scholarly journals 341 Observational multicentre study on effectiveness and tolerability of Alirocumab in real world, the OMERO study: interim data from the first 699 patients

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Alberico Luigi Catapano ◽  
Aldo Pietro Maggioni ◽  
Francesco Rossi ◽  
Giampaolo Tirone ◽  
Lucia Notarianni ◽  
...  

Abstract Aims OMERO is a prospective study, aimed to assess the long-term effectiveness, tolerability, and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9-i), in the real life in Italy. The study is planned to include 800 patients, from 40 Italian sites, treated with alirocumab on top of standard lipid lowering therapy. Methods and results This analysis concerns 699 (out of 800) patients with all data available: 65.5% male; mean age 60.6 ± 11.09 years; 29.6% with HeFH in primary prevention; 70.4% in secondary prevention (with/without HeFH). Before ALI administration, 461 patients (66%) were treated with statins while 231 (33%) reported statin intolerance, that resulted in the statin discontinuation. Mean baseline LDL-C was 161.5 ± (53.07) mg/dl. Based on clinical judgement, ALI was initially prescribed at 75 mg Q2W dosing regimen in 60.80% of participants, whereas the remainder received 150 mg Q2W. At V1 57 patients (89.06%) switch from 75 mg Q2W to 150 mg Q2W and 7 patients (10.94%) from 150 mg Q2W to 75 mg Q2W. LDL-C level reduction from baseline (before ALI administration) to 6 months from the study enrolment (V1), was −45% (V1: mean LDL-C was 73.5 ± 45.70 mg/dl). LDL-C levels at V1 by participant category are shown in Figure 1. The rate of patients with at least one adverse event was 25.6% (of which SAE 7.4%); the rate of patients with at least one related adverse reaction to treatment was 3.8% none of them were serious. Conclusions OMERO confirmed in clinical practice the results observed in trials: a significant reduction of LDL-C was observed with ALI 75/150 mg Q2W in participants at high CV risk with or without HeFH. ALI was generally well tolerated.

2021 ◽  
pp. 8-12
Author(s):  
М.А. НУРЖАНОВА ◽  
А.Е. ТЕМУРОВА ◽  
Ж.Ш. БАБАК ◽  
Г.Б. БЕКТІБАЙ ◽  
Ш.Б. БАТЫР ◽  
...  

В данной статье представлены особенности липидного спектра у пациентов с острым коронарным синдромом в отдаленном периоде после операции коронарного шунтирования (КШ), в сравнении групп с Инфарктом миокарда (ИМ) и Нестабильной стенокардии (НС), а также результаты приверженности к гиполипидемической терапии с особенностями достижения целевых уровней липидного спектра. Полученные результаты представляют, что по липидному спектру группы идентичны между собой и отличаются от нормы, пациенты с низкой приверженности к гиполипидемической терапии и не достигают целевых уровень по холестерин липопротеинов низкой плотности (ХС-ЛПНП) рекомендованным Европейского кардиологического общества (ESC, ЕОК) от 2019г. This article presents the features of the lipid spectrum in patients with acute coronary syndrome in the long-term period after coronary artery bypass grafting (CABG) surgery, in comparison with the groups with myocardial infarction and Unstable angina pectoris, as well as the results of adherence to lipid-lowering therapy with particularities of achieving target levels of the lipid spectrum. The results obtained represent that in terms of the lipid spectrum the groups are identical and differ from the norm, patients with low adherence to lipid-lowering therapy and do not reach the target levels for low-density lipoprotein cholesterol (LDL-C) recommended by the European Society of Cardiology (ESC) from 2019.


2016 ◽  
Vol 01 (02) ◽  
pp. 028-030
Author(s):  
Radhika Soanker ◽  
Arun Jyothi ◽  
Sita ram

AbstractStatins are a class of hypolipidemic drugs, that are primarily used for the treatment of dyslipidemia and the prevention of cardiovascular disease. ATP III guidelines, 2002, recommends that LDL cholesterol be the primary target of therapy, and lipid lowering therapy may be initiated based on evaluation of short term and long term cardiovascular risk(1). We are report a case of dysuria follow statin group of drugs, which is not enlisted in the side effect of these drugs. In the present case after re-challenge with similar group of drug patient again developed the symptoms. Underlying hyperlipidemia was effectively controlled with Fenofibrates.


1997 ◽  
Vol 80 (6) ◽  
pp. 802-805 ◽  
Author(s):  
Dwight D. Stapleton ◽  
Mandeep R. Mehra ◽  
Debi Dumas ◽  
Frank W. Smart ◽  
Richard V. Milani ◽  
...  

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K Dyrbus ◽  
M Gasior ◽  
P Desperak ◽  
T Osadnik ◽  
M Banach

Abstract Background Prevalence of familial hypercholesterolemia (FH) is high among patients with CAD. However, data on FH among ACS patients are still scarce. Therefore, we aimed to assess the prevalence, lipid-lowering therapy and short- and long-term outcomes in FH patients with ACS. Methods We finally included 19,781 consecutive patients from the Hyperlipidaemia Therapy in the tERtiary Cardiological cEnTer (TERCET) Registry for years 2006–2018, including 7,319 patients with ACS: 3,085 with STEMI, 2,256 with NSTEMI, and 1,978 due to unstable angina (UA) (stable CAD group [n=12,462] was treated as a reference). FH diagnosis was based on Dutch Lipid Clinic Network (DLCN) score. Results The overall occurrence of probable/definite FH and possible FH were 1.2% and 13.7% respectively. In ACS patients 1.6% had probable/definite FH and 17.0% possible FH. The highest occurrence of FH was observed in STEMI subgroup, where 20.6% of the patients had ≥3 points according to the DLCN criteria. In patients with definite/probable FH, 98.1% were administered statins at discharge (including 57.5% prescribed intensive statin therapy in comparison to only 23.7% in non-FH patients). Patients with definite/probable FH had higher in-hospital and 30-day mortality than patients without FH (3.5% vs 1.2%, p=0.0046 and 4.4% vs 1.7%, p=0.024, respectively). However, no significant differences in investigated outcomes were observed between the FH groups in the 12-month and 36-month follow-up. The number of patients with FH Conclusion The prevalence of FH (definite/probable/possible) in the Polish very high-risk population is even 14.9% and is significantly higher in patients with ACS than in patients with stable CAD. High intensive lipid lowering therapy, including the combination therapy allows improving long-term outcomes in patients with FH.


2019 ◽  
Vol 176 (3) ◽  
pp. 669-677 ◽  
Author(s):  
Yun Rose Li ◽  
Vicky Ro ◽  
Laura Steel ◽  
Elena Carrigan ◽  
Jenny Nguyen ◽  
...  

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
N Danchin ◽  
J Ferrieres ◽  
E Puymirat ◽  
G Cayla ◽  
Y Cottin ◽  
...  

Abstract Background Randomised trials evaluate the efficacy of individual medications, irrespective of overall patient management. We assessed the association between lipid-lowering therapy (LLT) intensity and long-term mortality in otherwise optimally-treated patients with acute myocardial infarction (AMI). Methods FAST-MI consists in one-month nationwide French surveys of patients admitted for a recent AMI, repeated every 5 years. We used the 2010 and 2015 data with 3-year follow-up. Background optimal therapy was defined as use of PCI, together with ESC guideline-recommended treatment with beta-blockers, ACEi/ARB, when indicated, and optimal antithrombotic medications including type of P2Y12-i; of 9,460 patients included, 4,042 were optimally-treated, with 478 (12%), 1120 (28%), and 2,444 (60%) respectively receiving conventional-dose statins (Gr 1), moderate-intensity statins (atorvastatin 40 mg or rosuvastatin 10 mg) (Gr2) or high-dose LLT (atorvastatin 80 mg, rosuvastatin ≥20 mg or statin-ezetimibe combination) (Gr3). Results Baseline characteristics markedly differed in the 3 groups (Table 1). Three-year Kaplan-Meier survival was 88.5%, 93.5% and 96.3% respectively for gr 1, 2 and 3, with Cox-adjusted HR of 0.75 (0.51–1.10), P=0.137, and 0.59 (0.41–0.86), P=0.006 for gr 2 and 3 compared with Gr1 (Figure). Conclusion In otherwise optimally-treated AMI patients, lipid-lowering regimen intensity at discharge was inversely associated with 3-year mortality. These results confirm that high-intensity lipid lowering therapy at discharge is likely beneficial even in patients receiving otherwise optimal therapy. Figure 1. 3-year survival Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): MSD, AstraZeneca


2021 ◽  
Vol 10 (24) ◽  
pp. 5938
Author(s):  
Jean Ferrières ◽  
François Roubille ◽  
Michel Farnier ◽  
Patrick Jourdain ◽  
Denis Angoulvant ◽  
...  

Introduction: Patients with established coronary artery disease (CAD) are at very high risk for cardiovascular events. Methods: The DAUSSET study is a national, multicenter, non-interventional study that included very high-risk CAD patients followed by French cardiologists. It aimed to describe real-life clinical practices for low-density lipoprotein (LDL) cholesterol control in the secondary prevention of CAD. Results: A total of 912 patients (mean age, 65.4 years; men, 76.1%; myocardial infarction, 69.4%; first episode, 80.1%) were analyzed. The LDL cholesterol goal was 70 mg/dL in most cases (84.9%). The LDL cholesterol goal <70 mg/dL was achieved in 41.7% of patients. Of the 894 (98.0%) patients who received lipid-lowering therapy, 81.2% had been treated more intensively after the cardiac event, 27.0% had been treated less intensively and 13.1% had been maintained. Participating cardiologists were very satisfied or satisfied with treatment response in 72.6% of patients. Moderate satisfaction or dissatisfaction with lipid-lowering therapy was related to not achieving objectives (100%), treatment inefficacy (53.7%), treatment intolerance (23.4%) and poor adherence (12.3%). Conclusion: These real-world results show that lipid control in very high-risk patients remains insufficient. More than half of the patients did not achieve the LDL cholesterol goal. Prevention of cardiovascular events in these very high-risk patients could be further improved by better education and more intensive lipid-lowering therapy.


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