44 results on '"Lebrec J"'
Search Results
2. PDB39 Dosing Patterns Among Patients with Type 2 Diabetes (T2D) Initiating Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAS) in France and the Netherlands
- Author
-
Norrbacka, K., primary, Divino, V., additional, Lebrec, J., additional, Vadher, K., additional, and DeKoven, M., additional
- Published
- 2021
- Full Text
- View/download PDF
3. Clinical characteristics, treatment patterns and persistence in patients with T2D initiating a Glucagon-like-peptide 1 receptor agonists (GLP-1 RA): a retrospective analysis of the Diabetes Prospective Follow-Up (DPV) registry
- Author
-
Jung, H, additional, Tittel, SR, additional, Schloot, N, additional, Heitmann, E, additional, Otto, T, additional, Lebrec, J, additional, Hummel, M, additional, Pavel, M, additional, Naudorf, M, additional, and Lanzinger, S, additional
- Published
- 2021
- Full Text
- View/download PDF
4. PDB119 GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS IN TYPE 2 DIABETES MELLITUS (T2DM): DATA FROM A REAL WORLD STUDY IN SPAIN
- Author
-
Norrbacka, K., primary, Sicras-Mainar, A., additional, Hernández, I., additional, Tofé-Povedano, S., additional, Díaz Cerezo, S., additional, Artime, E., additional, Lebrec, J., additional, and Romera, I., additional
- Published
- 2019
- Full Text
- View/download PDF
5. How useful is the EQ-5D in assessing the impact of caring for people with Alzheimer's disease?
- Author
-
Reed C, Barrett A, Lebrec J, Dodel R, Jones RW, Vellas B, Wimo A, Argimon JM, Bruno G, and Haro JM
- Subjects
Europe ,Health-related quality of life ,Observational study ,Caregiver burden ,Alzheimer’s disease ,Informal care - Abstract
BACKGROUND: The impact on informal caregivers of caring for people with Alzheimer's disease (AD) dementia can be substantial, but it remains unclear which measures(s) best assess such impact. Our objective was to use data from the GERAS study to assess the ability of the EuroQol 5-dimension questionnaire (EQ-5D) to measure the impact on caregivers of caring for people with AD dementia and to examine correlations between EQ-5D and caregiver burden. METHODS: GERAS was a prospective, non-interventional cohort study in community-dwelling patients with AD dementia and their informal caregivers. The EQ-5D and Zarit Burden Interview (ZBI) were used to measure health-related quality of life and caregiver burden, respectively. Resource-use data collected included caregiver time spent with the patient on activities of daily living (ADL). Spearman correlations were computed between EQ-5D scores, ZBI scores, and time spent on instrumental ADL (T-IADL) at baseline, 18 months, and for 18-month change scores. T-IADL and ZBI change scores were summarized by EQ-5D domain change category (better/stable/worse). RESULTS: At baseline, 1495 caregivers had mean EQ-5D index scores of 0.86, 0.85, and 0.82, and ZBI total scores of 24.6, 29.4, and 34.1 for patients with mild, moderate, and moderately severe/severe AD dementia, respectively. Change in T-IADL showed a stronger correlation with change in ZBI (0.12; P < 0.001) than with change in EQ-5D index score (0.02; P = 0.546) although both correlations were very weak. Worsening within EQ-5D domains was associated with increases in ZBI scores, although 68%-90% of caregivers remained stable within each EQ-5D domain. There was no clear pattern for change in T-IADL by change in EQ-5D domain. CONCLUSIONS: EQ-5D may not be the optimum measure of the impact of caring for people with AD dementia due to its focus on physical health. Alternative measures need further investigation.
- Published
- 2017
6. PDB110 - TREATMENT PERSISTENCE IN PATIENTS WITH TYPE 2 DIABETES TREATED WITH GLP-1 RECEPTOR AGONISTS IN CLINICAL PRACTICE IN SWEDEN: NATIONWIDE RETROSPECTIVE COHORT STUDY
- Author
-
Toll, A., primary, Eliasson, B., additional, Lebrec, J., additional, Karlsdotter, K., additional, Miftaraj, M., additional, Franzen, S., additional, and Svensson, A., additional
- Published
- 2018
- Full Text
- View/download PDF
7. PDB112 - TREATMENT AND DOSING PATTERNS AMONG PATIENTS WITH TYPE 2 DIABETES (T2D) INITIATING GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS (GLP-1 RAS) IN SEVERAL COUNTRIES
- Author
-
Norrbacka, K., primary, Divino, V., additional, Boye, K., additional, Lebrec, J., additional, and Dekoven, M., additional
- Published
- 2018
- Full Text
- View/download PDF
8. Drug uilization patterns in patients Initiating glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for the treatment of type 2 diabetes (T2D) in Germany: A retrospective cohort study
- Author
-
Jung, H, additional, Otto, T, additional, Lebrec, J, additional, Myland, M, additional, Richter, H, additional, and Norrbacka, K, additional
- Published
- 2018
- Full Text
- View/download PDF
9. Reduction of HbA1c with dulaglutide in type 2 diabetes (T2D) patients negative, low positive or high positive for GAD antibodies (GADA): a post hoc analysis of AWARD -2, -4 and -5
- Author
-
Pozzilli, P, additional, Leslie, RD, additional, Peters, AL, additional, Buzzetti, R, additional, Shankar, SS, additional, Milicevic, Z, additional, Pavo, I, additional, Lebrec, J, additional, Martin, S, additional, and Nanette, CS, additional
- Published
- 2018
- Full Text
- View/download PDF
10. Real-world Alzheimer’s disease drug treatment – 18-month results from an observational study in three European countries (GERAS; encore from 2016 EAN)
- Author
-
Ueda, K., primary, Reed, C., additional, Lebrec, J., additional, and Dell’Agnello, G., additional
- Published
- 2017
- Full Text
- View/download PDF
11. Predictors of Disease Progression in Mild Alzheimer’s Disease Dementia Patients – Results From the Geras Real World Cohort and Expedition Trials
- Author
-
Reed, C, primary, Lebrec, J, additional, Andrews, JS, additional, Bruno, G, additional, and Jones, RW, additional
- Published
- 2016
- Full Text
- View/download PDF
12. Burden of illness and health care resource utilization in adult psychiatric outpatients with attention-deficit/hyperactivity disorder in Europe
- Author
-
Karlsdotter, K., Bushe, C., Hakkaart, L., Sobanski, E., Kan, C.C., Lebrec, J., Kraemer, S., Dieteren, N.A., Deberdt, W., Karlsdotter, K., Bushe, C., Hakkaart, L., Sobanski, E., Kan, C.C., Lebrec, J., Kraemer, S., Dieteren, N.A., and Deberdt, W.
- Abstract
Item does not contain fulltext, OBJECTIVE: To assess the burden of illness and health care resource utilization of adult nonpsychotic psychiatric outpatients with attention-deficit/hyperactivity disorder (ADHD) in Europe. METHODS: This was a multicountry, cross-sectional, observational study where unselected routine patients from clinical psychiatric outpatient settings were screened and assessed for ADHD. Patients were evaluated using the Clinical Global Impressions of Severity (CGI-S) scale, the Sheehan Disability Scale (SDS), and the EuroQol-5 Dimensions questionnaire. Data on comorbidities, functional impairment, and health care resource utilization were captured. RESULTS: The study enrolled 2284 patients, of whom 1986 completed the study. The prevalence of ADHD was 17.4%, of whom 46.0% had a previous ADHD diagnosis. Patients with ADHD had a high clinical burden with psychiatric comorbidities, especially depression (43.0%) and anxiety disorders (36.4%). Substance abuse (9.2% vs. 3.4%) and alcohol abuse (10.3% vs. 5.2%) were more common in the ADHD cohort vs. the non-ADHD cohort. Only 11.5% of the patients with ADHD had no other psychiatric disorder. Various measures indicated a significantly poorer level of functioning for patients with ADHD than without ADHD, as indicated by higher scores for CGI-S (3.8 vs. 3.3) and SDS (18.9 vs. 11.6) and higher percentages of debt (35.5% vs. 24.3%) and criminality (13.8% vs. 6.1%). Lastly, the health care resource utilization was considerable and similar between adult psychiatric outpatients diagnosed and not diagnosed with ADHD. CONCLUSIONS: Although care was taken when choosing the sites for this study, to make it representative of the general outpatient adult psychiatric population, caution should be advised in generalizing the findings of our study to the general ADHD or psychiatric outpatient population. This was an observational study, thus no inference on causality can be drawn. Having ADHD imposes a considerable health and social burden on patient a
- Published
- 2016
13. How Useful are Eq-5d And Zbi In Assessing The Impact of Caring for Alzheimer’s Disease Patients?
- Author
-
Reed, C, primary, Barrett, A, additional, Lebrec, J, additional, Dodel, R, additional, Jones, RW, additional, Vellas, B, additional, Wimo, A, additional, Argimon, JM, additional, Bruno, G, additional, and Haro, JM, additional
- Published
- 2015
- Full Text
- View/download PDF
14. 51 * COST AND RESOURCE USE IN NON-INSTITUTIONALISED ALZHEIMER'S PATIENTS - RESULTS FROM AN OBSERVATIONAL STUDY IN THE UK OVER 18 MONTHS
- Author
-
Lenox-Smith, A., primary, Reed, C., additional, Lebrec, J., additional, Belger, M., additional, Smyth, A., additional, and Jones, R. W., additional
- Published
- 2015
- Full Text
- View/download PDF
15. The Effect of Attention-Deficit/Hyperactivity Disorder on Functioning and Resource Utilization by Psychiatric Outpatients in Europe
- Author
-
Televantou, F., primary, Sobanski, E., additional, Kan, C.C., additional, Lebrec, J., additional, Kraemer, S., additional, Dieteren, N.A.H.M., additional, and Deberdt, W., additional
- Published
- 2014
- Full Text
- View/download PDF
16. P.1.k.019 Prevalence of ADHD in non-psychotic adult psychiatric care (ADPSYC): a multinational cross-sectional study in Europe
- Author
-
Thome, J., primary, Lebrec, J., additional, Kraemer, S., additional, Fregenal, I., additional, Ramos-Quiroga, J.A., additional, Arif, M., additional, and Deberdt, W., additional
- Published
- 2014
- Full Text
- View/download PDF
17. PND5 - Predictors of Disease Progression in Mild Alzheimer’s Disease Dementia Patients – Results From the Geras Real World Cohort and Expedition Trials
- Author
-
Reed, C, Lebrec, J, Andrews, JS, Bruno, G, and Jones, RW
- Published
- 2016
- Full Text
- View/download PDF
18. PMH28 - The Effect of Attention-Deficit/Hyperactivity Disorder on Functioning and Resource Utilization by Psychiatric Outpatients in Europe
- Author
-
Televantou, F., Sobanski, E., Kan, C.C., Lebrec, J., Kraemer, S., Dieteren, N.A.H.M., and Deberdt, W.
- Published
- 2014
- Full Text
- View/download PDF
19. PND67 - How Useful are Eq-5d And Zbi In Assessing The Impact of Caring for Alzheimer’s Disease Patients?
- Author
-
Reed, C, Barrett, A, Lebrec, J, Dodel, R, Jones, RW, Vellas, B, Wimo, A, Argimon, JM, Bruno, G, and Haro, JM
- Published
- 2015
- Full Text
- View/download PDF
20. The real-world observational prospective study of health outcomes with dulaglutide and liraglutide in type 2 diabetes patients (TROPHIES): resource use and costs of treatment in clinical practice in France, Germany, and Italy.
- Author
-
Barrett A, Boye KS, García-Pérez LE, Giorgino F, Guerci B, Füchtenbusch M, Yu M, Sapin H, Dib A, Heitmann E, Federici MO, and Lebrec J
- Subjects
- Humans, Male, Female, Prospective Studies, Middle Aged, Aged, Health Resources statistics & numerical data, Health Resources economics, Models, Econometric, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 economics, Liraglutide therapeutic use, Liraglutide economics, Glucagon-Like Peptides analogs & derivatives, Glucagon-Like Peptides therapeutic use, Glucagon-Like Peptides economics, Glucagon-Like Peptides administration & dosage, Immunoglobulin Fc Fragments therapeutic use, Immunoglobulin Fc Fragments economics, Recombinant Fusion Proteins economics, Recombinant Fusion Proteins therapeutic use, Recombinant Fusion Proteins administration & dosage, Hypoglycemic Agents therapeutic use, Hypoglycemic Agents economics
- Abstract
Aims: To describe healthcare resource utilization (HCRU) and associated costs after initiation of injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy by adult patients with type 2 diabetes (T2D) in the prospective, observational, 24-month TROPHIES study in France, Germany, and Italy., Materials and Methods: HCRU data for cost calculations were collected by treating physicians during patient interviews at baseline and follow-up visits approximately 6, 12, 18, and 24 months after GLP-1 RA initiation with once-weekly dulaglutide or once-daily liraglutide. Costs were evaluated from the national healthcare system (third-party payer) perspective and updated to 2018 prices., Results: In total, 2,005 patients were eligible for the HCRU analysis (1,014 dulaglutide; 991 liraglutide). Baseline patient characteristics were generally similar between treatment groups and countries. The largest proportions of patients using ≥2 oral glucose-lowering medications (GLMs) at baseline (42.9-43.4%) and month 24 (44.0-45.1%) and using another injectable GLM at month 24 (15.3-23.2%) were in France. Mean numbers of primary and secondary healthcare contacts during each assessment period were highest in France (range = 4.0-10.7) and Germany (range = 2.9-5.7), respectively. The greatest proportions (≥60%) of mean annualized costs per patient comprised medication costs. Mean annualized HCRU costs per patient varied by treatment cohort and country: the highest levels were in the liraglutide cohort in France (€909) and the dulaglutide cohort in Germany (€883)., Limitations: Limitations included exclusion of patients using insulin at GLP-1 RA initiation and collection of HCRU data by physician, not via patient-completed diaries., Conclusions: Real-world HCRU and costs associated with the treatment of adults with T2D with two GLP-1 RAs in TROPHIES emphasize the need to avoid generalization with respect to HCRU and costs associated with a particular therapy when estimating the impact of a new treatment in a country-specific setting.
- Published
- 2024
- Full Text
- View/download PDF
21. The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES): Final patient-reported outcomes at 24 months.
- Author
-
Boye KS, Lebrec J, Dib A, Heitmann E, Federici MO, Yu M, Sapin H, Barrett A, Guerci B, Giorgino F, Füchtenbusch M, and García-Pérez LE
- Subjects
- Adult, Humans, Glucagon-Like Peptide-1 Receptor agonists, Glucagon-Like Peptides therapeutic use, Hypoglycemic Agents therapeutic use, Immunoglobulin Fc Fragments therapeutic use, Liraglutide therapeutic use, Outcome Assessment, Health Care, Patient Reported Outcome Measures, Prospective Studies, Quality of Life, Recombinant Fusion Proteins therapeutic use, Diabetes Mellitus, Type 2 drug therapy
- Abstract
Aim: To report health-related patient-reported outcomes (PROs) in people with type 2 diabetes (T2D) initiating their first injectable glucose-lowering medication (GLM) with two commonly prescribed glucagon-like peptide-1 receptor agonists (GLP-1RAs) from the prospective, observational TROPHIES study (The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients)., Materials and Methods: TROPHIES was a two-cohort, 24-month study conducted in France, Germany and Italy. Adults with a T2D diagnosis, naïve to injectable treatment for T2D and prescribed dulaglutide or liraglutide as their first injectable GLM, were eligible for inclusion. Study objectives included describing the following PROs associated with the treatment of T2D with GLP-1RAs: health-related quality of life; impact of weight on self-perception; life and work productivity; and patient satisfaction with treatment and injection device. Additional analyses formally compared PRO measures between the treatment cohorts., Results: Overall, improvements from baseline in PRO scores were observed among people who started dulaglutide or liraglutide. A more pronounced trend of improvement was observed in the dulaglutide cohort for changes from baseline in treatment satisfaction and impact of weight on self-perception, supported by statistically significant differences between treatment cohorts in additional comparative analyses at 12, 18 and 24 months. More positive patient perceptions of the injection device were observed with dulaglutide than with liraglutide., Conclusions: Improvements in PROs observed in TROPHIES, which were more evident with dulaglutide than liraglutide, reflect a relevant clinical benefit. From the patients' perspective, satisfaction, and confidence in continuing treatment with GLP-1RAs is likely to contribute to long-term treatment persistence., (© 2023 Eli Lilly and Company and The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
- Published
- 2023
- Full Text
- View/download PDF
22. The real-world observational prospective study of health outcomes with dulaglutide and liraglutide in patients with type 2 diabetes (TROPHIES): Final, 24-month analysis of time to first significant treatment change, treatment persistence and clinical outcomes.
- Author
-
Giorgino F, Guerci B, Füchtenbusch M, Lebrec J, Boye K, Orsini Federici M, Heitmann E, Dib A, Yu M, Sapin H, and García-Pérez LE
- Subjects
- Humans, Glucagon-Like Peptides therapeutic use, Glycated Hemoglobin, Hypoglycemic Agents therapeutic use, Immunoglobulin Fc Fragments therapeutic use, Liraglutide therapeutic use, Outcome Assessment, Health Care, Prospective Studies, Recombinant Fusion Proteins therapeutic use, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 epidemiology
- Abstract
Aims: To present the final results of the TROPHIES study (The real-world observational prospective study of health outcomes with dulaglutide and liraglutide in patients with type 2 diabetes)., Materials and Methods: The prospective, real-world TROPHIES study included patients with type 2 diabetes initiating their first injectable glucose-lowering medication (GLM), dulaglutide or liraglutide, in France, Germany and Italy. The primary endpoint was the time spent on dulaglutide or liraglutide until a significant treatment change over 24 months. Other endpoints measured persistence with treatment, clinical outcomes (glycated haemoglobin [HbA1c] and weight) and treatment patterns. Kaplan-Meier estimates of time to first significant treatment change and persistence with treatment were generated. Propensity-score-based inverse probability of treatment weighting (IPTW) was used to adjust for baseline imbalances in the comparison between cohorts., Results: The 286 of 1014 patients (28.2%) in the dulaglutide cohort and 448 of 991 patients (45.2%) in the liraglutide cohort had a significant treatment change over 24 months. By IPTW analysis, dulaglutide-initiating patients were less likely to have a significant treatment change (hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.46-0.63) and more likely to be persistent with treatment (HR 0.69, 95% CI 0.56-0.86) over 24 months than liraglutide-initiating patients. Dulaglutide and liraglutide yielded similar HbA1c (-11.80 mmol/mol [1.08%] and -11.91 mmol/mol [1.09%]) and weight (-3.5 kg and -3.3 kg) reductions from baseline to 24 months. Few changes in patterns of treatment with other GLMs were observed in the two cohorts., Conclusions: Dulaglutide-initiating patients had a longer time spent without any significant treatment change and higher persistence than those initiating liraglutide. Treatment with either glucagon-like peptide-1 receptor agonist yielded similar and clinically meaningful reductions in HbA1c and body weight., (© 2023 Eli Lilly and Company and The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
- Published
- 2023
- Full Text
- View/download PDF
23. Clinical characteristics, treatment patterns, and persistence in individuals with type 2 diabetes initiating a glucagon-like peptide-1 receptor agonist: A retrospective analysis of the Diabetes Prospective Follow-Up Registry.
- Author
-
Jung H, Tittel SR, Schloot NC, Heitmann E, Otto T, Lebrec J, Pavel M, and Lanzinger S
- Subjects
- Adult, Aged, Female, Humans, Male, Middle Aged, Follow-Up Studies, Glucagon-Like Peptide 1, Glucagon-Like Peptide-1 Receptor agonists, Glycated Hemoglobin, Hypoglycemic Agents, Insulin, Insulin, Regular, Human, Prospective Studies, Retrospective Studies, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 epidemiology
- Abstract
Aims: To describe clinical characteristics, treatment patterns and glucagon-like peptide-1 receptor agonist (GLP-1 RA) persistence in individuals with type 2 diabetes (T2D) initiating their first GLP-1 RA., Materials and Methods: A real-world analysis of adults with T2D initiating GLP-1 RA therapy between 2007 and June 2020 from the multicentre Diabetes Prospective Follow-Up (DPV) Registry, stratified by antidiabetes therapy at the time of GLP-1 RA initiation: oral antidiabetic drugs (OAD), insulin ± OAD or lifestyle modification (LM). GLP-1 RA treatment persistence in individuals with ≥12 months follow-up was determined by Kaplan-Meier analysis., Results: Overall, 15 111 individuals with T2D initiating GLP-1 RA therapy (55% men) were identified; median [interquartile range (IQR)] age [58.7 (50.6-66.7) years], diabetes duration [8.5 (3.6-14.7) years], glycated haemoglobin [HbA1c; 8.2 (7.1-9.8)%]. Median (95% confidence interval) GLP-1 RA persistence in eligible individuals (n = 5189) was 11 (10-12) months; OAD 12 (11-14) months (n = 2453); insulin ± OAD 11 (9-12) months (n = 2204); and LM 7 (5-9) months (n = 532). Median treatment persistence tended to increase from 2007-2012 to 2017-2020. Median (IQR) HbA1c decreased from baseline [8.2 (7.1-9.8)%] to discontinuation [7.5 (6.6-8.7)%], with a greater decrease observed in individuals with persistence >12 months versus ≤12 months. Individuals who discontinued GLP-1 RA therapy predominantly switched to insulin (if not already using) or dipeptidyl peptidase-4 inhibitors., Conclusion: Real-world registry data revealed improved outcomes with longer median GLP-1 RA persistence; ~50% of patients overall achieved HbA1c <7% at 12 months. Persistence was highest with baseline OAD and/or insulin, and tended to increase over the period 2007-2020., (© 2023 Eli Lilly and Company and The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
- Published
- 2023
- Full Text
- View/download PDF
24. Age-dependent prevalence of type 2 diabetes, cardiovascular risk profiles and use of diabetes drugs in Germany using health claims data.
- Author
-
Otto T, Diesing J, Borchert J, Heitmann E, C Schloot N, Lebrec J, Müller-Wieland D, and Haeckl D
- Subjects
- Humans, Aged, Risk Factors, Prevalence, Hypoglycemic Agents therapeutic use, Heart Disease Risk Factors, Insulin therapeutic use, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 epidemiology, Cardiovascular Diseases prevention & control
- Abstract
Aims: This study evaluates type 2 diabetes mellitus (T2DM) prevalence in Germany, focusing on patients at risk for, or with already established, cardiovascular disease (CVD), as well as their antidiabetic and cardiovascular treatments., Materials and Methods: Using anonymized claims data from the WIG2 database, we calculated 2018 T2DM prevalence, extrapolating rates to the German statutory health insurance population. In the study period, 3 376 228 patients were eligible in the database. Forming antidiabetic medication groups, we evaluated treatment regimens of patients at risk for, or with already established CVD, based on the REWIND study criteria. We also evaluated their CVD medication prescriptions., Results: Statutory health insurance extrapolated T2DM prevalence was estimated at 11.9%, with higher prevalence rates in older patients. When only patients with prescriptions of antidiabetic drugs were included, prevalence was 7.6%. At least 94% of patients with T2DM medication had at least one risk factor (without considering age) according to REWIND criteria, while 67%-80% had at least two risk factors depending on treatment received. Patients taking insulin combined with oral therapy comprised the largest proportion of patients with at least two REWIND risk factors. Approximately 85% of all patients with T2DM in the population were treated with antihypertensive medication., Conclusions: T2DM is widespread and affects older patients particularly. Most patients with T2DM had at least one CV risk factor, and about half already had established CVD. Early prevention of CVD, which disproportionately affects patients with T2DM, is necessary. Furthermore, the treatment of older patients with T2DM with insulin is still common and needs further evaluation., (© 2022 Lilly Germany GmbH. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
- Published
- 2023
- Full Text
- View/download PDF
25. The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Patients with Type 2 Diabetes (TROPHIES): Patient disposition, clinical characteristics and treatment persistence at 12 months.
- Author
-
Guerci B, Giorgino F, Sapin H, Boye K, Lebrec J, Federici MO, Heitmann E, Dib A, Füchtenbusch M, and García-Pérez LE
- Subjects
- Humans, Prospective Studies, Glycated Hemoglobin, Drug Administration Schedule, Glucagon-Like Peptides, Immunoglobulin Fc Fragments adverse effects, Recombinant Fusion Proteins adverse effects, Hypoglycemic Agents, Glucagon-Like Peptide 1, Outcome Assessment, Health Care, Glucagon-Like Peptide-1 Receptor agonists, Liraglutide, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 chemically induced
- Abstract
Aims: The primary objective of the TROPHIES observational study is to estimate the duration of treatment on dulaglutide or liraglutide without a significant treatment change by 24 months in patients with type 2 diabetes (T2D) initiating their first injectable treatment with these glucagon-like peptide-1 receptor agonists (GLP-1 RAs). This manuscript presents 12-month interim data., Materials and Methods: TROPHIES is a prospective, non-comparative, observational study of patients with T2D in Europe, naïve to injectable antihyperglycaemic treatments and initiating dulaglutide or liraglutide. Data on clinical characteristics, GLP-1 RA persistence and treatment patterns of glucose-lowering medication were collected at initiation of first injectable therapy and by 12 months., Results: By 12 months, 1014 dulaglutide and 991 liraglutide patients were eligible across France, Germany and Italy. Both cohorts presented a high probability [95% confidence interval (CI)] of GLP-1 RA persistence [dulaglutide, 0.88 (0.86 to 0.90); liraglutide, 0.83 (0.80 to 0.85)] and reduction in mean glycated haemoglobin percentage (95% CI) from baseline [dulaglutide, -1.18 (-1.27 to -1.08); liraglutide, -1.15 (-1.26 to -1.05)] with 48.2% of dulaglutide and 41.2% of liraglutide patients reaching their individualized glycated haemoglobin percentage target set by the physician at baseline. Mean weight (95% CI) change from baseline was -3.2 kg (-3.6 to -2.8) for dulaglutide and -3.4 kg (-3.9 to -3.0) for liraglutide. Slight changes in concomitant medications were observed compared with baseline., Conclusions: In the real-world setting, dulaglutide and liraglutide cohorts achieved good persistence with similarly improved glycaemic control that was accompanied by weight loss at 12 months, consistent with previous clinical trial results., (© 2022 Eli Lilly and Company and The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
- Published
- 2022
- Full Text
- View/download PDF
26. Real-World Use of Insulin Glargine U100 and U300 in Insulin-Naïve Patients with Type 2 Diabetes Mellitus: DosInGlar Study.
- Author
-
Duque N, Artime E, Romera I, Lebrec J, Díaz S, Rubio M, Sicras-Mainar A, Carretero-Anibarro E, Mundet X, Gorgojo-Martínez JJ, and Reviriego J
- Subjects
- Adult, Blood Glucose, Female, Glycated Hemoglobin analysis, Humans, Hypoglycemic Agents therapeutic use, Insulin, Insulin Glargine therapeutic use, Male, Middle Aged, Retrospective Studies, Spain, Diabetes Mellitus, Type 2 drug therapy
- Abstract
Introduction: In the EDITION clinical trial programme, patients with type 2 diabetes mellitus (T2DM) receiving insulin glargine (IGlar) U300 required 10-15% more insulin than those receiving IGlar U100. This study sought to determine whether this difference was apparent in real-world practice., Methods: In this observational, retrospective cohort study, electronic medical records in the Big-Pac® database (Real Life Data) relating to adult insulin-naïve patients with T2DM who initiated IGlar U100 or U300 treatment in Spain in 2016-2017 and remained on treatment for 18 months were selected. IGlar U100- and U300-treated patients were matched 1:1 (propensity score matching). The primary analysis compared changes from baseline in mean daily IGlar dose (U and U/kg) at 6 (± 2), 12 (± 2) and 18 (± 2) months between cohorts (paired t tests). Changes in glycated haemoglobin (HbA1c) and weight were analysed descriptively., Results: The IGlar U100 and U300 cohorts included 556 matched pairs (46.9% female) with the following mean (standard deviation) values at baseline, respectively: age 63.6 (12.8) versus 63.7 (11.9) years; years since diagnosis 9.5 (1.4) versus 9.5 (1.3); HbA1c 8.8 (1.3) versus 8.7 (1.5) %; weight 84.6 (16.9) versus 84.7 (17.1) kg. Mean IGlar dose at baseline was 0.19 U/kg/day (both cohorts). Patients receiving IGlar U300 showed a greater increase from baseline in IGlar dose at 6, 12 and 18 months [mean dose (U/kg/day) 5.1%, 10.3% and 12.8% greater, respectively, in IGlar U300-treated patients]. Mean HbA1c was 8.1% in both cohorts at 18 months. Mean (SD) weight at 18 months with IGlar U100 and IGlar300 was 86.8 (17.0) kg and 85.0 (17.1) kg, respectively., Conclusion: In real-world practice, insulin dose was significantly higher in IGlar U300-treated than U100-treated patients at 6, 12 and 18 months, with similar reductions in HbA1c. At equal IGlar price/unit in Spain, the increased dose requirements of IGlar U300 would result in higher costs., (© 2021. The Author(s).)
- Published
- 2021
- Full Text
- View/download PDF
27. Glucagon-Like Peptide 1 Receptor Agonists in Type 2 Diabetes Mellitus: Data from a Real-World Study in Spain.
- Author
-
Norrbacka K, Sicras-Mainar A, Lebrec J, Artime E, Díaz S, Tofé-Povedano S, Hernández I, and Romera I
- Abstract
Introduction: This study aimed to describe utilization patterns, persistence, resource utilization and costs in patients with type 2 diabetes mellitus initiating treatment with glucagon-like peptide 1 receptor agonists in routine clinical practice in Spain., Methods: This retrospective study of medical records in the Big-Pac database identified adults starting treatment with once-weekly (QW) dulaglutide, exenatide-QW or once-daily liraglutide between 1 November 2015 and 30 June 2017. Patients were followed for up to 18 months from treatment initiation. Data on clinical characteristics of patients, treatment patterns, average daily dose and costs were obtained for the three cohorts. Persistence over the 18-month period was evaluated using Kaplan-Meier curves. All analyses were descriptive., Results: A total of 1402 patients were included in this study (dulaglutide [n = 492], exenatide-QW [n = 438] or liraglutide [n = 472]); 52.8% were men, and the mean (SD) age was 62 (11) years, glycated haemoglobin (HbA1c) was 8.1% (1.2) and body mass index was 35.5 (3.2) kg/m
2 at treatment initiation. Persistence at 18 months was 59.1% (95% confidence interval [CI] 54.8-63.4) for dulaglutide, 45.7% (95% CI 41.0-50.4) for exenatide-QW and 46.6% (95% CI 42.1-51.1) for liraglutide. The average (SD) dose was 1.2 (0.4) mg/week for dulaglutide, 1.9 (0.3) mg/week for exenatide-QW and 1.1 (0.3) mg/day for liraglutide. The average reduction in HbA1c levels at 1 year was - 0.68% for patients who initiated dulaglutide, - 0.54% for patients who initiated exenatide-QW and - 0.50% for patients who initiated liraglutide. The mean (SD) total annual health care costs were €4072 (1946) for dulaglutide, €4418 (2382) for exenatide-QW and €4382 (2389) for liraglutide., Conclusion: Results suggest that patients who started treatment with dulaglutide had higher persistence over 18 months, presented lower HbA1c levels at 12 months and incurred lower annual total healthcare costs than patients who initiated exenatide-QW or liraglutide.- Published
- 2021
- Full Text
- View/download PDF
28. Treatment Patterns and Persistence With GLP-1 RA Treatments Among Patients With Type 2 Diabetes in France: A Retrospective Cohort Analysis.
- Author
-
Zimner Rapuch S, Divino V, Norrbacka K, Boye K, Lebrec J, Rosilio M, DeKoven M, and Guerci B
- Abstract
Introduction: In type 2 diabetes (T2D), persistence with injectable glucose-lowering therapy is associated with better outcomes. This study used real-world pharmacy data to report on persistence with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in patients with T2D in France., Methods: This retrospective cohort analysis presents longitudinal data from approximately 7500 French retail pharmacies that filled GLP-1-RA prescriptions for GLP-1 RA-naïve patients with T2D ('index therapy': dulaglutide; once-weekly exenatide [exenatide QW]; twice-daily exenatide [exenatide BID]; liraglutide) between January 2015 and December 2016 (follow-up ≥ 12 months). The main outcome was treatment persistence (absence of discontinuation [gap following index therapy prescription ≥ 2-fold the expected duration of that prescription] or switch [new non-index glucose-lowering prescription issued ≤ 30 days before/after index therapy discontinuation]). Persistence was calculated as the median duration through Kaplan-Meier survival analysis over the variable follow-up period and as the proportion of patients persistent at 12 months. In addition to persistence outcomes (discontinuation/switch), three other treatment modifications were assessed: augmentation/intensification with a new non-index glucose-lowering therapy; off-label dose increase (daily dose > 20 μg for exenatide BID; two consecutive prescriptions with daily dose > 1.8 mg for liraglutide); and off-label dose decrease (two consecutive prescriptions with average daily dose lower than the index dose). Off-label dose changes were not assessed for dulaglutide or exenatide QW (as single-dose, prefilled pens)., Results: Median persistence was longest for dulaglutide (373 days) versus liraglutide (205 days), exenatide QW (184 days) and exenatide BID (93 days). Twelve months after treatment initiation, the percentage of persistent patients ranged from 51% (dulaglutide) to 21% (exenatide BID). Overall, treatment modification occurred less commonly for dulaglutide than for the other index GLP-1 RAs., Conclusion: This analysis revealed marked differences in persistence among GLP-1 RAs, which was highest for dulaglutide and lowest for exenatide BID. The prospective TROPHIES study will provide additional information about persistence with dulaglutide and liraglutide, including reasons for treatment modifications.
- Published
- 2021
- Full Text
- View/download PDF
29. Treatment persistence in patients with type 2 diabetes treated with glucagon-like peptide-1 receptor agonists in clinical practice in Sweden.
- Author
-
Svensson AM, Toll A, Lebrec J, Miftaraj M, Franzén S, and Eliasson B
- Subjects
- Drug Administration Schedule, Glucagon-Like Peptides therapeutic use, Humans, Hypoglycemic Agents therapeutic use, Liraglutide therapeutic use, Retrospective Studies, Sweden epidemiology, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 epidemiology, Glucagon-Like Peptide-1 Receptor agonists
- Abstract
Aim: To compare treatment persistence in patients with type 2 diabetes initiating the glucagon-like peptide-1 receptor agonists (GLP-1 RAs) dulaglutide, exenatide once-weekly (QW), liraglutide or lixisenatide in routine clinical practice in Sweden and assess clinical outcomes., Materials and Methods: We performed a retrospective study using data from several nationwide Swedish health registries, including the National Diabetes Register and other mandatory and population-based registries. Individual level data were collected from 17 361 patients who initiated GLP-1 RA treatment from 23 May 2015 to 15 October 2017, up to 2.5 years postindex (treatment start date). Treatment persistence and modification, predictors of discontinuation, HbA1c and body weight were recorded. Non-persistence was defined as a treatment gap of more than 45 days. Treatment modification included switching and augmentation. Confounding was addressed through the use of propensity scores., Results: Treatment persistence was higher and treatment modifications were lower in patients initiating dulaglutide compared with those on exenatide QW, liraglutide and lixisenatide. Patients who remained on the same treatment for 1-year postindex experienced greater HbA1c reductions and a steadier decrease in body weight., Conclusions: Our study suggests that in clinical practice in Sweden there is a greater persistence of treatment among patients initiating dulaglutide compared with those on exenatide QW, liraglutide and lixisenatide. Persistence with the index GLP-1 RA was closely correlated with positive clinical outcomes and thus should be considered a critical factor of patient-centric treatment in Sweden., (© 2020 John Wiley & Sons Ltd.)
- Published
- 2021
- Full Text
- View/download PDF
30. Once-weekly dulaglutide versus insulin glargine in the early control of fasting serum glucose and HbA1c.
- Author
-
Romera I, Conget I, Vazquez LA, Gentilella R, Lebrec J, Jódar E, and Reviriego J
- Subjects
- Blood Glucose, Drug Administration Schedule, Drug Therapy, Combination, Glucagon-Like Peptides administration & dosage, Glycated Hemoglobin analysis, Humans, Hypoglycemia prevention & control, Hypoglycemic Agents administration & dosage, Diabetes Mellitus, Type 2 drug therapy, Glucagon-Like Peptides analogs & derivatives, Immunoglobulin Fc Fragments administration & dosage, Insulin Glargine administration & dosage, Recombinant Fusion Proteins administration & dosage
- Abstract
Aims: To determine the early benefit:risk balance of dulaglutide versus insulin glargine in patients with type 2 diabetes mellitus (T2DM)., Methods: This post hoc analysis used data from a randomized, open-label study (AWARD-2; modified intention-to-treat group) in which suboptimally controlled metformin + glimepiride-treated patients received dulaglutide 1.5 mg (n = 273) or insulin glargine (n = 262). Two composite endpoints were used: for weeks 2-20, fasting serum glucose (FSG) <130 mg/dL (<7.2 mmol/L) without hypoglycemia (blood glucose ≤70 mg/dL [≤3.9 mmol/L] or severe hypoglycemia); at week 26, patients with glycated hemoglobin (HbA1c) <7.0% (<53.0 mmol/mol) or reduction from baseline ≥1.0% (≥10.9 mmol/mol), no hypoglycemia (as defined above) and no weight gain. Odds ratios (ORs) were generated using logistic regression analysis., Results: The probability of reaching the FSG target without hypoglycemia was higher with dulaglutide than with insulin glargine at weeks 4 (OR 1.78; 95% confidence interval [CI] 1.22-2.60) and 8 (OR 1.69; 95% CI 1.15-2.48). The proportion of patients achieving the 26-week endpoint was higher with dulaglutide (37.4% vs. 10.3%; OR 5.28; 95% CI 3.28-8.48)., Conclusions: Dulaglutide's balanced efficacy-to-safety profile compares favorably with that of insulin glargine and is apparent soon after treatment initiation and after 6 months of therapy., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2020
- Full Text
- View/download PDF
31. GLP-1 RA Treatment and Dosing Patterns Among Type 2 Diabetes Patients in Six Countries: A Retrospective Analysis of Pharmacy Claims Data.
- Author
-
Divino V, Boye KS, Lebrec J, DeKoven M, and Norrbacka K
- Abstract
Introduction: The glucagon-like peptide-1 receptor agonist (GLP-1 RA) class is evolving and expanding. This retrospective database study evaluated recent real-world treatment and dosing patterns of patients with type 2 diabetes (T2D) initiating GLP-1 RAs in Belgium (BE), France (FR), Germany (DE), Italy (IT), the Netherlands (NL), and Canada (CA)., Methods: Adult T2D patients initiating GLP-1 RA therapy (dulaglutide [DULA], exenatide twice daily [exBID], exenatide once weekly [exQW], liraglutide [LIRA], or lixisenatide [LIXI]) from 2015 to 2016 were identified using the IQVIA (IQVIA, Durham, NC, and Danbury, CT, USA) Real-World Data Adjudicated Pharmacy Claims. The therapy initiation date was termed the 'index date.' Eligible patients had ≥ 180 days pre-index and ≥ 360 days post-index. Persistence (until discontinuation or switch) was evaluated over the variable follow-up using Kaplan-Meier (KM) survival analysis. Average daily dose (ADD) was calculated until discontinuation or switch., Results: A total of 34,649 DULA, 3616 exBID, 11,138 exQW, 48,317 LIRA, and 2,204 LIXI patients were included in the analysis (34.9-63.2% female; median age range 53-62 years; median follow-up 16-30 months). Proportion persistent at 1-year post-index was 36.8-67.2% for DULA, 5.9-44.4% for exBID, 24.7-44.2% for exQW, 22.2-57.5% for LIRA, and 15.5-40.0% for LIXI. Median time persistent (days) was 245-381 for DULA, 62-243 for exBID, 121-319 for exQW, 103-507 for LIRA, and 99-203 for LIXI. Mean ADD was 13.21-20.43 µg for exBID, 1.44-1.68 mg for LIRA, and 19.88-20.54 µg for LIXI. Mean average weekly dose (AWD) ranged from 2.03 to 2.14 mg for exQW. Mean AWD for DULA was 1.25 mg in Canada and ranged from 1.43 to 1.53 mg in the other countries., Conclusion: Across six countries, persistence was highest among DULA patients and generally lowest among exBID patients. ADD/AWD for all GLP-1 RAs was in line with the recommended label. Longer-term data would be useful to obtain a better understanding of GLP-1 RA treatment patterns over time., Funding: Eli Lilly and Company, Indianapolis, IN, USA.
- Published
- 2019
- Full Text
- View/download PDF
32. The Cost of Hypoglycemia Associated With Type 2 Diabetes Mellitus in Taiwan.
- Author
-
Strizek A, Chang CJ, Furnback W, Wang B, Lebrec J, and Lew T
- Subjects
- Adult, Aged, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 epidemiology, Female, Health Care Costs, Humans, Hypoglycemic Agents therapeutic use, Male, Middle Aged, Taiwan epidemiology, Cost of Illness, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemia drug therapy, Hypoglycemia economics, Hypoglycemic Agents economics
- Abstract
Objectives: To quantify the incremental burden of patients with type 2 diabetes mellitus (T2DM) and a hypoglycemic event in Taiwan using the National Health Insurance Research Database., Methods: Data from 2000 through 2013 with an index period of 2001 through 2012 from the National Health Insurance Research Database's 2-million-patient sample were used. Using a nested case-control study design, patients were indexed if they reported a diagnosis of T2DM during the index period. Patients with T2DM with a hypoglycemic event (defined by International Classification of Diseases, Ninth Revision, Clinical Modification codes) during the index period were identified. Patients with T2DM without a hypoglycemic event were included to form a 4:1 (controls to cases) matched cohort on the basis of age, sex, the Charlson Comorbidity Index, and the T2DM diagnosis date. Both cohorts were followed up for 1 year after the hypoglycemic event and had their treatment utilization, resource utilization, and healthcare costs measured., Results: A total of 144 213 patients with T2DM were identified, with 3 651 (2.5%) recording a hypoglycemic event. Before matching, patients with T2DM with a hypoglycemic event were, on average, older (64.2 vs 56.6) and had higher mean CCI scores (2.4 vs 1.9) than did patients with T2DM without a hypoglycemic event. After matching, patients with T2DM and a hypoglycemic event incurred an additional $1353 in average direct healthcare costs during the 1 year of follow-up compared with the matched cohort. Patients with T2DM with hypoglycemia also spent an additional 5.9 days in the hospital during the follow-up period compared with the matched cohort., Conclusions: Patients with hypoglycemic events, on average, experienced a substantially higher economic burden than did their counterparts without a hypoglycemic event during the same period., (Copyright © 2019 ISPOR--The professional society for health economics and outcomes research. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
- Full Text
- View/download PDF
33. Utilization patterns of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes mellitus in Germany: a retrospective cohort study.
- Author
-
Otto T, Myland M, Jung H, Lebrec J, Richter H, and Norrbacka K
- Subjects
- Adult, Aged, Female, Glucagon-Like Peptides analogs & derivatives, Glucagon-Like Peptides therapeutic use, Humans, Immunoglobulin Fc Fragments therapeutic use, Liraglutide therapeutic use, Male, Middle Aged, Recombinant Fusion Proteins therapeutic use, Retrospective Studies, Diabetes Mellitus, Type 2 drug therapy, Glucagon-Like Peptide-1 Receptor agonists, Hypoglycemic Agents therapeutic use
- Abstract
Objective: This retrospective database analysis complements previous research to understand treatment patterns for German patients newly-initiating or switching to subsequent GLP-1 RAs., Methods: Adult patients (≥18 years) initiating GLP-1 RA (Cohort 1 [C1]) or switching from a previous GLP-1 RA (Cohort 2 [C2]) to exenatide twice-daily (exBID), exenatide once-weekly (exQW), dulaglutide (DULA), or liraglutide (LIRA) were included in this analysis using IQVIA LRx from January 1, 2014-March 31, 2017. Patients were required to have ≥1 oral anti-hyperglycemic prescription during the 6-month pre-index period and ≥12 months follow-up. Persistence and treatment modifications were assessed within and beyond 12 months follow-up. Average daily/weekly dosage (ADD/AWD) was calculated during persistence., Results: C1 included 13,417 patients, while C2 included 4,264 patients. Mean ± standard deviation (SD) age was similar (57.7 ± 11.1 years [C1], 58.9 ± 10.1 years [C2]). Most patients using DULA in C2 had switched from LIRA (56.6%). For C1, mean ADD for LIRA was 1.41 ± 0.10 mg, slightly higher in C2, and increased over time. ADD for exBID was 16.9 ± 1.0 mcg, slightly greater in C2. AWD was 2.00 ± 0.05 mg for exQW users and 1.42 ± 0.03 mg for DULA users in C1, similar to C2. For C1, 27.0% exBID, 35.3% exQW, 50.9% DULA, and 48.1% LIRA users remained persistent at 12 months. Patients using DULA had a higher probability of remaining persistent over time (Kaplan-Meier) for both cohorts., Conclusions: Patients using DULA had the highest probability of remaining persistent over time, followed by LIRA. ADD/AWD for DULA, exQW, and exBID were aligned with the recommended combination therapy dose; LIRA ADD suggests some patients use the 1.8 mg dose.
- Published
- 2019
- Full Text
- View/download PDF
34. Response to the comment on: "Dulaglutide treatment results in effective glycaemic control in latent autoimmune diabetes in adults (LADA): A post-hoc analysis of the AWARD-2, -4 and -5 trials".
- Author
-
Leslie RD, Pozzilli P, Peters AL, Buzzetti R, Shankar SS, Milicevic Z, Pavo I, Lebrec J, Martin S, and Schloot NC
- Subjects
- Adult, Autoantibodies, Diabetes Mellitus, Type 1, Humans, Immunoglobulin Fc Fragments, Recombinant Fusion Proteins, Glucagon-Like Peptides analogs & derivatives, Latent Autoimmune Diabetes in Adults
- Published
- 2018
- Full Text
- View/download PDF
35. Dulaglutide treatment results in effective glycaemic control in latent autoimmune diabetes in adults (LADA): A post-hoc analysis of the AWARD-2, -4 and -5 Trials.
- Author
-
Pozzilli P, Leslie RD, Peters AL, Buzzetti R, Shankar SS, Milicevic Z, Pavo I, Lebrec J, Martin S, and Schloot NC
- Subjects
- Blood Glucose metabolism, Double-Blind Method, Female, Glucagon-Like Peptides administration & dosage, Glucagon-Like Peptides adverse effects, Glycated Hemoglobin metabolism, Humans, Hypoglycemic Agents adverse effects, Immunoglobulin Fc Fragments adverse effects, Insulin Glargine administration & dosage, Insulin Glargine adverse effects, Latent Autoimmune Diabetes in Adults blood, Male, Middle Aged, Recombinant Fusion Proteins adverse effects, Sitagliptin Phosphate administration & dosage, Sitagliptin Phosphate adverse effects, Treatment Outcome, Glucagon-Like Peptides analogs & derivatives, Glycated Hemoglobin drug effects, Hypoglycemic Agents administration & dosage, Immunoglobulin Fc Fragments administration & dosage, Latent Autoimmune Diabetes in Adults drug therapy, Recombinant Fusion Proteins administration & dosage
- Abstract
Aims: Patients with a type-2-diabetes (T2D) phenotype positive for glutamic acid decarboxylase antibodies (GADA) represent the majority of cases of latent autoimmune diabetes of the adult (LADA). The GLP-1 receptor agonist dulaglutide, recently introduced for treatment of T2D, has yet to be evaluated in LADA patients. Our primary objective was to evaluate the effect of dulaglutide on glycaemic control (HbA1c) in GADA-positive LADA vs GADA-negative T2D patients., Methods: A post-hoc analysis was performed using data from 3 randomized phase 3 trials (AWARD-2,-4,-5; patients with GADA assessment) which were part of the dulaglutide clinical development programme in T2D. LADA patients were identified by GADA ≥5 IU/mL (ELISA). Changes in HbA1c during 12 months of treatment with dulaglutide or comparator were analysed using mixed-effect model repeated measures., Results: Of 2466 adults tested for GADA (dulaglutide, 1710; glargine, 298; sitagliptin, 294; placebo, 164), 2278 (92.4%) were GADA-negative and 188 (7.6%) were GADA-positive, including 58 GADA-high patients (> 200 IU/mL) and 130 GADA-low patients (≤200 and ≥5 IU/mL). Overall, baseline parameters were comparable between the groups. Dulaglutide resulted in comparable HbA1c reductions in GADA-negative (LS mean change [95%CI], -1.09% [-1.15, -1.03]) and GADA-positive patients (-0.94% [-1.15, -0.72]) at 12 months. HbA1c reductions were numerically, but not statistically, significantly larger in GADA-low patients (-1.02% [-1.26, -0.78]) vs GADA-high patients (-0.72% [-1.21,-0.24]) at 12 months. Similar outcomes were observed at 3 and 6 months., Conclusions: These data are the first to indicate that dulaglutide was effective in reducing HbA1c in LADA patients., (© 2018 John Wiley & Sons Ltd.)
- Published
- 2018
- Full Text
- View/download PDF
36. Utilization Patterns of Glucagon-Like Peptide-1 Receptor Agonists in Patients with Type 2 Diabetes Mellitus in Italy: A Retrospective Cohort Study.
- Author
-
Federici MO, McQuillan J, Biricolti G, Losi S, Lebrec J, Richards C, Miglio C, and Norrbacka K
- Abstract
Introduction: Real-world evidence on glucagon-like peptide-1 receptor agonist (GLP-1 RAs) usage is emerging in different European countries but is lacking in Italy. This retrospective cohort study aimed to describe the real-world drug utilization patterns in patients initiating GLP-1 RAs for treating T2DM in Italy., Methods: Adults aged ≥ 20 years and with ≥ 1 oral antidiabetic drug (alone or in combination with insulin) other than GLP-1 RAs in the 6 months prior to initiating exenatide twice daily (exBID), exenatide once weekly (exQW), dulaglutide once weekly (DULA), liraglutide once daily (LIRA) or lixisenatide once daily (LIXI) between March and July 2016 were retrospectively identified in the Italian IMS LifeLink™ longitudinal prescriptions database (retail pharmacy data). Patients with ≥ 6-month follow-up (defined as evidence of any prescription activity) were included. Proportions of patients who remained persistent (continued treatment until discontinuation/switch) in the first 6 months and of those who discontinued or switched to a different GLP-1 RA over the entire follow-up were recorded. For each treatment, the average daily/weekly dosage (ADD/AWD) while persistent during the available follow-up was calculated., Results: We identified 7319 patients: 92 exBID, 970 exQW, 3368 DULA, 2573 LIRA and 316 LIXI. Across treatments, 89% patients were ≥ 50 years old, 54% were males, and the median follow-up duration ranged between 8.1 and 8.7 months. At 6 months, 35% exBID, 47% exQW, 62% DULA, 50% LIRA and 40% LIXI patients remained persistent. Over the entire follow-up, median persistence days varied from 73 (exBID) to > 300 days (DULA). The mean ± SD ADD/AWD was exBID: 17.7 ± 2.1 µg/day; exQW: 2.1 ± 0.1 mg/week; DULA: 1.5 ± 0.2 mg/week; LIRA: 1.5 ± 0.2 mg/day; LIXI: 21.0 ± 5.5 µg/day., Conclusions: This real-world analysis suggests differences exist in persistence between patients treated with various GLP-1 RAs. Among the investigated treatments, patients prescribed exBID recorded the lowest and those prescribed DULA the highest persistence with therapy., Funding: Eli Lilly and Co., Indianapolis, IN, USA.
- Published
- 2018
- Full Text
- View/download PDF
37. Potential cost savings to be made by slowing cognitive decline in mild Alzheimer's disease dementia using a model derived from the UK GERAS observational study.
- Author
-
Lenox-Smith A, Reed C, Lebrec J, Belger M, and Jones RW
- Subjects
- Aged, Aged, 80 and over, Alzheimer Disease prevention & control, Cognitive Dysfunction prevention & control, Cost Savings trends, Female, Health Care Costs trends, Humans, Male, Prospective Studies, United Kingdom epidemiology, Alzheimer Disease economics, Alzheimer Disease epidemiology, Cognitive Dysfunction economics, Cognitive Dysfunction epidemiology, Cost Savings economics, Models, Economic
- Abstract
Background: Given the high costs associated with the care of those with Alzheimer's disease (AD) dementia, we examined the likely impact of a reduction in the rate of cognitive decline upon cost outcomes associated with this disease., Methods: Using the group of patients with mild AD dementia from the GERAS study, generalised linear modelling (GLM) was used to explore the relationship between change in cognition as measured using the Mini-Mental State Examination (MMSE) and UK overall costs (health care and social care costs, and total societal costs) associated with AD dementia., Results: A total of 200 patients with mild AD dementia were identified. Least squares mean (LSM) ± standard error (SE) reduction in MMSE score was 3.6 ± 0.4 points over 18 months. Using GLM it was possible to calculate that this worsening in cognition was associated with an 8.7% increase in total societal costs, equating to an increase of approximately £2200 per patient over an 18-month period. If the rate of decline in cognition was reduced by 30% or 50%, the associated savings in total societal costs over 18 months would be approximately £670 and £1100, respectively, of which only £110 and £180, respectively, could be attributed to a saving of health care costs., Conclusion: This study demonstrates that there are potential savings to be made in the care of patients with AD dementia through reducing the rate of cognitive decline. A reduction in wider societal costs is likely to be the main contributor to these potential savings, and need to be further evaluated when intervention costs and cost offsets can be measured.
- Published
- 2018
- Full Text
- View/download PDF
38. Disease Progression in Mild Dementia due to Alzheimer Disease in an 18-Month Observational Study (GERAS): The Impact on Costs and Caregiver Outcomes.
- Author
-
Jones RW, Lebrec J, Kahle-Wrobleski K, Dell'Agnello G, Bruno G, Vellas B, Argimon JM, Dodel R, Haro JM, Wimo A, and Reed C
- Abstract
Background/aims: We assessed whether cognitive and functional decline in community-dwelling patients with mild Alzheimer disease (AD) dementia were associated with increased societal costs and caregiver burden and time outcomes., Methods: Cognitive decline was defined as a ≥3-point reduction in the Mini-Mental State Examination and functional decline as a decrease in the ability to perform one or more basic items of the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) or ≥20% of instrumental ADL items. Total societal costs were estimated from resource use and caregiver hours using 2010 costs. Caregiver burden was assessed using the Zarit Burden Interview (ZBI); caregiver supervision and total hours were collected., Results: Of 566 patients with mild AD enrolled in the GERAS study, 494 were suitable for the current analysis. Mean monthly total societal costs were greater for patients showing functional (+61%) or cognitive decline (+27%) compared with those without decline. In relation to a typical mean monthly cost of approximately EUR 1,400 at baseline, this translated into increases over 18 months to EUR 2,254 and 1,778 for patients with functional and cognitive decline, respectively. The number of patients requiring supervision doubled among patients showing functional or cognitive decline compared with those not showing decline, while caregiver total time increased by 70 and 33%, respectively and ZBI total score by 5.3 and 3.4 points, respectively., Conclusion: Cognitive and, more notably, functional decline were associated with increases in costs and caregiver outcomes in patients with mild AD dementia.
- Published
- 2017
- Full Text
- View/download PDF
39. Resource utilisation, costs and clinical outcomes in non-institutionalised patients with Alzheimer's disease: 18-month UK results from the GERAS observational study.
- Author
-
Lenox-Smith A, Reed C, Lebrec J, Belger M, and Jones RW
- Subjects
- Aged, Aged, 80 and over, Disease Progression, Female, Humans, Institutionalization statistics & numerical data, Intelligence Tests, Male, Prospective Studies, Severity of Illness Index, Treatment Outcome, United Kingdom epidemiology, Alzheimer Disease diagnosis, Alzheimer Disease economics, Alzheimer Disease epidemiology, Caregivers economics, Cost of Illness, Health Care Rationing statistics & numerical data, Health Resources statistics & numerical data, Independent Living economics, Independent Living statistics & numerical data
- Abstract
Background: Alzheimer's disease (AD), the commonest cause of dementia, represents a significant cost to UK society. This analysis describes resource utilisation, costs and clinical outcomes in non-institutionalised patients with AD in the UK., Methods: The GERAS prospective observational study assessed societal costs associated with AD for patients and caregivers over 18 months, stratified according to baseline disease severity (mild, moderate, or moderately severe/severe [MS/S]). All patients enrolled had an informal caregiver willing to participate in the study. Healthcare resource utilisation was measured using the Resource Utilization in Dementia instrument, and 18-month costs estimated by applying unit costs of services and products (2010 values). Total societal costs were calculated using an opportunity cost approach., Results: Overall, 526 patients (200 mild, 180 moderate and 146 MS/S at baseline) were recruited from 24 UK centres. Mini-Mental State Examination (MMSE) scores deteriorated most markedly in the MS/S patient group, with declines of 3.6 points in the mild group, 3.5 points in the moderate group and 4.7 points in the MS/S group; between-group differences did not reach statistical significance. Patients with MS/S AD dementia at baseline were more likely to be institutionalised (Kaplan-Meier probability 28% versus 9% in patients with mild AD dementia; p < 0.001 for difference across all severities) and had a greater probability of death (Kaplan-Meier probability 15% versus 5%; p = 0.013) at 18 months. Greater disease severity at baseline was also associated with concomitant increases in caregiver time and mean total societal costs. Total societal costs of £43,560 over 18 months were estimated for the MS/S group, versus £25,865 for the mild group and £30,905 for the moderate group (p < 0.001). Of these costs, over 50% were related to informal caregiver costs at each AD dementia severity level., Conclusions: This study demonstrated a mean deterioration in MMSE score over 18 months in patients with AD. It also showed that AD is a costly disease, with costs increasing with disease severity, even when managed in the community: informal caregiver costs represented the main contributor to societal costs.
- Published
- 2016
- Full Text
- View/download PDF
40. Broader conceptualization of remission assessed by the remission from depression questionnaire and its association with symptomatic remission: a prospective, multicenter, observational study.
- Author
-
Montoya A, Lebrec J, Keane KM, Fregenal I, Ciudad A, Moríñigo Á, Agüera-Ortiz L, Romera I, Gilaberte I, and Zimmerman M
- Subjects
- Adult, Depressive Disorder, Major psychology, Female, Humans, Male, Middle Aged, Prospective Studies, Surveys and Questionnaires, Treatment Outcome, Depressive Disorder, Major therapy, Psychiatric Status Rating Scales standards, Quality of Life psychology, Remission Induction
- Abstract
Background: Goals of treating major depressive disorder (MDD) include achieving remission and avoiding relapse. It is possible that patients may have a broader view of remission than what is captured via clinician-rated scales. This patient perspective may, in turn, have an impact on treatment outcomes., Methods: The association between a broader conceptualization of remission, based on the Remission from Depression Questionnaire (RDQ) score at baseline, and being in symptomatic remission after 6 months was evaluated in subjects (N = 613) with MDD in symptomatic remission at baseline (17-item Hamilton Rating Scale for Depression [HAMD-17] ≤7). Specific aspects of depression were assessed from physician and patient perspectives as secondary endpoints. A backwards selection strategy was used to statistically model remission status and determine association of factors with potential to influence remission., Results: At month 6, after adjustment for baseline HAMD-17 score, there was no association between baseline RDQ score and symptomatic remission status (HAMD-17), relapse, composite remission status, healthcare resource utilization, or quality of life. There was no association between functional impairment scores at baseline (Sheehan Disability Scale and Social and Occupational Functioning Assessment Scale) and symptomatic remission status (HAMD-17) at month 6., Conclusions: This study indicates that RDQ-constructs are independent from symptomatic remission. Symptom severity at study entry appeared to be the only significant predictor of eventual relapse during the 6-month follow-up period. However, our results also suggest that the current definition of remission that is based on symptom reduction should be further elaborated and that alternative or additional definitions should be considered in determining remission.
- Published
- 2016
- Full Text
- View/download PDF
41. Burden of illness and health care resource utilization in adult psychiatric outpatients with attention-deficit/hyperactivity disorder in Europe.
- Author
-
Karlsdotter K, Bushe C, Hakkaart L, Sobanski E, Kan CC, Lebrec J, Kraemer S, Dieteren NA, and Deberdt W
- Subjects
- Adult, Cost of Illness, Cross-Sectional Studies, Europe epidemiology, Female, Humans, Male, Middle Aged, Attention Deficit Disorder with Hyperactivity economics, Attention Deficit Disorder with Hyperactivity epidemiology, Attention Deficit Disorder with Hyperactivity therapy, Outpatients statistics & numerical data, Patient Acceptance of Health Care statistics & numerical data
- Abstract
Objective: To assess the burden of illness and health care resource utilization of adult nonpsychotic psychiatric outpatients with attention-deficit/hyperactivity disorder (ADHD) in Europe., Methods: This was a multicountry, cross-sectional, observational study where unselected routine patients from clinical psychiatric outpatient settings were screened and assessed for ADHD. Patients were evaluated using the Clinical Global Impressions of Severity (CGI-S) scale, the Sheehan Disability Scale (SDS), and the EuroQol-5 Dimensions questionnaire. Data on comorbidities, functional impairment, and health care resource utilization were captured., Results: The study enrolled 2284 patients, of whom 1986 completed the study. The prevalence of ADHD was 17.4%, of whom 46.0% had a previous ADHD diagnosis. Patients with ADHD had a high clinical burden with psychiatric comorbidities, especially depression (43.0%) and anxiety disorders (36.4%). Substance abuse (9.2% vs. 3.4%) and alcohol abuse (10.3% vs. 5.2%) were more common in the ADHD cohort vs. the non-ADHD cohort. Only 11.5% of the patients with ADHD had no other psychiatric disorder. Various measures indicated a significantly poorer level of functioning for patients with ADHD than without ADHD, as indicated by higher scores for CGI-S (3.8 vs. 3.3) and SDS (18.9 vs. 11.6) and higher percentages of debt (35.5% vs. 24.3%) and criminality (13.8% vs. 6.1%). Lastly, the health care resource utilization was considerable and similar between adult psychiatric outpatients diagnosed and not diagnosed with ADHD., Conclusions: Although care was taken when choosing the sites for this study, to make it representative of the general outpatient adult psychiatric population, caution should be advised in generalizing the findings of our study to the general ADHD or psychiatric outpatient population. This was an observational study, thus no inference on causality can be drawn. Having ADHD imposes a considerable health and social burden on patient and health care resource utilization comparable to other chronic psychiatric disorders.
- Published
- 2016
- Full Text
- View/download PDF
42. Effect of diabetes on caregiver burden in an observational study of individuals with Alzheimer's disease.
- Author
-
Lebrec J, Ascher-Svanum H, Chen YF, Reed C, Kahle-Wrobleski K, Hake AM, Raskin J, Naderali E, Schuster D, Heine RJ, and Kendall DM
- Subjects
- Activities of Daily Living psychology, Adaptation, Psychological, Aged, Aged, 80 and over, Alzheimer Disease diagnosis, Cross-Sectional Studies, Diabetes Mellitus diagnosis, Female, France epidemiology, Germany epidemiology, Health Resources statistics & numerical data, Health Resources trends, Humans, Male, Prospective Studies, United Kingdom epidemiology, Alzheimer Disease epidemiology, Alzheimer Disease psychology, Caregivers psychology, Cost of Illness, Diabetes Mellitus epidemiology, Diabetes Mellitus psychology
- Abstract
Background: The burden on caregivers of patients with Alzheimer's disease (AD) is associated with the patient's functional status and may also be influenced by chronic comorbid medical conditions, such as diabetes. This post-hoc exploratory analysis assessed whether comorbid diabetes in patients with AD affects caregiver burden, and whether caregivers with diabetes experience greater burden than caregivers without diabetes. Caregiver and patient healthcare resource use (HCRU) were also assessed., Methods: Baseline data from the GERAS observational study of patients with AD and their caregivers (both n = 1495) in France, Germany and the UK were analyzed. Caregiver burden was assessed using the Zarit Burden Interview (ZBI). Caregiver time on activities of daily living (ADL: basic ADL; instrumental ADL, iADL) and supervision (hours/month), and caregiver and patient HCRU (outpatient visits, emergency room visits, nights hospitalized) were assessed using the Resource Utilization in Dementia instrument for the month before the baseline visit. Regression analyses were adjusted for relevant covariates. Time on supervision and basic ADL was analyzed using zero-inflated negative binomial regression., Results: Caregivers of patients with diabetes (n = 188) were younger and more likely to be female (both p < 0.05), compared with caregivers of patients without diabetes (n = 1307). Analyses showed caregivers of patients with diabetes spent significantly more time on iADL (+16 %; p = 0.03; increases were also observed for basic ADL and total caregiver time but did not reach statistical significance) and had a trend towards increased ZBI score. Patients with diabetes had a 63 % increase in the odds of requiring supervision versus those without diabetes (p = 0.01). Caregiver and patient HCRU did not differ according to patient diabetes. Caregivers with diabetes (n = 127) did not differ from those without diabetes (n = 1367) regarding burden/time, but caregivers with diabetes had a 91 % increase in the odds of having outpatient visits (p = 0.01)., Conclusions: This cross-sectional analysis found caregiver time on iADL and supervision was higher for caregivers of patients with AD and diabetes versus without diabetes, while HCRU was unaffected by patient diabetes. Longitudinal analyses assessing change in caregiver burden over time by patient diabetes status may help clarify the cumulative impact of diabetes and AD dementia on caregiver burden.
- Published
- 2016
- Full Text
- View/download PDF
43. Describing the Sequence of Cognitive Decline in Alzheimer's Disease Patients: Results from an Observational Study.
- Author
-
Henneges C, Reed C, Chen YF, Dell'Agnello G, and Lebrec J
- Subjects
- Aged, Aged, 80 and over, Alzheimer Disease, Caregivers psychology, Disease Progression, Female, Humans, Longitudinal Studies, Male, Mental Status Schedule, Middle Aged, Neuropsychological Tests, Odds Ratio, Cognition Disorders etiology
- Abstract
Background: Improved understanding of the pattern of cognitive decline in Alzheimer's disease (AD) would be useful to assist primary care physicians in explaining AD progression to patients and caregivers., Objective: To identify the sequence in which cognitive abilities decline in community-dwelling patients with AD., Methods: Baseline data were analyzed from 1,495 patients diagnosed with probable AD and a Mini-Mental State Examination (MMSE) score ≤ 26 enrolled in the 18-month observational GERAS study. Proportional odds logistic regression models were applied to model MMSE subscores (orientation, registration, attention and concentration, recall, language, and drawing) and the corresponding subscores of the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog), using MMSE total score as the index of disease progression. Probabilities of impairment start and full impairment were estimated at each MMSE total score level., Results: From the estimated probabilities for each MMSE subscore as a function of the MMSE total score, the first aspect of cognition to start being impaired was recall, followed by orientation in time, attention and concentration, orientation in place, language, drawing, and registration. For full impairment in subscores, the sequence was recall, drawing, attention and concentration, orientation in time, orientation in place, registration, and language. The sequence of cognitive decline for the corresponding ADAS-cog subscores was remarkably consistent with this pattern., Conclusion: The sequence of cognitive decline in AD can be visualized in an animation using probability estimates for key aspects of cognition. This might be useful for clinicians to set expectations on disease progression for patients and caregivers.
- Published
- 2016
- Full Text
- View/download PDF
44. Prevalence of ADHD in nonpsychotic adult psychiatric care (ADPSYC): A multinational cross-sectional study in Europe.
- Author
-
Deberdt W, Thome J, Lebrec J, Kraemer S, Fregenal I, Ramos-Quiroga JA, and Arif M
- Subjects
- Absenteeism, Adolescent, Adult, Ambulatory Care statistics & numerical data, Attention Deficit Disorder with Hyperactivity therapy, Cross-Sectional Studies, Diagnostic and Statistical Manual of Mental Disorders, Efficiency, Employment statistics & numerical data, Europe epidemiology, Female, Humans, Male, Mental Health Services statistics & numerical data, Prevalence, Sex Distribution, Socioeconomic Factors, Young Adult, Attention Deficit Disorder with Hyperactivity epidemiology
- Abstract
Background: Attention-deficit/hyperactivity disorder (ADHD) often persists into adulthood. This study was designed to estimate the prevalence of ADHD in adult psychiatric outpatients in several European countries., Method: ADHD diagnosis was made using the Diagnostic Interview for ADHD in Adults, version 2.0 (DIVA), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) and 5th Edition (DSM-5)., Results: Of 5662 patients present/approached, 2284 (40.3 %) consented, of whom 1986 patients (87.0 %) completed the study. Based on the DIVA, and applying DSM-IV-TR or DSM-5 criteria, 15.8 % (95 % confidence interval [CI] 14.2 %-17.4 %) or 17.4 % (95 % CI 15.7 %-19.0 %) of patients were diagnosed with ADHD, respectively. The prevalence of ADHD was 15.3 % when counting as non-ADHD those patients who screened positive but did not complete the DIVA (DSM-5)., Conclusions: Estimates from this study indicate that a relevant part of the psychiatric outpatient care population suffers from ADHD.
- Published
- 2015
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.