Prevalence and Overlap of Cardiovascular, Kidney, and Metabolic Diseases in Korea: A Population-based Study

Обзор

This study tests the prevalence and characteristics of overlapping obesity, type 2 diabetes (T2D), cardiovascular disease (CVD), chronic kidney disease (CKD), and metabolic dysfunction-associated steatotic liver disease \[MASLD/Metabolic Dysfunction-Associated Steatohepatitis (MASH)\], osteoarthritis, hypertension, and dyslipidemia. The purpose of the study is to measure how common cardiovascular, kidney, and metabolic diseases are in the Korean adult population and how often they occur together (overlap) over time (2013-2023). Participants will not receive any study medicine as this is an observational analysis of existing survey data. The study does not involve a new investigational drug; it analyses health and outcome data collected in routine practice and national surveys.

Вмешательства

• Другое No treatment given
  No treatment given

Первичные конечные точки

• Proportion of participants with obesity (BMI ≥25 kilograms per square meter (kg/m^2)) [Срок оценки: 2013-2018 (Annually)]
• Proportion of participants with T2D [Срок оценки: 2013-2018 (Annually)]
• Proportion of participants with hypertension [Срок оценки: 2013-2018 (Annually)]
• Proportion of participants with dyslipidemia [Срок оценки: 2013-2018 (Annually)]
• Proportion of participants with CVD (ASCVD, HF with atrial fibrillation, HF without atrial fibrillation) [Срок оценки: 2013-2018 (Annually)]
• Proportion of participants with CKD [Срок оценки: 2013-2018 (Annually)]
• Proportion of participants with MASLD; at-risk Metabolic Dysfunction-Associated Steatohepatitis (MASH)(within MASLD) [Срок оценки: 2013-2018 (Annually)]
• Proportion of participants with Osteoarthritis (OA) [Срок оценки: 2013-2018 (Annually)]
• Multi-disease overlap (≥2, ≥3 conditions) [Срок оценки: 2013-2018 (Annually)]
• Patient characteristics in obesity/diabetes-anchored strata [Срок оценки: 2013-2018 (Annually)]

Вторичные конечные точки (11)

• Baseline characteristics by subgroup cohort [Срок оценки: Cohort index date (2013-2018)]
• All-cause mortality over cohort follow-up [Срок оценки: From cohort index date (entry restricted to 2013-2018; ≥5 yr potential follow up (FU))]
• Healthcare resource utilization (HCRU) over cohort follow-up (Number of participants) [Срок оценки: From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU)]
• Healthcare resource utilization (HCRU) over cohort follow-up (rates per person-year) [Срок оценки: From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU)]
• Total medical costs over cohort follow-up (Mean) [Срок оценки: From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU)]
• Total medical costs over cohort follow-up (Median) [Срок оценки: From cohort index date (entry restricted to 2013-2018; ≥5 yr potential FU)]
• Three-point major adverse cardiovascular events (3P-MACE) composite assessment for CV-death proxy, non-fatal myocardial infarction, and non-fatal stroke [Срок оценки: From cohort index date (entry restricted to 2013-2018; ≥5 yr potential (FU)]
• Proportion of participants with baseline organ-axis phenotype distribution (HF cohort): ASCVD, renal, metabolic, hepatic axes [Срок оценки: Cohort index date (2013-2018)]
• Proportion of participants with GDMT prescription patterns, calendar-year trends, and prescription disparities (HF cohort) [Срок оценки: Over cohort follow-up (2013-2023)]
• Time to CKM stage progression (CKM stage cohort) [Срок оценки: From cohort index date (entry restricted to 2013-2018; ≥5 years potential FU) to date of Progression]
• Time to tier change (High obesity cohort) [Срок оценки: From cohort index date (entry restricted to 2013-2018; ≥5 years potential FU) to tier change]

Критерии участия

Критерии включения

• For an eligible participant, all inclusion criteria must be answered "yes".

Primary Analysis:

• Enrolled in the Korean National Health Insurance Service (NHIS) with valid insurance eligibility during the assessment year.
• Adults aged 19 years or older at the index date (January 1 of each assessment year, annually from 2013 to 2023).

Secondary Analysis (Subgroup Cohorts):

• Enrolled in the Korean National Health Insurance Service (NHIS) with valid insurance eligibility during the cohort entry year.
• Adults aged 19 years or older at the cohort entry date (i.e., the index date defined per the relevant subgroup cohort in) (per the SAP).
• Meets the operational definition of the index disease or state for one of the four pre-specified subgroup cohorts (MASLD, HF, CKM stage, or High obesity) (per the SAP).

Критерии исключения

• For an eligible participant, all exclusion criteria must be answered "no".

Primary Analysis:

• Individuals with missing age or sex information in the NHIS database.
• Individuals with less than 1 year of continuous enrollment prior to the index date (to ensure adequate lookback period for disease identification).

Secondary Analysis (Subgroup Cohorts)

• Individuals with missing age or sex information in the NHIS database.
• Individuals with less than 1 year of continuous NHIS enrollment prior to the cohort entry date (to ensure adequate washout for incident-case ascertainment).
• Individuals with prior record of respective disease within the 1-year lookback window

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Novo Nordisk Pharma Korea, Ltd. — Seoul

Идентификаторы

NCT: NCT07673822 · DAS-8867 · U1111-1337-3930

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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