RESUMO
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.
Assuntos
Carcinoma Adenoide Cístico , Radioterapia com Íons Pesados , Terapia com Prótons , Sarcoma , Neoplasias de Tecidos Moles , Carbono/efeitos adversos , Radioterapia com Íons Pesados/efeitos adversos , Humanos , Íons/uso terapêutico , Fótons/efeitos adversos , Estudos Prospectivos , Terapia com Prótons/efeitos adversos , Prótons , Qualidade de Vida , Sarcoma/tratamento farmacológico , Neoplasias de Tecidos Moles/tratamento farmacológicoRESUMO
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: 4â 546â 680 patients (9â 010â 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 1â year, 3.66 (95% CI 1.84 to 7.29, p<0.001) between 1 and 2â years and 10.65 (95% CI 5.05 to 22.46, p<0.0001) beyond 2â 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.
Assuntos
Doença Celíaca , Imidazóis , Absorção Intestinal/efeitos dos fármacos , Síndromes de Malabsorção , Tetrazóis , Adulto , Idoso , Antagonistas de Receptores de Angiotensina/administração & dosagem , Antagonistas de Receptores de Angiotensina/efeitos adversos , Inibidores da Enzima Conversora de Angiotensina/administração & dosagem , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Doença Celíaca/diagnóstico , Doença Celíaca/epidemiologia , Feminino , França/epidemiologia , Hospitalização/estatística & dados numéricos , Humanos , Imidazóis/administração & dosagem , Imidazóis/efeitos adversos , Incidência , Revisão da Utilização de Seguros/estatística & dados numéricos , Síndromes de Malabsorção/induzido quimicamente , Síndromes de Malabsorção/diagnóstico , Síndromes de Malabsorção/epidemiologia , Síndromes de Malabsorção/terapia , Masculino , Pessoa de Meia-Idade , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Tetrazóis/administração & dosagem , Tetrazóis/efeitos adversosRESUMO
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.
Assuntos
Colite Ulcerativa/induzido quimicamente , Doença de Crohn/induzido quimicamente , Fármacos Dermatológicos/efeitos adversos , Isotretinoína/efeitos adversos , Adulto , Estudos de Casos e Controles , Bases de Dados Factuais , Feminino , França , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Fatores de RiscoRESUMO
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.
Assuntos
Fluorbenzenos/administração & dosagem , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Programas Nacionais de Saúde , Prevenção Primária/métodos , Pirimidinas/administração & dosagem , Sinvastatina/administração & dosagem , Sulfonamidas/administração & dosagem , Adulto , Idoso , LDL-Colesterol/antagonistas & inibidores , LDL-Colesterol/sangue , Estudos de Coortes , Bases de Dados Factuais , Feminino , Seguimentos , França/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Rosuvastatina Cálcica , Resultado do TratamentoRESUMO
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.
Assuntos
Hospitalização/estatística & dados numéricos , Pobreza/estatística & dados numéricos , Cobertura Universal do Seguro de Saúde/estatística & dados numéricos , Adolescente , Adulto , Criança , Pré-Escolar , Feminino , França , Pesquisa sobre Serviços de Saúde , Mortalidade Hospitalar , Hospitalização/economia , Humanos , Lactente , Recém-Nascido , Tempo de Internação/economia , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Pobreza/economia , Estudos Retrospectivos , Cobertura Universal do Seguro de Saúde/economia , Adulto JovemRESUMO
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.
Assuntos
Depressores do Apetite/efeitos adversos , Fenfluramina/análogos & derivados , Doenças das Valvas Cardíacas/induzido quimicamente , Implante de Prótese de Valva Cardíaca/estatística & dados numéricos , Adulto , Idoso , Insuficiência da Valva Aórtica/induzido quimicamente , Insuficiência da Valva Aórtica/epidemiologia , Depressores do Apetite/uso terapêutico , Estudos de Coortes , Bases de Dados Factuais , Diabetes Mellitus/tratamento farmacológico , Feminino , Fenfluramina/efeitos adversos , Fenfluramina/uso terapêutico , França/epidemiologia , Doenças das Valvas Cardíacas/epidemiologia , Doenças das Valvas Cardíacas/patologia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Registro Médico Coordenado/métodos , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/induzido quimicamente , Insuficiência da Valva Mitral/epidemiologia , Farmacoepidemiologia/métodos , RiscoRESUMO
OBJECTIVES: To identify outpatient and hospital health care usage among dementia patients compared to controls. METHODS: Analysis of the French National Health Insurance general regime reimbursement database, linked to the national hospitalization database for 2007; 258,809 subjects over the age of 60 with dementia were compared to a sample of 88,296 controls. RESULTS: Dementia patients more frequently had at least one annual visit to private psychiatrists and neurologists (21.9%, relative risk, RR = 7.0), nursing care (52%, RR = 1.3), physiotherapy (37%, RR = 1.45), and hospitalization (40.8%, RR = 1.7), and they less frequently consulted other private specialists (62%, RR = 0.85). Many diagnosis groups were significantly more frequent in dementia patients: nervous system (RR = 5.3), psychiatry (RR = 9.1), respiratory medicine (RR = 1.8), unspecified (RR = 2.4). Hospitalizations for endoscopy, radiotherapy, chemotherapy, and treatment of disabilities such as cataracts (RR = 0.7) were less frequent. Higher relative levels of health care use decreased with age for dementia patients. CONCLUSIONS: Although the use of some forms of health care can be explained by the clinical condition induced by dementia, others must be interpreted in light of modes of medical and social management and ethical justification for screening and investigations.
Assuntos
Demência/epidemiologia , Hospitalização/estatística & dados numéricos , Atenção Primária à Saúde/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Intervalos de Confiança , Bases de Dados Factuais , Demência/economia , Feminino , França/epidemiologia , Hospitalização/economia , Humanos , Masculino , Pessoa de Meia-Idade , Programas Nacionais de Saúde/estatística & dados numéricos , Atenção Primária à Saúde/economia , Medição de RiscoRESUMO
BACKGROUND AND AIM: A north-south gradient in inflammatory bowel disease (IBD) incidence has been found in Europe and the United States. Its existence is inferred from comparisons of registries that cover only small portions of territories. Several studies suggest that IBD incidence in the north has reached a plateau, whereas in the south it has risen sharply. This evolution tends to reduce the north-south gradient, and it is uncertain whether it still exists. In France, patients with IBD are fully reimbursed for their health expenses by the national health insurance system, which is a potential source of data concerning the incidence of IBD at the national level. The aim of this study was to assess the geographical distribution of Crohn's disease (CD) and ulcerative colitis (UC) in France and to test the north-south gradient hypothesis. METHODS: This study was conducted in metropolitan France and included patients to whom IBD reimbursement was newly attributed between January 1, 2000 and December 31, 2002. Data provided relate to age, sex, postcode area of residence, and IBD type. The mapping of geographical distribution of smoothed relative risks (RR) of CD and UC was carried out using a Bayesian approach, taking into account autocorrelation and population size in each département. RESULTS: In the overall population, incidence rates were 8.2 for CD and 7.2 for UC per 100,000 inhabitants. A clear north-south gradient was shown for CD. Départements with the highest smoothed RR were located in the northern third of France. By contrast, the geographical distribution of smoothed RR of UC was homogeneous. CONCLUSIONS: This study shows a north-south gradient in France for CD but not for UC.
Assuntos
Colite Ulcerativa/diagnóstico , Colite Ulcerativa/epidemiologia , Doença de Crohn/diagnóstico , Doença de Crohn/epidemiologia , Adolescente , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Feminino , França/epidemiologia , Geografia , Humanos , Doenças Inflamatórias Intestinais/diagnóstico , Doenças Inflamatórias Intestinais/epidemiologia , Masculino , Pessoa de Meia-Idade , Programas Nacionais de Saúde , Prevalência , Sistema de Registros , Índice de Gravidade de Doença , Distribuição por Sexo , Taxa de SobrevidaAssuntos
Medicina Geral , Atenção Primária à Saúde , Saúde Pública , Atenção à Saúde/normas , França , HumanosRESUMO
BACKGROUND: The prevalence of end-stage renal disease (ESRD) treated with renal dialysis is poorly known in France because there is no national registry of dialysis patients. The specific aims of this study are to determine the total number of patients treated with renal dialysis and their social, demographic, and clinical characteristics, as well as define the overall care they received. METHODS: We performed a cross-sectional descriptive study from June 2 to June 8, 2003, in all renal dialysis units (including pediatric units) by including all patients residing in France with ESRD who were dialyzed during that week, irrespective of age or the treatment they received. We gathered sociodemographic (age, sex, place of residence, and occupation) and clinical data (year they entered dialysis therapy, initial renal disease, comorbidities, and associated handicaps) and information concerning their overall treatment plan (waiting list for kidney transplant, therapeutic regimen, and dialysis technique used). RESULTS: A total of 30,882 patients residing in France were treated with renal dialysis. The unadjusted prevalence of dialysis was 513.1 patients per million population (pmp); 498.2 pmp in metropolitan France and 1,035.7 pmp in the overseas territories. Clinical and sociodemographic characteristics of patients and their therapeutic regimens were different in metropolitan France and the overseas territories. CONCLUSION: This study constitutes the first comprehensive inventory of dialysis therapy in France, where the prevalence of ESRD is among the highest in the world.
Assuntos
Falência Renal Crônica/epidemiologia , Falência Renal Crônica/terapia , Diálise Renal/estatística & dados numéricos , Adolescente , Adulto , Idoso , Criança , Comorbidade , Estudos Transversais , Feminino , França/epidemiologia , Guadalupe/epidemiologia , Guiana/epidemiologia , Unidades Hospitalares de Hemodiálise/estatística & dados numéricos , Humanos , Masculino , Martinica/epidemiologia , Pessoa de Meia-Idade , Mônaco , Prevalência , Reunião/epidemiologiaRESUMO
Epidemiologic data on end-stage renal disease (ESRD) treated with renal dialysis remain sparse and incomplete in France because there is no national registry of dialysis patients. The aim of this study was to determine the characteristics (age, gender, comorbidities, associated handicap) of patients treated with renal dialysis and to compare the dialysis regional practices. We performed a cross-sectional descriptive study from June 2 to June 8, 2003 in all renal dialysis units by enrolling all the patients residing in France with ESRD who were dialysed during that week, irrespective of the treatment they received or where they were being treated. In 2003, the type of dialysis units available and the technique they employ were quite different from one region to another, varying from 41.1 to 70.2% for highly specialized unit, 9.4 to 48.4% for self-care hemodialysis, and 2.9 to 26.5% for peritoneal dialysis.
Assuntos
Falência Renal Crônica/terapia , Diálise Renal/estatística & dados numéricos , Diálise Renal/normas , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Feminino , França , Humanos , Falência Renal Crônica/epidemiologia , Masculino , Pessoa de Meia-Idade , Programas Médicos Regionais/normas , Sistema de RegistrosRESUMO
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.
Assuntos
Doenças Cardiovasculares/complicações , Doenças Cardiovasculares/tratamento farmacológico , Bases de Dados como Assunto , Diabetes Mellitus/tratamento farmacológico , Ácidos Fíbricos/uso terapêutico , Atenção Primária à Saúde , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Fatores de Risco , Análise de Sobrevida , Resultado do TratamentoRESUMO
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.
Assuntos
Colonoscopia/efeitos adversos , Perfuração Intestinal/epidemiologia , Perfuração Intestinal/etiologia , Hemorragia Pós-Operatória/epidemiologia , Hemorragia Pós-Operatória/etiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , França , Humanos , Seguro Saúde , Masculino , Pessoa de Meia-Idade , Fatores de RiscoRESUMO
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.
Assuntos
Doenças Cardiovasculares/economia , Doenças Cardiovasculares/etnologia , Países em Desenvolvimento/economia , Programas Nacionais de Saúde/economia , Características de Residência , Adulto , Doenças Cardiovasculares/terapia , Feminino , França/etnologia , Humanos , Masculino , Pessoa de Meia-Idade , Pobreza/economia , Pobreza/etnologia , Fatores de Risco , Fatores Socioeconômicos , Resultado do Tratamento , Adulto JovemRESUMO
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.
Assuntos
Insuficiência Cardíaca/mortalidade , Hospitalização , Idoso , Idoso de 80 Anos ou mais , Cardiologia , Fármacos Cardiovasculares/uso terapêutico , Causas de Morte , Comorbidade , Gerenciamento Clínico , Feminino , Seguimentos , França/epidemiologia , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Hipolipemiantes/uso terapêutico , Masculino , Pessoa de Meia-Idade , Programas Nacionais de Saúde , Readmissão do Paciente/estatística & dados numéricos , Prognóstico , Encaminhamento e Consulta , Fatores de Risco , Inibidores de Simportadores de Cloreto de Sódio e Potássio/uso terapêutico , Taxa de Sobrevida , Resultado do TratamentoRESUMO
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.
Assuntos
Insulina de Ação Prolongada/efeitos adversos , Insulina/efeitos adversos , Neoplasias/induzido quimicamente , Neoplasias/epidemiologia , Adulto , Idoso , Bases de Dados Factuais , Feminino , França , Humanos , Insulina Detemir , Insulina Glargina , Masculino , Pessoa de Meia-IdadeRESUMO
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.
Assuntos
Anti-Hipertensivos/uso terapêutico , Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus/tratamento farmacológico , Dislipidemias/tratamento farmacológico , Hipertensão/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Hipolipemiantes/uso terapêutico , Padrões de Prática Médica/tendências , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anti-Hipertensivos/economia , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/epidemiologia , Criança , Pré-Escolar , Diabetes Mellitus/economia , Diabetes Mellitus/epidemiologia , Custos de Medicamentos , Uso de Medicamentos/tendências , Revisão de Uso de Medicamentos , Dislipidemias/economia , Dislipidemias/epidemiologia , Feminino , França/epidemiologia , Humanos , Hipertensão/economia , Hipertensão/epidemiologia , Hipoglicemiantes/economia , Hipolipemiantes/economia , Lactente , Recém-Nascido , Reembolso de Seguro de Saúde , Masculino , Pessoa de Meia-Idade , Padrões de Prática Médica/economia , Fatores de Risco , Fatores de Tempo , Adulto JovemRESUMO
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.
Assuntos
Fármacos Cardiovasculares/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Hospitalização , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Comorbidade , Quimioterapia Combinada , Feminino , França/epidemiologia , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/mortalidade , Mortalidade Hospitalar , Humanos , Incidência , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Readmissão do Paciente , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
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.