8 research outputs found
5. - Nouveaux outils pour la prévision hydrométéorologique et le suivi des systèmes précipitants. L'exemple du 22 septembre 1992
Sans revenir sur le déroulement météorologique de l'épisode du 22 Septembre 1992, on montre l’intérêt, pour la compréhension du phénomène et de sa dynamique, de la cartographie continue des champs de pluies horaires en utilisant : d'abord les données, les plus complètes possibles, d’un réseau sol de plus de 300 stations ; puis les données issues du radar météorologie de Nîmes-Manduel. On en tire des enseignements sur la structure interne du système précipitant et sur la complémentarité des données sol et des données radar. On évoque également l'intérêt des informations issues du système METEORAGE de localisation des impacts de foudre et l'on compare la distribution spatiale de ces impacts avec les cartes horaires de précipitations sus-citées.Tourasse Patrick, Garçon Rémy, Obled Charles, Aubonnet V., Dufour C. 5. - Nouveaux outils pour la prévision hydrométéorologique et le suivi des systèmes précipitants. L'exemple du 22 septembre 1992. In: Crues et inondations. 23èmes journées de l'hydraulique. Congrès de la Société Hydrotechnique de France. Nimes (France), 14-15-16 septembre 1994. Tome 2, 1994
Author response for "Pharmacokinetic and Pharmacodynamic Bioequivalence of Proposed Biosimilar MYL‐1501D With US and EU Insulin Glargine Formulations in Patients With Type 1 Diabetes Mellitus"
Author response for "Efficacy and Safety of MYL‐1501D Versus Insulin Glargine in Patients With Type 1 Diabetes Mellitus: Results of the INSTRIDE 3 Phase 3 Switch Study"
Primary prevention of diabetic retinopathy with fibrates: a retrospective, matched cohort study
Objectives To compare the progression of diabetic retinopathy (DR) in people with type 2 diabetes treated with fibrates with that of non-exposed controls.
Design Retrospective, matched cohort study.
Setting UK Clinical Practice Research Datalink (CPRD).
Participants 5038 people with type 2 diabetes with a history of fibrate exposure but without evidence of DR were identified. Three thousand one hundred and seventy-six (63%) people could be randomly matched to one non-exposed control; of these, 2599 (81.8%) were matched without any missing blood pressure or glycated haemoglobin (HbA1c) values.
Main outcome measures The primary endpoint was first recorded DR with a secondary endpoint of all-cause mortality or first DR. Time to clinical endpoints was compared using Cox proportional hazards models.
Results Mean follow-up was 5.1 and 5.0 years for fibrate-exposed and non-exposed patients, respectively. For fibrate-exposed participants, there was a reduction in DR: 33.4 events/1000 person-years vs 40.4 (p=0.002), and in death or DR: 50.6 vs 60.2 (p<0.001). For those matched with full systolic blood pressure and HbA1c data, crude event rates were 34.3 versus 43.9 for DR (p<0.001) and 51.2 vs 63.4 (p<0.001) for death or DR. Following adjustment, DR was significantly delayed for those treated with fibrates, with an adjusted HR (aHR) of 0.785 (p<0.001) for participants with complete data and an aHR of 0.802 (p<0.001) for all participants.
Conclusions The treatment with fibrates in people with type 2 diabetes was independently associated with reduced progression to a first diagnosis of DR
New Fixed-Dose Combinations of Fenofibrate/Simvastatin Therapy Significantly Improve the Lipid Profile of High-Risk Patients with Mixed Dyslipidemia Versus Monotherapies
Pharmacokinetic interaction between simvastatin and fenofibrate with staggered and simultaneous dosing: Does it matter?
Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies
Abstract
Background
MYL-1501D is a proposed biosimilar to insulin glargine. The noninferiority of MYL-1501D was demonstrated in patients with type 1 diabetes and type 2 diabetes in 2 phase 3 trials. Immunogenicity of MYL-1501D and reference insulin glargine was examined in both studies.
Methods
INSTRIDE 1 and INSTRIDE 2 were multicenter, open-label, randomized, parallel-group studies. In INSTRIDE 1, patients with type 1 diabetes received MYL-1501D or insulin glargine over a 52-week period. In INSTRIDE 2, patients with type 2 diabetes treated with oral antidiabetic drugs, insulin naive or not, received MYL-1501D or reference insulin glargine over a 24-week period. Incidence rates and change from baseline in relative levels of antidrug antibodies (ADA) and anti–host cell protein (anti-HCP) antibodies in both treatment groups were determined by a radioimmunoprecipitation assay and a bridging immunoassay, respectively. Results were analyzed using a mixed-effects model (INSTRIDE 1) or a nonparametric Wilcoxon rank sum test (INSTRIDE 2).
Results
Total enrollment was 558 patients in INSTRIDE 1 and 560 patients in INSTRIDE 2. The incidence of total and cross-reactive ADA was comparable between treatment groups in INSTRIDE 1 and INSTRIDE 2 (P > 0.05 for both). A similar proportion of patients had anti-HCP antibodies in both treatment groups in INSTRIDE 1 at week 52 (MYL-1501D, 93.9 %; reference insulin glargine, 89.6 %; P = 0.213) and in INSTRIDE 2 at week 24 (MYL-1501D, 87.3 %; reference insulin glargine, 86.9 %; P > 0.999).
Conclusions
In INSTRIDE 1 and INSTRIDE 2, similar immunogenicity profiles were observed for MYL-1501D and reference insulin glargine in patients with type 1 diabetes and type 2 diabetes, respectively.
Trial registration
ClinicalTrials.gov, INSTRIDE 1 (NCT02227862; date of registration, August 28, 2014); INSTRIDE 2 (NCT02227875; date of registration, August 28, 2014).
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