When should I recommend Ozempic (semaglutide) to patients?

From the Guidelines

Ozempic (semaglutide) should be recommended to adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control, particularly when other medications have not achieved target glucose levels, as it has demonstrated cardiovascular benefits, as shown in the SUSTAIN-6 trial 1.

Key Points to Consider

• The typical starting dose is 0.25 mg once weekly by subcutaneous injection for 4 weeks, then increased to 0.5 mg once weekly.
• If additional glycemic control is needed after at least 4 weeks, the dose can be increased to 1 mg weekly, with a maximum dose of 2 mg weekly.
• Patients should be counseled about common side effects including nausea, vomiting, diarrhea, abdominal pain, and constipation, which often improve over time.
• Ozempic works by mimicking the incretin hormone GLP-1, which stimulates insulin secretion, suppresses glucagon secretion, slows gastric emptying, and reduces appetite, leading to improved glycemic control and often weight loss.
• It should not be used in patients with type 1 diabetes, diabetic ketoacidosis, personal or family history of medullary thyroid carcinoma, or Multiple Endocrine Neoplasia syndrome type 2, and caution is advised in patients with a history of pancreatitis.

Evidence Supporting the Recommendation

• The SUSTAIN-6 trial, a randomized, double-blind trial, assessed the effect of semaglutide versus placebo on cardiovascular outcomes in 3,297 patients with type 2 diabetes, and found that the primary outcome of cardiovascular death, nonfatal MI, or nonfatal stroke occurred in fewer patients in the semaglutide group (6.6%) compared to the placebo group (8.9%) (HR 0.74 [95% CI 0.58–0.95]; P < 0.001) 1.
• The LEADER trial, a randomized, double-blind trial, assessed the effect of liraglutide, a GLP-1 receptor agonist, versus placebo on cardiovascular outcomes in 9,340 patients with type 2 diabetes, and found that the primary composite outcome of MI, stroke, or cardiovascular death occurred in fewer patients in the liraglutide group (13.0%) compared to the placebo group (14.9%) (HR 0.87 [95% CI 0.78–0.97]; P < 0.001 for noninferiority; P = 0.01 for superiority) 1.

From the FDA Drug Label

OZEMPIC is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease

You should recommend Ozempic to patients:

• With type 2 diabetes mellitus who require improvement in glycemic control as an adjunct to diet and exercise.
• With type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of major adverse cardiovascular events. Considerations should be made for patients with a history of pancreatitis, as Ozempic has not been studied in these patients, and other antidiabetic therapies may be more suitable 2.

From the Research

Patient Selection for Ozempic (Semaglutide)

When considering Ozempic for patients, several factors should be taken into account based on the available evidence:

• Type 2 Diabetes: Ozempic is indicated for the treatment of type 2 diabetes, particularly in patients who have not achieved adequate glycemic control with other treatments 3, 4.
• Cardiovascular Risk: Patients with established cardiovascular disease, chronic kidney disease, or those at high risk for these conditions may benefit from Ozempic due to its demonstrated cardiovascular safety and efficacy in reducing major adverse cardiovascular events 3, 5.
• Glycemic Control: Ozempic has been shown to improve glycemic control, as measured by HbA1c levels, in patients with type 2 diabetes 6, 4.
• Body Weight: Ozempic can also contribute to significant body weight loss, which may be beneficial for patients with type 2 diabetes who are overweight or obese 6, 4.

Key Considerations

• Dosing: The efficacy and safety of different doses of semaglutide, including the higher dose of 2.0 mg, have been evaluated, offering flexibility in treatment intensification for patients requiring additional glycemic control 4.
• Administration: Oral semaglutide offers an alternative to injectable GLP-1 receptor agonists, which may improve adherence for some patients 6, 5.
• Safety Profile: While generally well-tolerated, Ozempic can cause gastrointestinal side effects, and the incidence of serious adverse events should be monitored 4, 5.

Recommendations

Based on the evidence, Ozempic can be recommended for:

• Patients with type 2 diabetes who require improvement in glycemic control.
• Those at high risk for cardiovascular events, given its demonstrated cardiovascular benefits.
• Patients who may benefit from weight loss as part of their diabetes management plan.
• Consideration should be given to the patient's ability to tolerate potential gastrointestinal side effects and to adhere to the treatment regimen.