Step Studies Flashcards
S
Step 1 Weight Loss 68
-14.9 / -2.4
Step 1 Waist Circumference
5.3 / 1.6
Step 1 % >5
83.5% / 31.3
Step 1 Design
2:1 randomization 68 Week randomized, double blinded, placebo controlled
Step 1 AE Discontinue
7.0%/ 3.1%
Step 4 Study Run In
20 Week
16 week to get to 2.4 dose
Step 4 20-68 week outcome
Wegovy -7.9/ +6.9
Step 4 Secondary from week 0
Wegovy -17.4/ -5.0
Step 4 Objective
Effectively & Safety Wegovy for chronic weight management specifically in pts able to reach target 2.4 dose at 20 weeks
Step 4 trial set up
2;1 randomization 908 pts randomized double blinded placebo controlled withdrawal trial
Step 4 Discontinued during run in
5.3% patients GI related issues
Eating for pleasure -food reward
Hedonic
Eating for Hunger -meeting energy requirements
Homeostasis
Deciding to Eat
Executive function
Reduction in leptin after weight loss
Increase in appetite
Step 5 Study
Long term weight management 1;1 randomized 104 week
Step 5 Weight reduction end of study
-15.2% / -2.6%
Step 5 % of patients to get >5 %
77.1% /34.4%
Step 5 AE discontinue
6% Wegovy/ 15% Placebo
Step 5 Waist Circumference
Wegovy 5.7/ 2.0
Half Life of Wegovy
7 Days
% of endogenous hormone
94%
What is the Hunger Hormone- produces
Ghrelin - stomach
When are blood levels of Ghrelin highest
Before meals
Type of Study Select?
CVOT Event Driven Superiority
How was Select Randomized
1:1 Wegovy/ placebo & standard of care
% of MACE reduction
20% superior to placebo
Duration of study
41.8 months
Patients with 1st MACE in Select
6.5%/ 8.0
Step 4 Waist Circumference
2.5 Wegovy/ 1.3
Second Endpoint of MASE Weight Select
9.4% Wegovy/0.9 %
Contrave made of?
Generic name: bupropion and naltrexone
contains a combination of phentermine and topiramate
Qysimia
.25 .5 1 Wegovy
.5 ML pens
1.7 /2.4
.75ml
Temperature
46-86
Good for 28 days out prescription 28 days