Benfluorex and valvular heart disease: a cohort study of a million people with diabetes mellitus.

PURPOSE: To evaluate and quantify in diabetic patients treated with benfluorex in France, a fenfluramine-derivated product, a possible increase in risk of valvular heart disease, previously suggested by several published case reports. METHODS: This was a French comparative cohort study using data from two large national linked databases, health insurance system (SNIIRAM) and hospitalization (PMSI). Patients aged 40-69 years with reimbursement for oral antidiabetic and/or insulin in 2006 were eligible. Exposed patients were defined as patients with at least one benfluorex reimbursement in 2006. Selected admission diagnoses of interest in 2007 and 2008 PMSI databases were valvular insufficiency for any cause, mitral insufficiency, aortic insufficiency, and valvular replacement surgery with cardiopulmonary bypass. Relative risks (RR) were adjusted on gender, age, and history of chronic cardiovascular disease. RESULTS: A total of 1,048173 diabetic patients were included, with 43,044 (4.1%) exposed to benfluorex. The risk of hospitalization in 2007 and 2008 for any cardiac valvular insufficiency was higher in the benfluorex group: crude RR=2.9 [95% confidence interval 2.2-3.7] and adjusted RR=3.1 [2.4-4.0], with a lower risk for patients with lower cumulative dose of benfluorex. Adjusted RR for mitral insufficiency and aortic insufficiency admissions were 2.5 [1.9-3.7] and 4.4 [3.0-6.6], respectively. Adjusted RR for valvular replacement surgery was 3.9 [2.6-6.1]. CONCLUSIONS: Benfluorex in diabetic patients was significantly associated with hospitalization for valvular heart disease in the 2 years following benfluorex exposure. Linkage between SNIIRAM and PMSI databases is in France a valuable tool to quantify the risk of serious adverse drug reactions.

Patient characteristics and treatments one year after diagnosis of renal cancer in 2015 according to the presence or absence of metastasis and a history of another tumour: A national observational study.

INTRODUCTION: This study describes the characteristics, management and outcome of patients one year after a diagnosis of renal cancer, according to the presence of a history of another tumour and metastases at diagnosis or during the first year. METHODS: Based on information from the national health data system (SNDS), 10,989 general scheme beneficiaries (>15 years) with a first hospital stay in 2015 for renal cancer were divided into groups according to the presence of a history of another tumour or metastases. RESULTS: In this cohort of 10,989 people (75 years and older: 30%, men: 65%), 12% had a history of another tumour diagnosed during the two years before and 22% presented one or more metastases at the time of the index hospitalisation or during the following year. Overall, nephrectomy was performed in 56% of cases (partial nephrectomy in 29% of cases), in 63% and 36% of cases without metastases and in 68% and 40% of cases without metastases and with no history of another tumour. Overall, 2% of patients received at least one monoclonal antibody and 15% received a protein kinase inhibitor. These drugs were used in 6% and 53% of cases, respectively, in the presence of metastases and in 7% and 31% of cases, respectively, in the presence of metastases and a history of another tumour. CONCLUSION: This study highlights the high rate of a history of another tumour and adaptation of treatment according to a history of cancer and the presence of metastases.

A nationwide survey on bariatric surgery in France: two years prospective follow-up.

BACKGROUND: Most studies on bariatric surgery outcomes have been performed in clinical trials (eg. the SOS) or reflect the clinical experience and practice of specific and experienced centers. Little is known about the current practice at a nationwide level. METHODS: This is a systematic nationwide study on the 2-year outcome of all consecutive 1,236 bariatric operations performed in France. Data on mortality, weight loss, complications, and patient satisfaction were collected independently from the medical and surgical team involved in the patients' care. RESULTS: 87.3% of the patients underwent an adjustable gastric banding (ABG), 8.6% a vertical banded gastroplasty (VBG), 3.8% a Roux-en-Y gastric bypass (RYGBP) and 0.3% a biliopancreatic diversion (BPD). Loss of follow-up was 12% at year 1 and 18% at year 2. The rate of laparoscopic procedures was 98% for ABG and 73% for RYGBP. Mortality rate was 0.16% in the operative period and 0.27% during follow-up. Excess weight loss ranged from 43% (AGB) to 66% (RYGBP). Co-morbidities improved in more than 70% of patients. CONCLUSION: Outcomes of bariatric surgery in routine practice (mortality, weight loss, course of co-morbidities, and quality of life) are similar to the results published in clinical trials.

Current challenges in providing bariatric surgery in France: A nationwide study.

Bariatric surgery is a well-accepted procedure for severe and massive obesity management. We aimed to determine trends, geographical variations, and factors influencing bariatric surgery and the choice of procedure in France in a large observational study.The Health Insurance Fund for Salaried Workers (Caisse National Assurance Maladie Travailleurs Salariés) covers about 86% of the French population. The Système National d'Information Inter-régimes de l'Assurance Maladie database contains individualized and anonymized patient data on all reimbursements for healthcare expenditure. All types of primary bariatric procedures (Roux-en-Y gastric bypass [RYGB] or omega loop, adjustable gastric banding [AGB], or longitudinal sleeve gastrectomy [LSG]) performed during 2011 to 2013 were systematically recorded. Surgical techniques performed by region of residence and age-range relative risks with 95% confidence intervals of undergoing LSG or RYGB versus AGB were computed.In 2013, LSG was performed more frequently than RYGB and AGB (57% vs 31% and 13%, respectively). A total of 41,648 patients underwent a bariatric procedure; they were predominantly female (82%) with a mean (±standard deviation) age of 40 (±12) years and a body mass index ≥40 kg/m for 68% of them. A total of 114 procedures were performed in patients younger than 18 years and 2381 procedures were performed in patients aged 60 years and older. Beneficiaries of the French universal health insurance coverage for low-income patients were more likely to undergo surgery than the general population. Large nationwide variations were observed in the type choice of bariatric surgical procedures. Significant positive predictors for undergoing RYGB compared to those for undergoing AGB were as follows: referral to a center performing a large number of surgeries or to a public hospital, older age, female gender, body mass index ≥50 kg/m, and treatment for obstructive sleep apnea syndrome, diabetes, or depression. Universal health insurance coverage for low-income patients was inversely correlated with the probability of RYGB.Differences in access to surgery have been observed in terms of the patient's profile, geographical variations, and predictors of types of procedures. Several challenges must be met when organizing the medical care of this growing number of patients, when delivering surgery through qualified centers while assuring the quality of long-term follow-up for all patients.

Prevalence and incidence of systemic lupus erythematosus in France: a 2010 nation-wide population-based study.

To date, only a small number of studies have examined the epidemiology of systemic lupus erythematosus (SLE) on a nation-wide basis. We used French national administrative databases to analyze the nation-wide prevalence and incidence rates of SLE within the largest French health insurance scheme, which covers 86% of the population (almost 58,200,000 individuals). Patients with SLE were identified if they had full coverage for a chronic disease with a code (ICD-10th M32) in the health insurance information system, or if they had a SLE code in the hospital discharge database as a primary or secondary diagnosis in 2010. We defined incident cases as patients who had a new long-term disease diagnosis of SLE in 2010. Overall, 27,369 individuals were identified as having SLE, of whom 88% were female. The crude 2010 prevalence of identified SLE was 47.0/100,000, and the WHO age-standardized rate was 40.8/100,000. The crude 2010 annual incidence of SLE was 3.32 cases per 100,000 with peaks in females aged 30-39 years old (9.11/100,000) and in males aged 50-59 years old (1.78/100,000). Major differences in regional age-standardized prevalence rates were observed, with the highest rates in the Caribbean oversea areas (up to 126.7/100,000), and the lowest rates in north-western metropolitan territories (down to 29.6/100,000). This is the largest nation-wide population-based study of SLE patients to date, based on more than 58 million beneficiaries of the French health insurance system. These data and subsequent analyses provide guidance to both clinicians and policymakers for improving care of SLE.

Predictive factors of outcome after gastric banding: a nationwide survey on the role of center activity and patients' behavior.

BACKGROUND: Systematic studies of postoperative outcome of bariatric surgery provide information on the predictors of success. Surgeon's and institution experience and patient's behavior after surgery are key determinant of success or failure. Data on clinical trials generally reflect the experience of skilled obesity surgery centers. Little is known about the current practice at a nationwide level. The present study was realized in the frame of a national survey on medical and surgical practices conducted by the public health insurance system. The objective was to analyze systematically and prospectively the outcome of all bariatric surgery procedures consecutively performed in a given period, as registered by the French National Medical Insurance Service. This study at a nationwide level focused on predictive factors of success and analyzed how the experience of the centers relates to the patients' outcomes at 1 and 2 years after surgery. METHODS: This study examined prospectively the 2-year predictors of success of all consecutive 1236 bariatric operations performed at a nationwide level. Most (87.3%) were laparoscopic adjustable gastric banding (LAGB), so that the non-LAGB were eliminated from the study. Data were collected independently by consultants of the French National Medical Insurance Service: characteristics of the patients, evolution of body mass index (BMI), physical activity and comorbidities, changes in behavior, complications, reoperations. Information was available on the activity of the surgical teams. Excess weight loss (EWL) >50% was considered a "success," and EWL <50% "not a success." A backstep logistic regression (likelihood ratio test) was used to determine predictive factors. RESULTS: Statistical analysis showed significant differences in EWL with the following data: age <40 years (P < 0.01), initial BMI <50 kg/m (P < 0.001), experience of the surgeon(s) >2 procedures per week (P < 0.01), recovery of physical activity (P < 0.001), and change in eating habits (P < 0.001). Compared with 15- to 39-year-old patients, 40- to 49-year-old patients have a 1.5 higher risk not to have a success after surgery and over 50-year-old patients a 1.8 higher risk. Morbidly obese patients (40 < BMI < 49) had a 2.6 times higher risk not to have a success than patients with severe obesity (35 < BMI < 39). Superobese patients (BMI >50) had a 5.4 times higher risk not to succeed than patients with severe obesity. Being operated by a team with a surgical activity over 15 bariatric procedures/2 months doubles the chance of a successful operation when compared with patients operated by surgical teams having only performed 1 or 2 bariatric procedures. Patients who had not recovered or increased their physical activity after operation had a 2.3 times higher risk not to have a success than those who did. Patients who had not changed their eating habits had a 2.2 times higher risk not to have a success than those who did. CONCLUSIONS: This nationwide survey shows that the best profile for a success after gastric banding is a patient <40 years, with an initial BMI <50 kg/m, willing to change his eating habits and to recover or increase his physical activity after surgery and who has been operated by a team usually performing >2 bariatric procedures per week. This study emphasizes that obesity surgery requires a significant experience of the surgical team and a multidisciplinary approach to improve behavioral changes.