A randomized controlled phase III study comparing hadrontherapy with carbon ions versus conventional radiotherapy - including photon and proton therapy - for the treatment of radioresistant tumors: the ETOILE trial.

BACKGROUND: Some cancers such as sarcomas (bone and soft tissue sarcomas) and adenoid cystic carcinomas are considered as radioresistant to low linear energy transfer radiation (including photons and protons) and may therefore beneficiate from a carbon ion therapy. Despite encouraging results obtained in phase I/II trials compared to historical data with photons, the spread of carbon ions has been limited mainly because of the absence of randomized medical data. The French health authorities stressed the importance of having randomized data for carbon ion therapy. METHODS: The ETOILE study is a multicenter prospective randomized phase III trial comparing carbon ion therapy to either advanced photon or proton radiotherapy for inoperable or macroscopically incompletely resected (R2) radioresistant cancers including sarcomas and adenoid cystic carcinomas. In the experimental arm, carbon ion therapy will be performed at the National Center for Oncological Hadrontherapy (CNAO) in Pavia, Italy. In the control arm, photon or proton radiotherapy will be carried out in referent centers in France. The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival and local control, toxicity profile, and quality of life. In addition, a prospective health-economic study and a radiobiological analysis will be conducted. To demonstrate an absolute improvement in the 5-year PFS rate of 20% in favor of carbon ion therapy, 250 patients have to be included in the study. DISCUSSION: So far, no clinical study of phase III has demonstrated the superiority of carbon ion therapy compared to conventional radiotherapy, including proton therapy, for the treatment of radioresistant tumors. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02838602 . Date of registration: July 20, 2016. The posted information will be updated as needed to reflect protocol amendments and study progress.

Severe intestinal malabsorption associated with olmesartan: a French nationwide observational cohort study.

OBJECTIVES: Severe sprue-like enteropathy associated with olmesartan has been reported, but there has been no demonstration of an increased risk by epidemiological studies. AIM: To assess, in a nationwide patient cohort, the risk of hospitalisation for intestinal malabsorption associated with olmesartan compared with other angiotensin receptor blockers (ARB) and ACE inhibitors (ACEIs). DESIGN: From the French National Health Insurance claim database, all adult patients initiating ARB or ACEI between 1 January 2007 and 31 December 2012 with no prior hospitalisation for intestinal malabsorption, no serology testing for coeliac disease and no prescription for a gluten-free diet product were included. Incidence of hospitalisation with a discharge diagnosis of intestinal malabsorption was the primary endpoint. RESULTS: 4 546 680 patients (9 010 303 person-years) were included, and 218 events observed. Compared with ACEI, the adjusted rate ratio of hospitalisation with a discharge diagnosis of intestinal malabsorption was 2.49 (95% CI 1.73 to 3.57, p<0.0001) in olmesartan users. This adjusted rate ratio was 0.76 (95% CI 0.39 to 1.49, p=0.43) for treatment duration shorter than 1 year, 3.66 (95% CI 1.84 to 7.29, p<0.001) between 1 and 2 years and 10.65 (95% CI 5.05 to 22.46, p<0.0001) beyond 2 years of exposure. Median length of hospital stay for intestinal malabsorption was longer in the olmesartan group than in the other groups (p=0.02). Compared with ACEI, the adjusted rate ratio of hospitalisation for coeliac disease was 4.39 (95% CI 2.77 to 6.96, p<0.0001) in olmesartan users and increased with treatment duration. CONCLUSIONS: Olmesartan is associated with an increased risk of hospitalisation for intestinal malabsorption and coeliac disease.

Use of Fibrates Monotherapy in People with Diabetes and High Cardiovascular Risk in Primary Care: A French Nationwide Cohort Study Based on National Administrative Databases.

BACKGROUND AND AIM: According to guidelines, diabetic patients with high cardiovascular risk should receive a statin. Despite this consensus, fibrate monotherapy is commonly used in this population. We assessed the frequency and clinical consequences of the use of fibrates for primary prevention in patients with diabetes and high cardiovascular risk. DESIGN: Retrospective cohort study based on nationwide data from the medical and administrative databases of French national health insurance systems (07/01/08-12/31/09) with a follow-up of up to 30 months. METHODS: Lipid-lowering drug-naive diabetic patients initiating fibrate or statin monotherapy were identified. Patients at high cardiovascular risk were then selected: patients with a diagnosis of diabetes and hypertension, and > 50 (men) or 60 (women), but with no history of cardiovascular events. The composite endpoint comprised myocardial infarction, stroke, amputation, or death. RESULTS: Of the 31,652 patients enrolled, 4,058 (12.8%) received a fibrate. Age- and gender-adjusted annual event rates were 2.42% (fibrates) and 2.21% (statins). The proportionality assumption required for the Cox model was not met for the fibrate/statin variable. A multivariate model including all predictors was therefore calculated by dividing data into two time periods, allowing Hazard Ratios to be calculated before (HR < 540) and after 540 days (HR > 540) of follow-up. Multivariate analyses showed that fibrates were associated with an increased risk for the endpoint after 540 days: HR < 540 = 0.95 (95% CI: 0.78-1.16) and HR > 540 = 1.73 (1.28-2.32). CONCLUSION: Fibrate monotherapy is commonly prescribed in diabetic patients with high cardiovascular risk and is associated with poorer outcomes compared to statin therapy.

Frequency of cardiovascular diseases and risk factors treated in France according to social deprivation and residence in an overseas territory.

BACKGROUND: The frequencies of treated cardiovascular disease (CVD) and their associated risk factors (CVRF) may vary according to socioeconomic and territorial characteristics. METHODS: These frequencies have been described for 48million policyholders of the French general health insurance scheme, according to a metropolitan geographical deprivation index in five quintiles (from the least to the most deprived: Q1 to Q5), the existence of universal complementary health cover (CMUC) in individuals under the age of 60, and residence in a French overseas territory (FOT). The information system (SNIIRAM) was used to identify CVDs and anti-diabetic, anti-hypertensive or lipid-lowering treatments by three reimbursements in 2010. RESULTS: After age- and sex-specific adjustment, the inhabitants of the most deprived areas more often suffered from distal arterial disease (Q5/Q1=1.5), coronary artery disease (1.2) and cerebral vascular accident (1.1), as did the CMUC beneficiaries compared to non-beneficiaries (ratios of 1.7, 1.3 and 1.5), and the FOT residents in comparison to the most deprived metropolitan quintile (Q1), with the exception of coronary artery disease (1.2, 0.6 and 1.2). Inhabitants of the most deprived areas more often received anti-diabetic and anti-hypertensive treatment (Q5/Q1=1.4 and 1.2), as did the people on the CMUC (2.0 and 1.2) and the FOT inhabitants (FOT/Q1=2.4 and 1.3). These ratios were of 1.1, 1.0 and 0.8 for lipid-lowering drugs. CONCLUSION: These results pinpoint populations for which specific preventative initiatives could be supported. While health care service utilisation is facilitated (CMUC), it is probably not yet effective enough in view of the persistent increased cardiovascular risk.

Two-year outcome of patients after a first hospitalization for heart failure: A national observational study.

BACKGROUND: National population-based management and outcome data for patients of all ages hospitalized for heart failure have rarely been reported. AIM: National population-based management and outcome of patients of all ages hospitalized for heart failure have rarely been reported. The present study reports these results, based on 77% of the French population, for patients hospitalized for the first time for heart failure in 2009. METHODS: The study population comprised French national health insurance general scheme beneficiaries hospitalized in 2009 with a principal diagnosis of heart failure, after exclusion of those hospitalized for heart failure between 2006 and 2008 or with a chronic disease status for heart failure. Data were collected from the national health insurance information system (SNIIRAM). RESULTS: A total of 69,958 patients (mean age, 78 years; 48% men) were studied. The hospital mortality rate was 6.4%, with 1-month, 1-year and 2-year survival rates of 89%, 71% and 60%, respectively. Heart failure and all-cause readmission-free rates were 55% and 43% at 1 year and 27% and 17% at 2 years, respectively. Compared with a reference sample of 600,000 subjects, the age- and sex-standardized relative risk of death was 29 (95% confidence interval [CI] 28-29) at 2 years, 82 (95% CI 72-94) in subjects aged<50 years and 3 (95% CI 3-3) in subjects aged ≥ 90 years. For subjects aged < 70 years who survived 1 month after discharge, factors associated with a reduction in the 2-year mortality rate were: female sex; age < 55 years; absence of co-morbidities; and use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, lipid-lowering agents or oral anticoagulants during the month following discharge. Poor prognostic factors were treatment with a loop diuretic before or after hospitalization and readmission for heart failure within 1 month after discharge. CONCLUSIONS: This large population-based study confirms the severe prognosis of heart failure and the need to promote the use of effective medications and management designed to improve survival.

Isotretinoin and risk of inflammatory bowel disease: a French nationwide study.

OBJECTIVES: Isotretinoin, a drug widely prescribed for severe acne, has been suspected to increase the risk of ulcerative colitis (UC), but data are conflicting. To further examine the association between isotretinoin use and risk for UC and Crohn's disease (CD), we conducted a large nationwide case-control study in France. METHODS: We used information from the National Health Insurance system for all French people covered by the general scheme between 1 January 2008 and 31 December 2010, totaling over 50 million individuals (i.e., 76% of the whole French population). All incident claims for UC and CD and all medical drug reimbursements were automatically recorded in the database. For each case, four controls were matched on age, gender, year of enrollment, and follow-up duration. The association between isotretinoin use and UC or CD claim was estimated by conditional logistic regression. RESULTS: We included 7,593 cases of inflammatory bowel disease (IBD; 3,187 UC, 4,397 CD, and 9 indeterminate colitis) and 30,372 controls; among them, 26 cases (0.3%) (15 UC (0.5%) and 11 CD (0.3%)) and 140 controls (0.4%) were exposed to isotretinoin. Isotretinoin exposure was not associated with an increased risk for UC (odds ratio (OR)=1.36 (95% confidence intervals (CI): 0.76, 2.45)) but was associated with a decreased risk for CD (OR=0.45 (95% CI: 0.24, 0.85)), P value for homogeneity between UC and CD=0.001. Results were similar in analyses restricted to individuals below the age of 40 years, to cases with colonoscopy or intestinal surgery, or when adjusting for other acne treatments. CONCLUSIONS: In this population-based case-control study, isotretinoin use was not associated with increased UC risk but was associated with a decreased CD risk. This study provides reassuring data for people using isotretinoin.

Perforations and haemorrhages after colonoscopy in 2010: a study based on comprehensive French health insurance data (SNIIRAM).

BACKGROUND AND OBJECTIVE: To estimate the perforation and haemorrhage rate after colonoscopy in the French population in 2010 and to identify risk factors for these complications. METHOD: Study based on SNIIRAM and the PMSI databases. Patients treated for IBD or colorectal cancer were excluded. Two types of complications were investigated: perforation and haemorrhage. OR adjusted for patient (gender, age, chronic disease) and colonoscopy (polypectomy, emergency) characteristics were calculated by using a logistic regression model. RESULTS: The cohort was composed of 947,061 individuals. The estimated perforation rate was between 4.5 and 9.7 per 10,000 procedures and the estimated haemorrhage rate was between 9.9 and 11.0 per 10,000 procedures. The main risk factors associated with perforation and haemorrhage were the patient's age (over 80 years compared to under 40, OR=7.51 and 3.23), resection of polyps larger than 1 cm or more than 4 polyps (compared to no polypectomy, OR=2.72 and 5.12) and emergency colonoscopy (OR=4.63 and 5.99). Colonoscopy performed by a gastroenterologist performing less than 244 colonoscopies per year was associated with an increased risk of perforation (OR=2.29). Complication rates were higher in institutions performing less than 510 colonoscopies per year, but this was no longer the case after adjustment for emergency colonoscopies. CONCLUSIONS: This study, which includes nearly one million colonoscopies, suggests taking the gastroenterologist's number of colonoscopies into account to ensure optimal organization of the management of very elderly patients requiring colonoscopy.

Comparative effectiveness of rosuvastatin versus simvastatin in primary prevention among new users: a cohort study in the French national health insurance database.

PURPOSE: Using the French claims database (Système National d'Information Inter-Régimes de l'Assurance Maladie) linked to the hospital discharge database (Programme de Médicalisation des Systèmes d'Information), this observational study compared the effectiveness of rosuvastatin and simvastatin prescribed at doses with close LDL-cholesterol-lowering potency on all-cause mortality and cardiovascular and cerebrovascular diseases (CCDs) in primary prevention. METHODS: This historical cohort included patients with no prior CCD, aged 40-79 years, who initiated statin therapy with rosuvastatin 5 mg or simvastatin 20 mg in 2008-2009 in general practice. Follow-up started after a 1-year period used to select patients who regularly received the initial treatment. In an intention-to-treat analysis, patients were followed up to December 2011. In a per-protocol analysis, they were censored prematurely when they discontinued their initial treatment. Adjustment for baseline covariates (age, deprivation index, comedications, comorbidities, prior hospital admissions) was carried out by a Cox proportional hazards model. In the per-protocol analysis, estimation was done by "inverse probability of censoring weighting" using additional time-dependent covariates. Analyses were gender-specific. RESULTS: A total of 106941 patients initiated statin therapy with rosuvastatin 5 mg and 56860 with simvastatin 20 mg. Mean follow-up was 35.8 months. For both genders and both types of analyses, the difference in incidence rates of mortality and/or CCD between rosuvastatin 5 mg and simvastatin 20 mg users was not statistically significant after adjustment (e.g., for CCD and/or mortality in men, in intention-to-treat analysis HR=0.94 [95% CI=0.85-1.04], in per-protocol analysis HR=0.98 [0.87-1.10]). CONCLUSIONS: The results of this real-life study based on medico-administrative databases do not support preferential prescription of rosuvastatin compared to simvastatin for primary prevention of CCD.

First hospitalization for heart failure in France in 2009: patient characteristics and 30-day follow-up.

BACKGROUND: The incidence of heart failure (HF) is stable in industrialized countries, but its prevalence continues to increase, especially due to the ageing of the population, and mortality remains high. OBJECTIVE: To estimate the incidence in France and describe the management and short-term outcome of patients hospitalized for HF for the first time. METHOD: The study population comprised French national health insurance general scheme beneficiaries (77% of the French population) hospitalized in 2009 with a principal diagnosis of HF after exclusion of those hospitalized for HF between 2006 and 2008 or with a chronic disease status for HF. Data were collected from the national health insurance information system (SNIIRAM). RESULTS: A total of 69,958 patients (mean age 78 years; 48% men) were included. The incidence of first hospitalization for HF was 0.14% (≥ 55 years, 0.5%; ≥ 90 years, 3.1%). Compared with controls without HF, patients more frequently presented cardiovascular or other co-morbidities. The hospital mortality rate was 6.4% and the mortality rate during the 30 days after discharge was 4.4% (3.4% without readmission). Among 30-day survivors, all-cause and HF 30-day readmission rates were 18% (< 70 years, 22%; ≥ 90 years, 13%) and 5%, respectively. Reimbursements among 30-day survivors comprised at least a beta-blocker in 54% of cases, diuretics in 85%, angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) in 67%, a diuretic and ACEI/ARB combination in 23% and a beta-blocker, ACEI/ARB and diuretic combination in 37%. CONCLUSION: Patients admitted for HF presented high rates of co-morbidity, readmission and death at 30 days, and there remains room for improvement in their drug treatments; these findings indicate the need for improvement in return-home and therapeutic education programmes.

Antihypertensive, antidiabetic and lipid-lowering treatment frequencies in France in 2010.

BACKGROUND: The frequencies of treatment for cardiovascular risk factors are poorly documented in large populations, particularly according to the presence or absence of cardiovascular disease (CVD). AIMS: To assess frequencies of reimbursements for antihypertensive, lipid-lowering and antidiabetic medications in France among national health insurance beneficiaries in 2010 and their associations according to age, sex, French regions, level deprivation and the presence of certain CVD. METHODS: Treatment frequencies were calculated among the beneficiaries (58 million people) on the basis of reimbursements for three specific categories of medicinal products in 2010. The presence of CVD was defined by a diagnosis associated with chronic disease status and hospital stays in 2010. RESULTS: Among people aged greater or equal to 20years, treatment frequencies were 22% (men 20% vs. women 23%) for antihypertensives, 15% (14% vs. 16%) for lipid-lowering agents and 6% (6% vs. 5%) for antidiabetic medications. These frequencies were, respectively, 33%, 23% and 8% in patients aged greater or equal to 40years and 55%, 38% and 14% in patients aged greater or equal to 60 years. The frequency of at least one treatment for at least one of the three risk factors was 41% in patients aged greater or equal to 40 years and 66% in patients aged greater or equal to 60 years. Among patients aged greater or equal to 20 years, 22% were treated for at least one risk factor in the absence of CVD and 3% were treated for at least one risk factor in the presence of CVD. Regional differences were observed, with higher frequencies of antihypertensive and antidiabetic use in the North, North-East and Overseas regions. Treatment frequencies increased with level of deprivation, especially for antidiabetics. CONCLUSION: This national study more clearly defines treatment frequencies and the populations and regions with the highest treatment frequencies.

Does insulin glargine increase the risk of cancer compared with other basal insulins?: A French nationwide cohort study based on national administrative databases.

OBJECTIVE: To explore in France the relationship between insulin glargine use and overall and specific cancer risks in type 2 diabetic patients compared with other basal insulins. RESEARCH DESIGN AND METHODS: Data were extracted from French health insurance information system (Système National d'Information Inter-Régimes de l'Assurance Maladie) linked with data from the French Hospital Discharge database (Programme de Médicalisation des Systèmes d'Information). Included were 70,027 patients aged 40-79 years who started a basal insulin in 2007-2009. Cox proportional hazards models with age as time-scale were used to calculate multivariate-adjusted hazard ratios for associations between type of basal insulin and risk of overall cancer, breast cancer, and seven other cancer sites. RESULTS: The median follow-up was 2.67 years in patients exposed to insulin glargine. Absolute event rates for all cancer in patients exposed to glargine versus other basal insulin users were 1,622 and 1,643 per 100,000 person-years, respectively. No significant association was observed between glargine exposure and overall cancer incidence after adjustment for sex, with a hazard ratio of 0.97 (95% CI 0.87-1.07), or after additional adjustment for any other hypoglycemic agent use and duration of diabetes. No increased risk of breast cancer was observed for glargine users compared with other basal insulins users, with a fully adjusted hazard ratio of 1.08 (0.72-1.62). CONCLUSIONS: In a large cohort of patients newly treated by basal insulin, no increased risk of any cancer was observed in insulin glargine users compared with other basal insulin users. Because follow-up did not exceed 4 years, longer-term studies are needed.

[Vaccination against seasonal influenza in France in 2010 and 2011: decrease of coverage rates and associated factors]. / Vaccination contre la grippe saisonnière en France en 2010 et 2011 : diminution des taux de couverture et facteurs associés.

AIM: To measure the seasonal influenza vaccination coverage rate (VCR) in France in 2010, one year after the A(H1N1) influenza pandemic, and 2011 by age and target disease and to identify risk factors associated with a lack of vaccination in 2010 for those previously vaccinated in 2009. METHODS: At the beginning of each vaccination campaign, the National Health Insurance, covering 86% of the French population, sends free influenza vaccination vouchers to at-risk beneficiaries aged under 65 suffering from diverse target diseases and to all individuals aged 65 and over (around 11.5 million). RESULTS: The global VCR (50.4%), except people with asthma identified by drug refunds, decreased in 2010 compared with the previous three years when it was close to 60% (51.0% in 2011). For people under 65 years old, it fell from 40.3% in 2009 to 31.6% in 2010 (33.1% in 2011) and those aged 65 years and over from 63.3% to 53.8% (54.0% in 2011). The VCR of each target disease also decreased, especially for asthma, but not for HIV infection with campaign modification in 2010. It decreased among those aged 65 years and over with target disease (72.3% in 2009, 60.4% in 2010, 60.7% in 2011). Vaccination lack in 2010 was found to be associated with younger age, low number of drug deliveries and consultations with a general practitioner or a specialist, hospitalisation and the residence in a region of South of France or in overseas regions. CONCLUSION: An important decline of the VCR was observed in France since 2010 while the recommended VCR is 75%. Efforts must be led to improve the confidence of the insurant, especially towards the most fragile groups.

[Prostate-specific antigen use among men without prostate cancer in France (2008-2010)]. / Consommation du dosage de l'antigène spécifique de la prostate (PSA) en France chez les hommes sans cancer de la prostate déclaré (2008-2010).

This study evaluated the rate of prostate-specific antigen (PSA) dosage in men age 40 or older, affiliated to the general social security system in France between 2008 and 2010: 10.9 million men, excluding those with known prostate cancer. In 2010, 30.7% of this male population had at least one dosage of PSA, i.e. 12.3% of those between 40 and 54, 47.7% of those between 55 and 74, and 47.6% of those 75 years old or older. Percentages of men who had at least one dosage in the three-year period were 26.2%, 77.3% and 75.6% for the same age brackets, respectively. Overall, 13% of men age 40 or older, and in particular 21% of men 75 years old or older had more than three PSA dosages during the three-year time period. Eighty-eight percent of PSA dosages performed in 2010 were prescribed by a general practitioner and 3.2% by an urologist. Conflicting with French and internationally published recommendations regarding PSA dosage, the present results demonstrate a shift toward chaotic mass screening of prostate cancer particularly in men aged 75 or older.

Evaluation of the agreement between guidelines and initial antihypertensive drug treatment using a national health care reimbursement database.

RATIONALE, AIMS AND OBJECTIVES: To test the agreement between guidelines for the management of hypertension and medical practices while avoiding frequent limitations such as the use of non-representative samples of practitioners and self-reporting of their practices over a short period of time. METHODS: The characteristics of initial antihypertensive drug treatment in a large representative sample of the French population aged 50-80 (n = 17 855) were collected from a national health care reimbursement database and compared with national guidelines over a 5-year period. RESULTS: Major discrepancies are observed including the use of non-recommended drug classes such as loop and potassium sparing diuretics alone or in association and the absence of distinction between patients according to their age. More minor discrepancies are the preferential use of mono-therapies over drug combinations and of some bi-therapies among those recommended. Some degree of concordance with the guidelines is also observed including the specific characteristics of the treatment of diabetics compared with other categories of patients and the preferential use of long-acting dihydropyridine calcium antagonists and of low-dose thiazide diuretics when these drug classes are chosen. Several of these discrepancies or concordances, which mainly reflect general practitioner (GP) activity, show time trends over the entire follow-up period with no significant effect of the guideline released during this period. CONCLUSIONS: At the French national level, the agreement between initial antihypertensive drug treatment and guidelines varies considerably depending on the characteristics of the treatment that are considered. The GPs who delivered the treatment do not seem to have been influenced by the guidelines released over the last decade.

Impact of free universal medical coverage on medical care and outcomes in low-income patients hospitalized for acute myocardial infarction: an analysis from the FrenchNational Health Insurance system.

BACKGROUND: The type of medical coverage in patients with acute myocardial infarction (AMI) may affect their treatment and outcome. METHODS AND RESULTS: We used the reimbursement database from the French National Health Insurance to determine the impact of full medical coverage (Couverture Médicale Universelle Complémentaire, CMUC), a free supplemental insurance for low-income earners <60 years of age, on treatment and outcomes of patients with AMI. The population comprised consecutive patients <60 years of age hospitalized for AMI from January to June 2006 in France. Of 4939 patients with AMI aged <60 years, 587 (12%) were on the CMUC. CMUC patients were younger, with more prior cardiovascular and comorbid conditions. CMUC and non-CMUC patients were admitted to the same types of institutions, including academic hospitals and private clinics. The use of cardiac catheterization and coronary interventions was similar (adjusted relative risk, 0.97; 95% confidence interval, 0.91-1.05; P=0.45). In-hospital mortality was also comparable (3.1% versus 2.8%, P=0.69). There was no difference in early use of secondary prevention medications after multivariate adjustment. At 30 months, survival and acute coronary syndrome-free survival were lower in CMUC patients (trend, not significant after adjustment). Long-term adherence to statin therapy was lower in CMUC patients (64% versus 77%; adjusted relative risk, 0.82; 95% confidence interval, 0.73-0.92). CONCLUSIONS: Free full coverage for socially deprived people levels inequalities in the acute and midterm treatment of AMI patients. However, full reimbursement per se is not sufficient to ensure optimal patient adherence to secondary prevention medications and may not be enough to prevent an excess of long-term events.

Implantation and patient profiles for pacemakers and cardioverter-defibrillators in France (2008-2009).

BACKGROUND: An ageing population and the extension of indications will in all probability result in an increasing number of cardiac device implantations. METHODS: Patients implanted in 2008 and 2009 were identified by means of the French National Hospital Discharge database to establish the implantation rate and the National Health Insurance (NHI) Information System database for patient profiles (76% of the population). RESULTS: Of the 64,306 pacemaker implantations (1003.7 per million inhabitants [pmi]) in 2009, 21.4% were single chamber, 75.4% double chamber and 3.2% triple chamber (CRT-P). Of the 9028 cardioverter-defibrillator implantations (140.8 pmi) in 2009, 30.1% were single chamber, 27.5% double chamber and 42.5% triple chamber (CRT-D), accounting for 65% of cardiac resynchronization therapy (CRT) implants. Among NHI beneficiaries, 58.6% of cardioverter-defibrillators were implanted for primary prevention. Between 2008 and 2009, CRT-P implantations increased by 8.8% and CRT-D implantations by 29.3%. Regional variations in implantation rates were observed regarding single-chamber pacemakers (15-33%) and CRT-D among CRT (46.2-73.8%). Pacemaker implantations cost €158.4 million overall, 4.5% of which was for CRT-P; cardioverter-defibrillator implantations cost €96 million, 49% of which was for CRT-D. For NHI beneficiaries, 11.9% of CRT-P patients and 6.5% of CRT-D patients already had a device of the same type implanted in the 3 preceding years. CONCLUSION: The results confirm the increase in cardioverter-defibrillator implantations in France. The implantation rate remains lower than that in the USA but falls within the European average. Reasons behind significant regional variations in implantation rates need further study.

[Mortality and hospital admissions rates and diagnosis among individuals with low income and full health insurance coverage in France, 2009]. / Surmortalité et hospitalisations plus fréquentes des bénéficiaires de la couverture médicale universelle complémentaire en 2009.

AIM: Complementary Universal Health insurance (CMUC) providing free access to health care has been available in France since 2000 for people with an annual income less than 60% of the poverty threshold. Hospital admission and mortality rates in 2009 were compared between beneficiaries of the general scheme under the age of 60 years with (4.5 millions) or without CMUC (34.1 millions) in 2008 and still alive at the end of the year. METHODS: Data were derived from the French national health insurance reimbursements and short-stay hospital admissions database for 2009 (80% of subjects under the age of 60 years in France). Rates and relative risks (RR) were standardised for the gender and age. RESULTS: CMUC beneficiaries had greater overall mortality rates (3.32/1000 vs. 1.36/1000, RR=2.4) for both gender (males RR=2.6, females RR=2.1) and each 10 years age class below 60 years. Standardised hospitalisation rate of CMUC beneficiaries was 17.5% and the rate for non-CMUC beneficiaries was 13.2%. Among CMUC beneficiaries, admissions were significantly more frequent for the following activity groups: toxicology, intoxication and alcohol (RR=3.5), psychiatry (RR=2.8), burns (2.7), respiratory medicine (RR=1.9), infectious disease (RR=2.1), endocrinology and cardiology (RR=1.7), obstetrics (RR=1.6). Their hospital mortality rate was also significantly higher (8.9/1000 vs. 5.1/1000, RR=1.73). CONCLUSION: In this low income population with free access to health care, hospitalisation and hospital mortality rates were higher for many diseases that are more or less known targets for prevention and screening actions.

HPV vaccination in France: uptake, costs and issues for the National Health Insurance.

INTRODUCTION: Two vaccines for primary prevention of cervical cancer are available in France, Gardasil® and Cervarix®, since 2007 and 2008 respectively. Currently, the French guidelines indicate vaccination of girls aged 14 with a catch-up program for females from 15 to 23 years old. In France, the reimbursement rate for these vaccines is 65% of the vaccine price, resulting in Gardasil® being the fifth highest drug expenditure of the main scheme of the French National Health Insurance in 2008. The purpose of this study is to provide data on vaccination coverage and costs in France until 31 December 2009. In addition, the current vaccination coverage rate is compared with the coverage rates assumed in cost-effectiveness studies. METHODS: Data were extracted from the National Health Insurance Information System (SNIIRAM). The SNIIRAM records all reimbursements of medical costs to patients--including drugs--by the French public Health Insurance Schemes since 2004. The analysis was performed for the period of July 2007 until December 2009 using the data of the general scheme of National Health Insurance covering about 88% of the French population, i.e., 56.5 million people. Vaccination rates for one or three doses were determined for the target and catch-up population using the 2009 reference population from the general health insurance scheme as the denominator. RESULTS: The cumulative number of doses reached 2,900,000 at the end of 2009. About 1,200,000 girls and young women have been reimbursed for at least one vaccine dose, of these 96.5% females aged 14-23 years. Among the target group, reimbursement for at least one dose remained low, from 50.8% for girls aged 14 years in 2007 to 41.7% and 20.5% for girls aged 14 years in 2008 and 2009 respectively. In terms of complete vaccination, only 33.3% of girls of the age of 14 years in 2007 and 23.7% in 2008 were reimbursed for 3 doses of HPV vaccine. The maximum uptake in the catch-up group for both 1 and 3 doses was observed for women born in 1992 (15 years in 2007) with 52.5% and 35.6% respectively. CONCLUSION: Low rates of coverage have been observed both in the target and catch-up groups in France. Considering this, the cost-effectiveness of vaccination in combination with opportunistic screening or organized screening needs to be re-evaluated.

Hospitalization admission rates for low-income subjects with full health insurance coverage in France.

BACKGROUND: Complementary Universal Health insurance (CMUC) providing free access to health care has been available in France, since 2000 for people with an annual income <50% of the poverty threshold. METHODS: Data were derived from the French national health insurance reimbursements and short-stay admissions database for 2007 (80% of subjects under the age of 60 years in France, including 4.8 million CMUC beneficiaries). Rate ratios were calculated by dividing the rate of CMUC beneficiaries by that of other beneficiaries standardized for the sex and age distribution of CMUC beneficiaries. RESULTS: The hospitalization rate of CMUC beneficiaries was 17.2% and the standardized rate for non-CMUC beneficiaries was 13.2% (ratio: 1.3). It was equally raised regardless of gender and age of CMUC beneficiaries. The hospital mortality rate was 0.61% for CMUC beneficiaries and the adjusted rate for non-CMUC beneficiaries was 0.35% (1.8). The hospitalization ratio for CMUC beneficiaries was >1 for all of the 22 major diagnostic categories, including psychiatry, toxicology and alcohol (3.7), HIV (3.3), infectious diseases other than HIV (1.9), burns (2.6), trauma (1.7) and female genital tract tumours (1.6) but not breast tumours (0.8). Hospitalizations for investigations such as endoscopies were also more frequent, as well as stays of <48 h for radiotherapy (1.6), chemotherapy (1.5) and dialysis (2.2). CONCLUSIONS: In this low-income population with free access to health care, hospitalization and hospital mortality rates were higher for many diseases that are known targets for prevention and screening actions.