What are the considerations for adding Ozempic (semaglutide) to the treatment regimen of diabetic patients on insulin and metformin (metformin) with a history of multinodular goiter and known cholelithiasis (gallstones)?

From the Guidelines

Ozempic (semaglutide) can be added to the treatment regimen of diabetes patients already on insulin and metformin who have multinodular goiter and gallstones, but requires careful monitoring. According to the most recent evidence from 1, semaglutide, a GLP-1 receptor agonist, does not require dose adjustment, making it a viable option for patients with various comorbidities. When initiating Ozempic, start with a low dose of 0.25 mg once weekly for 4 weeks as an initial dose, then increase to 0.5 mg weekly, with potential further titration to 1 mg weekly if needed for glycemic control.

For patients with gallstones, it is essential to monitor for symptoms of biliary colic or cholecystitis, as GLP-1 receptor agonists like Ozempic may slightly increase the risk of gallbladder-related complications due to reduced gallbladder motility and altered bile composition 1. Regular assessment of gallstone symptoms and consideration of alternative treatments if complications arise is crucial.

Regarding multinodular goiter, there is no direct contraindication for the use of Ozempic, but thyroid function should be monitored regularly as there is a theoretical risk of medullary thyroid carcinoma based on animal studies, though this has not been conclusively demonstrated in humans. The benefits of adding Ozempic include improved glycemic control, potential weight loss, and possible insulin dose reduction, which can significantly impact the patient's quality of life and reduce morbidity and mortality associated with diabetes.

Key considerations for the addition of Ozempic to the treatment regimen include:

• Monitoring for gallstone-related complications
• Regular thyroid function tests for patients with multinodular goiter
• Potential for improved glycemic control and weight loss
• Possible reduction in insulin dosage
• Regular follow-up appointments every 3 months to assess efficacy, adjust insulin dosing, and monitor for any adverse effects related to the gallstones or thyroid condition.

Overall, the addition of Ozempic to the treatment regimen of diabetic patients on insulin and metformin with a history of multinodular goiter and known cholelithiasis requires careful consideration of the potential benefits and risks, but can be a valuable therapeutic option for improving glycemic control and reducing the risk of diabetes-related complications.

From the FDA Drug Label

It is not known if OZEMPIC will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Counsel patients regarding the potential risk for MTC with the use of OZEMPIC and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). OZEMPIC has not been studied in patients with a history of pancreatitis. OZEMPIC may affect the way some medicines work and some medicines may affect the way OZEMPIC works. Before using OZEMPIC, talk to your healthcare provider about low blood sugar and how to manage it Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.

The patient has a history of multinodular goiter, which may increase the risk of thyroid tumors. However, the FDA label does not provide direct information on the use of Ozempic in patients with multinodular goiter. The patient also has a history of cholelithiasis (gallstones), but the FDA label does not mention this condition as a consideration for the use of Ozempic. Considering the patient is on insulin and metformin, the use of Ozempic may increase the risk of low blood sugar (hypoglycemia). Given the lack of direct information in the FDA label regarding the use of Ozempic in patients with multinodular goiter and cholelithiasis, and considering the potential risks, a conservative clinical decision would be to exercise caution when adding Ozempic to the treatment regimen of this patient. It is essential to closely monitor the patient's condition, including their thyroid function, blood sugar levels, and potential side effects, and to adjust the treatment plan as needed. The patient should be informed about the potential risks and benefits of Ozempic and counseled on how to manage low blood sugar and recognize symptoms of thyroid tumors. 2 2

From the Research

Considerations for Adding Ozempic (Semaglutide) to Treatment Regimen

When considering the addition of Ozempic (semaglutide) to the treatment regimen of diabetic patients on insulin and metformin with a history of multinodular goiter and known cholelithiasis (gallstones), several factors should be taken into account:

• The patient's medical history, including the presence of multinodular goiter and cholelithiasis, does not appear to be directly contraindicated with the use of semaglutide, as evidenced by the studies 3, 4, 5, 6, 7.
• Metformin use has been associated with a lower risk of benign nodular goiter in patients with type 2 diabetes mellitus, which may be beneficial for patients with a history of multinodular goiter 4.
• Semaglutide has been shown to be effective in improving glycemic control, reducing body weight, and lowering the risk of cardiovascular events in patients with type 2 diabetes mellitus 3, 5, 7.
• The potential benefits of semaglutide on glycemic control and weight loss may outweigh the risks, but careful monitoring of the patient's condition is necessary to minimize potential adverse effects.
• It is essential to consider the individual patient's risk factors, such as the presence of cholelithiasis, and monitor for potential adverse effects, such as gastrointestinal symptoms or increased risk of pancreatitis, although these are not directly mentioned in the provided studies.

Potential Interactions and Contraindications

• There is no direct evidence in the provided studies to suggest that semaglutide interacts with insulin or metformin in a way that would be harmful to patients with a history of multinodular goiter or cholelithiasis.
• However, it is crucial to monitor the patient's condition closely and adjust the treatment regimen as necessary to minimize potential adverse effects.
• The use of semaglutide in patients with a history of cholelithiasis should be approached with caution, as there is limited evidence available on this specific topic in the provided studies.

Monitoring and Follow-up

• Regular monitoring of the patient's glycemic control, body weight, and cardiovascular risk factors is necessary to assess the effectiveness of semaglutide and minimize potential adverse effects.
• Close follow-up with the patient's healthcare provider is essential to adjust the treatment regimen as necessary and address any concerns or adverse effects that may arise.