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.
Only limited data are available in France on the incidence and health expenditure of type 2 diabetes. The objective of this study, based on national health insurance administrative database, is to describe the expenditure reimbursed to patients newly treated for type 2 diabetes and the proportion of expenditure attributable to diabetes. The study is conducted over a 6-year period from 2008, the year of incidence of treated diabetes, to 2014. Type 2 diabetic patients aged 45 years and older are identified on the basis of their drug consumption. To estimate expenditure attributable to diabetes, a matched control group is selected among more than 13 million beneficiaries over 44 years old not taking antidiabetic treatment. The expenditure attributable to diabetes is estimated by two methods: simple comparison of reimbursed health expenditure between both groups, and a difference-in-differences method including control variables. The cohort of incident type 2 diabetic patients comprises 170,013 patients in 2008. Mean global reimbursed expenditure is €4700 per patient in 2008 and €5500 in 2015. Expenditure attributable to diabetes, estimated by direct comparison with controls, is €1500 in the first year. We, thus, observe a decrease in the following year due to decreased hospitalisations, and then expenditure increase by an average of 7% per year to reach €1900 in the eighth year after the initiation of treatment.
A better understanding of the economic burden of diabetes constitutes a major public health challenge in order to design new ways to curb diabetes health care expenditure. The aim of this study was to develop a new cost-of-illness method in order to assess the specific and nonspecific costs of diabetes from a public payer perspective. Using medical and administrative data from the major French national health insurance system covering about 59 million individuals in 2012, we identified people with diabetes and then estimated the economic burden of diabetes. Various methods were used: (a) global cost of patients with diabetes, (b) cost of treatment directly related to diabetes (i.e., ‘medicalized approach’), (c) incremental regression-based approach, (d) incremental matched-control approach, and (e) a novel combination of the ‘medicalized approach’ and the ‘incremental matched-control’ approach. We identified 3 million individuals with diabetes (5% of the population). The total expenditure of this population amounted to €19 billion, representing 15% of total expenditure reimbursed to the entire population. Of the total expenditure, €10 billion (52%) was considered to be attributable to diabetes care: €2.3 billion (23% of €10 billion) was directly attributable, and €7.7 billion was attributable to additional reimbursed expenditure indirectly related to diabetes (77%). Inpatient care represented the major part of the expenditure attributable to diabetes care (22%) together with drugs (20%) and medical auxiliaries (15%). Antidiabetic drugs represented an expenditure of about €1.1 billion, accounting for 49% of all diabetes-specific expenditure. This study shows the economic impact of the assumption concerning definition of costs on evaluation of the economic burden of diabetes. The proposed new cost-of-illness method provides specific insight for policy-makers to enhance diabetes management and assess the opportunity costs of diabetes complications’ management programs.Electronic supplementary materialThe online version of this article (doi:10.1007/s10198-017-0873-y) contains supplementary material, which is available to authorized users.
Objective: To describe, based on the French National Health Insurance (NHI) data, time trends in diabetes medications after treatment initiation in two consecutive cohorts of people newly treated for type 2 diabetes (T2D) in 2008 (1st cohort) and 2013 (2nd cohort). Materials and methods: People, aged 45 years and older, newly treated for T2D in 2008 and 2013 were identified in the French NHI Data System. Treatment changes were collected for each year of follow-up. Logistic regression was performed to identify factors associated with metformin discontinuation. Results: Respectively, 157 940 and 160 670 beneficiaries (mean age: 63 and 64 years; men proportion: 53 and 52%) of the French NHI general scheme initiated a diabetes treatment in 2008 and 2013. Metformin was the first monotherapy and increased in use: 67% of monotherapies in 2008 versus 77% in 2013. Monotherapy percentage decreased from the second year onwards in both cohorts. A marked increase in metformin-DPP4i combination therapy was observed (14% of dual therapies in 2008 vs. 46% in 2015 in the first cohort), replacing the metformin-sulfonylureas combination as a second-line treatment. Metformin discontinuation was statistically associated with female gender, social deprivation, age and anti-diabetic polypharmacy.Discontinuation of diabetes treatment was observed after 5 years for, respectively, 10% and 13% in the first and second cohorts. Conclusion: Descriptive analysis of two consecutive national cohorts showed an evolution in the prescription patterns of anti-diabetic treatments over a short period.With early treatment intensification, increasing rate of metformin monotherapy, and changes in dual-therapy strategy.
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