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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1318-9978 | Other Identifier | World Health Organization (WHO) |
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This is a retrospective database study which includes administrative medical and pharmacy claims linked with clinical and laboratory measurements for patients in the US, to evaluate the effectiveness of once-weekly semaglutide 2.4 mg in reducing the risk of CV and other obesity-related clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort: Semaglutide Users | Participants age above or equal to (≥) 45 years with overweight or obesity and established ASCVD who initiated semaglutide 2.4 mg (semaglutide 2.4 mg users). |
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| Cohort: Semaglutide Non-users | Participants age above or equal to (≥) 45 years with overweight or obesity and established ASCVD who are semaglutide 2.4 mg non-users. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | No treatment given |
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| Measure | Description | Time Frame |
|---|---|---|
| Revised 5-Point Major Adverse Cardiovascular Events (MACE-5) (time-to-event) | Measured as months Occurrence of any of the following individual component events:
| Index date, earliest of revised MACE-5 and end of follow-up, up to 30 months |
| Revised 3-Point Major Adverse Cardiovascular Events (MACE-3) (time-to-event) | Measured as months Occurrence of any of the following individual component events:
| Index date, earliest of revised MACE-3 and end of follow-up, up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| MI (time-to-event) | Measured as months Participants who were diagnosed of MI (identified using International Classification of Disease, 10th Edition, Clinical Modification [ICD-10-CM] diagnosis codes) observed during an inpatient (IP) visit. The event date will be admission date of the IP visit. | Index date, earliest of MI and end of follow-up, up to 30 months |
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Inclusion Criteria:
Exclusion criteria:
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Adult participants, age above or equal to 45 years with overweight or obesity and established ASCVD will be included in the study. The eligibility date will be defined as the latest of the following dates: first overweight/ obesity ascertainment, first ASCVD diagnosis, and date participant reached age 45. Then, these participants will be divided into those who initiated semaglutide 2.4 mg (semaglutide 2.4 mg users) and those who did not (non-users).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Plainsboro | New Jersey | 08536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40926360 | Derived | Smolderen KG, Mena-Hurtado C, Zhao Z, Michalak W, Faurby M, Smolarz BG, Kosiborod MN, Song J, Chen Y, Boland J, Nanna MG. Lower risk of cardiovascular events in patients initiated on semaglutide 2.4 mg in the real-world: Results from the SCORE study (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity in the Real World). Diabetes Obes Metab. 2025 Nov;27(11):6691-6704. doi: 10.1111/dom.70080. Epub 2025 Sep 9. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| No treatment given |
| Other |
No treatment given |
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| Stroke (time-to-event) | Measured as months Participants who were diagnosed of stroke, including both ischemic and hemorrhagic, (identified using ICD-10- CM diagnosis codes) which was observed during an IP visit. The event date will be the admission date of the IP visit. | Index date, earliest of stroke and end of follow-up, up to 30 months |
| Hospitalization for HF (time-to-event) | Measured as months Participants who were diagnosed of HF (identified using ICD-10-CM diagnosis codes) observed during an IP visit. The event date will be the first observed admission date of the IP visit. | Index date, earliest of hospitalization for HF and end of follow up, up to 30 months |
| Coronary revascularization (time-to-event) | Measured as months Participants with evidence of coronary revascularization in any claim (identified using ICD-10-PCS, Current Procedural Terminology [CPT], or Healthcare Common Procedure Coding System [HCPCS] procedure codes). The event date will be the first observed date of coronary revascularization. | Index date, earliest of hospitalization for Coronary revascularization and end of follow up, up to 30 months |
| All-cause mortality (time-to-event) | Measured as months Participants with evidence of death as recorded at the month and year level in KRD and defined as a death record observed within the last month of follow-up. The event date will be the earliest of the end of follow-up (e.g., bariatric surgery within the month of death and last month of follow-up) or the last day of the recorded month of death. | Index date, end of follow up, up to 30 months |
| MACE-5 | Measured as months Occurrence of any of the following individual component events:
| Index date, earliest of MACE-5 and end of follow-up, up to 30 months |
| MACE-3 | Measured as months Occurrence of any of the following individual component events:
| Index date, earliest of MACE-3 and end of follow-up, up to 30 months |
| CV-related mortality (time-to-event) | Measured as months Partcipants with any claim within ≤30 days before the date of death (i.e., the last day of the recorded month of death, where death is observed in the last month of follow-up) of the following operational definition to indicate a CV-related mortality (identified using ICD-10-CM diagnosis codes): (1) A primary diagnosis of MI (2) A primary diagnosis of ischemic or hemorrhagic stroke (3) A primary diagnosis of HF (4) Evidence of peripheral arterial revascularization, coronary revascularization, CABG, PCI, or carotid intervention in any claim (identified using ICD-10-PCS, CPT, or HCPCS procedure codes). (5) A primary diagnosis of CV hemorrhage (excluding hemorrhagic stroke) (6) A primary diagnosis of other CV conditions including unstable angina, sudden cardiac arrest, cardiogenic shock, and other cerebrovascular and CV events. The event date will be the earliest of the end of follow-up (e.g., bariatric surgery within the month of death) or the date of death. | Index date, earliest of MACE-3 and end of follow-up, up to 30 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |