Oxtellar XR Flashcards

1
Q

Which of the following are reasons for nonadherence with AEDs? Select all that apply.

The patient forgets to take the medicine
The patient is not experiencing symptoms
The patient is experiencing side effects from the medication.
The patient missed doses previously and had no negative consequences.

A

The patient forgets to take the medicine
The patient is not experiencing symptoms
The patient is experiencing side effects from the medication.
The patient missed doses previously and had no negative consequences.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

The ability to continue taking medicine regularly for long periods of time is called ______.

Adherence
Endurance
Persistence
Compliance

A

Persistence

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Which of the following are consequences of nonadherence to an AED regimen? Select all that apply.

Neurological pain
Breakthrough seizures
Potential physical injury
Increase in seizure frequency

A

Breakthrough seizures
Potential physical injury
Increase in seizure frequency

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

A survey of 661 patients with epilepsy revealed that ____ forgot to take their medication at least once.

51%
61%
71%
81%

A

71%

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Of epilepsy patients who missed doses of their medication, _____ reported having a seizure.

40%
45%
50%
55%

A

45%

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

When was Trileptal first approved for use in the United States?

1999
2000
2001
2002

A

2000

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

When did Trileptal’s patent expire?

2007
2008
2009
2010

A

2007

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

10-monohydroxy derivative (MHD) is oxcarbazepine’s ______.

Generic name
Chemical name
Active metabolite
Chemical structure

A

Active metabolite

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Which of the following are accurate statements of some of Trileptal’s indications? Select all that apply.

Monotherapy for adults
Adjunctive therapy for adults
Monotherapy for children aged 2 - 16 years
Adjunctive therapy for children aged 4 - 16 years

A

Monotherapy for adults

Adjunctive therapy for adults

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Trileptal is indicated to treat which one of the following types of seizures?

Partial
Generalized only
Complex partial only
Secondarily generalized only

A

Partial

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

The recommended dosage frequency for Trileptal is:

Once a day
Twice a day
Three times a day
In the evenings only

A

Twice a day

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What does the abbreviation IR mean?

Immediate release
Immediate reaction
Immediate response
Immediate reduction

A

Immediate release

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Severe _____ is a metabolic condition in which there is not enough sodium (salt) in the body fluids outside the brian cell, causing them to swell.

Hypotension
Hyponatremia
Hyperactivity
Hypersensitivity

A

Hyponatremia

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What is that half-life of the chemical oxcarbazepine?

About 2 hours
About 4 hours
About 8 hours
About 9 hours

A

About 2 hours

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What is the half-life of the active metabolite MHD?

About 2 hours
About 4 hours
About 8 hours
About 9 hours

A

About 9 hours

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What is the Supernus proprietary delivery system for Oxtellar XR?

Calutrol
Dolutrol
Nalutrol
Solutrol

A

Solutrol

17
Q

Which of the following in the Oxtellar XR development program was a study on comparative bioavailabilty?

103
203
301
303

A

103

18
Q

Which of the following drugs were compared in the bioavailability study?

Trileptal and placebo
Oxtellar XR and MHD
Oxtellar XR and placebo
Oxtellar XR and Trileptal

A

Oxtellar XR and Trileptal

19
Q

Compared to Trileptal, Oxtellar XR takes _____ to reach peak plasma concentrations in the bloodstream.

Much shorter
A longer time
A shorter time
The same time

A

A longer time

20
Q

Which of the following is the main Phase III study of Oxtellar XR?

301
302
303
304

A

301

21
Q

What is abbreviated “nickname” of the Phase III Oxtellar XR study>

ACHIEVE
CONTROL
PREVENT
PROSPER

A

PROSPER

22
Q

For the Oxtellar XR Phase III study, research was conducted in 8 countries. Which of the following countries are among the 8? Select all that apply.

China
Bulgaria
Norway
United States

A

Bulgaria

United States

23
Q

How many patients were included in the Oxtellar XR Phase III study?

166
266
366
466

A

366

24
Q

For the Phase III Oxtellar XR study, patients were taking _____ concomitant AEDs.

1 - 3
1 - 4
2 - 3
2 - 4

A

1 - 3

25
Q

In terms of primary endpoint, Oxtellar XR significantly reduced seizure frequency from baseline in the ______ group.

600 mg/day
1200 mg/day
1800 mg/day
2400 mg/day

A

2400 mg/day

26
Q

Oxtellar XR 2400 mg/day was ______ significantly superior to placebo in median percent change in seizure reduction.

Logistically
Statistically
Numerically
Mathematically

A

Statistically

27
Q

Treatment response is defined as at least a _____ reduction in partial seizure frequency in the treatment phase relative to the baseline phase.

33%
50%
67%
75%

A

50%

28
Q

In addition to treatment response, ______ of patients taking the 2400 mg/day achieved freedom from seizures during the treatment phase.

11%
13%
15%
18%

A

11%

29
Q

What was the discontinuation rate for the Oxtellar XR 2400 mg/day group?

12%
16%
27%
30%

A

30%

30
Q

What was the discontinuation rate for Trileptal 2400 mg/day in its landmark study?

37%
47%
57%
67%

A

67%