Population pharmacokinetics and dosing simulations of amoxicillin in obese adults receiving co-amoxiclav.

BACKGROUND: Pneumonia, skin and soft tissue infections are more frequent in obese patients and are most often treated by co-amoxiclav, using similar dosing regimens to those used for non-obese subjects. No data are available on amoxicillin pharmacokinetics among obese subjects receiving co-amoxiclav. MATERIALS AND METHODS: Prospective, single-centre, open-label, non-randomized, crossover pharmacokinetic trial having enrolled obese otherwise healthy adult subjects. A first dose of co-amoxiclav (amoxicillin/clavulanate 1000/200 mg) was infused IV over 30 min, followed by a second dose (1000/125 mg) administered orally, separated by a washout period of ≥24 h. We assayed concentrations of amoxicillin by a validated ultra HPLC-tandem MS technique. We estimated population pharmacokinetic parameters of amoxicillin by non-linear mixed-effect modelling using the SAEM algorithm developed by Monolix. RESULTS: Twenty-seven subjects were included in the IV study, with 24 included in the oral part of the study. Median body weight and BMI were 109.3 kg and 40.6 kg/m2, respectively. Amoxicillin pharmacokinetics were best described by a two-compartment model with first-order elimination. Mean values for clearance, central volume, intercompartmental clearance and peripheral volume were, respectively, 14.6 L/h, 9.0 L, 4.2 L/h and 6.4 L for amoxicillin. Oral bioavailability of amoxicillin was 79.7%. Amoxicillin Cmax after oral administration significantly reduced with weight (P = 0.013). Dosing simulations for amoxicillin predicted that most of the population will achieve the pharmacodynamic target of fT>MIC ≥40% with the regimen of co-amoxiclav 1000/200 mg (IV) or 1000/125 mg (oral) q8h for MICs titrated up to 0.5 mg/L (IV) and 1 mg/L (oral). CONCLUSIONS: Pharmacokinetic/pharmacodynamic goals for amoxicillin can be obtained in obese subjects.

Multicentre cohort study of antihypertensive and lipid-lowering therapy cessation after bariatric surgery.

BACKGROUND: Few studies have assessed changes in antihypertensive and lipid-lowering therapy after bariatric surgery. The aim of this study was to assess the 6-year rates of continuation, discontinuation or initiation of antihypertensive and lipid-lowering therapy after bariatric surgery compared with those in a matched control group of obese patients. METHODS: This nationwide observational population-based cohort study used data extracted from the French national health insurance database. All patients undergoing gastric bypass or sleeve gastrectomy in France in 2009 were matched with control patients. Mixed-effect logistic regression models were used to analyse factors that influenced discontinuation or initiation of treatment over a 6-year interval. RESULTS: In 2009, 8199 patients underwent primary gastric bypass (55·2 per cent) or sleeve gastrectomy (44·8 per cent). After 6 years, the proportion of patients receiving antihypertensive and lipid-lowering therapy had decreased more in the bariatric group than in the control group (antihypertensives: -40·7 versus -11·7 per cent respectively; lipid-lowering therapy: -53·6 versus -20·2 per cent; both P < 0·001). Gastric bypass was the main predictive factor for discontinuation of therapy for hypertension (odds ratio (OR) 9·07, 95 per cent c.i. 7·72 to 10·65) and hyperlipidaemia (OR 11·91, 9·65 to 14·71). The proportion of patients not receiving treatment at baseline who were subsequently started on medication was lower after bariatric surgery than in controls for hypertension (5·6 versus 15·8 per cent respectively; P < 0·001) and hyperlipidaemia (2·2 versus 9·1 per cent; P < 0·001). Gastric bypass was the main protective factor for antihypertensives (OR 0·22, 0·18 to 0·26) and lipid-lowering medication (OR 0·12, 0·09 to 0·15). CONCLUSION: Bariatric surgery is associated with a good discontinuation of antihypertensive and lipid-lowering therapy, with gastric bypass being more effective than sleeve gastrectomy.

Long-term follow-up after bariatric surgery in a national cohort.

BACKGROUND: Lifelong medical follow-up is mandatory after bariatric surgery. The aim of this study was to assess the 5-year follow-up after bariatric surgery in a nationwide cohort of patients. METHODS: All adult obese patients who had undergone primary bariatric surgery in 2009 in France were included. Data were extracted from the French national health insurance database. Medical follow-up (medical visits, micronutrient supplementation and blood tests) during the first 5 years after bariatric surgery was assessed, and compared with national and international guidelines. RESULTS: Some 16 620 patients were included in the study. The percentage of patients with at least one reimbursement for micronutrient supplements decreased between the first and fifth years for iron (from 27.7 to 24.5 per cent; P < 0.001) and calcium (from 14·4 to 7·7 per cent; P < 0·001), but increased for vitamin D (from 33·1 to 34·7 per cent; P < 0·001). The percentage of patients with one or more visits to a surgeon decreased between the first and fifth years, from 87·1 to 29·6 per cent (P < 0·001); similar decreases were observed for visits to a nutritionist/endocrinologist (from 22·8 to 12·4 per cent; P < 0·001) or general practitioner (from 92·6 to 83·4 per cent; P < 0·001). The mean number of visits to a general practitioner was 7·0 and 6·1 in the first and the fifth years respectively. In multivariable analyses, male sex, younger age, absence of type 2 diabetes and poor 1-year follow-up were predictors of poor 5-year follow-up. CONCLUSION: Despite clear national and international guidelines, long-term follow-up after bariatric surgery is poor, especially for young men with poor early follow-up.

Effects of blood pressure lowering on cardiovascular risk according to baseline body-mass index: a meta-analysis of randomised trials.

BACKGROUND: The cardiovascular benefits of blood pressure lowering in obese people compared with people of normal weight might depend on choice of drug. We compared the effects of blood pressure-lowering regimens on cardiovascular risk in groups of patients categorised by baseline body-mass index (BMI). METHODS: We used individual patient data from trials included in the Blood Pressure Lowering Treatment Trialists' Collaboration to compare the effects of different classes of blood pressure-lowering regimens for the primary outcome of total major cardiovascular events (stroke, coronary heart disease, heart failure, and cardiovascular death). We used meta-analyses and meta-regressions to assess interactions between treatment and BMI when fitted as either a categorical variable (<25 kg/m(2), 25 to <30 kg/m(2), and ≥30 kg/m(2)) or a continuous variable. FINDINGS: Analyses were based on 135,715 individuals from 22 trials who had 14,353 major cardiovascular events. None of the six primary comparisons showed evidence that protection varied by drug class across the three BMI groups (all p for trend >0·20). When analysed as a continuous variable, angiotensin-converting-enzyme inhibitors gave slightly greater protection for each 5 kg/m(2) higher BMI than did calcium antagonists (hazard ratio 0·93, 95% CI 0·89-0·98; p=0·004) or diuretics (0·93, 0·89-0·98; p=0·002). The meta-regressions showed no relation between BMI category and the risk reduction for a given fall in systolic blood pressure. By contrast with a previous report, we noted no relation between BMI and the efficacy of calcium antagonists compared with diuretics. INTERPRETATION: We found little evidence that selection of a particular class of blood pressure-lowering drug will lead to substantially different outcomes for individuals who are obese compared with those who are lean. FUNDING: None.

pH monitoring of gastro-oesophageal reflux before and after laparoscopic sleeve gastrectomy.

BACKGROUND: Gastro-oesophageal reflux disease (GORD) is a common obesity-related co-morbidity that is assessed objectively by 24-h pH monitoring. Some concerns have been raised regarding the risk of de novo GORD or exacerbation of pre-existing GORD after laparoscopic sleeve gastrectomy. Here, 24-h pH monitoring was used to assess the influence of laparoscopic sleeve gastrectomy on postoperative GORD in obese patients with or without preoperative GORD. METHODS: From July 2012 to September 2014, all patients scheduled for laparoscopic sleeve gastrectomy were invited to participate in a prospective follow-up. Patients who underwent preoperative 24-h pH monitoring were asked to repeat the examination 6 months after operation. GORD was defined as an oesophageal pH < 4 for at least 4·2 per cent of the total time recorded. RESULTS: Of 89 patients, 76 had preoperative pH monitoring for GORD evaluation and 50 had postoperative reassessment. Patients without (group 1, 29 patients) or with (group 2, 21 patients) preoperative GORD were similar regarding age, sex ratio and body mass index. In group 1, the median (i.q.r.) total time at pH < 4 was significantly higher after surgery than before: 5·6 (2·5-9·5) versus 1·6 (0·7-2·9) per cent (P < 0·001). Twenty of the 29 patients experienced de novo GORD as determined by 24-h pH monitoring (P < 0·001). In group 2, total time at pH < 4 after surgery was no different from the preoperative value: 5·9 (3·9-10·7) versus 7·7 (5·2-10·3) per cent (P = 0·296). CONCLUSION: Laparoscopic sleeve gastrectomy was associated with de novo GORD in over two-thirds of patients, but did not seem to exacerbate existing GORD.

Association between depression and anemia in otherwise healthy adults.

OBJECTIVE: It remains debated whether anemia is associated with depression, independently of physical health factors. We report a large-scale cross-sectional study examining this association in adults free of chronic disease and medication from the general population. METHOD: Hemoglobin levels were measured among 44 173 healthy participants [63% men; mean [standard deviation] age = 38.4 (11.1) years] from the 'Investigations Préventives et Cliniques' (IPC) cohort study. Depression was measured with the Questionnaire of Depression 2nd version, Abridged. Logistic regression analyses were performed to examine the association between anemia and depression, while adjusting for a wide range of sociodemographic characteristics and health-related factors (i.e., sex, age, living status, education level, occupational status, alcohol intake, smoking status, physical activity, and body mass index). RESULTS: Depressed participants were significantly more likely to have anemia compared to non-depressed participants, even after adjustment for sociodemographic and health-related variables [odds ratio = 1.36; 95% confidence interval = (1.18; 1.57)]. Anemia prevalence increased with depression severity, suggesting a dose-response relationship (P for trend <0.001). CONCLUSION: In healthy adults from the general population, we found a significant and robust association between depression and anemia. Further studies are needed to assess the longitudinal relationship between both conditions and determine the mechanisms underlying this association.

Association between melanocortin-4 receptor mutations and eating behaviors in obese patients: a case--control study.

Melanocortin-4 receptor (MC4R) gene mutations are involved in the leptin-melanocortin pathways that control food intake. The effect of these mutations on eating behavior phenotypes is still debated. To determine the association between functional MC4R mutations and eating behaviors, dietary intake and physical activity, we sequenced the MC4R gene in 4653 obese adults. Among them, 19 adults carriers of functional MC4R mutation were matched on age, sex and body mass index with two randomly-paired controls without MC4R mutation (n=57). We found that eating behaviors and physical activity did not differ between groups. In particular, cases were not at increased risk of binge eating disorders. Subjects carriers of MC4R mutation reported a higher proportion of dietary carbohydrates intakes (43.2±7.1 and 39.2±8.1% of total energy intake, respectively, P=0.048) and a lower proportion of dietary lipids (34.3±6.7 and 38.5±6.7% of total energy intake, respectively, P=0.018). In conclusion, mutation carriers differ from controls by a higher consumption of carbohydrates counterbalanced by a lower consumption of lipids expressed as percentage of total energy intake. However, functional MC4R mutations do not have a higher risk of compulsive eating contrary to what was previously suggested.

Reassessment of the putative role of BLK-p.A71T loss-of-function mutation in MODY and type 2 diabetes.

AIMS/HYPOTHESIS: MODY is believed to be caused by at least 13 different genes. Five rare mutations at the BLK locus, including only one non-synonymous p.A71T variant, were reported to segregate with diabetes in three MODY families. The p.A71T mutation was shown to abolish the enhancing effect of BLK on insulin content and secretion from pancreatic beta cell lines. Here, we reassessed the contribution of BLK to MODY and tested the effect of BLK-p.A71T on type 2 diabetes risk and variations in related traits. METHODS: BLK was sequenced in 64 unelucidated MODY samples. The BLK-p.A71T variant was genotyped in a French type 2 diabetes case-control study including 4,901 cases and 4,280 controls, and in the DESIR (Data from an Epidemiological Study on the Insulin Resistance Syndrome) and SUVIMAX (Supplementation en Vitamines et Mineraux Antioxydants) population-based cohorts (n = 6,905). The variant effects were assessed by logistic and linear regression models. RESULTS: No rare non-synonymous BLK mutations were found in the MODY patients. The BLK p.A71T mutation was present in 52 normoglycaemic individuals, making it very unlikely that this loss-of-function mutation causes highly penetrant MODY. We found a nominal association between this variant and increased type 2 diabetes risk, with an enrichment of the mutation in the obese diabetic patients, although no significant association with BMI was identified. CONCLUSIONS/INTERPRETATION: No mutation in BLK was found in our MODY cohort. From our findings, the BLK-p.A71T mutation may weakly influence type 2 diabetes risk in the context of obesity; however, this will require further validation.

Eating behaviour in obese patients with melanocortin-4 receptor mutations: a literature review.

Melanocortin-4 receptor (MC4R) mutations are the most common known cause of monogenic obesity and an important contributor to polygenic obesity. MC4R mutations with partial or total loss of function, as well as the variant rs17782313 mapped near MC4R, are positively associated with obesity. MC4R is involved in the leptin-melanocortin signalling system, located in hypothalamic nuclei, that controls food intake via both anorexigenic or orexigenic signals. Impairment in this receptor might affect eating behaviours. Thus, in the case of MC4R mutation carriers, obesity could be related, at least partly, to inadequate control over eating behaviours. Many published studies address eating behaviours in MC4R mutation carriers. Most studies focus on binge eating disorder, whereas others examine various aspects of intake and motivation. Up to now, no evaluation of this literature has been performed. In this review, we examine the available literature on eating behaviours in carriers of MC4R mutations and variant rs17782313 near MC4R gene. We address binge eating disorder, bulimia nervosa, mealtime hyperphagia, snacking, psychological factors, satiety responsiveness and intake of energy and macro/micronutrient. In a small number of studies, MC4R mutations seem to impair eating behaviours or motivation, but no clear causal effects can be found in the balance of the evidence presented. Improvements in methodologies will be necessary to clarify the behavioural effects of MC4R mutations.

Medications for the treatment of obesity.

After several years with no real therapeutic alternatives, the management of obesity is entering a new era with the development of new surgical and endoscopic bariatric techniques, digital therapeutics and the arrival of new classes of drugs. New medication treatments aim to reduce food intake, targeting the hypothalamic regulation of food intake and satiety. The mechanism of their action remains poorly understood but, combines weight reduction and amelioration of cardiometabolic risk factors with a favorable benefit-risk balance and known side effects, mainly digestive. The future will tell us how these drugs will find their place in the management of this chronic disease that is obesity.

Bidirectional association between depression and obesity in middle-aged and older women.

OBJECTIVE: Although it has been hypothesized that the depression-obesity relation is bidirectional, few studies have addressed this hypothesis in a prospective setting. We aimed to examine the bidirectional relationship in middle-aged and elderly women. SUBJECTS: A total of 65 955 women aged 54-79 years in the Nurses' Health Study were prospectively followed from 1996 to 2006 with updated information on body weight, depression status and various covariates every 2 years. Depression was defined as self-report of physician-diagnosed depression and/or antidepressant use. Obesity was defined as a BMI ≥30.0 kg m(-2). The first three waves (1996-2000) were used as the baseline period and the last three waves (2002-2006) were used as the follow-up period. RESULTS: After adjusting for baseline age, physical activity, comorbidities, BMI and other covariates, depression at the baseline period was associated with an increased risk of obesity at the follow-up period in all women (multivariate-adjusted odds ratio (OR), 1.38; 95% confidence interval (95% CI), 1.24-1.53) and baseline non-obese women (OR, 1.51; 95% CI, 1.36-1.67). In the opposite direction, after adjusting for baseline age, physical activity, comorbidities, depression status and other covariates, obese women at baseline had a moderately increased risk of depression at the follow-up period compared with normal-weight women (OR, 1.11; 95% CI, 1.03-1.18), and this association was similar for new onset of depression (OR for obese versus normal weight women, 1.10; 95% CI, 1.02-1.20). CONCLUSIONS: Our results suggest a bidirectional association between depression and obesity in middle-aged and elderly women. Future studies are needed to confirm our findings in different populations, and investigate the potential mechanisms underlying this association. Our results underscore the importance of early detection and proper behavioral modifications to lower the burden of both conditions.

Association between dietary scores and 13-year weight change and obesity risk in a French prospective cohort.

BACKGROUND/OBJECTIVES: The relationship between diet quality and development of obesity is complex and unresolved. The aim of this study was to assess and compare the predictive value of six different dietary scores on both relative weight change and the risk of obesity after 13 years of follow-up in adults aged 45 years and older. SUBJECTS/METHODS: Six scores reflecting adherence to different nutritional recommendations (the French Programme National Nutrition Santé-Guideline Score (PNNS-GS), the Dietary Guidelines for Americans Index (DGAI), the Diet Quality Index-International (DQI-I), the Mediterranean Diet Scale (MDS), the relative Mediterranean Diet Score (rMED) and the Mediterranean Style Dietary Pattern Score (MSDPS)) were estimated in 3151 participants in the French SU.VI.MAX (SUpplémentation en VItamines et Minéraux AntioXydants) study. Associations of dietary scores with 13-year weight change were assessed through multivariate linear regression models, and obesity risk was analyzed with logistic regression, providing odds ratios (OR) and 95% confidence intervals (CI). RESULTS: Except for the MSDPS, higher scores, that is, better adherence to nutritional guidelines or to a Mediterranean diet, were associated with lower weight gain in men (all P-value for trend <0.05). In addition, among men, ORs for becoming obese after 13 years associated with a 1 s.d. increase in dietary scores ranged from 0.63, 95% CI: 0.51, 0.78 for DGAI to 0.72, 95% CI: 0.59, 0.88 for MDS. These associations were weaker or not statistically significant in women. CONCLUSION: Overall, the six dietary scores predicted obesity risk equally well. Among French adults, strong adherence to dietary guidelines appears to be protective with regard to weight gain and obesity, especially in men.

Weight changes and their predictors amongst 11 140 patients with type 2 diabetes in the ADVANCE trial.

AIMS: To determine the baseline characteristics and glucose-lowering therapies associated with weight change among patients with type 2 diabetes. METHODS: Eleven thousand one hundred and forty participants in the ADVANCE trial were randomly assigned to an intensive [aiming for a haemoglobin A1c (HbA1c) ≤6.5%] or a standard blood glucose-control strategy. Weight was measured at baseline and every 6 months over a median follow-up of 5 years. Multivariable linear regression and linear-mixed effect models were used to examine predictors of weight change. RESULTS: The mean difference in weight between the intensive and standard glucose-control arm during follow-up was 0.75 kg (95% CI: 0.56-0.94), p-value <0.001. The mean weight decreased by 0.70 kg (95% CI: 0.53-0.87), p < 0.001 by the end of follow-up in the standard arm but remained stable in the intensive arm, with a non-significant gain of 0.16 kg (95% CI: -0.02 to 0.34), p = 0.075. Baseline factors associated with weight gain were younger age, higher HbA1c, Caucasian ethnicity and number of glucose-lowering medications. Treatment combinations including insulin [3.22 kg (95% CI: 2.92-3.52)] and thiazolidinediones [3.06 kg (95% CI: 2.69-3.43)] were associated with the greatest weight gain while treatment combinations including sulphonylureas were associated with less weight gain [0.71 kg (95%CI: 0.39-1.03)]. CONCLUSIONS: Intensive glucose-control regimens are not necessarily associated with substantial weight gain. Patient characteristic associated with weight change were age, ethnicity, smoking and HbA1c. The main treatment strategies predicting weight gain were the use of insulin and thiazolidinediones.

Evolution of the nutritional status of COVID-19 critically-ill patients: A prospective observational study from ICU admission to three months after ICU discharge.

BACKGROUND & AIMS: Malnutrition following intensive care unit (ICU) stay is frequent and could be especially prominent in critically ill Coronavirus Disease 2019 (COVID-19) patients as they present prolonged inflammatory state and long length stay. We aimed to determine the prevalence of malnutrition in critically ill COVID-19 patients both at the acute and recovery phases of infection. METHODS: We conducted a prospective observational study including critically ill COVID-19 patients requiring invasive mechanical ventilation discharged alive from a medical ICU of a university hospital. We collected demographic, anthropometric and ICU stay data (SAPS2, recourse to organ support and daily energy intake). Nutritional status and nutritional support were collected at one month after ICU discharge (M1) by phone interview and at 3 months after ICU discharge (M3) during a specialized and dedicated consultation conducted by a dietitian. Malnutrition diagnosis was based on weight loss and body mass index (BMI) criteria following the Global Leadership Initiative on Malnutrition. Primary outcome was the prevalence of malnutrition at M3 and secondary outcomes were the evolution of nutritional status from ICU admission to M3 and factors associated with malnutrition at M3. RESULTS: From march 13th to may 15th, 2020, 38 patients were discharged alive from the ICU, median [IQR] age 66 [59-72] years, BMI 27.8 [25.5-30.7] kg/m2 and SAPS2 47 [35-55]. Thirty-three (86%) patients were followed up to M3. Prevalence of malnutrition increased during the ICU stay, from 18% at ICU admission to 79% at ICU discharge and then decreased to 71% at M1 and 53% at M3. Severe malnutrition prevailed at ICU discharge with a prevalence of 55% decreasing 32% at M3. At M3, the only factors associated with malnutrition in univariate analysis were the length of invasive mechanical ventilation and length of ICU stay (28 [18-44] vs. 13 [11-24] days, P = 0.011 and 32 [22-48] vs. 17 [11-21] days, P = 0.006, respectively), while no ICU preadmission and admission factors, nor energy and protein intakes distinguished the two groups. Only 35% of undernourished patients at M3 had benefited from a nutritional support. CONCLUSION: Malnutrition is frequent, protracted and probably underrecognized among critically ill Covid-19 patients requiring invasive mechanical ventilation with more than half patients still being undernourished three months after ICU discharge. A particular attention should be paid to the nutritional status of these patients not only during their ICU stay but also following ICU discharge.

Associations of diabetes mellitus with site-specific cancer mortality in the Asia-Pacific region.

BACKGROUND: Owing to the increasing prevalence of obesity and diabetes in Asia, and the paucity of studies, we examined the influence of raised blood glucose and diabetes on cancer mortality risk. MATERIALS AND METHODS: Thirty-six cohort Asian and Australasian studies provided 367, 361 participants (74% from Asia); 6% had diabetes at baseline. Associations between diabetes and site-specific cancer mortality were estimated using time-dependent Cox models, stratified by study and sex, and adjusted for age. RESULTS: During a median follow-up of 4.0 years, there were 5992 deaths due to cancer (74% Asian; 41% female). Participants with diabetes had 23% greater risk of mortality from all-cause cancer compared with those without: hazard ratio (HR) 1.23 [95% confidence interval (CI) 1.12, 1.35]. Diabetes was associated with mortality due to cancer of the liver (HR 1.51; 95% CI 1.19, 1.91), pancreas (HR 1.78; 95% CI 1.20, 2.65), and, less strongly, colorectum (HR 1.32; 95% CI 0.98, 1.78). There was no evidence of sex- or region-specific differences in these associations. The population attributable fractions for cancer mortality due to diabetes were generally higher for Asia compared with non-Asian populations. CONCLUSION: Diabetes is associated with increased mortality from selected cancers in Asian and non-Asian populations.

Predicting CHD risk in France: a pooled analysis of the D.E.S.I.R., Three City, PRIME, and SU.VI.MAX studies.

BACKGROUND: We aimed to develop and validate a simple coronary heart disease (CHD) risk algorithm applicable to asymptomatic men and women in France, and to compare its accuracy with that of the last published version of the Framingham risk function for cardiovascular disease. DESIGN: A pooled analysis of four French prospective general-population studies. METHODS: The baseline and follow-up data from D.E.S.I.R., PRIME, Three City, and SU.VI.MAX studies were used. The 10-year CHD risk was estimated by the Cox proportional hazards model with candidate variables including age, gender, body mass index, waist circumference, family history of coronary heart disease, smoking status, diabetes status, systolic blood pressure, and total and high-density lipoprotein (HDL) cholesterol. RESULTS: The study population included 22,256 subjects (61.4% men) aged (SD) 56.0 years (8.3) without a personal history of CHD at baseline. After a mean follow-up of 8.0 years (2.3), 788 first CHD events occurred, 726 in men and 62 in women. The final model included age, gender, age × gender interaction, current smoking status, diabetes status, systolic blood pressure, total and HDL cholesterol. Using this model, the number of predicted coronary events fitted that given by the 10-year Kaplan-Meier survival estimates within each decile of estimated risk (calibration). This model had fair discrimination: Harrell C-index, 0.7831 (95% CI: 0.7704-0.7957). For comparison, the recalibrated Framingham risk function had equivalent performances compared to the French risk equation. CONCLUSION: Our 10-year French CHD risk equation based on traditional risk factors performed at least as well as the recalibrated Framingham cardiovascular disease risk function.

The THEMA study: a sociodemographic survey of hypercholesterolaemic individuals.

BACKGROUND: Hypercholesterolaemia is estimated to affect 20% of the population, although little sociodemographic information is available on affected individuals. The present study aimed to gather relevant information and investigate social determinants of dietary compliance. METHODS: A telephone survey was carried out on a representative population sample. Quotas were applied for gender, geography and degree of urbanisation. Individuals were eligible if they were hypercholesterolaemic, and were being followed by a doctor. Sociodemographic, socioeconomic and health data were collected, as well as information about the individuals' perception of the disease, their relationship and beliefs surrounding food, and their food behaviour (shopping, cooking, eating-out, deviation from prescribed diet). The association between compliance with diet and medication was investigated. RESULTS: Overall, 802 individuals were included, representing 8% of those contacted, as opposed to the expected 20%. Mean (SD) age was 60 (14.2) years, with 51% of individuals living as a couple; 48% had a good level of physical activity; 44% considered that the hypercholesterolaemia was inherited; 31% felt that the disease was normal beyond the age of 45 years. The functional and convivial aspects of eating were of more importance than that of health maintenance. Cheese was particularly likely to be eaten in dietary lapses. Of a subgroup of 729 individuals, 476 (65%) took medication; of these 476 individuals, 51% complied with dietary recommendations (P < 0.05). CONCLUSIONS: The key factors associated with dietary compliance in hypercholesterolaemic individuals were identified: age, sex, the perceptions of hypercholesterolaemia, and the sociocultural aspects of food. By contrast to general assumptions, both dietary and medicinal measures are practised fairly well by a large proportion of these individuals.

Recommendations for nutritional care after bariatric surgery: Recommendations for best practice and SOFFCO-MM/AFERO/SFNCM/expert consensus.

Nutritional care after bariatric surgery is an issue of major importance, especially insofar as risk of deficiency has been extensively described in the literature. Subsequent to the deliberations carried out by a multidisciplinary working group, we are proposing a series of recommendations elaborated using the Delphi-HAS (official French health authority) method, which facilitates the drawing up of best practice and consensus recommendations based on the data of the literature and on expert opinion. The recommendations in this paper pertain to dietary management and physical activity, multivitamin and trace element supplementation and the prevention and treatment of specific deficiencies in vitamins B1, B9, B12, D and calcium, iron, zinc, vitamins A, E and K, dumping syndrome and reactive hypoglycemia.

Oral disease and subsequent cardiovascular disease in people with type 2 diabetes: a prospective cohort study based on the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified-Release Controlled Evaluation (ADVANCE) trial.

AIMS/HYPOTHESIS: While there are plausible biological mechanisms linking oral health with cardiovascular disease (CVD) and mortality rates, no study, to our knowledge, has examined this association in a representative population of people with type 2 diabetes. METHODS: We used the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified-Release Controlled Evaluation (ADVANCE) study, a large, detailed, randomised controlled trial among a general population of individuals with type 2 diabetes. For the purposes of the present analyses, data from the trial are used within a prospective cohort study design. A total of 10,958 men and women, aged 55 to 88 years and with type 2 diabetes, participated in a baseline medical examination, during which they counted their number of natural teeth and reported the number of days that their gums had bled over the preceding year. Study members were followed up for mortality and morbidity over 5 years. RESULTS: After controlling for a range of potential confounding factors, the group with no teeth had a markedly increased risk of death due to all causes (HR 1.48, 95% CI 1.24-1.78), CVD (1.35, 1.05-1.74) and non-CVD (1.64, 1.26-2.13), relative to the group with the most teeth (≥22 teeth). Frequency of bleeding gums was not associated with any of the outcomes of interest. There was no suggestion that treatment group or sex modified these relationships. CONCLUSIONS/INTERPRETATION: In people with type 2 diabetes, oral disease, as indexed by fewer teeth, was related to an increased risk of death from all causes and of death due to CVD and non-CVD.

Physical activity does not influence the effect of antioxidant supplementation at nutritional doses on the incidence of impaired fasting glucose: a 7.5 year post-hoc analysis from the SU.VI.MAX study.

Supplementation with high doses of antioxidant vitamins prevents the insulin-sensitizing effects of physical exercise. However, little is known whether antioxidant supplementation affects the incidence of impaired fasting glucose (IFG). Data from 8938 subjects included in a randomized controlled trial on supplementation with antioxidants vitamins and trace elements at nutritional doses (SU.VI.MAX) were used to examine the effects of antioxidants on incident IFG after 7.5 years of follow-up, with and without stratification for daily physical exercise. The odds-ratio (95% CI) for developing an IFG among study participants receiving antioxidant supplementation was 1.34 (0.90-1.97) (p=0.33), in comparison to placebo. This risk did not vary significantly according to physical activity level (p for homogeneity=0.10). Supplementation with trace elements and antioxidants at nutritional doses apparently does not affect the incidence of IFG irrespective of self-reported physical exercise habits.