Low dose oestrogen combined oral contraception and risk of pulmonary embolism, stroke, and myocardial infarction in five million French women: cohort study.

Objective: To assess the risk of pulmonary embolism, ischaemic stroke, and myocardial infarction associated with combined oral contraceptives according to dose of oestrogen (ethinylestradiol) and progestogen.

Design: Observational cohort study.

Setting: Data from the French national health insurance database linked with data from the French national hospital discharge database.

Risk of bleeding and arterial thromboembolism in patients with non-valvular atrial fibrillation either maintained on a vitamin K antagonist or switched to a non-vitamin K-antagonist oral anticoagulant: a retrospective, matched-cohort study.

Background: Patients with non-valvular atrial fibrillation who are receiving or have been previously exposed to a vitamin K antagonist could be switched to a non-vitamin K-antagonist oral anticoagulant (NOAC) but little information is available about the risk of bleeding and arterial thromboembolism after such a switch. We aimed to compare the risk of bleeding between individuals who switched and those who remained on a vitamin K antagonist (non-switchers) in real-world conditions.

Methods: We did a matched-cohort study with information from French health-care databases.

The Best Use of the Charlson Comorbidity Index With Electronic Health Care Database to Predict Mortality.

Background: The most used score to measure comorbidity is the Charlson index. Its application to a health care administrative database including International Classification of Diseases, 10th edition (ICD-10) codes, medical procedures, and medication required studying its properties on survival. Our objectives were to adapt the Charlson comorbidity index to the French National Health Insurance database to predict 1-year mortality of discharged patients and to compare discrimination and calibration of different versions of the Charlson index.

[Use in France of Baclofen for Alcohol Dependence from 2007 to 2013: Cohort Study Based on the Databases SNIIRAM and PMSI].

Aim: To quantify and describe the population starting treatment with baclofen for alcohol dependence during the period 2007-2013 in France.

Methods: The French national health insurance (système national d'information inter-régimes de l'Assurance maladie [SNIIRAM]) and French hospital discharge (programme de médicalisation des systèmes d'information [PMSI]) databases were used to identify the population starting treatment with baclofen, determine the algorithm of baclofen use, define patient characteristics and their treatment.

Results: About 200,000 subjects initiated baclofen therapy between 2007 and 2013, for alcohol dependence in 52.

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.

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.

Comparison of the short-term risk of bleeding and arterial thromboembolic events in nonvalvular atrial fibrillation patients newly treated with dabigatran or rivaroxaban versus vitamin K antagonists: a French nationwide propensity-matched cohort study.

Background: The safety and effectiveness of non-vitamin K antagonist (VKA) oral anticoagulants, dabigatran or rivaroxaban, were compared with VKA in anticoagulant-naive patients with nonvalvular atrial fibrillation during the early phase of anticoagulant therapy.

Methods And Results: With the use of the French medico-administrative databases (SNIIRAM and PMSI), this nationwide cohort study included patients with nonvalvular atrial fibrillation who initiated dabigatran or rivaroxaban between July and November 2012 or VKA between July and November 2011. Patients presenting a contraindication to oral anticoagulants were excluded.

Compliance with pregnancy prevention plan recommendations in 8672 French women of childbearing potential exposed to acitretin.

Purpose: Acitretin is an oral synthetic aromatic analogue of retinoic acid available in most European countries since 1988. It is mainly used to treat severe psoriasis. Like all systemic retinoids, acitretin is teratogenic.

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.

Elderly patients with colorectal cancer: treatment modalities and survival in France. National data from the ThInDiT cohort study.

Background: Few data exist on how elderly patients with colorectal cancer (CRC) are actually treated in real-life practice. Based on a national cohort, we analysed routine treatment modalities of the elderly who were diagnosed with CRC in France in 2009.

Patients And Methods: The characteristics of patients and tumours and the cancer treatments received during the first year of all national incident cases of CRC diagnosed between 1st April and 31st December 2009, were compared between a 'younger group' (YG), under 75 years of age (N = 18,410 patients), and an 'older group' (OG), aged 75 and over (N = 13,255 patients).

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.

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.

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.

[Vaccination against seasonal influenza in France in 2010 and 2011: decrease of coverage rates and associated factors].

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).

[Prostate-specific antigen use among men without prostate cancer in France (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.

Underrepresentation of elderly people in randomised controlled trials. The example of trials of 4 widely prescribed drugs.

Background: We aimed to determine the representation of elderly people in published reports of randomized controlled trials (RCTs). We focused on trials of 4 medications--pioglitazone, rosuvastatin, risedronate, and valsartan-frequently used by elderly patients with chronic medical conditions.

Methods And Findings: We selected all reports of RCTs indexed in PubMed from 1966 to April 2008 evaluating one of the 4 medications of interest.

Pioglitazone and risk of bladder cancer among diabetic patients in France: a population-based cohort study.

Aims/hypothesis: Previous studies have suggested an increased risk of bladder cancer with pioglitazone exposure. We aimed to investigate the association between pioglitazone exposure and bladder cancer in France.

Methods: This cohort study involved use of data from the French national health insurance information system (Système National d'Information Inter-régimes de l'Assurance Maladie; SNIIRAM) linked with the French hospital discharge database (Programme de Médicalisation des Systèmes d'Information; PMSI).

[Alzheimer disease and other dementia in France: Identification, management and neuroleptic use (2007-2009)].

Numbers of patients with Alzheimer's disease or other dementia (ADD) are necessary for care organisation and indicators development as rates of neuroleptics prescription will have a negative risk-benefit balance. Among people of 60 years old and more covered by the general regime (11 millions, 80% of French people), patients with ADD were identified by at least one of the following criteria: long-term affection status for ADD (67.1% of the identified), refunds for Alzheimer medication (67.

[Carpal tunnel syndrome surgery in France in 2008: patients' characteristics and management].

Introduction: Carpal tunnel syndrome (CTS) is the most common upper limb neuropathy. There has been a dramatic increase in CTS surgery since the 1990s. This study focuses on changing incidence of CTS surgery in France and associated factors.

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.

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.

Seasonal influenza vaccination coverage in France during two influenza seasons (2007 and 2008) and during a context of pandemic influenza A(H1N1) in 2009.

Objectives: To measure the seasonal influenza vaccination coverage rate (VCR) in France in 2009, year of the A(H1N1) influenza pandemic, by age and target disease and compare it with the VCR for the 2007 and 2008 influenza seasons.

Method: At the beginning of each annual seasonal 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 chronic diseases and to all individuals aged 65 and over (around 11 million). Vaccination is estimated from refund claims registered in the National Health Insurance Information System.

[Mortality and hospital admissions rates and diagnosis among individuals with low income and full health insurance coverage in France, 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.

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.