This transcript has been edited for readability.
Hi. Today we will speak about one other type of semaglutide. This type is known as Wegovy, and it is indicated for weight reduction in folks with or with out diabetes. It’s the next dose than we have used earlier than — 2.4 mg weekly. It has been FDA-approved and is coming in the marketplace quickly.
The indications, based mostly on the package insert, are a BMI ≥ 30 kg/m2 or a BMI ≥ 27 kg/m2 with one weight-related comorbid situation corresponding to diabetes. Like the opposite GLP-1 receptor agonists, it has a black field warning for medullary thyroid carcinoma, and it shouldn’t be utilized in sufferers with a private or household historical past of a number of endocrine neoplasia (MEN) syndrome.
I learn via the package deal insert in its entirety, and there wasn’t a lot that caught my eye. But the one factor we want to pay attention to is that there was a rise in charges of acute gallbladder disease. This was in all probability due to the load loss that we noticed, but it surely’s one thing to know.
In medical trials, cholelithiasis was reported by 1.6% of these taking semaglutide and 0.7% of these taking placebo. And when it comes to cholecystitis, the charges had been 0.6% with the upper dose of semaglutide vs 0.2% with placebo. These are comparatively low charges, however they’ll actually happen. There can also be a priority about pancreatitis, so know that these can happen and you must be careful for them if a affected person has indicators or signs of both.
The STEP Trials Broken Down
The information that had been used for approval got here from 4 section 3 trials — the STEP program, which concerned 4500 adults. We have plenty of information on semaglutide from the trials for the remedy of diabetes, so we all know this drug pretty effectively when it comes to dangers and advantages.
STEP 1 checked out obesity or chubby with a comorbidity, and the first endpoint was % change in weight from baseline to 68 weeks. With placebo, there was a 2.4% discount in weight vs a 14.9% discount in weight with the semaglutide.
STEP 3 is my favourite type of research as a result of it concerned intensive life-style intervention at the side of a medicine. In this research, they gave life-style intervention to people with weight problems or chubby and a preexisting comorbidity. Patients receiving solely life-style intervention misplaced 5.7% of their physique weight, in contrast with 16% of their physique weight with semaglutide.
And lastly, we have now STEP 4, which was fairly attention-grabbing. The investigators mainly took all people and randomized them to semaglutide or a placebo and watched them for 20 weeks. Then, in a subset of them, semaglutide was stopped they usually got placebo to see what occurs to their weight. Those on semaglutide continued to drop some pounds vs these on placebo, whose weight reduction stopped, and the load really began to return up once more.
Wegovy goes to be allotted in single-dose pens. This is totally different from the pens we have now for Ozempic. Each field of pens will embody 4 single-dose pens, they usually’ll be one in every of 5 totally different dose strengths: 0.25, 0.5, 1, 1.7, and a pair of.4 mg. Every 4 weeks, the affected person is meant to go as much as the next dose power till they get to the utmost tolerated dose or 2.4 mg.
These pens have a preattached needle, so the affected person simply has to twist off the highest and provides the dose. I do not assume the affected person has to work together with the needle a lot in any respect. These are quite simple pens and quite simple directions, however we have to make it possible for we give sufferers sufficient of those dose packs in order that they’ll really go up on the dose each month till they get to the two.4-mg dose.
I’m actually trying ahead to utilizing Wegovy in my sufferers who want weight reduction. I feel it may be efficient. It’s a drug that we have identified for various years, so it may be totally different when it comes to our expertise of prescribing one thing “new.” But all of us have to attend for this to grow to be accredited on varied formularies, and an enormous situation that we have all had is getting approval for weight reduction medication for our sufferers. Hopefully, it will by some means be simpler; I’m at all times an optimist. And always remember to debate life-style along with your sufferers, as a result of they’re going to do even higher in the event that they take this and enhance their life.
Anne L. Peters, MD, is a professor of drugs on the University of Southern California (USC) Keck School of Medicine and director of the USC medical diabetes packages. She has revealed greater than 200 articles, evaluations, and abstracts, and three books, on diabetes, and has been an investigator for greater than 40 analysis research. She has spoken internationally at over 400 packages and serves on many committees of a number of skilled organizations.