Diabetes research and clinical practice最新文献

{"title":"Gender differences in the association between insulin resistance assessed by estimated glucose disposal rate and the risk of all-cause and cardiovascular deaths in adults without diabetes.","authors":"Haixu Wang, Zeming Zhou, Xiaoxin Liu, Ying Chen","doi":"10.1016/j.diabres.2024.111966","DOIUrl":"https://doi.org/10.1016/j.diabres.2024.111966","url":null,"abstract":"<p><strong>Aim: </strong>We intended to examine the relationship between estimated glucose disposal rate (eGDR) and risks of all-cause and cardiovascular deaths in non-diabetic adults.</p><p><strong>Methods: </strong>38,175 participants from the National Health and Nutrition Examination Survey (1999-2018) were included, and deaths were identified through the National Death Index.</p><p><strong>Results: </strong>With a median follow-up of 9.8 years, we found that dose-response relationships between eGDR level and the risk of death differed between genders. In female participants, higher eGDR level was linearly correlated with lower risks of all-cause and cardiovascular deaths. In contrast, among male participants, there were L-shaped relationships between eGDR and risks of all-cause and cardiovascular deaths, with threshold points of 8.50 and 8.49 mg/kg/min, respectively. To the left of threshold points, eGDR was negatively linked with risks of all-cause (HR 0.91, 95 % CI 0.88-0.94, P < 0.001) and cardiovascular deaths (HR 0.87, 95 % CI 0.82-0.93, P < 0.001). After the inflection point, an increase in eGDR was not related to lower risks of all-cause and cardiovascular deaths (P > 0.05).</p><p><strong>Conclusion: </strong>Higher eGDR level was associated with lower risks of all-cause and cardiovascular deaths in a linear dose-response manner among non-diabetic females, while L-shaped relationships were observed among non-diabetic males.</p>","PeriodicalId":11249,"journal":{"name":"Diabetes research and clinical practice","volume":" ","pages":"111966"},"PeriodicalIF":6.1,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The impact of cold application on pain and comfort during the process of diabetic foot care.","authors":"Mensure Turan, Hediye Özbay, Melek Avşar","doi":"10.1016/j.diabres.2024.111968","DOIUrl":"https://doi.org/10.1016/j.diabres.2024.111968","url":null,"abstract":"<p><strong>Background and aim: </strong>Given the significance of pain management in the context of diabetic foot ulcer (DFU) care, particularly in terms of ensuring patient adherence to treatment regimens, this study was undertaken to ascertain the impact of cold washing on pain and comfort levels during diabetic foot care.</p><p><strong>Methods: </strong>A single-blind randomized controlled trial was conducted in the chronic wound care clinic of a teaching and research hospital in the southeastern region of Turkey. The sample consisted of 68 patients, with 34 assigned to the cold application group and 34 assigned to the control group. Pain and comfort levels were recorded at baseline, and during and after the application of a 0.9% NaCl solution (cold or warm) during DFU care.</p><p><strong>Results: </strong>A comparison of the Cold Application group with the control group revealed a statistically significant reduction in post-intervention pain scores (p = 0.000) and a statistically significant increase in comfort scores (p = 0.000) over time.</p><p><strong>Conclusion: </strong>It can be posited that cold washing represents an efficacious intervention in the management of pain and discomfort associated with diabetic foot care.</p>","PeriodicalId":11249,"journal":{"name":"Diabetes research and clinical practice","volume":" ","pages":"111968"},"PeriodicalIF":6.1,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient and practitioner perceptions around use of artificial intelligence within the English NHS diabetic eye screening programme.","authors":"Charlotte Wahlich, Lakshmi Chandrasekaran, Umar A R Chaudhry, Kathryn Willis, Ryan Chambers, Louis Bolter, John Anderson, Royce Shakespeare, Abraham Olvera-Barrios, Jiri Fajtl, Roshan Welikala, Sarah Barman, Catherine A Egan, Adnan Tufail, Christopher G Owen, Alicja R Rudnicka","doi":"10.1016/j.diabres.2024.111964","DOIUrl":"https://doi.org/10.1016/j.diabres.2024.111964","url":null,"abstract":"<p><strong>Aims: </strong>Automated retinal image analysis using Artificial Intelligence (AI) can detect diabetic retinopathy as accurately as human graders, but it is not yet licensed in the NHS Diabetic Eye Screening Programme (DESP) in England. This study aims to assess perceptions of People Living with Diabetes (PLD) and Healthcare Practitioners (HCP) towards AI's introduction in DESP.</p><p><strong>Methods: </strong>Two online surveys were co-developed with PLD and HCP from a diverse DESP in North East London. Surveys were validated through interviews across three centres and distributed via DESP centres, charities, and the British Association of Retinal Screeners. A coding framework was used to analyse free-text responses.</p><p><strong>Results: </strong>387 (24%) PLD and 98 (37%) HCP provided comments. Themes included trust, workforce impact, the patient-practitioner relationship, AI implementation challenges, and inequalities. Both groups agreed AI in DESP was inevitable, would improve efficiency, and save costs. Concerns included job losses, data security, and AI decision safety. A common misconception was that AI would directly affect patient interactions, though it only processes retinal images.</p><p><strong>Conclusions: </strong>Limited understanding of AI was a barrier to acceptance. Educating diverse PLD groups and HCP about AI's accuracy and reliability is crucial to building trust and facilitating its integration into screening practices.</p>","PeriodicalId":11249,"journal":{"name":"Diabetes research and clinical practice","volume":" ","pages":"111964"},"PeriodicalIF":6.1,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The journey of MASLD: Tracking resolution, relapse, and predictive factors after sleeve gastrectomy and one-anastomosis gastric bypass, a propensity score-matched cohort study.","authors":"Sara Sadeghi, Farhad Hosseinpanah, Alireza Khalaj, Maryam Mahdavi, Majid Valizadeh, Hamidreza Taheri, Maryam Barzin","doi":"10.1016/j.diabres.2024.111969","DOIUrl":"https://doi.org/10.1016/j.diabres.2024.111969","url":null,"abstract":"<p><strong>Aims: </strong>To assess the rates and predictors of resolution and relapse of metabolic-dysfunction associated steatotic liver disease (MASLD) in individuals undergoing sleeve gastrectomy (SG) or one-anastomosis gastric bypass (OAGB).</p><p><strong>Methods: </strong>This observational prospective cohort study involved 1618 propensity score-matched participants (81.5% female) with concurrent MASLD and obesity who underwent SG or OAGB between 2013 and 2023.</p><p><strong>Results: </strong>In the context of a maximum follow-up of four years with a median follow-up of 2.2 years (IQR: 1.0-3.3), the overall rates of MASLD resolution and relapse were 71.1 per 1000 person-month and 8.7 per 1000 person-month, respectively. These rates were comparable between the SG and OAGB groups. Significant resolution predictors were a lower percentage of hepatic steatosis, a higher percentage of 12-month excess weight loss (EWL%), and younger age. In contrast, an increased percentage of liver steatosis, a higher pre-operative (Pre-Op) fat mass percentage (FM%), and older age were significant predictors of relapse.</p><p><strong>Conclusion: </strong>This study found no significant differences in MASLD resolution and relapse rates between SG and OAGB. Key factors influencing MASLD outcomes included the percentage of hepatic steatosis, 12-month EWL%, Pre-Op FM%, and age.</p>","PeriodicalId":11249,"journal":{"name":"Diabetes research and clinical practice","volume":" ","pages":"111969"},"PeriodicalIF":6.1,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparing ADA and IDF diagnostic criteria for intermediate hyperglycaemia and diabetes in the SHiDS study.","authors":"Yinan Zhang, Shuang Liu, Baige Cao, Jinfang Xu, Weiping Jia, Congrong Wang","doi":"10.1016/j.diabres.2024.111963","DOIUrl":"https://doi.org/10.1016/j.diabres.2024.111963","url":null,"abstract":"<p><strong>Aims: </strong>This study aimed to assess the prevalence of IH and diabetes, as well as insulin secretion, insulin sensitivity, and related curve patterns in subjects with different glucose tolerance categories according to the diagnostic criteria established by the American Diabetes Association (ADA) and the more recently published International Diabetes Federation (IDF) guidelines.</p><p><strong>Methods: </strong>We used data of 5,387 adult participants from the Shanghai High-risk Diabetic Screen (SHiDS) study. All participants underwent a five-point 75 g oral glucose tolerance test (OGTT). Glycemic states were then classified according to the ADA/IDF diagnostic criteria, while OGTT-derived indices were employed to evaluate insulin secretion and sensitivity.</p><p><strong>Results: </strong>Overall, 3,729 subjects were diagnosed consistently under ADA/IDF criteria; while 941 and 717 subjects exhibited inconsistencies in the diagnostic classification for diabetes and IH, respectively. Notably, all of these individuals with discrepant diagnoses displayed β-cell dysfunction and/or insulin resistance compared to the NGT/NGT group.</p><p><strong>Conclusions: </strong>The ADA criteria can identify individuals with elevated haemoglobinA1c (HbA1c) levels when the 1-hour plasma glucose (1-h PG) stay within the normal range, while the IDF criteria can identify subjects with impaired insulin sensitivity and secretion when fasting plasma glucose (FPG), 2-hour plasma glucose (2-h PG) and HbA1c values are in the normal range.</p>","PeriodicalId":11249,"journal":{"name":"Diabetes research and clinical practice","volume":" ","pages":"111963"},"PeriodicalIF":6.1,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Temporal incremental healthcare costs associated with complications in Hong Kong Chinese patients with type 2 diabetes: A prospective study in Joint Asia diabetes evaluation (JADE) Register (2007-2019).","authors":"Juliana N M Lui, Eric S H Lau, Abby Q Y Li, Yuzheng Zhang, Lee-Ling Lim, Chun-KwunO, Kelly T C Wong, Aimin Yang, Hongjiang Wu, Ronald C W Ma, Alice P S Kong, Risa Ozaki, Andrea O Y Luk, Elaine Y K Chow, Juliana C N Chan","doi":"10.1016/j.diabres.2024.111961","DOIUrl":"10.1016/j.diabres.2024.111961","url":null,"abstract":"<p><strong>Objective: </strong>We examined incremental healthcare costs (inpatient and outpatient) related to complications in Chinese patients with type 2 diabetes (T2D) during the year of occurrence and post-event years, utilizing the Joint Asia Diabetes Evaluation (JADE) Register cohort of Hong Kong Chinese patients with T2D between 2007 and 2019.</p><p><strong>Research design and methods: </strong>19,440 patients with T2D underwent structured evaluation utilizing the JADE platform with clinical outcomes data retrieved from territory-wide electronic medical records including inpatient, outpatient and emergency care. Two-part model was adopted to account for skewed healthcare costs distribution. Incremental healthcare costs associated with nine non-fatal diabetes complications and all-cause death were estimated, adjusted for demographic, clinical, lifestyle factors and comorbidities.</p><p><strong>Results: </strong>In this prospective cohort [mean ± SD age:59.9 ± 11.9 years, 56.6 % men, duration of diabetes:7.3 ± 7.5 years, HbA1C:7.5 ± 1.6 %] observed for 7 (interquartile range:4-9) years (142,132 patient-years), the mean annual healthcare costs, mainly due to inpatient cost, were USD$2,990 ± 9,960. Lower extremity amputation (LEA) (USD$31,302; 95 %CI: 25,706-37,004), hemorrhagic stroke (USD$21,164; 17,680-24,626), ischemic stroke (USD$17,976; $15,937-20,352) and end-stage disease (ESRD) (USD$14,774; 13,405-16,250) in the year of event incurred the highest cost. Residual healthcare costs in the post-event years were highest for ESRD, LEA, haemorrhagic stroke and incident cancer.</p><p><strong>Conclusion: </strong>These comprehensive temporal healthcare cost estimates for diabetes-related complications allows the performance of long-term, patient-level, cost-effectiveness analyses on T2D prevention and treatment strategies relevant to an Asian and possibly global contexts. These may inform decision-makers on resource allocation aimed at reducing the burden of T2D and chronic diseases.</p>","PeriodicalId":11249,"journal":{"name":"Diabetes research and clinical practice","volume":" ","pages":"111961"},"PeriodicalIF":6.1,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Men with type 1 diabetes had a more than 7-fold odds of elevated depressive symptoms compared to men without diabetes.","authors":"Kimberly A Driscoll, Cristy R Geno Rasmussen, Holly O'Donnell, Paige Trojanowski, Amy C Alman, Amena Keshawarz, Janet K Snell-Bergeon","doi":"10.1016/j.diabres.2024.111947","DOIUrl":"https://doi.org/10.1016/j.diabres.2024.111947","url":null,"abstract":"<p><strong>Objective: </strong>To examine: 1) differences in prevalence of elevated depressive symptoms between individuals with type 1 diabetes and without any type of diabetes overall and by sex; and 2) associations between depressive symptoms and HbA1c, self-management behaviors, and cardiovascular health.</p><p><strong>Research design and methods: </strong>Adults (n = 414) with type 1 diabetes (mean age = 52 ± 9 years, mean duration = 38 ± 9 years; mean HbA1c = 7.8 ± 1.1 mg/dL or 177 mmol/L; 55 % female) and without any type of diabetes (n = 488; mean age = 51 ± 9 years; 51 % female) from the fourth study visit of CACTI, an observational study, completed questionnaires about depressive symptoms and dietary intake. Adults with type 1 diabetes completed a questionnaire about diabetes self-management. Hierarchical logistic regression models were used to examine demographic and clinical characteristics associated with depressive symptoms.</p><p><strong>Results: </strong>Depressive scores were higher in people with type 1 diabetes overall and in both sexes. Men with type 1 diabetes had >7-fold increased odds of elevated depressive symptoms compared to men without diabetes (OR 7.4, 95 % CI: 2.1-26.4), whereas there were no increased odds in women (OR 1.4, 95 % CI: 0.6-2.9, significant sex x diabetes interaction [p = 0.03]). Higher levels of depressive symptoms were associated with both lower engagement in self-management behaviors and physical activity.</p><p><strong>Conclusions: </strong>Our results demonstrate that there is an urgent need to screen adults with type 1 diabetes for depressive symptoms as part of routine medical care and to test interventions to minimize their impact on type 1 diabetes outcomes.</p>","PeriodicalId":11249,"journal":{"name":"Diabetes research and clinical practice","volume":" ","pages":"111947"},"PeriodicalIF":6.1,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors influencing the acceptability of automated insulin delivery systems in youths with type 1 diabetes and their parents.","authors":"Roberto Franceschi, Riccardo Pertile, Marco Marigliano, Enza Mozzillo, Claudio Maffeis, Silvana Zaffani, Carlotta Dusini, Annalisa Antonelli, Giulio Maltoni, Francesca Di Candia, Erika Cantarelli, Nicola Minuto, Marta Bassi, Ivana Rabbone, Silvia Savastio, Stefano Passanisi, Fortunato Lombardo, Valentino Cherubini, Maria Alessandra Saltarelli, Stefano Tumini","doi":"10.1016/j.diabres.2024.111962","DOIUrl":"https://doi.org/10.1016/j.diabres.2024.111962","url":null,"abstract":"<p><strong>Aims: </strong>New technology has been reported as a factor driving people to choose an automatic insulin delivery system (AIDs) and to sustain its acceptance. We aimed to explore the role of continuous glucose monitoring (CGM) technology (instant scanning vs. real-time) and insulin treatment modality to determine the future acceptance of AIDs among T1D individuals.</p><p><strong>Methods: </strong>239 consecutively enrolled T1D youth and their parents returned the AP questionnaire. All individuals were on CGM, using multiple daily injections (MDI) or sensor-augmented pump (SAP) therapy.</p><p><strong>Results: </strong>The AP-acceptance was more than neutral, with mean overall scores of 3.91 ± 0.47 and 3.99 ± 0.43 (p = 0.07), youths and parents, respectively. Domains' analysis revealed high scores in intention to use, usefulness, and trust in AIDs, with favorable expected judgments by others. The items with the highest overall mean scores revealed high glucose control and QoL benefits; the main hassle was the size and discomfort of wearing two devices. Multivariate analysis found that male gender and SAP therapy were associated with a higher AP-acceptance overall score (p = 0.045, 0.015, 0.0001, respectively).</p><p><strong>Conclusions: </strong>Participants receiving SAP therapy demonstrated higher expectations and optimistic views about AIDs. This treatment modality can act as a trampoline to AIDs despite individuals' glucose control and diabetes history.</p>","PeriodicalId":11249,"journal":{"name":"Diabetes research and clinical practice","volume":" ","pages":"111962"},"PeriodicalIF":6.1,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Type 2 diabetes and the minor allele of PNPLA3 consistently identify high-risk metabolic dysfunction associated steatotic liver disease.","authors":"Zobair M Younossi, J Michael Estep, Sean Felix, Brian Lam, Zaid Younossi, Andrei Racila, Maria Stepanova","doi":"10.1016/j.diabres.2024.111960","DOIUrl":"10.1016/j.diabres.2024.111960","url":null,"abstract":"<p><strong>Background: </strong>Association of genetic factors with non-invasive tests (NITs) for MASLD has not been well established.</p><p><strong>Methods: </strong>Clinical and laboratory data, liver biopsy and/or liver stiffness measurement (LSM) by transient elastography were collected from MASLD patients seen in tertiary care hepatology practices. Minor allele frequency for genomic loci rs641738 (MBOAT7), rs58542926 (TM6SF2), rs738409 (PNPLA3), rs62305723 (HSD1713B) were evaluated for association with high ELF (≥11.3), high FIB-4 (≥3.25), high LSM (≥10 kPa), histologic fibrosis (stage 3/4 vs. stages 0-2).</p><p><strong>Results: </strong>Among 2289 MASLD patients with available polymorphism and liver fibrosis/NIT data [52 ± 13 years, 46 % male, BMI 36.6 ± 9.9, 35 % type 2 diabetes (T2D)], 53 % had high-risk allele (C > G) at rs738409 (PNPLA3), 70 % high-risk allele (C > T) at rs641738 (MBOAT7), 18 % high-risk minor allele (C > T) at rs58542926 (TM6SF2), 11 % low-risk minor allele (G > A) at rs62305723 (HSD17b13). Only PNPLA3-rs738409 (47 % CC, 40 % CG, 13 % GG) was significantly associated with higher NIT scores and histologic fibrosis: high ELF 2.8 % CC vs. 8.1 % CG/GG; high FIB-4 4.7 % CC vs. 11.6 % CG/GG; high LSM 10 % vs. 19 %; advanced histologic fibrosis 34 % CC vs. 60 % CG/GG (all p < 0.01). Similar associations of PNPLA3-rs738409 with NITs were observed in a subgroup of MASLD patients with T2D (n = 799; all p < 0.05). The PNPLA3-rs738409 CG/GG genotype, older age and T2D were independently associated with high ELF [OR (95 % CI) = 3.25 (2.03-5.20)], FIB-4 [OR = 2.75 (1.90-3.98)], LSM [OR = 2.71 (1.60-4.59)] scores and advanced histologic fibrosis [OR = 2.56 (1.81-3.62)].</p><p><strong>Conclusions: </strong>The polymorphism rs738409 in the PNPLA3 gene, T2D, and older age were independent predictors of high-risk MASLD.</p>","PeriodicalId":11249,"journal":{"name":"Diabetes research and clinical practice","volume":" ","pages":"111960"},"PeriodicalIF":6.1,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827924","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world safety of dapagliflozin plus metformin in patients of type 2 diabetes mellitus in China: Post-hoc analysis of the DONATE study.","authors":"Lixin Guo, Jing Wang, Li Li, Lin Yuan, Sheng Chen, Hui Wang, Tonghuan Li, Lin Qi, Hong Yang","doi":"10.1016/j.diabres.2024.111959","DOIUrl":"https://doi.org/10.1016/j.diabres.2024.111959","url":null,"abstract":"<p><strong>Aim: </strong>DONATE (NCT03156985) is a large-scale real-world study investigating the safety of dapagliflozin in Chinese type 2 diabetes mellitus (T2DM) patients. This post-hoc analysis aims to further evaluate the real-world safety of dapagliflozin plus metformin.</p><p><strong>Methods: </strong>Safety outcomes were assessed in patients receiving concomitant dapagliflozin and metformin, with or without other antidiabetics. The safety of dapagliflozin-based dual-therapies and dapagliflozin and metformin-based triple-therapies were also analysed.</p><p><strong>Results: </strong>Among the 2,990 patients in DONATE, 2,165 (72.4 %) received concomitant metformin. Among these 2,165 patients, 780 (36.0 %) experienced ≥ 1 adverse event (AE), 129 (6.0 %) experienced serious AE (SAE), and 96 (4.4 %) experienced AE leading to dapagliflozin discontinuation. The most common AEs were upper respiratory tract infection (4.0 %), urinary tract infection (UTI, 2.1 %) and constipation (1.5 %). The most common AEs of special interest of dapagliflozin were UTI (2.3 %), genital tract infection (1.5 %) and hypoglycaemia (1.1 %). In the dapagliflozin and metformin dual-therapy subgroup, the incidences of AE, SAE and AE leading to dapagliflozin discontinuation were 26.7 %, 2.5 %, and 1.9 %, respectively, numerically lower than that of the total population and most other dual-therapy subgroups. These patients also had numerically improved metabolic outcomes than baseline.</p><p><strong>Conclusion: </strong>Dapagliflozin and metformin combination therapy is well-tolerated in real-world Chinese T2DM patients.</p>","PeriodicalId":11249,"journal":{"name":"Diabetes research and clinical practice","volume":" ","pages":"111959"},"PeriodicalIF":6.1,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}