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ATHENA Trial ATHENA Trial (A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter)

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ATHENA Trial

ATHENA Trial(A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter)

Presented at Heart Rhythm 2008 in San Francisco, USA

Presented by Stefan H. Hohnloser, MD

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ATHENA Trial: Background

  • Atrial fibrillation (AF) impairs patients’ lives, leading to increased risks of cardiovascular complications.

  • Over the course of 20 years of clinical drug trials in AF no drug has demonstrated a significant reduction in the risk of cardiac death.

  • ATHENA set out to evaluate the effect of Multaq® (dronedarone), a multi-channel blocker with anti-adrenergic properties, on a composite primary endpoint of all-cause mortality and cardiovascular hospitalization in patients with AF.

JCE 2008; 19.1/Heart Rhythm 2008


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Dronedarone (Multaq®) manufactured by Sanofi-aventis is a new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

Unlike amiodarone, this drug does not contain iodine radical and hence does not result in adverse effects on thyroid and lung functions.

ATHENA Trial: Dronedarone

JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Study Design new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

4,628 patients >75 years with atrial fibrillation or 70-75 years with atrial fibrillation and at least one additional cardiovascular risk factor prior to randomization.

Double blind. Randomized. Placebo controlled. International multicenter. Mean follow-up 21 months.

R

Multaq® (dronedarone)

400 mg BID

Placebo

12-30 mos. follow-up

  • Primary Endpoint: composite of all-cause mortality combined with cardiovascular hospitalization

  • Secondary Endpoint: death from any cause, cardiovascular death, hospitalization for cardiovascular reasons

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Inclusion Criteria new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

≥75 yrs with or without additional risk factors

≥70 yrs with at least one of the following risk factors: arterial hypertension (ongoing therapy with at least two antihypertensive drugs of different classes), diabetes mellitus, prior stroke or transient ischemic attack or systemic embolism, left atrium diameter ≥ 50 mm by M-mode echocardiography, LVEF < 0.40 by 2D-echocardiography.

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Inclusion Criteria Cont. new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

Availability of one 12-lead ECG within the last 6 months, indicating prior or current AF/A flutter

Access to a second 12-lead ECG within the last 6 months showing prior or current SR

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Exclusion Criteria new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

Presence of one of the following cardiac conditions:

Permanent AF

Unstable hemodynamic situation (i.e., recently decompensated heart failure)

Congestive heart failure NYHA class IV

Planned major non-cardiac or cardiac surgery

Acute myocarditis

Bradycardia < 50 bpm and/or a PR interval > 0.28 seconds

Significant sinus node disease in the past, if not treated with a pacemaker

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Exclusion Criteria cont. new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

Refusal or inability to give informed consent

Any non-cardiac severe illness limiting life expectancy

Pregnancy and breast feeding

Women of child-bearing potential without adequate birth control

Participation in another clinical trial

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Exclusion Criteria cont. new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

A calculated GFR at baseline < 10mL/min using the Cockroft Gault formula

Potassium level < 3.5 mmol/L if not corrected

Need for concomitant medication prohibited within ATHENA (i.e., other antiarrhythmic drugs of Vaughan-Williams class I or III)

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Baseline Characteristics new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

*AF at baseline: according to the stratification factor at randomization.

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JCE 2008; 19.1 /Heart Rhythm 2008


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ATHENA Trial: Baseline Characteristics new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

**Structural heart disease: coronary heart disease and/or ischemic dilated cardiomyopathy and/or nonischemic dilated cardiomyopathy and/or rheumatic valvular heart disease and/or nonrheumatic valvular heart disease and/or hypertrophic cardiomyopathy and/or history of congestive heart failure and/or left ventricular ejection fraction (LVEF) < 45%.

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Baseline Characteristics new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

***Lone atrial fibrillation: patients without hypertension and without structural heart disease.

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Primary Endpoint Results new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

Multaq® (dronedarone) decreased the risk of cardiovascular hospitalizations or death from any cause by 24% (p<0.001).

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Secondary Endpoint Results new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

Compared to placebo, Multaq® (dronedarone) significantly decreased the risk of cardiovascular death by 30% (p=0.034).

Multaq® (dronedarone) was associated with numerically fewer deaths from any cause (16%, p=0.17).

First cardiovascular hospitalization was reduced by 25% (p=<0.001).

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Other Outcomes new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

Death from arrhythmias was reduced by 45% (p=0.01) when patients were treated with Multaq® (dronedarone).

Multaq® (dronedarone) demonstrated a lower risk of pro-arrhythmia than placebo and no excess of hospitalizations for congestive heart failure.

The rate of study drug discontinuation was similar between the two study arms.

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Adverse Events new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

  • There was a higher frequency of reported gastro-intestinal complications in the Multaq® (dronedarone) group than in the placebo arm.

Gastro-intestinal Effects (%)

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Adverse Events new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

  • Multaq® (dronedarone) was associated with a more frequent occurrence of skin disorders as compared to placebo.

Skin disorders (mainly rash) (%)

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Adverse Events new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

  • Patients treated with Multaq® (dronedarone) demonstrated increased serum creatinine more frequently than those given placebo.

Increased Blood Creatinine (%)

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JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Limitations new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

  • Future trials should consider patients under 75 years of age without additional cardiovascular risk factors and those with decompensated heart failure.

  • The exclusion of these patients from this study limits the applicability of the results.

JCE 2008; 19.1/Heart Rhythm 2008


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ATHENA Trial: Summary new multi-channel blocker that affects the calcium, potassium and sodium channels and has anti-adrenergic properties.

  • Multaq® (dronedarone) has been discovered as the first safe drug to benefit patients with atrial fibrillation.

  • Findings include decreased rates of cardiovascular hospitalization and mortality.

JCE 2008; 19.1/Heart Rhythm 2008


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