A RandomizEd, double-blind, cross-over Study to assess Erenumab effecT on BRAIN networks function and structure in comparison to placebo in episodic migraine patients (RESET BRAIN) - RESET BRAIN

开始日期2019-05-29

申办/合作机构

Novartis Farma

EUCTR2014-002630-31-IT / Not yet recruiting临床3期

A phase IIIb multicenter, open-label, single arm study to evaluate the efficacy and safety of pasireotide in patients with acromegaly inadequately controlled with first generation somatostatin analogues - NA

开始日期2016-06-07

申办/合作机构

Novartis Farma

EUCTR2014-000316-34-IT / Not yet recruitingN/A

A phase I/II multicenter, open-label study of CLR457 administered orally in adult patients with advanced solid malignancies

开始日期2015-04-24

申办/合作机构

Novartis Farma

100 项与 Novartis Farma 相关的临床结果

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0 项与 Novartis Farma 相关的专利（医药）

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项与 Novartis Farma 相关的文献（医药）

2023-11-09·European Heart Journal

Low-density-lipoprotein cholesterol target attainment in high-risk patients with history of diabetes or major adverse cardiac and cerebrovascular event: an (un)expected gender bias

作者: Berteotti, M ; Casolo, G ; Francesconi, P ; Zuppiroli, A ; Profili, F ; Marcucci, R ; Mannucci, E ; Ferrante, N ; Lotti, E ; Grisillo, D

AbstractBackgroundLowering low-density lipoprotein cholesterol (LDL-C) is the cornerstone of cardiovascular disease prevention, especially after the occurrence of a major adverse cardiac and cerebrovascular event (MACCE). Collection of epidemiological data is crucial for monitoring healthcare appropriateness and the fulfillment of guidelines recommendations.PurposeThis analysis aimed to evaluate the proportion of high-risk patients who achieved LDL-C goal as suggested by the international guidelines by analyzing regional administrative data and to explore the predictors of therapeutic failure, with a focus on the role of gender.MethodsBy linking health administrative and laboratory data, we collected data from seven Local Health Districts on residents aged ≥45 years. Inclusion criteria were: 1) at least one LDL-C measurement in the year; 2) a history of MACCE (defined as myocardial infarction and/or stroke and/or revascularization of the coronary, carotid, or peripheral arteries) and/or type 2 diabetes mellitus (T2DM). Cohorts were defined at 1st January 2019 and 1st January 2020. Lipid lowering therapy use (defined as ≥2 prescription fillings or ≥75% coverage of treatment days) over the past 6 months if LDL-C data were available or over the past year if no LDL-C data were available was monitored. The outcome was the number of patients with on-treatment LDL-C optimal levels, as defined by levels <55 mg/dl for patients with MACCE and <70 mg/dl for patients with T2DM without MACCE.ResultsA cohort of 174,200 individuals was analyzed (55% males). As regards subjects on lipid-lowering therapies, we found that female gender was associated with a significantly lower probability to have LDL-C levels at target (OR: 0.58±0.01; p<0.0001) in patients with MACCE with or without T2DM, in a model adjusted for age, district area, and the presence of cardiovascular risk factors and comorbidities (renal failure, heart failure, atrial fibrillation). This result was confirmed also in the analysis conducted in subjects without lipid-lowering therapies (OR: 0.56±0.01; p<0.0001). No significant differences were documented by stratifying for the presence of clinical pathways aimed to the active call of the patients by clinicians ("Initiative Health").ConclusionsThese results demonstrated that females have a significantly lower probability to reach LDL-C levels recommended targets. This datum is confirmed even in the absence of lipid-lowering therapies. These results call for action aimed to: 1) education for general population and for patients with MACCE with a specific target on females; 2) information for clinicians for the need of assessing adequate lipid-lowering therapy prescription and adherence irrespectively of gender; 3) organization of clinical pathways - from admission to recovery and follow-up - with a specific focus on secondary prevention target attainment.

2023-11-01·Journal of neurology

The effect of erenumab on brain network function in episodic migraine patients: a randomized, placebo-controlled clinical trial (RESET BRAIN).

Article

作者: Messina, Roberta ; Colombo, Bruno ; Valsasina, Paola ; Turrini, Renato ; Bartezaghi, Marta ; Sacco, Simona ; Raimondi, Debora ; Cetta, Ilaria ; Grazzi, Licia ; Russo, Antonio ; Splendiani, Alessandra ; Filippi, Massimo ; Ornello, Raffaele ; Martinelli, Daniele ; Pichiecchio, Anna ; Rocca, Maria Assunta ; Tassorelli, Cristina

BACKGROUNDWe aimed to explore whether erenumab, a monoclonal antibody targeting the calcitonin gene-related peptide receptor, could exert a central effect on brain network function in migraine, and investigate the persistence of such an effect following treatment discontinuation.METHODSThis was a randomized, double-blind, placebo-controlled, multicenter trial with a crossover design performed in adult episodic migraine patients with previous treatment failure. Patients were randomized (1:1) to 12 weeks of erenumab 140 mg or placebo, followed by a 12-week crossover. Resting state (RS) functional connectivity (FC) changes of brain networks involved in migraine were investigated using a seed-based correlation approach.RESULTSSixty-one patients were randomized to treatment. In each treatment sequence, 27 patients completed the visit at week 12. Forty-four enrolled patients, 22 in each treatment sequence, completed the study procedures with no major protocol violations. We observed a carry-over effect of erenumab during the placebo treatment and therefore data analysis was performed as a parallel comparison of erenumab vs placebo of the first 12 weeks of treatment. From baseline to week 12, compared to placebo, patients receiving erenumab showed RS FC changes within the cerebellar, thalamic and periaqueductal gray matter networks, significantly associated with clinical improvement. Compared to non-responders, patients achieving a 50% reduction in migraine days had distinct patterns of thalamic and visual network RS FC. Brain RS FC changes reversed when erenumab was stopped. A lower baseline RS FC of the pontine network identified patients responding to erenumab.CONCLUSIONErenumab modulates RS FC of networks involved in migraine pathophysiology. In line with clinical response, erenumab-induced brain RS FC changes tend to reverse when treatment is stopped.

2023-09-13·Hematology reports

Real-World Clinical Characterisation of Polycythaemia Vera Patients from a Prospective Registry in Portugal: Is Resistance to Hydroxyurea a Reality?

Article

作者: Ferreira, Gisela ; Roriz, Diana ; Freitas, Jorge ; Duarte, Marta ; Costa, Inês ; Sanchez, Juan ; Pacheco, Judite ; Ponte, Sandra ; Sarmento, Maria ; Brás, Daniel ; Silva, Maria José Monteiro ; Fernandes, Laura

Patients with polycythaemia vera (PV) are at increased risk of thrombosis and haemorrhages. Although hydroxyurea (HU) has been the frontline therapy for patients at high risk of vascular complications, about 25% of patients develop resistance/intolerance to this therapy. The aim of this non-interventional, multicentre cohort study was to understand the clinical characteristics and HU treatment response of Portuguese PV patients. HU resistance/intolerance was defined according to adjusted European LeukemiaNet (ELN) criteria. In total, 134 PV patients with a mean (SD) disease duration of 4.8 (5.0) years were included and followed up for 2 years. At baseline, most patients were ≥60 years old (83.2%), at high risk for thrombotic events (87.2%), and receiving HU therapy (79.1%). A total of 10 thrombotic events and 8 haemorrhagic events were reported, resulting in a 5-year probability of thrombo-haemorrhagic events of 17.2%. Haematocrit (p = 0.007), haemoglobin (p = 0.012) and MPN10 symptom score (12.0 (11.6) vs. 10.3 (9.1); p = 0.041) decreased significantly at the 24-month visit compared to baseline. Overall, 75.9% of patients met at least one of the adjusted ELN criteria for HU resistance, and 14.4% of patients remained on HU throughout the study. The results from this real-world study may help identify the subset of patients at higher risk for disease sequelae who may benefit from earlier second-line treatment.

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