The U.S. Food and Drug Administration approved tirzepatide (Zepbound) injection for chronic weight management in adults with a BMI of 30 or with a BMI of 27 or greater with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol) this November. Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist.

Up to 25% body weight loss

The SURMOUNT clinical trials demonstrated that tirzepatide therapy not only improved glucose levels but also had a substantial impact on body weight reduction. At the highest dose (15 mg), people taking Zepbound lost on average 48 lb., while at the lowest dose (5 mg), people lost on average 34 lb. (compared to 7 lb. on placebo).

Additionally, 1 in 3 clinical participants taking Zepbound at the highest dose lost over 58 lb. (25% of body weight), compared to 1.5% on placebo, according to data not controlled for type 1 error. The average starting weight was 231 lb. Zepbound is recommended along with healthy eating and increased activity.

About the SURMOUNT clinical trial program
The SURMOUNT phase 3 global clinical development program for tirzepatide in chronic weight management began in late 2019 and has enrolled more than 5,000 people with obesity or overweight across six registration studies, four of which are global. SURMOUNT-1 and SURMOUNT-2 were submitted to the FDA and demonstrated tirzepatide significantly reduced body weight compared with placebo in people living with obesity or overweight, with or without type 2 diabetes.

The dual action of tirzepatide on both GIP and GLP-1 receptors allows for a comprehensive approach to blood sugar regulation with substantial weight loss. Tirzepatide, the active ingredient in Zepbound, is already approved under the trade name Mounjaro to be used along with diet and exercise to help improve blood sugar in adults with type 2 diabetes. With this new FDA approval for weight loss, people who meet the BMI and risk criteria qualify to use this novel medication class, whether or not they have diabetes.

Cost

Zepbound is expected to be available in the U.S. by the end of the year in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) at a list price of $1,059.87

Side effects:

Zepbound may be associated with gastrointestinal adverse reactions, sometimes severe. The most commonly reported adverse events (observed in ? 5% of clinical trial participants) were nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection-site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease. In studies, most nausea, diarrhea, and vomiting occurred when people increased their dose – but the effects generally decreased over time. Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath, and avoid using if there is a family history of medullary thyroid carcinoma (MTC).

For more information, see FDA Approval Information.

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Want to learn more about Diabetes Medications?

Meds Management Update for Type 2 Diabetes

Airs live on December 21, 2023, at 11:30 am PST

Topics:

• Describe the role of Diabetes Care & Education Specialists in advocating for optimal therapeutic approaches.
• Discuss the application of the new ADA/EASD Guidelines to improve glucose and reduce CV and renal risk.
• List strategies to initiate & adjust oral & injectable therapy using a person-centered approach.

In this exciting webinar, Coach Beverly walks participants through the “Management of Hyperglycemia in Type 2 Diabetes” as outlined by the most recent American Diabetes Association (ADA) guidelines. She kicks-it off with a brief overview of the different classes of medications then uses a case study approach to apply the ADA algorithm.

Can’t make it live? No worries. We will send post the recorded version to the Online University within 24 hours of the broadcast

Instructor: Beverly Thomassian RN, MPH, CDCES, has been Board Certified in Advanced Diabetes Management for over 20 years. She is an Associate Clinical Professor at UCSF, a working educator, and a nationally recognized diabetes expert. She has a Master’s Degree in Public Health from UCLA, with a focus on behavioral health and education.

All hours earned count toward your CDCES Accreditation Information

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