{"title":"The Efficacy and Safety of Sodium-Glucose Co-transporter 2 (SGLT2) Inhibitors in Real-World Clinical Practice: Potential Cautionary Use in Elderly Patients with Type 2 Diabetes (T2D).","authors":"Dong-Hwa Lee, Ji Hwan Oh, Hyun Jeong Jeon, Tae Keun Oh","doi":"10.1007/s13300-024-01604-8","DOIUrl":"10.1007/s13300-024-01604-8","url":null,"abstract":"<p><strong>Introduction: </strong>Sodium-glucose co-transporter 2 (SGLT2) inhibitors have shown safe and therapeutic efficacy in randomized controlled trials (RCT) to reduce adverse cardiorenal events in high-risk patients with type 2 diabetes (T2D). In this study, we investigated the efficacy and safety of SGLT2 intervention in patients with T2D in a real-world clinical practice to confirm the validity of the RCT results.</p><p><strong>Methods: </strong>As a retrospective study, we evaluated medical records from 596 patients with T2D treated with SGLT2 inhibitors (dapagliflozin or empagliflozin) in addition to their prior drug regimen to improve glucose control between 2015 and 2019 in the Endocrinology Department at Chungbuk National University Hospital. No control arm was evaluated to compare the effects of adding SGLT inhibitors to the pre-existing regimen. The primary objective was the measurement of glycated hemoglobin (HbA1c) from each individual patient over a 36-month period at 6-month intervals. The secondary parameters were the measurement of fasting plasma glucose (FPG) and body weight (Bwt) changes, as well as the monitoring of adverse events (AEs) and determining the reasons for drug discontinuation.</p><p><strong>Results: </strong>HbA1c levels were reduced at each of the time points throughout the 36-month period and were significantly reduced by 12.5% (P < 0.01) from time 0 (8.8 ± 1.3%) to 36 months (7.7 ± 1.0%). FPG levels [from basal (180 ± 60 mg/dL) to 36 months (138 ± 38 mg/dL)] and Bwt [from basal (74 ± 15 kg) to 36 months (72 ± 15 kg)] were also significantly reduced (P < 0.01) for both measurements in the SGLT2 inhibitor add-on group. Similar to HbA1c profile, the FPG and Bwt were measured at a consistently lower level at 6 months until the end of the study. The most common AEs were hypoglycemia (n = 57), genitourinary infection (GUI) (n = 31), and polyuria (n = 28). In the elderly population (≥ 75 years old), AEs (31%) were generally more prevalent (P < 0.001) than those (21%) in the adult (< 75 years old) patients. Over the study period, 211 (35%) patients either dropped or completely discontinued the use of the SGLT2 inhibitor, and the elderly patients tended to have a higher discontinuation rate (52%; P = 0.005) than the adults (33%).</p><p><strong>Conclusions: </strong>In this study, we demonstrated that SGLT2 inhibitors are an effective and durable hypoglycemic agent to control blood glucose levels with reduced maintenance of Bwt, but their use in the elderly (≥ 75 years old) patients with T2D may warrant some additional caution due to increased probability of AEs and discontinuation of drug use.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11211288/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141070384","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}
Diabetes TherapyPub Date : 2024-07-01Epub Date: 2024-05-09DOI: 10.1007/s13300-024-01587-6
Luis A Vázquez, Santiago Tofé-Povedano, Diego Bellido-Guerrero, Marta Botella-Serrano, Alfonso Soto-González, Pedro Mezquita-Raya, Elías Delgado, Carmen Fajardo-Montañana, Cristóbal Morales-Portillo, Ana Causanilles, Miriam Rubio-de Santos, Irene Romera, Esteban Jódar-Gimeno
{"title":"Use of Tirzepatide in Adults with Type 2 Diabetes Mellitus: Scientific Evidence and Practical Aspects.","authors":"Luis A Vázquez, Santiago Tofé-Povedano, Diego Bellido-Guerrero, Marta Botella-Serrano, Alfonso Soto-González, Pedro Mezquita-Raya, Elías Delgado, Carmen Fajardo-Montañana, Cristóbal Morales-Portillo, Ana Causanilles, Miriam Rubio-de Santos, Irene Romera, Esteban Jódar-Gimeno","doi":"10.1007/s13300-024-01587-6","DOIUrl":"10.1007/s13300-024-01587-6","url":null,"abstract":"<p><p>Tirzepatide is a novel antidiabetic medication a single-molecule, agonist to the glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptors. It is approved in the USA and EU for the treatment of type 2 diabetes mellitus (T2DM) and obesity. Due to the potential novelty represented by incorporating tirzepatide to clinical practice, we aim to review practical aspects of tirzepatide use in T2DM and the supporting scientific evidence. A group of ten endocrinologists involved as investigators in the phase 3 SURPASS clinical trial program followed a nominal group technique, a qualitative research methodology designed as a semi-structured group discussion to reach a consensus on the selection of a set of practical aspects. The scientific evidence for tirzepatide has been reviewed with respect to a number of patients' clinical profiles and care goals. Information of interest related to adverse events, special warnings and precautions, and other considerations for tirzepatide use has been included. Finally, information provided to the patients has been summarized. The practical aspects reported herein may be helpful in guiding physicians in the use of tirzepatide and contribute to optimizing the management of T2DM.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11211290/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140897695","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}
Diabetes TherapyPub Date : 2024-06-01Epub Date: 2024-05-06DOI: 10.1007/s13300-024-01597-4
Frederick Keen, Bunny Bhukya, Lyndon M Evans
{"title":"Social Media in the Management of Obesity and Diabetes: An Underutilised Population Educational Tool.","authors":"Frederick Keen, Bunny Bhukya, Lyndon M Evans","doi":"10.1007/s13300-024-01597-4","DOIUrl":"10.1007/s13300-024-01597-4","url":null,"abstract":"<p><p>Obesity and diabetes are two of the most common chronic medical conditions encountered, putting an ever-increasing strain on healthcare systems worldwide. Social media meanwhile has taken the world by storm over the last 2 decades, providing a way to distribute information instantly and on a vast scale at the click of a button. The use of social media to aid in the management of obesity and diabetes though is an underutilised tool, with the potential to help in educating and supporting these patients in numerous ways both now and in the future, on a grand scale. The caveat to this, however, is the negative side of social media, which can include the spread of disinformation and bullying. In this commentary, we discuss the methodology and wide scale of positive and negative effects of social media across the management of obesity and diabetes, as well as the possible methods we can use this to our advantage in the medical profession to help our patients going forward.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11096135/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140858793","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}
Diabetes TherapyPub Date : 2024-05-01Epub Date: 2024-03-23DOI: 10.1007/s13300-024-01559-w
Esteban J Gimeno, Mette Bøgelund, Sara Larsen, Anna Okkels, Signe B Reitzel, Hongye Ren, Domingo Orozco-Beltran
{"title":"Adherence and Persistence to Basal Insulin Among People with Type 2 Diabetes in Europe: A Systematic Literature Review and Meta-analysis.","authors":"Esteban J Gimeno, Mette Bøgelund, Sara Larsen, Anna Okkels, Signe B Reitzel, Hongye Ren, Domingo Orozco-Beltran","doi":"10.1007/s13300-024-01559-w","DOIUrl":"10.1007/s13300-024-01559-w","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetes is associated with a number of complications, particularly if glycaemic targets are not achieved. Glycaemic control is highly linked to treatment persistence and adherence. To understand the burden of poor persistence and adherence, this systematic literature review identified existing evidence regarding basal insulin adherence/non-adherence and persistence/non-persistence among people with diabetes in Western Europe (defined as the UK, France, Spain, Switzerland, the Netherlands, Ireland, Austria, Portugal, Denmark, Norway, Sweden, Finland, Italy, Germany, Iceland and Belgium).</p><p><strong>Methods: </strong>Eligible studies were systematically identified from two databases, Medline and Embase (published between 2012 and June 2022). Conference abstracts from ISPOR and EASD were manually included. Identified studies were screened by two independent reviewers in a two-step blinded process. The eligibility of studies was decided on the basis of pre-established criteria. A proportional meta-analysis and comparative narrative analyses were conducted to analyse the included studies.</p><p><strong>Results: </strong>Twelve studies were identified. Proportions of adherence/non-adherence and persistence/non-persistence varied across studies. Pooled rates of non-persistence at 6, 12 and 18 months were 20.3% (95% CI 13.8; 27.8), 33.8% (95% CI 24.1; 44.3) and 36.5% (95% CI 33.6; 39.4), respectively. In the literature, the proportion of adherent people ranged from 41% to 64% (using the outcome measure medication possession ratio (MPR) > 80%), with a pooled rate of 55.6% (95% CI 45.3; 65.6), suggesting that approximately 44% of people with type 2 diabetes (T2D) are non-adherent.</p><p><strong>Conclusion: </strong>The results highlight that almost half of patients with T2D in Western Europe have poor adherence to insulin therapy and, at 18 months, one in three patients do not persist on treatment. These findings call for new basal insulin therapies and diabetes management strategies that can improve treatment persistence and adherence among people with T2D.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11043249/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140193568","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}
Diabetes TherapyPub Date : 2024-05-01Epub Date: 2024-03-18DOI: 10.1007/s13300-024-01557-y
Sakiko Terui, Mari Igari, Takahiro Tsuno, Tomoko Okuyama, Ryota Inoue, Mayu Kyohara, Yasuo Terauchi, Jun Shirakawa
{"title":"Immediate Impact of Switching from Dipeptidyl Peptidase 4 (DPP4) Inhibitors to Low-Dose (0.3 mg) Liraglutide on Glucose Profiles: A Retrospective Observational Study.","authors":"Sakiko Terui, Mari Igari, Takahiro Tsuno, Tomoko Okuyama, Ryota Inoue, Mayu Kyohara, Yasuo Terauchi, Jun Shirakawa","doi":"10.1007/s13300-024-01557-y","DOIUrl":"10.1007/s13300-024-01557-y","url":null,"abstract":"<p><strong>Introduction: </strong>As treatment agents for diabetes, liraglutide is a long-acting glucagon-like peptide 1 receptor agonist, and dipeptidyl peptidase 4 (DPP4) inhibitors are widely used because of their safety and tolerability. Regular treatment with liraglutide has been reported to significantly reduce blood glucose levels, but the impact of low-dose (0.3 mg) liraglutide on blood glucose levels immediately after treatment switching from a DPP4 inhibitor remains unknown.</p><p><strong>Methods: </strong>We conducted a single-arm, retrospective, observational study in 55 inpatients with type 2 diabetes (T2D) to investigate the changes (Δ) in their blood glucose levels at six time points (6-point) from the day before (day -1) to the day after (day 1) by switching the antidiabetic treatment from a DPP4 inhibitor to liraglutide 0.3 mg (low-dose liraglutide) once daily. We also attempted to identify factors associated with the blood glucose-lowering effects of liraglutide.</p><p><strong>Results: </strong>The median values of the changes in fasting, preprandial, and postprandial blood glucose levels and the fluctuations in the blood glucose levels expressed as the standard deviation of the 6-point blood glucose levels were significantly lower on day 1 than on day -1 (P < 0.05, P < 0.0001, P < 0.0001, P < 0.01, respectively); there were no cases of severe hypoglycemia. The Δ blood glucose levels were not associated with the baseline serum hemoglobin A1c values or with any markers of the insulin secreting capacity. There were no associations between the previously used blood glucose-lowering drug and the Δ blood glucose levels.</p><p><strong>Conclusion: </strong>Switching from a DPP4 inhibitor to low-dose (0.3 mg) liraglutide once daily significantly reduced the blood glucose levels and excursions of the blood glucose levels even from the very day after the treatment switch, with no serious adverse events.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11043256/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140142950","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}
Diabetes TherapyPub Date : 2024-05-01Epub Date: 2024-03-12DOI: 10.1007/s13300-024-01556-z
Adam G Tabak, Peter Kempler, Cristian Guja, Roy Eldor, Martin Haluzik, Tomasz Klupa, Nikolaos Papanas, Anca Pantea Stoian, Boris Mankovsky
{"title":"Expert Opinion on Current Trends in the Use of Insulin in the Management of People with Type 2 Diabetes from the South-Eastern European Region and Israel.","authors":"Adam G Tabak, Peter Kempler, Cristian Guja, Roy Eldor, Martin Haluzik, Tomasz Klupa, Nikolaos Papanas, Anca Pantea Stoian, Boris Mankovsky","doi":"10.1007/s13300-024-01556-z","DOIUrl":"10.1007/s13300-024-01556-z","url":null,"abstract":"<p><p>Despite the availability of various antihyperglycaemic therapies and comprehensive guidelines, glycaemic control in diabetes management has not improved significantly during the last decade in the real-world clinical setting. Treatment inertia arising from a complex interplay among patient-, clinician- and healthcare-system-related factors is the prime reason for this suboptimal glycaemic control. Also, the key factor leading to inadequate glycaemic levels remains limited communication between healthcare professionals (HCPs) and people with type 2 diabetes (PwT2D). Early insulin administration has several advantages including reduced glucotoxicity, high efficacy and preserved β-cell mass/function, leading to lowering the risk of diabetes complications. The current publication is based on consensus of experts from the South-Eastern European region and Israel who reviewed the existing evidence and guidelines for the treatment of PwT2D. Herein, the experts emphasised the timely use of insulin, preferably second-generation basal insulin (BI) analogues and intensification using basal-plus therapy, as the most-potent glucose-lowering treatment choice in the real-world clinical setting. Despite an increase in the use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), the experts urged timely insulin initiation for inadequate glycaemic control in PwT2D. Furthermore, the combination of BI and GLP-1 RA addressing both fasting plasma glucose and post-prandial excursions as a free- or fixed-ratio combination was identified to reduce treatment complexity and burden. To minimise discontinuation and improve adherence, the experts reiterated quality, regular interactions and discussions between HCPs and PwT2D/carers for their involvement in the diabetes management decision-making process. Clinicians and HCPs should consider the opinions of the experts in accordance with the most recent recommendations for diabetes management.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11043254/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140109552","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}
Diabetes TherapyPub Date : 2024-05-01Epub Date: 2024-03-18DOI: 10.1007/s13300-024-01561-2
Yan Bi, Song Lu, Jiani Tang, Liying Du, Linong Ji
{"title":"Efficacy and Safety of Tirzepatide in Patients with Type 2 Diabetes: Analysis of SURPASS-AP-Combo by Different Subgroups.","authors":"Yan Bi, Song Lu, Jiani Tang, Liying Du, Linong Ji","doi":"10.1007/s13300-024-01561-2","DOIUrl":"10.1007/s13300-024-01561-2","url":null,"abstract":"<p><strong>Introduction: </strong>Tirzepatide is a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist. In the SURPASS-AP-Combo trial, once-weekly tirzepatide was associated with improved glycemic control and weight loss versus insulin glargine and was generally well tolerated in an Asia-Pacific, predominately Chinese, population with type 2 diabetes (T2D). This post hoc subgroup analysis of SURPASS-AP-Combo assessed the potential influence of patient baseline characteristics on the efficacy and safety of tirzepatide.</p><p><strong>Methods: </strong>Changes from baseline to week 40 in HbA1c, body weight, fasting serum glucose (FSG), and daily glucose average from self-measured blood glucose profiles were analyzed by potential influential factors including age (< 65, ≥ 65 years), sex, baseline HbA1c (≤ 8.5, > 8.5%), body mass index (BMI) (< 25, ≥ 25 kg/m<sup>2</sup>), body weight (< 75, ≥ 75 kg), duration of diabetes (< 10, ≥ 10 years), and concomitant oral antihyperglycemic medications (metformin, metformin plus sulphonylurea). Gastrointestinal adverse events and hypoglycemia were also evaluated.</p><p><strong>Results: </strong>At week 40, all tirzepatide doses were associated with reduced HbA1c, body weight, FSG, and daily glucose average from baseline in all subgroups. Greater HbA1c reductions were achieved in patients with higher baseline HbA1c across all tirzepatide doses, higher body weight with 10 mg and younger age with 15 mg tirzepatide. Greater reductions in body weight were observed in patients with higher body weight across all tirzepatide doses, lower baseline HbA1c with 5 mg and higher BMI with 5 mg tirzepatide.</p><p><strong>Conclusions: </strong>In this post hoc analysis, tirzepatide was associated with reduced blood glucose and body weight in a predominantly Chinese population with T2D across different subgroups, consistent with previous reports for tirzepatide.</p><p><strong>Clinical trial registration: </strong>NCT04093752.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11043231/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140142948","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}
Diabetes TherapyPub Date : 2024-05-01Epub Date: 2024-03-23DOI: 10.1007/s13300-024-01549-y
Anu Gupta, Alpesh Goyal, Roopa Rajan, Venugopalan Y Vishnu, Mani Kalaivani, Nikhil Tandon, Madakasira V P Srivastava, Yashdeep Gupta
{"title":"Validity of Montreal Cognitive Assessment to Detect Cognitive Impairment in Individuals with Type 2 Diabetes.","authors":"Anu Gupta, Alpesh Goyal, Roopa Rajan, Venugopalan Y Vishnu, Mani Kalaivani, Nikhil Tandon, Madakasira V P Srivastava, Yashdeep Gupta","doi":"10.1007/s13300-024-01549-y","DOIUrl":"10.1007/s13300-024-01549-y","url":null,"abstract":"<p><strong>Introduction: </strong>Guidelines recommend screening older people (> 60-65 years) with type 2 diabetes (T2D) for cognitive impairment, as it has implications in the management of diabetes. The Montreal Cognitive Assessment (MoCA) is a sensitive test for the detection of mild cognitive impairment (MCI) in the general population, but its validity in T2D has not been established.</p><p><strong>Methods: </strong>We administered MoCA to patients with T2D (age ≥ 60 years) and controls (no T2D), along with a culturally validated neuropsychological battery and functional activity questionnaire. MCI was defined as performance in one or more cognitive domains ≥ 1.0 SD below the control group (on two tests representing a cognitive domain), with preserved functional activities. The discriminant validity of MoCA for the diagnosis of MCI at different cut-offs was ascertained.</p><p><strong>Results: </strong>We enrolled 267 patients with T2D and 120 controls; 39% of the participants with T2D met the diagnostic criteria for MCI on detailed neuropsychological testing. At the recommended cut-off on MoCA (< 26), the sensitivity (94.2%) was high, but the specificity was quite low (29.5%). The cut-off score of < 23 showed an optimal trade-off between sensitivity (69.2%), specificity (71.8%), and diagnostic accuracy (70.8%). The cut-off of < 21 exhibited the highest diagnostic accuracy (74.9%) with an excellent specificity (91.4%), a good positive and negative predictive value (78.5% and 73.7%, respectively).</p><p><strong>Conclusions: </strong>The recommended screening cut-off point on MoCA of < 26 has a suboptimal specificity and may increase the referral burden in memory clinics. A lower cut-off of < 21 on MoCA maximizes the diagnostic accuracy. Interactive Visual Abstract available for this article.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11043253/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140193570","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}
Diabetes TherapyPub Date : 2024-05-01Epub Date: 2024-03-18DOI: 10.1007/s13300-024-01541-6
Kristin Castorino, Beatrice Osumili, Theophilus Lakiang, Kushal Kumar Banerjee, Andrea Goldyn, Carolina Piras de Oliveira
{"title":"Insulin Use During Gestational and Pre-existing Diabetes in Pregnancy: A Systematic Review of Study Design.","authors":"Kristin Castorino, Beatrice Osumili, Theophilus Lakiang, Kushal Kumar Banerjee, Andrea Goldyn, Carolina Piras de Oliveira","doi":"10.1007/s13300-024-01541-6","DOIUrl":"10.1007/s13300-024-01541-6","url":null,"abstract":"<p><strong>Introduction: </strong>Insulin is the first-line pharmacologic therapy for women with diabetes in pregnancy. However, conducting well-designed randomized clinical trials (RCTs) and achieving recommended glycemic targets remains a challenge for this unique population. This systematic literature review (SLR) aimed to understand the evidence for insulin use in pregnancy and the outcome metrics most often used to characterize its effect on glycemic, maternal and fetal outcomes in gestational diabetes mellitus (GDM) and in pregnant women with diabetes.</p><p><strong>Methods: </strong>An SLR was conducted using electronic databases in Medline, EMBASE via Ovid platform, evidence-based medicine reviews (2010-2020) and conference proceedings (2018-2019). Studies were included if they assessed the effect of insulin treatment on glycemic, maternal or fetal outcomes in women with diabetes in pregnancy. Studies on any type of diabetes other than gestational or pre-existing diabetes as well as non-human studies were excluded.</p><p><strong>Results: </strong>In women diagnosed with GDM or pre-existing diabetes, most studies compared treatment of insulin with metformin (n = 35) followed by diet along with lifestyle intervention (n = 24) and glibenclamide (n = 12). Most studies reporting on glycemic outcomes compared insulin with metformin (n = 22) and glibenclamide (n = 4). Fasting blood glucose was the most reported clinical outcome of interest. Among the studies reporting maternal outcomes, method of delivery and delivery complications were most commonly reported. Large for gestational age, stillbirth and perinatal mortality were the most common fetal outcomes reported.</p><p><strong>Conclusion: </strong>This SLR included a total of 108 clinical trials and observational studies with diverse populations and treatment arms. Outcomes varied across the studies, and a lack of consistent outcome measures to manage diabetes in pregnant women was observed. This elucidates a need for global consensus on study design and standardized clinical, maternal and fetal outcomes metrics.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11043323/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140142951","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}
Diabetes TherapyPub Date : 2024-05-01Epub Date: 2024-03-27DOI: 10.1007/s13300-024-01562-1
Klara R Klein, Trine J Abrahamsen, Anna R Kahkoska, G Caleb Alexander, Christopher G Chute, Melissa Haendel, Stephanie S Hong, Hemalkumar Mehta, Richard Moffitt, Til Stürmer, Kajsa Kvist, John B Buse
{"title":"Association of Premorbid GLP-1RA and SGLT-2i Prescription Alone and in Combination with COVID-19 Severity.","authors":"Klara R Klein, Trine J Abrahamsen, Anna R Kahkoska, G Caleb Alexander, Christopher G Chute, Melissa Haendel, Stephanie S Hong, Hemalkumar Mehta, Richard Moffitt, Til Stürmer, Kajsa Kvist, John B Buse","doi":"10.1007/s13300-024-01562-1","DOIUrl":"10.1007/s13300-024-01562-1","url":null,"abstract":"<p><strong>Introduction: </strong>People with type 2 diabetes are at heightened risk for severe outcomes related to COVID-19 infection, including hospitalization, intensive care unit admission, and mortality. This study was designed to examine the impact of premorbid use of glucagon-like peptide-1 receptor agonist (GLP-1RA) monotherapy, sodium-glucose cotransporter-2 inhibitor (SGLT-2i) monotherapy, and concomitant GLP1-RA/SGLT-2i therapy on the severity of outcomes in individuals with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.</p><p><strong>Methods: </strong>Utilizing observational data from the National COVID Cohort Collaborative through September 2022, we compared outcomes in 78,806 individuals with a prescription of GLP-1RA and SGLT-2i versus a prescription of dipeptidyl peptidase 4 inhibitors (DPP-4i) within 24 months of a positive SARS-CoV-2 PCR test. We also compared concomitant GLP-1RA/SGLT-2i therapy to GLP-1RA and SGLT-2i monotherapy. The primary outcome was 60-day mortality, measured from the positive test date. Secondary outcomes included emergency room (ER) visits, hospitalization, and mechanical ventilation within 14 days. Using a super learner approach and accounting for baseline characteristics, associations were quantified with odds ratios (OR) estimated with targeted maximum likelihood estimation (TMLE).</p><p><strong>Results: </strong>Use of GLP-1RA (OR 0.64, 95% confidence interval [CI] 0.56-0.72) and SGLT-2i (OR 0.62, 95% CI 0.57-0.68) were associated with lower odds of 60-day mortality compared to DPP-4i use. Additionally, the OR of ER visits and hospitalizations were similarly reduced with GLP1-RA and SGLT-2i use. Concomitant GLP-1RA/SGLT-2i use showed similar odds of 60-day mortality when compared to GLP-1RA or SGLT-2i use alone (OR 0.92, 95% CI 0.81-1.05 and OR 0.88, 95% CI 0.76-1.01, respectively). However, lower OR of all secondary outcomes were associated with concomitant GLP-1RA/SGLT-2i use when compared to SGLT-2i use alone.</p><p><strong>Conclusion: </strong>Among adults who tested positive for SARS-CoV-2, premorbid use of either GLP-1RA or SGLT-2i is associated with lower odds of mortality compared to DPP-4i. Furthermore, concomitant use of GLP-1RA and SGLT-2i is linked to lower odds of other severe COVID-19 outcomes, including ER visits, hospitalizations, and mechanical ventilation, compared to SGLT-2i use alone. Graphical abstract available for this article.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":null,"pages":null},"PeriodicalIF":3.8,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11043305/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140305195","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}