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Purpose

CHARM Added: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Added. Purpose

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Purpose

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  1. CHARM Added: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Added Purpose To determine whether addition of the angiotensin II receptor blocker candesartan is beneficial in patients with chronic heart failure (CHF) who are taking angiotensin converting enzyme (ACE) inhibitors Reference McMurray JJV, Östergren J, Swedberg K, et al. for the CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors: the CHARM-Added trial. Lancet 2003;362:767–71.

  2. CHARM Added: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Added- TRIAL DESIGN - Design Multicenter, multinational, randomized, double-blind, placebo-controlled Patients 2548 patients aged >18 years with symptomatic CHF (NYHA class II–IV), who had left ventricular ejection fraction <40% and were receiving ACE inhibitors Follow up and primary endpoint Primary endpoint: cardiovascular deathor hospital admission for CHF. Median 41 months follow up. Treatment Placebo or candesartan titrated to 32 mg once daily

  3. Candesartan Candesartan Placebo Placebo (n=1272) (n=1276) (n=1276) (n=1272) 64.1 64.0 55 56 79 79 30 30 24 24 49 48 73 73 4 3 125.6 124.7 100 100 90 90 56 55 62 63 17 17 26 27 7 6 52 51 CHARM Added: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Added- TRIAL DESIGN continued- Baseline characteristics (%) Age (years)a History MI Male Diabetes mellitus NYHA class: II Hypertension III IV Medications Systolic BP (mmHg)a ACE inhibitor Diuretic Heart failure cause: Beta-blocker Ischemic Spironolactone Idiopathic Hypertensive Aspirin McMurray et al. Lancet 2003;362:767–71. a Mean

  4. CHARM Added: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Added- RESULTS - • Primary outcome of cardiovascular death or hospital admission for CHF significantly reduced in candesartan group compared with placebo (37.9 vs. 42.3%, hazard ratio 0.85, 95% CI 0.75–0.96,P=0.011):each component was reduced significantly • Secondary outcomes –composites of primary outcome and MI, nonfatal stroke and coronary revascularization – also significantly reduced • All-cause mortality not significantly reduced (30 vs. 32%, hazard ratio 0.89, 95% CI 0.77–1.02, P=0.086) • Benefits similar in patients taking beta-blockers and those who were not (P=0.14 for treatment interaction), and regardless of whether recommended dose of ACE inhibitor achieved (P=0.26) • Permanent discontinuation due to adverse event or laboratory abnormality more frequent with candesartan (24.2 vs. 18.3%, P=0.0003)

  5. Placebo Candesartan CHARM Added: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Added- RESULTS continued - Cardiovascular death or hospital admission for CHF Proportion 50 with event (%) 40 30 20 Hazard ratio 0.85 (95% CI 0.75–0.96) 10 P = 0.011 0 0 1.0 2.0 3.0 3.5 Years after randomization McMurray et al. Lancet 2003;362:767–71.

  6. Cardiovascular death 347 (27.3) 302 (23.7) 0.84 (0.72–0.98) 0.029 Hospital admission for CHF 356 (28.0) 309 (24.2) 0.83 (0.71–0.96) 0.014 CHARM Added: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Added- RESULTS continued - Primary and secondary outcomes Placebo Candesartan Hazard ratio P (n=1272) (n=1276) (95% CI) No. (%) No. (%) Cardiovascular death or 538 (42.3) 483 (37.9) 0.85 (0.75–0.96) 0.011 hospital admission for CHF Cardiovascular death, hospital 550 (43.2) 495 (38.8) 0.85 (0.76–0.96) 0.010 admission for CHF, or MI Cardiovascular death, hospital 559 (43.9) 512 (40.1) 0.87 (0.77–0.98) 0.020 admission for CHF, MI, or stroke Cardiovascular death, hospital 596 (46.9) 548 (42.9) 0.87 (0.77–0.97) 0.015 admission for CHF, MI, stroke, or coronary revascularization McMurray et al. Lancet 2003;362:767–71.

  7. CHARM Added: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Added- RESULTS continued - Cardiovascular death or hospital admission for CHF in relation to concomitant treatment at baseline Placebo Candesartan P for treatment interaction Candesartan better Placebo better No. of events/n No. of events/n β-blocker Yes 274/711 223/702 0.14 No 264/561 260/574 Recommended dose of ACE inhibitor Yes 275/648 232/643 0.26 No 263/624 251/633 All patients 538/1272 483/1276 0.6 0.8 1.0 1.2 McMurray et al. Lancet 2003;362:767–71.

  8. CHARM Added: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Added- SUMMARY - In patients with symptomatic CHF who were taking ACE inhibitors, candesartan reduced: • Cardiovascular death and hospitalization for CHF • Secondary outcomes that combined these with MI, stroke and coronary revascularization procedures Benefit was independent of concurrent beta-blocker therapy and ACE inhibitor dose

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