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.

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. METHODS: Our cohort included all adults discharged from a hospital stay in France in 2010 registered in the French National Health Insurance general scheme. The pathologies of the Charlson index were identified through ICD-10 codes of discharge diagnoses and long-term disease, specific medical procedures, and reimbursement of specific medications in the past 12 months before inclusion. RESULTS: We included 6,602,641 subjects at the date of their first discharge from medical, surgical, or obstetrical department in 2010. One-year survival was 94.88%, decreasing from 98.41% for Charlson index of 0-71.64% for Charlson index of ≥5. With a discrimination of 0.91 and an appropriate calibration curve, we retained the crude Cox model including the age-adjusted Charlson index as a 4-level score. CONCLUSIONS: Our study is the first to adapt the Charlson index to a large health care database including >6 million of inpatients. When mortality is the outcome, we recommended using the age-adjusted Charlson index as 4-level score to take into account comorbidities.

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.

[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.

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.

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.

[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.

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.

Evidence-based pharmacotherapy after myocardial infarction in France: adherence-associated factors and relationship with 30-month mortality and rehospitalization.

BACKGROUND: International guidelines recommend long-term use of evidence-based treatment (EBT) combining beta-blockers, aspirin/clopidogrel, statins and either angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEIs/ARBs) after a myocardial infarction (MI), to reduce cardiac morbidity and mortality. AIMS: To evaluate medication adherence after hospital admission for MI and the relationship with mortality and readmission for acute coronary syndrome. METHODS: Observational, 30-month follow-up of patients admitted for acute MI in France in the first half of 2006 and still alive 6 months later. Data from the national hospital discharge database and the outpatient medications reimbursement database were linked for all patients covered by the general health insurance scheme (70% of the French population). A patient was considered as adherent when the proportion of days covered by a filled prescription was greater than 80%. RESULTS: The proportion of nonadherent patients was 32.0% for beta-blockers, 24.0% for statins, 22.7% for ACEIs/ARBs, 18.3% for aspirin/clopidogrel and 50.0% for combined EBT. Adherence to EBT was decreased significantly by age greater than 74 years, comorbidities and full healthcare coverage for low earners. Prior EBT use and stent implantation, before or during index hospitalization, increased adherence. After adjustment for patient characteristics and management, prior use of each class decreased mortality. Nonadherence to EBT after MI increased mortality and readmission (hazard ratio=1.43, P<0.0001). CONCLUSION: After MI, nonadherence to EBT is associated with a marked increase in all-cause mortality and readmission for acute coronary syndrome. Cost-effective strategies for adherence improvement should be developed among patient groups with poor adherence.

[The cost of dialysis and kidney transplantation in France in 2007, impact of an increase of peritoneal dialysis and transplantation]. / Coût de la prise en charge de l'IRCT en France en 2007 et impact potentiel d'une augmentation du recours à la dialyse péritonéale et à la greffe.

INTRODUCTION: This study estimates the costs for the national health insurance in 2007 of the patients with end-stage renal disease (ESRD) according to therapies modalities. METHOD: Data for all patients covered by the general health insurance scheme (77% of the French population) from hospital discharge and outpatients reimbursement databases were linked. ESRD therapies were identified using an algorithm mainly based on discharge diagnosis and immunosuppressive drugs refunds. RESULTS: Extrapolated to all French population at the end of 2007, 60,900 patients had an ESRD therapy: 30,900 were treated on haemodialysis (HD) (51%), 2600 on peritonea dialysis (DP) (4%) and 27,300 had a kidney transplant (45%). Patients with dialysis therapies had more often complementary universal coverage for low earners. According to the French regions, patient treated with DP were between 0 to 26% and 19 to 57% for those with a transplant. The total refund cost for National Health Insurance was four billion euro of which 77% for HD. Annual mean costs per patient were 64 keuro for DP, 89 keuro for HD, 86 keuro for the year of transplantation and 20 keuro for the following years. A 25% increase of DP would allow a decrease of the annual cost of 155 millions euro and 900 transplantations more each year during 10 years a decrease of 2.5 billions euro. CONCLUSION: The increase of ESRD prevalence and its total cost require patients and professionals information and formation about the less expensive and more autonomous therapies and others alternatives facing the lack of kidney transplants from deceased donors.

Primary health care use and reasons for hospital admissions in dementia patients in france: database study for 2007.

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.

Combined secondary prevention after hospitalization for myocardial infarction in France: analysis from a large administrative database.

BACKGROUND: Both French and international guidelines recommend long-term use of betablockers, antiplatelet drugs, statins, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers (ACE-I/ARB) after a myocardial infarction (MI), but data on their combined use are scarce in France. AIMS: To evaluate the use of combined medication 6 months after hospital admission for MI and the factors that can significantly influence their use. METHODS: All hospital admissions for MI in France from January to June 2006 were selected from the national hospital discharge database. Data on medications used 6 months before and after hospitalization for patients covered by the general health insurance scheme (70% of French population) were collected from the reimbursement information system. A medication was considered to be used when there were more than three reimbursement applications over the 6 months following the index episode. Comorbidities were ascertained from the use of disease-specific medication reimbursements and registration in the national database of full coverage for 30 long-term disorders. RESULTS: Of the 11,671 patients included, 82% were reimbursed for betablockers, 92% for antiplatelets, 85% for statins, 80% for ACE-I/ARBs and 62% for all four classes. After adjustment, significant underuse was found for women, the elderly and those with several comorbidities. Treatment at a university hospital or high-volume centre, follow-up by a cardiologist and use of revascularization procedures were associated with improved rates of combination therapy use. CONCLUSION: Overall, use of recommended medications after MI in France is satisfactory, though not optimal. Specific recommendations focusing on subgroups such as older patients or those with comorbidities, as well as information directed towards non-specialized healthcare professionals, should help to improve appropriate use of these medications.