For adults with T2D at high risk of major CV events
Ozempic® (semaglutide) pill: proven CV risk reduction7
Start Ozempic® pill today in adults with T2D who are at high risk for major CV events
Ozempic® pill can significantly lower the risk of MACE7,8
Reduction in risk of MACE with semaglutide tablets 14 mg vs placebo when both were added to SOC in adults with T2D and established CVD and/or CKD7
Primary composite endpoint: Time to first confirmed MACE (CV death, nonfatal MI, or nonfatal stroke)7,8,b
NNT 50
Number needed to treat to preventd
1 MACE
(3 years)8,d
Ozempic® tablets 1.5 mg, 4 mg, 9 mg are an updated formulation with increased bioavailability. This updated formulation is established with comparable mean exposure and peak concentration. The safety and effectiveness of Ozempic® tablets were established through adequate and well-controlled studies of semaglutide tablets 3 mg, 7 mg, 14 mg.7,9
aPrimary prevention: Reducing the risk of atherosclerotic cardiovascular disease (ASCVD) in individuals without established ASCVD by managing risk factors. Secondary prevention: Reducing the risk of recurrent ASCVD events in individuals with established ASCVD.10
bTime-to-first-event outcomes are shown for the intention-to-treat population (all the individual participants who had undergone randomization) during the trial observation period. All the outcomes were analyzed with the use of a Cox proportional-hazards model with randomized group assignment as a categorical fixed factor. Data from participants without events of interest were censored at the end of their trial observation period.7
cTwo-sided P values are shown. After accounting for the results from the interim analysis, the nominal two-sided significance level for the primary outcome was 0.04561.8
dIn a prespecified analysis of primary-outcome events occurring through Week 156 (3 years), the absolute risk reduction was 2%, and the number needed to treat to prevent one event in this population was 50 persons (95% CI: 31-125).8
SOUL: Cardiovascular outcomes trial7,8
SOUL evaluated cardiovascular outcomes with semaglutide tablets once daily in adults with T2D with CVD and/or CKD7,8
A randomized, international, double-blind, parallel-group, placebo-controlled, event-driven, superiority CVOT.7,8
At baseline, patients had a mean A1C of 8.0%, 71% had CAD, 21% had CeVD, 16% had PAD, and 13% had CKD.7,8
At baseline, 97% were treated with one or more glucose-lowering medications: metformin (76%), insulin (51%), SGLT-2 inhibitor (27%), sulfonylurea (29%), and DPP-4 inhibitors (23%); 89% were taking lipid-lowering medications including platelet-aggregation inhibitors (77%), ACE inhibitors or angiotensin receptor blockers (79%), and beta-blockers (64%).7,8
Mean duration of follow-up was 47.5±10.9 months.7,8
eCAD was defined as at least one of: prior MI; prior coronary revascularization procedure; ≥50% stenosis in ≥1 coronary artery documented by cardiac catheterization or CT coronary angiography; or CAD with ischemia documented by stress test with any imaging modality; CeVD was defined as at least one of: prior stroke; prior carotid artery revascularization procedure; ≥50% stenosis in carotid artery documented by X-ray angiography, magnetic resonance angiography, CT angiography, or Doppler ultrasound; symptomatic PAD was defined as at least one of the following: intermittent claudication with an ankle-brachial index <0.85 at rest; intermittent claudication with a ≥50% stenosis in ≥1 peripheral artery (excluding carotid) documented by X-ray angiography, magnetic resonance angiography, CT angiography, or Doppler ultrasound; prior peripheral artery revascularization procedure (excluding carotid); or lower extremity amputation at or above the ankle due to atherosclerotic disease (excluding, eg, trauma or osteomyelitis); CKD was defined as an eGFR <60 mL/min/1.73 m2 (based on medical records using assessment that was the latest available and no more than 6 months old).11
Scroll below for MACE events by weight-loss category (post hoc analysis)
Majority of patients had CVD and were receiving SOC7,8,f
97% were receiving glucose-lowering medications7
Patient characteristics at baseline (N=9650)7,8
Select history of CVD at baseline (N=9650)7,8
Select history of medication use at baseline (N=9650)7,11
fStandard care consisted of glucose-lowering and cardiovascular risk–reducing therapies administered in accordance with local guidelines.7
gCKD was defined as eGFR <60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration method.8
ACE=angiotensin-converting enzyme; ARB=angiotensin receptor blocker; BMI=body mass index; CAD=coronary artery disease; CKD=chronic kidney disease; CVD=cardiovascular disease; eGFR=estimated glomerular filtration rate; HF=heart failure; MI=myocardial infarction; PAD=peripheral artery disease; SGLT-2=sodium-glucose co-transporter-2; SOC=standard of care; T2D=type 2 diabetes.
This analysis is descriptive and observational only and not intended to inform clinical decisions.3
The clinical validity of these results cannot be determined.3
This post hoc exploratory subgroup analysis was not prespecified in the trial and the trial was neither designed nor powered for this analysis. As such, the analysis is hypothesis-generating, not hypothesis testing.3
These data were analyzed by Novo Nordisk and the results are not published.3
No apparent differences were observed in rates of MACE across weight-change subgroups3
Change in body weight from baseline to Week 104 was a prespecified secondary endpoint in SOUL.8
Ozempic® pill is not indicated for weight loss.7
Forest plot of rate of MACE outcomes by weight-loss category with 95% CI3
hNumber of patients with a MACE divided by the total number of patients per subgroup.3
Study design: The primary objective of this retrospective, exploratory post hoc analysis of the semaglutide tablets arm in SOUL was to explore 3-point MACE (nonfatal MI, nonfatal stroke, and CV death) rates in patients treated with semaglutide tablets (N=4304) after Week 52 by weight-loss category, determined by their weight measured at baseline and Week 52. Patients who had events or left the study prior to their visit at Week 52 were excluded from the post hoc population. Those without weight measurement at Week 52 were also excluded.3
Limitations: The study is subject to the inherent limitations of post hoc analyses. Sample size (N=4304) and generalizability are the most limiting factors of this analysis, as they are limited to the data collected during the SOUL trial and are focused only on patients who were taking semaglutide tablets. The placebo arm does not have enough patients in each category to make referenceable comparisons, and thus these patients were excluded from the analysis. Additionally, as this analysis was not factored into the original power calculations for the SOUL trial, interpretation should be limited to understanding the influence of body weight on treatment benefit, rather than the benefit itself, which is addressed by the primary analysis in SOUL.3
Ozempic® pill has once-daily dosing6
More ways to help your patients with T2D
ACE=angiotensin-converting enzyme; ARR=absolute risk reduction; CAD=coronary artery disease; CeVD=cerebrovascular disease; CI=confidence interval; CKD=chronic kidney disease; CT=computed tomography; CV=cardiovascular; CVD=cardiovascular disease; CVOT=cardiovascular outcomes trial; DPP-4=dipeptidyl peptidase-4; eGFR=estimated glomerular filtration rate; MACE=major adverse cardiovascular event; MI=myocardial infarction; NNT=number needed to treat; PAD=peripheral artery disease; RRR=relative risk reduction; SGLT-2=sodium-glucose co-transporter-2; SOC=standard of care; T2D=type 2 diabetes.
Important Safety Information for Ozempic®
WARNING: RISK OF THYROID C-CELL TUMORS
- In rodents, semaglutide causes dose-dependent and treatment-duration- dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Ozempic® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined
- 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). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Ozempic®
Contraindications
- Ozempic® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in Ozempic®. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Ozempic®
Warnings and Precautions
- Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging
- Acute Pancreatitis: Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide. Observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), with or without nausea or vomiting. If pancreatitis is suspected, discontinue Ozempic® and initiate appropriate management
- Diabetic Retinopathy Complications: In a 2-year trial involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with Ozempic® injection (3%) compared to placebo (1.8%). In a pooled analysis of glycemic control trials, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with semaglutide tablets and 3.8% with comparator). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline than among patients without a known history.
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy - Never Share an Ozempic® Pen Between Patients: Ozempic® pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens
- Hypoglycemia: Patients receiving Ozempic® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia
- Acute Kidney Injury Due to Volume Depletion: There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide. The majority of reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Ozempic® that could lead to volume depletion, especially during dosage initiation and escalation
- Severe Gastrointestinal (GI) Adverse Reactions: Use of Ozempic® has been associated with GI adverse reactions, sometimes severe. In clinical trials, severe GI adverse reactions were reported more frequently among patients who received Ozempic® injection (0.5 mg 0.4%, 1 mg 0.8%) than placebo (0%); and severe GI adverse reactions were reported more frequently among patients who received semaglutide tablets (7 mg 0.6%, 14 mg 2%) than placebo (0.3%). Severe GI adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. Ozempic® is not recommended in patients with severe gastroparesis
- Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with Ozempic®. If hypersensitivity reactions occur, discontinue use of Ozempic®; treat promptly per standard of care, and monitor until signs and symptoms resolve. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist
- Acute Gallbladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients treated with Ozempic® injection 0.5 mg and 1 mg, respectively, and not reported in placebo-treated patients. In placebo-controlled trials to improve glycemic control, cholelithiasis was reported in 1% of patients treated with semaglutide tablets 7 mg. In a 4-year CV outcomes trial (Trial 7), cholelithiasis was reported in 1.1% of patients treated with semaglutide tablets 14 mg and in 0.9% of placebo-treated patients. In Trial 7, cholecystitis was reported in 1.1% treated with semaglutide tablets 14 mg and in 0.7% of placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated
- Pulmonary Aspiration During General Anesthesia or Deep Sedation: Ozempic® delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Ozempic®
Adverse Reactions
- The most common adverse reactions reported in ≥5% of patients taking Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation. Decreased appetite was also reported in ≥5% of patients taking semaglutide tablets
Drug Interactions
- When initiating Ozempic®, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia
- Ozempic® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Monitor the effects of oral medications concomitantly administered with Ozempic®. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring
Use in Specific Populations
- Pregnancy: Available data with semaglutide use in pregnant women are not sufficient to determine a drug associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Discontinue Ozempic® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide
- Lactation: A clinical lactation study reported semaglutide concentrations below the lower limit of quantification in human breast milk. However, salcaprozate sodium (SNAC) and/or its metabolites are present in human milk. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC, an absorption enhancer for Ozempic® tablets, and because there are alternative formulations of semaglutide that do not contain SNAC that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with Ozempic® tablets
Please click here for Ozempic® injection Prescribing Information, including Boxed Warning.
Please click here for Ozempic® tablets Prescribing Information, including Boxed Warning.
Indications and Usage
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg and Ozempic® (semaglutide) tablets 4 mg or 9 mg are indicated:
- as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Ozempic® injection is indicated:
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes and established CV disease
- to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease
Ozempic® tablets are indicated:
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes who are at high risk for these events
Important Safety Information for Ozempic®
WARNING: RISK OF THYROID C-CELL TUMORS
- In rodents, semaglutide causes dose-dependent and treatment-duration- dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Ozempic® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined
- 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). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Ozempic®
Important Safety Information for Ozempic®
WARNING: RISK OF THYROID C-CELL TUMORS
- In rodents, semaglutide causes dose-dependent and treatment-duration- dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Ozempic® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined
- 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). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Ozempic®
Contraindications
- Ozempic® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in Ozempic®. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Ozempic®
Warnings and Precautions
- Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging
- Acute Pancreatitis: Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide. Observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), with or without nausea or vomiting. If pancreatitis is suspected, discontinue Ozempic® and initiate appropriate management
- Diabetic Retinopathy Complications: In a 2-year trial involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with Ozempic® injection (3%) compared to placebo (1.8%). In a pooled analysis of glycemic control trials, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with semaglutide tablets and 3.8% with comparator). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline than among patients without a known history.
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy - Never Share an Ozempic® Pen Between Patients: Ozempic® pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens
- Hypoglycemia: Patients receiving Ozempic® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia
- Acute Kidney Injury Due to Volume Depletion: There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide. The majority of reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Ozempic® that could lead to volume depletion, especially during dosage initiation and escalation
- Severe Gastrointestinal (GI) Adverse Reactions: Use of Ozempic® has been associated with GI adverse reactions, sometimes severe. In clinical trials, severe GI adverse reactions were reported more frequently among patients who received Ozempic® injection (0.5 mg 0.4%, 1 mg 0.8%) than placebo (0%); and severe GI adverse reactions were reported more frequently among patients who received semaglutide tablets (7 mg 0.6%, 14 mg 2%) than placebo (0.3%). Severe GI adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. Ozempic® is not recommended in patients with severe gastroparesis
- Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with Ozempic®. If hypersensitivity reactions occur, discontinue use of Ozempic®; treat promptly per standard of care, and monitor until signs and symptoms resolve. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist
- Acute Gallbladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients treated with Ozempic® injection 0.5 mg and 1 mg, respectively, and not reported in placebo-treated patients. In placebo-controlled trials to improve glycemic control, cholelithiasis was reported in 1% of patients treated with semaglutide tablets 7 mg. In a 4-year CV outcomes trial (Trial 7), cholelithiasis was reported in 1.1% of patients treated with semaglutide tablets 14 mg and in 0.9% of placebo-treated patients. In Trial 7, cholecystitis was reported in 1.1% treated with semaglutide tablets 14 mg and in 0.7% of placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated
- Pulmonary Aspiration During General Anesthesia or Deep Sedation: Ozempic® delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Ozempic®
Adverse Reactions
- The most common adverse reactions reported in ≥5% of patients taking Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation. Decreased appetite was also reported in ≥5% of patients taking semaglutide tablets
Drug Interactions
- When initiating Ozempic®, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia
- Ozempic® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Monitor the effects of oral medications concomitantly administered with Ozempic®. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring
Use in Specific Populations
- Pregnancy: Available data with semaglutide use in pregnant women are not sufficient to determine a drug associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Discontinue Ozempic® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide
- Lactation: A clinical lactation study reported semaglutide concentrations below the lower limit of quantification in human breast milk. However, salcaprozate sodium (SNAC) and/or its metabolites are present in human milk. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC, an absorption enhancer for Ozempic® tablets, and because there are alternative formulations of semaglutide that do not contain SNAC that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with Ozempic® tablets
Please click here for Ozempic® injection Prescribing Information, including Boxed Warning.
Please click here for Ozempic® tablets Prescribing Information, including Boxed Warning.
Indications and Usage
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg and Ozempic® (semaglutide) tablets 4 mg or 9 mg are indicated:
- as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Ozempic® injection is indicated:
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes and established CV disease
- to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease
Ozempic® tablets are indicated:
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes who are at high risk for these events
References:
- Ozempic® injection [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- Marso SP, Bain SC, Consoli A, et al; SUSTAIN-6 Investigators. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375(19):1834-1844. doi:10.1056/NEJMoa1607141
- Data on file. Novo Nordisk Inc; Plainsboro, NJ.
- Marso SP, Bain SC, Consoli A, et al; SUSTAIN-6 Investigators. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. Supplementary appendix. N Engl J Med. 2016;375(19):1834-1844. doi:10.1056/NEJMoa1607141
- Das SR, Everett BM, Birtcher KK, et al. 2020 Expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2020;76(9):1117-1145. doi:10.1016/j.jacc.2020.05.037
- Navas A, Noone J, Laney N, et al. Semaglutide and cardiovascular outcomes in people with type 2 diabetes: a SUSTAIN-6 post hoc analysis by weight loss category. Diabetes Ther. 2026;17(6):897-910. doi:10.1007/s13300-026-01875-3
- Ozempic® tablets [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- McGuire DK, Marx N, Mulvagh SL, et al; SOUL Study Group. Oral semaglutide and cardiovascular outcomes in high-risk type 2 diabetes. N Engl J Med. 2025;392(20):2001-2012. doi:10.1056/NEJMoa2501006
- Nielsen MS, Brøndsted L, Kankam M, et al. A bioequivalence study of two formulations of oral semaglutide in healthy participants. Diabetes Ther. 2025;16(2):269-287. doi:10.1007/s13300-024-01674-8
- Blumenthal RS, Morris PB, Gaudino M, et al; Peer Review Committee Members. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. Published online March 13, 2026. doi: 10.1016/j.jacc.2025.11.016
- McGuire DK, Marx N, Mulvagh SL, et al; SOUL Study Group. Oral semaglutide and cardiovascular outcomes in high-risk type 2 diabetes. Supplementary appendix. N Engl J Med. 2025;392(20):2001-2012. doi:10.1056/NEJMoa2501006