Safety and efficacy of alirocumab in real life setting: analysis of the Belgian cohort of the ODYSSEY APPRISE trial with review of current lipid treatment guidelines and its implementation in clinical practice

Author(s):  
Sébastien Verdickt ◽  
Bart Van der Schueren ◽  
Roman Vangoitsenhoven ◽  
Olivier S. Descamps ◽  
Ann Mertens
2020 ◽  
Vol 10 (4) ◽  
pp. 266-276 ◽  
Author(s):  
Carlo Lavalle ◽  
Luca Di Lullo ◽  
Antonio Bellasi ◽  
Claudio Ronco ◽  
Stefano Radicchia ◽  
...  

Background: The availability of direct oral anticoagulants (DOAC) in clinical practice has transformed the health care provided to patients for the prevention and treatment of thromboembolism. Safety and efficacy data guide clinicians in the choice of the drug used. To date, no evidence is available from head-to-head trials comparing different DOAC with regard to safety and efficacy; information is mainly derived from several meta-analyses and real-life studies. Conclusions from these studies are inconsistent and unsatisfactory. The evaluation of self-reported adverse drug reactions (ADR) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision-making. Objective: To analyze potential suspected ADR of DOAC using a previously described risk index (RI) in daily clinical practice in Italy. Methods: The National Pharmacovigilance Network database (from the AIFA website) was searched in order to retrieve information on all ADR related to oral anticoagulants occurring from 2013 to 2018. The ADR RI for each drug was calculated, where an RI = 1 indicates a balance between the percentage of ADR share and the percentage of market share for each DOAC; and an RI <1 indicates a rate of ADR lower than the rate of market share (safer DOAC). The following DOAC molecules were considered: dabigatran, rivaroxaban, apixaban, and edoxaban. Results: The results showed that rivaroxaban is the DOAC with the lowest RI among the 4 molecules available today in Italy. Conclusions: Based on the RI, we identified rivaroxaban as the DOAC having the best safety profile.


2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Christian Hauptmann ◽  
Armin Ströbel ◽  
Mark Williams ◽  
Nitesh Patel ◽  
Hannes Wurzer ◽  
...  

Purpose. Primary tinnitus has a severe negative influence on the quality of life of a significant portion of the general population. Acoustic coordinated reset neuromodulation is designed to induce a long-lasting reduction of tinnitus symptoms. To test acoustic coordinated reset neuromodulation as a treatment for chronic, tonal tinnitus under real life conditions, an outpatient study “RESET Real Life” was commissioned by ANM GmbH. Herein we present the results of this study.Methods. In a prospective, open-label, nonrandomized, noncontrolled multicenter clinical study with 200 chronic tinnitus patients, tinnitus questionnaire TBF-12 and Global Clinical Improvement-Impression Scale (CGI-I7) are used to study the safety and efficacy of acoustic coordinated reset neuromodulation. 189 patients completed the last 12-month visit, 11 patients dropped out (8 because of nontreatment related reasons; 2 because tinnitus did not change; and 1 because tinnitus got louder).Results. Acoustic coordinated reset neuromodulation caused a statistically and clinically significant decrease in TBF-12 scores as well as in CGI-I7 after 12 months of therapy under real life conditions. There were no persistent adverse events reported that were related to the therapy.Conclusion. The field study “RESET Real Life” provides evidence for safety and efficacy of acoustic coordinated reset neuromodulation in a prospective, open-label, real life setting.


2021 ◽  
Vol 11 (2) ◽  
Author(s):  
Valentín Garcia-Gutiérrez ◽  
Alejandro Luna ◽  
Juan M. Alonso-Dominguez ◽  
Natalia Estrada ◽  
Concepcion Boque ◽  
...  

2019 ◽  
Vol 89 (3) ◽  
Author(s):  
Amelia Licari ◽  
Riccardo Ciprandi ◽  
Gianluigi Marseglia ◽  
Giorgio Ciprandi

Emotional disorders, namely anxiety and depression, frequently affect adolescents with asthma. In addition, their parents also may present emotional problems. The objective of this study was to investigate anxiety and depression in asthmatic adolescents and in their parents in a real-life setting. A series of adolescents with allergic asthma were consecutively enrolled. Asthma was diagnosed according to the GINA document and consistently the symptom control grade was assessed. We used the HADS questionnaire for the adolescents, and HADS, STAY, and BDI questionnaires for their parents. Globally, 121 adolescents (71 males, 50 females, mean age 13.4±0.8 years, age ranging between 12 and 15 years) with allergic asthma and their parents were evaluated. Only 29% of adolescents had controlled asthma. Adolescents with controlled asthma had lower HADS-A and HADS-D scores than other patients, whereas there was no difference among parents. Severe maternal anxiety was more frequent in poorly controlled subjects than in partially controlled ones; absence of maternal anxiety was more common in controlled subjects. The preliminary results of the current study suggest that anxiety and depression are common in adolescents suffering from asthma as well as in their parents, mainly in mothers. Emotional disorders might affect also the asthma control. Thus, in clinical practice, the psychological assessment could be included in the asthma work-up.


2018 ◽  
Author(s):  
A Amato ◽  
F Radaelli ◽  
V Cennamo ◽  
E Di Giulio ◽  
L Fuccio ◽  
...  
Keyword(s):  

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 130-LB
Author(s):  
DIEGO ESPINOZA-PERALTA ◽  
ARNULFO GONZÁLEZ-CANTÚ ◽  
ALEJANDRA I. SILVA ◽  
JUAN G. COLLADO ◽  
JORGE DAVID ROGEL-MANZANARES ◽  
...  

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