PI Assessment Flashcards
Patients in the PALLAS trial had _______
Permanent Afib and additional risk factors for thromboemboism
The ANDROMEDA study was stopped prematurely due to _________
Excess of deaths in the MULTAQ group
The package insert states that MULTAQ __________ with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure, and in patients in atrial fibrillation who will not or cannot be cardioverted.
Is contraindicated in patients
For patients taking MULTAQ, if an increase in serum creatinine occurs it reaches a plateau after ______
7 days
In the ATHENA study, how did the percentage of patients with cardiovascular hospitalization (secondary endpoint) in the MULTAQ group compared to placebo in the final analysis of the results?
Significantly lower
If pulmonary toxicity is confirmed, the Warnings and Precautions Section of the PI recommends:
Discontinue Multaq
Which of the following is true about MULTAQ clinical study results?
Both EURIDIS and ADONIS trials showed a signilicant decrease in the recurrence of AF and atrial flutter (AFL)
What dose of MULTAQ was established as safe and effective for the prevention of AF relapse after cardioversion?
800 mg/ day
In what clinical trials was baseline use of digoxin associated with an increased risk of arrhythmic or sudden death in dronedarone-treated patients compared to placebo?
ANDROMEDA
The PALLAS Trial was terminated because of a significant increase in ______ in the drondedarone group vs. the placebo group.
A) MortalityB) StrokeC) Hospitaizations for heart failureALL of the Above!
Grapefruit juice, a moderate inhibitor of CYP 3A, resulted in a(n)________ in dronedarone exposure.
Significant increase
Which of the following best describes the mechanism of action of MULTAQ?
The mechanism of action of dronedarone is unknown
If digoxin treatment is continued with MULTAQ, what consideration should be made?
Halve the dose of digoxin, monitor serum levels closely, observe
The main reason for death in the ANDROMEDA study was ______.
Worsening heart failure
Multaq is contraindicated in patients who had liver and lung toxicity related to previous use of ________?
Amiodarone
MULTAQ has been assigned to which of the following pregnancy categories?
Category X
What was a major finding of the ATHENA study?
MULTAQ demonstrated a significant decrease in the combined cardiovascular hospitalization or death.
The patients enrolled in ANDROMEDA had relatively severe heart failure and had been hospitalized, or referred to a specialty heart failure clinic, for which of the following?
Worsening symptoms of heart failure, notably shortness of breath
In clinical trials of MULTAQ, patients treated with dronedarone received a variety of concomitant medications including which of the following?
A) Beta-blockers, digoxinB) Caicium antagonists, statinsC) Oral anticoagulantsD) All of the aboveALL of the Above!
In the pooled data from EURIDIS and ADONIS, dronedarone delayed the recurrence of AF/ AFL, lowering the risk of first AF/AFL recurrence during month study period by about ______%
RR Was 25%The ARR was 11%
MULTAQ is an antiarrhythmic drug indicated to ________
Reduce the risk of hospitalization for Atrial Fibrillation in patients in sinus rhythmwith a history of paroxysmal or persistent Afib.
After intravenous administration of dronedarone, the volume of distribution at steady state (Vss) is about ______
1200 L to 1400 L
What were the most frequent adverse reactions observed with MULTAQ 400 MG twice daily in the 5 studies?
Diarrhea, nausea, abdominal pain, vomiting and asthenia
Which of the following is true with regard to differences in dronedarone exposure based on race or ethnicity following single dose administration?
Asian males have about a 2-fold higher exposure than Caucasian
DAFNE was a _________ study in patients with recurrent AF, evaluating the effect of dronedarone in comparison with placebo in maintaining sinus rhythm.
Dose-response
Concomitant use of which drugs or herbal products that prolong the QT interval in might increase the risk of Torsade de Pointes?
Class I or III antiarrhythmics
lf the QTC Bazett interval is_______ , MULTAQ should be stopped.
> = 500 msOr if the PR interval is > 280 ms
All of the following patient types should NOT take MULTAQ except:
Patients with structural heart disease
The Multaq PI states “Consider obtaining periodic hepatic serum enzymes, especially during the first ________of treatment”
6 Months
What was the objective of the ATHENA study?
Determine whether dronedarone could delay death from any cause orhospitalization for cardiovascular reasons.
In the ATHENA study, hospitalizations occurred in less than or equal to 1% for which of the following events?
Major bleeding, syncope, and ventricular arrhythmia
Which type of medication is associated with reduced potassium and magnesiumlevels in your blood when used in combination with MULTAQ?
Diuretics
Which of the following is a true characterization of the patients who should takeMULTAQ?
Has a history of paroxysmal or persistent afib who is in Sinus Rhythm This should follow the Indication!
If a dose is missed, what should the patient do?
Take the next dose at the regularly scheduled time
In the EURIDIS and ADONIS trials, what was the absolute difference in recurrence rate at 12 months?
ARR was @ 11%RR was 25%
How should MULTAQ be administered with regard to serum potassium levels?
Potassium levels should be within the normal range prior to administration of MULTAQ Potassium levels should be maintained in the normal range during administration ofMULTAQ BOTH
In subjects with moderate hepatic impairment, the mean dronedarone exposure ___________ relative to subjects with normal hepatic function.
Increased by 1.3-fold
