Diabetes Therapy最新文献

{"title":"Experience of People with Diabetes Treated with Insulin Delivery Systems in France: A Comparative Analysis of Multiple Daily Injections, Tubeless Pumps, Tubed Pumps, and Hybrid Closed Loops.","authors":"Jacques Beltrand, Pierre-Yves Benhamou, Carine Choleau, Ben Braithwaite, Alice Bonin, Jean-Pierre Riveline","doi":"10.1007/s13300-024-01682-8","DOIUrl":"https://doi.org/10.1007/s13300-024-01682-8","url":null,"abstract":"<p><strong>Introduction: </strong>While people with diabetes (PWD)'s experiences with their insulin delivery systems (IDS) are frequently reported in clinical trials, few real-world data exist on the subject. This study aimed to assess the real-world experience and satisfaction with IDS in PWD.</p><p><strong>Methods: </strong>This cross-sectional survey of PWD treated with tubed or tubeless insulin pumps, hybrid closed loop (HCL) systems, or multiple daily injections (MDI) for at least 3 months ran from 4 to 16 May 2023. The questionnaire containing bespoke questions and the Insulin Delivery System Rating Questionnaire (IDSRQ) satisfaction and interference subscales was answered by subscribers of the Aide aux Jeunes Diabétiques patient association and users of the MyDiabby Healthcare web platform.</p><p><strong>Results: </strong>Of 896 analysable respondents (552 children [age 10.7 ± 3.8 years, 46.9% female, all type 1] and 344 adults [age 43.1 ± 19.3 years, 61.9% female, 87.2% type 1]), HCL and pump users reported greater satisfaction with their IDS on the IDSRQ satisfaction subscale (HCL, 70.9 ± 17.7 [n = 208]; tubeless, 66.6 ± 19.1 [n = 272]; tubed, 64.1 ± 21.6 [n = 215]) than MDI users (53.1 ± 23.0 [n = 201]; all p < 0.001). Regarding the interference subscale, tubeless pumps (31.1 ± 24.8) performed similarly to HCLs (37.0 ± 25.5; p = 0.07) and significantly better than tubed pumps (38.6 ± 26.0; p < 0.001) and MDI (42.2 ± 24.3; p < 0.001). Furthermore, 84.6% of tubeless pump users would retain their style of pump for their ideal HCL, almost twice as often as tubed pump users.</p><p><strong>Conclusion: </strong>These results demonstrate a more positive person-reported experience with HCLs or tubeless pumps than with tubed pumps or MDI, primarily due to less interference with daily life, which most tubeless pump users would like to retain when transitioning to a HCL system. Overall, this pioneering study underscores the importance of patient preferences, providing valuable information for physicians prescribing IDS, and facilitating discussions about treatment options.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881510","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 Long-Term Cost-Effectiveness of Tirzepatide 5 mg versus Dulaglutide 0.75 mg for the Treatment of People with Type 2 Diabetes in Japan.","authors":"Toshihiko Aranishi, Ataru Igarashi, Kazuo Hara, Beatrice Osumili, Zhihong Cai, Aska Mizogaki, Manaka Sato, Masakazu Takeuchi, Alice Minghetti, Barnaby Hunt, Takashi Kadowaki","doi":"10.1007/s13300-024-01675-7","DOIUrl":"https://doi.org/10.1007/s13300-024-01675-7","url":null,"abstract":"<p><strong>Introduction: </strong>This analysis aimed to evaluate the long-term cost-effectiveness of tirzepatide 5 mg versus dulaglutide 0.75 mg (both administered once weekly) in people not achieving glycemic control on metformin, based on the results of the head-to-head SURPASS J-mono trial from a Japanese healthcare payer perspective.</p><p><strong>Methods: </strong>A cost-utility analysis was performed over a 50-year time horizon using an implementation of the UKPDS Outcomes Model 2 developed in Microsoft Excel. Baseline cohort characteristics, treatment effects and adverse event rates were sourced from the SURPASS J-mono trial. Simulated patients were assumed to receive either tirzepatide 5 mg or dulaglutide 0.75 mg until HbA1c exceeded 8.0%, at which point treatment was discontinued and basal insulin was initiated. Direct costs were derived from the Japan Medical Data Center claims database. Future costs and clinical benefits were discounted at 2% annually.</p><p><strong>Results: </strong>In this cost-utility modeling analysis, tirzepatide 5 mg was associated with lower diabetes-related complication rates, improved life expectancy, improved quality-adjusted life expectancy and higher direct costs versus dulaglutide 0.75 mg. This resulted in an incremental cost-effectiveness ratio (ICER) of JPY (Japanese yen) 1,302,240 per quality-adjusted life year (QALY) gained for tirzepatide 5 mg versus dulaglutide 0.75 mg (JPY 140 = USD 1). Tirzepatide remained cost-effective versus dulaglutide over a range of sensitivity analyses.</p><p><strong>Conclusions: </strong>In this analysis, tirzepatide 5 mg was associated with an ICER below the commonly quoted willingness-to-pay threshold of JPY 5,000,000 per QALY gained, suggesting that tirzepatide is a cost-effective treatment option for adult patients with type 2 diabetes mellitus, compared with dulaglutide 0.75 mg.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871662","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":"A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants.","authors":"Mette Søndergaard Nielsen, Lise Brøndsted, Martin Kankam, Gaetano Morelli, David Nguyen, Trine Vang Skjøth, Usha Rani Patted, Marloes van Hout","doi":"10.1007/s13300-024-01674-8","DOIUrl":"https://doi.org/10.1007/s13300-024-01674-8","url":null,"abstract":"<p><strong>Introduction: </strong>The glucagon-like peptide-1 (GLP-1) analogue semaglutide is approved as an oral formulation for the treatment of type 2 diabetes. This study aimed to confirm bioequivalence between a new, second-generation (2G) oral semaglutide formulation (1.5, 4 and 9 mg) and the initially approved first-generation (1G) formulation (3, 7 and 14 mg).</p><p><strong>Methods: </strong>This was a randomised, multicentre, open-label, full replicate crossover study to confirm bioequivalence between 2G and 1G oral semaglutide formulations at steady-state (SS) in healthy participants (NCT05227196). Participants were recruited to three groups. In each group, participants were randomised to one of two alternating sequences comparing once-daily oral semaglutide treatment of 9 and 14 mg (group 1), 4 and 7 mg (group 2) or 1.5 and 3 mg (group 3) at SS. Treatment duration was 20 weeks, comprising four 5-week steady-state periods on alternating formulations. Repeated 24-h blood sampling at the end of each steady-state period supported pharmacokinetic analysis. Co-primary endpoints were area under the semaglutide plasma concentration-time curve during a dosing interval at SS (AUC_0-24h,SS) and maximum semaglutide plasma concentration at SS (C_{max, 0-24h,SS}). Bioequivalence for co-primary endpoints was assessed using European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA) criteria. Safety was monitored.</p><p><strong>Results: </strong>A total of 222, 201 and 123 participants were recruited into groups 1, 2 and 3, respectively. The prespecified EMA, FDA and PMDA bioequivalence criteria were met for 2G versus 1G oral semaglutide for all three dose levels (1.5 vs 3 mg, 4 vs 7 mg and 9 vs 14 mg). The safety profile of 2G oral semaglutide was consistent with 1G oral semaglutide.</p><p><strong>Conclusions: </strong>The 2G oral semaglutide formulation was confirmed as bioequivalent to 1G oral semaglutide, with no new safety concerns identified.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05227196.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871658","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 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":"https://doi.org/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":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of Polypharmacy and Burden of Comorbidities on COVID-19 Adverse Outcomes in People with Type 1 or Type 2 Diabetes.","authors":"Juhi K Gupta, Rathi Ravindrarajah, George Tilston, William Ollier, Darren M Ashcroft, Adrian H Heald","doi":"10.1007/s13300-024-01681-9","DOIUrl":"https://doi.org/10.1007/s13300-024-01681-9","url":null,"abstract":"<p><strong>Introduction: </strong>It is widely accepted that the higher the number of medications prescribed and taken by an individual, the higher the risk of poor health outcomes. We have investigated whether polypharmacy and comorbidities conveyed more risk of adverse health outcomes following COVID-19 infection (as a paradigm of serious viral infections in general) in people with type 1 diabetes (T1DM) or type 2 diabetes (T2DM).</p><p><strong>Methods: </strong>The Greater Manchester Care Record (GMCR) is an integrated database of electronic health records containing data collected from 433 general practices in Greater Manchester. Baseline demographic information (age, body mass index [BMI], gender, ethnicity, smoking status, deprivation index), hospital admission or death within 28 days of infection were extracted for adults (18+) diagnosed with either T1DM or T2DM.</p><p><strong>Results: </strong>The study cohort included individuals diagnosed as T1DM and T2DM separately. Across the Greater Manchester Region, a total of 145,907 individuals were diagnosed with T2DM and 9705 were diagnosed with T1DM. For the T2DM individuals, 45.2% were women and for the T1DM individuals, 42.7% were women. For T2DM, 16-20 medications (p = 0.005; odds ratio [OR] [95% confidence interval (CI) 2.375 [1.306-4.319]) and > 20 medications (p < 0.001; OR [95% CI] 3.141 [1.755-5.621]) were associated with increased risk of death following COVID-19 infection. Increased risk of hospital admissions in T2DM individuals was associated with 11 to 15 medications (p = 0.013; OR = 1.341 (95% CI) [1.063-1.692]). This was independent of comorbidities, metabolic and demographic factors. For T1DM, there was no association of polypharmacy with hospital admission. Additionally, respiratory, cardiovascular/cerebrovascular and gastrointestinal conditions were associated with increased risk of hospital admissions and deaths in T2DM (p < 0.001). Many comorbidities were common across both T1DM and T2DM.</p><p><strong>Conclusions: </strong>We have shown in T2DM an independent association of multiple medications taken from 11 upwards with adverse health consequences following COVID-19 infection. We also found that individuals with diabetes develop comorbidities that were common across both T1DM and T2DM. This study has laid the foundation for future investigations into the way that complex pharmacological interactions may influence clinical outcomes in people with T2DM.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863646","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":"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":"https://doi.org/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":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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/s13300-024-01673-9","DOIUrl":"https://doi.org/10.1007/s13300-024-01673-9","url":null,"abstract":"<p><strong>Introduction: </strong>The MiniMed™ 780G system uses an advanced hybrid closed loop algorithm to improve outcomes in people with type 1 diabetes (T1D). The MiniMed™ 780G Glycemic Control and Quality of Life (EQOL) study aimed to provide routine clinical practice data on system effectiveness and associated patient-reported outcomes (PROs) in France.</p><p><strong>Methods: </strong>Individuals aged ≥ 7 years with T1D were enrolled. A 14-day run-in phase in Manual mode preceded a 12-month study phase using Auto mode. The primary endpoint was absolute change in time in range (TIR) from baseline to 6 months. Secondary endpoints included changes in glycemic targets, glycated hemoglobin (HbA1c), and hypoglycemia. PROs included treatment satisfaction, quality of life (QoL), and fear of hypoglycemia.</p><p><strong>Results: </strong>Two-hundred seventy participants formed the intent-to-treat population at 6 months. TIR increased by 11.8 percentage points (standard deviation [SD] 8.96, 95% confidence interval 10.7 to 12.9, p < 0.0001), from 61.9% (SD 11.0) to 73.7% (SD 7.4), equivalent to 2.8 h per day more in range. Time < 70 mg/dL decreased by 1.5 percentage points (p < 0.0001), from 4.0% to 2.5%. All glycemic parameters significantly improved. HbA1c decreased by 0.52% and 0.42% at 6 and 12 months, respectively. More patients met glycemic targets, while severe hypoglycemia was reduced. At 12 months, treatment satisfaction increased across age groups, and QoL improved in adults. Fear of hypoglycemia decreased in adults and children.</p><p><strong>Conclusion: </strong>In France, people with T1D initiating the MiniMed™ 780G system demonstrated sustained TIR and HbA1c improvements. System usage reduced hypoglycemia and fear of hypoglycemia, and increased treatment satisfaction.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT04308291.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834430","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":"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":"https://doi.org/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":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","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":"https://doi.org/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":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiovascular Events in Adults with Type 2 Diabetes and ASCVD Initiating Once-Weekly Semaglutide vs DPP-4is in the USA.","authors":"Silvio E Inzucchi, Xi Tan, Yuanjie Liang, Larisa Yedigarova, Lin Xie, Adam de Havenon","doi":"10.1007/s13300-024-01678-4","DOIUrl":"https://doi.org/10.1007/s13300-024-01678-4","url":null,"abstract":"<p><strong>Introduction: </strong>Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have demonstrated cardiovascular benefits in trials involving high-risk patients with type 2 diabetes (T2D), while dipeptidyl peptidase 4 inhibitors (DPP-4is) have not. However, DPP-4is are still commonly prescribed in patients with T2D and atherosclerotic cardiovascular disease (ASCVD). This study compared time to occurrence of cardiovascular events, health care resource utilization (HCRU), and medical costs in patients with T2D and ASCVD who initiated once-weekly semaglutide vs a DPP-4i.</p><p><strong>Methods: </strong>Two separate observational cohort analyses were conducted using Optum's de-identified Clinformatics^® Data Mart Database (CDM) and Komodo Healthcare Map™ (January 1, 2018 to September 30, 2022). Patients had T2D and ASCVD and received semaglutide or a DPP-4i. Baseline characteristics were balanced using inverse probability of treatment weighting.</p><p><strong>Results: </strong>After weighting, the CDM analysis included 14,461 semaglutide users and 38,630 DPP-4i users and the Komodo Healthcare Map analysis included 48,303 semaglutide users and 109,179 DPP-4i users. In CDM, semaglutide users had significantly decreased risk of stroke (hazard ratio [HR], 0.54), myocardial infarction (HR 0.64), and their composite (HR 0.59) vs DPP-4is. Semaglutide users also had fewer ASCVD-related and all-cause hospitalizations and outpatient visits and lower ASCVD-related and all-cause hospitalization and total medical costs. Results from Komodo Health were generally consistent with those from CDM.</p><p><strong>Conclusion: </strong>Semaglutide users had significantly reduced risk of cardiovascular outcomes, HCRU, and medical costs compared with DPP-4is. This corroborates results from prior studies of once-weekly GLP-1 RAs and reinforces the important role of semaglutide treatment for patients with T2D and ASCVD. Graphical abstract available for this article.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834432","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}