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

Adding Ozempic (semaglutide) to the treatment regimen of diabetic patients on insulin and metformin with a history of multinodular goiter and known cholelithiasis (gallstones) is generally acceptable with appropriate monitoring, as it has no known direct effect on thyroid nodules in humans and its benefits in glycemic control and cardiovascular risk reduction may outweigh the potential risks 1. When considering the addition of Ozempic to the treatment regimen, several factors should be taken into account:

• The patient's current glycemic control and the potential for Ozempic to improve it, as well as its cardiovascular benefits, which have been demonstrated in large CV outcome trials 1.
• The potential for increased risk of gallbladder-related issues, such as biliary colic or cholecystitis, due to the effects of GLP-1 receptor agonists on gallbladder motility and bile composition, and the need for monitoring for symptoms of these conditions.
• The potential for gastrointestinal side effects, including nausea, vomiting, and diarrhea, which typically improve over time, and the importance of advising patients about these potential side effects.
• The potential for increased risk of hypoglycemia when Ozempic is added to insulin therapy, and the need for insulin dose reduction (typically 10-20% initially) to mitigate this risk, especially in patients with tight glycemic control.
• The importance of regular monitoring of blood glucose levels during initiation and dose adjustments of Ozempic.

In terms of dosing, Ozempic can be initiated at 0.25 mg once weekly subcutaneously for the first 4 weeks as a starting dose, then increased to 0.5 mg weekly, with potential further titration to 1 mg weekly based on glycemic response and tolerability. It is also important to note that, according to the most recent guidelines, no dose adjustment of semaglutide is required in patients with chronic kidney disease, which may be a consideration in some patients with diabetes 1.

Overall, the decision to add Ozempic to the treatment regimen of diabetic patients on insulin and metformin with a history of multinodular goiter and known cholelithiasis should be made on a case-by-case basis, taking into account the individual patient's needs and medical history, and with careful monitoring for potential side effects and adjustments to the treatment regimen as needed.

From the FDA Drug Label

OZEMPIC is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1)]. 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). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with OZEMPIC.

The patient has a history of multinodular goiter, but there is no mention of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). However, the presence of multinodular goiter may increase the risk of thyroid tumors. Key considerations for adding Ozempic to the treatment regimen of diabetic patients on insulin and metformin with a history of multinodular goiter and known cholelithiasis (gallstones) include:

• Monitoring for symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarsiness)
• Awareness of the potential risk for MTC with the use of OZEMPIC
• Regular evaluation of the patient's thyroid condition
• Consideration of the patient's gallstones, as Ozempic may cause gallbladder disease It is essential to weigh the benefits and risks of adding Ozempic to the patient's treatment regimen and to closely monitor the patient for any potential adverse effects 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 type 2 diabetes management: Semaglutide has been shown to be effective in reducing HbA1c levels and body weight, with additional cardiovascular benefits 3, 4.
• The presence of multinodular goiter: Metformin use has been associated with a lower risk of benign nodular goiter in patients with type 2 diabetes mellitus 5. However, the effect of semaglutide on multinodular goiter is not well established.
• The presence of cholelithiasis (gallstones): There is no direct evidence in the provided studies regarding the effect of semaglutide on cholelithiasis.
• Potential interactions with other medications: Semaglutide can be combined with basal insulin and metformin, but the potential interactions with other medications should be carefully evaluated 3.
• The patient's overall health and medical history: Semaglutide has been shown to be safe in adults and elderly patients with renal or hepatic disorders, but the patient's individual health status should be considered 4.

Potential Benefits and Risks

The potential benefits of adding semaglutide to the treatment regimen include:

• Improved glycemic control and weight loss 3, 4, 6
• Cardiovascular benefits 3, 4
• Potential improvement in psoriasis symptoms (if present) 6 The potential risks and considerations include:
• Gastrointestinal adverse effects 4
• Potential effects on multinodular goiter (unknown)
• Potential interactions with other medications
• Individual patient factors, such as renal or hepatic disorders 4