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Phase 1 Assessments > PI Assessment > Flashcards

PI Assessment Flashcards

1
Q

Patients in the PALLAS trial had _______

A

Permanent Afib and additional risk factors for thromboemboism

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2
Q

The ANDROMEDA study was stopped prematurely due to _________

A

Excess of deaths in the MULTAQ group

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3
Q

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.

A

Is contraindicated in patients

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4
Q

For patients taking MULTAQ, if an increase in serum creatinine occurs it reaches a plateau after ______

A

7 days

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5
Q

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?

A

Significantly lower

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6
Q

If pulmonary toxicity is confirmed, the Warnings and Precautions Section of the PI recommends:

A

Discontinue Multaq

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7
Q

Which of the following is true about MULTAQ clinical study results?

A

Both EURIDIS and ADONIS trials showed a signilicant decrease in the recurrence of AF and atrial flutter (AFL)

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8
Q

What dose of MULTAQ was established as safe and effective for the prevention of AF relapse after cardioversion?

A

800 mg/ day

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9
Q

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?

A

ANDROMEDA

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10
Q

The PALLAS Trial was terminated because of a significant increase in ______ in the drondedarone group vs. the placebo group.

A

A) MortalityB) StrokeC) Hospitaizations for heart failureALL of the Above!

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11
Q

Grapefruit juice, a moderate inhibitor of CYP 3A, resulted in a(n)________ in dronedarone exposure.

A

Significant increase

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12
Q

Which of the following best describes the mechanism of action of MULTAQ?

A

The mechanism of action of dronedarone is unknown

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13
Q

If digoxin treatment is continued with MULTAQ, what consideration should be made?

A

Halve the dose of digoxin, monitor serum levels closely, observe

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14
Q

The main reason for death in the ANDROMEDA study was ______.

A

Worsening heart failure

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15
Q

Multaq is contraindicated in patients who had liver and lung toxicity related to previous use of ________?

A

Amiodarone

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16
Q

MULTAQ has been assigned to which of the following pregnancy categories?

A

Category X

17
Q

What was a major finding of the ATHENA study?

A

MULTAQ demonstrated a significant decrease in the combined cardiovascular hospitalization or death.

18
Q

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?

A

Worsening symptoms of heart failure, notably shortness of breath

19
Q

In clinical trials of MULTAQ, patients treated with dronedarone received a variety of concomitant medications including which of the following?

A

A) Beta-blockers, digoxinB) Caicium antagonists, statinsC) Oral anticoagulantsD) All of the aboveALL of the Above!

20
Q

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 ______%

A

RR Was 25%The ARR was 11%

21
Q

MULTAQ is an antiarrhythmic drug indicated to ________

A

Reduce the risk of hospitalization for Atrial Fibrillation in patients in sinus rhythmwith a history of paroxysmal or persistent Afib.

22
Q

After intravenous administration of dronedarone, the volume of distribution at steady state (Vss) is about ______

A

1200 L to 1400 L

23
Q

What were the most frequent adverse reactions observed with MULTAQ 400 MG twice daily in the 5 studies?

A

Diarrhea, nausea, abdominal pain, vomiting and asthenia

24
Q

Which of the following is true with regard to differences in dronedarone exposure based on race or ethnicity following single dose administration?

A

Asian males have about a 2-fold higher exposure than Caucasian

25
Q

DAFNE was a _________ study in patients with recurrent AF, evaluating the effect of dronedarone in comparison with placebo in maintaining sinus rhythm.

A

Dose-response

26
Q

Concomitant use of which drugs or herbal products that prolong the QT interval in might increase the risk of Torsade de Pointes?

A

Class I or III antiarrhythmics

27
Q

lf the QTC Bazett interval is_______ , MULTAQ should be stopped.

A

> = 500 msOr if the PR interval is > 280 ms

28
Q

All of the following patient types should NOT take MULTAQ except:

A

Patients with structural heart disease

29
Q

The Multaq PI states “Consider obtaining periodic hepatic serum enzymes, especially during the first ________of treatment”

A

6 Months

30
Q

What was the objective of the ATHENA study?

A

Determine whether dronedarone could delay death from any cause orhospitalization for cardiovascular reasons.

31
Q

In the ATHENA study, hospitalizations occurred in less than or equal to 1% for which of the following events?

A

Major bleeding, syncope, and ventricular arrhythmia

32
Q

Which type of medication is associated with reduced potassium and magnesiumlevels in your blood when used in combination with MULTAQ?

A

Diuretics

33
Q

Which of the following is a true characterization of the patients who should takeMULTAQ?

A

Has a history of paroxysmal or persistent afib who is in Sinus Rhythm This should follow the Indication!

34
Q

If a dose is missed, what should the patient do?

A

Take the next dose at the regularly scheduled time

35
Q

In the EURIDIS and ADONIS trials, what was the absolute difference in recurrence rate at 12 months?

A

ARR was @ 11%RR was 25%

36
Q

How should MULTAQ be administered with regard to serum potassium levels?

A

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

37
Q

In subjects with moderate hepatic impairment, the mean dronedarone exposure ___________ relative to subjects with normal hepatic function.

A

Increased by 1.3-fold

Phase 1 Assessments (3 decks)

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