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  • 1
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    Risk of severe hypoglycemia in sulfonylurea‐treated patients from diabetes centers in Germany/Austria: How big is the problem? Which patients are at risk?
    Wiley ; 2016
    In:  Diabetes/Metabolism Research and Reviews Vol. 32, No. 3 ( 2016-03), p. 316-324
    Details
    In: Diabetes/Metabolism Research and Reviews, Wiley, Vol. 32, No. 3 ( 2016-03), p. 316-324
    Abstract: We investigated the rate of severe hypoglycemic events and confounding factors in patients with type 2 diabetes treated with sulfonylurea at specialized diabetes centers, documented in the German/Austrian DPV–Wiss database. Methods Data from 29 485 sulfonylurea‐treated patients were analyzed (median[IQR] age 70.8[62.2–77.8] years, diabetes duration 8.2[4.3–12.8] years). The primary objective was to estimate the event rate of severe hypoglycemia (requiring external help, causing unconsciousness/coma/convulsion and/or emergency hospitalization). Secondary objectives included exploration of confounding risk factors through group comparison and Poisson regression. Results Severe hypoglycemic events were reported in 826(2.8%) of all patients during their most recent year of sulfonylurea treatment. Of these, n  = 531(1.8%) had coma, n  = 501(1.7%) were hospitalized at least once. The adjusted event rate of severe hypoglycemia [95%CI] was 3.9[3.7–4.2] events/100 patient‐years (coma: 1.9[1.8–2.1]; hospitalization: 1.6[1.5–1.8] ). Adjusted event rates by diabetes treatment were 6.7 (sulfonylurea + insulin), 4.9 (sulfonylurea + insulin + other OAD), 3.1 (sulfonylurea + other OAD) and 3.8 (sulfonylurea only). Patients with ≥1 severe event were older ( p   〈  0.001) and had longer diabetes duration ( p  = 0.020) than patients without severe events. Participation in educational diabetes‐programs and indirect measures of insulin‐resistance (increased BMI, plasma‐triglycerides) were associated with fewer events (all p   〈  0.001). Impaired renal function was common ( n  = 3113 eGFR; ≤30 mL/min) and associated with an increased rate of severe events (≤30 mL/min: 7.7; 30‐60 mL/min: 4.8; 〉 60 mL/min: 3.9). Conclusions These real‐life data showed a rate of severe hypoglycemia of 3.9/100 patient‐years in sulfonylurea‐treated patients from specialized diabetes centers. Higher risk was associated with known risk factors including lack of diabetes education, older age and decreased eGFR but also with lower BMI and lower triglyceride levels, suggesting that sulfonylurea treatment in those patients should be considered with caution. Copyright © 2015 John Wiley & Sons, Ltd.
    Type of Medium: Online Resource
    ISSN: 1520-7552 , 1520-7560
    URL: Issue
    URL: Article
    DOI: 10.1002/dmrr.v32.3
    DOI: 10.1002/dmrr.2722
    Language: English
    Publisher: Wiley
    Publication Date: 2016
    detail.hit.zdb_id: 2001565-3
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  • 2
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    Discovery of drug–omics associations in type 2 diabetes with generative deep-learning models
    Springer Science and Business Media LLC ; 2023
    In:  Nature Biotechnology Vol. 41, No. 3 ( 2023-03), p. 399-408
    Details
    In: Nature Biotechnology, Springer Science and Business Media LLC, Vol. 41, No. 3 ( 2023-03), p. 399-408
    Abstract: The application of multiple omics technologies in biomedical cohorts has the potential to reveal patient-level disease characteristics and individualized response to treatment. However, the scale and heterogeneous nature of multi-modal data makes integration and inference a non-trivial task. We developed a deep-learning-based framework, multi-omics variational autoencoders (MOVE), to integrate such data and applied it to a cohort of 789 people with newly diagnosed type 2 diabetes with deep multi-omics phenotyping from the DIRECT consortium. Using in silico perturbations, we identified drug–omics associations across the multi-modal datasets for the 20 most prevalent drugs given to people with type 2 diabetes with substantially higher sensitivity than univariate statistical tests. From these, we among others, identified novel associations between metformin and the gut microbiota as well as opposite molecular responses for the two statins, simvastatin and atorvastatin. We used the associations to quantify drug–drug similarities, assess the degree of polypharmacy and conclude that drug effects are distributed across the multi-omics modalities.
    Type of Medium: Online Resource
    ISSN: 1087-0156 , 1546-1696
    URL: Article
    DOI: 10.1038/s41587-022-01520-x
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 1494943-X
    detail.hit.zdb_id: 1311932-1
    SSG: 12
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  • 3
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    Correction to: A Budget Impact and Cost Per Additional Responder Analysis for Baricitinib for the Treatment of Moderate-to-Severe Rheumatoid Arthritis in Patients with an Inadequate Response to Tumor Necrosis Factor Inhibitors in the USA
    Springer Science and Business Media LLC ; 2020
    In:  PharmacoEconomics Vol. 38, No. 1 ( 2020-01), p. 123-123
    Details
    In: PharmacoEconomics, Springer Science and Business Media LLC, Vol. 38, No. 1 ( 2020-01), p. 123-123
    Type of Medium: Online Resource
    ISSN: 1170-7690 , 1179-2027
    URL: Article
    DOI: 10.1007/s40273-019-00857-7
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2043876-X
    SSG: 15,3
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  • 4
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    Processes Underlying Glycemic Deterioration in Type 2 Diabetes: An IMI DIRECT Study
    American Diabetes Association ; 2021
    In:  Diabetes Care Vol. 44, No. 2 ( 2021-02-01), p. 511-518
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 44, No. 2 ( 2021-02-01), p. 511-518
    Abstract: We investigated the processes underlying glycemic deterioration in type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS A total of 732 recently diagnosed patients with T2D from the Innovative Medicines Initiative Diabetes Research on Patient Stratification (IMI DIRECT) study were extensively phenotyped over 3 years, including measures of insulin sensitivity (OGIS), β-cell glucose sensitivity (GS), and insulin clearance (CLIm) from mixed meal tests, liver enzymes, lipid profiles, and baseline regional fat from MRI. The associations between the longitudinal metabolic patterns and HbA1c deterioration, adjusted for changes in BMI and in diabetes medications, were assessed via stepwise multivariable linear and logistic regression. RESULTS Faster HbA1c progression was independently associated with faster deterioration of OGIS and GS and increasing CLIm; visceral or liver fat, HDL-cholesterol, and triglycerides had further independent, though weaker, roles (R2 = 0.38). A subgroup of patients with a markedly higher progression rate (fast progressors) was clearly distinguishable considering these variables only (discrimination capacity from area under the receiver operating characteristic = 0.94). The proportion of fast progressors was reduced from 56% to 8–10% in subgroups in which only one trait among OGIS, GS, and CLIm was relatively stable (odds ratios 0.07–0.09). T2D polygenic risk score and baseline pancreatic fat, glucagon-like peptide 1, glucagon, diet, and physical activity did not show an independent role. CONCLUSIONS Deteriorating insulin sensitivity and β-cell function, increasing insulin clearance, high visceral or liver fat, and worsening of the lipid profile are the crucial factors mediating glycemic deterioration of patients with T2D in the initial phase of the disease. Stabilization of a single trait among insulin sensitivity, β-cell function, and insulin clearance may be relevant to prevent progression.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc20-1567
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2021
    detail.hit.zdb_id: 1490520-6
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  • 5
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    758-P: Changes in Liver and Abdominal Fat in Tirzepatide-Treated Patients Achieving Normoglycemia in the SURPASS-3 MRI Substudy
    American Diabetes Association ; 2023
    In:  Diabetes Vol. 72, No. Supplement_1 ( 2023-06-20)
    Details
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: Tirzepatide (TZP), a novel, once-weekly GIP/GLP-1 receptor agonist, significantly reduced liver fat content (LFC) and volumes of visceral and abdominal subcutaneous adipose tissue (VAT and ASAT) vs insulin degludec in a subpopulation of patients in the SURPASS-3 phase 3 trial. This post-hoc analysis evaluated changes from baseline to Week 52 in these outcomes and other clinical and laboratory parameters in TZP-treated patients achieving or not achieving normoglycemia (HbA1c & lt;5.7%) at Week 52. LFC, VAT and ASAT volumes were assessed with MRI prior to randomization and at Week 52 in insulin-naïve patients with type 2 diabetes inadequately controlled on metformin with/without SGLT-2i and fatty liver index ≥60 at baseline. Analyses used pooled data from all TZP arms (5, 10, and 15 mg). Patients achieving HbA1c & lt;5.7% were slightly younger and had lower baseline HbA1c and VAT vs those not achieving HbA1c & lt;5.7%. Substantial reductions in LFC, VAT and ASAT volumes, weight, HbA1c, and overall improvement in lipids profile were observed in both subsets of patients (Table). Among patients achieving HbA1c & lt;5.7% and ≥5.7%, respectively, 56% and 27% achieved LFC & lt;6%, and 91% and 64% achieved ≥30% reduction in LFC. In summary, in TZP-treated patients, changes in LFC, VAT and ASAT, and lipids were more pronounced in those achieving normoglycemia. Disclosure Á.Rodríguez: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. K.Cusi: Consultant; Poxel SA, Altimmune, Arrowhead Pharmaceuticals, Inc., AstraZeneca, 89bio, Inc., Bristol-Myers Squibb Company, Lilly, Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Medscape, Myovant, Novo Nordisk, ProSciento, Quest Diagnostics, Sagimet, Sonic Incytes, Terns, Research Support; Echosens, Inventiva, LabCorp, Zydus. A.Gastaldelli: Advisory Panel; Pfizer Inc., Novo Nordisk, Merck Sharp & Dohme Corp., Boehringer Ingelheim International GmbH, Consultant; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Fractyl Health, Inc., Merck Sharp & Dohme Corp., Other Relationship; Pfizer Inc., Speaker's Bureau; Eli Lilly and Company. C.Nicolay: Employee; Eli Lilly and Company. A.Torcello-gomez: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. L.Fernandez lando: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company
    Type of Medium: Online Resource
    ISSN: 0012-1797
    URL: Article
    DOI: 10.2337/db23-758-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
    detail.hit.zdb_id: 1501252-9
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  • 6
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    772-P: Tirzepatide vs. Basal Insulins in People with T2D and Different Baseline Glycemic Patterns—Post Hoc Analyses of the SURPASS-3 and -4 Trials
    American Diabetes Association ; 2023
    In:  Diabetes Vol. 72, No. Supplement_1 ( 2023-06-20)
    Details
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: While basal insulins act primarily by reducing fasting serum glucose (FSG), the once-weekly GIP/GLP-1 receptor agonist tirzepatide targets both FSG and postprandial glucose (PPG). This post-hoc analysis assessed the efficacy of tirzepatide vs insulin degludec (SURPASS-3) and glargine (SURPASS-4) in people with T2D and different baseline glycemic patterns. We assessed change from baseline to Week 52 in HbA1c, FSG, and PPG across subgroup categories in participants on assigned treatment without rescue medication (efficacy estimand) using mixed-model repeated measures. Four subgroups were defined by different combinations of FSG and PPG (low FSG/low PPG, low FSG/high PPG, high FSG/low PPG, high FSG/high PPG). Low and high FSG and PPG were split based on median values of these parameters in SURPASS-3 (162 and 187 mg/dL) and -4 (164 and 197 mg/dL). While reductions in FSG were generally similar between tirzepatide and the basal insulins in both studies, decreases in PPG were greater with tirzepatide in all subgroups. This resulted in greater HbA1c reductions with tirzepatide vs basal insulin in all subgroups. The extent of reduction in FSG, PPG, and HbA1c in each subgroup was related to baseline values of these parameters. These data support previous observations of superior glycemic control with TZP compared with basal insulin, irrespective of baseline FSG and PPG levels. Disclosure F.Giorgino: Advisory Panel; Boehringer-Ingelheim, Amarin Corporation, Medtronic, Roche Diabetes Care, Sanofi, Bayer Inc., Novo Nordisk, Consultant; Novo Nordisk, Lilly, Research Support; Lilly, Roche Diabetes Care, AlfaSigma, Speaker's Bureau; Abbott, Boehringer-Ingelheim, Lilly, Sanofi, Medscape. D.R.Franco: Advisory Panel; Abbott, Eli Lilly and Company, Medtronic, Speaker's Bureau; Eli Lilly and Company, Boehringer Ingelheim and Eli Lilly Alliance, Medtronic, Sanofi, AstraZeneca, Roche Diabetes Care, Abbott Diabetes. C.Nicolay: Employee; Eli Lilly and Company. A.Hemmingway: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. Á.Rodríguez: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. R.Wiese: Employee; Eli Lilly and Company. Funding Eli Lilly and Company
    Type of Medium: Online Resource
    ISSN: 0012-1797
    URL: Article
    DOI: 10.2337/db23-772-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
    detail.hit.zdb_id: 1501252-9
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  • 7
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    General versus central adiposity as risk factors for cardiovascular-related outcomes in a high-risk population with type 2 diabetes: a post hoc analysis of the REWIND trial
    Springer Science and Business Media LLC ; 2023
    In:  Cardiovascular Diabetology Vol. 22, No. 1 ( 2023-03-10)
    Details
    In: Cardiovascular Diabetology, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2023-03-10)
    Abstract: In clinical practice, anthropometric measures other than BMI are rarely assessed yet may be more predictive of cardiovascular (CV) risk. We analyzed the placebo group of the REWIND CV Outcomes Trial to compare several anthropometric measures as baseline risk factors for cardiovascular disease (CVD)-related outcomes in participants with type 2 diabetes (T2D). Methods Data from the REWIND trial placebo group (N = 4952) were analyzed. All participants had T2D, age ≥ 50 years, had either a previous CV event or CV risk factors, and a BMI of ≥ 23 kg/m 2 . Cox proportional hazard models were used to investigate if BMI, waist-to-hip ratio (WHR), and waist circumference (WC) were significant risk factors for major adverse CV events (MACE)-3, CVD-related mortality, all-cause mortality, and heart failure (HF) requiring hospitalization. Models were adjusted for age, sex, and additional baseline factors selected by LASSO method. Results are presented for one standard deviation increase of the respective anthropometric factor. Results Participants in the placebo group experienced 663 MACE-3 events, 346 CVD-related deaths, 592 all-cause deaths, and 226 events of HF requiring hospitalization during the median follow-up of 5.4 years. WHR and WC, but not BMI, were identified as independent risk factors of MACE-3 (hazard ratio [HR] for WHR: 1.11 [95% CI 1.03 to 1.21] ; p = 0.009; HR for WC: 1.12 [95% CI 1.02 to 1.22]; p = 0.012). WC adjusted for hip circumference (HC) showed the strongest association with MACE-3 compared to WHR, WC, or BMI unadjusted for each other (HR: 1.26 [95% CI 1.09 to 1.46] ; p = 0.002). Results for CVD-related mortality and all-cause mortality were similar. WC and BMI were risk factors for HF requiring hospitalization, but not WHR or WC adjusted for HC (HR for WC: 1.34 [95% CI 1.16 to 1.54]; p  〈  0.001; HR for BMI: 1.33 [95% CI 1.17 to 1.50]; p  〈  0.001). No significant interaction with sex was observed. Conclusions In this post hoc analysis of the REWIND placebo group, WHR, WC and/or WC adjusted for HC were risk factors for MACE-3, CVD-related mortality, and all-cause mortality; while BMI was only a risk factor for HF requiring hospitalization. These findings indicate the need for anthropometric measures that consider body fat distribution when assessing CV risk.
    Type of Medium: Online Resource
    ISSN: 1475-2840
    URL: Article
    DOI: 10.1186/s12933-023-01757-z
    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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    Prostaglandin E2 Affects Interleukin 6 and Monocyte Chemoattractant Protein 1/CCL2 Production by Cultured Stem Cells of Apical Papilla
    Elsevier BV ; 2020
    In:  Journal of Endodontics Vol. 46, No. 3 ( 2020-03), p. 413-418
    Details
    In: Journal of Endodontics, Elsevier BV, Vol. 46, No. 3 ( 2020-03), p. 413-418
    Type of Medium: Online Resource
    ISSN: 0099-2399
    URL: Article
    DOI: 10.1016/j.joen.2019.12.001
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2020
    detail.hit.zdb_id: 2083582-6
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  • 9
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    Growth response to an individualized versus fixed dose GH treatment in short children born small for gestational age: the OPTIMA study
    Oxford University Press (OUP) ; 2009
    In:  European Journal of Endocrinology Vol. 160, No. 2 ( 2009-02), p. 149-156
    Details
    In: European Journal of Endocrinology, Oxford University Press (OUP), Vol. 160, No. 2 ( 2009-02), p. 149-156
    Abstract: Initial GH-induced catch up growth is highly variable in short children born small for gestational age (SGA) and mainly influenced by age at start of therapy and GH dose. This study compared the first year growth-promoting effect of an individually adjusted GH dose (IAD) versus a fixed high GH dose (FHD) in pre-pubertal children born SGA with severe short stature. Design This was a randomized, open-label, multi-center study. Methods The FHD group received 0.067 mg/kg per day GH throughout the 12-month study. The IAD group initially received 0.035 mg/kg per day GH; at 3 months the Cologne growth-prediction model for first year change in height SDS was applied; if predicted change was 〈 0.75, GH was increased to 0.067 mg/kg per day for the remaining 9 months, otherwise the initial dose was continued. Results In the IAD group, 38 out of the 80 patients required the higher GH dose from month 3. From an ANCOVA for non-inferiority, mean difference in change in height SDS between IAD and FHD groups was −0.24 (95% confidence interval (CI) −0.35: −0.12), the CI for height SDS being above the pre-defined non-inferiority margin of −0.5. GH dose reductions due to IGF-I SDS 〉 0.5 and IGFBP-3 SDS 〈 −0.5 were performed in 4/99 FHD patients, but none of the IAD group patients. Safety data were similar between groups. Conclusion With a mean treatment group difference of 1 cm in 12-month growth response, although statistically significant, the IAD group was considered non-inferior compared with the FHD group. Early growth prediction can be used to tailor the dose to the individual patient's needs, resulting in lower overall GH dose.
    Type of Medium: Online Resource
    ISSN: 0804-4643 , 1479-683X
    URL: Article
    DOI: 10.1530/EJE-08-0301
    RVK:
    WA 15000
    Language: Unknown
    Publisher: Oxford University Press (OUP)
    Publication Date: 2009
    detail.hit.zdb_id: 1485160-X
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  • 10
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    A Network Meta-Analysis to Compare Effectiveness of Baricitinib and Other Treatments in Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate
    The Journal of Health Economics and Outcomes Research ; 2020
    In:  Journal of Health Economics and Outcomes Research ( 2020-04-10), p. 10-23
    Details
    In: Journal of Health Economics and Outcomes Research, The Journal of Health Economics and Outcomes Research, ( 2020-04-10), p. 10-23
    Abstract: Background/Objectives: This article compares the effectiveness of baricitinib (BARI) 4 mg (oral, Janus kinase [JAK] 1/2 inhibitor) versus other targeted synthetic/biologic disease-modifying antirheumatic drugs, in combination with methotrexate (MTX), in moderate-to-severe rheumatoid arthritis patients with inadequate response (IR) to MTX. Methods: A systematic literature review was conducted to identify randomized controlled trials (RCTs) of the interventions of interest. Bayesian network meta-analyses (NMA) were used to compare American College of Rheumatology (ACR) responses at 24 weeks. A series of prespecified sensitivity analyses addressed the potential impact of, among others, baseline risk, treatment effect modifiers, and trial design on treatment response. Results: Nineteen RCTs were included in the NMA (primary analysis). For ACR20, BARI 4 mg + MTX was found to be more effective than adalimumab (ADA) 40 mg + MTX (Odds Ratio [OR] 1.33), abatacept (ABA) 10 mg + MTX (IV/4 weeks) (OR 1.45), infliximab (IFX) 3 mg + MTX (IV/8 wks) (OR 1.63), and rituximab (RTX) 1000 mg + MTX (OR 1.63). No differences were found on ACR50. For ACR70, BARI 4 mg + MTX was more effective than ADA 40 mg + MTX (OR 1.37), ABA 10 mg + MTX (OR 1.86), and RTX 1000 mg + MTX (OR 2.26). Sensitivity analysis including 10 additional RCTs with up to 20% of patients with prior biologic use showed BARI 4 mg + MTX to be more effective than tocilizumab (TCZ) 8 mg + MTX on ACR20 (OR 1.44). Results for all sensitivity analyses were consistent with the direction and magnitude of the primary results. Key limitations include the time span in which trials were conducted (1999–2017), during which patient characteristics and treatment approaches might have changed. Conclusion: This NMA suggests that BARI 4 mg + MTX is an efficacious treatment option in the MTX-IR population as evidenced by the robustness of results.
    Type of Medium: Online Resource
    ISSN: 2327-2236
    URL: Journal
    URL: Article
    DOI: 10.36469/00001
    DOI: 10.36469/jheor.2020.12273
    Language: Unknown
    Publisher: The Journal of Health Economics and Outcomes Research
    Publication Date: 2020
    detail.hit.zdb_id: 2746906-2
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