scholarly journals Evolocumab use in Europe: clinical guidelines vs. reimbursement thresholds – results from the HEYMANS study

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
K K Ray ◽  
E Bruckert ◽  
P Filardi ◽  
C Ebenbichler ◽  
A Vogt ◽  
...  
Keyword(s):  
Clinical Guidelines ◽  
Clinical Characteristics ◽  
Lipid Lowering ◽  
Moderate Intensity ◽  
Lipid Lowering Therapy ◽  
Pcsk9 Inhibitors ◽  
Private Company ◽  
Statin Monotherapy ◽  
Very High

Abstract Background 2019 ESC/EAS guidelines recommend a 50% lowering in untreated LDL-C and use of PCSK9 inhibitors (PCSK9i) for patients (pts) at very high cardiovascular (CV) risk when LDL-C goals of <1.4mmol/L are not met despite maximally tolerated statins and ezetimibe. However, the LDL-C threshold at which PCSK9i are reimbursed are higher than the goals recommended in clinical guidelines. Purpose This prospective observational cohort study describes clinical characteristics and LDL-C control among pts initiating evolocumab across 12 EU countries. Methods Pts are followed from evolocumab initiation (baseline). Demographic/clinical characteristics, lipid lowering therapy (LLT) and lipid values are being collected from medical records (6 months before evolocumab up to 30 months post initiation). We report interim data from pts initiating evolocumab from August 2015 followed-up until July 2020. Results Of the 1,952 pts in whom evolocumab was initiated as per local reimbursement criteria, most (1844 [94%]) had 12 months follow-up, 785 (40%) had 24 months follow-up; mean follow-up: 20 months. Mean (SD) age was 60 (10.8) years; 85% of pts had a history of CV disease, 45% had familial hypercholesterolemia, 19% had type 2 diabetes, 65% were hypertensive, 7% had chronic kidney disease and 51% were prior/current smokers. At evolocumab initiation, 60% reported statin intolerance and 41% were on no background LLT. Fewer than half (846 [43%]) were receiving a statin (± ezetimibe); of these, most received a high/moderate intensity (68%/22%), with 13% receiving statin monotherapy. Median (Q1, Q3) baseline LDL-C was 3.98 (3.17, 5.07) mmol/L. Within 3 months of initiation median LDL-C fell by 58% to 1.63mmol/L. This reduction was maintained over time (Figure 1). Overall, 58% of pts achieved at least one LDL-C <1.4mmol/L during follow-up. Among pts receiving background statins ± ezetimibe at evolocumab initiation, 67% (710/1053) achieved at least one LDL-C <1.4mmol/L, versus 44% (317/714) of pts not receiving background statins/ezetimibe. During follow-up background oral LLT did not materially change; 40–45% pts received no LLT, 41–44% received statin ± ezetimibe, 12–14% received statin monotherapy. Conclusion In Europe, pts initiated on evolocumab had baseline LDL-C levels almost 3x higher than the present threshold for PCSK9i use recommended in guidelines reflecting disparities between local reimbursement criteria and guidelines. Although evolocumab led to a >50% reduction in LDL-C, only ∼50% pts achieved an LDL-C <1.4mmol/L, as approximately 41% received only evolocumab as monotherapy. LDL-C goal attainment was however higher among pts receiving evolocumab with background LLT. Therefore, lowering the LDL-C threshold for PCSK9i reimbursement, would result in more patients receiving combination therapy with oral LLT plus PCSK9i, thus increasing the likelihood of more pts achieving very-high risk LDL-C goals. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Amgen Europe GmbH

Does Evolocumab use in Europe match 2019 ESC/EAS lipid guidelines? Results from the HEYMANS study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.K Ray ◽  
E Bruckert ◽  
B Van Hout ◽  
M Feudjo Tepie ◽  
I Bridges ◽  
...  
Keyword(s):  
Goal Attainment ◽  
Moderate Intensity ◽  
Funding Source ◽  
Pcsk9 Inhibitors ◽  
Statin Intolerance ◽  
Private Company ◽  
Statin Monotherapy ◽  
Lipid Guidelines ◽  
Cv Disease

Abstract Background 2019 ESC/EAS dyslipidaemia guidelines recommend a 50% lowering in untreated LDL-C and use of PCSK9 inhibitors (PCSK9i) for patients at very-high cardiovascular (CV) risk when LDL-C target goals of <1.4 mmol/L or <1.0 mmol/L (for those with 2 CV events within two-years) are not met despite maximally tolerated statins and ezetimibe. Purpose This observational study describes a cohort of patients initiating evolocumab across 10 EU countries. Methods Patients are followed from evolocumab initiation (baseline). Demographic/clinical characteristics, lipid modifying therapy (LLT) and lipid values were collected from medical records (6 months prior to evolocumab initiation through 30 months post initiation). We report interim data from patients initiating evolocumab from August 2015 with follow-up through October 2019. Results 1896 patients initiated on evolocumab as per local reimbursement criteria were included in this interim analysis (planned sample size: N=2,000). Most (1663 [88%]) had 12 months follow-up, 665 (35%) had 18 months follow-up; mean follow-up, 16.3 months. Mean (SD) age was 60.0 (10.8) years; 85% of patients had a history of CV disease (CVD), 44% had a diagnosis of familial hypercholesterolemia (FH), 19% had type 2 diabetes, 66% were hypertensive, 7% had renal impairment and half (51%) were prior or current smokers. The majority (60%) reported statin intolerance and 42% were not receiving any LLT at evolocumab initiation. Fewer than half (805 [43%]) were receiving a statin (±ezetimibe) at evolocumab initiation; of these, most were on a high/moderate intensity (68%/22%). 12% of patients were receiving statin monotherapy. Median (Q1, Q3) baseline LDL-C was 3.98 (3.16, 5.06) mmol/L. Within 3 months of evolocumab initiation median LDL-C fell by 58% to 1.62 mmol/L. This reduction was maintained over time (Figure). Overall, 58% of patients achieved at least one LDL-C <1.4 mmol/L during follow-up. Among patients receiving background statins and/or ezetimibe at evolocumab initiation, 67% (667/990) achieved at least one LDL-C <1.4 mmol/L, compared with 43% (295/679) of patients not receiving background statins/ezetimibe. During follow-up, 39–46% patients received no background LLT, 40–44% received statin ±ezetimibe, 11–14% received statin monotherapy. Conclusion In Europe, patients initiated on evolocumab had baseline LDL-C levels almost 3 times higher than the present threshold for PCSK9i use, reflecting local reimbursement criteria. Evolocumab resulted in a more than 50% reduction in LDL-C; however, only approximately half of all patients achieved an LDL-C <1.4 mmol/L. LDL-C goal attainment was higher among patients receiving evolocumab with background LLT, suggesting that achievement of EAS/ESC LDL-C goals requires multiple LLTs and a lower threshold for PCSK9i initiation. LDL-C levels after evolocumab initiation Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Amgen

scholarly journals Lipid lowering therapy in primary and secondary prevention in Austria: are LDL-C goals achieved?

2021 ◽  
Author(s):  
Peter Siostrzonek ◽  
Helmut Brath ◽  
Robert Zweiker ◽  
Heinz Drexel ◽  
Robert Hoelzl ◽  
...  
Keyword(s):  
Secondary Prevention ◽  
High Intensity ◽  
Lipid Lowering ◽  
Moderate Intensity ◽  
Lipid Lowering Therapy ◽  
Pcsk9 Inhibitors ◽  
Cross Sectional ◽  
Lipid Management ◽  
Lowering Therapy ◽  
Statin Monotherapy

Summary Background Cardiovascular disease (CVD) is the most frequent cause of death in Austria. The European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines recommend intensive lipid lowering therapy (LLT) in patients at high or very high CV risk. Lipid management and achievement of low-density lipoprotein cholesterol (LDL-C) goals in Austria have not recently been assessed. Methods Subgroup analysis for Austria of a European 18 country, cross-sectional, observational study. Patients received LLT for primary (PP) or secondary prevention (SP). Data including LLT in the preceding 12 months and most recent LDL‑C were collected during a single visit between June 2017 and November 2018. Achievement of the risk-based 2016 and 2019 ESC/EAS LDL‑C goal while receiving stabilized LLT was assessed. Results A total of 293 patients were enrolled from 8 Austrian sites, of which 200 (PP = 104, SP = 96) received stabilized LLT at the LDL‑C measurement date. Overall, 58% (71% PP, 43% SP) and 38% (52% PP, 23% SP) achieved the risk-based 2016 and 2019 goals, respectively. Most patients received moderate-intensity statin monotherapy (46%), while 34% used high-intensity statin monotherapy. Combination therapy of moderate/high-intensity statin with ezetimibe (12%), or proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors with statin ± ezetimibe (1%), was used infrequently. Conclusion The current Austrian routine lipid management using mainly moderate-intensity or high-intensity statin monotherapy is insufficient to attain ESC/EAS guideline goals, in particular the more stringent 2019 recommendations, a situation comparable to other participating European countries. In addition to switching to and optimizing doses of high-intensity statins, a combination with ezetimibe or PCSK9 inhibitors will be needed in many cases.

scholarly journals Screening and treatment of familial hypercholesterolemia in a French sample of ambulatory care patients: A retrospective longitudinal cohort study

PLoS ONE ◽  
2021 ◽  
Vol 16 (8) ◽  
pp. e0255345
Author(s):  
Jean Ferrières ◽  
Victoria Banks ◽  
Demetris Pillas ◽  
Francesco Giorgianni ◽  
Laurene Gantzer ◽  
...  
Keyword(s):  
Ambulatory Care ◽  
Familial Hypercholesterolemia ◽  
Density Lipoprotein ◽  
Lipid Lowering ◽  
Moderate Intensity ◽  
Health Improvement ◽  
Lipid Lowering Therapy ◽  
Pcsk9 Inhibitors ◽  
Pharmacological Management

Background and aims Untreated Familial Hypercholesterolemia (FH) leads to premature morbidity and mortality. In France, its epidemiology and management are understudied in ambulatory care. We described the clinical profile, pharmacological management, and clinical outcomes in a French sample of FH patients. Methods This was a retrospective longitudinal study on patients from The Health Improvement Network (THIN®) database in France, between October 2016-June 2019. Patients ≥18 years, with probable/definite FH based on the Dutch Lipid Clinic Network (DLCN) criteria were included. Baseline characteristics, lipid profile, lipid-lowering therapy (LLT), low-density lipoprotein-cholesterol (LDL-C) goal achievement; and disease management at 6-month of follow-up were analyzed. Results 116 patients with probable (n = 70)/definite (n = 46) FH were included (mean age:57.8±14.0 years; 56.0% women; 9.5% with personal history of cardiovascular events); 90 patients had data available at follow-up. At baseline, 77.6% of patients had LDL-C>190 mg/dL, 27.6% were not receiving LLTs, 37.9% received statins alone, 20.7% statins with other LLTs, and 7.7% other LLTs. High-intensity statins were prescribed to 11.2% of patients, 30.2% received moderate-intensity statins, and 8.6% low-intensity statins. Only 6.0% of patients achieved LDL-C goal. At 6-month of follow-up, statins discontinuation and switching were 22.7% and 2.3%, respectively. None of the patients received proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors at baseline nor follow-up. Conclusions Despite the existence of effective LLTs, FH patients are suboptimally-treated, do not achieve LDL-C goal, and exhibit worsened pharmacological management over time. Future studies with longer follow-up periods and assessment of factors affecting LDL-C management, including lifestyle and diet, are needed.

scholarly journals What is the potential cardiovascular risk reduction associated with achieving LDL-C levels recommended in the ESC/EAS guidelines for very high-risk patients? Data from 18 European countries

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.K Ray ◽  
S Bray ◽  
A.L Catapano ◽  
N Poulter ◽  
G Villa
Keyword(s):  
High Risk ◽  
Risk Reduction ◽  
Absolute Risk ◽  
European Countries ◽  
Lipid Lowering ◽  
Funding Source ◽  
Lipid Lowering Therapy ◽  
Cardiovascular Risk Reduction ◽  
Private Company ◽  
Very High

Abstract Background/Introduction For patients at very-high risk of cardiovascular (CV) events, the 2016 ESC/EAS dyslipidaemia guidelines recommended lipid-lowering therapy (LLT) to achieve an LDL-C level below 70 mg/dL. This was lowered to an LDL-C level below 55 mg/dL in the 2019 guidelines. Purpose To assess: 1) the risk profile of European patients with established atherosclerotic CV disease (ASCVD) receiving LLT; and 2) the treatment gap between the estimated risk and the population benefits if all patients were to achieve LDL-C levels of 70 mg/dL and 55 mg/dL. Methods We used data from Da Vinci, an observational cross-sectional study conducted across 18 European countries. Data were collected at a single visit between June 2017 and November 2018, for consented adults who had received any LLT in the prior 12 months and had an LDL-C measurement in the prior 14 months. LDL-C level was assessed at least 28 days after starting the most recent LLT (stabilised LLT). For each patient with established ASCVD receiving stabilised LLT, we: 1) calculated their absolute LDL-C reduction required to achieve LDL-C levels of 70 mg/dL and 55 mg/dL; 2) predicted their 10-year CV risk using the REACH score based on demographic and medical history; 3) simulated their relative risk reduction (RRR) by randomly sampling from the probability distribution of the rate ratio per 38.7 mg/dL (1 mmol/L) estimated by the Cholesterol Treatment Trialists Collaboration meta-analysis; and 4) calculated their absolute risk reduction (ARR) achieved by meeting LDL-C levels of 70 mg/dL and 55 mg/dL. Results A total of 2039 patients with established ASCVD were included in the analysis. Mean (SD) LDL-C was 83.1 (35.2) mg/dL. 40.4% and 19.3% of patients achieved LDL-C levels of 70 mg/dL and 55 mg/dL, respectively. Mean (SD) 10-year CV risk calculated using the REACH score was 36.3% (15.4%). Mean absolute LDL-C reductions of 19.6 mg/dL and 30.4 mg/dL were needed to reach LDL-C levels of 70 mg/dL and 55 mg/dL, respectively. When adjusted for the LDL-C reduction required to achieve an LDL-C level of 70 mg/dL, mean ARR was 3.0%, leaving a mean (SD) residual 10-year CV risk of 33.3% (15.5%). When adjusted for the LDL-C reduction required to achieve an LDL-C level of 55 mg/dL, mean ARR was 4.6%, leaving a mean (SD) residual 10-year CV risk of 31.7% (15.2%). Conclusion(s) In a contemporary European cohort with ASCVD receiving LLT, the 10-year risk of CV events is high and many patients do not achieve LDL-C levels of 55 mg/dL or even of 70 mg/dL. Moreover, even if all patients were to achieve recommended LDL-C levels, they would still remain at a high residual risk of CV events. These data suggest these patients require even more intensive LLT. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Amgen

Do European patients with peripeheral arterial disease receive optimal lipid lowering therapy and achieve LDL-C goals? Results from the DA VINCI study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.K Ray ◽  
M Feudjo Tepie ◽  
A.L Catapano ◽  
P Giovas ◽  
S Bray ◽  
...  
Keyword(s):  
Da Vinci ◽  
Arterial Disease ◽  
Lipid Lowering ◽  
Moderate Intensity ◽  
Funding Source ◽  
Lipid Lowering Therapy ◽  
Private Company ◽  
Cerebral Disease ◽  
Study Visit ◽  
Lowering Therapy

Abstract Background 2016 and 2019 EAS/ESC dyslipidemia guidelines recommend lipid lowering therapy (LLT) to reduce LDL-C in patients with peripheral arterial disease (PAD) with or without established cardiovascular (CV) disease, and recommend target LDL-C goals based on individual CV risk. Data regarding the implementation of these guidelines in clinical practice across Europe is currently lacking. Purpose Describe LLT and achievement of the target LDL-C goals recommended in EAS/ESC dyslipidemia guidelines in patients with PAD. Methods The cross-sectional Da Vinci study enrolled consenting adults who had received LLT in the 12 months prior to the study visit and had at least one LDL-C measurement in the 14 months prior to the study visit, seen in a primary or secondary care setting across 18 European countries. Patients with coronary, peripheral and cerebral disease were enrolled at a ratio of 1:2:2. FH patients with prior CV events were excluded. Data were collected from medical records at a single visit between Jun '17–Nov '18, including LLT and most recent LDL-C. Primary outcome was LDL-C goal attainment ≥28 days after starting most recent LLT (treatment-stabilised LLT). Results Of 5888 patients enrolled, 2794 met our definition of atherosclerotic cardiovascular disease (ASCVD). Of these ASCVD patients, 1036 (37%) had PAD. 31% (323/1036) of PAD patients were female and mean (SD) age was 69 (9.4) years. Concomitant CV risk factors included diabetes mellitus (473/1036 patients [46%]), hypertension (809/1036 [78%]) and smoking (794/1036 [77%]). 26% (271/1036) of patients with PAD also had coronary vascular disease and 12% (122/1036) also had cerebrovascular disease. At the visit date, approximately half (497/1036 [48%]) of all PAD patients were receiving moderate intensity statins and 41% (421/1036) were receiving high intensity statins. 818 (73%) of the PAD patients had a treatment-stabilised LDL-C measurement (median, 2.20 mmol/L), of whom 40% (326/818) achieved the 2016 EAS/ESC LDL-C goal of 1.8 mmol/L and only 19% (159/818) achieved the 2019 goal of 1.4mmol/L. Conclusions European patients with PAD are not treated as per EAS/ESC recommendations, with a large proportion receiving suboptimal LLT and fewer than half achieving target LDL-C levels. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Amgen

The current LDL-C target <1.4mmol/l of the ESC is achieved in less than 16% of patients with Coronary Heart Disease despite effective lipid-lowering therapy: data from the LLT-R registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Noack ◽  
B Schwaab ◽  
H Voeller ◽  
K Eckrich ◽  
M Guha ◽  
...  
Keyword(s):  
Coronary Heart Disease ◽  
Heart Disease ◽  
Cardiac Rehabilitation ◽  
Lipid Lowering ◽  
Funding Source ◽  
Lipid Lowering Therapy ◽  
Pcsk9 Inhibitors ◽  
Lowering Therapy ◽  
Rehabilitation Clinic

Abstract Background In the current guideline of the ESC, in patients with very high cardiovascular risk such as coronary heart disease (CHD) a treatment target for LDL-C &lt;1.4mmol/l and/or a halving of the initial value are defined. It is unclear whether these treatment targets are achievable with standard therapy including statins and/or ezetemibe. Methods The primary objective of this prospective, multi-centre register study was the question of the guidance-based adaptation and adherence to lipid-lowering therapy during and after a cardiac rehabilitation in 1,100 patients with CHD up to 12 months after discharge from the six rehabilitation clinics involved. Patients were included from 2016 to 2018. Results The median age of the 1,100 patients was 63.4±10.4 years, the mean BMI was 28.5±4.7kg/m2, and 24.1% of patients were female. 12.2% were active smokers, 91.6% reported dyslipoproteinemia, 33.9% suffered from diabetes mellitus and 86.5% from hypertension. The majority of patients were included with the main indications NSTEMI (31.6%), STEMI (29.6%) and after CABG surgery (26.4%). The proportion of patients treated with statins was more than 94% when admitted and discharged from the rehabilitation clinic, as well as in 3- and 12-months follow-ups. Approximately 9% of patients were treated with ezetemibe at baseline. On discharge from the rehabilitation clinic 23% of patients were treated with ezetemibe, which remains stable at 3 and 12 months. PCSK9 inhibitors were used in 0.1–0.3% of patients at all times. The adjustment of LLT during three week cardiac rehabilitation resulted in median LDL-C values of 2.27mmol/l (1.80/2.84) at baseline, 1.97mmol/l (1.57/2.47) on discharge (p&lt;0.001 compared to baseline), 1.94mmol/l (1.57/2.49) after three months and 1.94mmol/l (1.53/2.40) after 12 months. The proportion of patients with LDL-C &lt;1.4mmol/l was 9% at baseline, 15.7% on discharge (p&lt;0.001 compared to baseline), 15.6% at three-month follow-up and 15.1% at 12-month follow-up (Figure 1). Discussion In the context of cardiac rehabilitation, an effective adjustment of LLT is carried out, which resulted in a significant reduction of LDL-C. However, despite a high percentage of patients on statins and ezetemibe, the proportion of patients in the new target range &lt;1.4mmol/l was only achievable in a small percentage and the question arises whether these treatment targets can be achieved without additional administration of PCSK9 inhibitors in majority of patients with CHD. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was supported by an unrestricted grant from Sanofi-Aventis Germany.

Differences in lipid treatment patterns in women versus men in a large cohort of patients with atherosclerotic cardiovascular disease in Ontario, Canada

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Fairbairn ◽  
R Goeree ◽  
S.G Goodman ◽  
R.M Rogoza ◽  
M Packalen ◽  
...  
Keyword(s):  
High Intensity ◽  
Lipid Lowering ◽  
Moderate Intensity ◽  
Data Repository ◽  
Funding Source ◽  
Atherosclerotic Cardiovascular Disease ◽  
Treatment Goals ◽  
Private Company ◽  
Male Patients

Abstract Background/Introduction The prevalence of ischaemic heart disease is lower in women vs men in Canada. Studies have shown that women are more likely to be underdiagnosed and less likely to receive guideline-recommended treatments than men. Women receiving lipid-lowering therapies (LLTs) are also less likely to attain treatment goals vs men. Purpose We analysed use of LLTs and attainment of low-density lipoprotein cholesterol (LDL-C) treatment goals in a recent longitudinal cohort of patients with ASCVD with public drug coverage in Ontario to describe differences observed between female and male patients. Methods Patients ≥65 years with a primary ASCVD event/procedure between 1 Apr 2005 and 31 Mar 2016, treated with an LLT and with index and follow up LDL-C values were identified from claims data at the Institute for Clinical Evaluative Sciences data repository. Patients were assessed over a 1 year follow up period for LDL-C goal attainment (&lt;2.0 mmol/L or 50% reduction from index LDL-C as per Canadian Cardiovascular Society Guidelines) and analysed by LLT category. Results 143,302 patients with ASCVD ≥65 years on LLTs were identified of which 41% were female. A higher proportion of female vs male patients were prescribed low (3% vs 2%) and medium intensity statins (51% vs 44%) compared with high intensity statins (43% vs 52%). A higher proportion of women failed to attain LDL-C goal compared to men (33% vs 24%) (Figure). When analysed by low, moderate or high intensity statin, 65%, 35%, and 27% of female patients and 49%, 25% and 19% of male patients failed to attain LDL-C goal at follow up. Conclusions In this retrospective study, women with a diagnosis of ASCVD were more frequently treated with low/moderate intensity statins whereas men were more frequently treated with high intensity statins. Approximately 2 of 3 women and 3 of 4 men receiving statin treatment attained LDL-C goal during the 1-year follow up period. Overall, there appear to be treatment differences between female and male patients with ASCVD, with males receiving higher intensity statin therapy and attaining LDL-C goal more frequently. Further research is needed to determine why these discrepancies exist. This study made use of de-identified data from the ICES Data Repository, which is managed by the Institute for Clinical Evaluative Sciences with support from its funders and partners: Canada's Strategy for Patient-Oriented Research (SPOR), the Ontario SPOR Support Unit, the Canadian Institutes of Health Research and the Government of Ontario. The opinions, results and conclusions reported are those of the authors. No endorsement by ICES or any of its funders or partners is intended or should be inferred. Parts of this material are based on data and/or information compiled and provided by CIHI. However, the analyses, conclusions, opinions and statements expressed in the material are those of the author(s), and not necessarily those of CIHI. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Amgen Canada Inc

Non-statin lipid-lowering therapy in coronary atherosclerosis regression: a meta-analysis and meta-regression

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L.M Lobo ◽  
G Molinero ◽  
W Masson ◽  
D Siniawski ◽  
G Masson ◽  
...  
Keyword(s):  
Coronary Atherosclerosis ◽  
Meta Analysis ◽  
Lipid Lowering ◽  
Forest Plot ◽  
Lipid Lowering Therapy ◽  
Pcsk9 Inhibitors ◽  
Lowering Therapy ◽  
Meta Regression ◽  
Statin Drugs

Abstract Introduction Several studies have investigated the association between non-statin lipid-lowering therapy and regression of atherosclerosis. However, the studies were mostly small and their results were not always robust. Objectives (1) to define if a dual lipid-lowering therapy (statin ± non-statin drugs) is associated with coronary atherosclerosis regression, estimated by intravascular ultrasound (IVUS); (2) to assess the association between dual lipid-lowering-induced changes in LDL-C and non-HDL-C levels and atherosclerosis regression. Methods We performed a meta-analysis including trials of non-statin lipid-lowering therapy, reporting C-LDL, non-HDL-C and total atheroma volume (TAV) with a minimum of 6 months of follow-up. The primary endpoint was defined as the change in TAV measured from baseline to follow-up, comparing groups of subjects on statins alone versus combination of statin and non-statin drugs. The random-effects model and meta-regression were performed. Results Eight eligible trials of non-statin lipid-lowering drugs (1759 patients) were included. Overall, the dual lipid-lowering therapy was associated with a significant reduction in TAV [−3.5 mm3 (95% CI: −4.5 to −2.6)]; I2=11%]. In the analysis stratified according to the lipid-lowering drug class (ezetimibe or PCSK9 inhibitors), the findings were similar. In a meta-regression, a 10% decrease in LDL-C or non-HDL-C levels, was associated, respectively, with 0.92 mm3 and 1.05 mm3 regressions in TAV. Conclusion Our data suggest the addition of ezetimibe or PCSK9 inhibitors to statin therapy results in significantly increased regression of TAV. When the LDL-C and non-HDL-C levels reached were lower, the observed effect was also greater. Forest Plot by Drugs Group Funding Acknowledgement Type of funding source: None

scholarly journals PCSK9 Inhibitors in Clinical Practice: Experience of a Specialized Lipid Center

2022 ◽  
Vol 17 (6) ◽  
pp. 808-815
Author(s):  
A. V. Blokhina ◽  
A. I. Ershova ◽  
A. S. Limonova ◽  
O. V. Kopylova ◽  
A. N. Meshkov ◽  
...  
Keyword(s):  
High Intensity ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Lipid Lowering ◽  
Lipid Lowering Therapy ◽  
Pcsk9 Inhibitors ◽  
Lipid Clinic ◽  
Lowering Therapy ◽  
Lipid Metabolism Disorders ◽  
Very High

Aim. To characterize patients receiving PCSK9 inhibitors, and assess the efficiency of their treatment in a specialized lipid center.Material and methods. A retrospective analysis of the medical records of patients who visited the Lipid clinic of the National Medical Research Center for Therapy and Preventive Medicine (Moscow, Russia), receiving PCSK9 inhibitor and having lipid profile in dynamics, was carried out (n=77). Cardiovascular risk (CVR) and low-density lipoprotein cholesterol (LDL-C) target levels were evaluated in accordance with the Russian guidelines for the diagnostics and correction of dyslipidemias 2020.Results. Of 77 patients taking PCSK9 inhibitors (44.2% males, the median of age 56 [47; 66] years), the majority (64.0%) had a probable or definite familial hypercholesterolemia (FH). The proportion of other lipid metabolism disorders, pure hypercholesterolemia and combined hyperlipidemia was 21% and 15%. More than half of the patients (68.8%) had a very high CVR, mainly due to the presence of coronary heart disease (84.9%). The proportion of patients receiving PCSK9 inhibitors as monotherapy was 7.8%, in combination with high-intensity statin therapy – 33.8%, as part of triple lipid-lowering therapy (high-intensity statin, ezetimibe, PCSK9 inhibitors) – 50.6%. Addition of PCSK9 inhibitors to combined lipid-lowering therapy enabled to reduce the LDL-C level to 1.02 [0.62; 1.39] mmol/l with its total decrease from the baseline by 87.3%. While taking PCSK9 inhibitors, LDL-C <1.8 mmol/l and <1.4 mmol/l achieved at 78.3% and 57.7% FH patients with high and very high CVR, respectively. Among patients with other hyperlipidemias, 74.1% of patients with very high CVR was achieved the target LDL-C level <1.4 mmol/l.Conclusion: In a specialized lipid center, PCSK9 inhibitors are prescribed to patients with high or very high CVR, most of whom are FH patients. The effectiveness of the use of PCSK9 inhibitors in real-world practice is comparable to the results of clinical trials.

scholarly journals Patient"s awareness of recommended LDL-C goals in primary prevention and observed achievement

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
A Ioannidis ◽  
A Pechlevanis ◽  
M Paraskelidou ◽  
D Lakias
Keyword(s):  
Primary Prevention ◽  
Risk Score ◽  
Lipid Lowering ◽  
Moderate Intensity ◽  
Lipid Lowering Therapy ◽  
The Novel ◽  
Pcsk9 Inhibitor ◽  
Prevention Measure ◽  
Very High ◽  
Risk Categories

Abstract Funding Acknowledgements Type of funding sources: None. Introduction The novel 2019 ESC/EAS Guidelines on lipids recommend more intensive reduction on LDL-C across CV risk categories in comparison with the 2016 edition. Purpose This cross-sectional observation study aims to assess whether patients on lipid lowering therapy, as a primary prevention measure, are aware of the new set goals and if they achieved them. Methods Patients, taking currently any statin as a primary prevention measure, visiting the Emergency Department of a tertiary hospital in northern Greece were invited to participate by answering a short questionnaire followed by a phone call to provide the exact lab results or other details. Results In total 412 eligible patients (54.1% female) were enrolled from January to October 2020 (mean age 61 ± 13 years old). Mean duration of statin prescription was about 8 years (7.8 ± 5 years). The majority (381, 92.5%) of patients reported lab tests yearly while most of them (394, 95.6%) were being followed up in outpatient clinics or private offices. Patients were allocated into CV categories: low (48, 11.7%), medium (239, 58.0%), high (108, 26.2%) and very high (17, 4.1%). The estimated 10-year risk of CV death was calculated using SCORE. Almost two thirds of the patients (282, 68.4%) were taking moderate intensity statins (as monotherapy) while one out of ten (45, 10.9%) was taking a statin plus ezetimibe combination. No patient was prescribed a PCSK9 inhibitor. Only two out of five (171, 41.5%) patients reached the LDL-C goal, though differences were noted between risk categories with almost half of the low and medium CV risk patients achieving the desired LDL-L level: low (23, 47.9%), medium (124, 51.9%), high (21, 19.4%) and very high (3, 17.6%). No significant difference was observed in terms of potency of statin. As expected, patients taking a statin and ezetimibe combination achieved lower LDL-C levels, with almost two thirds (31 out of 45 patients, 68.9%) reaching the goal. No information could be collected regarding why patients not reaching the goal were not offered a statin of higher potency and/or dosing, a combination with ezetimibe or a PCSK9 inhibitor. Disturbingly enough, none of the patient was aware that the LDL-C goals recommended by scientific societies had been lowered in 2019, while only 29 patients (7.0%) could recall discussing LDL-C goals with their physician. Moreover, merely three patients could remember the calculation of any CV risk score. The majority of the patients (379, 92.0%) reported that they would like to know their personal CV risk score and their LDL-C goal. Conclusions Greek primary prevention patients taking statins are overall unaware of the novel set LDL-C goals and it seems that they have not been offered a total CV risk score assessment. Hardly acceptable attainment of LDL-C goals was observed. Further research is warranted to assess the barriers that obstruct a satisfactory goal achievement. Abstract Figure.

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