change from baseline in ABP, mmhg hour p=0.046 p=0.080 Daytime p=0.036 p=0.187 Nighttime p=0.178 p=0.092 Amlodipine 5-10 mg alone: n=2 Prazosin 10 mg + amlodipine 5-10 mg (n=6) or 300 mg diltiazem (n=2) No additional AHT treatment: n=4 Amar L, et al. Hypertension, published online Sep 13, 2010
19 Phase 2: dose-response study of LCI699 in essential hypertensive patients Changes from baseline in 24-hour mean ambulatory SBP and DBP at week 8 White WB. et al. JACC 2010; 55: A61.E582
20 Potential indications for aldosterone-synthase inhibition 1. High normal blood pressure 2. Metabolic syndrome 3. Congestive heart failure 4. Resistant hypertension 5. Low renin/high aldosterone hypertension 6. Primary hyperaldosteronism solitary adenoma macro and micro-nodular hyperplasia idiopathic hyperaldosteronism 7. Glucocorticoid remediable aldosteronism (GRA) 8. Liver cirrhosis 9. Cyclic oedema
21 aldosterone-synthase inhibition Potential safety issues Hyperkalemia Hyponatremia Hypotension Renal insufficiency Severe hypoaldosteronism when combined with spironolactone Risk situations Low residual aldosterone production Poor renal function Diabetes Dehydration, general anesthesia, Co-prescription of COX inhibitors, RAAS blockers, heparin )
22 Potential limitations of aldosterone-synthase inhibition How much inhibition is needed? The magnitude of the aldosterone-synthase inhibition necessary to neutralize aldosterone in a biologically significant way is still unknown Can the system escape? The accumulation of desoxycorticosterone during aldosterone-synthase inhibition may act as a substitute for aldosterone. Can we leave MR not blocked? Cardiac MR receptors may stay active locally and be occupied by cortisol instead of aldosterone.
23 MR atagonists are effective even when circulating aldosterone is low. Conclusion: The Aldo/Renin ratio did not predict the blood pressure response to Spironolactone. SPIRO 50mg was significantly more effective than a thiazide (BFZ 2.5mg) in lowering SBP irrespective of baseline ARR, plasma renin activity or aldosterone. J Hypertens 28: Q 2010
24 Aldosterone antagonists ACTH Aldosterone Cortisol Aldo Synthase Inhibitors MR LCI MSD
25 Toward non steroidal, non renal MR antagonists Genration Selectivity (sex side effects) potency Vasculra/renal effect Priamry Aldo Antiinflammatory First Spiro Second Eplerenone Third Non steroidal Fourth Non renal
26 MRAs vs. Aldo Syntahse Inhibitors
Aldosterone synthase inhibitors. John McMurray BHF Cardiovascular Research Centre University of Glasgow
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