Diabetes Therapy最新文献

{"title":"Cardiovascular Outcomes in Patients with Complex Type 2 Diabetes Mellitus Treated with the Dual SGLT Inhibitor Sotagliflozin: A Meta-analysis.","authors":"Hong Wang, Quannan Zu, Ming Lu, Rongfa Chen, Zhangui Tang, Zhiren Yang","doi":"10.1007/s13300-025-01696-w","DOIUrl":"10.1007/s13300-025-01696-w","url":null,"abstract":"<p><strong>Introduction: </strong>Scientific publications have shown sodium-glucose co-transporter-2 (SGLT2) inhibitors to have several beneficial effects in patients with complex type 2 diabetes mellitus (T2DM). However, sodium-glucose co-transporter-1 (SGLT-1) inhibitor is still under investigation in clinical trials. Recently, a dual inhibitor of sodium-glucose co-transporter (SGLT1/2), sotagliflozin, has been approved for use in patients with T2DM. In this analysis, we aimed to systematically compare the cardiovascular outcomes in patients with complex T2DM who were treated with the newly approved dual (SGLT 1 and 2) inhibitor sotagliflozin.</p><p><strong>Methods: </strong>Electronic databases, including Embase, MEDLINE, http://www.</p><p><strong>Clinicaltrials: </strong>gov , Web of Science, Google Scholar, the Cochrane database, and reference lists of relevant publications, were searched for publications comparing the novel SGLT1/2 inhibitor versus placebo for the treatment of patients with complex T2DM. The primary endpoint, including total number of deaths from cardiovascular causes, hospitalization for heart failure, and urgent visits for heart failure, death from cardiovascular causes, cardiac mortality, hospitalization for heart failure, non-fatal myocardial infarction, and total number of cardiac events, were considered as the endpoints in this analysis. The RevMan software version 5.4 was used to carry out the statistical analysis. Risk ratios (RR) with 95% confidence intervals (CI) were used to represent the data following analysis.</p><p><strong>Results: </strong>A total of 13,054 participants enrolled between 2017 and 2020 were included in this analysis, with 6734 participants assigned to sotagliflozin and 6320 assigned to placebo. The results of this analysis showed that the primary endpoint was significantly in favor of sotagliflozin with (RR: 0.73, 95% CI 0.67-0.80; P = 0.00001). Hospitalization for heart failure (RR: 0.67, 95% CI 0.60-0.75; P = 0.00001) and the total number of cardiac events (RR: 0.73, 95% CI 0.67-0.79; P = 0.00001) were also significantly lower with sotagliflozin when compared to placebo in these patients with complex T2DM. However, the risk for cardiovascular mortality and non-fatal myocardial infarction were not significantly different with (RR: 0.91, 95% CI 0.76-1.09; P = 0.31) and (RR: 0.92, 95% CI 0.27-3.12; P = 0.89), respectively.</p><p><strong>Conclusions: </strong>Cardiovascular outcomes, including the total number of adverse cardiac events and hospitalization for heart failure, were significantly reduced with the newly approved SGLT1/2 inhibitor sotagliflozin apparently showing its cardiovascular efficacy in patients with complex T2DM. Future trials with larger sample sizes and a longer follow-up time could possibly confirm this hypothesis.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"485-498"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11867987/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction to: Advanced Hybrid Closed Loop Algorithm Use in Type 1 Diabetes: The French MiniMed™ Glycemic Control and Quality of Life Study.","authors":"Laurence Kessler, Charles Thivolet, Alfred Penfornis, Didier Gouet, Christine Coffin, Myriam Moret, Sophie Borot, Saïd Bekka, Emmanuel Sonnet, Michael Joubert, Sandrine Lablanche, Geoffrey Burtin, Fabio Di Piazza, Tim van den Heuvel, Ohad Cohen","doi":"10.1007/s13300-025-01698-8","DOIUrl":"10.1007/s13300-025-01698-8","url":null,"abstract":"","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"429-430"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11867991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Efficacy and Safety of Oral Semaglutide in Asians and Non-Asians Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis.","authors":"Tianzuo Wang, Yuying Cui, Lin Liao","doi":"10.1007/s13300-024-01689-1","DOIUrl":"10.1007/s13300-024-01689-1","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;More than half of diabetes patients are Asians, and their tolerance to antidiabetic drugs may differ from that of non-Asians. Oral semaglutide has recently gained attention for its advantages in glycemic and body weight control. However, its effects across different ethnic groups remain unknown.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;All available databases of randomized controlled trials (RCTs) on oral semaglutide in patients with type 2 diabetes mellitus were included. These databases provided detailed patient information, including HbA1c levels, body weight, and adverse events (AEs and serious adverse events [SAEs]).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Ten randomized controlled trials involving 7817 patients were included: six conducted in European and American populations and four in East Asian populations. In both the Asian and non-Asian patients' subgroups, oral semaglutide 3, 7, and 14 mg was more effective in reducing HbA1c than placebo, and between-subgroups analysis showed that semaglutide 3, 7, and 14 mg was more effective in reducing HbA1c in the Asian patients' subgroup than in the non-Asian patients' subgroup. There were no significant differences between subgroups in the number of patients achieving HbA1c &lt; 5%. Non-Asian patients with type 2 diabetes showed significant weight reduction with 7 mg and 14 mg oral semaglutide, and Asian patients reduced body weight only with 14 mg oral semaglutide. Between-subgroups analysis showed that 7 mg oral semaglutide was more effective for weight reduction in non-Asian patients than in Asian patients. In the analysis of the efficacy of oral semaglutide at weeks 26 and 52 in Asian and non-Asian patients, in Asian patients, the hypoglycemic efficacy of oral semaglutide at 3-, 7-, and 14-mg doses at week 52 was significantly lower than that at week 26. In non-Asian patients, there was no significant difference in the reducing HbA1c efficacy of these doses of oral semaglutide at weeks 26 and 52. The weight-reduction efficacy of all doses of oral semaglutide did not change significantly with treatment duration in either Asian or non-Asian patients. Compared with sitagliptin, oral semaglutide was more effective in HbA1c reduction and weight reduction in both Asian and non-Asian patients. Subgroup analysis showed that compared with sitagliptin, Asian patients received oral semaglutide to achieve greater efficacy (HbA1c and weight reduction) than non-Asian patients. In the analysis of adverse events, oral semaglutide, as compared with placebo, was not associated with serious adverse events in either subgroup. The incidence of other (not including series) adverse events was significantly higher in non-Asian patients receiving 7 mg and 14 mg oral semaglutide.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Oral semaglutide demonstrates superior efficacy in reducing HbA1c levels and a rapid onset of action in Asian patients. However, its efficacy appears to diminish with prolonged treatment in ","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"449-470"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11868037/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142964030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Podcast on Patient and Physician Perspectives in the Holistic Care of Heart-Related Challenges of Type 2 Diabetes.","authors":"Jonathan D Rich, Hyvelle Ferguson-Davis","doi":"10.1007/s13300-024-01669-5","DOIUrl":"10.1007/s13300-024-01669-5","url":null,"abstract":"<p><p>Type 2 diabetes (T2D) frequently coexists with cardiorenal complications. Therefore, a holistic approach to patient management is required, with specialists such as primary care physicians, cardiologists, endocrinologists, and nephrologists working together to provide patient care. Although glycemic control is important in the management of T2D, patients with T2D and acceptable glycemic control are still at risk from cardiovascular (CV) events such as stroke, heart attack, and heart failure (HF). Therefore, management of other risk factors, such as high blood pressure, high cholesterol, smoking cessation, and excess bodyweight, are imperative for reducing the risk of CV disease and HF in patients with T2D. In addition to pharmacological interventions, patient self-care, including beneficial dietary changes, regular exercise, and smoking cessation are critical for improving heart health and reducing the risk of CV events and progression of HF. In this podcast, a patient with lived experience of the heart-related challenges of T2D and a cardiologist discuss the link between T2D and heart-related complications, the pharmacological interventions and lifestyle modifications that can be used to reduce the risk of CV events and prevent HF, and the complexities of engaging with the healthcare system when managing multiple comorbidities. The discussion highlights the importance of patient education and empowerment for the management of heart-related challenges of T2D, and the central role of collaborative care between physicians of multiple specialties to reduce CV risk for patients with T2D.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"137-144"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794770/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of Cardioprotective Adjuncts in Type 1 Diabetes.","authors":"Jerry R Greenfield, Ruth Frampton, Kellie Millard, Jennifer R Snaith","doi":"10.1007/s13300-024-01687-3","DOIUrl":"10.1007/s13300-024-01687-3","url":null,"abstract":"<p><p>Type 1 diabetes is associated with excess cardiovascular risk, even after accounting for traditional cardiovascular risk factors, including glycaemia. Hence, there is an urgent need to document the metabolic abnormalities that contribute to the cardiovascular mortality gap in type 1 diabetes, and to examine whether cardioprotective type 2 diabetes medications prevent premature morbidity and mortality in this population.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"145-148"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794932/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"AUGMENTed Real-World Data Enhances Comparative Efficacy Between Once-Weekly Insulin Icodec with Dosing Guide App Versus Once-Daily Insulin Glargine U300 in Insulin-Naive Type 2 Diabetes.","authors":"Liana K Billings, Marisse Asong, Martin Bøg, Simon Clancy, Christian Kruse, Elisabeth de Laguiche, Ernesto Maddaloni","doi":"10.1007/s13300-024-01679-3","DOIUrl":"10.1007/s13300-024-01679-3","url":null,"abstract":"<p><strong>Introduction: </strong>ONWARDS 5 evaluated the effectiveness and safety of insulin icodec (icodec) titrated with a dosing guide app (icodec with app) versus once-daily insulin analogs in insulin-naive adults with type 2 diabetes. The insulin glargine U300 (glargine U300) stratum was too small to enable a robust post hoc efficacy comparison. Augmentation methodology was applied to increase the glargine U300 group size using real-world data (RWD), to facilitate efficacy comparisons of icodec with app versus glargine U300, and to demonstrate the potential of the augmentation methodology to strengthen underpowered treatment comparisons (AUGMENT study).</p><p><strong>Methods: </strong>ONWARDS 5 data were augmented with RWD collected from the US Ambulatory Electronic Medical Records database. Randomized and augmented comparisons (propensity-score-matched) between icodec with app and glargine U300 were weighted to provide a fully augmented estimate of the primary outcome (change in glycated hemoglobin [HbA_1c] after 52 weeks). Data were adjusted for trial effects. Sensitivity analyses were conducted.</p><p><strong>Results: </strong>The nonaugmented randomized estimated treatment difference (ETD; 95% CI) between icodec with app and glargine U300 (trial stratum) for change in HbA_1c was - 0.21 (- 0.70 to 0.28) percentage points. After adjusting for trial effects, the overall fully augmented ETD (95% CI) was - 0.33 (- 0.68 to 0.01) percentage points numerically in favor of icodec with app, although not statistically significant. Sensitivity analyses supported the findings.</p><p><strong>Conclusions: </strong>Using augmented data, the precision of the change in HbA_1c estimate was increased compared with the trial stratum analysis alone. These findings help to validate the principle of utilizing augmentation to strengthen trial outcomes.</p><p><strong>Trial registration number: </strong>The ONWARDS 5 trial is registered with ClinicalTrials.gov (NCT04760626).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"227-239"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794749/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-Effectiveness of FreeStyle Libre for Glucose Self-Management Among People with Diabetes Mellitus: A Canadian Private Payer Perspective.","authors":"Stewart Harris, Sal Cimino, Yen Nguyen, Kirk Szafranski, Yeesha Poon","doi":"10.1007/s13300-024-01677-5","DOIUrl":"10.1007/s13300-024-01677-5","url":null,"abstract":"<p><strong>Introduction: </strong>For people living with diabetes, effective glucose monitoring is a key component in diabetes care, helping to reduce disease burden, complications, and healthcare utilization. Sensor-based glucose monitoring systems, which can provide more comprehensive information about glucose levels than capillary-based self-monitoring of blood glucose (SMBG), are becoming established among people living with diabetes. The objective of this study was to assess the cost-effectiveness of glucose monitoring with FreeStyle Libre systems, compared with SMBG, from the perspective of a Canadian private payer.</p><p><strong>Methods: </strong>The analysis used the validated, person-level microsimulation model DEDUCE (Determination of Diabetes Utilities, Costs, and Effects). Analyses were conducted separately for populations of people with type 1 and type 2 diabetes mellitus (T1DM; T2DM), with time horizons of 40 and 25 years, respectively. T2DM treatment was assumed to be 84% non-insulin, 10% basal insulin, and 6% multiple daily injections of insulin. The effect of FreeStyle Libre was modeled as reductions versus SMBG in glycated hemoglobin level (T1DM, - 0.42%; insulin-treated T2DM, - 0.59%; non-insulin-treated T2DM, - 0.3%) and in acute diabetic events (hypoglycemia and diabetic ketoacidosis). Costs (in 2023 Canadian dollars (Can$)) and utilities were discounted at 1.5%. Outcomes were assessed as costs and quality-adjusted life years (QALYs).</p><p><strong>Results: </strong>In both populations, FreeStyle Libre was dominant to SMBG, providing more QALYs at a lower cost (T1DM: + 1.25 QALYs, - Can$32,287 costs; T2DM: + 0.48 QALYs, - Can$8091 costs). Reductions were seen in the cumulative incidence of all complications (except blindness in the T1DM analysis). FreeStyle Libre was dominant to SMBG in all scenarios tested. Probabilistic sensitivity analysis showed that FreeStyle Libre had a 100% probability of being dominant to SMBG for T1DM and a 91% probability of being dominant for T2DM.</p><p><strong>Conclusion: </strong>This economic analysis shows that, from a Canadian private payer perspective, FreeStyle Libre is cost-effective compared with SMBG for all people living with diabetes.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"169-186"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794756/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Profile and Treatment Adherence in Patients with Type 2 Diabetes and Chronic Kidney Disease Who Initiate an SGLT2 Inhibitor: A Multi-cohort Study.","authors":"Catherine B Johannes, Ryan Ziemiecki, Manel Pladevall-Vila, Natalie Ebert, Csaba P Kovesdy, Reimar W Thomsen, Brenda N Baak, Aníbal García-Sempere, Hiroshi Kanegae, Craig I Coleman, Michael Walsh, Ina Trolle Andersen, Clara Rodríguez Bernal, Celia Robles Cabaniñas, Christian Fynbo Christiansen, Alfredo E Farjat, Alain Gay, Patrick Gee, Ron M C Herings, Isabel Hurtado, Naoki Kashihara, Frederik Pagh Bredahl Kristensen, Fangfang Liu, Suguru Okami, Jetty A Overbeek, Fernie J A Penning-van Beest, Satoshi Yamashita, Yuichiro Yano, J Bradley Layton, David Vizcaya, Nikolaus G Oberprieler","doi":"10.1007/s13300-024-01671-x","DOIUrl":"10.1007/s13300-024-01671-x","url":null,"abstract":"<p><strong>Introduction: </strong>The clinical landscape for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) is rapidly evolving. As part of the FOUNTAIN platform (NCT05526157; EUPAS48148), we described and compared cohorts of adult patients with CKD and T2D initiating a sodium-glucose cotransporter 2 inhibitor (SGLT2i) before the launch of finerenone in Europe, Japan, and the United States (US).</p><p><strong>Methods: </strong>This was a multinational, multi-cohort study of patients with T2D in five data sources: the Danish National Health Registers (DNHR) (Denmark), PHARMO Data Network (The Netherlands), Valencia Health System Integrated Database (VID) (Spain), Japan Chronic Kidney Disease Database Extension (J-CKD-DB-Ex) (Japan), and Optum's de-identified Clinformatics^® Data Mart Database (CDM) (US). Eligible patients had CKD (based on either diagnosis codes, eGFR values, and/or urine ACR) and initiated an SGLT2i between 2012 and 2021. Baseline demographic, lifestyle, and clinical characteristics were analyzed, and drug utilization patterns were described.</p><p><strong>Results: </strong>The final cohorts included 21,739 patients in DNHR, 381 in PHARMO, 31,785 in VID, 1157 in J-CKD-DB-Ex, and 56,219 in CDM. Across data sources, approximately 41-70% had CKD stage 1 or 2 at baseline; severe CKD (stage 4) was uncommon (1.6-6.7%). The median duration of SGLT2i therapy ranged from 7.5 months in PHARMO to 17.0 months in VID. At least 50% of patients were currently receiving SGLT2i treatment at 1 year after initiation.</p><p><strong>Conclusions: </strong>At a 1-year follow-up, at least half of the patients with CKD and T2D were receiving SGLT2i treatment across the data sources. In patients initiating SGLT2i, treatment options for T2D and CKD were heterogeneous and dynamic within and among data sources.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"205-226"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794911/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834434","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Impact of Age and Sex on Fasting Plasma Glucose and Glycated Haemoglobin (HbA1c) in the Non-diabetes Population.","authors":"Mike Stedman, Adrian H Heald, David Holland, Ian Halsall, Lewis Green, Pensee Wu, Kashyap Patel, Jonathan Scargill, Martin Gibson, Fahmy W F Hanna, Anthony A Fryer","doi":"10.1007/s13300-024-01680-w","DOIUrl":"10.1007/s13300-024-01680-w","url":null,"abstract":"<p><strong>Introduction: </strong>We previously reported sex differences in the distribution of glycated haemoglobin (HbA1c) for men/women aged < 50 years vs older individuals, with implications for delayed diabetes diagnosis. Here, we explored whether this pattern was also seen in matched fasting plasma glucose (FPG) levels.</p><p><strong>Methods: </strong>We extracted data on same-day, paired HbA1c and FPG levels from clinical biochemistry laboratory databases from Mersey and West Lancashire Teaching Hospitals NHS Trust (n = 10,153) and Cambridge University Hospitals NHS Foundation Trust (n = 10,022) between Jan 2019 and Dec 2023. Only cases with a single, general-practice HbA1c test were utilised to minimise the risk of including non-diagnostic tests and tests from specialist care (e.g. endocrinology, antenatal services; final dataset: n = 17,271). We examined the links of HbA1c and FPG levels to age and sex.</p><p><strong>Results: </strong>Median HbA1c levels were 1 mmol/mol lower in women aged < 45 years compared to men aged < 45 years but not in those aged ≥ 45 years. This pattern was not seen with FPG, where median levels in women were 0.1-0.2 mmol/L lower across all ages. The HbA1c:FPG ratio was significantly higher in women than men in the 45-54 and ≥ 55 years age groups (p = 0.004, Z-score = 2.9 and p =  < 0.001, Z-score = 8.9, respectively) but not in the < 45 years age group (p = 0.649, Z-score = 0.5). We confirmed our previous finding that median HbA1c levels in women aged ≥ 55 years and 45-55 years were the same as those in men (39 and 37 mmol/mol, respectively) and that for women aged < 45 years, the median HbA1c (34 mmol/mol) was 1 mol/mol lower than for men (35 mmol/mol). This is reflected in the Z-scores, which showed the largest deviation from zero in the < 45 years age group (- 9.1) and the smallest in the older age group (- 2.9).</p><p><strong>Conclusion: </strong>We showed differences in HbA1c and FPG patterns with age between men and women, with implications for the diabetes diagnostic threshold for HbA1c in pre-menopausal women, the underdiagnosis of type 2 diabetes in younger women, and missed opportunities for intervention. We propose that a suggested change to HbA1c reference ranges in this group warrants serious consideration and detailed evaluation.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"257-267"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794718/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characteristics and Dosing Patterns of Tirzepatide Users with Type 2 Diabetes in the United States.","authors":"Reema Mody, Karishma Desai, Chia-Chen Teng, Gally Reznor, Grace Stockbower, Michael Grabner, Brian D Benneyworth","doi":"10.1007/s13300-024-01684-6","DOIUrl":"10.1007/s13300-024-01684-6","url":null,"abstract":"<p><strong>Introduction: </strong>The study objective was to describe characteristics and utilization patterns of tirzepatide users with type 2 diabetes (T2D) using the Healthcare Integrated Research Database in the USA.</p><p><strong>Methods: </strong>Adults (≥18 years) included had T2D diagnosis; ≥1 tirzepatide claim (May 2022-January 2023; first claim date = index date); and continuous medical and pharmacy enrollment during the 6-month baseline and follow-up periods from the index date. Baseline demographics, clinical characteristics, and 6-month follow-up dosing and treatment patterns were summarized descriptively.</p><p><strong>Results: </strong>The study included 15,665 patients with T2D initiating tirzepatide (mean age: 53.2 years; 58.5% women; 76.7% non-Hispanic white). During the 6-month baseline period, hypertension (69.2%), dyslipidemia (69.2%), overweight/obesity (58.4%), and obstructive sleep apnea (22.8%) were commonly reported comorbidities. Over half of the patients (51.2%) had used glucagon-like peptide-1 (GLP-1) receptor agonist (RA) before initiating tirzepatide. The mean glycated hemoglobin (HbA1c) was 7.6% (n = 5175), and 58.4% of these patients had HbA1c ≥7%. The mean body mass index (BMI) was 38.7 kg/m² (n = 3459), and 87.8% of these patients either had Class 1, 2, or 3 obesity. Among patients with a single prescription on each fill date (N = 14,986), 84.1% initiated tirzepatide at ≤5 mg dose. During sixth prescription refill (n = 7304), 56.5% were receiving tirzepatide doses of <10 mg. During the 6-month follow-up period, 69.6% of patients had ≥1 dose escalation and 17.2% had ≥1 dose de-escalation. The mean time to first dose escalation was 59.1 days and first dose de-escalation was 104.8 days. Tirzepatide adherence (proportion of days covered [PDC] ≥80%) was 57.5% and persistence (45-day gap) was 73.3% at 6 months. Of patients who discontinued tirzepatide (n = 4177; 26.7%), 29.1% re-initiated tirzepatide (45-day gap).</p><p><strong>Conclusion: </strong>Patients with T2D initiating tirzepatide had multimorbidity; uncontrolled diabetes; and mean BMI was consistent with Class 2 obesity. Patients showed favorable tirzepatide adherence and persistence profiles, and the majority remained at <10 mg doses during the 6-month follow-up period.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"307-327"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794899/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142964029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}