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Focus on outcomes: Only MULTAQ is proven to reduce the risk of CV hospitalization

In the ATHENA trial, MULTAQ reduced the combined endpoint of CV hospitalization or mortality, entirely attributable to reduction in CV hospitalization (P<0.0001). 24% RRR with MULTAQ P<0.001.
  • Incidence of primary endpoint events was 31.6% with MULTAQ vs 39.2% with placebo (HR=0.76; 95% CI=0.68-0.83; P<0.0001)
39% RRR in hospitalizations

MULTAQ decreased risk of being hospitalized for AFib events1
39% RRR* in hospitalizations
related to AFib and other supraventricular rhythm disorders (HR=0.61; 95% CI=0.53-0.71; P<0.0001)

    • Incidence was 12.7% with MULTAQ vs 19.6% with placebo
  • AFib hospitalization was a component of the secondary endpoint of CV hospitalization (26% RRR, HR=0.74; 95% CI=0.67-0.82; P<0.0001)
    • Incidence was 29.1% with MULTAQ vs 36.8% with placebo

*Relative risk reduction (RRR) observed over the study period (median 22-month treatment and follow-up; minimum 12 months, maximum 30 months).

ATHENA study design

Data from a prospective, randomized, placebo-controlled, double-blind, multinational, multicenter, parallel-group trial (30-month maximum duration; N=4628; n=2301 in MULTAQ arm; n=2327 in placebo arm). Primary endpoint was time to first CV hospitalization, or death from any cause (results entirely attributable to effect on CV hospitalization, principally related to AFib; P<0.0001). Secondary endpoints were CV hospitalization (P<0.0001) and all-cause mortality (P=NS).1,2

Adverse events in the ATHENA trial2

ATHENA trial adverse events

References: 1. MULTAQ® (dronedarone) Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC. 2. Hohnloser SH, Crijns HJGM, van Eickels M, et al; for the ATHENA Investigators. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med. 2009;360(7):668-678.

Indication and Important Safety Information for MULTAQ® (dronedarone)

Indication

MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AFib) in patients in sinus rhythm with a history of paroxysmal or persistent AFib.

Important Safety Information

WARNING: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION

MULTAQ is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure. MULTAQ doubles the risk of death in these patients.

MULTAQ is contraindicated in patients in atrial fibrillation (AFib) who will not or cannot be cardioverted into normal sinus rhythm. In patients with permanent AFib, MULTAQ doubles the risk of death, stroke, and hospitalization for heart failure.

MULTAQ is also contraindicated in patients:

Cardiovascular Death in NYHA Class IV or Decompensated Heart Failure
MULTAQ is contraindicated in patients with NYHA Class IV heart failure or symptomatic heart failure with recent decompensation requiring hospitalization because it doubles the risk of death.

Cardiovascular Death and Heart Failure in Permanent AFib
MULTAQ doubles the risk of cardiovascular death (largely arrhythmic) and heart failure events in patients with permanent AFib. Patients treated with MULTAQ should undergo monitoring of cardiac rhythm no less often than every 3 months. Cardiovert patients who are in AFib (if clinically indicated) or discontinue MULTAQ. MULTAQ offers no benefit in subjects in permanent AFib.

Increased Risk of Stroke in Permanent AFib
In a placebo-controlled study in patients with permanent AFib, dronedarone was associated with an increased risk of stroke, particularly in the first two weeks of therapy. MULTAQ should only be initiated in patients in sinus rhythm who are receiving appropriate antithrombotic therapy.

New Onset or Worsening Heart Failure
New onset or worsening of heart failure has been reported during treatment with MULTAQ in the postmarketing setting. In a placebo-controlled study in patients with permanent AFib, increased rates of heart failure were observed in patients with normal left ventricular function and no history of symptomatic heart failure, as well as those with a history of heart failure or left ventricular dysfunction.

Advise patients to consult a physician if they develop signs or symptoms of heart failure, such as weight gain, dependent edema, or increasing shortness of breath. If heart failure develops or worsens and requires hospitalization, discontinue MULTAQ.

Liver Injury
Hepatocellular liver injury, including acute liver failure requiring transplant, has been reported in patients treated with MULTAQ in the postmarketing setting. Advise patients treated with MULTAQ to report immediately symptoms suggesting hepatic injury (such as anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching). Consider obtaining periodic hepatic serum enzymes, especially during the first 6 months of treatment. It is not known whether routine periodic monitoring of serum enzymes will prevent the development of severe liver injury. If hepatic injury is suspected, promptly discontinue MULTAQ and test serum enzymes, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase, as well as serum bilirubin, to establish whether there is liver injury. If liver injury is found, institute appropriate treatment and investigate the probable cause. Do not restart MULTAQ in patients without another explanation for the observed liver injury.

Pulmonary Toxicity
Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported in patients treated with MULTAQ in the post-marketing setting. Onset of dyspnea or non-productive cough may be related to pulmonary toxicity and patients should be carefully evaluated clinically. If pulmonary toxicity is confirmed, MULTAQ should be discontinued.

Hypokalemia and Hypomagnesemia with Potassium-Depleting Diuretics
Hypokalemia and hypomagnesemia may occur with concomitant administration of potassium-depleting diuretics. Potassium levels should be within the normal range prior to administration of MULTAQ and maintained in the normal range during administration of MULTAQ.

QT Interval Prolongation
MULTAQ induces a moderate (average of about 10 ms but much greater effects have been observed) QTc (Bazett) prolongation. If the QTc Bazett interval is ≥500 ms, discontinue MULTAQ.

Renal Impairment and Failure
Marked increase in serum creatinine, pre-renal azotemia and acute renal failure, often in the setting of heart failure or hypovolemia, have been reported in patients taking MULTAQ. In most cases, these effects appear to be reversible upon drug discontinuation and with appropriate medical treatment. Monitor renal function periodically.

Small increases in creatinine levels (about 0.1 mg/dL) following MULTAQ treatment initiation have been shown to be a result of inhibition of creatinine's tubular secretion. The elevation has a rapid onset, reaches a plateau after 7 days and is reversible after discontinuation.

Women of Childbearing Potential
Premenopausal women who have not undergone a hysterectomy or oophorectomy must use effective contraception while using MULTAQ. Dronedarone caused fetal harm in animal studies at doses equivalent to recommended human doses. Counsel women of childbearing potential regarding appropriate contraceptive choices.

Drug-Drug Interactions

Adverse Reactions
In studies, the most common adverse reactions observed with MULTAQ were diarrhea, nausea, abdominal pain, vomiting, and asthenia.

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Indication

MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AFib) in patients in sinus rhythm with a history of paroxysmal or persistent AFib.

Important Safety Information

WARNING: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION