The CARMEN-France registry of adult patients with immune thrombocytopenia and autoimmune hemolytic anemia in France.

The CARMEN-France registry is a prospective, multicenter registry in France including adult patients with a new diagnosis of immune thrombocytopenia or of autoimmune immune hemolytic anemia (2402 patients included in December 31, 2023). The recording of clinical, biological and treatment data allows detailed epidemiological and pharmacoepidemiological real-world studies. This review summarizes the CARMEN-France registry protocol, gives examples of studies conducted in the registry, and indicates future directions such as inclusion of patient reported outcomes, linkage with the French national health insurance database and linkage with other registries in Europe.

[Alpha-blockers or hexanic extract of Serenoa repens for 6 months: sub-analysis of the PERSAT study]. / Alpha-bloquants ou extrait hexanique de Serenoa repens pendant 6 mois : sous-analyse de l'étude PERSAT.

OBJECTIVE: The objective of this sub-analysis of the PERSAT study was to evaluate the efficacy of hexanic extract of S. Repens (HESr) and alpha-blockers (AB), at 6 months in patients with moderate to severe LUTS/BPH. METHODS: The PERSAT observational study was conducted in France by general practitioners on patients with BPH with an IPSS≥12 score. The primary endpoint was the percentage of responders (decrease in total IPSS score ≥ 3) at 6 months. Improvement in quality of life (IPSS-QoL) as well as patient satisfaction were also measured. RESULTS: Of the 759 patients in the study, 324 treated with HESr and 309 with AB were reviewed at 6 months, with no change in treatment during follow-up. Characteristics at inclusion were globally similar with a mean IPSS of 18.2±4.9. The response rates at 6 months (IPSS-total decrease ≥ 3) were 93.7% and 94.8% for patients treated with HESr and AB, with a mean decrease in IPSS score of 10.1±5.6 points, which reached 13.6 and 14.8 points respectively, in severe patients (IPSS>19), without major difference between groups. More than 95% of HESr or AB patients reported a significant overall improvement in their LUTS/BPH. The most frequently reported adverse events with AB were ejaculation disorders (4.9%) and hypotension (4.2%) and with HESr digestive disorders (1.5%). CONCLUSION: This sub-analysis of the PERSAT cohort reported the clinical efficacy of HESr and AB as a first-line treatment in the management of moderate or severe LUTS/BPH patients.

[Real life retrospective study of 98 eyes treated with intravitreal dexamethasone or anti-VEGF injections for macular edema due to diabetes or retinal vein occlusion]. / Étude rétrospective de vraie vie de patients traités par injections intra-vitréennes de dexaméthasone ou d'anti-VEGF pour œdèmes maculaires diabétiques ou secondaires à une occlusion veineuse rétinienne : à propos de 98 yeux.

PURPOSE: To evaluate long term outcomes of patients presenting with diabetic macular edema (DME) or edema secondary to a retinal vein occlusion (RVO). METHODS: This is a real world, retrospective, single-center study of 65 eyes of 47 patients treated for DME and 33 eyes of 33 patients with macular edema secondary to RVO between July 2012 and October 2018. The patients treated were treatment-naive and were followed for at least one year. We collected data such as visual acuity, central macular thickness, intravitreal injections (number/year, injection schedule, number of switches), number of visits and cases of vision loss. RESULTS: DME: the mean age at inclusion was 65.9years with 60.4% women, and the mean follow-up was 28.5months. The mean gain in visual acuity after 1year of follow-up was 6.4 ETDRS letters for patients treated with anti-VEGF and 2.6 letters for patients treated with dexamethasone. The average number of intravitreal injections of anti-VEGF was 5.6/year, compared to 2.9/year for dexamethasone. Fourteen patients initially treated with anti-VEGF were switched to dexamethasone. RVO: the mean age at inclusion was 68.8years with 54.5% women and a mean follow-up of 31.1months. The mean gain in visual acuity after 1year of follow-up was 26.7 ETDRS letters for patients treated with anti-VEGF and 7.0 letters for patients treated with dexamethasone. The average number of intravitreal injections of anti-VEGF was 5.8/year, compared to 2.4/year for dexamethasone. Five patients initially treated with anti-VEGF were switched to dexamethasone in the first year of follow-up. CONCLUSION: In this real-life retrospective study, we found good anatomical and functional results similar to those reported in other studies, remaining stable over time, for patients with DME or macular edema secondary to RVO.

[Alpha-blockers or phytotherapy as first-line treatment of LUTS/BPH in general medicine: The PERSAT non-interventional study]. / Alpha-bloquants ou phytothérapie en traitement de première intention des SBAU/HBP en médecine générale : l'étude non interventionnelle PERSAT.

PURPOSE: The objective of the PERSAT study was to evaluate first-line treatment of BPH-associated LUTS in real-life conditions. METHODS: This prospective observational study was conducted in France by general practitioners (GP) on patients with moderate to severe LUTS (IPSS ≥12). GPs freely decided to prescribe either an alpha-blocker (AB) or phytotherapeutic treatment (PT). The main criterion was the percentage of responding patients (decrease in total IPSS score ≥3) at 6 months. RESULTS: Of the 849 patients included, 759 were analysed (381 treated with AB and 378 with PT); 718 were followed up at 6 months, 90% of which had no treatment modification. Their inclusion characteristics were similar between the AB and PT groups (mean IPSS: 18.6±4.5 and 17.8±4.1, respectively). Treatment response rates at 6 months were 94.2% [91.2%; 96.4%] in AB and 92.5% [89.2%; 95.1%] in PT. The IPSS decreased by 10.0±5.6 points, with no difference between groups. The proportion of patients bothered by their LUTS (IPSS-QoL ≥4) evolved from 88.5% to 6.5% at 6 months. The improvement of LUTS was perceived by more than 94% of patients (PGI-I) and doctors (CGI-I), 93% of patients were satisfied with the treatment at 6 months, regardless of the treatment initiated. The most reported adverse reactions were ejaculation disorder (3.9% for AB and 0.9% for PT). CONCLUSION: PERSAT confirms in current practice the effectiveness of AB and PT treatments, recommended as first-line treatment in LUTS/BPH. LEVEL OF PROOF: 3.

Efficacy and follow-up of anti-VEGF injections in diabetic macular edema in real-life practice at the Dijon university medical centre through the Save Sight Registries.

PURPOSE: To evaluate the efficacy of intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections (IVT) in diabetic macular edema (DME) in real-life practice using the Save Sight Registries (SSR). MATERIAL AND METHODS: We conducted an observational, single-centre, retrospective study in the department of ophthalmology of the Dijon University Hospital. We included treatment-naive patients who presented with DME between January 2016 and December 2017. Demographic and clinical data, follow-up visits, and treatments administered were entered into the SSR, an international online ophthalmic registry. Primary endpoints were the change in best-corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline to 12 and 24 months. RESULTS: Fifty-eight eyes of 43 patients with a mean [standard deviation (SD)] age of 67.1 [9.5] years were included. Forty-one eyes completed 12 months of follow-up, and 17 eyes completed 24 months of follow up. Median [SD] baseline BCVA was 56.1 [22.9] ETDRS letters and the median [95% confidence interval (95% CI)] baseline CST was 447.9 [161.0] micrometers (µm). Median [95% CI] improvement in BCVA from baseline to months 12 and 24 were respectively, +5.6 [+0.5; +10.7] ETDRS letters and +7.7 [-2.8; +18.2] ETDRS letters. The median [95% CI] decrease in CST from baseline to months 12 and 24 were respectively, -110.9 [-154.5; -67.3] µm and -125.5 [-198.0; -53.0] µm. CONCLUSION: Our clinical practice can be evaluated easily with the SSR system. In real life, anti-VEGF IVT are an effective treatment for DME, which result in improved BCVA and decreased CST.

[Dexamethasone intravitreal implant (Ozurdex) in patients with diabetic macular edema: Real life safety and efficacy]. / Implant de dexaméthasone (Ozurdex) dans l'œdème maculaire diabétique : efficacité, et sécurité d'utilisation en vraie vie.

PURPOSE: The goal of this study was to investigate the safety and efficacy of the intravitreal dexamethasone implant (DI) for patients with diabetic macular edema (DME) in real life. METHODS: We conducted a monocentric retrospective analysis of the change in visual acuity and central macular thickness (CMT) after intravitreal injection of the DI at peak efficacy (2 months after injection) as well as the timing of reinjections and complications in patients with a loss of vision due to DME. RESULTS: Forty eyes of 33 patients were included, with a mean follow-up of 12.6 months. Thirty percent of the eyes experienced an increase in best corrected visual acuity (BCVA)>15 letters at peak efficacy (P<0.05) after each ID injection. Treatment-naive patients had a sustained response after Ozurdex injection, with better visual acuity at 3 months (P=0.02) and 4 months (P=0.04) than non-naïve patients and better visual acuity at 6 months despite identical baseline visual acuity (P<0.05). Anatomical efficacy was good, with approximately 60% of patients with CMT<300 microns at peak efficacy after each injection of ID. Thirty percent of eyes demonstrated ocular hypertension (OHT)>25mmHg at peak efficacy, and 12.5% of eyes required cataract surgery during follow-up. CONCLUSION: The DI has good functional and anatomic efficacy in these patients, with a good safety profile. Treatment-naïve patients with more recent DME had a more sustained increase in visual acuity after the injections and better visual recovery at 6 months. This encourages us to initiate DI therapy early if there is no response to anti-vascular endothelial growth factor (anti-VEGF) treatment.

[Early efficacy of dexamethasone implant (OZURDEX®) in diabetic macular edema: Real life study]. / Efficacité précoce de l'implant de dexaméthasone (OZURDEX®) évaluée en vraie vie dans le traitement de l'œdème maculaire diabétique.

PURPOSE: To assess early efficacy of dexamethasone intravitreal implant 0.7mg (OZURDEX®) at the time of peak efficacy (2 months after injection) in patients with decreased visual acuity secondary to diabetic macular edema (DME). MATERIALS AND METHODS: Retrospective monocentric study. Inclusion criteria were best-corrected visual acuity (BCVA)≤70 letters (20/40) due to DME and central retinal thickness (CRT)≥300 microns (Cirrus 2, Carl Zeiss Meditec, Inc, Dublin). Enrolled patients could be treatment naive or not (after failure of laser photocoagulation and/or anti-VEGF therapy). Follow-up was at least 6 months. Our primary endpoint was BCVA gain at M2 after injection. Secondary endpoints were best-corrected visual acuity at 2 and 4 months, central retinal thickness at 2 and 4 months, mean interval between 2 injections, and adverse events. RESULT: Nineteen eyes of 19 patients were included in this study. The mean age was 67.45 years, sex ratio was 2.17 men/women, and the patients were all type 2 diabetics. Three of 19 patients were treatment naive for anti-VEGF intravitreal injection, and 52.3% were pseudophakic (10/19 patients). The mean gain of BCVA at M2 was +7.7 letters. The mean BCVA was 51.1 ETDRS letters at baseline and 58.8 at M2. Mean CRT was 568.9µm at baseline and 291.2µm at M2. Treatment with dexamethasone implant was mainly a second-line treatment after failure of other treatments (macular laser photocoagulation and/or intravitreal injection of anti-VEGF). Three patients were naive of anti-VEGF treatment. Intraocular pressure≥25mmHg was found in 2 patients, and controlled medically. No glaucoma surgery was performed. CONCLUSION: The dexamethasone implant (OZURDEX®) allows an anatomical and functional improvement in patients suffering from vision loss due to DME. In this series, the implant was well tolerated.

[Management algorithm of age-related macular degeneration with aflibercept: Real-life application]. / Algorithme de prise en charge de la dégénérescence maculaire liée à l'âge avec aflibercept : application en vraie vie.

Aflibercept is indicated in France for wet age-related macular degeneration (wAMD) since November 2013. Its official dosage consists in administrating one monthly intravitreal injection (IVT) during three months followed by one control visit and one IVT every two months the first year. In 2015, a group of French ophthalmologists, specialized in wAMD management, established a therapeutic algorithm to optimize naive patient management with aflibercept in order to obtain visual acuity gain. It indicates that official administration scheme is adapted for 80% of patients and that an adaptation of therapeutic scheme is needed for others. These experts recommended mostly the use of personalized proactive administration scheme. Since, aflibercept clinical use has significantly grown with interventional observational studies which results are now available. Use of aflibercept and of personalized proactive administration schemes allow in real-life obtaining important visual acuity gain, which is consistent with the established algorithm.

One-year incidence and clinical impact of bleeding events in patients treated with prasugrel or clopidogrel after ST-segment elevation myocardial infarction.

BACKGROUND: Little information is available on the long-term incidence of bleeding events after ST-segment elevation myocardial infarction (STEMI) with the current antithrombotic strategy. AIMS: To evaluate the effect of bleedings for up to 12months on clinical events and therapeutic compliance in unselected STEMI patients treated with prasugrel or clopidogrel. METHODS: Patients were treated with clopidogrel or prasugrel according to guidelines. The primary endpoint was first occurrence of a bleeding event from hospital discharge to 12months, assessed by the Bleeding Academic Research Consortium (BARC) classification using a dedicated questionnaire. Topography of bleedings, causes of premature cessation and ischaemic events were compared between clopidogrel- and prasugrel-treated patients. RESULTS: A total of 390 patients were enrolled (211 in the prasugrel group, 179 in the clopidogrel group). Elderly, female and low-body weight patients were more likely to receive clopidogrel. At 12months, the incidence of major bleedings (BARC 3) was lower with prasugrel (1% vs 6%; P=0.02), mainly due to fewer transfusions. Elderly age was a risk factor for severe bleeding. Premature treatment cessation was related to ischaemic complications (P=0.03), and occurred more frequently with prasugrel (P=0.001). One-year mortality was very low (1.9 per 100 person-years, 95% confidence interval 0.9-4.0), and was higher in the clopidogrel group (P=0.03). CONCLUSIONS: In this unselected STEMI population, the rate of major bleedings with prasugrel at 12months was low, but nuisance bleedings were frequent and led to more premature cessations than with clopidogrel. Prevention of bleeding complications, even minor, is necessary to prevent disruption of antithrombotic medication.

Safety of prasugrel in real-world patients with ST-segment elevation myocardial infarction: 1-year results from a prospective observational study (Bleeding and Myocardial Infarction Study).

BACKGROUND: Antiplatelet therapies, including prasugrel, are a cornerstone in the treatment of ST-segment elevation myocardial infarction (STEMI), but are associated with a bleeding risk. This risk has been evaluated in randomized trials, but few data on real-world patients are available. AIM: To evaluate prasugrel safety in real-world patients with STEMI. METHODS: Consecutive patients with STEMI were recruited over 1 year. Follow-up was done at 3 months and 1 year to evaluate prasugrel safety from hospital discharge to the STEMI anniversary date. The primary outcome was occurrence of any major bleeding according to the Bleeding Academic Research Consortium (BARC) 3 or 5 definitions, or minor bleeding according to the BARC 2 definition. RESULTS: Overall, 1083 patients were recruited. Compared to patients treated with aspirin+clopidogrel, patients treated with aspirin+prasugrel had fewer BARC 3 or 5 bleedings (two [0.4%] patients vs. nine [1.8%] patients; P=0.04), but more BARC 2 bleedings (45 [9.3%] patients vs. 20 [4.0%] patients; P<0.001). The baseline characteristics of prasugrel- and clopidogrel-treated patients differed because the former were carefully selected (younger, higher body mass index, less frequent history of stroke). In the overall population, rates of in-hospital and out-of-hospital major bleeding were 2.6% (n=28) and 1.3% (n=13), respectively. CONCLUSION: The rate of major bleeding, particularly out-of-hospital bleeding, in patients treated with prasugrel is low within 1 year after a STEMI. Accurate selection of patient candidates for prasugrel is likely to have reduced the risk of bleeding.

[Which place for direct oral anticoagulants in routine hospital medical practice?]. / Quelle place pour les anticoagulants oraux directs en pratique hospitalière quotidienne?

PURPOSE: More than one million patients received an oral anticoagulant treatment in France. This medication is the first aetiology of iatrogenic events. Recently, direct oral anticoagulant (DOA) provided efficacy and safety in the treatment of atrial fibrillation and venous thromboembolic events. Given the growing increase in the prescription of these molecules, with many advantages but also disadvantages, it seemed interesting to assess in routine hospital medical practice, the proportion of patients for which the initiation of AOD could be safe. METHODS: This prospective, observational study was conducted in the department of internal medicine from October 2012 and September 2013. All inpatients receiving oral anticoagulant treatment have been included. Demographic data, indication of anticoagulant treatment, contraindications and interactions have been reported. From these information, we have established the percentage of patients who could benefit from DOA safely and securely. RESULTS: Two hundred and ninety inpatients were included with a mean age of 76.3±15.2 years old. Atrial fibrillation and thromboembolic venous disease were the most prevalent indications of anticoagulant treatments (67.2% and 22.4% of cases respectively). Among all patients, 260 had an indication of DOA (89.7%), authorized by the French National health agency. Eighty percent had both indication and no contraindication for DOA. However, only 53.1% of patients neither had drug-drug interaction. Main contraindications were severe renal failure (clearance<30mL/min) in 10.7% of cases, and recent history of gastric ulcer in 15.3% of cases. The most frequent interactions with DOA were antiplatelet agent (14.5%) and amiodarone (11.6%). Almost two thirds of inpatients (65.1%) had at least one drug-drug interaction with VKA. CONCLUSION: These results, coming from "real life", provide that only 53.1% of inpatients under anticoagulants could receive DOA safely. Caution is warranted, and VKA still have a preponderant role among anticoagulant drugs.