Step Studies Flashcards

S

1
Q

Step 1 Weight Loss 68

A

-14.9 / -2.4

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2
Q

Step 1 Waist Circumference

A

5.3 / 1.6

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3
Q

Step 1 % >5

A

83.5% / 31.3

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4
Q

Step 1 Design

A

2:1 randomization 68 Week randomized, double blinded, placebo controlled

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5
Q

Step 1 AE Discontinue

A

7.0%/ 3.1%

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6
Q

Step 4 Study Run In

A

20 Week
16 week to get to 2.4 dose

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7
Q

Step 4 20-68 week outcome

A

Wegovy -7.9/ +6.9

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8
Q

Step 4 Secondary from week 0

A

Wegovy -17.4/ -5.0

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9
Q

Step 4 Objective

A

Effectively & Safety Wegovy for chronic weight management specifically in pts able to reach target 2.4 dose at 20 weeks

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10
Q

Step 4 trial set up

A

2;1 randomization 908 pts randomized double blinded placebo controlled withdrawal trial

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11
Q

Step 4 Discontinued during run in

A

5.3% patients GI related issues

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12
Q

Eating for pleasure -food reward

A

Hedonic

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13
Q

Eating for Hunger -meeting energy requirements

A

Homeostasis

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14
Q

Deciding to Eat

A

Executive function

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15
Q

Reduction in leptin after weight loss

A

Increase in appetite

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16
Q

Step 5 Study

A

Long term weight management 1;1 randomized 104 week

17
Q

Step 5 Weight reduction end of study

A

-15.2% / -2.6%

18
Q

Step 5 % of patients to get >5 %

A

77.1% /34.4%

19
Q

Step 5 AE discontinue

A

6% Wegovy/ 15% Placebo

20
Q

Step 5 Waist Circumference

A

Wegovy 5.7/ 2.0

21
Q

Half Life of Wegovy

A

7 Days

22
Q

% of endogenous hormone

A

94%

23
Q

What is the Hunger Hormone- produces

A

Ghrelin - stomach

24
Q

When are blood levels of Ghrelin highest

A

Before meals

25
Q

Type of Study Select?

A

CVOT Event Driven Superiority

26
Q

How was Select Randomized

A

1:1 Wegovy/ placebo & standard of care

27
Q

% of MACE reduction

A

20% superior to placebo

28
Q

Duration of study

A

41.8 months

29
Q

Patients with 1st MACE in Select

A

6.5%/ 8.0

30
Q

Step 4 Waist Circumference

A

2.5 Wegovy/ 1.3

31
Q

Second Endpoint of MASE Weight Select

A

9.4% Wegovy/0.9 %

32
Q

Contrave made of?

A

Generic name: bupropion and naltrexone

33
Q

contains a combination of phentermine and topiramate

A

Qysimia

34
Q

.25 .5 1 Wegovy

A

.5 ML pens

35
Q

1.7 /2.4

A

.75ml

36
Q

Temperature

A

46-86
Good for 28 days out prescription 28 days