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Aim DIALOG assessed the prevalence and predictors of hypoglycaemia in patients with type 1 (T1DM) or insulin-treated type 2 diabetes mellitus (T2DM) in a real-life setting. Methods In this observational study, insulin-treated patients ( n =3048) completed prospective daily questionnaires reporting the frequency and consequences of severe/confirmed non-severe hypoglycaemia over 30 days. Patients ( n =3743) also retrospectively reported severe hypoglycaemia over the preceding year. Results In this prospective survey, 85.3% and 43.6% of patients with T1DM and T2DM, respectively, reported experiencing at least one confirmed hypoglycaemic event over 30 days, while 13.4% and 6.4%, respectively, reported at least one severe event. Hypoglycaemia frequency increased with longer duration of diabetes and insulin therapy. Strongly predictive factors for hypoglycaemia were previous hypoglycaemia, >2 injections/day, BMI 2 and duration of insulin therapy>10 years. HbA 1c level was not predictive of hypoglycaemia in either T1DM or T2DM. The confirmed hypoglycaemia rate was increased in the lowest compared with the highest tertile of HbA 1c in T1DM, but not T2DM. At the time of enrolment, physicians reported severe hypoglycaemia in 23.6% and 11.9% of T1DM and T2DM patients, respectively, during the preceding year; the retrospective survey yielded frequencies of 31.5% and 21.7%, respectively. Also, severe hypoglycaemia led to medical complications in 10.7% and 7.8% of events in T1DM and T2DM patients, respectively, over 30 days. Conclusion Using a unique combined prospective and retrospective approach, the DIALOG study found a relatively high frequency of hypoglycaemia among insulin-treated patients. These findings emphasize the importance of a patient-centred approach for managing diabetes in which hypoglycaemia risk evaluation is critical. Trial registration ClinicalTrials.gov: NCT01628341.

Aim This study aimed to evaluate changes in the prevalence of glucose-lowering agents in a large, unselected general French population from 1997 to 2007, with specific focus on changes in other cardiovascular risk factors in relation to diabetic status during 2001–2002 and 2006–2007. Methods The prevalence of treated diabetes was assessed in a large population who had a health check-up at the “Investigations Preventives et Cliniques” Center between 1997–2007. Baseline characteristics and risk profiles of individuals with and without treatment for diabetes were assessed and compared with data for 2001–2002 and 2006–2007. Results From 1997 to 2007, the prevalence of treatment for diabetes increased from 0.75% to 1.73% in men and from 0.7% to 2.28% in women. In 2006–2007 compared with 2001–2002, the odds ratios for receiving glucose-lowering agents, adjusted for age, body mass index (BMI) and educational level, were 1.54 (95% CI: 1.28–1.86) in men and 1.59 (95% CI: 1.26–2.03) in women. In those treated for diabetes compared with untreated subjects, greater decreases in blood pressure, cholesterol and glycaemia were found, stress and depression scores improved, and a greater increase in BMI was found. Smoking decreased in both treated and untreated individuals. Physical activity decreased in treated individuals, but remained unchanged in the general population. Conclusion The prevalence of people treated with diabetes increased in the Paris area. Although most concomitant risk factors decreased more in treated individuals than in the general population, physical activity and BMI worsened, thus, emphasizing the need for improving patient education.

Resume L’enquete Evolution des objectifs et des pratiques en diabetologie : place et contribution des therapeutiques innovantes (EVOLUTIV) a ete conduite en ligne sur internet, aupres de 135 medecins generalistes (MG) et 135 medecins specialistes (82,8 % d’endocrinologues-diabetologues) habitues au suivi des patients diabetiques de type 2 (DT2). La methodologie utilisee, celle des vignettes cliniques, a permis de leur proposer cinq profils de patients DT2, comportant chacun deux redactions differentes du meme cas clinique, combinant des situations de pratique clinique (bitherapie orale, diabete recent ou ancien, controle glycemique insuffisant ou desequilibre du diabete, absence ou presence de complications microvasculaire ou cardiovasculaire). Chaque medecin devait determiner le traitement antidiabetique pour ces dix cas cliniques, alors que, pour chacun d’entre eux, variaient deux parametres de base : le taux d’HbA 1c et l’indice de masse corporelle (IMC). Pour chaque cas clinique, quatre questions leur etaient posees, portant sur l’objectif glycemique (HbA 1c ) vise, l’objectif de perte de poids vise, la strategie therapeutique preconisee, les principaux criteres de decision ayant amene au choix therapeutique. Au total, 2 570 cas cliniques complets ont ete recueillis et analyses. L’analyse des reponses a mis en evidence : – des objectifs glycemiques et de perte de poids globalement ambitieux, alors que les strategies therapeutiques choisies, particulierement par les MG, ne paraissaient pas toujours en adequation avec ces objectifs ; – une difference de comportement entre MG et specialistes en termes d’intensification therapeutique. Les MG privilegiaient le maintien des strategies orales et sous-utilisaient les strategies injectables (analogue du glucagon-like peptide-1 [GLP-1] et insuline), alors qu’elles etaient plus largement et plus precocement preconisees par les specialistes, en particulier en cas d’HbA 1c ≥ 8 % et/ou d’IMC ≥ 29 kg/m 2 . Le recours a la classe des inhibiteurs de la dipeptidyl peptidase IV (DPP-4) en ajout a la metformine predominait, tant chez les MG que chez les specialistes, avec, pour consequence, un recours plus tardif aux analogues du GLP-1, particulierement chez les MG (hors IMC de 35 kg/m 2 ) ; – le critere de decision predominant etait l’HbA 1c . Cependant, aux stades precoces du diabete, les moyens therapeutiques preconises par les MG n’etaient generalement pas adaptes a l’atteinte d’un objectif strict. Aux stades plus complexes (diabete ancien desequilibre et/ou complique), le taux de recours aux specialistes augmentait fortement, principalement pour les taux d’HbA 1c les plus eleves (≥ 9 %) et d’autant plus que l’IMC augmentait (≥ 29 kg/m 2 ).

Dans cette revue, les relations entre le poids, le controle glycemique et le risque cardiovasculaire sont analysees a partir des dernieres donnees de la litterature. Le registre suedois des patients diabetiques de type 2 montre qu’un gain ponderal d’une unite d’Indice de masse corporelle (IMC) augmente significativement le risque vasculaire de 13 %, une amplitude presque equivalente a la reduction obtenue avec une baisse du taux d’HbA1c de 1 %. Plusieurs etudes sur le risque cardiovasculaire du diabetique ont produit des donnees convergentes et soulignent l’interet de maintenir l’objectif de reduction ponderale comme un element central de la strategie therapeutique de ces patients. Les etudes d’intervention visant a demontrer l’effet de la perte de poids sur la prevention des evenements cardiovasculaires sont en cours. Cet objectif therapeutique est difficile a atteindre ou a maintenir et doit faire appel a des outils depassant le simple cadre de la dietetique pour aborder des aspects de sciences humaines en cours de transposition dans le monde medical. Quoi qu’il en soit, tout doit etre fait pour eviter autant que faire se peut une prise de poids par l’utilisation de traitement(s) ayant un effet neutre ou favorable sur l’exces ponderal, dans les limites de leur efficacite.

L’etude ENTRED 2007 (Echantillon national temoin representatif des personnes diabetiques) est une enquete epidemiologique descriptive visant a observer, decrire et, par comparaison avec la premiere enquete ENTRED en 2001, suivre l’evolution des caracteristiques, de l’etat de sante et de la prise en charge des personnes diabetiques de type 1 comme de type 2 en France (n = 9 987). Sont aussi decrits le mode de suivi et les attitudes therapeutiques des soignants, la demarche educative, les depenses de sante liees a ces pathologies. On retient que cette population est âgee (moyenne d’âge de 65 ans, et 25 % ont plus de 75 ans), economiquement desavantagee, et pour 23 % nee a l’etranger. Comme en 2001, 92 % presenteraient un diabete de type 2. Il est note une progression sensible en ce qui concerne l’atteinte des objectifs : HbA1c (moyenne : 7,1 % pour le type 2, dont 54 % ≤ 7 %, et 7,9 % pour le type 1), LDL-cholesterol, pression arterielle ; et une meilleure utilisation des molecules recommandees par les autorites de sante. Toutefois, on note un recours tardif a la consultation dietetique (lors de la mise sous insuline), un retard de renforcement des strategies de controle glycemique (maintien en mono- et bitherapie malgre des taux d’HbA1c superieurs aux objectifs) et un controle tensionnel encore perfectible. De meme, le fond d’œil et la gradation du risque podologique, et plus encore le dosage de la microalbuminurie, sont insuffisamment pratiques. Ces donnees montrent les progres realises, mais aussi les lacunes de notre systeme de soin, et permettront d’orienter les futures recommandations.

Suite a la demande de la Direction Generale de la Sante, une etude a ete mise en place afin d’evaluer les modalites d’utilisation de l’insuline glargine chez des patients diabetiques en conditions de pratique reelle en France, de decrire le niveau de controle glycemique obtenu et l’incidence des hypoglycemies observees. Il s’agissait d’une etude prospective, observationnelle, multicentrique, nationale de suivi sur un an d’une cohorte de patients diabetiques de type 1 (DT1) et de type 2 (DT2) traites depuis au moins un mois avec de l’insuline glargine et suivis pendant un an par des medecins generalistes, diabetologues et pediatres. L’analyse porte sur 1 707 patients, dont 609 patients DT1 et 1 097 patients DT2 (et un patient avec un diabete non determine). L’âge moyen des patients etait de 42,0 ± 19,4 ans pour les DT1 et de 67,0 ± 11,9 ans pour les DT2, 642 (58,5 %) patients etaient âges de 65 ans et plus et 325 (29,6 %) de 75 ans et plus. L’anciennete moyenne du diabete etait respectivement de 15,8 ± 12,5 et 14,0 ± 8,8 ans. Parmi les patients DT2, 57 % etaient naifs d’insuline avant l’initiation de l’insuline glargine (DT2-IN) et 43 % etaient deja traites par une insuline (DT2-IT). La raison de l’initiation de l’insuline glargine etait principalement un mauvais controle de la glycemie. L’utilisation de l’insuline glargine a conduit a une augmentation importante de l’utilisation du schema therapeutique basal-bolus chez les DT1 et DT2-IT, respectivement de 32 % a 84,7 % et de 8,4 % a 38,8 % et a une diminution du nombre d’antidiabetiques oraux associes chez les DT2-IN, ainsi que chez les patients âges de plus de 65 ans. La dose moyenne d’insuline glargine a l’inclusion etait de 24,2 U/j chez les DT1, de 31,6 U/j chez les DT2-IT et de 23,6 U/j chez les DT2-IN. Au cours du suivi, cette dose est restee stable pour les DT1, et a augmente chez les DT2 (atteignant 35 U/j pour les DT2-IT et 29,7 U/j pour les DT2-IN) La proportion de patients atteignant les objectifs glycemiques (HbA1c En conclusion, les resultats de cette etude en vie reelle ont montre un profil d’utilisation de l’insuline glargine en France conforme au bon usage et aux recommandations de prise en charge du patient diabetique conjointes de la HAS et de l’AFSSAPS en vigueur. Le controle glycemique, initialement ameliore suite a l’instauration de l’insuline glargine, s’est maintenu pendant le suivi a 12 mois. Une augmentation du nombre de patients atteignant l’objectif d’HbA1c (

Aim. - Metformin has recently been considered as a possible pharmacological complement to lifestyle measures for preventing type 2 diabetes in high-risk subjects. However, little is known of its effects on metabolic and cardiovascular risk factors in non-diabetic subjects. Methods. - The BIGPRO1 trial was a 1-year multicentre, randomized, double-blind, controlled clinical trial of metformin versus placebo, carried out in the early 1990s, in 457 upper-body obese non-diabetic subjects with no cardiovascular diseases or contraindications to metformin. We compared the changes (1-year minus baseline) in cardiometabolic risk factors between treatment groups in two subsets of trial subjects: those with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (n = 101); and those who fulfilled the inclusion criteria of the Diabetes Prevention Program (DPP) (it = 5 1). Comparisons were adjusted for age and gender. Results. - In the IFG/IGT subset, significant differences in 1-year changes were observed for systolic blood pressure, which decreased markedly more in the metformin group than in the placebo group (P < 0.003), and for fasting plasma glucose, and total and LDL cholesterol, which decreased slightly in the metformin group, but increased in the placebo group (P < 0.04). Similar results were observed in the subset with DPP criteria. Also, there were no significant differences in 1-year changes for weight, waist-to-hip ratio, 2-h post-load blood glucose, fasting and 2-h post-load insulin, HDL cholesterol, triglycerides and fibrinolytic markers between the two treatment groups. Conclusion. - In subjects at high risk of developing diabetes, the use of metformin showed beneficial and no untoward effects on cardiometabolic risk factors.

Aims To estimate the prevalence of diagnosed type 2 diabetes mellitus in the French general population. Secondary objectives were to evaluate treatments and diabetic complications. Methods In this cross-sectional epidemiological survey, a representative sample of the French adult population was selected using a stratified quota method: 10,038 individuals were evaluated by a standardized face-to-face interview. The diagnosis of type 2 diabetes was determined on the basis of replies to six questions using a specific algorithm. Data were collected on risk factors, diabetes history, familial antecedents and diabetic complications. These patients also identified their treatments from an exhaustive list. Results The prevalence of type 2 diabetes was 5.08% in men and 4.11% in women, and rose progressively after the age of 50. Of these, 79patients (13.4%) received no pharmacological treatment, 477 (80.9%) were taking an oral antidiabetic drug and 134 (22.7%) were taking insulin. Renal and ocular complications were reported by 6.8% and 21.0%, respectively, of the patients. Also, 10.4% had been hospitalized at some time of that year for a diabetes-related problem. The most frequently reported treatments were metformin and sulphonylureas, used by more than 50% of the patients. In addition, 380 patients (65.9%) claimed to be following a diet and 228 (39.2%) were consulting a dietitian. Conclusion The prevalence of treated and untreated type 2 diabetes mellitus in France was 4.57%.

Aims The metabolic syndrome is a cluster of cardiovascular risk factors which include central obesity, dyslipidaemia, glucose intolerance and hypertension. These risk factors are common in patients with growth hormone (GH) deficiency, suggesting a role for the somatotropic axis in the development of metabolic syndrome. Methods We used factor analysis to investigate the relationships linking serum levels of GH and insulin-like growth factor I (IGF-I) to metabolic syndrome variables (high-density lipoprotein cholesterol, triglycerides, fasting glucose, blood pressure and waist circumference). We studied 359 men and 388 women from the Data from an Epidemiological Study on the Insulin Resistance syndrome (DESIR). Their age range was 30–64 years. Results Three independent latent factors explained 61% of the total variance in women and four factors explained 73% in men. In both men and women, IGF-I showed a strong positive correlation with the lipid factor and a negative correlation with the obesity/glucose factor. In women, GH showed a strong negative correlation with the obesity/glucose factor but not the lipid factor. In men, GH was unrelated to the lipid and obesity/glucose factors. The blood pressure factor was not related to GH or IGF-I. In contrast with IGF-I, GH was significantly lower in women with metabolic syndrome (1575 ± 449 pg/ml) than in the other women (2121 ± 520 pg/ml, P = 0.002). No significant difference was observed in men for GH or IGF-I. Conclusion Our results support a link between the somatotropic axis and several features of the metabolic syndrome, and suggest distinct effects of GH and IGF-I on these parameters.

Aims To measure the prevalence of low high-density lipoprotein (HDL)-cholesterol (men

Aim To explore the frequency of hypoglycaemic episodes, their risk factors, and associations with patient-reported outcomes in patients with type 2 diabetes enrolled in the PANORAMA cross-sectional study. Methods Five thousand seven hundred and eighty-three patients aged ≥ 40 years with type 2 diabetes duration ≥ 1 year were recruited in nine European countries. Patients reported severe and non-severe hypoglycaemic episodes during the past year at a single study visit. Patient-reported outcomes were measured by the Audit of Diabetes-Dependent Quality of Life, Diabetes Treatment Satisfaction Questionnaires, Hypoglycaemia Fear Survey-II, and EQ-5D Visual Analog Scale. Results During the previous year, 4.4% of the patients experienced ≥1 severe hypoglycaemic episode; among those without severe hypoglycaemia, 15.7% experienced ≥1 non-severe episode. Patients experiencing any hypoglycaemic episode reported a greater negative impact of diabetes on quality of life, greater fear of hypoglycaemia, less treatment satisfaction and worse health status than those with no episodes. In multivariate analyses hypoglycaemia was significantly associated with longer diabetes duration; presence of microvascular and, to a lesser extent, macrovascular complications; treatment with insulin, glinides or sulfonylureas; and use of self-monitoring blood glucose. Conclusion In patients with type 2 diabetes, severe hypoglycaemic episodes were not uncommon and one in five experienced some form of hypoglycaemia during the previous year. Hypoglycaemia was associated with more negative patient-reported outcomes. The risk of hypoglycaemia increased with diabetes duration, presence of diabetes-related complications, use of self-monitoring blood glucose, insulin secretagogues, and insulin treatment.

Aim To describe the association between socio-economic position, health status and quality of diabetes care in people with Type 2 diabetes in France, where people may receive full healthcare coverage for chronic disease. Methods Data from a national cross-sectional survey performed in people pharmacologically treated for diabetes were used. They combined data from medical claims, hospital discharge, questionnaires for patients (n = 3894 with Type 2 diabetes) and their physicians (n = 2485). Socio-economic position was assessed using educational level (low, intermediate, high) and ability to make ends meet (financial difficulties vs. financially comfortable). Results People with diabetes reporting financial difficulties were more likely to be smokers (adjusted odds ratio 1.4; 95% CI 1.1–1.6) and obese (adjusted odds ratio 1.3; 95% CI 1.2–1.6) and to have poorer glycaemic control (HbA1c > 64 mmol/mol (8%); adjusted odds ratio 1.4; 95% CI 1.1–1.8), than those who were financially comfortable. They were more likely to have their diabetes diagnosed because of complications (adjusted odds ratio 1.6; 95% CI 1.3–2.0). They were also more likely to have coronary and podiatric complications (adjusted odds ratios 1.3; 95% CI 1.1–1.6 and 1.7; 95% CI 1.4–2.2, respectively). They benefited more often from full coverage (adjusted odds ratio 1.3; 95% CI 1.1–1.6), visited general practitioners more often (ratio of estimated marginal means 1.2; 95% CI 1.1–1.2) but specialists less often (adjusted odds ratio 0.7; 95% CI 0.6–0.8 for a visit to private ophthalmologist). They also felt less well informed about their condition. Conclusions Despite frequent access to full healthcare coverage, socio-economic position has an impact on the diagnosis of diabetes, health status and quality of diabetes care in France.

The IDAHO 2 epidemiological survey was conducted in departments of diabetology in insulin-naïve type 2 diabetics for whom insulin was initiated. The objective was to assess the patients' profile, the treatments proposed during hospital stay and after one year.797 patients were analysed. Their characteristics were: age 64+/-12 years, 49% males, weight: 78+/-17 kg, BMI: 29+/-6 kg/m2, diabetes duration 11 years, prevalence of complications: 68%, fasting blood glucose 13+/-6 mmol/l, HbA1c: 10+/-2.2%; treatment prior to insulin comprised: at least 2 OHA: 71% of cases, one: 21%, no OAD: 8%. At hospital discharge, 54% of the patients used basal insulin. After 1 year, 670 continued on insulin. The insulin initiation was accompanied by a decrease in the FBG level (baseline: 13+/-6 mmol/l; final: 8.5+/-2.75 mmol/l; P0.0001) and a HbA1c improvement (baseline: 10+/-2.2%; final: 7.9+/-1.4%; P0.0001). This was observed du-ring the first 6 months (HbA1c: 7.8%, P0.0001 versus baseline). 80% of the patients remained on the same insulin regimen after 1 year: 35% had 1 injection/day, 44% had 2, 12% had 3 and 9% had a complex regimen. The weight gain, the final daily dose and hypoglycaemias increased with the number of injections. The mean daily insulin dose was 33 U/day (24 U with 1 injection/day).The IDAHO study shows that insulin is effective in type 2 diabetics however, management is inadequate with insulin therapy being initiated too late and at doses which are low after one year.

Summary Aim It has been shown, mainly in men, that gamma-glutamyltransferase (φGT) and alanine-aminotransferase (ALT) predict the development of type 2 diabetes. This study investigates the association between hepatic markers and the 3-year risk of diabetes. Methods Incident diabetes was studied in 2071 men and 2130 women without diabetes at baseline from the D.E.S.I.R. cohort. Results Adjusting on age, only φGT was predictive of diabetes in both sexes, whereas ALT and aspartate-aminotransferase (AST) were only predictive in men, and bilirubin was not predictive. After adjustment on classical confounding factors and on ALT activity, the odds ratios (OR) for incident diabetes increased across baseline φGT quartiles: 1, 3.1, 2.6, 5.0 in men (P Conclusion φGT was the main hepatic risk marker for type-2 diabetes in both sexes, especially in subjects with central adiposity.

Summary Objectives The aim of this observational study was to evaluate the screening for diabetic retinopathy (DR) using eye fundus photography taken by a nonmydriatic camera and transmitted trough the Internet to an ophthalmological reading centre, as compared to a dilated eye examination performed by an ophthalmologist. Methods A total of 456 and 426 diabetic patients were included by two different groups of primary care physicians (PCPs), 358 being screened with the non-mydriatic camera (experimental group) and 320 with dilated eye fundus exam (control group). Results The proportion of screened patients for whom PCPs received a screening report within the 6-month follow-up period was 74,1% for the experimental group and 71,5% for the control group. Screening for DR was negative in 77,6% of patients with eye fundus photographs vs 89,6% with dilated eye examination. DR was diagnosed in 62 patients (17,3%) with eye fundus photographs versus 31 with dilated eye examination (10,4%). Referral to an ophthalmologist was required in 59 reports of patients with photographs (16.5%), 23 of them due to high grade DR. Finally, the non-mydriatic camera was found of little inconvenience by patients. Conclusion The telemedical approach to DR screening proved to be effective in providing primary care practitioners with information about their patient's eye status. This screening method allowed to identify patients requiring prompt referral to the ophthalmologist for further complete eye examination. In conclusion, this study provided successful results of DR screening using fundus photography in primary care patients, and strongly supports the need to further extend this screening program in a larger number of French sites.

Resume Objectifs. – Evaluer le taux de poursuite a 2 ans d’un traitement hormonal substitutif (THS) dans deux cohortes de femmes traitees l’une par l’association orale, fixe, de valerate d’estradiol et d’acetate de medroxyprogesterone l’autre par un gel percutane de 17 β-estradiol associe a un progestatif administre oralement, au choix du prescripteur. Patientes et methodes. – Etude prospective comparative, randomisee, ouverte portant sur un total de 885 patientes suivies deux ans dont 477 dans une cohorte THS oral et 408 dans une cohorte THS cutane. La randomisation s'est faite par groupe avec prescription a priori du THS de la cohorte. On a utilise pour comparer les deux groupes de traitement les tests χ2 et test exact de Fisher pour les variables qualitatives, test « t » de Student ou test de Wilcoxon pour les variables quantitatives, la methode de Kaplan Meier pour le taux de poursuite du THS et les comparaisons ont ete effectuees en utilisant le test du log-rank. La valeur pronostique des parametres initiaux sur le taux de poursuite du THS a ete etudiee avec le modele de Cox (test de Wald, odds ratio). Resultats. – Parmi les patientes etudiees, 711 ont recu le THS de leur cohorte (382 dans la cohorte THS oral, 329 dans la cohorte THS cutane), au bout de 2 ans, 77,9 % des patientes traitees de la cohorte THS oral et 73,4 % des patientes traitees de la cohorte THS cutane poursuivaient un THS (p = 0,076), 37,9 % des patientes de la cohorte THS oral, et 20,2 % de la cohorte THS cutane (p Conclusion. – Bien que la difference d’observance entre les deux traitements n’ait pas ete significative, on peut toutefois avancer que l’observance du THS par une association estroprogestative fixe sequentielle est, dans cet essai, au moins egale a celle de l’association libre d’un estrogene transdermique et d’un progestatif dont la nature, la posologie et la duree de la sequence sont choisies par le prescripteur. D’autre part, les modifications de traitement sont plus frequentes dans la cohorte THS cutanee, ce qui est logique puisque le propre des traitements par associations libres est la possibilite d’adapter individuellement les doses.

Round table no. 2 was devoted to the postmarketing evaluation of drugs. The debates involved both the questions posed by postmarketing evaluation and the methods for responding to them. The major categories of questions likely to be posed are as follows: efficacy in actual situations; safety in actual situations; prognostic factors and patients responding; place in the therapeutic strategy; impact on the healthcare care system; the 'joined' population (those who actually obtain benefit); and drug utilisation review. In addition, the methodological approaches have been divided into three categories: the experimental approach, the observational approach and the modelling approach. Each of these methodological approaches has been qualified with respect to each of the questions. The objective was neither to establish a classification of the methods according to the level of proof, nor to propose methodological formulae. Instead, the participants applied themselves to describe the strengths and the limits of the different methods for each of the questions in turn. The debates then focused on the process of identification of pertinent questions and appropriate methods. In this context, the round-table participants applied an analysis of the current system of postmarketing study projects and formulated some propositions for their improvement. Finally, the place of existing databases in the postmarketing evaluation was discussed and the participants emphasised the importance of initiating a very detailed assessment of the information that could be provided by such databases before instituting ad hoc studies.

The Cost of Diabetes in Europe - Type II study is the first large coordinated attempt to measure the current standard of care and determine the costs of managing patients with Type II (non-insulin-dependent) diabetes mellitus.The study evaluated glycaemic control, blood lipid levels and blood pressure, all of which are risk factors for complications. Records of these clinical characteristics were collected from over 7000 patients during the 6-month study period.The mean HbA(1c) value for the entire study population was 7.5%, ranging from 7.0% in Sweden to 7.8% in the United Kingdom. Only 31% of individuals achieved good glycaemic control (HbA(1c)or = 6.5%) according to current European guidelines. Only 64% of the total study population were tested for HbA(1c) values at least once within the 6-month study period (ranging from 49% in Spain to 71% in the UK), although HbA(1c) testing every 3 months is recommended for all patients, by European Diabetes Policy Group guidelines. The majority of patients had borderline total cholesterol values, with a mean value of 5.7 mmol/l. Overall, 21% of patients were classified as having low risk cholesterol levels (4.8 mmol/l). Good triglyceride levels (1.7 mmol/l) were achieved by 47% of the total study population. During the study period, 81% of patients had their blood pressure measured, with 35% and 53.3% of the patients reaching the recommended targets for systolic and diastolic blood pressure, respectively.This study showed that a high proportion of patients with risk factors for diabetes-related complications are not adequately controlled. Improvements in disease management and monitoring are therefore required to ensure that guideline targets are met, thus reducing the long-term complications of Type II diabetes.

Aim This analysis estimates the prevalence of type 2 diabetes mellitus (T2DM) in French adults participating in the ObEpi (obesity epidemiology) 2012 survey and also proposes a description of that population, according to comorbidities, treatments and sociodemographic factors related to the disease. Methods A self-administered questionnaire was posted to 20,000 households from the Kantar Health panel. In total, 25,714 adults aged≥18 years and representative of the French population completed the survey between January and March 2012. Results The prevalence of T2DM was 5.5±0.3% (95% CI) in this representative sample of the adult French population. Average age of patients was 65.9 years; 55% were men. Mean body mass index was 29.9kg/m 2 (men: 29.4kg/m 2 , women: 30.6 kg/m 2 ; P 0.01); the prevalence of obesity was 43.1% (men: 39.9%, women: 47.1%; P 0.01). Patient-reported treatments for comorbidities were frequent: high blood pressure, 59.1%; dyslipidaemia, 59.9%; myocardial infarction/angina pectoris, 9.7%; revascularization, 7.8%; heart failure, 7.4%; sleep apnoea, 8.3%; and osteoarthritis, 10.7%. With regards to known treatments, 81.4% of patients were taking oral antidiabetic drugs (OADs), and 15.3% were using insulin therapy. Also, 18.8% of diabetic respondents reported financial hardship. Conclusion T2DM remains a disease of major concern: compared with the non-diabetic population, all parameters surveyed showed unfavourable ratings, particularly for women.

The relationship between microalbuminuria and tissue-type plasminogen activator antigen (tPA-ag) and fibrinogen was evaluated in non-diabetic subjects. Subjects were participants of the D.E.S.I.R. (Data from an Epidemiological Study on the Insulin Resistance syndrome) Study. Analyses were carried out on 2248 women and 2402 men for fibrinogen and on 272 women and 284 men for tPA-ag. Microalbuminuria was defined as urinary albumin concentration greater than 20 mg/l. Men with microalbuminuria had a 6% higher fibrinogen concentration than those without (3.07 g/l (95% confidence interval: 2.99,3.15) vs. 2.89 g/l (2.87,2.91), adjusted for age and smoking). This relationship existed in hypertensive as well as non-hypertensive subjects. The association between microalbuminuria and tPA-ag existed only in hypertensive men, those with microalbuminuria having a 21% higher tPA-ag than those without (4.39 ng/ml (3.70,5.08) vs. 3.63 ng/ml (3.32,3.94), adjusted for age and smoking). Adjustment for other risk markers for cardiovascular disease did not change the results. There was no relationship between microalbuminuria and these haemostatic factors in women. The results of this study suggest that in non-diabetic men, microalbuminuria is associated with fibrinogen, but with tPA-ag only when concomitant with hypertension.

OBJECTIVE: To investigate associations between adiposity indices and food intake in nonobese prepubertal free-living children. SUBJECTS: Five-hundred and one children, 280 boys and 221 girls aged 5–11 y in two little towns in northern France. DESIGN: Cross-sectional survey. MAIN OUTCOME MEASURES: Height and weight, four skinfolds (biceps, triceps, subscapular, suprailiac), waist and hip girths, were measured. Sum of skinfolds (SSF), body mass index (BMI), and relative weight (RW) were calculated. Energy intake (EI), percentage of energy intake ascribed to carbohydrates (%EIC), complex carbohydrates (%EICC), fats (%EIF), saturated fats (%EISF) and proteins (%EIP) were assessed by a single 24 h record. Basal metabolic rate (BMR) was estimated according to Schofield's equations. Obese (RW≥120%), and underreporting children according to Goldberg's and Black's equations were excluded. RESULTS: In multiple linear regressions analyses performed with hierarchical mixed models, adiposity indices were significantly and inversely associated in girls with %EIC (all P-values

OBJECTIVE: To determine if energy intake underreporting concerns all major food groups or if it occurs for specific food groups only. DESIGN: Cross-sectional study on dietary habits and food consumption. SUBJECTS: Five-hundred and four women and 529 men, aged between 25 and 55 y participating in the Fleurbaix Laventie Ville Sante study. MEASUREMENTS: A nutritional survey was conducted between March and June 1993 using a 3-day food record. Reported weight and height were used to estimate body mass index and basal metabolic rate. Underreporters were defined as subjects whose ratio of mean energy intake to basal metabolic rate was lower than 1.05. Food consumption was compared between underreporters and non-underreporters. RESULTS: Energy percentage of fat and carbohydrate were lower in underreporters than in non-underreporters in contrast to the energy percentage of protein. This was due to the fact that food items rich in fat and/or carbohydrates (such as butter, French fries, sugars and confectionery, cakes and pastries) were reported to be less frequently eaten and/or in smaller quantities in underreporters compared to non-underreporters. CONCLUSION: Although this study presents some limitations, like the use of reported weight and a standard value for physical activity, it shows that reported foods differed, quantitatively and qualitatively, between severe underreporters and non-underreporters. Underreporting of food intake does not result from a systematical underestimation of portion sizes for all food items, but seems to concern specific food items which are generally considered ‘bad for health’.

OBJECTIVE: To estimate the direct medical costs associated with obesity in France. DESIGN: Analysis of the French 1991–1992 National Household Survey database comprising a representative sample of 14,670 individuals aged 18 y and over. A subgroup of subjects with a body mass index (BMI)≥30 kg/m2 was compared with a control group of normal-weight individuals (BMI 18.5–25 kg/m2) matched on age, gender and education level. MEASUREMENTS: Self-reported weight and height used to calculate individual body mass index and health expenditures in a 3 month period, and morbidity as declared by respondents to the national household survey and verified on medical records. RESULTS: The direct cost attributable to obesity (BMI≥30 kg/m2) was estimated to be in the range 4.2–8.7 billion French Francs (FF) in 1992 value, that is between 0.7 and 1.5% of total health expenditures. CONCLUSION: These results were of the same order of magnitude as similar estimates obtained by a top-down approach for the same year and setting.

Objective: Several studies, mainly in animals, but also in humans, have shown that diet in infancy is associated with differences in blood cholesterol concentrations later in life. The objective was to examine this relationship in children aged 5–11 y after taking into account their current diet and parental hypercholesterolemia. Setting and subjects: 251 prepubertal boys and 223 prepubertal girls enrolled in the schools in two little towns in northern France. Design and methods: Cross-sectional evaluation including measurements of cholesterol concentrations on capillary blood and a single weekday food intake record. Infant feeding patterns were obtained by questionnaire given to the mothers Results: 50% of the children had been breast-fed for a median duration of less than 2 months. Cow’s milk was introduced in the diet as whole milk for 33% of the children. After adjustment for age, height, and sibship, capillary cholesterol concentration was lower in boys who had been breast fed (geometric mean: 4.4, 95% confidence interval of the mean: 4.2–4.6 mmol/L) than in those fed with formula (4.7, 4.5–4.8 mmol/L, P

Objective: Antipyretic/analgesic drugs (AADs) are among the most commonly used drugs in children. Their efficacy and adverse effects have often been debated and new AADs have been introduced over the past few years. The aim of this study was to assess the characteristics of the use of AADs in children in France, and their trends. Methods: Two surveys on household health care consumption were undertaken in France, in 1981 and in 1992. They included 5060 and 4841 children, respectively. The AADs studied were aspirin, paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs). Results: The proportion of children exposed to AADs increased significantly between 1981 and 1992 (+28% in 11 years). Among them, the percentage of subjects treated with aspirin decreased (−27%). In contrast, the percentage increased for paracetamol (+19%) and for NSAIDs (+179%). Aspirin was the AAD most used in 1981 (57.4%) and it was replaced by paracetamol in 1992 (71.6%). Nasopharyngitis was the main reason for AAD prescription under the age of 11 years; for older children it was influenza-like syndrome, irrespective of the study year. A change in AAD choice occurred in nasopharyngitis, acute bronchitis and influenza-like syndrome irrespective of the age group, and in otitis/sinusitis between 4 and 10 years. In all these cases aspirin prescription decreased, in contrast with paracetamol and NSAIDs. Self-medication of AAD was uncommon (8.3% for aspirin and 10.3% for paracetamol in 1992) and decreased (−29% and −33%). It was used principally for nasopharyngitis, influenza-like syndrome and pain. Conclusion: The consumption of AADs in children is high and is increasing. Paracetamol and NSAIDs tend to replace aspirin prescription in children and physicians have played the main role in this change.

Comparer l’efficacite de l’association du liraglutide a la metformine (Met + Lira) dans le cadre du suivi de l’etude observationnelle EVIDENCE®, apres 2 ans vs son ajout aux autres associations antidiabetiques. EVIDENCE® est une etude observationnelle post-inscription, prospective, mandatee par la HAS. L’objectif de cette analyse post-hoc est de comparer l’efficacite de la bitherapie (Met + Lira) vs. toutes les autres associations de traitement, incluant la metformine (autres + Lira) en termes de variation de l’HbA1c, du poids et du pourcentage de patients ayant atteint l’objectif d’HbA1c

OBJECTIVE To assess the association between high but nondiabetic blood glucose levels and the risk of death from all causes, coronary heart disease (CHD), cardiovascular disease, and neoplasms. RESEARCH DESIGN AND METHODS We studied the 20-year mortality of non-diabetic, working men, age 44–55 years, in three European cohorts known as the Whitehall Study (n = 10,025), the Paris Prospective Study (n = 6,629), and the Helsinki Policeman Study (n = 631). These men were identified by their 2-h glucose levels following an oral glucose tolerance test and by the absence of a prior diagnosis of diabetes. As the protocol for the oral glucose tolerance test and methods for measuring glucose differed between studies, mortality was analyzed according to the percentiles of the 2-h and fasting glucose distributions, using the Cox's proportional hazards model. RESULTS Men in the upper 20% of the 2-h glucose distributions and those in the upper 2.5% for fasting glucose had a significantly higher risk of all-cause mortality in comparison with men in the lower 80% of these distributions, with age-adjusted hazard ratios of 1.6 (95% CI 1.4–1.9) and 2.0 (1.6–2.6) for the upper 2.5%. For death from cardiovascular and CHD, men in the upper 2.5% of the 2-h and fasting glucose distributions were at higher risk, with age-adjusted hazard ratios for CHD of 1.8 (1.4–2.4) and 2.7 (1.7–4.4), respectively. CONCLUSIONS If early intervention aimed at lowering blood glucose concentrations can be shown to reduce mortality, it may be justified to lower the levels of both 2-h and fasting glucose, which define diabetes.

This 9-month pragmatic study compared 2 therapeutic regimens in the management of osteoarthritis of the hip and knee. Patients received either diacerein 100 mg/day plus standard osteoarthritic therapy for 6 months, followed by a 3-month monitoring period without diacerein, or standard therapy alone for the entire 9-month period. A total of 207 patients with osteoarthritis of the knee and hip were enrolled. Improvements in Lequense's functional index and quality-of-life scores (revised Arthritis Impact Measurement Scales Health Status Questionnaire and Nottingham Health Profile), and decreases in nonsteroidal anti-inflammatory drug and analgesic consumption were significantly greater with diacerein plus standard therapy than with standard therapy alone. The overall assessment of therapy by patients was good or excellent for 60% of those who received diacerein plus standard therapy, compared with 26% who received standard therapy alone. Medical and paramedical procedures carried out in addition to those stipulated in the protocol (medical consultations, physiotherapy, nursing, etc.), osteoarthritis-related, were fewer and less costly in the diacerein plus standard therapy group than in the standard therapy group. The average outpatient cost (in 1995 French francs) of osteoarthritis treatment in the standard therapy group was FF2272 compared with FF2360 in the diacerein plus standard therapy group. The cost-effectiveness ratios per point scored on Lequesne's index were FF1893 for the standard therapy group and FF1072 for the diacerein plus standard therapy group, leading to a saving of 43% with diacerein plus standard therapy. The marginal cost (additional cost corresponding to the clinical benefit obtained by adding diacerein to standard treatment) was FF88 per point scored on Lequesne's index.

OBJECTIVE: To study the determinants and nature of dietary underreporting in a free-living population. DESIGN: Cross-sectional study of nutritional and behavioural characteristics. SUBJECTS: 1030 weight-stable subjects, 501 women and 529 men older than 15y, included in the Fleurbaix Laventie Ville Sante study. MEASUREMENTS: Dietary intake was assessed using a 3 d dietary record. Self assessed body weight and height were also recorded. Behavioural and socio-economic data were obtained from a questionnaire. Underreporters were defined as people with a reported ratio of energy intake to estimated basal metabolic rate lower than 1.05. RESULTS: Underreporting concerned 16% of the population and was significantly more frequent in obese than in non obese subjects (P < 0.001). Underreporting was significantly associated with a high socio-professional class (P < 0.05), having dieted at least once (P

Objectif analyse descriptive du sous-groupe de patients DT2 de l’etude EVIDENCE inclus uniquement par les medecins generalistes (MG). Patients et methodes EVIDENCE est une etude observationnelle post-inscription avec un suivi de 2 ans, mandatee par la HAS, conduite chez des patients DT2 pris en charge par des MG et des diabetologues. L’objectif principal de l’etude etait de determiner le pourcentage de patients encore sous traitement et avec une HbA1c Resultats Au total 3152 patients DT2 ont ete inclus dans l’etude EVIDENCE dont 1398 par les MG. Un total de 1044 patients de ce sous-groupe ont complete les 2 ans de suivi. Ces patients presentaient un diabete moins evolue et moins complique. A 2 ans, 39 % de ces patients etaient encore sous liraglutide et avaient une HbA1c Discussion Ces resultats traduisent non seulement des differences dans les profils de patients inclus par les MG et les diabetologues mais egalement dans leurs modalites de recours a la classe des analogues du GLP-1.

A national survey was performed in France from May to June, 1993. The aim of this study was to evaluate general practitioners' attitudes and behaviors when diagnosing and managing patients with lower extremity arterial disease (LEAD). One thousand general practitioners, randomly drawn from an exhaustive list, were contacted to participate in a telephone interview concerning the last patient with intermittent claudication seen in their practice. Four hundred seventy-six general practitioners participated. Risk factors noted for these 476 patients with intermittent claudication were in agreement with the literature : 86% were men aged 64 ± 10 years (mean ± SD) and 14% were women aged 73 ± 8 years. Sixty-two percent had a pain-free walking distance of between 100 and 500 meters at diagnosis. Forty-five percent were former smokers and 37% currently smoked ; 55% had hypertension, 14% diabetes, and 56% disturbances of lipid metabolism. A majority of them were hypercholesterolemic. The diagnosis of the disease was based primarily on a clinical assessment, confirmed for 33% by Doppler or echo Doppler. The mean duration of diagnosis was 4.4 + 4.1 years. Management of the disease was mainly by prescription of vasodilators (91%), antiplatelet agents (59%), and anticoagulants (8%). Use of Doppler or echo Doppler was recommended once a year. Infection was observed in 27% of patients. Thirty-eight percent had had a cardiac incident (angina pectoris or myocardial infarction) and 10% a cerebrovascular accident. They differed significantly from those with LEAD alone for the following parameters : age (68.5 ± 9.2 vs. 63.2 ± 10.3 years ; p < 0.001) ; duration of LEAD (5.6 ± 4.6 vs. 3.6 ± 3.5 years ; p < 0.001) ; hypertension (65% vs. 50% ; p < 0.01) ; and current smoking (29% vs. 43% ; p < 0.01). This survey confirmed the feasibility of telephone interviewing, on a large sample of general practitioners in France. The high level of association with other cardiac incidents was, for these patients, a much higher risk of mortality and morbidity than LEAD alone. It would be interesting to validate the associations observed with a prospective study of comorbidity.

L'efficacite de la prevention d'un risque medicamenteux depend de la precision avec laquelle ses facteurs declenchants ou favorisants sont connus et de la qualite de l'information donnee a son sujet aux prescripteurs et aux utilisateurs. L'identification d'un risque devrait mettre a profit l'ensemble des donnees precliniques et cliniques disponibles pour la specialite pharmaceutique consideree et les confronter aux donnees existantes pour des medicaments partageant un meme mode d'action ou une meme strategie therapeutique. L'information doit s'appuyer sur un plan de communication adapte au contexte de la pathologie traitee, des alternatives therapeutiques existantes et du benefice attendu.

Effective prevention of drug-induced risks depends on an accurate understanding of their triggering or predisposing factors, and the quality of information on these available to prescribing practitioners and users. All preclinical and clinical data available on the proprietary medicinal product concerned should facilitate identification of a risk, and these data should be compared with existing data on drugs sharing the same mode of action or therapeutic strategy. This information should be based on a communication plan adapted to the context of the disease under treatment, the therapeutic alternatives available and the benefits expected.

PDB83 THE EPIDEMIOLOGY AND BURDEN OF OBESITY AND DIABETES IN FRANCE: A METHODOLOGICAL COMPARISON Moisan C1, Eschwege E2, Basdevant A3, Charles MA2, DiBonaventura MD4, Bonnelye G5 1ROCHE, Neuilly sur Seine Cedex, France, 2INSERM, Villejuif, France, 3Assistance PubliqueHopitaux de Paris, Paris, France, 4Kantar Health, New York, NY, USA, 5Kantar Health, Montrouge , France OBJECTIVES: The aim of the current study is to utilize two different methodologies to estimate the prevalence and burden of type 2 diabetes (T2D) and obesity among the adult population in France. METHODS: Two separate representative data sources were used for the adult French population. Data from the French respondents of the EU National Health and Wellness Survey (NHWS) (N 15,051) and the OBEPI survey (N 25,286) were used. The NHWS is an internet-based annual survey and the OBEPI is a mailed survey conducted every three years, validated by the French authorities. Prevalence information for T2D, comorbid treatments, and BMI were analyzed using both data sources. The humanistic and economic burden of T2D was analyzed only from the NHWS data. RESULTS: From NHWS, 44.3% of respondents from France were male and the average age was 45.1 years (SD 15.5). From OBEPI, 47.8% were male and the average age was 48.2 years (SD 17.8). A total of 30.5% (OBEPI 31.9%) and 15.6% (OBEPI 14.5%) of the French population were estimated to be overweight and obese, respectively. A total of 4.4% (from NHWS) and 4.8% (from OBEPI) of the adult French population reported suffering from T2D. Among these patients, 15.1% and 80.5% were taking an insulin and oral treatment, respectively (12.4% by OHA insulin and 76.0% by OHA only as estimated by OBEPI). From NHWS, a significant burden was observed among patients with T2D as they reported significantly lower levels physical quality of life (using the SF-12v2; 42.6 vs. 50.1, p .05) and significantly greater work impairment (26.7% vs. 18.2%, p .05) and physician visits (8.7 vs. 5.5, p .05). CONCLUSIONS: Both internet and mailed survey methodologies provided consistent prevalence estimates of diabetes and obesity among the French population. Further, despite the high prevalence of treatment, significant effects are observed on health outcomes among T2D patients, highlighting the unmet need.

Objectif Determiner si le traitement par liraglutide est plus efficace sur la baisse d’HbA1c aux stades precoces du diabete de type 2. Patients et methodes EVIDENCE® est une etude observationnelle post-inscription evaluant l’efficacite et la tolerance du liraglutide. L’analyse de la reduction d’HbA1c apres 2 ans a ete stratifiee selon l’anciennete du diabete (0–5 ; 6–10 ; > 10 ans) et les traitements anterieurs (nombre d’antidiabetiques oraux [ADO] ± insuline). Resultats Parmi les 2029 patients sous liraglutide en fin d’etude, l’anciennete du diabete et le type de traitements anterieurs etaient disponibles pour 1921 et 1895 patients, respectivement. La reduction d’HbA1c etait de −1,27 %, −1,09 % et −0,80 % dans les groupes d’anciennete 0–5, 6–10 et > 10 ans (tous p 10 ans (−0,21 %). L’ HbA1c etait egalement significativement reduite selon les traitements anterieurs (1 ADO : −1,29 % ; 2 ADO : −1,33 % ; ≥ 3 ADO : −0,81 % ; insuline ± ADO : −0,72 %). Cette reduction etait plus importante pour 1 ADO vs ≥ 3 ADO (−0,48 %), et vs insuline ± ADO (−0,57 %) ; ainsi que pour 2 ADO vs 3 ADO (−0,52 %) et vs insuline ± ADO (−0,61 %). Discussion La reponse au liraglutide etait meilleure avec un diabete plus recent et un traitement anterieur moins complexe. Ceci pourrait en partie s’expliquer par l’ajout du liraglutide aux therapies existantes, contrairement a un diabete ancien traite plus intensivement ou le liraglutide substitue un traitement anterieur.

Objectifs Evaluer l’efficacite et la tolerance du liraglutide a 2 ans en pratique clinique courante, en France. Patients et methodes EVIDENCE® est une etude multicentrique observationnelle post-inscription, prospective, mandatee par la HAS. Les patients initiant le liraglutide etaient recrutes par des diabetologues et des generalistes. L’objectif principal etait de determiner le pourcentage de patients encore sous traitement et avec une HbA1C Resultats Parmi 3152 patients inclus, 2029 (64,4 %) etaient encore sous liraglutide a 2 ans. A l’inclusion, la majorite des patients (n = 2804, 90 %) avait un taux d’HbA1c ≥ 7 %. La proportion de patients avec une HbA1c Discussion L’efficacite du liraglutide en pratique clinique courante est similaire a celle observee dans les essais cliniques randomises (ECR) (jusqu’a –1,5 % de reduction d’HbA1c et –3,24 kg de perte ponderale). Cependant, en l’absence de bras controle, il est difficile d’evaluer si ces ameliorations sont dues au liraglutide seul. L’incidence des evenements gastro-intestinaux etait inferieure a celle rapportee dans les ECR (jusqu’a 26,5 %). En conclusion, ces resultats suggerent que les donnees des ECR se traduisent par des benefices therapeutiques en pratique clinique courante.

Objectif Evaluer chez des patients DT2, l’efficacite, la tolerance et la maintenance de la vildagliptine en conditions reelles d’utilisation. Patients et methodes Une cohorte observationnelle prospective suivie sur 24 mois a ete initiee en France en 2010 a la demande de la HAS. Un echantillon representatif de patients DT2 traites par vildagliptine a ete inclus par 483 generalistes et 84 endocrinologues. Les donnees finales apres 24 mois de suivi apres l’initiation de la vildagliptine sont presentees. Resultats 1 700 patients font partie de la population d’analyse : 60 % d’hommes, âge moyen 63 ± 11 ans, anciennete du diabete 7 ± 6,5 ans, IMC moyen = 30 ± 6 kg/m2, 17 % etaient obeses, 70 % etaient traites pour une HTA et 66 % pour une dyslipidemie. Les donnees de suivi etaient disponibles pour respectivement 96,3 %, 90,7 %, 86,5 % et 81,8 % des patients a 6, 12 18 et 24 mois. Le taux moyen d’HbA1C etait de 7,8 % a l’initiation de vildagliptine, puis a baisse jusqu’a 7,0 % pendant les 6 premiers mois de suivi pour ensuite rester stable sur les 2 annees de suivi. Le poids moyen, le debit de filtration glomerulaire, les transaminases et les fractions LDL et HDL du cholesterol sont restes stables sur toute la duree de l’etude. L’incidence des hypoglycemies symptomatiques etait de 2,5 pour 100 patients-annees (IC95 % = [1,9 % ; 3,1 %]), et celui des hypoglycemies severes etait de 0,24/100 patients-annee (IC95 % = [0,10 ; 0,46]). Ces dernieres sont survenues chez 8 patients, tous traites par insuline et/ou sulfamide. La proportion de patients traites par vildagliptine etait de 88,8 % (IC 95 % [87,2 % ; 90,4 %]) a 24 mois. Seuls 4,1 % des patients ont arrete le traitement suite a un EI. 1,6 % des patients ont rapporte un EIG potentiellement lie a la vildagliptine. Conclusion La vildagliptine a montre une efficacite comparable a celle observee dans les essais cliniques et stable sur 24 mois, avec tres peu d’hypoglycemies.

Aim This study evaluated the profiles of patients with type 2 diabetes (T2DM) to identify sets of opinions and attitudes towards the disease that might influence self-care behaviours. Methods Altogether, 1,092 patients with T2DM, aged 45 or older from a large representative French cohort, completed a self-questionnaire exploring their knowledge and perceptions of diabetes, its impact on various aspects of daily life and self-management practices. Canonical and cluster analyses were used to identify sets of homogeneous ‘profiles' of patients linking attitudes and opinions to specific disease-related behaviours (such as changes in lifestyle, drug compliance, treatment satisfaction, impact on everyday life and weight gain). Results Demographics of the T2DM study population were previously reported along with the main results (60% male; mean age: 66 years; mean age at diagnosis: 55 years; mean BMI: 29kg/m 2 ). Five distinct patient types emerged from the typological approach: ‘committed' (25%); ‘carefree' (23%); ‘bitter' (19%); ‘disheartened' (19%); and ‘overwhelmed' (15%). Each patient type defined a set of attitudes and beliefs towards T2DM that influenced disease-related behaviours, leading to different degrees of diabetes self-management. Conclusion The DIABASIS survey provides important information for diabetes care by identifying distinct patients' profiles that express different degrees of difficulty in implementing self-management. For this reason, patients in each category require different kinds of customized support from their physician to induce behavioural changes that may be key in improving their metabolic control.

International audience; L'objectif de cette étude était d'analyser l'effet de la cohorte de naissance dans l'évolution de la prévalence de l'obésité après prise en compte de l'âge et de la période d'enquête. Pour chaque année d'enquête Obepi (1997, 2000, 2003, 2006), des données sur le poids et la taille ont été obtenues par des questionnaires envoyés à 20 000 ménages représentatifs de la population nationale. La prévalence de l'obésité a été analysée à l'aide d'un modèle logistique avec l'âge, la période et la cohorte comme variables explicatives. Etant donnée la relation linéaire entre ces variables, seuls les effets non linéaires peuvent être estimés de manière unique dans un modèle avec certaines contraintes imposées par le statisticien. Un écart important à la linéarité a été noté pour l'effet cohorte uniquement : nous avons observé une accélération de l'augmentation de la prévalence de l'obésité pour les sujets nés à partir du milieu des années 1960, aussi bien pour les hommes que pour les femmes, mais de façon plus prononcée pour les femmes. Ces résultats suggèrent que comparées aux anciennes générations, les hommes et les femmes nés après les années 1960 ont été exposés à un environnement qui a augmenté leur susceptibilité à l'obésité tout au long de la vie.

The Paris Prospective Study is a long-term, large-scale study of the factors predicting coronary heart disease in healthy middle-aged men. Subjects with impaired glucose tolerance or diabetes (not treated by insulin) at the first follow-up examination (n = 973) were selected from the total cohort for a separate analysis of the predictors of death from coronary heart disease. An index of body fat distribution, the iliac to thigh ratio, was entered into the list of potentially predictive variables, despite the fact that it had been measured one year before the first follow-up examination. After 15 years of mean follow-up, 41 of the selected subjects had died from coronary heart disease. Univariate analysis showed that these subjects differed from the subjects who died of another cause or who were alive at 15 years on the following variables: iliac to thigh ratio (p less than 0.0005), plasma triglyceride level (p less than 0.006), systolic blood pressure (p less than 0.01), and body mass index (p less than 0.04). In multivariate regression analysis using the Cox model, only iliac to thigh ratio and triglyceride plasma level achieved statistical significance as independent predictors. This result supports the current hypothesis that upper-body fat distribution, a characteristic trait of subjects with diabetes of glucose intolerance, plays an important role towards their high cardiovascular risk. However, it is unlikely that this role would be mediated through the lipid abnormalities that have been described as associated with upper-body fat deposition.

Aim. – The main purpose of this survey was to describe type 2 diabetes (T2DM) from the patient’s standpoint in a representative French panel in 2008. Methods. – Fourteen thousand two hundred and one individuals from the general population aged 45 or older completed a self-questionnaire exploring knowledge about diabetes; 1092 replies were from patients with T2DM. Results. – The prevalence of T2DM in this population was 7.7%, with demographics as follows: 60% men; mean age: 66 years; mean age at diagnosis: 55 years; mean BMI: 29 kg/m 2 . Eighty-five percent of T2DM patients reported that they wanted more information about at least one aspect of the disease at diagnosis; they reported feeling anxious (30%), frightened (13%), angry (4%) or that the disease was unfair (12%). Half of the patients had modified their dietary habits but 71% found it difficult to engage in regular physical activity. Most patients (90%) were treated with drugs: 81% with oral antidiabetic drugs (OAD) (44% in monotherapy) while 19% received insulin (alone or in combination with OAD). Twenty-three percent complained of weight gain since start of current therapy (average gain of 7.3 kg). Insulin initiation represented a turning point for patients who became more aware of the disease severity, more willing to follow advice and to take greater control over their disease management. The mean time from diagnosis to insulin initiation was 13.8 years. Half of the patients perceived their disease as severe especially women, patients who initially reacted with anxiety, insulin-treated patients and those actively involved in their disease management. Some gender differences emerged: women took the disease more seriously, were more engaged in self-management, and reported a higher impact on daily life. Conclusions. – DIABASIS provides important information for diabetes care by highlighting patients’ views of the disease, such as distress at diagnosis, lack of adequate information to cope with this distress and the important supportive role played by the family. A deeper understanding of patients’ perception of the disease would help optimize customized care. © 2009 Elsevier Masson SAS. All rights reserved.

Aims In type 2 diabetes (T2D), to describe treatments to prevent cardiovascular disease, to compare current practice to French guidelines, and to identify factors associated with recommended treatments. Methods In the Echantillon National Temoin Representatif des Personnes Diabetiques (ENTRED) study, 10,000 adults treated for diabetes (any type) were randomly selected from the French National Health Insurance System database. Deliveries during the last quarter of 2001 of treatments to prevent cardiovascular disease were extracted. The questionnaires were mailed to these people and their care providers. Final populations included 3324 people with T2D and their 1553 care providers. Results Overall, 18% reported coronary heart disease (CHD) and 44% others were classified as having a high cardiovascular risk; 68% received one or more antihypertensive treatment: ACE inhibitor/angiotensin receptor blocker (ARB), 44%; diuretic, 35%; calcium channel blocker, 25%; beta-blocker, 24%. Among those receiving antihypertensive treatment, 59% had blood pressure greater than 130/80mmHg. Overall, 42% received a hypolipidaemic treatment: statin, 25%; fibrate, 18%. About half the people with a high cardiovascular risk had LDL cholesterol greater than 1g/L, but only 32% were given a statin. Among people with an abnormal albumin/creatinine ratio (11%), 59% received an ACE inhibitor/ARB. Among those with CHD, 35% received the two treatments recommended in 1999 (beta-blockers and antiplatelet agents); in multivariate analyses, this two-treatment delivery was positively associated with male gender, self-reported hypertension and consulting a cardiologist. Conclusion Cardiovascular risk profiles reported by providers in T2D people are high. Despite recent progress, there is a need for major improvement in practices intended to prevent cardiovascular disease in these people, especially in those at greatest CHD risk.

There are few studies on the effects of postprandial hyperglycaemia, and usually it is assumed that its effects are the same as those of post-glucose-load hyperglycaemia, following a standard 75 g oral glucose tolerance test. There is some evidence from a study with blood drawn following ingestion of a standardised "diabetes screening product" or a 75 g oral glucose load, that the glucose concentrations during the 2-hour period of these two tests are highly correlated. There is epidemiological evidence that the 2-hour post-load-glucose is more predictive of cardiovascular mortality than fasting glucose, but it would appear that they are equally predictive of retinopathy. While hyperglycaemia is related with cardiovascular mortality, clinical trials lowering glucose levels in type 2 diabetic patients, have not succeeded in reducing cardiovascular disease rates, in contrast to the beneficial effects on micro-vascular disease. STOP-NIDDM, a clinical trial testing the prevention of type 2 diabetes, used the glucose lowering agent acarbose, a drug which lowers postprandial glucose. There was a beneficial effect on cardiovascular outcomes, however, the number of events was extremely small and the study was not designed to test this effect. Confirmatory studies are required before it is possible to conclude that acarbose is effective in cardiovascular prevention, and that indeed it is the treatment of postprandial glucose which is beneficial. The cardiovascular disease in diabetic patients may be due to the presence of other cardiovascular risk factors associated with diabetes.