April 24th, 2024 | Uncategorized
So, your patient has gotten good results with Tirzepatide [“Zepbound”]. and now you want to maintain results. What happens to them if they stop the drug, keep a calorie deficit, exercise and get a Placebo? Here comes a study called SURMOUNT-4 to help answer that question. Now, before we go much further this study looked at people who were Obese, but did NOT have Diabetes.
What Did They Do?
Let’s look at SURMOUNT-4. Tirzepatide was administered once weekly as a subcutaneous injection. During the 36-week study, the starting dose of tirzepatide was 2.5 mg and was increased by 2.5 mg every 4 weeks until a maximum tolerated dose of 10 or 15 mg was achieved. Just as a reference pint, 15 mg is the max dose of Tirzepatide. In SURMOUNT-4 they wanted to focus on the 10 and 15 mg group.
Throughout the study, symptoms were managed by dietary counseling, medications, or even skipping of a single dose of treatment, which is OK to do! If food counseling, meds or missing a dose didn’t help, then it was time for “deescalation” meaning decreasing the next dose and then trying again, bringing the dose back-up no more than 2.5 mg per injection. Then, once they had their group, they used a computer-generated method to keep some folks on their maintenance dose and others switched to a placebo. This was the “randomization”. Everyone in the study kept a 500 calorie deficit in their diet and exercised. The researchers followed everyone for safety and blood work was done as well. Most of the people in the study were White Women with a BMI of 38. The split between the Tirzepatide group and the placebo group went on between week 36 and week 88…to make that simple, it means ONE YEAR more of either continued Tirzepatide or going on a Placebo after getting Tirzepatide for th initial 36 weeks.
From starting Tirzepatide to “going into the later randomization” 36 weeks later, 70% of the users lost 20% of their weight, and if you lowered the target to losing 15% of the weight, that was seen in 80% of the people.
Staying on their maintenance dose throughout that time period between week 36 and week 88 allowed a significant number of user to keep off, or “maintain” 80% of the weight they had initially lost. Some the the continued-medicine user lost another 5% of their weight. What about the people that were switched to placebo? They stared re-gaining…but stayed around 9-10% lighter than they were at baseline…so in real numbers, it means hat about half of the weight was regained without medication. The blood results seen in the continued users showed the improvements we have come to expect: A1C levels for glucose, lipids, and blood pressure. In the pacebo users, even though they had maintained some of the initial loss, the blood markers started going in the wrong direction….meaning some of the metabolic advantages were getting lost.
80% had side effects. Mainly stomach-issues. Nausea, diarrhea, constipation and vomiting, in that order. Fortunately, most were mild to moderate. No cases of pancreatitis, Gallstones were reported in 0.9% of the people and an “acute Gallbladder” was seen in 4 people.
My Opinion
This trial was excellent, but on a bigger note, it’s really looking at Obesity the same way e need to loo at other diseases, such as diabetes or high blood pressure. These medicine may not be the “jump-start” people are looking for….these may be better viewed as a needed therapy tat may need to be continued, such as one would do with a cholesterol or blood pressure medicine. Will intermittent treatment be the way to go? Every other week/ Every other month? We simply do not know. Time and more research will tell. But when it comes close to the plateau, my opinion is FOCUS on the quality and quantity of food, not just calories.
As for weight loss surgery, the way Insurance works, it may still be the cheaper way to go, as crazy as that sounds. Keep this in mind…only 3% of Obese patients in the US presently get treated for Obesity.
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