Diabetes Drug - Tirzepatide Gets FDA Approval for Weight Loss

About

Obesity and diabetes are often termed as twin epidemics due to their increasing prevalence worldwide. Obesity, which influences both action of insulin and cell function, is likely to be responsible for the rise in the prevalence of type 2 diabetes(1^✔).

Weight loss is the single most important factor for improving health outcomes in people with obesity who have type 2 diabetes. The recently FDA approved medication Tirzepatide, is becoming a game changer for both diabetes and obesity treatment, thanks to its unique dual-action mechanism targeting two different receptors.

The US 'Food and Drug Administration' (FDA) has approved Eli Lilly's brand Zepbound that has the generic tirzepatide for chronic weight management in individuals who are obese or overweight. The drug should be prescribed along with diet and exercise for both the diabetes and weight-management(2^✔).

Ttirzepatide (Zepbound) is the first and only obesity treatment medication that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. GIP and GLP-1 are the two primary incretin hormones secreted from the intestine to stimulate insulin secretion from pancreatic β-cells. Tirzepatide reduces appetite and food intake by activating GLP-1 and GIP receptors(3^✔).

Zepbound and Weight Loss: The SURMOUNT Trial

The safety and efficacy of Zepbound for chronic weight management were studied in two randomized, double-blind, placebo-controlled trials of obese or overweight adults who had at least one weight-related condition. Participants were randomly assigned to receive Zepbound at 5 mg, 10 mg, 15 mg or placebo once weekly subcutaneously for 72 weeks as an addition to lifestyle modification.

Patients who received Zepbound at all three dose levels experienced a significant reduction in body weight after 72 weeks of treatment when compared to those who received placebo.

Patients who received the highest dose of Zepbound (15 mg once weekly) lost an average of 21% of their body weight, as compared with a 3% weight loss in the placebo group(4^✔).

Which is better for Weigh Loss Semaglutide vs Tirzepatide?

Both Semaglutide and Tirzepatide mimic gut hormones, which help delay gastric emptying and control appetite. Recent studies have compared Tirzepatide with Semaglutide and found that Tirzepatide is more effective than Semaglutide in lowering HbA1c levels and body weight, with similar gastrointestinal side effects(5^✔).

Dosage and Administration of Zepbound

Zepbound is administered once a week via subcutaneous injection (under the skin). It is available in different dosages: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg. The maximum dose of Zepbound is 15 mg once a week. Zepbound's dose can be started at a lower dose and gradually increased to a maximum of 15 mg over 4 to 40 weeks(6^✔).

What are the Side Effects of Tirzepatide (Zepbound)?

The most common side effects are gastrointestinal issues such as nausea, vomiting, gastroesophageal reflux, diarrhea, constipation, stomach pain, and discomfort.

Tirzepatide (Zepbound) may also cause injection site reactions, fatigue, burping, hair loss, allergic rash, and fever(7^✔).

What are the Contraindications of Tirzepatide (Zepbound)?

Zepbound has been found to cause thyroid C-cell tumors in rats and is therefore not recommended for those who have a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2.

Avoid using Zepbound along with Mounjaro or a GLP-1 receptor agonist since the safety and efficacy of co-administration of Zepbound with other weight loss drugs have not been established.

Patients with a history of severe allergic reactions to Tirzepatide should avoid using Zepbound(8^✔).

What are the Warnings and Precautions While Taking Zepbound?

Zepbound should be used with caution in patients with pancreatitis, gallbladder issues, severe gastrointestinal disorders, hypoglycemia, acute renal injury, diabetic retinopathy, and suicidal thoughts or behaviors as there is insufficient data on the drug's safety in these conditions(9^✔).

References:

1. Why Does Obesity Cause Diabetes? - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8740746/)
2. FDA Green-Lights Tirzepatide, Marketed as Zepbound, for Chronic Weight Management - (https://pubmed.ncbi.nlm.nih.gov/37966831/)
3. Tirzepatide, a New Era of Dual-Targeted Treatment for Diabetes and Obesity: A Mini-Review - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9268041/)
4. Tirzepatide: A Systematic Update - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9741068/)
5. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes - (https://pubmed.ncbi.nlm.nih.gov/34170647/)
6. Tirzepatide injection - (https://medlineplus.gov/druginfo/meds/a622044.html)
7. FDA Approves New Medication for Chronic Weight Management - (https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management)
8. Tirzepatide: Overview - (https://www.ncbi.nlm.nih.gov/books/NBK585056/)
9. Zepbound (Tirzepatide) Injection, for subcutaneous use - (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217806s000lbl.pdf)

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