{"title":"A comprehensive investigation of the relationship between dietary fatty acid intake and preserved ratio impaired spirometry: multimethodology based on NHANES.","authors":"Chenyuan Deng, Yu Jiang, Yuechun Lin, Hengrui Liang, Wei Wang, Jianxing He, Ying Huang","doi":"10.1186/s12944-025-02674-8","DOIUrl":"https://doi.org/10.1186/s12944-025-02674-8","url":null,"abstract":"<p><strong>Background: </strong>Preserved ratio impaired spirometry (PRISm) has been identified as a potential precursor to chronic obstructive pulmonary disease (COPD) and demonstrates a significant correlation with unfavorable clinical outcomes. Modification of PRISm-related risk factors is a higher priority in public health than treating PRISm itself. Dietary fatty acids (FAs) affect human health through a variety of physiological pathways. However, no prior research has investigated the associations of FAs and their subclasses with PRISm, particularly the combined effects of different types of FAs.</p><p><strong>Methods: </strong>Data analysis was conducted on 8,836 individuals drawn from the NHANES dataset spanning the years 2007 to 2012. Logistic regression and smooth curve fitting were first used to assess relationships of individual FA intake with PRISm. Multiple comparisons were adjusted using the Benjamini-Hochberg (BH) correction. Threshold effect analysis was conducted to explore potential nonlinear associations. Subsequently, innovative implementation of the principal component analysis (PCA), Weighted Quantile Sum (WQS) regression, and Bayesian Kernel Machine Regression (BKMR) approaches were employed to assess the joint impact of the various intake of FAs, as well as total saturated, monounsaturated, and polyunsaturated FAs on PRISm. To facilitate the prediction of PRISm, six distinct machine learning algorithms were constructed, followed by the application of SHAP analysis to elucidate the contribution of individual predictors. For improved clinical utility, the most effective model was further implemented as an online tool.</p><p><strong>Results: </strong>The weighted prevalence of PRISm observed in this study was 8.81%. The results from the single-exposure models demonstrated that most FAs were negatively associated with PRISm, and these associations remained significant after BH correction. In all three models, saturated FAs revealed impressive protective associations with PRISm. LightGBM was identified as the most effective machine learning model. Among all variables, race was the most influential factor and butyric acid (SFA 4:0) was identified as the most critical FA subclass.</p><p><strong>Conclusions: </strong>Adequate dietary intake of FAs may reduce the prevalence of PRISm. Furthermore, an interactive Web-based application enables healthcare professionals to estimate individuals' odds of having PRISm and to design personalized dietary interventions based on their specific needs.</p>","PeriodicalId":18073,"journal":{"name":"Lipids in Health and Disease","volume":"24 1","pages":"258"},"PeriodicalIF":3.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Vitamin D immune modulation of the anti-inflammatory effects of HDL-associated proteins.","authors":"Hanaa Mousa, Susu M Zughaier","doi":"10.1186/s12944-025-02639-x","DOIUrl":"10.1186/s12944-025-02639-x","url":null,"abstract":"<p><p>Vitamin D is a crucial element in bone metabolism and plays a role in innate immunity and inflammation suppression. Deficiency in this vitamin leads to disturbances in many biological functions, including the lipid profile. The decrease in HDL levels is associated with disruptions in its function and dynamic modifications in its components, such as apolipoproteins, including ApoM, ApoA-1, and ApoD. Consequently, the anti-inflammatory potential of HDL and HDL-associated proteins is reduced, resulting in heightened inflammation. However, the relationship between modifications in lipid profile, apolipoproteins, inflammation, and vitamin D remains unclear. This review highlights the connection between vitamin D status and its possible effects on the lipid profile, specifically HDL-associated proteins.</p>","PeriodicalId":18073,"journal":{"name":"Lipids in Health and Disease","volume":"24 1","pages":"257"},"PeriodicalIF":3.9,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12315321/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144760485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Roshan Javanshad, Wenping Li, Koralege C Pathmasiri, Stephanie M Cologna
{"title":"Advances in mass spectrometry of lipids for the investigation of Niemann-pick type C disease.","authors":"Roshan Javanshad, Wenping Li, Koralege C Pathmasiri, Stephanie M Cologna","doi":"10.1186/s12944-025-02675-7","DOIUrl":"10.1186/s12944-025-02675-7","url":null,"abstract":"<p><p>Niemann-Pick type C (NPC) disease is a devastating, fatal, neurodegenerative disease and a form of lysosomal storage disorder. It is caused by mutations in either NPC1 or NPC2 genes, leading to the accumulation of cholesterol and other lipids in the late endosome/lysosome system, a hallmark of the disease. Due to aberrant lipid trafficking in NPC, various techniques have been employed to study cholesterol and lipid dysregulation. Among them, mass spectrometry (MS)-based lipidomics has emerged as a state-of-the-art approach, providing valuable insights into disease pathophysiology, progression, and therapeutic target development. This review highlights the MS instruments used for lipidomics studies and discusses lipid biomarkers identified using MS in the context of NPC disease. Furthermore, integrating lipidomics with other -omics approaches, and leveraging the power of artificial intelligence, should be prioritized in future studies to holistically understand NPC disease.</p>","PeriodicalId":18073,"journal":{"name":"Lipids in Health and Disease","volume":"24 1","pages":"254"},"PeriodicalIF":3.9,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12308988/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144753734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jiaxiu Zhao, Xueying Ji, Yixin Chen, Jiaofeng Wang, Jie Chen, Yiqin Huang, Zhijun Bao
{"title":"Associations of the Neutrophil-to-Lymphocyte Ratio(NLR), Triglyceride-Glucose Index (TyG), and TyG-derived indices with vitality decline in older adults in China: a study within the Integrated Care for Older People (ICOPE) framework.","authors":"Jiaxiu Zhao, Xueying Ji, Yixin Chen, Jiaofeng Wang, Jie Chen, Yiqin Huang, Zhijun Bao","doi":"10.1186/s12944-025-02671-x","DOIUrl":"10.1186/s12944-025-02671-x","url":null,"abstract":"<p><strong>Background/objectives: </strong>Aging populations have led to numerous health challenges. The World Health Organization (WHO) proposed \"Healthy Aging\" to promote elderly health by optimizing Intrinsic Capacity (IC) with vitality as a core component of metabolic homeostasis. The relationships between vitality decline and inflammatory-metabolic indicators (the NLR and TyG index) remain to be investigated.</p><p><strong>Methods: </strong>This study recruited 986 community-dwelling adults ≥ 60 years old at the Beixingjing Street Community from March 25, 2024, to June 17, 2024, in Shanghai, China. Participants underwent comprehensive face‒to-face assessments with IC evaluations conducted according to the Integrated Care for Older People (ICOPE) guidelines. Vitality was evaluated using the Mini Nutritional Assessment-Short Form (MNA-SF). The study population was divided into two groups based on vitality decline (scores < 12). Multivariable logistic regression was used to analyze associations between vitality decline and other IC domains as well as between vitality decline and inflammatory (NLR) and metabolic indices (TyG, TyG-WC, TyG-BMI, and TyG-WHtR). Three logistic regression models constructed with progressive adjustments were used to assess associations between indices (NLR, TyG, TyG-WC, TyG-BMI, and TyG-WHtR) and vitality decline. Restricted cubic spline (RCS) analyses explored potential nonlinear relationships and threshold effects. Receiver Operating Characteristic (ROC) curve analysis was used to assess the discriminative capacity of different models.</p><p><strong>Results: </strong>The prevalence of vitality decline was 16.43%. Vitality decline was strongly associated with psychological and locomotor capacity decline in fully adjusted models (p < 0.05). An elevated NLR showed a significant association with greater vitality decline (OR = 1.233, p = 0.045). Participants in the highest NLR quartile (Q4) demonstrated significantly greater odds of vitality decline compared to those in the lowest quartile (Q1) (OR = 1.886, p = 0.043). Conversely, unit increases in TyG-derived indices demonstrated protective effects as follows: TyG-WC (OR = 0.988, p < 0.001), TyG-BMI (OR = 0.952, p < 0.001) and TyG-WHtR (OR = 0.120, p < 0.001). In contrast, TyG alone did not reach statistical significance (OR = 0.622, p = 0.078). The highest-quartile (Q4) participants presented a significantly lower risk of vitality decline than the lowest-quartile (Q1) participants as follows: TyG-WC (OR = 0.104, p < 0.001), TyG-BMI (OR = 0.052, p < 0.001), and TyG-WHtR (OR = 0.070, p < 0.001). Interaction terms between NLR, TyG and its indicators were analyzed in separate models and across quartiles. These terms did not show consistent significant associations with vitality decline. RCS analysis with vitality decline as the dependent variable identified threshold effects at TyG-WC = 794.358, TyG-BMI = 209.179, and TyG-WHtR = 4.476. The analysis revealed significant posi","PeriodicalId":18073,"journal":{"name":"Lipids in Health and Disease","volume":"24 1","pages":"256"},"PeriodicalIF":3.9,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12312603/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144753735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Intracellular cholesterol: new functions and therapeutic approaches in NSCLC EGFR-TKI resistance.","authors":"Linjuan Wang, Yue Qiu, Xiang Huang, Shimei Zhang, Min Zhao, Qiufang Chen","doi":"10.1186/s12944-025-02559-w","DOIUrl":"10.1186/s12944-025-02559-w","url":null,"abstract":"<p><p>Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have markedly enhanced survival rates among patients with advanced non-small cell lung cancer (NSCLC) exhibiting EGFR mutations. However, acquired resistance diminishes their therapeutic efficacy over time. Recent investigations have linked intracellular cholesterol with the emergence and advancement of various cancers. Elevated cholesterol levels could correlate with resistance to EGFR-TKIs in NSCLC. This review examines the association between cholesterol and EGFR-TKI resistance in NSCLC, with the objective of identifying more effective treatments and surmounting resistance.</p>","PeriodicalId":18073,"journal":{"name":"Lipids in Health and Disease","volume":"24 1","pages":"255"},"PeriodicalIF":3.9,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12312335/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144753736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zengxiao Zhang, Shunke Li, Shizhe Zhou, Lin Wang, Xudong Yan, Longgang Yu, Yan Jiang
{"title":"Peripheral blood metabolic profiles of chronic rhinosinusitis and their mediating role between obesity and disease.","authors":"Zengxiao Zhang, Shunke Li, Shizhe Zhou, Lin Wang, Xudong Yan, Longgang Yu, Yan Jiang","doi":"10.1186/s12944-025-02672-w","DOIUrl":"10.1186/s12944-025-02672-w","url":null,"abstract":"<p><strong>Background: </strong>Chronic rhinosinusitis (CRS) is increasingly linked to systemic inflammation, however, research on peripheral blood metabolic patterns in CRS patients remains limited. This study aimed to investigate peripheral blood metabolic profiles in eosinophilic CRS and non-eosinophilic CRS, while exploring the mediating role of metabolites in the relationship between body mass index and CRS.</p><p><strong>Methods: </strong>Clinical data were collected from 1,151 CRS patients and 814 healthy controls, classifying patients into eosinophilic CRS and non-eosinophilic CRS groups based on tissue eosinophil counts. Peripheral blood metabolic profiles were compared across different CRS endotypes and between CRS patients and healthy controls. Causal mediation analysis assessed the mediating effects of metabolites on the relationship between body mass index and CRS.</p><p><strong>Results: </strong>CRS patients exhibited distinct metabolic profiles, with dysregulated lipid metabolism characterized by increased triglycerides, free fatty acids, and lipoprotein(a), but patients with eosinophilic CRS had higher triglycerides, while non-eosinophilic CRS had higher free fatty acids. Cystatin-C effectively differentiated CRS endotypes (area under the curve = 0.735). Elevated body mass index was a risk factor for both eosinophilic CRS and non-eosinophilic CRS patients, with peripheral free fatty acids and Cystatin-C mediating this effect.</p><p><strong>Conclusions: </strong>This study reveals distinct metabolic profiles in patients with CRS, supporting its link to systemic inflammation. Promoting healthy dietary habits and weight control is therefore a cornerstone of sustainable, preventive care, offering a practical strategy to improve long-term patient well-being, particularly in refractory cases.</p>","PeriodicalId":18073,"journal":{"name":"Lipids in Health and Disease","volume":"24 1","pages":"251"},"PeriodicalIF":3.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12306000/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144732072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Asia Sikora Kessler, Seth J Baum, Emily Kutrieb, Montserrat Vera Llonch, Alex Lonshteyn, Derek Weycker, Daniel E Soffer
{"title":"Rates of acute pancreatitis and cardiovascular events among adults with severe or extreme hypertriglyceridemia in US clinical practice.","authors":"Asia Sikora Kessler, Seth J Baum, Emily Kutrieb, Montserrat Vera Llonch, Alex Lonshteyn, Derek Weycker, Daniel E Soffer","doi":"10.1186/s12944-025-02658-8","DOIUrl":"10.1186/s12944-025-02658-8","url":null,"abstract":"<p><strong>Background: </strong>Severe and extreme hypertriglyceridemia (sHTG [TG 500-879 mg/dL; 5.65-9.93 mmol/L]; eHTG [TG ≥ 880 mg/dL; ≥ 9.94 mmol/L]) are important risk factors for acute pancreatitis (AP) and cardiovascular (CV) events. The objective of this study was to estimate rates of AP and CV events for adults with (and without) sHTG/eHTG in US clinical practice.</p><p><strong>Methods: </strong>A retrospective design and data from the MarketScan Research Databases were employed. Study population comprised adults with ≥ 1 TG value and was stratified by index TG (< 150, 150-499, 500-879, ≥ 880 mg/dL; < 1.69, 1.69-5.64, 5.65-9.93, ≥ 9.94 mmol/L). AP/CV events (per 1,000 person-years [PY]) were ascertained from index TG through end of study period, and were estimated for TG-specific subgroups and selected subsets defined therein.</p><p><strong>Results: </strong>Study population totaled 1.8 M adults (TG < 150 mg/dL [< 1.69 mmol/L]: N = 1.3 M; TG 150-499 mg/dL [1.69-5.64 mmol/L]: N = 449 K; TG 500-879 mg/dL [5.65-9.93 mmol/L]: N = 12,050; TG ≥ 880 mg/dL [≥ 9.94 mmol/L]: N = 3,944). AP rates (per 1,000 PY) increased from lowest to highest TG value (0.6 [< 150 mg/dL; < 1.69 mmol/L]) to 9.9 [≥ 880 mg/dL; ≥ 9.94 mmol/L]); rates were highest for adults with TG ≥ 880 mg/dL (≥ 9.94 mmol/L) and history of AP (193.0), pre-existing diabetes (13.9), or history of LLT (13.9). CV event rates (per 1,000 PY) also increased from lowest to highest TG value (3.3 [< 150 mg/dL; < 1.69 mmol/L]) to 10.3 [≥ 880 mg/dL; ≥ 9.94 mmol/L]); rates were highest for adults with TG ≥ 880 mg/dL (≥ 9.94 mmol/L) and history of CV events (116.5), pre-existing diabetes (18.1), or history of LLT (14.5).</p><p><strong>Conclusion: </strong>Rates of AP/CV events are substantially higher among adults with elevated TG values, and are especially high among adults with sHTG or eHTG, in particular those with these conditions and other risk factors. Understanding the magnitude of disease risk among sHTG/eHTG patients, with increasing TG levels as well as within important subgroups, is critical to improving patient care and outcomes.</p>","PeriodicalId":18073,"journal":{"name":"Lipids in Health and Disease","volume":"24 1","pages":"252"},"PeriodicalIF":3.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12305886/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144732073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Association between visceral fat area and heart rate variability in high altitude migrants with OSA: the mediating effect of insulin resistance.","authors":"Shanshan Jia, Yongxing Fu, Yong Wu, Hongwei Li, Doudou Hao, Yunhong Wu, Xiaoping Chen, Liming Zhao","doi":"10.1186/s12944-025-02626-2","DOIUrl":"10.1186/s12944-025-02626-2","url":null,"abstract":"","PeriodicalId":18073,"journal":{"name":"Lipids in Health and Disease","volume":"24 1","pages":"253"},"PeriodicalIF":3.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12306044/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144732071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hyung Joon Joo, Seung Gyu Yun, Jae Hyoung Park, Soon Jun Hong, Cheol Woong Yu, Seung Yong Shin, Eung Ju Kim
{"title":"Predictors of lipoprotein(a) variability in clinical practice and their impact on cardiovascular risk.","authors":"Hyung Joon Joo, Seung Gyu Yun, Jae Hyoung Park, Soon Jun Hong, Cheol Woong Yu, Seung Yong Shin, Eung Ju Kim","doi":"10.1186/s12944-025-02666-8","DOIUrl":"10.1186/s12944-025-02666-8","url":null,"abstract":"<p><strong>Background: </strong>Lipoprotein(a) (Lp[a]) is an established cardiovascular risk marker; however, its intraindividual variability and implications for risk stratification remain poorly understood. This study investigated the clinical and biochemical predictors of high Lp(a) levels and evaluated their potential roles in cardiovascular risk assessment to inform evidence-based public health strategies for cardiovascular disease prevention.</p><p><strong>Methods: </strong>This retrospective multicenter observational study was conducted using data from three tertiary university hospitals in Korea. Patients with at least two Lp(a) measurements taken ≥ 90 days apart were included (n = 5,305). High Lp(a)-level variability was defined as an absolute change of > 10 mg/dL and a relative change of > 25%. Predictors of high-variability were identified through regression analyses, and risk reclassification across Lp(a) risk categories was performed.</p><p><strong>Results: </strong>Baseline and follow-up Lp(a) levels were strongly correlated (r = 0.89, P < 0.01); however, substantial individual variability was observed, with a median absolute change of 3.9 mg/dL and a median percentage change of 26.3%. Approximately 19.9% of the patients exhibited high Lp(a) level variability, which was associated with lower baseline Lp(a) levels and higher follow-up Lp(a) levels, lower body mass indices, higher hemoglobin levels, elevated white blood cell and platelet counts, increased serum glucose levels, lower high-density lipoprotein cholesterol levels, and use of antihypertensive medications. Notably, risk reclassification analysis revealed marked variability among patients in the intermediate \"gray-zone.\"</p><p><strong>Conclusions: </strong>The findings of this study indicate that Lp(a) level variability is associated with adverse cardiovascular risk profiles and dynamic risk reclassification. These results highlight the potential of serial Lp(a) measurements to refine cardiovascular risk stratification, particularly in intermediate-risk patients. Integrating these findings into clinical practice guidelines has the potential to improve cardiovascular risk management at the population level, reduce healthcare disparities, and inform targeted public health interventions aimed at cardiovascular prevention.</p>","PeriodicalId":18073,"journal":{"name":"Lipids in Health and Disease","volume":"24 1","pages":"250"},"PeriodicalIF":3.9,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288285/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xianyou Ji, Jinlan Xia, Hong Zhang, Changjie Ren, Guang Ma, Shenwen Fu, Jun Zhang, Ying Chen, Xuebin Han, Jianming Zhang, Zhengxu Fang, Bo Yang, Baisong Yang, Wenjun Huang, Gang Yin, Hong Qi, Hao Gong, Dongfang Wang, Liuyi Hao, Xiufeng Zhao, Zhaohui Pei, Peijian Wang, Xiaodong Li, Ling Lin, De Li, Zhi Li, Lin Zhang, Bo Yin, Ying Cheng, Zhiqing You, Jianlong Sheng, Jie Wu, Ling Chen, Zhongcai Fan, Wang Zhao, Shuiping Zhao
{"title":"Multiply doses of FDC of rosuvastatin and ezetimibe versus rosuvastatin monotherapy in Chinese patients with hypercholesterolemia (ROSE-CH): multicenter, randomized-controlled trial.","authors":"Xianyou Ji, Jinlan Xia, Hong Zhang, Changjie Ren, Guang Ma, Shenwen Fu, Jun Zhang, Ying Chen, Xuebin Han, Jianming Zhang, Zhengxu Fang, Bo Yang, Baisong Yang, Wenjun Huang, Gang Yin, Hong Qi, Hao Gong, Dongfang Wang, Liuyi Hao, Xiufeng Zhao, Zhaohui Pei, Peijian Wang, Xiaodong Li, Ling Lin, De Li, Zhi Li, Lin Zhang, Bo Yin, Ying Cheng, Zhiqing You, Jianlong Sheng, Jie Wu, Ling Chen, Zhongcai Fan, Wang Zhao, Shuiping Zhao","doi":"10.1186/s12944-025-02670-y","DOIUrl":"10.1186/s12944-025-02670-y","url":null,"abstract":"<p><strong>Objective: </strong>Rosuvastatin plus ezetimibe improves the lipid-lowering effect through different mechanisms of action. This study intended to compare the efficacy and safety of the fixed-dose combination (FDC) of rosuvastatin/ezetimibe vs. rosuvastatin alone in hypercholesterolemia patients.</p><p><strong>Methods: </strong>ROSE-CH (ROSuvastatin and Ezetimibe in Chinese Hypercholesterolemia patients) was a multicenter, randomized, double-blind, positive drug-controlled, superiority-tested phase III clinical trial; 743 patients were randomized into rosuvastatin/ezetimibe 10/10 mg, 5/10 mg, and 2.5/10 mg groups, as well as rosuvastatin 10 mg and 5 mg groups at a 1:1:1:1:1 ratio. A total of 143, 127, 263, and 137 patients had low, intermediate, high, and very-high baseline atherosclerotic cardiovascular disease (ASCVD) risks. The study period spanned from December 24, 2021, to December 6, 2022.</p><p><strong>Results: </strong>Efficacy and safety assessments were conducted in 670 and 696 patients. Percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline to week (W)12 was greater in the rosuvastatin/ezetimibe 10/10 mg group vs. rosuvastatin 10 mg group [least-squares means (LSmean): -51.48% vs. -42.47%], rosuvastatin/ezetimibe 5/10 group vs. rosuvastatin 5 mg group (LSmean: -50.08% vs. -40.17%), and rosuvastatin/ezetimibe 2.5/10 mg group vs. the rosuvastatin 5 mg group (LSmean: -48.47% vs. -40.17%) (all P < 0.001). The same trend was observed for the percentage change in LDL-C from baseline to W4 and W8 (all P < 0.001). In patients with baseline very high ASCVD risk, the achievement of LDL-C target at W12 was higher in rosuvastatin/ezetimibe 10/10 mg vs. rosuvastatin 10 mg groups and rosuvastatin/ezetimibe 2.5/10 mg vs. rosuvastatin 5 mg groups (both P < 0.05). The incidence of adverse events was 36.0%, 38.7%, 25.2%, 31.4%, and 38.6% in each group. Regarding serious adverse events, the incidence was 2.2%, 2.9%, 0.7%, 3.6%, and 0.7% in each group. The incidence of drug-related adverse events was relatively high, which was 26.6%, 31.4%, 18.5%, 23.6%, and 29.0% in each group, respectively, irrespective of the absence of serious drug-related adverse events.</p><p><strong>Conclusion: </strong>The FDC of rosuvastatin/ezetimibe has superior LDL-C-lowering effects over rosuvastatin alone, with good safety profiles in hypercholesterolemia patients.</p>","PeriodicalId":18073,"journal":{"name":"Lipids in Health and Disease","volume":"24 1","pages":"249"},"PeriodicalIF":3.9,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12281852/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144690668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}