Background Romosozumab, a potent anabolic agent for osteoporosis, has been associated with an increased risk of adjudicated cardiovascular events compared with alendronate in postmenopausal women, although such an association was not observed in a placebo-controlled trial. Evidence from real-world clinical practice remains limited.
Methods In this multicenter observational study, we analyzed patients aged ≥50 years who were newly prescribed romosozumab 120 mg monthly or denosumab 60 mg every 6 months for osteoporosis at three tertiary hospitals in South Korea between January 1, 2020, and the end of each site’s data collection period. The primary outcomes were major adverse cardiovascular events (MACE; acute myocardial infarction, ischemic stroke, or sudden cardiac death) and all cardiovascular adverse events (CVAEs; MACE, heart failure, peripheral artery disease, and non-coronary revascularization), assessed at 1- and 3-year follow-up. Large-scale 1:1 propensity score matching and Cox proportional hazards models were applied within a common data model framework with individual-level meta-analysis.
Results A total of 4,896 patients were included in the MACE analysis (4,758 in the CVAE analysis). At 1 year, the incidence rate of MACE did not differ significantly between the romosozumab and denosumab groups (9.20 per 1,000 person-years vs. 6.43 per 1,000 person-years; adjusted hazard ratio [aHR], 1.42; 95% confidence interval [CI], 0.64 to 3.19). The risk of CVAE was also similar between groups (16.23 per 1,000 person-years vs. 15.45 per 1,000 person-years; aHR, 1.05; 95% CI, 0.62 to 1.78). At 3 years, no significant differences were observed for MACE (aHR, 1.51; 95% CI, 0.79 to 2.88) or CVAE (aHR, 1.04; 95% CI, 0.69 to 1.58).
Conclusion In real-world clinical practice, romosozumab use was not associated with a statistically significant increase in cardiovascular risk compared with denosumab.
Mineral, bone & muscle Big Data Articles (National Health Insurance Service Database)
Background Osteoporosis is a global health concern. Despite emerging treatment options for this condition, limited data are available on hospital practices in South Korea. This study addresses the need for a hospital network database that reflects changes in routine clinical practice for osteoporosis in a timely manner.
Methods We analyzed prescription patterns for anti-osteoporosis medications (AOMs) in postmenopausal women aged ≥50 years diagnosed with osteoporosis between 2012 and 2021 using data from Osteoporosis Analysis and Surveillance Initiative using Standardized data (OASIS) (four tertiary hospitals in South Korea) and a nationwide database from the Health Insurance Review and Assessment (HIRA) Service. AOMs were categorized into antiresorptive and anabolic agents, with a focus on secular changes in the use of oral bisphosphonates, denosumab, selective estrogen receptor modulators (SERMs), and anabolic agents.
Results In the OASIS cohort, oral bisphosphonates were the most prescribed first-line AOM (49.0%), followed by denosumab (15.7%) and SERMs (18.0%). Denosumab use increased from 2% in 2016 to 40% in 2020, while oral bisphosphonate use declined from 69% in 2012 to 22% in 2021. The use of anabolic agents, including romosozumab and teriparatide, doubled to 6% after 2019. In the HIRA cohort, parenteral bisphosphonates were most common (54.3%), with significant denosumab use (17.3%).
Conclusion Pronounced shifts in AOM prescription patterns were observed in South Korea, marked by a notable increase in denosumab prescriptions and a decline in bisphosphonate use. These trends highlight the impact of policy changes and clinical guidelines on osteoporosis treatment and may inform future management strategies.
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Comparison of the Efficacy of Denosumab and Alendronate in Improving Bone Mineral Density in Osteoporosis Patients and High-Risk Populations: A Systematic Review and Meta-Analysis Kejia Zhu, Hang Li, Hui Zhang, Zongke Zhou, Bin Shen, Yong Nie Clinical Drug Investigation.2026; 46(3): 243. CrossRef
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Thyroid Big Data Articles (National Health Insurance Service Database)
Jung A Kim, Kyeong Jin Kim, Jimi Choi, Kyoung Jin Kim, Eyun Song, Ji Hee Yu, Nam Hoon Kim, Hye Jin Yoo, Ji A Seo, Nan Hee Kim, Kyung Mook Choi, Sei Hyun Baik, Sin Gon Kim
Endocrinol Metab. 2025;40(1):125-134. Published online January 13, 2025
Background Antithyroid drug (ATD) treatment is the preferred initial treatment for Graves’ disease (GD) in South Korea, despite higher treatment failure rates than radioactive iodine (RAI) therapy or thyroidectomy. This study aimed to evaluate the incidence of treatment failure associated with the primary modalities for GD treatment in real-world practice.
Methods We included 452,001 patients diagnosed with GD between 2004 and 2020 from the Korean National Health Insurance Service-National Health Information Database. Treatment failure was defined as switching from ATD, RAI, or thyroidectomy treatments, and for ATD specifically, inability to discontinue medication for over 2 years.
Results Mean age was 46.2 years, with females constituting 70.8%. Initial treatments for GD included ATDs (98.0%), thyroidectomy (1.3%), and RAI (0.7%), with a noted increment in ATD application from 96.2% in 2004 to 98.8% in 2020. During a median follow- up of 8.5 years, the treatment failure rates were 58.5% for ATDs, 21.3% for RAI, and 2.1% for thyroidectomy. Multivariate analysis indicated that the hazard ratio for treatment failure with ATD was 2.81 times higher than RAI. RAI treatments ≥10 mCi had 37% lower failure rates than doses <10 mCi.
Conclusion ATDs are the most commonly used for GD in South Korea, followed by thyroidectomy and RAI. Although the risk of treatment failure for ATD is higher than that of RAI therapy, initial RAI treatment in South Korea is relatively limited compared to that in Western countries. Further studies are required to evaluate the cause of low initial RAI treatment rates in South Korea.
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Treatment patterns and preferences for patients with Graves’ disease (GD) vary across countries. In this study, we assessed the initial therapies and subsequent treatment modalities employed for GD in real-world clinical practice in Korea. We analyzed 452,001 patients with GD from 2004 to 2020, obtained from the Korean National Health Insurance Service database. Initial treatments included antithyroid drug (ATD) therapy (98% of cases), thyroidectomy (1.3%), and radioactive iodine (RAI) therapy (0.7%). The rates of initial treatment failure were 58.5% for ATDs, 21.3% for RAI, and 2.1% for thyroidectomy. Even among cases of ATD treatment failure or recurrence, the rates of RAI therapy remained low. Regarding initial treatment, the 5-year remission rate was 46.8% among patients administered ATDs versus 91.0% among recipients of RAI therapy; at 10 years, these rates were 59.2% and 94.0%, respectively. Our findings highlight a marked disparity in the use of RAI therapy in Korea compared to Western countries. Further research is required to understand the reasons for these differences in treatment patterns.
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Original Article
Mineral, Bone & Muscle Big Data Articles (National Health Insurance Service Database)
Background Acromegaly leads to various skeletal complications, and fragility fractures are emerging as a new concern in patients with acromegaly. Therefore, this study investigated the risk of fractures in Korean patients with acromegaly.
Methods We used the Korean nationwide claims database from 2009 to 2019. A total of 931 patients with acromegaly who had never used an osteoporosis drug before and were treated with surgery alone were selected as study participants, and a 1:29 ratio of 26,999 age- and sex-matched osteoporosis drug-naïve controls without acromegaly were randomly selected from the database.
Results The mean age was 46.2 years, and 50.0% were male. During a median follow-up of 54.1 months, there was no difference in the risks of all, vertebral, and non-vertebral fractures between the acromegaly and control groups. However, hip fracture risk was significantly higher (hazard ratio [HR], 2.73; 95% confidence interval [CI], 1.32 to 5.65), and non-hip and non-vertebral fractures risk was significantly lower (HR, 0.40; 95% CI, 0.17 to 0.98) in patients with acromegaly than in controls; these results remained robust even after adjustment for socioeconomic status and baseline comorbidities. Age, type 2 diabetes mellitus, cardio-cerebrovascular disease, fracture history, recent use of acid-suppressant medication, psychotropic medication, and opioids were risk factors for all fractures in patients with acromegaly (all P<0.05).
Conclusion Compared with controls, patients surgically treated for acromegaly had a higher risk of hip fractures. The risk factors for fracture in patients with acromegaly were consistent with widely accepted risk factors in the general population.
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Lifestyle is a critical aspect of diabetes management. We aimed to define a healthy lifestyle using objectively measured parameters obtained from a wearable activity tracker (Fitbit) in patients with type 2 diabetes. This prospective observational study included 24 patients (mean age, 46.8 years) with type 2 diabetes. Expectation–maximization clustering analysis produced two groups: A (n=9) and B (n=15). Group A had a higher daily step count, lower resting heart rate, longer sleep duration, and lower mean time differences in going to sleep and waking up than group B. A Shapley additive explanation summary analysis indicated that sleep-related factors were key elements for clustering. The mean hemoglobin A1c level was 0.3 percentage points lower at the end of follow-up in group A than in group B. Factors related to regular sleep patterns could be possible determinants of lifestyle clustering in patients with type 2 diabetes.
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Original Articles
Diabetes, Obesity and Metabolism Big Data Articles (National Health Insurance Service Database)
Background There are differences in risk and risk factor findings of postpartum type 2 diabetes mellitus (T2DM) after gestational diabetes depending on study design and subjects of previous studies. This study aimed to assess these risk and risk factors more accurately through a population-based study to provide basic data for prevention strategies.
Methods This open retrospective cohort included data of 419,101 women with gestational diabetes and matched 1,228,802 control women who delivered between 2004 and 2016 from the South Korea National Health Information Database of the National Health Insurance Service. Following 14 (median 5.9) years of follow-up, the incidence and hazard ratio (HR) of postpartum T2DM were evaluated using Kaplan-Meier curves and Cox proportional regression models.
Results The incidence and HR of postpartum T2DM in women with gestational diabetes (compared to women without gestational diabetes) after the 14-year follow-up was 21.3% and 2.78 (95% confidence interval [CI], 2.74 to 2.82), respectively. Comorbid obesity (body mass index [BMI] ≥25 kg/m2) increased postpartum T2DM risk 7.59 times (95% CI, 7.33 to 7.86). Significant risk factors for postpartum T2DM were fasting glucose level, BMI, age, family history of diabetes, hypertension, and insulin use during pregnancy.
Conclusion This population-based study showed higher postpartum T2DM risk in women with gestational diabetes than in those without, which was further increased by comorbid obesity. BMI and fasting glucose level were important postpartum risk factors. The management of obesity and glycemic control may be important strategies to prevent the incidence of diabetes after delivery.
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Background We investigated how 100-g oral glucose tolerance test (OGTT) results can be used to predict adverse pregnancy outcomes in gestational diabetes mellitus (GDM) patients.
Methods We analyzed 1,059 pregnant women who completed the 100-g OGTT between 24 and 28 weeks of gestation. We compared the risk of adverse pregnancy outcomes according to OGTT patterns by latent profile analysis (LPA), numbers to meet the OGTT criteria, and area under the curve (AUC) of the OGTT graph. Adverse pregnancy outcomes were defined as a composite of preterm birth, macrosomia, large for gestational age, low APGAR score at 1 minute, and pregnancy-induced hypertension.
Results Overall, 257 participants were diagnosed with GDM, with a median age of 34 years. An LPA led to three different clusters of OGTT patterns; however, there were no significant associations between the clusters and adverse pregnancy outcomes after adjusting for confounders. Notwithstanding, the risk of adverse pregnancy outcome increased with an increase in number to meet the OGTT criteria (P for trend=0.011); odds ratios in a full adjustment model were 1.27 (95% confidence interval [CI], 0.72 to 2.23), 2.16 (95% CI, 1.21 to 3.85), and 2.32 (95% CI, 0.66 to 8.15) in those meeting the 2, 3, and 4 criteria, respectively. The AUCs of the OGTT curves also distinguished the patients at risk of adverse pregnancy outcomes; the larger the AUC, the higher the risk (P for trend=0.007).
Conclusion The total number of abnormal values and calculated AUCs for the 100-g OGTT may facilitate tailored management of patients with GDM by predicting adverse pregnancy outcomes.
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