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  • 1
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    Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity : The STEP 4 Randomized Clinical Trial
    American Medical Association (AMA) ; 2021
    In:  JAMA Vol. 325, No. 14 ( 2021-04-13), p. 1414-
    Details
    In: JAMA, American Medical Association (AMA), Vol. 325, No. 14 ( 2021-04-13), p. 1414-
    Abstract: The effect of continuing vs withdrawing treatment with semaglutide, a glucagon-like peptide 1 receptor agonist, on weight loss maintenance in people with overweight or obesity is unknown. Objective To compare continued once-weekly treatment with subcutaneous semaglutide, 2.4 mg, with switch to placebo for weight maintenance (both with lifestyle intervention) in adults with overweight or obesity after a 20-week run-in with subcutaneous semaglutide titrated to 2.4 mg weekly. Design, Setting, and Participants Randomized, double-blind, 68-week phase 3a withdrawal study conducted at 73 sites in 10 countries from June 2018 to March 2020 in adults with body mass index of at least 30 (or ≥27 with ≥1 weight-related comorbidity) and without diabetes. Interventions A total of 902 participants received once-weekly subcutaneous semaglutide during run-in. After 20 weeks (16 weeks of dose escalation; 4 weeks of maintenance dose), 803 participants (89.0%) who reached the 2.4-mg/wk semaglutide maintenance dose were randomized (2:1) to 48 weeks of continued subcutaneous semaglutide (n = 535) or switched to placebo (n = 268), plus lifestyle intervention in both groups. Main Outcomes and Measures The primary end point was percent change in body weight from week 20 to week 68; confirmatory secondary end points were changes in waist circumference, systolic blood pressure, and physical functioning (assessed using the Short Form 36 Version 2 Health Survey, Acute Version [SF-36]). Results Among 803 study participants who completed the 20-week run-in period (with a mean weight loss of 10.6%) and were randomized (mean age, 46 [SD, 12] years; 634 [79%] women; mean body weight, 107.2 kg [SD, 22.7 kg]), 787 participants (98.0%) completed the trial and 741 (92.3%) completed treatment. With continued semaglutide, mean body weight change from week 20 to week 68 was −7.9% vs +6.9% with the switch to placebo (difference, −14.8 [95% CI, −16.0 to −13.5] percentage points; P   & amp;lt; .001). Waist circumference (−9.7 cm [95% CI, −10.9 to −8.5 cm]), systolic blood pressure (−3.9 mm Hg [95% CI, −5.8 to −2.0 mm Hg] ), and SF-36 physical functioning score (2.5 [95% CI, 1.6-3.3]) also improved with continued subcutaneous semaglutide vs placebo (all P   & amp;lt; .001). Gastrointestinal events were reported in 41.9% of participants who continued subcutaneous semaglutide vs 26.1% with placebo; similar proportions discontinued treatment because of adverse events with continued semaglutide (2.4%) and placebo (2.2%). Conclusions and Relevance Among adults with overweight or obesity who completed a 20-week run-in period with subcutaneous semaglutide, 2.4 mg once weekly, maintaining treatment with semaglutide compared with switching to placebo resulted in continued weight loss over the following 48 weeks. Trial Registration ClinicalTrials.gov Identifier: NCT03548987
    Type of Medium: Online Resource
    ISSN: 0098-7484
    URL: Article
    DOI: 10.1001/jama.2021.3224
    RVK:
    XA 10000
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2021
    detail.hit.zdb_id: 2958-0
    detail.hit.zdb_id: 2018410-4
    SSG: 5,21
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  • 2
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    Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial
    Elsevier BV ; 2019
    In:  The Lancet Diabetes & Endocrinology Vol. 7, No. 7 ( 2019-07), p. 515-527
    Details
    In: The Lancet Diabetes & Endocrinology, Elsevier BV, Vol. 7, No. 7 ( 2019-07), p. 515-527
    Type of Medium: Online Resource
    ISSN: 2213-8587
    URL: Article
    DOI: 10.1016/S2213-8587(19)30192-5
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
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  • 3
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    Abstract 12948: Low Use of Statins in People With Type 2 Diabetes With or Without Cardiovascular Disease: A Capture Post Hoc Analysis
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Circulation Vol. 142, No. Suppl_3 ( 2020-11-17)
    Details
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 142, No. Suppl_3 ( 2020-11-17)
    Abstract: Background and aim: The association between LDL levels, CVD and the benefits of statin use are well established. The CAPTURE study estimated the contemporary (2019) global prevalence of CVD and medication use in adults with type 2 diabetes across 13 countries. This post hoc analysis assessed serum lipid status and statin use in people with type 2 diabetes without CVD (NoCVD), with established CVD, and atherosclerotic CVD (AsCVD, a subgroup of CVD). Methods: CAPTURE was a multinational, cross-sectional and non-interventional study. Participant information on CVD status, serum lipid profiles, and medication use were ascertained during single routine clinical visit in primary or specialist setting. This analysis included people who had data on serum LDL-C and lipid-lowering therapies. LDL-C targets were set at 〈 100 mg/dL ( 〈 2.6 mmol/L) and 〈 70 mg/dL ( 〈 1.8 mmol/L) for people without and with CVD/AsCVD, respectively according to the ADA 2019 guidelines. Data were analyzed descriptively. Results: The CAPTURE study enrolled 9823 people aimed to be representative of the general type 2 diabetes population. Most ( 〉 80%) had blood LDL-C information. Mean serum levels of lipids varied across 3 groups. (Table) The overall use of any statin was 38% in the NoCVD, 53% in CVD, and 55% in AsCVD groups. In those with documented serum LDL-C levels, 48% in the NoCVD, 67% in CVD, and 66% in AsCVD groups were above LDL-C targets with statin use of 34%, 57%, and 60%, respectively in these participants. Overall, the use of ezetimibe was 3-8% in all the groups and usually in combination with a statin. PCSK9 inhibitors use was 〈 0.1% and used only in participants with CVD. (Table) Conclusion: In conclusion, this CAPTURE post hoc analysis found that two-thirds of people with CVD and AsCVD had LDL-C levels above recommendations and only around 60% of them were on statins. Intolerability of statins might partly explain this lower than expected statin use.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    URL: Article
    DOI: 10.1161/circ.142.suppl_3.12948
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 1466401-X
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  • 4
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    Asthma in Youth and Early-onset Type 2 Diabetes: A Nationwide Study of 1.72 Million Israeli Adolescents
    The Endocrine Society ; 2021
    In:  The Journal of Clinical Endocrinology & Metabolism ( 2021-07-22)
    Details
    In: The Journal of Clinical Endocrinology & Metabolism, The Endocrine Society, ( 2021-07-22)
    Abstract: The prevalence of both asthma and early-onset diabetes is on the rise; however, the association between them remains unclear. We examined a possible association of asthma at adolescence with type 2 diabetes in young adulthood. Methods This is a nationwide, population-based study of 1 718 541 Israeli adolescents (57% males; mean age 17.3 years; range 16-19 years), examined before compulsory military service between 1992 and 2016, with data linked to the Israeli National Diabetes Registry. Asthma diagnosis and severity were determined by a board-certified pulmonologist and based on spirometry tests. Results Type 2 diabetes developed in 58/9090 (0.64%), 507/97 059 (0.52%), 114/23 332 (0.49%), and 7095/1 589 060 (0.44%) persons with moderate-to-severe, mild, inactive, and no history of asthma, respectively, during a mean follow-up & gt;13 years. The respective odds ratios (ORs) were 1.33 (95% CI, 1.02-1.74), 1.17 (1.06-1.28), and 1.09 (0.9-1.31), considering those without asthma history as the reference, in a model adjusted for birth year, sex, body mass index, and other sociodemographic variables. The association persisted when the analysis accounted for coexisting morbidities, and when persons without asthma, individually matched by age, sex, birth year, and body mass index were the reference. Both mild and moderate-to-severe asthma were associated with type 2 diabetes before age 35 years: ORs 1.18 (1.05-1.34) and 1.44 (1.05-2.00), respectively. The strength of the association was accentuated over time. The effect was unchanged when adjusted for oral and inhaled glucocorticoid use. Conclusion Adolescents with active asthma have higher risk to develop type 2 diabetes. This seems related to disease severity, independent of adolescent obesity status, apparent before age 35 years, and more pronounced in recent years.
    Type of Medium: Online Resource
    ISSN: 0021-972X , 1945-7197
    URL: Article
    DOI: 10.1210/clinem/dgab542
    RVK:
    XA 10000
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2021
    detail.hit.zdb_id: 2026217-6
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  • 5
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    Stuttering and Incident Type 2 Diabetes: A Population-Based Study of 2.2 Million Adolescents
    The Endocrine Society ; 2021
    In:  The Journal of Clinical Endocrinology & Metabolism Vol. 106, No. 4 ( 2021-03-25), p. e978-e987
    Details
    In: The Journal of Clinical Endocrinology & Metabolism, The Endocrine Society, Vol. 106, No. 4 ( 2021-03-25), p. e978-e987
    Abstract: To investigate the association between stuttering in adolescence and incident type 2 diabetes in young adulthood. Methods This nationwide population-based study included 2 193 855 adolescents of age 16 to 20 years who were assessed for military service between 1980 and 2013. Diagnoses of stuttering in adolescence were confirmed by a speech-language pathologist. Diabetes status for each individual as of December 31, 2016, was determined by linkage to the Israeli National Diabetes Registry. Relationships were analyzed using regression models adjusted for socioeconomic variables, cognitive performance, coexisting morbidities, and adolescent body mass index. Results Analysis was stratified by sex (Pinteraction = 0.035). Of the 4443 (0.4%) adolescent men with stuttering, 162 (3.7%) developed type 2 diabetes, compared with 25 678 (2.1%) men without stuttering (adjusted odds ratio [OR] 1.3; 95% CI, 1.1-1.6). This relationship persisted when unaffected brothers of men with stuttering were used as the reference group (adjusted OR = 1.5; 95% CI, 1.01-2.2), or when the analysis included only adolescents with unimpaired health at baseline (adjusted OR = 1.4; 95% CI, 1.1-1.7). The association was stronger in later birth cohorts, with an adjusted OR of 2.4 (1.4-4.1) for cases of type 2 diabetes before age 40. Of the 503 (0.1%) adolescent women with stuttering 7 (1.4%) developed type 2 diabetes, compared with 10 139 (1.1%) women without stuttering (OR = 2.03; 95% CI, 0.48-2.20). Conclusions Adolescent stuttering is associated with an increased risk for early-onset type 2 diabetes among men.
    Type of Medium: Online Resource
    ISSN: 0021-972X , 1945-7197
    URL: Article
    DOI: 10.1210/clinem/dgaa988
    RVK:
    XA 10000
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2021
    detail.hit.zdb_id: 2026217-6
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  • 6
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    From glucose lowering agents to disease/diabetes modifying drugs: a “SIMPLE” approach for the treatment of type 2 diabetes
    Springer Science and Business Media LLC ; 2021
    In:  Cardiovascular Diabetology Vol. 20, No. 1 ( 2021-12)
    Details
    In: Cardiovascular Diabetology, Springer Science and Business Media LLC, Vol. 20, No. 1 ( 2021-12)
    Abstract: During the last decade we experienced a surge in the number of glucose lowering agents that can be used to treat patients with type 2 diabetes. Especially important are the discoveries that sodium glucose co-transporter type 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA) improve patients’ cardiovascular and renal outcomes. Accordingly, various medical associations have updated their guidelines for the treatment of diabetes in this new era. Though not agreeing on every issue, these position-statements generally share a detailed and often complex workflow that may be too complicated for the busy and overworked primary care setting, where the majority of patients with type 2 diabetes are managed in many countries. Other guidelines, generally those from the cardiology associations focus primarily on the population of patients with high risk for or pre-existing cardiovascular disease, which represent only the minority of patients with type 2 diabetes. We believe that we should re-define SGLT2i and GLP-1 RA as diabetes/disease modifying drugs (DMDs) given the recent evidence of their cardiovascular and renal benefits. Based on this definition we have designed a SIMPLE approach in order to assist primary care teams in selecting the most appropriate therapy for their patients. We believe that most subjects newly diagnosed with type 2 diabetes should initiate early combination therapy with metformin and a prognosis changing DMD. The decision whether to use GLP-1 RA or SGLT2i should be made based on specific patient’s risk factors and preferences. Importantly, DMDs are known to have a generally safe side-effect profile, with lower risk for hypoglycemia and weight gain, further promoting their wider usage. Early combination therapy with DMDs may improve the multiple pathophysiological abnormalities responsible for type 2 diabetes and its complications, thus resulting in the greatest long term benefits.
    Type of Medium: Online Resource
    ISSN: 1475-2840
    URL: Article
    DOI: 10.1186/s12933-021-01281-y
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2093769-6
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  • 7
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    Systolic blood pressure reduction with tirzepatide in patients with type 2 diabetes: insights from SURPASS clinical program
    Springer Science and Business Media LLC ; 2023
    In:  Cardiovascular Diabetology Vol. 22, No. 1 ( 2023-03-24)
    Details
    In: Cardiovascular Diabetology, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2023-03-24)
    Abstract: Tirzepatide, a once-weekly glucose-dependent insulinotropic polypeptide/ glucagon-like peptide-1 receptor agonist, is approved in the United States, Europe and Japan for the treatment of type 2 diabetes. Across the SURPASS-1 to -5 clinical studies, tirzepatide 5, 10 and 15 mg demonstrated significant improvements in glycated haemoglobin A1c (HbA1c) (− 1.9 to − 2.6%), body weight (− 6.6 to − 13.9%) and systolic blood pressure (SBP) (− 2.8 to − 12.6 mmHg) at the end of study treatment. Methods Post-hoc mediation analyses were conducted to evaluate weight-loss dependent and weight-loss independent effects of tirzepatide on SBP reductions across the 5 SURPASS studies. The safety population (all randomized patients who took at least 1 dose of study drug) of each study was analyzed. Additional analyses were conducted at individual study level or pooled across 5 SURPASS trials. Results The difference in mean SBP change from baseline at 40 weeks (total effect) between the tirzepatide and comparator groups was − 1.3 to − 5.1 mmHg (tirzepatide 5 mg), − 1.7 to − 6.5 mmHg (tirzepatide 10 mg) and − 3.1 to − 11.5 mmHg (tirzepatide 15 mg). These SBP reductions were primarily mediated through weight loss, with different degrees of contributions from weight-loss independent effects across the different trials. In the SURPASS-4 study, which enrolled patients with established cardiovascular disease, weight-loss independent effects explained 33% to 57% of difference in SBP change between tirzepatide and insulin glargine groups. In a pooled analysis of the SURPASS-1 to -5 studies, there was a significant (p  〈  0.001) but weak correlation (r = 0.18 to 0.22) between change in body weight and SBP. Reductions in SBP with tirzepatide were not dependent on concomitant antihypertensive medications at baseline as similar reductions were observed whether participants were receiving them or not (interaction p = 0.77). The largest SBP reductions were observed in the highest baseline category ( 〉  140 mmHg), while those in the first quartile of baseline SBP category ( 〈  122 mmHg) observed no further decrease in SBP. Conclusions Tirzepatide-induced SBP reduction was primarily mediated through weight loss, with different degrees of contributions from weight-loss independent effects across the different trials. SBP reduction was not dependent on antihypertensive medication use but dependent on baseline SBP value, alleviating theoretical concerns of hypotension.
    Type of Medium: Online Resource
    ISSN: 1475-2840
    URL: Article
    DOI: 10.1186/s12933-023-01797-5
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2093769-6
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  • 8
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    Preventing all‐cause hospitalizations in type 2 diabetes with sodium‐glucose cotransporter‐2 inhibitors and glucagon‐like peptide ‐1 receptor agonists: A narrative review and proposed clinical approach
    Wiley ; 2022
    In:  Diabetes, Obesity and Metabolism Vol. 24, No. 6 ( 2022-06), p. 969-982
    Details
    In: Diabetes, Obesity and Metabolism, Wiley, Vol. 24, No. 6 ( 2022-06), p. 969-982
    Abstract: Patients with type 2 diabetes (T2D) are at increased risk for hospital admissions, and acute hospitalizations are associated with a worse prognosis. However, outcomes related to all‐cause hospital admissions (ACHAs) were often overlooked in trials that demonstrated the cardiovascular and kidney benefits of sodium‐glucose cotransporter‐2 (SGLT2) inhibitors and glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs). This review includes a contemporary literature summary of emerging data regarding the effects of SGLT2 inhibitors and GLP‐1RAs on ACHAs. The role of SGLT2 inhibitors in preventing ACHAs was shown in exploratory investigations of several randomized controlled trials (RCTs) and was further supported by real‐world evidence (RWE). However, the association between GLP‐1RA use and lower ACHA risk was mainly shown through RWE, with minimal available RCT data. We also discuss the advantages and challenges of studying ACHAs. Finally, we propose an easily memorized (“ABCDE” acronym) clinical approach to evaluating T2D status and treatment in admitted patients, as they transition from hospital to community care. This systematic approach may assist clinicians in recognizing possible pitfalls in T2D management, thereby preventing subsequent hospitalizations and improving patient prognoses. While acute admission can sometimes be perceived as a management failure, it should also be viewed as an opportunity to take action to prevent the next hospitalization.
    Type of Medium: Online Resource
    ISSN: 1462-8902 , 1463-1326
    URL: Issue
    URL: Article
    DOI: 10.1111/dom.v24.6
    DOI: 10.1111/dom.14675
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2004918-3
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  • 9
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    Cardiovascular risk and lifetime benefit from preventive treatment in type 2 diabetes: A post hoc analysis of the CAPTURE study
    Wiley ; 2023
    In:  Diabetes, Obesity and Metabolism Vol. 25, No. 2 ( 2023-02), p. 435-443
    Details
    In: Diabetes, Obesity and Metabolism, Wiley, Vol. 25, No. 2 ( 2023-02), p. 435-443
    Abstract: To assess the potential gain in the number of life‐years free of a (recurrent) cardiovascular disease (CVD) event with optimal cardiovascular risk management (CVRM) and initiation of glucose‐lowering agents with proven cardiovascular benefit in people with type 2 diabetes (T2D). Materials and Methods 9,416 individuals with T2D from the CAPTURE study, a non‐interventional, cross‐sectional, multinational study, were included. The diabetes lifetime‐perspective prediction model was used for calculating individual 10‐year and lifetime CVD risk. The distribution of preventive medication use was assessed according to predicted CVD risk and stratified for history of CVD. For the estimation of absolute individual benefit from lifelong preventive treatment, including optimal CVRM and the addition of glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and sodium‐glucose co‐transporter‐2 inhibitors (SGLT‐2is), the model was combined with treatment effects from current evidence. Results GLP‐1 RA or SGLT‐2i use did not greatly differ between patients with and without CVD history, while use of blood pressure‐lowering medication, statins and aspirin was more frequent in patients with CVD. Mean (standard deviation [SD]) lifetime benefit from optimal CVRM was 3.9 (3.0) and 1.3 (1.9) years in patients with and without established CVD, respectively. Further addition of a GLP‐1 RA and an SGLT‐2i in patients with CVD gave an added mean (SD) lifetime benefit of 1.2 (0.6) years. Conclusions Life‐years gained free of (recurrent) CVD by optimal CVRM and the addition of a GLP‐1 RA or aSGLT‐2i is dependent on baseline CVD status. These results aid individualizing prevention and promote shared decision‐making in patients with T2D.
    Type of Medium: Online Resource
    ISSN: 1462-8902 , 1463-1326
    URL: Issue
    URL: Article
    DOI: 10.1111/dom.v25.2
    DOI: 10.1111/dom.14887
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 2004918-3
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  • 10
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    Hypoglycaemia manifestations and recurrent events: L essons from the SAVOR‐TIMI 53 outcome study
    Wiley ; 2017
    In:  Diabetes, Obesity and Metabolism Vol. 19, No. 7 ( 2017-07), p. 1045-1050
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    In: Diabetes, Obesity and Metabolism, Wiley, Vol. 19, No. 7 ( 2017-07), p. 1045-1050
    Abstract: Hypoglycaemia is a well‐known risk associated with the use of sulphonylureas and insulin, often limiting achievement of glycaemic goals. Recognizing the precipitants and recurrence patterns of hypoglycaemic events, particularly major events, is therefore clinically important. The SAVOR‐TIMI ‐53 trial was a cardiovascular outcome study of 16 492 patients allocated to saxagliptin vs placebo added to conventional care for a median of 2.1 years. Hypoglycaemic events were a prespecified outcome in the study and were defined as a symptomatic episode that recovered with carbohydrates or any recorded blood glucose 〈 3.0 mmol/l ( 〈 54 mg/ dL) . A major event was defined as one that required third‐party assistance. Analysis of the features of the first hypoglycaemic event for each patient showed that a precipitant for the event was recognized by fewer than half of the patients, with the precipitant most often being a missed meal. In 40% of patients reporting major hypoglycaemic events, no precipitating factor was recognized, and in 〉 60%, no previous hypoglycaemic event was reported during the timespan of the study, underscoring the lack of predictability of such an event.
    Type of Medium: Online Resource
    ISSN: 1462-8902 , 1463-1326
    URL: Issue
    URL: Article
    DOI: 10.1111/dom.2017.19.issue-7
    DOI: 10.1111/dom.12903
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 2004918-3
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