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Murviel-lès-Montpellier, France

Daien V.,National Health Research Institute | Vergely L.,Hopital Arnaud de Villeneuve
European Journal of Ophthalmology | Year: 2012

Purpose. To evaluate the 12-month outcome and predictive factors of visual acuity (VA) changes following bevacizumab therapy for central retinal vein occlusion (CRVO). Methods. A total of 50 eyes from 50 patients with CRVO were consecutively included in this prospective study. Predictive factors were assessed by comparing baseline characteristics of patients classified into 3 groups: those showing a decrease in VA; those displaying a change in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score between 0 and 15; and those in whom an increase in VA ≥15 letters was achieved. Baseline variables considered in the analyses of predictive factors were demographic and clinical characteristics. Results. Mean baseline ETDRS letter score was 20±12 and mean macular thickness was 575.1±152.7 μm. Mean final ETDRS letter score improved significantly, reaching 27±20, p=0.04, while mean macular thickness decreased significantly to 391.1±229.6 μm, p<0.001. The predictive factors associated with an increase in VA ≥15 ETDRS letters were younger age (p=0.002), shorter duration of symptoms before treatment initiation (p=0.001), and a higher visual acuity pretreatment (p=0.004). The frequency of ischemic CRVO and low vision at baseline was higher among nonresponsive patients (p=0.005). Conclusions. Intravitreal bevacizumab seems to be an effective primary treatment option for macular edema due to CRVO. Its main drawback is that multiple injections are often necessary to maintain visual improvement. Early injections of bevacizumab in young patients in whom VA is relatively preserved leads to a significant improvement in VA. Ischaemic CRVO and poor baseline VA are associated with nonresponse to such therapy. © 2012 Wichtig Editore. Source


Maimoun L.,Service dHormonologie | Coste O.,Service dHormonologie | Jaussent A.,Hopital Arnaud de Villeneuve | Mariano-Goulart D.,Service de Medecine Nucleaire | And 2 more authors.
Clinical Endocrinology | Year: 2010

Objectives Although hypoleptinaemia has been reported in female peripubertal athletes, data are lacking on leptin and bone mass variations in puberty and the effects of leptin on bone mineralization during this period. This study therefore investigated the variations in leptin level and bone mineral density (BMD) in young elite female rhythmic gymnasts (FRG) according to pubertal stage. The effects of leptin, IGF-1 and sex hormones on bone mineral acquisition were also evaluated. Patients and measurements Plasma leptin levels were analysed in 43 elite FRG (mean age: 13·3 ± 1·8 years range: 10·6-17·2, body mass index: 17·52 ± 1·85 kg/m, training status: 17·9-23·8 h/week) according to their pubertal stage (Tanner I, n = 7; II, n = 10; III, n = 9; IV, n = 8; V, n = 9). IGF-1, IGFBP-3 and sex hormones were also evaluated. BMD was measured by dual-energy X-ray absorptiometry at various bone sites. Results Plasma leptin increased throughout pubertal growth and the values measured in Tanner stages IV-V were significantly higher than in stages I-II. Gains in BMD were measured throughout puberty at all bone sites, particularly between Tanner stages II and IV. In simple correlation analysis, BMD at all bone sites was positively correlated with plasma leptin, age, bone age, BMI, oestrogen, testosterone, IGF-1 and IGFBP-3. However, multivariate analysis using a linear regression model by block (including bone age, anthropometric data and biological parameters) was then performed to determine the factors independently associated with each BMD site, and only bone age, fat-free soft tissue and BMI remained independent predictors. Conclusion In FRG characterized by high training volume and low fat mass, plasma leptin levels increased throughout puberty and were partially related to body composition changes. Despite the simultaneous increases in plasma leptin and BMD during pubertal growth, it was not possible to differentiate the leptin impact on bone independently from anthropometric parameters. © 2010 Blackwell Publishing Ltd. Source


Brucker C.,Klinikum Nurnberg Nord | Hedon B.,Hopital Arnaud de Villeneuve | The H.S.,St Antonius Ziekenhuis | Hoschen K.,Grunenthal GmbH | And 2 more authors.
Contraception | Year: 2010

Objective: This study was conducted to assess the long-term efficacy and safety of a low-dose monophasic combined oral contraceptive (COC) containing 0.02 mg ethinylestradiol (EE) and 2 mg chlormadinone acetate (CMA) in a novel regimen administered daily for 24 days followed by a 4-day placebo interval. Study Design: In this multicenter, uncontrolled, Phase III trial, 1665 subjects took the COC 0.02 mg EE/2 mg CMA for up to 21 cycles. The overall Pearl Index was the primary end point; cycle control, safety, effect on acne and seborrhea, and changes in body weight and libido were secondary end points. Results: Contraceptive efficacy was analyzed for 1653 subjects completing 21,495 cycles. Six pregnancies occurred during trial duration with one attributable to method failure. The overall Pearl Index for the first year of use was 0.33 (95% confidence interval, 0.09-0.85). The mean number of bleeding/spotting days during six 90-day reference periods (RPs) decreased from 17.0 (RP 1) to 11.7 (RP 6), and the number of bleeding episodes per RP decreased from 3.8 (RP 1) to 2.7 (RP 6). Among subjects who presented with acne at the baseline visit, a decrease of papules/pustules and comedones was observed during the course of the trial. The most common "at least possibly related" adverse events were headache, breast discomfort and nausea. The tolerability and well-being was reported as being excellent or good in the majority of trial subjects (84.6% and 80.2%, respectively). Conclusions: The low-dose COC 0.02 mg EE/2 mg CMA administered daily for 24 days followed by a 4-day placebo interval provides high contraceptive efficacy combined with an adequate cycle control and safety profile, beneficial effects on acne, and is well tolerated. © 2010 Elsevier Inc. All rights reserved. Source


Konstan M.W.,Case Western Reserve University | Flume P.A.,Medical University of South Carolina | Kappler M.,Ludwig Maximilians University of Munich | Chiron R.,Hopital Arnaud de Villeneuve | And 6 more authors.
Journal of Cystic Fibrosis | Year: 2011

Background: A light-porous-particle, dry-powder formulation of tobramycin was developed, using PulmoSphere® technology, to improve airway delivery efficiency, substantially reduce delivery time, and improve patient convenience and satisfaction. We evaluated the safety, efficacy and convenience of tobramycin inhalation powder (TIP™) versus tobramycin inhalation solution (TIS, TOBI®) for treating Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients aged ≥ 6 years. Methods: In this open-label study, 553 patients were randomized 3:2 to TIP (total 112. mg tobramycin) via the Novartis T-326 Inhaler or TIS 300. mg/5. mL via PARI LC® PLUS nebulizer twice daily for three treatment cycles (28. days on-drug, 28. days off-drug). Safety, efficacy, and treatment satisfaction outcomes were evaluated. Results: TIP was generally well-tolerated; adverse events were similar in both groups. The rate of cough suspected to be study drug related was higher in TIP-treated patients (TIP: 25.3%; TIS: 4.3%), as was the overall discontinuation rate (TIP: 26.9%; TIS: 18.2%). Increases in FEV1% predicted from baseline to Day 28 of Cycle 3 were similar between groups; the mean reduction in sputum P. aeruginosa density (log10 CFU/g) on Day 28 of Cycle 3 was also comparable between groups. Administration time was significantly less for TIP (mean: 5.6 versus 19.7min, p<0.0001). Treatment satisfaction was significantly higher for TIP for effectiveness, convenience, and global satisfaction. Conclusions: TIP has a safety and efficacy profile comparable with TIS, and offers a far more convenient treatment option for pseudomonas lung infection in CF. © 2010 European Cystic Fibrosis Society. Source


Price D.,University of Aberdeen | Bosnic-Anticevich S.,University of Sydney | Briggs A.,University of Glasgow | Chrystyn H.,University of Huddersfield | And 3 more authors.
Respiratory Medicine | Year: 2013

Whilst the inhaled route is the first line administration method in the management of asthma, it is well documented that patients can have problems adopting the correct inhaler technique and thus receiving adequate medication. This applies equally to metered dose inhalers and dry powder inhalers and leads to poor disease control and increased healthcare costs. Reviews have highlighted these problems and the recent European Consensus Statement developed a call to action to seek solutions. This review takes forward the challenge of inhaler competence by highlighting the issues and suggesting potential solutions to these problems. The opportunity for technological innovation and educational interventions to reduce errors is highlighted, as well as the specific challenges faced by children. This review is intended as a policy document, as most issues faced by patients have not changed for half a century, and this situation should not be allowed to continue any longer. Future direction with respect to research, policy needs and practice, together with education requirements in inhaler technique are described. © 2012 Published by Elsevier Ltd. Source

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