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New Therapies Heather Kertland, PharmD
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Eplerenone Ultrafiltration CRT Outline New Agents
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Rales Study PopulationNYHA Class III and IV heart failure and LVEF≤35% Comparator spironolactone target dose 50 mg/day vs. placebo Outcomen = 1,663; mean follow-up = 24 months; mean LVEF 25.6%; mean dose = 26 mg/day; All-cause mortality: spironolactone was associated with a 30% RRR compared to placebo (34.5% vs. 46%, p<0.001) ARR = 11%; NNT = 9 SafetyHyperkalemia ≥ 6.0 μmol/L: 2% spironolactone vs. 1% placebo (p=0.42) Gynecomastia in men: 9% spironolactone vs. 1% placebo New Engl J Med 1999
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Eplerenone (Inspra) A chemical derivative of spironolactone, enhanced selective binding to the mineralocorticoid receptor minimizing binding to progesterone and androgen receptors
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Ephesus trial Population3 to 14 days post-MI with either symptoms of HF or diabetes without HF symptoms; NYHA classes I-IV; LVEF≤40% Comparatoreplerenone target dose 50 mg/day vs. placebo Outcomen = 6,642; mean follow-up 16 months; mean LVEF 33%; mean dose = 43.5 mg/day; All-cause mortality: eplerenone demonstrated a 15% RRR compared to placebo (14.4% vs. 16.7%; p=0.008) ARR = 2.3%; NNT = 43 Composite endpoint of death from CV causes or first hospitalization from a CV event: eplerenone demonstrated a 13% RRR compared to placebo (26.7% vs. 30.0%, p=0.002) ARR = 3.3%; NNT = 30 New Engl J Med 2003;348:
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Ephesus SafetyHyperkalemia ≥ 6.0 μmol/L: 5.5% eplerenone vs. 3.9% placebo Gynecomastia in men: 0.5% eplerenone vs. 0.6% placebo OtherDI: substrate for CYP3A4 (concomitant use of strong CYP3A4 inhibitors is contraindicated)
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New Engl J Med 2004;351:542-51 Hyperkalemia
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Rx info Monitoring K+ –48 hours post 1 st dose –1,4 and 5 weeks –1 week after any dose change Coverage –Common Drug Review (CDR) – do not cover –ODB Exceptional Access - Experience AMI, have evidence of heart failure and left ventricular systolic dysfunction (EF <40%) and tried spironolactone but experienced severe symptomatic (painful) gynecomastia.
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Ultrafiltration Pts not responding to diuretics Clinic/inpatient setting Results 2 – 3 kg greater weight loss than diuretics, no effect on dyspnea No adverse effects on Serum Cr Anticoagulation is required
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SMH experience EndpointN=8 Age66.1 yrs Duration of UF36 hrs (15 – 65 hrs) UF rate50 – 250 mL/hr Average weight loss7.5 kg
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SMH Experience
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Summary UF is an alternative to diuretics for removing fluid Well tolerated with respect to renal function, although can remove fluid too quickly/too much No known effects on drug concentrations determined to date
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Resynchronization Therapy (CRT) Delayed conduction of electrical signal Ventricles do not contract at the same time QRS interval > 120 msec on ECG + HF symptoms + reduced EF
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New Engl J Med 2010
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Summary Indication is heart failure not bradycardia Can have pacing capabilities Can be combined with ICD Impact on drug therapy –Implantation – holding of anticoagulation –Post – improvement in symptoms – decrease in furosemide
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