Bourg-la-Reine, France
Bourg-la-Reine, France

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Lafuma A.,Cemka eval | Aguade A.-S.,Cemka eval | Berdeaux G.,Alcon | Berdeaux G.,French National Conservatory of Arts and Crafts
Clinical Ophthalmology | Year: 2011

Background: This study compared the efficacy of the EX-PRESS® glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery. Methods: Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values ≤ 18 mmHg without medication. Results: The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation. Conclusion: This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma. © 2011 de Jong et al, publisher and licensee Dove Medical Press Ltd.


Dahan E.,University of Witwatersrand | Ben Simon G.J.,Goldschleger Eye Institute | Lafuma A.,Cemka Eval
Eye (Basingstoke) | Year: 2012

Purpose: To compare intraocular pressure (IOP) over time after standard trabeculectomy vsEx-PRESS implantation in patients with bilateral primary open-angle glaucoma (POAG). Design: Prospective, randomised study. Patients and methods: This study included adult patients with bilateral POAG necessitating surgery. Each patient underwent trabeculectomy in one eye and Ex-PRESS implantation under a scleral flap in the other eye according to randomised contralateral allocations. Efficacy was assessed by IOP values and success rates (IOP threshold and/or need for topical glaucoma medication) during 30 months. Statistical analysis included Generalised Estimate Equation and Cox Survival models, and paired t-tests. Results: Thirty eyes of 15 patients were studied for a mean of 23.6 months (SD, ±6.9). At the last follow-up visit, mean pre-operative IOP decreased from 31.1 (±14.2) to 16.2 (±1.5) mm Hg after trabeculectomy, and from 28.1 (±9.0) to 15.7 (±1.8) mm Hg after Ex-PRESS implantation (P=0.001). The mean number of anti-glaucoma medicines prescribed at the last follow-up decreased from 3.7 pre-operatively (both groups) to 0.9 after trabeculectomy vs0.3 after Ex-PRESS implantation (P=0.001). Complete success rates (5


Mariotti C.,Marche Polytechnic University | Dahan E.,University of Witwatersrand | Nicolai M.,Marche Polytechnic University | Levitz L.,University of Witwatersrand | Bouee S.,Cemka Eval
Eye (Basingstoke) | Year: 2014

PurposeTo report on the long-term outcomes and risk factors for failure with the EX-PRESS shunt implanted under a scleral flap.SettingsEye Department, University of Ancona, Ancona, Italy and the Oxford Eye Center, University of Witwatersrand, Johannesburg, South Africa.MethodsThe medical records of glaucoma patients who underwent consecutive EX-PRESS implantations under a scleral flap between 2000 and 2009 were reviewed. The operations were performed by two experienced surgeons using an identical surgical technique. The potential risk factors for failure that were analysed included age, sex, race, glaucoma type, previous antiglaucoma medications, previous glaucoma surgeries, diabetes, and smoking. Complete success was defined as postoperative intraocular pressure (IOP) 5 mm Hg>IOP<18 mm Hg without antiglaucoma medications. Qualified success was defined as 5 mm Hg>IOP<18 mm Hg with or without antiglaucoma medications.ResultsTwo hundred and forty-eight eyes of 211 consecutive patients were included. The mean IOP was reduced from 27.63±8.26 mm Hg preoperatively (n=248) to 13.95±2.70 mm Hg at 5 years (n=95). The mean follow-up was 3.46±1.76 years. Complete and qualified success rates decreased gradually from 83% and 85% at 1 year to 57% and 63% at 5 years follow-up, respectively. The risk factors for failure were diabetes, non-Caucasian race, and previous glaucoma surgery. Complete success rates of diabetic patients and non-Caucasian patients decreased from 63% and 75% at 1 year to 42% and 40% at 5 years follow-up, respectively.ConclusionsEX-PRESS success rates decrease over time but compare favourably with trabeculectomy literature data. The main identifiable risk factors for failure are diabetes, non-Caucasian race, and previous glaucoma surgery. © 2014 Macmillan Publishers Limited All rights reserved.


Ye X.,ETHICON,Inc. | Lafuma A.,Cemka Eval | Torreton E.,Cemka Eval | Arnaud A.,Ethicon
BMC Health Services Research | Year: 2013

Background: Limited information is available on the epidemiology and economics of bleeding during surgery in France. Method. The objective of this study was to examine the incidence, costs and length of stay (LOS) of bleeding-related complications during various surgical procedures.A retrospective DRG (diagnosis-related group) analysis was conducted using the French National database PMSI (Programme Médicalisé des Systèmes d'Informations). Patients undergoing surgery during 2008 were identified according to their DRG classifications and those with at least one episode of secondary haemostasis and blood transfusion (according to French procedure codes) were designated as 'with bleeding' (WB). The analysis focussed on DRGs where ≥10% of patients presenting with bleeding and compared them to patients who did not require blood transfusions (i.e. without bleeding: WoB).Hospital LOS and costs (age and gender adjusted) were compared between WB and WoB patients within each DRG. Hospitalisation periods exceeding the LOS average (derived from the PMSI database) were compared using multivariate logistic regression adjusted for patient characteristics. Results: Amongst all 88 different surgical DRGs recognised by the French database 24 (totalling 321,657 hospitalisations) yielded WB rates ≥10% (range 10.3-25.3%). The highest DRG rates were for transplantations, cardiac and major orthopaedic surgery, vascular and solid organ surgery. The average LOS for the WB population (adjusted for age, gender, number of procedures and secondary diagnoses) were 3.38 days (26.5%) longer than for the WoB population (p < 0.001). The average adjusted LOS costs for a WB patient were estimated at 12,087, and for a WoB patient 10,086 i.e. 19.9% higher than for WB patients (p < 0.001). The overall mean LOS was exceeded by 42.3% of WB patients compared to 37.0% of WoB patients (p < 0.001). Also, WB patients were more likely to exceed the average LOS than were WoB patients (Odds Ratio (OR) = 1.09, p < 0.001), after adjusting for patient characteristics. Conclusions: The present study for France demonstrates a significant increase of hospital LOS and associated costs following post-surgical bleeding, supporting the need for blood conservation strategies. © 2013 Ye et al.; licensee BioMed Central Ltd.


Charbonnel B.,Nantes University Hospital Center | Penfornis A.,Besancon University Hospital Center | Varroud-Vial M.,Service de diabetologie | Kusnik-Joinville O.,CEMKA EVAL | Detournay B.,CEMKA EVAL
Diabetes and Metabolism | Year: 2012

Aims: To describe insulin therapy in patients with diabetes, to determine treatment costs and to compare costs among treatment regimens. Methods: This observational study was performed by 734 French pharmacists. Adult patients filling an insulin prescription were invited to participate. Participants provided information on their diabetes history and management. Levels of intensification of insulin therapy were determined by the number of injections in type 1 diabetes mellitus (T1DM) patients, and by the different schemes used in type 2 (T2DM) patients, such as basal/intermediate-acting insulin only, and regimens using both basal and rapid-acting insulin. Costs were evaluated according to official medication costs, nurse visits and glucose monitoring kits. Results: A total of 361 patients with T1DM and 1902 with T2DM were enrolled in the survey. Patients with T1DM more frequently took 1-2. injections per day (46.3% of patients) and used single-dose basal insulin together with ≥ 1 dose of rapid insulin (43.8%). Patients with T2DM used multiple treatment regimens, with 58 different combinations documented. Most took basal/intermediate insulin only (42.5%) or combinations of basal/intermediate and rapid insulins (52.7%). Mean cost of insulin therapy was € 27.4/week for T1DM and € 45.4/week for T2DM. In T1DM, insulin was the biggest cost component and increased with the number of injections/day. In T2DM, nurse visits were the most important cost contributors irrespective of treatment regimen. Overall, the cost of insulin therapy increased with the complexity of the insulin schemes. Conclusion: Considerable heterogeneity is found in insulin treatment regimens used in everyday diabetes care. Payers should consider the full costs associated with the use of insulin rather than the cost of insulin alone. Treatment algorithms to harmonize insulin therapy should help to improve care, while encouraging patients to self-inject insulin should help to reduce costs. © 2011 Elsevier Masson SAS.


Economics was only recently considered as a dimension of health technology assessment in France. Yet there are always limits in resources that we collectively agree to devote to health. A comparative "economic" appraisal is therefore needed to guide health choices and contribute to price regulation. Methodologies are based on the determination of incremental cost-effectiveness ratios compared with a reference. The interpretation of these ratios is never isolated from the context of the decision. Health economic evaluation is not involved in healthcare rationing, but it contributes to the rationality of decisions in the interest of the overall population. © 2014 médecine/sciences - Inserm.


The objective of this study was to estimate the investment of pharmaceutical industry in hospital clinical research in France for 2010. The method consisted in combining data extracted from various sources about volumes of patients and unit costs per patient according to phase (I, II and II) and therapeutic domains. The numbers of French patients enrolled were estimated through an extraction of the National Institute of Health (NIH) database. Unit costs per patient were estimated from a sample of 54 clinical studies covering the most frequent combinations of phases and therapeutic domains and documented independently by 5 international companies. We identified 1â 178 clinical studies ongoing in 2010, having included a total of about 73â 000 French patients. Among these studies, 40.3% and 12.8% concerned Onco-Haematology and Rare Diseases respectively. The total annual investment from industry was estimated at 488 million euros, comprising 83.6 M€ of medical honoraria (17%), 73 M€ of hospital extra cost (15%), 99 M€ of drug provision (20%) and 232 M€ of internal cost for french affiliates (48%). © 2012 Société Française de Pharmacologie et de Thérapeutique.


Demarteau N.,Glaxosmithkline | Detournay B.,Glaxosmithkline | Tehard B.,Cemka Eval | El Hasnaoui A.,Glaxosmithkline | Standaert B.,Glaxosmithkline
International Journal of Public Health | Year: 2011

Objective: This study aimed at evaluating the cost-effectiveness of human papillomavirus virus (HPV) vaccination in France, using a generally applicable succinct cohort model. Methods: A lifetime Markov cohort model, adapted to the French setting, simulate the natural history of oncogenic HPV infection towards cervical cancer (CC). Additional modules account for the effects of screening and vaccination. The girls' cohort is vaccinated at age 12 and follows current screening. Costs and outcomes (discounted at 3 and 1.5%, respectively) were compared with a cohort receiving screening alone. Results: The model results agreed well with real-life data. Vaccination in addition to screening would substantially reduce the incidence of and mortality from CC, compared with screening alone, at an estimated cost-effectiveness of 9,706 per quality-adjusted-life-year. Sensitivity analysis showed that the discount rate and the parameters related to the disease history have the largest impact on the results. Conclusion: This succinct cohort model indicated that HPV vaccination would be a cost-effective policy option in France. It uses readily available data and should be generally applicable to the evaluation of HPV vaccination in a variety of countries and settings. © 2010 Swiss School of Public Health.


Bruckert E.,Hopital Pitie Salpetriere | Saheb S.,Haemobiotherapy Clinical Center | Bonte J.R.,Cemka Eval | Coudray-Omnes C.,Cemka Eval
Atherosclerosis Supplements | Year: 2014

Homozygous familial hypercholesterolaemia (HoFH) is a rare and severe hereditary lipid disorder that is typically associated with high serum levels of low-density lipoprotein cholesterol (LDL-C). Excessive exposure to high levels of LDL-C puts affected individuals at very high risk of premature onset coronary heart disease, and this considerably limits life expectancy. Although the clinical features and treatment of HoFH have been extensively researched, societal and socio-psychological impacts of the disease have not been reported to date. The current study was conducted to investigate the burden of disease and treatment from the patient's perspective by means of semi-structured interviews with 24 HoFH patients. The findings of the survey indicate that HoFH represents a considerable burden for patients, not only due to physical signs and limitations caused by the disease but also a number of psychosocial factors, treatment-related issues and impact on their education and employment situation. © 2014 Elsevier Ireland Ltd.


Detournay B.,Cemka Eval
Archives of Cardiovascular Diseases Supplements | Year: 2016

Vitamin K antagonists (VKAs) were until recently the main oral anticoagulants pharmaceutical class. Their large use can result in significant costs to the health system in France that cannot be summarized in the direct price of VKAs but might also take into account the costs associated with biological monitoring (INR) and the accidents due to over- (hemorrhage) or under-dosage (ischemic complications) associated with these treatments.On the basis of data from the various systems of health insurance in France in 2013, the expenses amounts reimbursed for VKA reached about €40 million for more than 12 million of boxes. About 20 million INR measures were prescribed the same year, with a cost of €156 million reimbursed that year. The number of INR seems in line with the recommendations (1.6 measures per month per patient).The annual cost of hospitalizations for major bleeding related to the VKA would be meanwhile at least €90 million for 40 000 hospitalizations per year. The cost of INR monitoring by health professionals is more difficult to estimate as well as the costs associated with complications resulting from VKA underdosage or minor complications of VKA over-dosage. On the basis of these estimates, the direct costs reimbursed by health insurance for VKA treatment probably exceed €300 million per year. The societal costs (including indirect costs) and the burden are still higher. © 2016 Elsevier Ltd.

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