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Baseline observations from the EVIDENCE Study: characteristics of type 2 diabetes patients initiating liraglutide
p r i m a r y c a r e d i a b e t e s 7 ( 2 0 1 3 ) 71–89
77
P14
P15
Prescribing liraglutide to patients with type 2 diabetes in a clinical practice setting: the EVIDENCE study
Baseline observations from the EVIDENCE Study: characteristics of type 2 diabetes patients initiating liraglutide
G. Charpentier 1 , L. Martínez 2 , S. Madani 3 , A. Penfornis 4 , P. Gourdy 5 , J.F. Gautier 6
L. Martínez 1 , P. Gourdy 2 , E. Eschwège 3 , S. Charpentier 5 , A. Penfornis 6 , J.P. Gautier 7
1
1
Department of Internal Medicine, Endocrinology and Diabetology, Sud Francilien Hospital Centre, Corbeil-Essonnes, France 2 Department of General Practice, Pierre and Marie Curie University, Paris, France 3 Novo Nordisk, Paris, France 4 Department of Endocrinology-Metabolism and DiabetologyNutrition, Jean Minjoz Hospital, University of Franche-Comteˇı, Besanc¸on, France 5 Department of Diabetology, Metabolic Diseases and Nutrition, Toulouse University Hospital, Toulouse, France 6 Department of Diabetes and Endocrinology, Saint-Louis Hospital, Paris, France
Aims: EVIDENCE study is a post-marketing authorization observational study that aims to assess the effectiveness, conditions of use, and adherence to liraglutide treatment in patients with type 2 diabetes (T2D) in a clinical practice setting. This is a national multi-centre study in France that will last 2 years. Materials and methods: The primary objective is to determine the percentage of patients still taking liraglutide after 2 years and with A1c < 7%. Secondary objectives include A1c, fasting glycaemia, weight, adherence to treatment, tolerance, and treatment satisfaction, assessed using the Diabetes Treatment Satisfaction Questionnaire. An interim analysis is scheduled at 1 year. The cohort was calculated at 2845 patients (contact lost and missing data estimated at 40%) recruited by 750 consultants and 2000 general practitioners. Diabetologists/endocrinologists (n = 2300) and general practitioners (n = 19,280) involved in the care of patients with T2D using injectable antidiabetic medication were randomly selected from a database, and contacted by letter, telephone, and email Results: Of the doctors contacted, 3453 (16%) agreed to take part in the study. A total of 2162 centres were set up (645 consultants and 1517 general practitioners, i.e. 28% and 8% of the doctors contacted, respectively) and 46% of them recruited ≥1 patient (69% and 31%, respectively). In the past 12 months, 3151 patients have been included. In this study, 59% of the doctors work in urban communities with < 100,000 inhabitants, and 9% work in the Paris area. The average age of the doctors was 51, and 36% of the doctors were female. Despite the difficulties in recruiting doctors, the number of patients included in the study reached the target set. Conclusion: The EVIDENCE study will provide information about the effectiveness of liraglutide after 2 years and how well the treatment is adhered to and tolerated in clinical practice. http://dx.doi.org/10.1016/j.pcd.2012.10.057
Madani 4 , G.
Pierre and Marie Curie University, Paris, France Toulouse UniversityHospital, Toulouse, France 3 National Institute of Health and Medical Research (INSERM), Villejuif, France 4 Novo Nordisk, Paris, France 5 Sud Francilien Hospital Centre, Corbeil, France 6 University of Franche-Comté, Besanc¸on, France 7 Saint Louis Hospital, Paris, France 2
Background and aims: EVIDENCE is a post-marketing requested by the French National Authority for Health. It aims to describe the characteristics of patients treated with liraglutide, the conditions of use for this product, the treatment compliance rate, the reasons for discontinuing treatment and the change in HbA1C, weight and long-term safety (2 years). The baseline characteristics are presented here. Design and methods: EVIDENCE is a multicentre, prospective, observational study led in ambulatory settings. French diabetologists and general practitioners (GPs) recruited 3137 patients starting treatment with liraglutide. Patients and physicians completed questionnaires at study entry, 3 months and 6 months, the nat six-monthly intervals for a further 18 months. Results: There were 546 GPs and 445 diabetologists who recruited 1390 and 1747 patients respectively. 53% were male. Their mean age was 59 years (SD 11). On average, BMI was 34 kg/m2 (SD 6,7). The mean duration of diabetes was 10 years (SD 6). One-third of the patients showed at least one diabetesrelated complication. The mean HbA1c was 8.5% (SD 1.5%) whereas 9.8% of patients had an HbA1C < 7%. 7% of patients had experienced hypoglycaemia during the 4 weeks preceding inclusion. Physicians stated that life style advice was offered to 95.2% of patients but these adhered mildly. At inclusion, 84% of patients were treated by two or more antidiabetic agents. Metformin was prescribed to 88% of patients, then by decreasing percentage rank, sulfonylurea (57%), dipeptidyl peptidase-4 inhibitor (40%), and insulin (16%). The main reason for initiating liraglutide was the lack of efficacy of the current treatment (84.1%), where aside effects were declared by 6.2% of physicians. Conclusion: The main reason for prescribing liraglutide was the poor control of diabetes. Apart from those patients treated with insulin, this is in accordance with regulatory indication of liraglutide. http://dx.doi.org/10.1016/j.pcd.2012.10.058
77
P14
P15
Prescribing liraglutide to patients with type 2 diabetes in a clinical practice setting: the EVIDENCE study
Baseline observations from the EVIDENCE Study: characteristics of type 2 diabetes patients initiating liraglutide
G. Charpentier 1 , L. Martínez 2 , S. Madani 3 , A. Penfornis 4 , P. Gourdy 5 , J.F. Gautier 6
L. Martínez 1 , P. Gourdy 2 , E. Eschwège 3 , S. Charpentier 5 , A. Penfornis 6 , J.P. Gautier 7
1
1
Department of Internal Medicine, Endocrinology and Diabetology, Sud Francilien Hospital Centre, Corbeil-Essonnes, France 2 Department of General Practice, Pierre and Marie Curie University, Paris, France 3 Novo Nordisk, Paris, France 4 Department of Endocrinology-Metabolism and DiabetologyNutrition, Jean Minjoz Hospital, University of Franche-Comteˇı, Besanc¸on, France 5 Department of Diabetology, Metabolic Diseases and Nutrition, Toulouse University Hospital, Toulouse, France 6 Department of Diabetes and Endocrinology, Saint-Louis Hospital, Paris, France
Aims: EVIDENCE study is a post-marketing authorization observational study that aims to assess the effectiveness, conditions of use, and adherence to liraglutide treatment in patients with type 2 diabetes (T2D) in a clinical practice setting. This is a national multi-centre study in France that will last 2 years. Materials and methods: The primary objective is to determine the percentage of patients still taking liraglutide after 2 years and with A1c < 7%. Secondary objectives include A1c, fasting glycaemia, weight, adherence to treatment, tolerance, and treatment satisfaction, assessed using the Diabetes Treatment Satisfaction Questionnaire. An interim analysis is scheduled at 1 year. The cohort was calculated at 2845 patients (contact lost and missing data estimated at 40%) recruited by 750 consultants and 2000 general practitioners. Diabetologists/endocrinologists (n = 2300) and general practitioners (n = 19,280) involved in the care of patients with T2D using injectable antidiabetic medication were randomly selected from a database, and contacted by letter, telephone, and email Results: Of the doctors contacted, 3453 (16%) agreed to take part in the study. A total of 2162 centres were set up (645 consultants and 1517 general practitioners, i.e. 28% and 8% of the doctors contacted, respectively) and 46% of them recruited ≥1 patient (69% and 31%, respectively). In the past 12 months, 3151 patients have been included. In this study, 59% of the doctors work in urban communities with < 100,000 inhabitants, and 9% work in the Paris area. The average age of the doctors was 51, and 36% of the doctors were female. Despite the difficulties in recruiting doctors, the number of patients included in the study reached the target set. Conclusion: The EVIDENCE study will provide information about the effectiveness of liraglutide after 2 years and how well the treatment is adhered to and tolerated in clinical practice. http://dx.doi.org/10.1016/j.pcd.2012.10.057
Madani 4 , G.
Pierre and Marie Curie University, Paris, France Toulouse UniversityHospital, Toulouse, France 3 National Institute of Health and Medical Research (INSERM), Villejuif, France 4 Novo Nordisk, Paris, France 5 Sud Francilien Hospital Centre, Corbeil, France 6 University of Franche-Comté, Besanc¸on, France 7 Saint Louis Hospital, Paris, France 2
Background and aims: EVIDENCE is a post-marketing requested by the French National Authority for Health. It aims to describe the characteristics of patients treated with liraglutide, the conditions of use for this product, the treatment compliance rate, the reasons for discontinuing treatment and the change in HbA1C, weight and long-term safety (2 years). The baseline characteristics are presented here. Design and methods: EVIDENCE is a multicentre, prospective, observational study led in ambulatory settings. French diabetologists and general practitioners (GPs) recruited 3137 patients starting treatment with liraglutide. Patients and physicians completed questionnaires at study entry, 3 months and 6 months, the nat six-monthly intervals for a further 18 months. Results: There were 546 GPs and 445 diabetologists who recruited 1390 and 1747 patients respectively. 53% were male. Their mean age was 59 years (SD 11). On average, BMI was 34 kg/m2 (SD 6,7). The mean duration of diabetes was 10 years (SD 6). One-third of the patients showed at least one diabetesrelated complication. The mean HbA1c was 8.5% (SD 1.5%) whereas 9.8% of patients had an HbA1C < 7%. 7% of patients had experienced hypoglycaemia during the 4 weeks preceding inclusion. Physicians stated that life style advice was offered to 95.2% of patients but these adhered mildly. At inclusion, 84% of patients were treated by two or more antidiabetic agents. Metformin was prescribed to 88% of patients, then by decreasing percentage rank, sulfonylurea (57%), dipeptidyl peptidase-4 inhibitor (40%), and insulin (16%). The main reason for initiating liraglutide was the lack of efficacy of the current treatment (84.1%), where aside effects were declared by 6.2% of physicians. Conclusion: The main reason for prescribing liraglutide was the poor control of diabetes. Apart from those patients treated with insulin, this is in accordance with regulatory indication of liraglutide. http://dx.doi.org/10.1016/j.pcd.2012.10.058