Introduction
A second-generation basal insulin analogue insulin glargine 300 U/mL (Gla-300) has been marketed in France since June 2016. This real-world study was designed to assess persistence with ...Gla-300 and the prevalence of related hypoglycemia requiring hospitalization as compared to first-generation basal insulins, in patients with type 2 diabetes mellitus (T2DM).
Methods
A retrospective study was conducted using data in the large French comprehensive national healthcare system claims databases. Patients with T2DM newly treated with insulin in 2016 and 2017 (2-year period) were included. Three basal insulins Gla-300, glargine 100 U/mL (Gla-100; both branded and biosimilar) and insulin detemir (IDet) were compared for (1) persistence until treatment discontinuation using adjusted Cox models and (2) hypoglycemia requiring hospitalization over the period of insulin exposure.
Results
During the 2-year study period, in France, 181,263 patients initiated basal insulin therapy (in a basal scheme or a more complex insulin scheme), of whom 74% initiated Gla-100, 14.2% initiated IDet and 11.8% initiated Gla-300. Patient characteristics varied according to the insulin regimen in terms of age, gender, social coverage, insulin scheme, and Charlson Comorbidity Index. Overall, 72% of patients were still treated with any basal insulin after 1 year (75% in basal scheme). In all insulin treatment regimens, patients were less likely to discontinue Gla-300 as compared to Gla-100 adjusted odds ratio (OR) 0.39, 95% confidence interval (CI) 0.37–0.41, with similar results when only the basal scheme was considered (adjusted OR 0.38, 95% CI 0.35–0.40). Persistence with IDet was similar to that with Gla-100. Patients treated with Gla-100 had higher crude hospitalization rates for hypoglycemia than those receiving Gla-300 (1.4 for 100 patients-years; OR 0.67, 95% CI 0.55–0.81); however, this difference was not statistically significant after adjustment for patient characteristics. Emergency Room (ER) visits were less frequent in patients treated with Gla-300 versus Gla-100 with or without adjustment for patient characteristics (
p
< 0.0001).
Conclusion
Real-world persistence for basal insulin therapy in patients with T2DM was significantly better in those on Gla-300 compared with those on Gla-100 and IDet. A trend to a lower frequency of hospitalization for hypoglycemia and ER visits, whatever the cause, was also observed in patients on Gla-300.
Objectif Étude des caractéristiques pronostiques des TNE pancréatiques, non syndromiques, enregistrées dans la base de données RENATEN Limousin (analyse de survie). Matériels et méthodes Étude ...descriptive multicentrique (CHU de Limoges, clinique Chenieux Limoges, CH Brive, Tulle et Gueret), rétrospective, référés au réseau RENATEN Limousin (2011 à 2015). 63 cas ont été recensés, les formes génétiques ont été exclues (10 cas). Résultats L’âge moyen au diagnostic est de 55,8 ± 15,6 ans avec prédominance féminine. 25 patients ont des métastases hépatiques, deux tiers synchrones au diagnostic. Les analyses anatomopathologiques complètes étaient disponibles pour 34 patients. Selon le Ki67 : 20 patients étaient grade 1, 13 grade 2, 1 grade 3. La survie globale est d’environ 70 % à 10 ans. La survie des patients non métastatiques est significativement plus favorable que les métastatiques ( p = 0,03), comme pour les patients ayant un Ki67 ≤ 2 versus > 2 ( p = 0,007). Le Ki67 était plus élevé chez les patients métastatiques ( p = 0,035). La taille de la tumeur était plus grande dans le groupe métastase ( p < 0,05). Discussion Dans la littérature, la taille fait partie des facteurs de mauvais pronostic 1 . Incontestablement, le caractère métastatique et le Ki67 > 2 représentent des éléments péjoratifs. Sur les 7 décès enregistrés, 6 présentaient ces 2 caractères.
Little is known about the epidemiology and patterns of care of intrahepatic cholangiocarcinoma (iCCA) in daily clinical practice. The aims of this study were to estimate the number of declared cases ...during the study period 2014–2015 in France from a hospitalization database and to describe the healthcare trajectories of these patients.
A retrospective analysis was carried out using the French nationwide prospective hospitalization database. All pts with a new diagnosis of "carcinoma of the intrahepatic bile duct" who had a first hospital stay in the Medicine, Surgery and Obstetrics departments (MSO) between 2014 and 2015 with a 2-year follow-up were included. Data related to the first identified stay (S1) in the MSO and on all subsequent stays in the MSO, aftercare and rehabilitation or home hospitalization were analysed.
A total of 3650 new iCCA cases were identified. At S1 (admission via emergency room (ER) in 28%), the median age of the patients was 73 years, 57% were male and 35% had metastases. Jaundice/anaemia/ascites/cholangitis were reported in 17%/16%/12%/7% of patients, respectively. The care of patients at S1 was mainly provided in general hospitals (CHG, 60%). A total of 896 (24%) patients died during S1. They were more frequently hospitalized via the ER (48% vs 23%), metastatic (52% vs 35%) and symptomatic. Subsequent stays were identified for 2507 (69%) patients. Three healthcare pathways were defined: surgery (n = 519; 14%), chemotherapy (CT) without surgery (n = 812; 22%) and best supportive care (BSC) (n = 2319; 63%). CT, surgery and BSC were most frequently performed in the cancer centres, university hospitals and CHG, respectively.
This medico administrative study reveals a higher number of iCCA cases than that previously reported by registries and highlights the severity of this disease.
This study was sponsored by Incyte Biosciences International Sàrl., Geneva, Switzerland. INCYTE validated the design of the study, the analysis, the interpretation of data and the writing of the manuscript which was first written by the 2 experts and CEMKA.
Background:
Medial arterial calcification (MAC) is a vascular disease distinct from atherosclerosis. Recently, several studies have demonstrated that MAC is an important marker of cardiovascular ...events. We aim to assess the presence of MAC during ultrasound screening of lower-limb vasculature and its association with both cardiovascular (CV) and lower-limb events in patients with type-2 diabetes.
Methods:
A retrospective cohort study was conducted on 1119 patients with type-2 diabetes free from CV disease. A CV work-up, including vascular ultrasound, was performed for each patient. The presence of MAC was assessed on posterior tibial arteries and ankle–brachial index (ABI) was measured. Major acute CV events (MACEs) and lower-limb events (MALEs) were recorded as a composite endpoint for a 5-year period.
Results:
We identified MAC among 212 (18.9%) patients. The independent determinants of MAC were age and diabetic retinopathy. Over a period of 5 years, 125 MACEs and 22 MALEs occurred. MAC was significantly associated with the composite outcome MACE + MALE (HR = 1.94; 95% CI: 1.23, 3.08, p = 0.005) or with MACE (HR = 1.85; 95% CI: 1.16, 2.95, p = 0.010). Adjusted for ABI and diabetic foot wound, MAC remained a determinant of MALE (HR = 5.49; 95% CI: 2.19, 13.76, p < 0.001). Considering each ABI group, MAC was associated with both MACE and MALE in the normal ABI group.
Conclusions:
Ultrasound-detected MAC on tibial arteries seems to be a determinant of both CV and lower-limb events, independent from ABI. MAC helps to refine the CV risk in patients with normal ABI.
La neurofibromatose de type 1 (NF1), ou maladie de Von Recklinghausen, maladie génétique autosomique dominante, coexiste avec des affections endocriniennes dont la plus connue est le phéochromocytome ...qui survient dans 0,5 à 5 % des NF1. Quelques cas d’association avec une hyperparathyroïdie primaire sont décrits dans la littérature 1.
Nous rapportons l’observation d’un patient âgé de 34 ans porteur d’une NF1 présentant des taches café au lait, neurofibromes cutanés, neurofibromes plexiformes multi-étagés.
Découverte d’un processus expansif de la surrénale droite lors d’un bilan d’asthénie avec présence d’une triade de Ménard, hypertension artérielle orientant vers un phéochromocytome confirmé sur le bilan sécrétoire dérivés méthoxylés et chromogranine A et scintigraphie à la MIBG.
Simultanément découverte d’une hypercalcémie avec un profil d’hyperparathyroïdie primaire avec échographie et scintigraphie des parathyroïdes concordantes pour un adénome parathyroïdien inférieur droit. Présence également d’un nodule thyroïdien de 3,7cm de grand axe TIRADS 3 (calcitonine négative).
Prise en charge chirurgicale : surrénalectomie droite, lobectomie thyroïdienne gauche et exérèse adénome parathyroïdien gauche.
Normalisation à 6 mois de la symptomatologie, négativation des dérivés méthoxylés, scanner surrénalien et bilan phosphocalcique normalisés.
Ce cas clinique souligne que les formes frontières (NF1, Néoplasie multiple de type 2 NEM2) existent probablement. D’autres équipes ont rapporté des cas similaires d’associations cliniques 2 sans démontrer a nature génétique de ce possible variant de NEM.
Objectives:
The objectives of this study were to describe the impact of systemic sclerosis associated interstitial lung disease, on quality of life, to estimate the correlation between quality of ...life and severity of lung disease and to assess the impact of interstitial lung disease on caregivers.
Methods:
Seven investigators included systemic sclerosis associated interstitial lung disease patients from December 2019 to April 2020. Sociodemographics and clinical data were collected. Patients reported outcomes and questionnaires were used with 1 generic patients reported outcome (EQ-5D-5L), 1 specific PRO (Brief Interstitial Lung Disease) and 2 self-reported questionnaires on impact of SSc complications and impact on caregivers. The correlation between forced vital capacity and EQ-5D-5L score was estimated with a multivariate linear regression model adjusted on several covariates.
Results:
In all, 89 patients were included. 26.4% were males, mean age was 58.2 ± 14.5 years. Mean EQ-5D-5L score = 0.79 ± 0.22 (median = 0.85). Mean EQ-5D-5L visual analog scale score = 60.8 ± 20.4 (median = 61.5). Mean King’s Brief Interstitial Lung Disease score = 58.4 ± 12.7 (median = 58.0). After adjustment on covariates, a significant correlation between forced vital capacity and EQ-5D-5L score was found with an increase of 0.003 of the EQ-5D-5L score for a 1% increase of FVC (p = 0.0096). No significant correlation between forced vital capacity and the EQ-VAS and King’s Brief Interstitial Lung Disease score were found. The impact of SSc on other organs was significantly correlated with EQ- 5D-5L score, respectively, for the impact scores on the lung system (p = 0.0003), heart system (p = 0.0182), Raynaud’s syndrome (p = 0.0015), digestive system (p = 0.0032), joints/muscles (p = 0.0003), skin (p < 0.0001), kidney (p = 0.0052) and gastro-oesophageal reflux (p = 0.0063). Significant correlations between King’s Brief Interstitial Lung Disease score and lung system (p < 0.0001), heart system (p < 0.0001), digital ulcers (p = 0.058), digestive system (p < 0.0001), kidney (p = 0.0004), skin (p = 0.0499) and gastro-oesophageal reflux (p = 0.0033) scores were found 68.5% of patients reported their need for a caregiver to help them in their daily life activities.
Conclusion:
Our study highlighted the strong burden of systemic sclerosis associated interstitial lung disease` for patients, especially with an impact on quality of life, on other organs manifestations and need for caregivers in their daily life.
Data on health care consumption and costs of asthma in the French population are scarce.
The study objective was to describe the burden of asthma according to GINA treatment steps in the CONSTANCES ...cohort.
Data from 162,725 participants included between 2012 and 2019 were extracted. Participants were considered as current asthmatics if asthma was reported at inclusion and asthma symptoms and/or treatments were reported in 2019. Participants were classified in three categories according to GINA treatment steps. The results were compared to non-asthmatic participants matched with a propensity score calculated on age, sex, region of residence, precariousness score and year of inclusion.
Among 162,725 participants aged 18–69 years, 6783 asthmatics (1566 not treated for asthma, 2444 + 251 GINA steps 1 + 2, 1054 + 1315 GINA steps 3 + 4, and 153 GINA step 5) were matched with 6783 controls. Average annual ambulatory cost and average annual hospitalization cost were respectively €1925 and €719 for asthmatics versus €1376 and €511 for participants without asthma (p < 0,0001). Cardiovascular risk factors, co-morbidities, visits and hospitalizations were higher for asthma participants as compared to controls and increased with GINA steps, as well as inpatient and outpatient costs. However, for cardiovascular risk factors and co-morbidities, differences were non-significant in multivariate analyses. Pharmacy costs were ten times higher for GINA step 5 participants than for GINA steps 1–2 participants: €3187 versus €393 (p < 0,0001).
mean cost of asthma was estimated at €757 per patient/year and increased with GINA treatment step.
•Data on the economic burden of asthma in France are rare and old.•An actual and precise estimate of the cost of asthma in France and its burden in terms of symptoms and comorbidities.•We provide estimations of the impact of clinical care and health programs on costs, which can inform decision-makers.
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