Updates in primary hyperaldosteronism and the rule
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1 Updates in primary hyperaldosteronism and the rule I. David Weiner, M.D. Professor of Medicine and Physiology and Functional Genomics University of Florida College of Medicine and NF/SGVHS
2 The Rule Rule: Over a continual cycle of 20 years, 50% of what we think we know in medicine Is shown to be wrong Promise: Medical care is better now than in the past, and The future will be even better! Implication: We should be humble when we think that we re doing is the best thing for our patients
3 Hypertension and the Rule 40 years ago Hypertension frequently due to aldosterone 20 years ago Hypertension rarely due to aldosterone Now Hypertension frequently due to aldosterone
4 Renin-Angiotensin System and BP BP or Plasma Volume Renin Angiotensinogen Angiotensin I ACE Angiotensin II
5 Relative importance of Ang II vs aldosterone for BP regulation Normal 115 Aldosterone Synthase Deficient ng AI/ml/hr or pg/ml MAP (mm Hg) Renin Ang II WT KO Makhanova N, et al. Am J Physiol Renal 290:F61-9, 2006.
6 How does aldosterone increase BP? NaCl retention Increased amiloride-sensitive Na + channel expression Increased expression of Cl - -absorbing pendrin protein Increased thiazide-sensitive NaCl cotransporter expression
7 But, NaCl-dependent volume expansion is NOT the only mechanism
8 Renin-Angiotensin System and BP BP or Plasma Volume Angiotensinogen Renin BP BP Angiotensin I ACE Renal NaCl Retention Decreased Increased Vasodilation Vasoconstriction Endothelin Angiotensin II SNS Tone CNS Aldosterone Adrenal Gland
9 Untreated primary hyperaldosteronism and cardiovascular events 20% 20% 15% 11% 15% 10% 5% 8% 3% 3% 2% 6% Essential hypertension Primary Aldosteronism 0% MI or reversible ischemia CVA or TIA Sustained arrhythmia PAD C Catena, et al, Arch Int Med 168:80-85, 2008.
10 Treating primary aldosteronism reduces CV risk Combined incidence of MI, CVA, revascularization or sustained arrhythmia C Catena, et al, Arch Int Med 168:80-85, 2008.
11 Meds vs surgery no difference Combined incidence of MI, CVA, revascularization or sustained arrhythmia C Catena, et al, Arch Int Med 168:80-85, 2008.
12 Primary hyperaldosteronism - how to define aldosterone excess? Outside normal limits Plasma aldosterone Random After NaCl loading Urinary aldosterone Problem: Normal limits don t consider the current physiologic state of the person What are normal physiologic determinants of aldosterone synthesis and release K+ and Ang II Excessive aldosterone for this person
13 When is aldosterone too much? Aldosterone excessive for primary endogenous regulators (K+ and AII) Absence of hyperkalemia Renin used as surrogate for AII Aldosterone:Renin Ratio (ARR) measurements > 3x normal ratio Aldosterone not suppressed Different investigators use >10, > 15 and >20
14 Hyperaldosteronism prevalence and hypertension severity 14% 12% 13.2% 10% 8% 6% 8.0% 4% 2% 0% 1.6% 2.0% <130/ / / >180/110 Hypertension 42: 161, 2003.
15 Problem Two renin assays in clinical use Normal Aldosterone:Renin Ratio Plasma renin activity, ~10 Direct renin assay, ~1
16 Key Point Primary hyperaldosteronism does not require aldosterone levels outside the normal range!
17 Causes of primary hyperaldosteronism Histology Hyperplasia Bilateral adrenal hyperplasia Unilateral adrenal hyperplasia Adenoma Aldosterone-producing adenoma (APA) Bilateral adrenal adenoma Treatment-defined Unilateral (surgical) Aldosterone-producing adenoma Unilateral adrenal hyperplasia Bilateral (medical) Bilateral adrenal hyperplasia Bilateral adrenal adenoma
18 APA is associated with more severe hyperaldosteronism J Hypertens 22: , 2004
19 Effect of using ARR screening on case identification Cases diagnosed per year Before ARR With ARR J Clin Endocrinol Metab 89: , 2004
20 Hypokalemia is less frequent using ARR screening Before ARR 100% 90% 98% After ARR 96% 100% % Hypokalemic 75% 50% 66% 25% 25% 37% 22% 37% 0% Torino Rochester Brisbane Singapore Santiago 9% J Clin Endocrinol Metab 89: , 2004
21 More cases of aldosterone-producing adenoma identified 25 Before ARR 23 With ARR APA Cases Per Year Torino Rochester Brisbane Singapore Santiago 2 2 J Clin Endocrinol Metab 89: , 2004
22 Likelihood of a patient with primary hyperaldosteronism having APA is lower 100% % with APA 75% 50% 70% Before ARR 68% With ARR 75% 86% 50% 83% 25% 30% 28% 30% 0% Torino Rochester Brisbane Singapore Santiago 9% J Clin Endocrinol Metab 89: , 2004
23 Causes of primary hyperaldosteronism Histology Hyperplasia Bilateral adrenal hyperplasia Unilateral adrenal hyperplasia Adenoma Aldosterone-producing adenoma (APA) Bilateral adrenal adenoma Treatment-defined Unilateral Aldosterone-producing adenoma Unilateral adrenal hyperplasia Bilateral Bilateral adrenal hyperplasia Bilateral adrenal adenoma
24 Differentiating unilateral vs bilateral aldosterone release Indirect assessment Imaging CT scan adrenal imaging protocol Angiotensin II regulation of aldosterone Saline suppression test Postural stimulation test Steroid metabolites Direct assessment Adrenal vein aldosterone measurement
25 Limitation of adrenal vein sampling Modified from C Clemente. Human Anatomy, 1975
26 Limitation of adrenal vein sampling Modified from C Clemente. Human Anatomy, 1975
27 Treatment of primary hyperaldosteronism Unilateral Laparoscopic adrenalectomy
28 Response to adrenalectomy Cure, 50% SBP DBP Improved 100% 1.2 ± 1.3 medications per day Predictor Age < Before After A Meyer, et al. World J Surgery 29:155-9, 2005.
29 Response to adrenalectomy 100% 80% 60% 98% Predictors of cure Family history in multiple individuals Number of medications 40% 33% 20% 0% Cure Improved AM Sawka, et al. Ann Intern Med 135:258-61, 2001.
30 Treatment of primary hyperaldosteronism Unilateral Laparoscopic adrenalectomy Bilateral Aldosterone receptor antagonists Spironolactone Eplerenone
31 Aldosterone receptor antagonists Spironolactone mg qd Limitations Gynecomastia, gynecodynia, menstrual irregularities Cost $ per day Eplerenone mg qd Limitations Cost, $1-2 per day
32 Which is better, spironolactone or eplerenone?
33 Which is better, spironolactone or eplerenone? 4 entry criteria patients must meet ALL criteria Serum aldosterone > 20 ng/dl while on 150 mmol d ¹ NaCl diet, or > 5 ng/dl after 2 L NS infused over 4 hr Renin AM plasma renin activity < 1.0 ng/ml/hr, or Upright immunoreactive renin < 15 pg/ml ARR > 23 Urine aldosterone > 20 µg d ¹ with urine Na+ > 150 mmol d ¹ HK Parthasarathy, et al, J Hypertension 29: , 2011.
34 Which is better, spironolactone or eplerenone? HK Parthasarathy, et al, J Hypertension 29: , 2011.
35 SBP response to eplerenone vs spironolactone HK Parthasarathy, et al, J Hypertension 29: , 2011.
36 DBP response to eplerenone vs spironolactone HK Parthasarathy, et al, J Hypertension 29: , 2011.
37 Likelihood of response DBP < 90 or Δ 10 80% 70% 60% 50% P=0.001 P<0.022 % Responding 40% 30% P<0.001 Spironolactone Eplerenone 20% 10% 0% Weeks HK Parthasarathy, et al, J Hypertension 29: , 2011.
38 Study withdrawals 40% 35% 30% 25% 20% 20% Spironolactone 15% 11% Eplerenone 10% 5% 4% 4% 0% Total withdrawals Treatment failure Adverse event Other HK Parthasarathy, et al, J Hypertension 29: , 2011.
39 Study withdrawals 40% 37% 35% 30% 25% 20% 20% 20% Spironolactone 15% 10% 5% 4% 11% 10% 4% 7% Eplerenone 0% Total withdrawals Treatment failure Adverse event Other HK Parthasarathy, et al, J Hypertension 29: , 2011.
40 Why does spironolactone appear more effective? Spironolactone Higher affinity for MR Highly protein bound, >90% Rapid first-pass metabolism (half-life 1-2 hrs) Metabolites, Biologically active Long half-life, ~15 hrs Effectively is a pro-drug of a variety of compounds with long half-lives Eplerenone Less protein binding, ~50% Half-life, ~4 hrs Metabolites Biologically inactive
41 Major adverse effects Spironolactone Gynaecomastia, 21%* Headache, 21% Female breast pain, 21%* Menstrual disorder, 10% Impotence, 6% Eplerenone Headache, 17% URI, 6% Gynaecomastia, 4% HK Parthasarathy, et al, J Hypertension 29: , 2011.
42 Tolerability differences Favoring eplerenone Breast discomfort (M&F) Breast tenderness (M&F) Favoring spironolactone Feeling out of touch with reality Difficulty thinking Feeling lost, disoriented Unawareness of what is going on General weakness Difficulty planning, organizing Tiredness, feeling weary HK Parthasarathy, et al, J Hypertension 29: , 2011.
43 Confirmation of successful adrenal vein sampling Anatomic confirmation is NOT adequate Biochemical confirmation is NECESSARY Adrenal vein aldosterone Inadequate to differentiate APA from unsuccessful cannulation Adrenal vein cortisol If ACTH levels low, adrenal cortisol production low Cortrosyn-stimulated adrenal vein cortisol ~10-fold greater than IVC cortisol
44 Refractory Hypertension ARR and Plasma Aldosterone ARR <25 ARR ARR >50 and [Aldo] > 10 Primary hyperaldosteronism Primary hyperaldosteronism unlikely Suppressed Plasma aldosterone after oral NaCl loading Non-suppressed Surgical Candidate? Begin MR Blocker Yes Positive Adrenal Protocol CT Scan No Adrenal Vein Aldosterone Sampling Negative Optimize MR Blocker Unilateral Aldosterone Release Laparoscopic Adrenalectomy Bilateral Aldosterone Release Optimize MR Blocker No Optimize MR Blocker Adequate BP Response? Yes Continue Therapy
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