CHF and arrhythmias:
Diabetes:
Indications for: OZEMPIC
As adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). To reduce the risk of major cardiovascular (CV) events (eg, CV death, non-fatal MI or non-fatal stroke) in adults with T2DM and established CV disease.
Limitations of Use:
Not studied in those with a history of pancreatitis. Not for treating type 1 diabetes.
Clinical Trials:
Monotherapy Use of Ozempic in Patients with Type 2 Diabetes Mellitus
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The efficacy of Ozempic as monotherapy was evaluated in a 30-week double-blind trial (NCT02054897) in 388 patients with type 2 diabetes who were inadequately controlled with diet and exercise. Patients were randomly assigned to Ozempic 0.5mg or 1mg once weekly or placebo.
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Ozempic 0.5mg and 1mg once weekly achieved a statistically significant reduction in HbA1c at week 30 vs placebo. Patients treated with Ozempic 0.5mg had a change in HbA1c of -1.4% at week 30 (difference from placebo, -1.2 [95% CI, -1.5, -0.9]; P <.0001); patients treated with Ozempic 1mg had a change in HbA1c of -1.6% at week 30 (difference from placebo, -1.4 [95% CI, -1.7, -1.1]; P <.0001).
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Ozempic 0.5mg and 1mg treatment arms also had greater mean changes in body weight from baseline to week 30 vs placebo (-3.8kg, -4.7kg vs -1.2kg, respectively).
Combination Therapy Use of Ozempic in Patients with Type 2 Diabetes Mellitus
Combination with metformin and/or thiazolidinediones
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The efficacy of Ozempic was evaluated in a 56-week double-blind trial (NCT01930188) in 1231 patients with type 2 diabetes. Patients were randomly assigned to Ozempic 0.5mg or 1mg once weekly or sitagliptin 100mg once daily, plus metformin (94%) and/or thiazolidinediones (6%).
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Ozempic 0.5mg and 1mg once weekly achieved a statistically significant reduction in HbA1c compared with sitaglitin.
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Patients treated with Ozempic 0.5mg had a change in HbA1c of -1.3% at week 56 (difference from sitagliptin, -0.6 [95% CI, -0.7, -0.4]; P <.0001); patients treated with Ozempic 1mg had a change in HbA1c of -1.5% at week 56 (difference from sitagliptin, -0.8 [95% CI, -0.9, -0.6]; P <.0001).
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Ozempic 0.5mg and 1mg treatment arms also had greater mean changes in body weight from baseline to week 56 vs sitagliptin (-4.2kg, -5.5kg vs -1.7kg, respectively).
Combination with metformin or metformin with sulfonylurea
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The efficacy of Ozempic was evaluated in a 56-week open-label trial (NCT01885208) in 813 patients with type 2 diabetes on metformin alone (49%), metformin with sulfonylurea (45%), or other (6%). Patients were randomly assigned to Ozempic 1mg once weekly or exenatide 2mg once weekly.
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Ozempic 1mg once weekly achieved a statistically significant reduction in HbA1c compared with exenatide.
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Patients treated with Ozempic 1mg had a change in HbA1c of -1.4% at week 56 (difference from exenatide, -0.5 [95% CI, -0.7, -0.3]; P <.0001).
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Ozempic 1mg treatment arms also had greater mean changes in body weight from baseline to week 56 vs exenatide (-4.8kg vs -2.0kg, respectively).
Combination with metformin or metformin with sulfonylurea
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The efficacy of Ozempic was evaluated in a 30-week open-label trial (NCT02128932) in 1089 patients with type 2 diabetes. Patients were randomly assigned to Ozempic 0.5mg or 1mg once weekly or insulin glargine once daily, plus background therapy with metformin (48%), or metformin and sulfonylurea (51%).
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Ozempic 0.5mg and 1mg once weekly achieved a statistically significant reduction in HbA1c compared with insulin glargine.
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Patients treated with Ozempic 0.5mg had a change in HbA1c of -1.2% at week 30 (difference from insulin glargine, -0.3 [95% CI, -0.5, -0.1]; P <.0001); patients treated with Ozempic 1mg had a change in HbA1c of -1.5% at week 30 (difference from insulin glargine, -0.6 [95% CI, -0.8, -0.4]; P <.0001).
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Ozempic 0.5mg and 1mg treatment arms also had greater mean changes in body weight from baseline to week 30 vs insulin glargine (-3.2kg, -4.7kg vs 0.9kg, respectively).
Combination with metformin or metformin with sulfonylurea
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The efficacy of Ozempic was evaluated in a 40-week double-blind trial (NCT03989232) in 961 patients with type 2 diabetes currently treated with metformin with or without sulfonylurea. Patients were randomly assigned to Ozempic 2mg or 1mg once weekly.
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Ozempic 2mg once weekly achieved a statistically significant reduction in HbA1c compared with Ozempic 1mg.
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Patients treated with Ozempic 2mg had a change in HbA1c of -2.1% at week 40 (difference from Ozempic 1mg, -0.2 [95% CI, -0.31, -0.04]; P <.01).
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The Ozempic 2mg arm also had greater mean changes in body weight from baseline to week 40 vs Ozempic 1mg (-6.4kg vs -5.6kg, respectively). This was not statistically significant.
Combination with basal insulin
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The efficacy of Ozempic was evaluated in a 30-week double-blind trial (NCT02305381) in 397 patients with type 2 diabetes who are inadequately controlled with basal insulin, with or without metformin. Patients were randomly assigned to Ozempic 0.5mg or 1mg once weekly, or placebo.
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Ozempic 0.5mg and 1mg once weekly achieved a statistically significant reduction in HbA1c at week 30 compared with placebo.
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Patients treated with Ozempic 0.5mg had a change in HbA1c of -1.3% at week 30 (difference from placebo, -1.1 [95% CI, -1.4, -0.8]; P <.0001); patients treated with Ozempic 1mg had a change in HbA1c of -1.7% at week 30 (difference from placebo, -1.6 [95% CI, -1.8, -1.3]; P <.0001).
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Ozempic 0.5mg and 1mg treatment arms also had greater mean changes in body weight from baseline to week 30 vs placebo (-3.5kg, -6.0kg vs -1.2kg, respectively).
Cardiovascular Outcomes Trial of Ozempic in Patients with Type 2 Diabetes Mellitus and Cardiovascular Disease
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The approval was based on data from the 2-year, multicenter, double-blind, placebo-controlled SUSTAIN 6 trial that assessed the risk of MACE when adding Ozempic or placebo to standard of care in adults with diabetes and established CV disease (N=3297).
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Patients were randomly assigned 1:1 to receive Ozempic 0.5mg or 1mg once weekly or placebo. The primary endpoint was the time to first occurrence of MACE, defined as CV death, nonfatal myocardial infarction, or nonfatal stroke.
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Treatment with Ozempic significantly reduced the risk of MACE occurrence by 26% vs placebo (estimated hazard ratio [HR] for time to first MACE, 0.74 [95% CI, 0.58-0.95]; P <.001); the primary composite endpoint occurred in 6.6% of the Ozempic group vs 8.9% of the placebo arm.
Adult Dosage:
Give by SC inj in abdomen, thigh, or upper arm; rotate inj sites. Initially 0.25mg once weekly for 4 weeks, then increase to 0.5mg once weekly. If additional control needed after at least 4 weeks, may increase to 1mg once weekly. If additional control needed after at least 4 weeks on the 1mg dosage, may then increase to max 2mg once weekly.
Children Dosage:
<18yrs: not established.
OZEMPIC Contraindications:
History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.
Boxed Warning:
Risk of thyroid C-cell tumors.
OZEMPIC Warnings/Precautions:
Risk of thyroid C-cell tumors; inform patients of potential risk and symptoms. History of pancreatitis; consider other antidiabetics. Monitor for pancreatitis; discontinue if suspected; do not restart if confirmed. History of diabetic retinopathy; monitor for progression. Do not reuse or share pens or needles between patients. History of anaphylaxis or angioedema with other GLP-1 receptor agonist. Discontinue if hypersensitivity reactions occur. Acute gallbladder disease (eg, cholelithiasis, cholecystitis). Perform gallbladder studies and clinical follow-up if cholelithiasis is suspected. Monitor renal function when initiating or escalating dose. Pregnancy. Females of reproductive potential: discontinue ≥2 months prior to planned pregnancy. Nursing mothers.
OZEMPIC Classification:
Glucagon-like peptide-1 (GLP-1) receptor agonist.
OZEMPIC Interactions:
Concomitant insulin; administer as separate injections not adjacent to each other. Increased risk of hypoglycemia with concomitant insulin secretagogues (eg, sulfonylureas) or insulin; consider reducing dose of these. May affect absorption of concomitant oral drugs (delayed gastric emptying); caution.
Adverse Reactions:
Nausea, vomiting, diarrhea, abdominal pain, constipation; rare: pancreatitis, acute renal injury, hypersensitivity reactions.
Drug Elimination:
Apparent clearance in patients with type 2 diabetes: approximately 0.05 L/h. Elimination half-life: ~1 week. Semaglutide will be present in circulation for about 5 weeks after the last dose. Primary excretion routes of semaglutide: urine and feces.
Generic Drug Availability:
NO
How Supplied:
Single-patient-use prefilled pen—1 (w. NovoFine needles)