Tribouilloy C.,French Institute of Health and Medical Research |
Rusinaru D.,French Institute of Health and Medical Research |
Marechaux S.,Groupement Hospitalier Of Linstitut Catholique Of Lille |
Jeu A.,French Institute of Health and Medical Research |
And 9 more authors.
Circulation | Year: 2012
BACKGROUND: Benfluorex was withdrawn from European markets in June 2010 after reports of an association with heart valve lesions. The link between benfluorex and valve regurgitations was based on small observational studies and retrospective estimations. We therefore designed an echocardiography-based multicenter study to compare the frequency of left heart valve regurgitations in diabetic patients exposed to benfluorex for at least 3 months and in diabetic control subjects never exposed to the drug. METHODS AND RESULTS: This reader-blinded, controlled study conducted in 10 centers in France between February 2010 and September 2011 prospectively included 376 diabetic subjects previously exposed to benfluorex who were referred by primary care physicians for echocardiography and 376 diabetic control subjects. Through the use of propensity scores, 293 patients and 293 control subjects were matched for age, sex, body mass index, smoking, dyslipidemia, hypertension, and coronary artery disease. The main outcome measure was the frequency of mild or greater left heart valve regurgitations. In the matched sample, the frequency and relative risk (odds ratio) of mild or greater left heart valve regurgitations were significantly increased in benfluorex patients compared with control subjects: 31.0% versus 12.9% (odds ratio, 3.55; 95% confidence interval, 2.03-6.21) for aortic and/or mitral regurgitation, 19.8% versus 4.7% (odds ratio, 5.29; 95% confidence interval, 2.46-11.4) for aortic regurgitation, and 19.4% versus 9.6% (odds ratio, 2.38; 95% confidence interval, 1.27-4.45) for mitral regurgitation. CONCLUSIONS: Our results indicate that the use of benfluorex is associated with a significant increase in the frequency of left heart valve regurgitations in diabetic patients. The natural history of benfluorex-induced valve abnormalities needs further research. © 2012 American Heart Association, Inc.
PubMed | Caen University Hospital Center, Center Hospitalier Of Compiegne and Center Hospitalier Of Soissons
Type: Journal Article | Journal: Gynecologie, obstetrique & fertilite | Year: 2015
Every year, 20,000 mastectomy are realized. The most common complication of these surgical procedure is seroma, occurring in a range of 10 to 85% of the cases, which may be responsible for an increased morbidity by complications: disunity of surgical flap, infection, and delay in administrating adjuvant therapies.We focused on a post-mastectomy padding technique, aiming at decreasing incidence of postoperative seromas.We conducted a retrospective study of patients treated with mastectomy from January 2012 to March 2014 in Amiens University Hospital. Forty-two patients were included: 20 to the paddings group and 22 to the controls group.Drainage flow was significantly decreased at Day 1, Day 2, Day 3 and throughout hospitalization after padding (358.5mL versus 685mL; P=0.02). Hospital stays were significantly shortened by 2 days (5.3 versus 7.3 days; P<0.05) for patients receiving padding surgery.Our results show a benefit in the mastectomy padding flap. However, the retrospective character of our study and its strength character imply bias and data not available such as complications in type of wound dehiscence, pain, necrosis, the period from the establishment of the adjuvant therapies and aesthetic evaluation of technique. As such, we initiated a prospective randomized multicenter study late 2013, named PRELYMCA, which should be able to answer the pending questions.
PubMed | Hopital Hotel Dieu, Brest University Hospital Center, Hopital Sud, Joseph Fourier University and 16 more.
Type: Comparative Study | Journal: Arthritis & rheumatology (Hoboken, N.J.) | Year: 2016
Findings from the WEGENT trial and other short-term studies have suggested that azathioprine (AZA) or methotrexate (MTX) could effectively maintain remission of granulomatosis with polyangiitis (Wegeners) (GPA) or microscopic polyangiitis (MPA). This study was undertaken to examine whether differences in rates of relapse or adverse events would appear after discontinuation of these 2 maintenance regimens, when assessed over a longer followup period.Long-term outcomes in patients enrolled in the WEGENT trial were analyzed according to their randomized treatment group (AZA or MTX). Parameters at trial entry were evaluated as potential prognostic factors for death, relapse, or damage in multivariate models.Data from 10 years of followup were available for 112 (88.8%) of the 126 original trial participants. The median followup time was 11.9 years (95% confidence interval [95% CI] 11.3-12.5 years). In patients receiving AZA and those receiving MTX, the 10-year overall survival rates were 75.1% (95% CI 64.8-86.9%) and 79.9% (95% CI 70.3-90.8%) (P=0.56), respectively, and relapse-free survival rates were 26.3% (95% CI 17.3-40.1%) and 33.5% (95% CI 23.5-47.7%) (P=0.29), respectively. No between-treatment differences were observed with regard to rates of relapse, adverse events, damage, survival without severe side effects, and survival without relapse and severe side effects. In analyses limited to the 97 patients with GPA, no between-treatment differences in survival rates were observed. The 10-year relapse-free survival rate was lower in patients with GPA than in patients with MPA. However, in the multivariate analysis, anti-proteinase 3 antineutrophil cytoplasmic antibody (ANCA) positivity, and not GPA, was retained as being independently associated with the relapse rate.The results of this long-term analysis confirm that AZA and MTX are comparable treatment options for maintaining remission of GPA or MPA. Despite achieving good overall survival with these treatments, relapse rates, adverse events, and damage remain matters of concern and further studies are needed to reduce their frequency in these ANCA-associated vasculitides.
PubMed | Center Hospitalier Of Beauvais, Brest University Hospital Center, University of Bordeaux Segalen, French Institute of Health and Medical Research and 7 more.
Type: Journal Article | Journal: European heart journal cardiovascular Imaging | Year: 2015
The Food and Drug Administration (FDA) criteria for diagnosis of drug-induced valvular heart disease (DIVHD) are only based on the observation of aortic regurgitation mild and/or mitral regurgitation moderate. We sought to evaluate the diagnostic value of FDA criteria in a cohort of control patients and in a cohort of patients exposed to a drug (benfluorex) known to induce VHD.This prospective, multicentre study included 376 diabetic control patients not exposed to valvulopathic drugs and 1000 subjects previously exposed to benfluorex. Diagnosis of mitral or aortic DIVHD was based on a combined functional and morphological echocardiographic analysis of cardiac valves. Patients were classified according to the FDA criteria [mitral or aortic-FDA(+) and mitral or aortic-FDA(-)]. Among the 376 control patients, 2 were wrongly classified as mitral-FDA(+) and 17 as aortic-FDA(+) (0.53 and 4.5% of false positives, respectively). Of those exposed to benfluorex, 48 of 58 with a diagnosis of mitral DIVHD (83%) were classified as mitral-FDA(-), and 901 of the 910 patients (99%) without a diagnosis of the mitral DIVHD group were classified as mitral-FDA(-). All 40 patients with a diagnosis of aortic DIVHD were classified as aortic-FDA(+), and 105 of the 910 patients without a diagnosis of aortic DIVHD (12%) were classified aortic-FDA(+). Older age and lower BMI were independent predictors of disagreement between FDA criteria and the diagnosis of DIVHD in patients exposed to benfluorex (both P 0.001).FDA criteria solely based on the Doppler detection of cardiac valve regurgitation underestimate for the mitral valve and overestimate for the aortic valve the frequency of DIVHD. Therefore, the diagnosis of DIVHD must be based on a combined echocardiographic and Doppler morphological and functional analysis of cardiac valves.
Borel J.C.,AGIRadom |
Tamisier R.,French Institute of Health and Medical Research |
Dias-Domingos S.,French Institute of Health and Medical Research |
Sapene M.,Unite Sommeil et Vigilance |
And 10 more authors.
PLoS ONE | Year: 2013
Rationale:In obstructive sleep apnea patients (OSA), continuous positive airway pressure (CPAP) adherence is crucial to improve symptoms and cardiometabolic outcomes. The choice of mask may influence CPAP adherence but this issue has never been addressed properly.Objective:To evaluate the impact of nasal pillows, nasal and oronasal masks on CPAP adherence in a cohort of OSA.Methods:Newly CPAP treated OSA participating in "Observatoire Sommeil de la Fédération de Pneumologie", a French national prospective cohort, were included between March 2009 and December 2011. Anthropometric data, medical history, OSA severity, sleepiness, depressive status, treatment modalities (auto-CPAP versus fixed pressure, pressure level, interface type, use of humidifiers) and CPAP-related side effects were included in multivariate analysis to determine independent variables associated with CPAP adherence.Results:2311 OSA (age = 57(12) years, apnea+hypopnea index = 41(21)/h, 29% female) were included. Nasal masks, oronasal masks and nasal pillows were used by 62.4, 26.2 and 11.4% of the patients, respectively. In univariate analysis, oronasal masks and nasal pillows were associated with higher risk of CPAP non-adherence. CPAP non-adherence was also associated with younger age, female gender, mild OSA, gastroesophageal reflux, depression status, low effective pressure and CPAP-related side effects. In multivariate analysis, CPAP non-adherence was associated with the use of oronasal masks (OR = 2.0; 95%CI = 1.6; 2.5), depression, low effective pressure, and side effects.Conclusion:As oronasal masks negatively impact on CPAP adherence, a nasal mask should be preferred as the first option. Patients on oronasal masks should be carefully followed. © 2013 Borel et al.
PubMed | Grenoble University Hospital Center, Center Hospitalier Intercommunal Creteil, Center Hospitalier Of Compiegne, Unite Sommeil et Vigilance and Pneumologie
Type: Journal Article | Journal: Sleep medicine | Year: 2015
The aim of this study was to determine whether nocturia is an independent predictor for prevalent hypertension in obstructive sleep apnea (OSA).We analyzed data from a national prospective clinical cohort of OSA patients participating in the French national prospective registry. Anthropometric data, comorbidities, OSA severity, and number of voids/night were included in multivariate analyses to determine the independent variables associated with prevalent hypertension.A total of 22,674 OSA patients were included, of which 11,332 were hypertensive. The prevalence of hypertension among OSA patients was about 1.3 times higher in patients suffering from nocturia at 61.45% versus 46.52% in hypertensive and non-hypertensive OSA patients (p<0.001). There was a significant positive relationship between hypertension and the severity of nocturia beyond two voids/night: two voids/night versus none: odds ratio (OR)=1.270 (95% confidence interval (CI)=1.175; 1.372), three voids/night versus none: OR=1.422 (95% CI=1.293; 1.565), and four voids/night versus none: OR=1.575 (95% CI=1.394; 1.781). The strength of the association was enhanced in patients over 64 years of age.Nocturia is a strong independent predictor of prevalent hypertension in OSA. This association exhibited a dose-response relationship beyond two voids/night. The resolution of nocturia after continuous positive airway pressure (CPAP) treatment might be an important outcome to consider for the response of hypertension to CPAP.
Nahon S.,Center Hospitalier Intercommunal le Raincy Montfermeil |
Hagege H.,Center Hospitalier Intercommunal Of Creteil |
Latrive J.P.,Center Hospitalier Of Compiegne |
Rosa I.,Center Hospitalier Intercommunal Of Creteil |
And 9 more authors.
Endoscopy | Year: 2012
Background and study aims: The mortality rate from upper gastrointestinal bleeding (UGIB) remains high, at 5%-10%. The aim of the current study was to describe the epidemiological characteristics, prognostic factors, and actual practice in a cohort of patients with UGIB admitted to French general hospitals. Methods: From March 2005 to February 2006, a prospective multicenter study was conducted at 53 French hospitals. A total of 3298 patients admitted for UGIB were enrolled consecutively. Patient data were collected up to the date of discharge from hospital. Results: Data were available for 2130 men and 1073 women (mean age 63 ± 18 years), one-third of whom were taking drugs that would increase the risk of UGIB. The two main causes of bleeding were peptic ulcers (38%) and esophagogastric varices (EGV) or portal hypertensive gastropathy (24.5%). Mean Rockall score was 5.0 ± 2.3.Endoscopy was performed on 96% of patients (within 24 hours in 79%), and 66% of those with ulcers and 62.5% of the EGV patients underwent hemostatic therapy when indicated. Rebleeding occurred in 9.9% of the patients, and 8.3% died. Independent predictors of rebleeding were: need for transfusion (odds ratio [OR] 19.1; 95% confidence interval [95%CI] 10.1-35.9); hemoglobin<10g/dL (OR: 1.7; 95%CI 1.1-3.3); Rockall score (OR: 1.4 for each 1 point score increase; 95%CI 1.0-1.9), systolic blood pressure <100mmHg (OR: 1.9; 95%CI 1.4-2.5), and signs of recent bleeding (OR: 2.4; 95%CI 1.7-3.5). Independent predictors of mortality were: Rockall score (OR: 2.8; 95%CI 2.0-4.0), co-morbidities (OR: 3.6 for each additional co-morbidity; 95%CI 2.0-6.3), and systolic blood pressure <100mmHg (OR: 2.1; 95%CI 1.8-2.8). Rockall score, blood pressure and co-morbidities were taken as continuous variables meaning that the OR was 1.4 for every point increase, it was the same for blood pressure. Conclusion: UGIB still occurs mainly as a result of peptic ulcers and portal hypertension in France, and causes significant rates of mortality. There is scope for improvement via better prevention (better use of UGIB-facilitating drugs), endoscopic therapy, and management of co-morbidities. © Georg Thieme Verlag KG Stuttgart · New York.
PubMed | McGill University, University of Rouen, University of Quebec at Montréal, University of Montréal and 3 more.
Type: Journal Article | Journal: Canadian journal of psychiatry. Revue canadienne de psychiatrie | Year: 2015
To compare the coping strategies of adolescents with borderline personality disorder (BPD) to the coping strategies of adolescents without BPD, and to explore the association of coping with suicidal ideation and attempts among adolescents with BPD.Adolescent inpatients (n = 167) aged 13 to 17 years were admitted after suicide attempts and evaluated within 10 days, using the abbreviated version of the Diagnostic Interview for Borderlines-Revised, the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version supported by a team consensus best estimate method for the primary diagnosis, the Adolescent Coping Scale, and the Columbia-Suicide Severity Rating Scale.Firstly, compared with adolescents without BPD, adolescents with BPD relied more on nonproductive coping strategies, mostly avoidant strategies, and less on productive coping strategies. Secondly, coping appeared as a factor associated with suicidal ideation in adolescents with BPD. While while controlling for age, sex, and depression, multivariate analyses showed a significant positive association between the coping strategy to focusing on solving the problem and suicidal ideation.The use of avoidant strategies by adolescents with BPD could be viewed as attempts to increase emotional regulation. Problem-solving strategies in the immediate aftermath of a suicide attempt may prevent adolescents with BPD from overcoming a crisis and may increase suicidal ideation.
Meimoun P.,Compigne Hospital |
Meimoun P.,Center Hospitalier Of Compiegne |
Sayah S.,Compigne Hospital |
Luycx-Bore A.,Compigne Hospital |
And 6 more authors.
Journal of the American Society of Echocardiography | Year: 2011
Background: Assessment of the functional significance of left anterior descending coronary artery (LAD) stenosis of intermediate severity (50%-70% diameter stenosis) is challenging. The aim of this study was to compare the value of noninvasive coronary flow reserve (CFR) with that of invasive fractional flow reserve (FFR) in the setting of LAD stenosis of angiographic intermediate severity. Methods: Fifty stable consecutive patients (mean age, 63 ± 13 years; 11 women; mean left ventricular ejection fraction, 61 ± 10%) with angiographic proximal LAD stenoses of intermediate severity (55.5 ± 5% diameter stenosis on quantitative coronary angiography), no previous anterior myocardial infarction, and various vascular risk factors were prospectively studied. They underwent FFR assessment with intracoronary bolus adenosine (150 μg), and CFR assessment using intravenous adenosine (140 μg/kg/min over 2 min) in the distal part of the LAD on the same day in nearly all patients. CFR was defined as hyperemic peak diastolic LAD flow velocity divided by baseline flow velocity (normal value >2), and FFR was defined as distal pressure divided by mean aortic pressure during maximal hyperemia (normal value >0.8). Results: The mean FFR and CFR were 0.84 ± 0.07 and 2.7 ± 0.75, respectively, in the whole population. Concordant results between FFR and CFR were seen in 44 patients (88%) and discordant results in six patients (12%). There was a significant correlation between CFR and FFR (r = 0.59, P < .01). A better correlation was found between FFR and percentage LAD diameter stenosis, and lesion length (all P values < .05), than between CFR and the same anatomic markers of stenosis severity (all P values = NS). The sensitivity, specificity, and positive and negative predictive values of CFR >2 to detect a nonsignificant lesion defined by normal FFR were 95%, 69%, 90%, and 82%, respectively. Conclusions: In patients with LAD stenosis of intermediate severity, discordant results between noninvasive CFR and FFR were not unusual, and the anatomic determinants of the stenosis were better correlated to FFR than to CFR. However, CFR, which is a global evaluation of the coronary tree, has very high sensitivity to detect a nonsignificant lesion, despite the high prevalence of vascular risk factors. © 2010 by the American Society of Echocardiography.