Does the Benefit Associated with Treating Hypertension Apply to Children
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Slide 1 :
“Does the Benefit Associated with Treating Hypertension Apply to Children?" Ronald Portman, MD Professor and Director Division of Pediatric Nephrology and Hypertension University of Texas -Houston Past-Chair, International Pediatric Hypertension Association
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Disease Prevalence in Childhood Congenital heart disease 1% Epilepsy 3-5% ADHD 3-5% Asthma 7% Hypertension 4-5% Obesity 18-25%
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Fourth Working Group Report 2004 2004: 4th Working Group Report Measurement techniques and dilemmas Norms continue to be based epidemiologically by gender, age, height New definition of HTN in concert with JNC 7 Presence of end organ damage presented Evaluation guidelines including co-morbidities Most comprehensive therapeutic guidelines to date
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Classification of Hypertension in Children and Adolescents SBP or DBP Percentile Normal <90th percentile Prehypertension 90th percentile to <95th percentile, or if BP exceeds 120/80 even if below the 90th percentile up to <95th percentile Stage 1 hypertension 95th percentile to the 99th percentile plus 5 mmHg Stage 2 hypertension >99th percentile plus 5 mmHg
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SBP (mmHg) DBP (mmHg) Age BP Percentile of Height Percentile of Height (Year) Percentile 5th 10th 25th 50th 75th 90th 95th 5th 10th 25th 50th 75th 90th 95th 12 50th 102 103 104 105 107 108 109 61 61 61 62 63 64 64 90th 116 116 117 119 120 121 122 75 75 75 76 77 78 78 95th 119 120 121 123 124 125 126 79 79 79 80 81 82 82 99th 127 127 128 130 131 132 133 86 86 87 88 88 89 90 Blood Pressure Levels for Boys by Age and Height Percentile
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Evaluation The Four Questions Am I really hypertensive? Repetitive measurements/ABPM What other modifiable risk factors for CVD do I have? Diabetes, smoking, hypercholesterolemia, proteinuria What has hypertension done to my body? End organ damage No hard endpoints of death, MI or stroke; Evaluation of subtle subclinical changes
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Evaluation The Four Questions What is the cause of my hypertension? Primary hypertension most prevalent but secondary causes more common than in adults The younger the child and the more severe the hypertension; the more likely to be a secondary etiology Final issue: what do we do about all this?
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Etiology of Secondary Hypertension in Pediatrics 78% renal parenchymal 12% renovascular 2% coarctation of the aorta 0.5% pheochromocytoma 7.5% others
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Target-organ abnormalities are detectable in hypertensive children and adolescents. LVH reported (51 g/m2.7) in 34-38% of children with mild, untreated HTN with high correlation to BP and in particular ABPM Working Group Recommendations: Echocardiographic assessment of LV mass should be performed at diagnosis of HTN and periodically thereafter. The presence of LVH is an indication to initiate or intensify antihypertensive therapy. NO STUDIES HAVE BEEN DONE TO DEMONSTRATE REGRESSION WITH THERAPY AS YET (one completed and results pending)
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CVD in Children Death rate per 100,000 0 10 100 1000 10000 0-14 15-19 20-30 Age (years) Adapted from Parekh et al, J Pediatr, 2002 Dialysis Transplant General Population Black White
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Prevalence of Hypertension/LVH in Children with CKD 38 60 74 CRI Dialysis Transplant % Use of BP Medications LVH 22-31% 55-85% 30-75%
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Hypertension and CKD Progression CrCl < 75ml/min/1.73m2 HTN: >95th % (Task Force) Normotensive: n=1987 (52%) Hypertensive: n=1874 (48%) Endpoint: ? CrCl by 10 ml/min/1.73m2 Renal replacement therapy P<0.001 Mitsnefes et al, J Am Soc Nephrol 2003 NAPRTCS CRI Database: 58% 49%
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New HTN patients (n=53) and NTN controls (n=33) HTN defined as BP > 95th percentile, and overweight BMI >25 kg/m2
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ESCAPE TRIAL CKD patients n=352; Age 3-18 yo; European Multi-center Trail GFR 11-80 cc/min/1.73m2 6 months duration of study; ramipril 6 mg/m2; no placebo BP was reduced by 7.1 ± 8.0 mmHg in all groups Higher the initial BP and greater the proteinuria; the greater the BP lowering effect 87.3% of patients achieved normotension with 56% less than the 50th percentile Proteinuria reduced in 50% of patients Wuehl et al. Kidney International 2004;66:768-776
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Classification of Hypertension in Children and Adolescents: Therapy Recommendations All patients to receive Therapeutic Life-style Changes (TLC)
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Indications for Antihypertensive Drug Therapy in Children with Stage 1 HTN Symptomatic hypertension Secondary hypertension Hypertensive target-organ damage Diabetes (types 1 and 2), CKD, ?obesity Persistent hypertension despite nonpharmacologic measures
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Pharmacologic Therapy for Childhood Hypertension Pharmacologic therapy should be initiated with a single drug. The goal for antihypertensive treatment in children should be reduction of BP to <95th percentile, unless concurrent conditions are present: <90th percentile. resolution of end organ damage
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Food and Drug Administration Modernization Act of 1997 (FDAMA) Prior to FDAMA Almost all antihypertensives had been used for treatment of HTN in children No drugs had approved for children with HTN No doses established for safety nor efficacy No available dosage forms
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Food and Drug Administration Modernization Act of 1997 (FDAMA) If drug has potential for use in children, written request issued Suggested study designs furnished and design reviewed by FDA before study begins Voluntary program with 6 months additional patent protection as ‘compensation’ New pediatric rule would make these studies required for drug approval but FDA has discretion to get approval in adults first FDAMA is very successful program; FDA very cooperative, interested, innovative, advocate for children
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Recent Pediatric Phase III or IV Antihypertensive Programs AstraZeneca Felodipine (Plendil)* Metoprolol (Toprol-XL)# Candesartan (Atacand) Bristol-Myers Squibb Fosinopril (Monopril)** Irbesartan (Avapro)# Boehringer Ingelheim Telmisartan (Micardis) CibaGeneva Benazepril (Lotensin)# Merck Enalapril (Vasotec)* Lisinopril* (Prinivil/Zestril) Losartan (Cozaar)* Novartis Valsartan (Diovan) Parke-Davis Quinapril (Accupril)# Pfizer Amlodipine (Norvasc)* Eplerenone (Inspra) Sankyo Olmesartan (Benicar) Wyeth-Ayerst/King Bisoprolol-HCTZ (Ziac)* Altace (Ramipril) ESCAPE Trial* Germany Ramipril in CKD, proteinuria and BP *published Meta-analysis in progress # completed; not yet published
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The Agency can require studies of antihypertensive drugs in children prior to approval for use in adults. Should they do this? First question: are antihypertensive drugs used in children and their use warranted? Yes, but is there proof of efficacy beyond BP lowering? Not yet. Should they do this? No Any new compound should be thoroughly tested for safety and efficacy in adults first unless compelling indication However, pediatric studies must be done after adult approval
Slide 22 :
The Agency can also promote studies in children by granting additional exclusivity for assessing the effects of antihypertensive drugs in children. Should they do this? Yes This program has yielded tremendous knowledge about pediatric hypertension
Slide 23 :
FDAMA Studies for exclusivity: safety and efficacy Initial dose ranging studies had low expectations Pharmacokinetic studies required for each drug New set of FDA written requests required an interpretable study (age 6-16 yrs) 40-60% African American Sub-studies for end organ damage, metabolic effects Encouragement to obtain labeling Compounding of pediatric dosage forms Year long safety study Beginning to examine effects on development Examining younger age groups (1-5 years old) New study with end point other than BP lowering
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Is study of effects on blood pressure adequate? Not anymore
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FDAMA: The Next Generation Studies designed to determine optimum dose or use; not just an ‘effective’ dose Study to determine the most effective drug for pediatric hypertension Studies to determine EOD and disease reversibility Studies using other end points beside BP lowering Studies for long-term BP control Studies of antihypertensive combinations
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FDAMA: The Next Generation Examine specific therapies for most prevalent diseases such as obesity, CKD Commercially available preparations as no medicaid funding for drug compounding Begin to examine neonatal/infant hypertension PREVENTION
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