Primer registro nacional de evolocumab en la práctica clínica en unidades de cardiología en España. Estudio RETOSS-CARDIO

Barrios, Vivencio; Escobar, Carlos; Arrarte, Vicente; Roldán, C.

doi:10.1016/j.recesp.2019.11.014

Cited by 13 publications

(10 citation statements)

References 6 publications

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“…Finally, the study was not designed or powered to assess the effect of cardiovascular events, but we believe that our results might represent a relevant issue in major cardiovascular event incidence. Since LDLc reductions and clinical features were similar to previous reports, 3,4,14,[21][22][23][24][25][26][27]32,34,35 this might make our results representative and useful for daily clinical practice.…”

Section: Discussionsupporting

confidence: 85%

“…The clinical benefit of evolocumab and alirocumab was obtained by randomized clinical trials that included very high‐risk patients with LDLc <100 mg/dl. Current reimbursement conditions in Spain, as in many other countries, are limited to patients with LDLc >100 mg/dL, and all real‐world cohorts agree in showing that baseline LDLc is much higher than the ones reported in clinical trials 14,21–25 . Thereafter, the efficacy of LDLc reduction in real‐world patients might translate to even higher reductions of major cardiovascular events and, also, a higher impact on other lipoproteins 28 or beyond LDLc regulation 29 .…”

Section: Discussionmentioning

confidence: 89%

“…Current reimbursement conditions in Spain, as in many other countries, are limited to patients with LDLc >100 mg/dL, and all real-world cohorts agree in showing that baseline LDLc is much higher than the ones reported in clinical trials. 14,[21][22][23][24][25] Thereafter, the efficacy of LDLc reduction in real-world patients might translate to even higher reductions of major cardiovascular events and, also, a higher impact on other lipoproteins 28 or beyond LDLc regulation. 29 Patients at increased risk of coronary artery disease, as our cohort, frequently have a proatherogenic lipoprotein phenotype characterized by elevated plasma levels of both triglyceride-rich lipoproteins and small, dense LDL and low concentrations of HDLc.…”

Section: Discussionmentioning

confidence: 99%

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Effect of PCSK9 inhibitors on remnant cholesterol and lipid residual risk: The LIPID‐REAL registry

Cordero

Olmo

Quiroga

et al. 2022

Eur J Clin Investigation

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Background Monoclonal antibodies that inhibit the proprotein convertase subtilisin/kexin type 9 (PCSK9) reduce low‐density lipoprotein cholesterol (LDLc) by 55%, regardless of baseline treatments. Nonetheless, the effect of other lipid parameters, such as cholesterol remnants or, the so‐called lipid residual risk, is unknown. Methods Multicenter and retrospective registry of patients treated with PCSK9 inhibitors from 14 different hospitals in Spain. Before and on‐treatment lipid parameters were recorded. Residual lipid risk was estimated by (1) cholesterol remnants, (2) triglycerides/HDLc ratio (TG/HDL), (3) total cholesterol/HDLc (TC/HDL) and (4) the triglycerides‐to‐glucose index (TGGi). Results Six hundred fifty‐two patients were analysed, mean age of 60.2 (9.63) years, 24.69% women and mean LDLc before treatment 149.24 (49.86) mg/dl. Median time to second blood determination was 187.5 days. On‐treatment LDLc was 67.46 (45.78) mg/dl, which represented a 55% reduction. Significant reductions were observed for TG/HDL ratio, cholesterol remnants, TC/HDL ratio and TGGi. As consequence, 34.61% patients had LDLc <55 mg/dl and cholesterol remnants <30 mg/dl; additionally, 31.95% had cholesterol remnants <30 mg/dl but LDLc >55 mg/dl. Patients who had levels of cholesterol remnants >30 mg/dl before initiating the treatment with PCSK9 had higher reductions in cholesterol remnants, TG/HDL ratio, TC/HDL and TGGi. By contrast, no reduction differences were observed according to baseline LDLc (< or > the mean), age, gender or obesity. Conclusions This multicenter and retrospective registry of real‐world patients treated with PCSK9 inhibitors demonstrates a positive effect on cholesterol remnants and lipid residual risk beyond LDLc reductions.

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Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 89%

Section: Discussionmentioning

confidence: 99%

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Effect of PCSK9 inhibitors on remnant cholesterol and lipid residual risk: The LIPID‐REAL registry

Cordero

Olmo

Quiroga

et al. 2022

Eur J Clin Investigation

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“…11 A subanalysis of the FOURIER trail found no significant interaction of sex for the benefit of evolocumab on major cardiovascular events incidence 12 ; nonetheless, baseline LDLc levels in the FOURIER and ODYSSEY OUTCOMES trials were much lower than patients receiving PCSK9 inhibitors in real daily practice. [13][14][15][16][17][18] Circulating PCSK9 levels are independent predictors of incident CVD, 19,20 and recent evidence has demonstrated that women have significantly higher levels. 21 Evolocumab and alirocumab are available since mid 2016, and most real-world cohorts' results have been mainly focused on safety and efficacy on LDLc reduction.…”

Section: Introductionmentioning

confidence: 99%

“…21 Evolocumab and alirocumab are available since mid 2016, and most real-world cohorts' results have been mainly focused on safety and efficacy on LDLc reduction. [13][14][15]17,18 Under these premises, we tested the possible sex differences in the effect of PCSK9 inhibitors among real-world patients.…”

Section: Introductionmentioning

confidence: 99%

Sex Differences in Low-Density Lipoprotein Cholesterol Reduction With PCSK9 Inhibitors in Real-world Patients: The LIPID-REAL Registry

Cordero

Olmo

Quiroga

et al. 2022

Journal of Cardiovascular Pharmacology

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Background:Previous evidence supports that monoclonal antibodies that inhibit the proprotein convertase subtilisin/kexin type 9 (PCSK9) reduce low-density lipoprotein cholesterol (LDLc) by 50%–65%, regardless of baseline treatments. We tested possible sex differences in a multicentre registry of real-world patients treated with PCSK9 inhibitors.Methods:This is a multicentre and retrospective study of 652 patients initiating treatment with any PCSK9 inhibitor in 18 different hospitals. Before-treatment and on-treatment LDLc and medical treatments, clinical indication, and clinical features were recorded.Results:Women represented 24.69% of the cohort. The use of statins was similar in both sexes, but women were receiving most frequently ezetimibe. Before-treatment median LDLc was 135 (interquartile range 115–166) mg, and it was higher in women. The median on-treatment LDLc was 57 (interquartile range 38–84) mg/dL, which represented a mean 54.5% reduction. On-treatment LDLc was higher in women, and the mean LDLc reduction was lower in women (47.4% vs. 56.9%; P = 0.0002) receiving evolocumab or alirocumab. The percentage of patients who achieved ≥50% LDLc reduction was higher in men (71.36% vs. 57.62%; P = 0.002). According to LDLc before-treatment quartiles, LDLc reduction was statistically lower in women in the 2 highest and a significant interaction of women and baseline LDLc >135 mg/dL was observed. Women were negatively associated with lower rates of LDLc treatment target achievement (odds ratio: 0.31). Differences were also observed in women with body mas index >25 kg/m2. Only 14 patients (2.14%) presented side effects.Conclusions:This multicentre and retrospective registry of real-world patients treated with PCSK9 inhibitors highlights significant gender differences in LDLc reduction.

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Clinical profile of patients treated with evolocumab in lipid/internal medicine units of Spain. Observational study (RETOSS-IMU)

Masana

López‐Miranda

Civeira

et al. 2020

Clínica e Investigación en Arteriosclerosis (English Edition)

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Primer registro nacional de evolocumab en la práctica clínica en unidades de cardiología en España. Estudio RETOSS-CARDIO

Cited by 13 publications

References 6 publications

Effect of PCSK9 inhibitors on remnant cholesterol and lipid residual risk: The LIPID‐REAL registry

Effect of PCSK9 inhibitors on remnant cholesterol and lipid residual risk: The LIPID‐REAL registry

Sex Differences in Low-Density Lipoprotein Cholesterol Reduction With PCSK9 Inhibitors in Real-world Patients: The LIPID-REAL Registry

Clinical profile of patients treated with evolocumab in lipid/internal medicine units of Spain. Observational study (RETOSS-IMU)

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