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Gasa M.,Joseph Fourier University | Gasa M.,University of Barcelona | Tamisier R.,Joseph Fourier University | Tamisier R.,Grenoble University Hospital Center | And 10 more authors.
Journal of Sleep Research

Hypoxic brain damage might explain persistent sleepiness in some continuous positive airway pressure-compliant obstructive sleep apnea called residual excessive sleepiness. Although continuous positive airway pressure may not be fully efficient in treating this symptom, wake-promoting drug prescription in residual excessive sleepiness is no longer allowed by the European Medicines Agency. The aim of this study is to describe residual excessive sleepiness phenotypes in a large prospective sample of patients with obstructive sleep apnea. Residual excessive sleepiness was defined by an Epworth Sleepiness Scale score ≥ 11. Eligible patients from the French National Sleep Registry attending follow-up continuous positive airway pressure visits numbered 1047. Patients using continuous positive airway pressure < 3 h (n = 275), with residual apnea-hypopnea index > 15 h-1 (n = 31) or with major depression were excluded (n = 150). Residual excessive sleepiness prevalence in continuous positive airway pressure-treated obstructive sleep apnea was 13% (18% for those with an initial Epworth Sleepiness Scale score > 11), and significantly decreased with continuous positive airway pressure use (9% in ≥ 6 h night-1 continuous positive airway pressure users, P < 0.005). At the time of diagnosis, patients with residual excessive sleepiness had worse subjective appreciation of their disease (general health scale, Epworth Sleepiness Scale and fatigue score), and complained more frequently of continuous positive airway pressure side-effects. Residual excessive sleepiness prevalence was lower in severe obstructive sleep apnea than in moderate obstructive sleep apnea (11% when AHI > 30 h-1 versus 18% when AHI 15-30, P < 0.005). There was no relationship between residual excessive sleepiness and body mass index, cardiovascular co-morbidities or diabetes. Continuous positive airway pressure improved symptoms in the whole population, but to a lower extent in patients with residual excessive sleepiness (fatigue scale: -5.2 versus -2.7 in residual excessive sleepiness- and residual excessive sleepiness+ patients, respectively, P < 0.001). Residual excessive sleepiness prevalence decreased with continuous positive airway pressure compliance. Hypoxic insult is unlikely to explain residual excessive sleepiness as obstructive sleep apnea severity does not seem to be critical. Residual symptoms are not limited to sleepiness, suggesting a true 'continuous positive airway pressure-resistant syndrome', which may justify treatment by wake-promoting drugs. © 2013 European Sleep Research Society. Source

Marechaux S.,University of Lille Nord de France | Rusinaru D.,Center Hospitalier University Amiens | Jobic Y.,Brest University Hospital Center | Ederhy S.,University Pierre and Marie Curie | And 9 more authors.
European heart journal cardiovascular Imaging

AIMS: 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.METHODS AND RESULTS: 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).CONCLUSIONS: 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. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com. Source

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.

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. Source

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.

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. Source

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.

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. Source

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