Pub Date : 2024-08-01Epub Date: 2024-05-22DOI: 10.1007/s13300-024-01594-7
Si Xiong, Ruoyu Gou, Xudong Liang, Hao Wu, Shuitao Qin, Bing Li, Changjun Luo, Junan Chen
Introduction: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have attracted much attention because of their significant hypoglycemic and weight-loss effects. Previous preparations can only be subcutaneously injected. Oral administration of GLP-1RAs semaglutide helps to broaden treatment options, but its safety in the real world still needs to be observed. This study is based on FDA adverse event reporting system (FAERS) database to mine adverse drug events (ADE) of oral semaglutide, and provide references for the clinical safe use of this drug.
Methods: To analyze the signal quality of oral semaglutide, which is a drug used in the FAERS database from the third quarter of 2019 to the third quarter of 2023, we collected ADE data and performed data mining by using disproportionate analysis. Then, we standardized the data and used a variety of signal-quantification techniques, including reported odds ratio (ROR), proportional reporting ratio (PRR), Bayesian belief propagation neural network (BCPNN), and multiple empirical Bayesian gamma Poisson contractions (MGPS), for further analysis.
Results: We screened 2398 reports on the use of semaglutide tablets, involving a total of 5653 ADE. These reports were mainly submitted by consumers, and the reporting country was mainly the United States. A total of 23 system organ classes (SOC) and 93 preferred terms (PT) were mined for the signals of semaglutide tablets. The three most common SOC were gastrointestinal disorders, general disorders and administration site conditions, and investigations. At the PT level, metabolism and nutrition disorders exhibit the highest number of signals, with the top three being thyroid cyst, acute cholecystitis, and ketosis. Gastrointestinal disorders rank second, primarily involving eructation, pancreatitis, impaired gastric emptying, and regurgitation. In addition, vith nerve paralysis occurs and the signal intensity is high.
Conclusions: Our study provides a deeper and broader understanding of the safety of oral semaglutide. The results of the ROR, PRR, BCPNN, and MGPS algorithms exhibit high consistency, with metabolism and nutrition-related disorders having the highest number of signals. The conclusions align with the technical specifications of the product. Notably, other unexpected effects are reported, including acute cholecystitis, paralysis of the abducens nerve, and positional vertigo.
{"title":"Adverse Events of Oral GLP-1 Receptor Agonist (Semaglutide Tablets): A Real-World Study Based on FAERS from 2019 to 2023.","authors":"Si Xiong, Ruoyu Gou, Xudong Liang, Hao Wu, Shuitao Qin, Bing Li, Changjun Luo, Junan Chen","doi":"10.1007/s13300-024-01594-7","DOIUrl":"10.1007/s13300-024-01594-7","url":null,"abstract":"<p><strong>Introduction: </strong>Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have attracted much attention because of their significant hypoglycemic and weight-loss effects. Previous preparations can only be subcutaneously injected. Oral administration of GLP-1RAs semaglutide helps to broaden treatment options, but its safety in the real world still needs to be observed. This study is based on FDA adverse event reporting system (FAERS) database to mine adverse drug events (ADE) of oral semaglutide, and provide references for the clinical safe use of this drug.</p><p><strong>Methods: </strong>To analyze the signal quality of oral semaglutide, which is a drug used in the FAERS database from the third quarter of 2019 to the third quarter of 2023, we collected ADE data and performed data mining by using disproportionate analysis. Then, we standardized the data and used a variety of signal-quantification techniques, including reported odds ratio (ROR), proportional reporting ratio (PRR), Bayesian belief propagation neural network (BCPNN), and multiple empirical Bayesian gamma Poisson contractions (MGPS), for further analysis.</p><p><strong>Results: </strong>We screened 2398 reports on the use of semaglutide tablets, involving a total of 5653 ADE. These reports were mainly submitted by consumers, and the reporting country was mainly the United States. A total of 23 system organ classes (SOC) and 93 preferred terms (PT) were mined for the signals of semaglutide tablets. The three most common SOC were gastrointestinal disorders, general disorders and administration site conditions, and investigations. At the PT level, metabolism and nutrition disorders exhibit the highest number of signals, with the top three being thyroid cyst, acute cholecystitis, and ketosis. Gastrointestinal disorders rank second, primarily involving eructation, pancreatitis, impaired gastric emptying, and regurgitation. In addition, vith nerve paralysis occurs and the signal intensity is high.</p><p><strong>Conclusions: </strong>Our study provides a deeper and broader understanding of the safety of oral semaglutide. The results of the ROR, PRR, BCPNN, and MGPS algorithms exhibit high consistency, with metabolism and nutrition-related disorders having the highest number of signals. The conclusions align with the technical specifications of the product. Notably, other unexpected effects are reported, including acute cholecystitis, paralysis of the abducens nerve, and positional vertigo.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1717-1733"},"PeriodicalIF":3.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263519/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141075535","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}
Pub Date : 2024-08-01Epub Date: 2024-06-22DOI: 10.1007/s13300-024-01609-3
Zhihui Tu, Juan Du, Xiaoxu Ge, Wenfang Peng, Lisha Shen, Lili Xia, Xiaohong Jiang, Fan Hu, Shan Huang
Introduction: The triglyceride-glucose index (TyG) has been identified as a dependable and simple indicator marker of insulin resistance (IR). Research has demonstrated a correlation between macrovascular complications and TyG. However, limited research exists regarding the relationship between TyG and diabetic microvascular complications. Consequently, the objective of this study is to investigate the association between TyG and diabetic kidney disease (DKD) and diabetic peripheral neuropathy (DPN).
Methods: This is a cross-sectional, observational study. A total of 2048 patients from Tongren Hospital, Shanghai Jiao Tong University School of Medicine were enrolled. The primary outcomes are DKD and DPN. Quantile regression analysis was employed to investigate the implicit factors of TyG quartiles. Subsequently, based on implicit factors, logistic regression models were constructed to further examine the relationship between TyG and DKD and DPN.
Results: In the baseline, TyG exhibited higher values across patients with DKD, DPN, and co-existence of DKD and DPN (DKD + DPN) in type 2 diabetes (T2D). Univariate logistic regressions demonstrated a significant association between an elevated TyG and an increased risk of DKD (OR = 1.842, [95% CI] 1.317-2.578, P for trend < 0.01), DPN (OR = 1.516, [95% CI] 1.114-2.288, P for trend < 0.05), DKD + DPN (OR = 2.088, [95% CI] 1.429-3.052, P for trend < 0.05). Multivariable logistic regression models suggested a statistically significant increase in the risk of DKD (OR = 1.581, [95% CI] 1.031-2.424, p < 0.05), DKD + DPN (OR = 1.779, [95% CI] 1.091-2.903, p < 0.05) after adjusting the implicit factors of TyG quartiles. However, no significant relationship was observed between TyG and DPN in the multivariable regression analysis.
Conclusions: Elevated TyG was significantly associated with an increased risk of DKD in T2D, but no significant relationship was shown with DPN. This finding provided further evidence for the clinical significance of integrating TyG into the initial assessment of diabetic microvascular complications.
{"title":"Triglyceride Glucose Index for the Detection of Diabetic Kidney Disease and Diabetic Peripheral Neuropathy in Hospitalized Patients with Type 2 Diabetes.","authors":"Zhihui Tu, Juan Du, Xiaoxu Ge, Wenfang Peng, Lisha Shen, Lili Xia, Xiaohong Jiang, Fan Hu, Shan Huang","doi":"10.1007/s13300-024-01609-3","DOIUrl":"10.1007/s13300-024-01609-3","url":null,"abstract":"<p><strong>Introduction: </strong>The triglyceride-glucose index (TyG) has been identified as a dependable and simple indicator marker of insulin resistance (IR). Research has demonstrated a correlation between macrovascular complications and TyG. However, limited research exists regarding the relationship between TyG and diabetic microvascular complications. Consequently, the objective of this study is to investigate the association between TyG and diabetic kidney disease (DKD) and diabetic peripheral neuropathy (DPN).</p><p><strong>Methods: </strong>This is a cross-sectional, observational study. A total of 2048 patients from Tongren Hospital, Shanghai Jiao Tong University School of Medicine were enrolled. The primary outcomes are DKD and DPN. Quantile regression analysis was employed to investigate the implicit factors of TyG quartiles. Subsequently, based on implicit factors, logistic regression models were constructed to further examine the relationship between TyG and DKD and DPN.</p><p><strong>Results: </strong>In the baseline, TyG exhibited higher values across patients with DKD, DPN, and co-existence of DKD and DPN (DKD + DPN) in type 2 diabetes (T2D). Univariate logistic regressions demonstrated a significant association between an elevated TyG and an increased risk of DKD (OR = 1.842, [95% CI] 1.317-2.578, P for trend < 0.01), DPN (OR = 1.516, [95% CI] 1.114-2.288, P for trend < 0.05), DKD + DPN (OR = 2.088, [95% CI] 1.429-3.052, P for trend < 0.05). Multivariable logistic regression models suggested a statistically significant increase in the risk of DKD (OR = 1.581, [95% CI] 1.031-2.424, p < 0.05), DKD + DPN (OR = 1.779, [95% CI] 1.091-2.903, p < 0.05) after adjusting the implicit factors of TyG quartiles. However, no significant relationship was observed between TyG and DPN in the multivariable regression analysis.</p><p><strong>Conclusions: </strong>Elevated TyG was significantly associated with an increased risk of DKD in T2D, but no significant relationship was shown with DPN. This finding provided further evidence for the clinical significance of integrating TyG into the initial assessment of diabetic microvascular complications.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1799-1810"},"PeriodicalIF":3.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263315/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141440316","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}
Pub Date : 2024-08-01Epub Date: 2024-06-11DOI: 10.1007/s13300-024-01603-9
Christophe De Block, Alice Y Y Cheng, Gayathri Anil, John M D'Cruz, Anna Ginovker
Introduction: This study assessed experiences, attitudes, and behaviors of people with diabetes (PwD) regarding diabetes self-management and glucose control, and their level of awareness, knowledge, and attitudes toward time in range (TIR).
Methods: This quantitative survey was conducted using an online questionnaire across seven countries. Respondents were PwD classified into three subgroups: type 1 (T1), type 2 insulin (T2 insulin), and type 2 not on insulin (T2 N/insulin).
Results: Respondents included 621 people in the T1, 780 people in the T2 insulin, and 735 people in the T2 N/insulin subgroups. Awareness of TIR was low, particularly in the T2 N/insulin subgroup (T1 53%, T2 insulin 29%, T2 N/insulin 9%). Despite a lower current use of continuous glucose monitoring (CGM) among the T2 insulin and T2 N/insulin participants (38% and 9%, respectively), versus T1 participants (64%), most (> 70%) were positive toward utilizing new tools and measures to self-manage blood glucose. Recommendations from their healthcare professionals (HCPs) were cited as a strong motivator to try new measures for analyzing glucose levels. The main barriers cited were limited access to CGM and lack of understanding of TIR benefits. Cost was the main reason given by ≥ 40% of respondents for stopping CGM use.
Conclusions: There is an unmet need in diabetes management, and TIR and CGM offer a potential solution. PwD are motivated to manage their blood glucose levels and are positive toward utilizing new tools and measures to achieve this goal. HCPs play a pivotal role in informing and guiding PwD on new measures for analyzing glucose.
{"title":"Perspectives and Behaviors of People with Diabetes toward Time in Range and Glucose Control in Diabetes Management: An Online Survey.","authors":"Christophe De Block, Alice Y Y Cheng, Gayathri Anil, John M D'Cruz, Anna Ginovker","doi":"10.1007/s13300-024-01603-9","DOIUrl":"10.1007/s13300-024-01603-9","url":null,"abstract":"<p><strong>Introduction: </strong>This study assessed experiences, attitudes, and behaviors of people with diabetes (PwD) regarding diabetes self-management and glucose control, and their level of awareness, knowledge, and attitudes toward time in range (TIR).</p><p><strong>Methods: </strong>This quantitative survey was conducted using an online questionnaire across seven countries. Respondents were PwD classified into three subgroups: type 1 (T1), type 2 insulin (T2 insulin), and type 2 not on insulin (T2 N/insulin).</p><p><strong>Results: </strong>Respondents included 621 people in the T1, 780 people in the T2 insulin, and 735 people in the T2 N/insulin subgroups. Awareness of TIR was low, particularly in the T2 N/insulin subgroup (T1 53%, T2 insulin 29%, T2 N/insulin 9%). Despite a lower current use of continuous glucose monitoring (CGM) among the T2 insulin and T2 N/insulin participants (38% and 9%, respectively), versus T1 participants (64%), most (> 70%) were positive toward utilizing new tools and measures to self-manage blood glucose. Recommendations from their healthcare professionals (HCPs) were cited as a strong motivator to try new measures for analyzing glucose levels. The main barriers cited were limited access to CGM and lack of understanding of TIR benefits. Cost was the main reason given by ≥ 40% of respondents for stopping CGM use.</p><p><strong>Conclusions: </strong>There is an unmet need in diabetes management, and TIR and CGM offer a potential solution. PwD are motivated to manage their blood glucose levels and are positive toward utilizing new tools and measures to achieve this goal. HCPs play a pivotal role in informing and guiding PwD on new measures for analyzing glucose.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1735-1747"},"PeriodicalIF":3.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263454/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141300331","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}
Pub Date : 2024-08-01Epub Date: 2024-06-27DOI: 10.1007/s13300-024-01612-8
Ibrahim Sahin, Okan Bakiner, Tevfik Demir, Ramazan Sari, Aysegul Atmaca
The increasing burden of type 2 diabetes (T2D), in relation to alarming rise in the prevalence; challenges in the diagnosis, prevention, and treatment; as well as the substantial impact of disease on longevity and quality of life, is a major concern in healthcare worldwide. Sulfonylureas (SUs) have been a cornerstone of T2D pharmacotherapy for over 60 years as oral antidiabetic drugs (OADs), while the newer generation SUs, such as gliclazide modified release (MR), are known to be associated with low risk of hypoglycemia in addition to the cardiovascular neutrality. This scoping review aimed to specifically address the current position of gliclazide MR among other SUs in the contemporary treatment paradigm for T2D and to provide a practical guidance document to assist clinicians in using gliclazide MR in real-life clinical practice. The main topics addressed in this paper include the role of early and sustained glycemic control and use of SUs in T2D management, the properties of gliclazide MR in relation to its effectiveness and safety, the use of gliclazide therapy in special populations, and the place of SUs as a class and gliclazide MR specifically in the current T2D treatment algorithm.
2 型糖尿病(T2D)的发病率急剧上升,诊断、预防和治疗面临挑战,对寿命和生活质量造成严重影响,因此,2 型糖尿病的负担日益加重,成为全球医疗保健领域的一个主要问题。60多年来,磺脲类药物(SU)作为口服抗糖尿病药物(OAD)一直是T2D药物治疗的基石,而新一代的磺脲类药物,如格列齐特改良释放型(MR),除了对心血管无影响外,还具有低血糖的低风险性。本范围界定综述旨在具体探讨格列齐特(MR)在当代 T2D 治疗范例中与其他 SUs 相比的当前地位,并提供一份实用的指导文件,以协助临床医生在实际临床实践中使用格列齐特(MR)。本文讨论的主要议题包括:早期和持续血糖控制以及使用 SUs 在 T2D 治疗中的作用、格列齐特 MR 的有效性和安全性特性、格列齐特疗法在特殊人群中的应用,以及 SUs 作为一类药物,特别是格列齐特 MR 在当前 T2D 治疗方案中的地位。
{"title":"Current Position of Gliclazide and Sulfonylureas in the Contemporary Treatment Paradigm for Type 2 Diabetes: A Scoping Review.","authors":"Ibrahim Sahin, Okan Bakiner, Tevfik Demir, Ramazan Sari, Aysegul Atmaca","doi":"10.1007/s13300-024-01612-8","DOIUrl":"10.1007/s13300-024-01612-8","url":null,"abstract":"<p><p>The increasing burden of type 2 diabetes (T2D), in relation to alarming rise in the prevalence; challenges in the diagnosis, prevention, and treatment; as well as the substantial impact of disease on longevity and quality of life, is a major concern in healthcare worldwide. Sulfonylureas (SUs) have been a cornerstone of T2D pharmacotherapy for over 60 years as oral antidiabetic drugs (OADs), while the newer generation SUs, such as gliclazide modified release (MR), are known to be associated with low risk of hypoglycemia in addition to the cardiovascular neutrality. This scoping review aimed to specifically address the current position of gliclazide MR among other SUs in the contemporary treatment paradigm for T2D and to provide a practical guidance document to assist clinicians in using gliclazide MR in real-life clinical practice. The main topics addressed in this paper include the role of early and sustained glycemic control and use of SUs in T2D management, the properties of gliclazide MR in relation to its effectiveness and safety, the use of gliclazide therapy in special populations, and the place of SUs as a class and gliclazide MR specifically in the current T2D treatment algorithm.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1687-1716"},"PeriodicalIF":3.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263312/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141455832","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}
Pub Date : 2024-08-01Epub Date: 2024-06-27DOI: 10.1007/s13300-024-01610-w
Martin Haluzik, Zoltan Taybani, Aleksandra Araszkiewicz, Anca Cerghizan, Boris Mankovsky, Agbaria Zuhdi, Maciej Malecki
The management of type 2 diabetes (T2D) often necessitates treatment intensification, and sometimes simplification to achieve glycaemic targets and mitigate complications. This expert opinion paper evaluates the use and positioning of the fixed-ratio combinations (FRCs) of basal insulin (BI) and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) in optimising T2D management. On the basis of the evidence presented and discussions, these FRCs offer a promising approach for both treatment intensification and simplification in people with suboptimal glucose control despite receiving various therapies. In treatment intensification, FRCs provide a synergistic effect by addressing multiple pathophysiological defects contributing to hyperglycaemia. These FRCs effectively control both fasting and postprandial glucose (PPG) excursions, offering significantly improved glycaemic control with a lower hypoglycaemia risk and weight neutrality compared to traditional or complex insulin regimens. Moreover, the reduced injection frequency (once daily) and flexibility in the dosing schedule (with any major meal of the day) help mitigate patient resistance to insulin initiation or titration. This further reduces treatment burden, facilitating treatment adherence and enhancing patient convenience. These key benefits of FRCs over complex insulin regimens play a crucial role in long-term glycaemic management and overall treatment outcomes. Hence, the timely use of FRCs in the treatment algorithm for people with T2D represents a valuable strategy for optimising glycaemic control, addressing treatment barriers and enhancing patient-reported outcomes.
{"title":"Expert Opinion on Optimising Type 2 Diabetes Treatment Using Fixed-Ratio Combination of Basal Insulin and GLP-1 RA for Treatment Intensification and Simplification.","authors":"Martin Haluzik, Zoltan Taybani, Aleksandra Araszkiewicz, Anca Cerghizan, Boris Mankovsky, Agbaria Zuhdi, Maciej Malecki","doi":"10.1007/s13300-024-01610-w","DOIUrl":"10.1007/s13300-024-01610-w","url":null,"abstract":"<p><p>The management of type 2 diabetes (T2D) often necessitates treatment intensification, and sometimes simplification to achieve glycaemic targets and mitigate complications. This expert opinion paper evaluates the use and positioning of the fixed-ratio combinations (FRCs) of basal insulin (BI) and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) in optimising T2D management. On the basis of the evidence presented and discussions, these FRCs offer a promising approach for both treatment intensification and simplification in people with suboptimal glucose control despite receiving various therapies. In treatment intensification, FRCs provide a synergistic effect by addressing multiple pathophysiological defects contributing to hyperglycaemia. These FRCs effectively control both fasting and postprandial glucose (PPG) excursions, offering significantly improved glycaemic control with a lower hypoglycaemia risk and weight neutrality compared to traditional or complex insulin regimens. Moreover, the reduced injection frequency (once daily) and flexibility in the dosing schedule (with any major meal of the day) help mitigate patient resistance to insulin initiation or titration. This further reduces treatment burden, facilitating treatment adherence and enhancing patient convenience. These key benefits of FRCs over complex insulin regimens play a crucial role in long-term glycaemic management and overall treatment outcomes. Hence, the timely use of FRCs in the treatment algorithm for people with T2D represents a valuable strategy for optimising glycaemic control, addressing treatment barriers and enhancing patient-reported outcomes.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1673-1685"},"PeriodicalIF":3.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263442/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141455833","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}
Pub Date : 2024-07-01Epub Date: 2024-05-09DOI: 10.1007/s13300-024-01589-4
Caroline Swift, Monica S Frazer, Noelle N Gronroos, Andrew Sargent, Michael Leszko, Erin Buysman, Sara Alvarez, Tyler J Dunn, Josh Noone, Mico Guevarra
Introduction: The treatment landscape for type 2 diabetes mellitus (T2DM) is complex and constantly evolving, and real-world evidence of prescribing patterns is limited. The objectives of this study were to characterize lines of therapy (LOTs), calculate the length of time spent on each LOT, and identify the reasons for the LOT end among patients who initiated oral semaglutide for T2DM.
Methods: This retrospective, claims-based study included commercial and Medicare Advantage adults with T2DM. Data from November 1, 2019, and June 30, 2020, were obtained from Optum Research Database. Patients with ≥ 1 claim for oral semaglutide and continuous health plan enrollment for ≥ 12 months prior to (baseline period) and ≥ 6 months following (follow-up period) the date of the first oral semaglutide claim were included. LOT 1 began on the date of the first oral semaglutide claim. The start date of any subsequent LOTs was the date of the first claim for an additional non-insulin anti-diabetic drug class or a reduction in drug class with use of commitment medications. The LOT ended at the first instance of medication class discontinuation, change in regimen or end of follow-up.
Results: Of the 1937 patients who initiated oral semaglutide, 950 (49.0%) remained on their initial regimen over the 6-month follow-up period, 844 (43.6%) had at least one subsequent LOT, and 89 (4.6%) had at least two subsequent LOTs. Among patients with more than one LOT, approximately 20%-25% used oral semaglutide as monotherapy or combination therapy during LOTs 2 and 3. Metformin was frequently used during treatment across all LOTs.
Conclusion: This study provides insight for physicians and payers into the real-world prescribing practices within the first 6 months following oral semaglutide initiation and fills the gap in understanding the frequency of regimen changes in the constantly evolving and complex environment of T2DM care.
{"title":"Real-World Treatment Patterns Among Patients with Type 2 Diabetes Mellitus Initiating Treatment with Oral Semaglutide.","authors":"Caroline Swift, Monica S Frazer, Noelle N Gronroos, Andrew Sargent, Michael Leszko, Erin Buysman, Sara Alvarez, Tyler J Dunn, Josh Noone, Mico Guevarra","doi":"10.1007/s13300-024-01589-4","DOIUrl":"10.1007/s13300-024-01589-4","url":null,"abstract":"<p><strong>Introduction: </strong>The treatment landscape for type 2 diabetes mellitus (T2DM) is complex and constantly evolving, and real-world evidence of prescribing patterns is limited. The objectives of this study were to characterize lines of therapy (LOTs), calculate the length of time spent on each LOT, and identify the reasons for the LOT end among patients who initiated oral semaglutide for T2DM.</p><p><strong>Methods: </strong>This retrospective, claims-based study included commercial and Medicare Advantage adults with T2DM. Data from November 1, 2019, and June 30, 2020, were obtained from Optum Research Database. Patients with ≥ 1 claim for oral semaglutide and continuous health plan enrollment for ≥ 12 months prior to (baseline period) and ≥ 6 months following (follow-up period) the date of the first oral semaglutide claim were included. LOT 1 began on the date of the first oral semaglutide claim. The start date of any subsequent LOTs was the date of the first claim for an additional non-insulin anti-diabetic drug class or a reduction in drug class with use of commitment medications. The LOT ended at the first instance of medication class discontinuation, change in regimen or end of follow-up.</p><p><strong>Results: </strong>Of the 1937 patients who initiated oral semaglutide, 950 (49.0%) remained on their initial regimen over the 6-month follow-up period, 844 (43.6%) had at least one subsequent LOT, and 89 (4.6%) had at least two subsequent LOTs. Among patients with more than one LOT, approximately 20%-25% used oral semaglutide as monotherapy or combination therapy during LOTs 2 and 3. Metformin was frequently used during treatment across all LOTs.</p><p><strong>Conclusion: </strong>This study provides insight for physicians and payers into the real-world prescribing practices within the first 6 months following oral semaglutide initiation and fills the gap in understanding the frequency of regimen changes in the constantly evolving and complex environment of T2DM care.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1547-1559"},"PeriodicalIF":3.8,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11211303/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140897693","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}
Pub Date : 2024-07-01Epub Date: 2024-05-21DOI: 10.1007/s13300-024-01598-3
Diana Brixner, Steven V Edelman, Ray Sieradzan, James R Gavin
The growing prevalence of type 2 diabetes (T2D) remains a leading health concern in the US. Despite new medications and technologies, glycemic control in this population remains suboptimal, which increases the risk of poor outcomes, increased healthcare resource utilization, and associated costs. This article reviews the clinical and economic impacts of suboptimal glycemic control in patients on basal-bolus insulin or multiple daily injections (MDI) and discusses how new technologies, such as tubeless insulin delivery devices, referred to as "patch pumps", have the potential to improve outcomes in patients with T2D.
{"title":"Addressing the Burden of Multiple Daily Insulin Injections in Type 2 Diabetes with Insulin Pump Technology: A Narrative Review.","authors":"Diana Brixner, Steven V Edelman, Ray Sieradzan, James R Gavin","doi":"10.1007/s13300-024-01598-3","DOIUrl":"10.1007/s13300-024-01598-3","url":null,"abstract":"<p><p>The growing prevalence of type 2 diabetes (T2D) remains a leading health concern in the US. Despite new medications and technologies, glycemic control in this population remains suboptimal, which increases the risk of poor outcomes, increased healthcare resource utilization, and associated costs. This article reviews the clinical and economic impacts of suboptimal glycemic control in patients on basal-bolus insulin or multiple daily injections (MDI) and discusses how new technologies, such as tubeless insulin delivery devices, referred to as \"patch pumps\", have the potential to improve outcomes in patients with T2D.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1525-1534"},"PeriodicalIF":3.8,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11211306/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141070382","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}
Pub Date : 2024-07-01Epub Date: 2024-05-21DOI: 10.1007/s13300-024-01601-x
Man Wu, Fangting Guo, Xiaowei He, Dayin Zheng, Weiqian Ye, Shaobin Li, Zhihua Lin, Fengxiong Wang
Introduction: This study aimed to determine the pathogen distribution and drug susceptibility of diabetic foot wound secretions in a tertiary hospital in a coastal area of southeastern China to guide clinical antibiotic selection.
Methods: A retrospective analysis was conducted on 212 patients with diabetic foot hospitalized at Xiamen Third Hospital from 2018 to 2023, and foot wound secretions were collected for microbial culture and drug susceptibility testing.
Results: Among 212 cases of patients with diabetic foot wound secretions, 163 cases (76.9%) were cultured with pathogenic bacteria, and a total of 207 strains of pathogenic bacteria were cultured, including 75 strains (36.23%) of Gram-positive (G+) bacteria, 118 strains of Gram-negative (G-) bacteria (57.00%), 14 strains of fungi (6.76%), 120 cases of single microorganism infection (73.62%), 43 cases of mixed infection (26.38%), and 15 strains of multidrug-resistant bacteria (7.25%). The top three pathogenic bacteria were Staphylococcus aureus, Klebsiella pneumoniae, and Pseudomonas aeruginosa. G+ bacteria were dominated by S. aureus. Drug susceptibility results showed that G+ bacteria were highly susceptible to vancomycin, linezolid, tigecycline, quinupristin/dalfopristin, rifampicin, and furotoxin, and somewhat resistant to penicillin, erythromycin, clindamycin, and cefoxitin. Among G- bacterial infections, Klebsiella pneumoniae, Pseudomonas aeruginosa, Escherichia coli, and Proteus were the major species. Drug susceptibility testing indicated that carbapenems such as imipenem and ertapenem were the most effective antibacterial drugs against G- strains, followed by amikacin, piperacillin, and tazabactams to which these bacteria were also relatively sensitive, while resistance to penicillins and first-generation cephalosporins increased significantly. We isolated one strain of pathogenic bacteria from a Wagner grade 1 ulcer, which was G+ bacteria. In Wagner grade 2 ulcers, the distribution of pathogenic bacteria was mainly G+ bacteria. In Wagner grade 3 and 4 ulcers, the distribution of pathogenic bacteria was mainly G- bacteria, and the increased rate of mixed infection was mainly due to mixed infection of G+ and G-. Two strains of pathogenic bacteria were isolated at Wagner grade 5, which were mixed infections of G+ and G-.
Conclusions: Pathogenic bacteria in diabetic foot wounds are predominantly G- bacteria, followed by G+ bacteria. As the Wagner ulcer grade increases, the distribution of pathogenic bacteria changes from G+ bacteria to G- bacteria, and the mixed infection rate increases. G+ bacteria are highly susceptible to vancomycin, linezolid, tigecycline, quinupristin/dalfopristin, rifampicin, and furotoxin, and somewhat resistant to penicillin, erythromycin, clindamycin, and cefoxitin. G- bacteria are more sensitive to the antimicrobial drugs ertapenem, imipenem, amikacin, piperacillin tazo
{"title":"Analysis of Distribution and Drug Susceptibility Test Results of Pathogenic Bacteria in Diabetic Foot Ulcers.","authors":"Man Wu, Fangting Guo, Xiaowei He, Dayin Zheng, Weiqian Ye, Shaobin Li, Zhihua Lin, Fengxiong Wang","doi":"10.1007/s13300-024-01601-x","DOIUrl":"10.1007/s13300-024-01601-x","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to determine the pathogen distribution and drug susceptibility of diabetic foot wound secretions in a tertiary hospital in a coastal area of southeastern China to guide clinical antibiotic selection.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on 212 patients with diabetic foot hospitalized at Xiamen Third Hospital from 2018 to 2023, and foot wound secretions were collected for microbial culture and drug susceptibility testing.</p><p><strong>Results: </strong>Among 212 cases of patients with diabetic foot wound secretions, 163 cases (76.9%) were cultured with pathogenic bacteria, and a total of 207 strains of pathogenic bacteria were cultured, including 75 strains (36.23%) of Gram-positive (G+) bacteria, 118 strains of Gram-negative (G-) bacteria (57.00%), 14 strains of fungi (6.76%), 120 cases of single microorganism infection (73.62%), 43 cases of mixed infection (26.38%), and 15 strains of multidrug-resistant bacteria (7.25%). The top three pathogenic bacteria were Staphylococcus aureus, Klebsiella pneumoniae, and Pseudomonas aeruginosa. G+ bacteria were dominated by S. aureus. Drug susceptibility results showed that G+ bacteria were highly susceptible to vancomycin, linezolid, tigecycline, quinupristin/dalfopristin, rifampicin, and furotoxin, and somewhat resistant to penicillin, erythromycin, clindamycin, and cefoxitin. Among G- bacterial infections, Klebsiella pneumoniae, Pseudomonas aeruginosa, Escherichia coli, and Proteus were the major species. Drug susceptibility testing indicated that carbapenems such as imipenem and ertapenem were the most effective antibacterial drugs against G- strains, followed by amikacin, piperacillin, and tazabactams to which these bacteria were also relatively sensitive, while resistance to penicillins and first-generation cephalosporins increased significantly. We isolated one strain of pathogenic bacteria from a Wagner grade 1 ulcer, which was G+ bacteria. In Wagner grade 2 ulcers, the distribution of pathogenic bacteria was mainly G+ bacteria. In Wagner grade 3 and 4 ulcers, the distribution of pathogenic bacteria was mainly G- bacteria, and the increased rate of mixed infection was mainly due to mixed infection of G+ and G-. Two strains of pathogenic bacteria were isolated at Wagner grade 5, which were mixed infections of G+ and G-.</p><p><strong>Conclusions: </strong>Pathogenic bacteria in diabetic foot wounds are predominantly G- bacteria, followed by G+ bacteria. As the Wagner ulcer grade increases, the distribution of pathogenic bacteria changes from G+ bacteria to G- bacteria, and the mixed infection rate increases. G+ bacteria are highly susceptible to vancomycin, linezolid, tigecycline, quinupristin/dalfopristin, rifampicin, and furotoxin, and somewhat resistant to penicillin, erythromycin, clindamycin, and cefoxitin. G- bacteria are more sensitive to the antimicrobial drugs ertapenem, imipenem, amikacin, piperacillin tazo","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1627-1637"},"PeriodicalIF":3.8,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11211311/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141070383","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}
Introduction: Diabetes is a multifactorial disease with far-reaching consequences. Environmental factors, such as urban or rural residence, influence its prevalence and associated comorbidities. Haryana-a north Indian state-has undergone rapid urbanisation, and part of it is included in the National Capital Region (NCR). The primary aim of the study is to estimate the prevalence of diabetes in Haryana with urban-rural, NCR and non-NCR regional stratification and assess the factors affecting the likelihood of having diabetes among adults.
Methods: This sub-group analysis of the Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study (a nationally representative cross-sectional population-based survey) was done for Haryana using data from 3722 participants. The dependent variable was diabetes, while residence in NCR/non-NCR and urban-rural areas were prime independent variables. Weighted prevalence was estimated using state-specific sampling weights and standardized using National Family Health Survey-5 (NFHS-5) study weights. Associations were depicted using bivariate analysis, and factors describing the likelihood of living with diabetes were explored using a multivariable binary logistic regression analysis approach.
Results: Overall, the weighted prevalence of diabetes in Haryana was higher than the national average (12.4% vs. 11.4%). The prevalence was higher in urban (17.9%) than in rural areas (9.5%). The prevalence of diabetes in rural areas was higher in the NCR region, while that of prediabetes was higher in rural non-NCR region. Urban-rural participants' anthropometric measurements and biochemical profiles depicted non-significant differences. Urban-rural status, age and physical activity levels were the most significant factors that affected the likelihood of living with diabetes.
Conclusions: The current analysis provides robust prevalence estimates highlighting the urban-rural disparities. Urban areas continue to have a high prevalence of diabetes and prediabetes; rural areas depict a much higher prevalence of prediabetes than diabetes. With the economic transition rapidly bridging the gap between urban and rural populations, health policymakers should plan efficient strategies to tackle the diabetes epidemic.
{"title":"Urban-Rural Differences in the Prevalence of Diabetes Among Adults in Haryana, India: The ICMR-INDIAB Study (ICMR-INDIAB-18).","authors":"Sanjay Kalra, Ranjit Mohan Anjana, Madhur Verma, Rajendra Pradeepa, Nikita Sharma, Mohan Deepa, Omna Singh, Ulagamadesan Venkatesan, Nirmal Elangovan, Sameer Aggarwal, Rakesh Kakkar, Viswanathan Mohan","doi":"10.1007/s13300-024-01602-w","DOIUrl":"10.1007/s13300-024-01602-w","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetes is a multifactorial disease with far-reaching consequences. Environmental factors, such as urban or rural residence, influence its prevalence and associated comorbidities. Haryana-a north Indian state-has undergone rapid urbanisation, and part of it is included in the National Capital Region (NCR). The primary aim of the study is to estimate the prevalence of diabetes in Haryana with urban-rural, NCR and non-NCR regional stratification and assess the factors affecting the likelihood of having diabetes among adults.</p><p><strong>Methods: </strong>This sub-group analysis of the Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study (a nationally representative cross-sectional population-based survey) was done for Haryana using data from 3722 participants. The dependent variable was diabetes, while residence in NCR/non-NCR and urban-rural areas were prime independent variables. Weighted prevalence was estimated using state-specific sampling weights and standardized using National Family Health Survey-5 (NFHS-5) study weights. Associations were depicted using bivariate analysis, and factors describing the likelihood of living with diabetes were explored using a multivariable binary logistic regression analysis approach.</p><p><strong>Results: </strong>Overall, the weighted prevalence of diabetes in Haryana was higher than the national average (12.4% vs. 11.4%). The prevalence was higher in urban (17.9%) than in rural areas (9.5%). The prevalence of diabetes in rural areas was higher in the NCR region, while that of prediabetes was higher in rural non-NCR region. Urban-rural participants' anthropometric measurements and biochemical profiles depicted non-significant differences. Urban-rural status, age and physical activity levels were the most significant factors that affected the likelihood of living with diabetes.</p><p><strong>Conclusions: </strong>The current analysis provides robust prevalence estimates highlighting the urban-rural disparities. Urban areas continue to have a high prevalence of diabetes and prediabetes; rural areas depict a much higher prevalence of prediabetes than diabetes. With the economic transition rapidly bridging the gap between urban and rural populations, health policymakers should plan efficient strategies to tackle the diabetes epidemic.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1597-1613"},"PeriodicalIF":3.8,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11211308/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141070385","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}
Introduction: Lifestyle management, including appropriate modifications of nutrition, exercise, and medication behaviors, is essential for optimal glycemic control. The absence of appropriate monitoring methods to validate the lifestyle change may hinder the modification and continuation of behaviors. In this study, we evaluated whether once-weekly glycated albumin (GA) measurement received via a smartphone application could improve glycemia management in patients with type 2 diabetes mellitus by supporting self-review and modification of lifestyle behaviors.
Methods: This open-label, randomized controlled, single-center study in Japan with an 8-week intervention period was conducted in individuals with type 2 diabetes mellitus and HbA1c levels between 7.0 and 9.0% (53‒75 mmol/mol). The intervention was once-weekly home monitoring of GA with a daily self-review of lifestyle behaviors using a smartphone application, in addition to conventional treatment.
Results: A total of 98 participants (72.0% males; age 63.2 ± 11.4 years; HbA1c 7.39 ± 0.39% [57.3 ± 4.3 mmol/mol]) were randomly assigned to the intervention or control group. Significant decreases of the GA and HbA1c levels from the baseline to the last observation day were observed in the intervention group (- 1.71 ± 1.37% [- 39.1 ± 31.3 mmol/mol] and - 0.32 ± 0.32% [- 3.5 ± 3.5 mmol/mol], respectively). Significant decreases of the body weight, waist circumference, and caloric expenditure (p < 0.0001 and p = 0.0003, p = 0.0346, respectively), but not of the caloric intake (p = 0.678), were also observed in the intervention group as compared with the control group.
Conclusions: Self-review of lifestyle behaviors in combination with once-weekly GA home testing received via a smartphone application might potentially benefit glycemic management in people with type 2 diabetes mellitus.
{"title":"Efficacy of Self-Review of Lifestyle Behaviors with Once-Weekly Glycated Albumin Measurement in People with Type 2 Diabetes: A Randomized Pilot Study.","authors":"Hideaki Jinnouchi, Akira Yoshida, Mariko Taniguchi, Eisaku Yamauchi, Daisuke Kurosawa, Kenji Yachiku, Itsushi Minoura, Takashi Kadowaki, Toshimasa Yamauchi, Masakazu Aihara, Naoto Kubota, Koshin Sekimizu","doi":"10.1007/s13300-024-01599-2","DOIUrl":"10.1007/s13300-024-01599-2","url":null,"abstract":"<p><strong>Introduction: </strong>Lifestyle management, including appropriate modifications of nutrition, exercise, and medication behaviors, is essential for optimal glycemic control. The absence of appropriate monitoring methods to validate the lifestyle change may hinder the modification and continuation of behaviors. In this study, we evaluated whether once-weekly glycated albumin (GA) measurement received via a smartphone application could improve glycemia management in patients with type 2 diabetes mellitus by supporting self-review and modification of lifestyle behaviors.</p><p><strong>Methods: </strong>This open-label, randomized controlled, single-center study in Japan with an 8-week intervention period was conducted in individuals with type 2 diabetes mellitus and HbA1c levels between 7.0 and 9.0% (53‒75 mmol/mol). The intervention was once-weekly home monitoring of GA with a daily self-review of lifestyle behaviors using a smartphone application, in addition to conventional treatment.</p><p><strong>Results: </strong>A total of 98 participants (72.0% males; age 63.2 ± 11.4 years; HbA1c 7.39 ± 0.39% [57.3 ± 4.3 mmol/mol]) were randomly assigned to the intervention or control group. Significant decreases of the GA and HbA1c levels from the baseline to the last observation day were observed in the intervention group (- 1.71 ± 1.37% [- 39.1 ± 31.3 mmol/mol] and - 0.32 ± 0.32% [- 3.5 ± 3.5 mmol/mol], respectively). Significant decreases of the body weight, waist circumference, and caloric expenditure (p < 0.0001 and p = 0.0003, p = 0.0346, respectively), but not of the caloric intake (p = 0.678), were also observed in the intervention group as compared with the control group.</p><p><strong>Conclusions: </strong>Self-review of lifestyle behaviors in combination with once-weekly GA home testing received via a smartphone application might potentially benefit glycemic management in people with type 2 diabetes mellitus.</p><p><strong>Trial registration: </strong>jRCTs042220048.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1561-1575"},"PeriodicalIF":3.8,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11211309/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140943203","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}