[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
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).
Fibrate monotherapy is commonly prescribed in diabetic patients with high cardiovascular risk and is associated with poorer outcomes compared to statin therapy.
[Show abstract][Hide abstract] ABSTRACT: Severe sprue-like enteropathy associated with olmesartan has been reported, but there has been no demonstration of an increased risk by epidemiological studies.
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).
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.
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.
Olmesartan is associated with an increased risk of hospitalisation for intestinal malabsorption and coeliac disease.
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[Show abstract][Hide abstract] ABSTRACT: Introduction
Prostate-specific antigen (PSA) testing is high in France. The aim of this study was to estimate their frequency and those of biopsy and newly diagnosed cancer (PCa) according to the presence or absence of treated benign prostatic hyperplasia (BPH).
Patients and methods
This study concerned men 40 years and older covered by the main French national health insurance scheme (73 % of all men of this age). Data were collected from the national health insurance information system (SNIIRAM). This database comprehensively records all of the outpatient prescriptions and healthcare services reimbursed. This information are linked to data collected during hospitalisations.
The frequency of men without diagnosed PCa (10.9 millions) with at least one PSA test was very high in 2011 (men aged 40 years and older: 30 %, 70–74 years: 56 %, 85 years and older: 33 % and without HBP: 25 %, 41 % and 19 %). Men with treated BPH totalized 9 % of the study population, but 18 % of the men with at least one PSA test, 44 % of those with at least one prostate biopsy and 40 % of those with newly managed PCa. Over a 3-year period, excluding men with PCa, 88 % of men with BPH had at least one PSA test and 52 % had three or more PSA tests versus 52 % and 15 % for men without BPH. One year after PSA testing, men of 55–69 years with BPH more frequently underwent prostate biopsy than those without BPH (5.4 % vs 1.8 %) and presented PCa (1.9 % vs 0.9 %).
PSA testing frequencies in France are very high even after exclusion of men with BPH, who can be a group with more frequent managed PCa.
Level of evidence
Full-text · Article · Jul 2014 · Progrès en Urologie
[Show abstract][Hide abstract] ABSTRACT: National population-based management and outcome data for patients of all ages hospitalized for heart failure have rarely been reported.
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.
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).
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.
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.
Full-text · Article · Mar 2014 · Archives of cardiovascular diseases
[Show abstract][Hide abstract] ABSTRACT: The frequencies of treated cardiovascular disease (CVD) and their associated risk factors (CVRF) may vary according to socioeconomic and territorial characteristics.
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.
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.
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.
Full-text · Article · Mar 2014 · International journal of cardiology
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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]).
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.
Full-text · Article · Mar 2014 · Pharmacoepidemiology and Drug Safety
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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.
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.
No preview · Article · Feb 2014 · The American Journal of Gastroenterology
[Show abstract][Hide abstract] ABSTRACT: Objectif
Selon les recommandations les diabétiques en prévention primaire à haut risque cardiovasculaire devraient recevoir une statine. Malgré ce consensus, il est courant d’observer des fibrates prescrits à ces patients. Notre objectif est d’évaluer la fréquence et les conséquences cliniques de l’utilisation des fibrates en prévention primaire chez les diabétiques de type 2 à haut risque cardiovasculaire.
Patients et méthodes
Une étude de cohorte issue des bases de données médico-administratives de l’assurance maladie (SNIIRAM) et du PMSI a identifié du 01/07/08 au 31/12/09 les patients diabétiques ayant eu une instauration de fibrate ou de statine en monothérapie par un généraliste. Nous avons sélectionné des patients à haut risque cardiovasculaire (hypertendus traités), âgés de plus de 50 (hommes) ou 60 ans (femmes) et sans évènement cardiovasculaire enregistré en ALD ou dans les 30 mois d’hospitalisation précédents. Le suivi a été effectué jusqu’à 900 jours (infarctus du myocarde, AVC, amputation, décès).
Parmi les 31 652 sujets inclus, 4 058 (12,8 %) ont reçu un fibrate. 167 évènements sont survenus dans le groupe fibrate, contre 1 026 parmi les 27 594 patients traités par statine. Les taux annuels ajustés (sexe et âge) des évènements étaient de 2,42 % (fibrate) et 2,21 % (statine). Les courbes de survie suggéraient que l’hypothèse de proportionnalité requise pour le modèle de Cox n’était pas respectée pour la variable fibrate/statine. Le modèle multivarié a intégré tous les facteurs prédictifs en univarié, et un Hazard Ratio avant et après 540 jours de suivi (HR < 540 et HR > 540) montre que les fibrates sont associés à un risque augmenté au-delà de 540 jours : HR < 540 = 0,95 (IC 95 % : 0,78–1,16), et HR > 540 = 1,73 (1,28–2,32).
En France la prescription de fibrates chez des patients diabétiques à haut risque cardiovasculaire est fréquente et en faveur d’une perte de chance.
No preview · Article · Feb 2014 · Revue d Épidémiologie et de Santé Publique
[Show abstract][Hide abstract] ABSTRACT: To estimate the perforation and haemorrhage rate after colonoscopy in the French population in 2010 and to identify risk factors for these complications.
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.
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 1cm 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.
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.
No preview · Article · Nov 2013 · Gastroentérologie Clinique et Biologique
[Show abstract][Hide abstract] ABSTRACT: 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.
To estimate the incidence in France and describe the management and short-term outcome of patients hospitalized for HF for the first time.
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).
A total of 69,958 patients (mean age 78years; 48% men) were included. The incidence of first hospitalization for HF was 0.14% (≥55years, 0.5%; ≥90years, 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 30days after discharge was 4.4% (3.4% without readmission). Among 30-day survivors, all-cause and HF 30-day readmission rates were 18% (<70years, 22%; ≥90years, 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%.
Patients admitted for HF presented high rates of co-morbidity, readmission and death at 30days, and there remains room for improvement in their drug treatments; these findings indicate the need for improvement in return-home and therapeutic education programmes.
Full-text · Article · Oct 2013 · Archives of cardiovascular diseases
[Show abstract][Hide abstract] ABSTRACT: 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).
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.
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.
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.
This national study more clearly defines treatment frequencies and the populations and regions with the highest treatment frequencies.
Full-text · Article · May 2013 · Archives of cardiovascular diseases
[Show abstract][Hide abstract] ABSTRACT: Objectif
Étudier les hospitalisations pour amputation et plaie du pied (PP) chez les personnes diabétiques.
Patients et méthodes
Les séjours hospitaliers pour amputation et PP ont été isolés à partir du PMSI 2011 pour les assurés du régime général de l’assurance maladie (environ 90 % de la population en France). Du fait de nombreuses hospitalisations de longue durée dans cette population spécifique, l’existence d’un diabète a été recherchée par la présence de ≥ 3 remboursements d’antidiabétiques oraux/insuline au cours d’1 des 3 dernières années, ou l’existence d’une affection de longue durée diabète dans le SNIIRAM.
En 2011, on dénombre 9 591 séjours et 7 687 personnes hospitalisées pour amputation ; ainsi que 29 287 séjours et 17 346 personnes hospitalisées pour PP. Entre 2008 et 2011, l’effectif a augmenté mais le taux standardisé de personnes amputées a diminué (304/10 0000 vs 272/100 000) ; alors que les effectifs et les taux de personnes hospitalisées pour PP ont augmenté, chez les hommes et les femmes. L’âge moyen est de 71 ans chez les amputés et ceux hospitalisés pour PP. Il est stable chez les amputés mais s’est un peu élevé chez ceux hospitalisés pour PP. La proportion d’hommes est élevée (amputés : 72 %, PP : 60 %) et a un peu augmenté entre 2008 et 2011. Le niveau d’amputation s’est modifié, vers des amputations un peu plus souvent distales : 50 % au niveau des orteils (versus 46 % en 2008), 18 % du pied (versus 17 %), 18 % de la jambe (versus 19 %), et 14 % de la cuisse ou du sacrum (versus 17 %).
Alors que la prévalence du diabète augmente, on observe une diminution de la fréquence d’une complication grave du diabète, compensée par une plus grande fréquence des hospitalisations pour PP. Ces analyses seront complétées par l’étude de la prise en charge (par forfait podologique) des personnes ayant une hospitalisation pour PP.
No preview · Article · Mar 2013 · Diabetes & Metabolism