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Valensi P.,Paris Nord University | de Pouvourville G.,ESSEC Inc | Benard N.,MSD France | Chanut-Vogel C.,MSD France | And 4 more authors.
Diabetes and Metabolism | Year: 2015

Aim: The study compared the duration of maintenance of treatment in patients with type 2 diabetes (T2D) using dual therapy with either metformin and sitagliptin (M-Sita) or metformin and a sulphonylurea (M-SU). Materials and methods: This observational study included adult patients with T2D who had responded inadequately to metformin monotherapy and therefore had started de-novo treatment with Met-Sita or Met-SU within the previous eight weeks. Patient follow-up and changes to treatment were performed according to their general practitioner's usual clinical practice. The primary outcome was time to change in treatment for whatever cause. HbA1c and symptomatic hypoglycaemia were also documented. Results: The median treatment duration for patients in the M-Sita group (43.2 months) was significantly longer (P<0.0001) than in the M-SU group (20.2 months). This difference persisted after adjusting for baseline differences and confounders. A similar reduction in HbA1c was noted in both arms (-0.6%), and the incidence of hypoglycaemia prior to treatment modification was lower with M-Sita (9.7%) than with M-SU (21.0%). Adverse events potentially related to treatment were reported in 2.8% (n=52) and 2.7% (n=20) of patients in the M-Sita and M-SU arms, respectively. Conclusion: Under everyday conditions of primary diabetes care, dual therapy with M-Sita can be maintained for longer than M-SU. In addition, while efficacy, as measured by changes in HbA1c, was similar between treatments, the incidence of hypoglycaemia was lower in patients taking M-Sita. © 2015 Elsevier Masson SAS.


Crijns H.J.G.M.,Maastricht University | Weijs B.,Maastricht University | Fairley A.-M.,Maastricht University | Lewalter T.,University of Bonn | And 12 more authors.
International Journal of Cardiology | Year: 2014

Aims Electrical and pharmacological cardioversion (ECV, PCV) are important treatment options for symptomatic patients with recent onset atrial fibrillation (AF). RHYTHM-AF is an international registry of present-day cardioversion providing information that is not currently available on country differences and acute and long-term arrhythmia outcomes of ECV and PCV. Methods and results 3940 patients were enrolled, of whom 75% underwent CV. All patients were followed for 2 months. There were large variations concerning mode of CV used, ECV being heterogeneous. A choice of PCV drug depended on the clinical patient profile. Sinus rhythm was restored in 89.7% of patients by ECV and in 69.1% after PCV. Among patients not undergoing CV during admission, 34% spontaneously converted to sinus rhythm within 24 h. ECV was most successful in patients pretreated with antiarrhythmic drugs (mostly amiodarone). PCV was enhanced by class Ic antiarrhythmic drugs; conversion rate on amiodarone was similar to that seen with rate control drugs. Female patients and those with paroxysmal and first detected AF as well as those without previous ECV responded well to PCV. The median duration of hospital stay was 16.2 and 24.0 h for ECV and PCV patients, respectively. There were very few CV-related complications regardless of mode of CV. Chronic maintenance of sinus rhythm was enhanced in patients on chronic antiarrhythmic drugs, beta-blockers or inhibitors of the renin-angiotensin system. Conclusions Mode of CV varied significantly, but both PCV and ECV were safe and effective. Class Ic drugs were most effective conversion drugs, but amiodarone is used most frequently despite providing merely rate control rather than shorten time to conversion. © 2014 Elsevier Ireland Ltd.


PubMed | Karolinska Institutet, University of Bonn, Institute For Herzinfarktforschung, Sharp Corporation and 9 more.
Type: Journal Article | Journal: International journal of cardiology | Year: 2014

Electrical and pharmacological cardioversion (ECV, PCV) are important treatment options for symptomatic patients with recent onset atrial fibrillation (AF). RHYTHM-AF is an international registry of present-day cardioversion providing information that is not currently available on country differences and acute and long-term arrhythmia outcomes of ECV and PCV.3940 patients were enrolled, of whom 75% underwent CV. All patients were followed for 2 months. There were large variations concerning mode of CV used, ECV being heterogeneous. A choice of PCV drug depended on the clinical patient profile. Sinus rhythm was restored in 89.7% of patients by ECV and in 69.1% after PCV. Among patients not undergoing CV during admission, 34% spontaneously converted to sinus rhythm within 24h. ECV was most successful in patients pretreated with antiarrhythmic drugs (mostly amiodarone). PCV was enhanced by class Ic antiarrhythmic drugs; conversion rate on amiodarone was similar to that seen with rate control drugs. Female patients and those with paroxysmal and first detected AF as well as those without previous ECV responded well to PCV. The median duration of hospital stay was 16.2 and 24.0 h for ECV and PCV patients, respectively. There were very few CV-related complications regardless of mode of CV. Chronic maintenance of sinus rhythm was enhanced in patients on chronic antiarrhythmic drugs, beta-blockers or inhibitors of the renin-angiotensin system.Mode of CV varied significantly, but both PCV and ECV were safe and effective. Class Ic drugs were most effective conversion drugs, but amiodarone is used most frequently despite providing merely rate control rather than shorten time to conversion.


Lip G.Y.H.,University of Birmingham | Gitt A.K.,Med Klinik B Und Institute F Herzinfarktforschung Ludwigshafen | Le Heuzey J.-Y.,University of Paris Descartes | Bash L.D.,Merck And Co. | And 5 more authors.
American Journal of Cardiology | Year: 2014

Antithrombotic therapy is central to the management of atrial fibrillation. This analysis from the RHYTHM-atrial fibrillation (RHYTHM-AF) registry explored the appropriateness of antithrombotic therapy in relation to stroke risk and atrial fibrillation duration in patients with atrial fibrillation. RHYTHM-AF, a prospective multinational registry, enrolled consecutive adult patients with atrial fibrillation considered for cardioversion. We compared the type of antithrombotic therapy administered at the time of cardioversion and at discharge with stroke risk ("high stroke risk" defined by CHA 2DS2-VASc >1) and duration of atrial fibrillation (≤48 vs >48 hours or unknown duration). Of 2,972 patients who were cardioverted (34.5% through pharmacologic cardioversion [PCV] and 65.5% through electrical cardioversion [ECV]), 65% were at high risk of stroke and 30% presented with atrial fibrillation of >48-hour or unknown duration. At the time of PCV and ECV, 36% (n = 242) and 84% (n = 1,075) of high-risk patients, respectively, were taking vitamin K antagonists or heparin. At discharge, these rates increased to 62% (n = 414) and 93% (n = 1,191), respectively. Of all low-stroke risk patients with short-duration atrial fibrillation undergoing PCV (n = 260) and ECV (n = 111), 7% (n = 17) and 30% (n = 33), respectively, were taking vitamin K antagonists or heparin at the time of cardioversion. At discharge, these rates increased to 19% (n = 50) and 40% (n = 44), respectively. In conclusion, ECV was frequently performed under appropriate antithrombotic therapy for most high-risk patients with atrial fibrillation, whereas PCV was frequently performed without appropriate antithrombotic therapy. To enhance pericardioversion stroke prevention, cardioversion algorithms should focus less on the type of conversion and more on stroke risk factors and atrial fibrillation duration. © 2014 Elsevier Inc. All rights reserved.


PubMed | Med Klinik B Und Institute F Herzinfarktforschung Ludwigshafen, Institute F Herzinfarktforschung Ludwigshafen, MSD France, University of Paris Descartes and 3 more.
Type: Comparative Study | Journal: The American journal of cardiology | Year: 2014

Antithrombotic therapy is central to the management of atrial fibrillation. This analysis from the RHYTHM-atrial fibrillation (RHYTHM-AF) registry explored the appropriateness of antithrombotic therapy in relation to stroke risk and atrial fibrillation duration in patients with atrial fibrillation. RHYTHM-AF, a prospective multinational registry, enrolled consecutive adult patients with atrial fibrillation considered for cardioversion. We compared the type of antithrombotic therapy administered at the time of cardioversion and at discharge with stroke risk (high stroke risk defined by CHA2DS2-VASc >1) and duration of atrial fibrillation (48 vs >48 hours or unknown duration). Of 2,972 patients who were cardioverted (34.5% through pharmacologic cardioversion [PCV] and 65.5% through electrical cardioversion [ECV]), 65% were at high risk of stroke and 30% presented with atrial fibrillation of >48-hour or unknown duration. At the time of PCV and ECV, 36% (n = 242) and 84% (n = 1,075) of high-risk patients, respectively, were taking vitamin K antagonists or heparin. At discharge, these rates increased to 62% (n = 414) and 93% (n = 1,191), respectively. Of all low-stroke risk patients with short-duration atrial fibrillation undergoing PCV (n = 260) and ECV (n = 111), 7% (n = 17) and 30% (n = 33), respectively, were taking vitamin K antagonists or heparin at the time of cardioversion. At discharge, these rates increased to 19% (n = 50) and 40% (n = 44), respectively. In conclusion, ECV was frequently performed under appropriate antithrombotic therapy for most high-risk patients with atrial fibrillation, whereas PCV was frequently performed without appropriate antithrombotic therapy. To enhance pericardioversion stroke prevention, cardioversion algorithms should focus less on the type of conversion and more on stroke risk factors and atrial fibrillation duration.


PubMed | Takeda France, Hoffmann-La Roche, MSD France, University Paris Est Creteil and 6 more.
Type: Journal Article | Journal: Therapie | Year: 2016

Medico-economic evaluations estimate, for a given health technology, the added cost and the clinical benefit compared to a reference strategy. The objective here is to analyze the criteria used to measure clinical benefit as the basis for market access and reimbursement decisions for drugs in oncology both in France and in Europe. Prolonged overall survival is the criterion of choice to demonstrate the benefit of an anticancer drug; a survival gain of 2 to 3 months or more would be considered as relevant for a new product versus the comparator. In the absence of survival benefit or mature data on survival, progression-free survival or symptom-free survival and the availability of alternative curative treatments, decrease in drug toxicity and quality of life improvement may be considered. Differences in clinical benefit assessment between regulatory agencies and payers are not specific to France. Case studies show that it is difficult to find a consistency in reimbursement and pricing decisions and to identify factors that may fully explain reimbursement decisions when survival benefit is not demonstrated.


Drexel H.,VIVIT Vorarlberg Institute for Vascular Investigation and Treatment | Drexel H.,University of Liechtenstein | Chazelle F.,MSD France | Fauer C.,MSD Austria | And 2 more authors.
Wiener Klinische Wochenschrift | Year: 2011

BACKGROUND: Statins reduce cardiovascular events by about one third; thus two out of three events occurring without any lipid lowering treatment still might happen under statin treatment. One reason may be that lipid targets are not met. The DYSlipidemia International Study (DYSIS) was performed to determine the prevalence of persistent dyslipidemia despite statin treatment in Austria. PATIENTS AND METHODS: Between April 2008 and February 2009, 910 outpatients on current statin treatment and aged ≥ 45 years were recruited by general practitioners, cardiologists, endocrinologists, and internists. A clinical examination was performed and lipid values were obtained under stable statin therapy. The ESC guidelines version 2007 served as criteria to judge the attainment of treatment targets for LDL cholesterol and to reach normal HDL cholesterol and triglyceride levels. In 765 patients a full lipid profile including fasting cholesterol, fasting triglycerides, HDL-cholesterol, and LDL-cholesterol could be obtained. RESULTS: Of our patients, 74.5% had at least one lipid parameter not at target. Specifically, 52.3% did not reach the LDL-cholesterol target as according to the ESC guidelines 2007 - and 56.4% as according to the Austrian lipid consensus 2010 -, 59.1% had above-target total cholesterol levels and 42.5% had elevated triglyceride levels. In 23% of the patients the HDL cholesterol was below levels associated with increased cardiovascular risk. In patients with only one single value beyond normal or targeted level, LDL cholesterol had a prevalence of 24.3%, HDL of 11.9% and triglycerides of 24.5%. In 8.4% of patients, all 3 parameters, LDL-cholesterol, HDL-cholesterol and triglycerides, were out of range. CONCLUSIONS: About three quarters of the Austrian patients under chronic statin therapy in routine clinical practice failed to meet lipid values as set by international and Austrian guidelines. There is an urgent need for more effective strategies to better control dyslipidemia in statin treated patients with the aim of further reducing cardiovascular events. © 2011 Springer-Verlag.


Demoly P.,Montpellier University Hospital Center | Demoly P.,University Pierre and Marie Curie | Serrano E.,Toulouse University Hospital Center | Didier A.,Toulouse University Hospital Center | And 2 more authors.
Revue Francaise d'Allergologie | Year: 2015

To analyze how French patients with allergic rhinitis (AR) and their physicians perceive this disease, the OPERA Observatory carried out a study based on the response to a "physician questionnaire" and a self-administered "patient questionnaire". The study included a sample of 372 randomly selected General Practitioners (GPs) and 1817 patients, with a median age 41. years, 53.2% women, and the mean duration of the AR 7.9. ±. 8.1. years. The aim of the study was to identify the patients' expectations and their level of satisfaction with the therapeutic care they received. According to the ARIA classification, 62.6% had persistent AR and 37.4% had intermittent AR. Moderate to severe AR was diagnosed in 85.7% of the patients. The most troublesome symptoms in order of frequency were rhinorrhea (94.8%), nasal obstruction (93.4%) and sneezing (92.9%). The most frequently prescribed treatments were oral H1 antihistamines (87.7%), followed by intranasal corticosteroids (56.7%) and to a lesser extent the nasal H1 anti-histamines (20.8%) and decongestants (20.2%). Oral H1anti-histamines and corticosteroids were more frequently prescribed in patients with moderate to severe AR, respectively, 88.6% and 14.2% compared to 82.2% and 5.8% in patients suffering from mild AR (P= 0.004 for the antihistamines and P<. 0.001 for the corticosteroids). The majority of patients reported being satisfied with their treatment, with rapid relief of symptoms (66.3%) and good tolerance to the drugs (84.2%). The physician/patient relationship was considered satisfactory, although some patients said they would like more information on the management of their symptoms, their treatments and the potential side effects. This survey showed that the AR associated with persistent moderate to severe symptoms was the most commonly AR observed in general practice. © 2015 Elsevier Masson SAS.


Bousquet P.J.,French Institute of Health and Medical Research | Devillier P.,CNRS Laboratory for Molecular and Pharmacological Mechanisms of Bronchial Obstruction | Tadmouri A.,ClinSearch | Mesbah K.,MSD France | And 3 more authors.
International Archives of Allergy and Immunology | Year: 2015

Background: Disease stratification, using phenotypic characterization performed either by hypothesis-or data-driven methods, was developed to improve clinical decisions. However, cluster analysis has not been used for allergic rhinitis. Objective: To define clusters in allergic rhinitis and to compare them with ARIA (Allergic Rhinitis and Its Impact on Asthma), a hypothesis-driven approach. Methods: A French observational prospective multicenter study (EVEIL: Echelle visuelle analogique dans la rhinite allergique) was carried out on 990 patients consulting general practitioners for allergic rhinitis and treated as per clinical practice. In this study, changes in symptom scores, visual analogue scales and quality of life were measured at baseline and after 14 days of treatment. A post hoc analysis was performed to identify clusters of patients with allergic rhinitis-using Ward's hierarchical method-and to define their clinical relevance at baseline and after 14 days of treatment. The cluster approach was compared to the ARIA approach. Results: Patients were clustered into 4 phenotypes which partly followed the ARIA classes. These phenotypes differed in their disease severity including symptoms and quality of life. Physicians in real-life practice prescribed medication regardless of the phenotype and severity, with the exception of patients with ocular symptoms. Prescribed treatments were comparable in hypothesis-and data-driven analyses. The prevalence of uncontrolled patients during treatment was similar in the 4 clusters, but was significantly different according to the ARIA classes. Conclusion: Cluster analysis using demographic and clinical parameters only does not appear to add relevant information for disease stratification in allergic rhinitis. © 2015 S. Karger AG, Basel.


Bousquet P.J.,Montpellier University | Demoly P.,Montpellier University Hospital Center | Devillier P.,CNRS Laboratory for Molecular and Pharmacological Mechanisms of Bronchial Obstruction | Mesbah K.,MSD France | And 2 more authors.
International Archives of Allergy and Immunology | Year: 2013

Background: Allergic rhinitis (AR) impairs quality of life (QoL), sleep and work. The Allergic Rhinitis and its Impact on Asthma (ARIA) classification is widely used, but the impact of the different symptoms on QoL is not clear. Objective: To describe characteristics of patients consulting in primary care for AR and to study the impact of AR symptoms and the ARIA classes on QoL. Methods: A multicenter prospective observational cross-sectional study assessed the visual analogue scale (VAS) in the management of AR in 990 patients consulting general practitioners for AR. Patients were classified according to the four classes of ARIA. VAS, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and total symptom score (TSS) for nasal and non-nasal symptoms were evaluated. VAS and TSS measures were compared with RQLQ. Results: Mild intermittent rhinitis was diagnosed in 20% of patients, mild persistent rhinitis in 17%, moderate/severe intermittent rhinitis in 15% and moderate/severe persistent rhinitis in 48%. The presence of treatments did not affect VAS levels. Both severity and duration of rhinitis had an impact on QoL and VAS levels. Ocular symptoms (OR: 2.78, 95% CI: 1.965-3.939) including eyelid edema (OR: 2.07, 95% CI: 1.274-3.360) and asthenia (OR: 2.73, 95% CI: 1.922-3.877) had more impact on RQLQ than nasal obstruction (OR: 1.61, 95% CI: 1.078-2.405) and nasal pruritus (OR 1.45, 95% CI: 1.028-2.042). Sneezing and rhinorrhea did not impact RQLQ. Conclusions: This study confirmed that ocular symptoms and, to a lesser degree, nasal obstruction and pruritus have a significant impact on QoL. Copyright © 2012 S. Karger AG, Basel.

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