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Heart failure: The national burden VBWG • Affects 1 million Americans • >550,000 new cases annually • >53,000 deaths in 2002 • Leading Medicare hospital diagnosis • >1 million hospitalizations annually • Direct and indirect costs: $27.9 billion AHA. Heart disease and stroke statistics–2005 update. Koelling TM et al. Am Heart J. 2004;147:74-8. ACC/AHA: Heart failure stages A and B VBWG Stage A Stage B Definition No structural heart disease/asymptomatic Structural heart disease/asymptomatic Patients Hypertension CAD Diabetes Obesity Metabolic syndrome Previous MI LV remodeling LV hypertrophy Low EF Goals Treat BP, lipids Smoking cessation Regular exercise Alcohol/drug use All measures under stage A Therapy ACEI or ARB for vascular disease/diabetes* ACEI or ARB* -Blockers* *Appropriate patients Hunt SA et al. J Am Coll Cardiol. 2005;46:1-82. ACC/AHA: Heart failure stages C and D VBWG Stage C Stage D Definition Structural heart disease Prior/current symptoms Refractory HF Patients Shortness of breath Fatigue Exercise capacity Marked symptoms at rest despite maximal therapy Goals All Stage A and B Dietary salt restriction All Stage A, B, and C Decision re: appropriate level of care Drug therapy Routine drugs Diuretics ACEI -Blockers Options Compassionate care/hospice Selected patients Aldosterone antagonist ARBs Digitalis Hydralazine/nitrates Devices* Extraordinary measures Heart transplant Chronic inotropes Permanent mechanical support Experimental surgery/drugs Biventricular pacing Implantable defibrillators *Selected patients Hunt SA et al. J Am Coll Cardiol. 2005;46:1-82. VBWG CHARM: HF patients with LV dysfunction CHARM-Alternative CHARM-Added Patients N = 2028 LVEF ≤40% Intolerant to ACEI N = 2548 LVEF ≤40% Treated with ACEI Therapy Candesartan 32 mg/d vs placebo Candesartan 32 mg/d vs placebo + ACEI and other HF therapy Follow-up 41 months 33.7 months Primary outcome* 23% RRR (P < 0.001) 7% absolute 15% RRR (P < 0.011) 4% absolute *CV mortality/HF hospitalization RRR = relative risk reduction Granger CB et al. Lancet. 2003;362:772-6. McMurray JJV et al. Lancet. 2003;362:767-71. VALIANT: Study design VBWG Patients N = 14,703 with MI within ≤10 days HF and/or LVEF <35%* Therapy Valsartan 160 mg 2/d (n = 4909) Captopril 50 mg 3/d (n = 4909) Captopril 50 mg 3/d + valsartan 80 mg 2/d (n = 4885) Follow-up 24.7 months *<40% by radionuclide ventriculography (RVG) Pfeffer MA et al. N Engl J Med. 2003;349:1893-906. VALIANT: Primary outcome— Death from any cause VBWG 0.4 Valsartan* Valsartan plus captopril† Captopril 0.3 Probability 0.2 of event 0.1 0.0 0 *P = 0.98 vs captopril †P = 0.73 vs captopril 6 12 18 24 30 36 Months Pfeffer MA et al. N Engl J Med. 2003;349:1893-906. VBWG ACC/AHA recommendations: ARBs in patients with LV dysfunction Class Alternative therapy: Use ARBs approved for the treatment of HF in patients witih current or prior HF symptoms who are ACEI intolerant ARBs are reasonable alternatives to ACEI as first-line therapy for patients with mild to moderate HF, especially those already taking ARBs for other indications ARBs should be administered to post-MI patients without HF symptoms who are intolerant of ACEIs and have a low LVEF Added therapy: Consider adding ARBs in persistently symptomatic patients with reduced LVEF who are already treated with conventional therapy Level of evidence I A IIa A I B IIb B Hunt SA et al. J Am Coll Cardiol. 2005;46:1-82. CHARM-Added: Effects of adding candesartan to -blocker and ACEI VBWG Candesartan Placebo 223/702 260/574 274/711 264/561 0.14 Recommended dose of ACE inhibitor Yes 232/643 No 251/633 275/648 263/624 0.26 All patients 538/1272 -Blocker Yes No 483/1276 Candesartan better Placebo better P* 0.6 0.7 0.8 0.9 1.0 1.1 1.2 Hazard ratio *For treatment interaction McMurray JVV et al. Lancet. 2003;362:767-71. VBWG HF with LV dysfunction: Patients, efficacy, and dosing considerations Efficacy Initial dose(s) Maximum dose(s) ARB Patients Candesartan HF CV mortality HF hospitalizations 4–8 mg 1/d 32 mg 1/d Valsartan HF Post-MI CV mortality 20–40 mg 2/d 160 mg 2/d Adapted from Hunt SA et al. J Am Coll Cardiol. 2005;46:1-82. VBWG CHARM: Prevention of diabetes with candesartan 12 10 8 Proportion of patients (%) Placebo RRR = 22% HR = 0.78 (0.64–0.96) P = 0.020 6 n = 202 (7.4%) n = 163 (6.0%) 4 Candesartan 2 0 0 1.0 2.0 3.0 3.5 Years RRR = relative risk reduction Yusuf S et al. Circulation. 2005;112:48-53.