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 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

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 (<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

Resource utilization and costs associated with achieved LDL-C levels in patients following a myocardial infarction treated with lipid-lowering therapies in Spain

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Escobar Cervantes ◽  
I Campos Tapias ◽  
F Sorio Vilela ◽  
J Lozano ◽  
D.A Kahangire ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Resource Utilization ◽  
Resource Use ◽  
Index Date ◽  
Lipid Lowering ◽  
Funding Source ◽  
Private Company ◽  
Productivity Costs ◽  
Cv Disease

Abstract Background/Introduction Reduction in low-density lipoprotein cholesterol (LDL-C) significantly reduces cardiovascular (CV) risk, especially in patients with atherosclerotic CV disease. There is, however, a lack of evidence on the association between achieved LDL-C and resource utilization and costs. Purpose Assess the association of achieved LDL-C levels and resource use and costs in patients treated with lipid-lowering therapies (LLT) following a myocardial infarction (MI). Methods Retrospective observational study using the BIG-PAC® database, with anonymized electronic medical records from 1.9 million inhabitants from 7 regions in Spain. Eligible patients were adults (≥18 years), hospitalized for an MI (index date) between January 2015 and December 2017, treated with LLTs (statins and/or ezetimibe) during follow-up (up to 18 months), and with recorded LDL-C values at baseline and follow-up. Direct (related to health care interventions) and indirect (related to loss of productivity) costs were estimated in 2018€. Costs incurred during follow-up were computed by achieved LDL-C. Achieved LDL-C was obtained in the year following the MI and at least 2 months after the index date. LDL-C categories were defined as per the 2016 and 2019 ESC/EAS guidelines for dyslipidaemias management: <55 mg/dL, 55–69 mg/dL, 70–99 mg/dL, 100–129 mg/dL and ≥130 mg/dL. Results were adjusted for age, gender, CV disease history and comorbidities. Results 6025 patients were included. Mean age (SD) was 69.7 (12.2) and 77% were male. Resource use (not reported in this abstract) and costs monotonically increased with achieved LDL-C. Mean total costs ranged from 5044€ for patients with LDL-C <55 mg/dL to 7567€ for patients with LDL-C ≥130 mg/dL (Table 1). Only 11% (641/6025) of patients reached recommended LDL-C levels for very-high-risk patients as per 2016 ESC/EAS guidelines (<70 mg/dL), and 1% (68/6025) the LDL-C levels (<55 mg/dL) proposed in the 2019 guidelines. Conclusions Achieving lower LDL-C levels following an MI may be associated to lower resource use and costs. Many patients do not achieve recommended LDL-C levels despite treatment with LLT. These data suggest that use of more intense LLT, with a greater reduction in LDL-C, would be beneficial from a clinical and economic perspective. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Amgen (Europe) GmbH

Baseline triglycerides and non-HDL-C and apoB goal attainment in the ORION-10 and ORION-11 trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.K Ray ◽  
D Kallend ◽  
F.J Raal ◽  
R Stoekenbroek ◽  
W Koenig ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Goal Attainment ◽  
Therapeutic Option ◽  
Funding Source ◽  
Private Company ◽  
Atherogenic Dyslipidaemia ◽  
Secondary Endpoints ◽  
Cv Disease ◽  
Total Burden ◽  
The Impact

Abstract Introduction Elevated triglyceride (TG) levels contribute to the total burden of circulating atherogenic lipoprotein levels and are associated with increased cardiovascular (CV) risk. LDL-C underestimates risk in patients with elevated TG. Therefore, 2019 ESC/EAS guidelines recommend apoB or non-HDL-C as secondary lipid goals for patients with TG >150mg/dL. Purpose To assess the impact of inclisiran on apoB and non-HDL-C goal attainment across a range of TG levels among patients with atherosclerotic CV disease (ASCVD). Methods The ORION-10 and ORION-11 trials included 3178 patients with ASCVD and LDL-C >70mg/dl despite maximally tolerated statins randomized to inclisiran or placebo (1:1). Pre-specified secondary endpoints were placebo-corrected changes in lipids at Day 510. For this analysis patients were stratified by TG quartiles at baseline within each trial. The proportion of individuals attaining apoB <55 mg/dL or non-HDL-C <70mg/dl within each trial were assessed across TG strata and the likelihood of goal attainment within TG strata assessed using logistic regression. Results In ORION-10, TG quartiles were ≤94, 94 to ≤128, 128 to ≤181 and >181mg/dl respectively and in ORION-11 corresponding values were ≤101, 101 to ≤135, 135 to ≤183 and >183mg/dl. As compared to placebo a significantly greater proportion of patients randomised to inclisiran attained apoB goals within each TG strata (Table). Similar results were observed for non-HDL-C. Conclusion Among patients with ASCVD on maximally tolerated statin and high TG levels, attainment of apoB and non-HDL-C secondary lipid targets was more likely with inclisiran than placebo. Inclisiran may be a useful therapeutic option for patients with atherogenic dyslipidaemia. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The Medicines Company

scholarly journals Silent cerebral embolisation during TAVI: evolution, predictors and neurocognitive effects

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M De Carlo ◽  
R Liga ◽  
G.M Migaleddu ◽  
M Scatturin ◽  
C Spaccarotella ◽  
...  
Keyword(s):  
White Matter ◽  
Median Number ◽  
Funding Source ◽  
Private Company ◽  
Diffuse White Matter ◽  
Transcatheter Aortic Valve ◽  
Age Related ◽  
Cerebral Mri ◽  
Neurocognitive Evaluation

Abstract Background Most patients undergoing transcatheter aortic valve implantation (TAVI) develop silent cerebral ischemic lesions (SCIL) detectable at magnetic resonance imaging (MRI). The natural history and clinical relevance of SCIL are not well established. We aimed to assess the characteristics, predictors, evolution, and neurocognitive effects of SCIL. Methods Cerebral MRI was performed within 7 days before TAVI to assess baseline status and age-related white matter changes (ARWMC) score. MRI was repeated postoperatively to assess the occurrence, location, number and dimensions of SCIL. Patients developing SCIL underwent a third MRI at 3–5 months follow-up. A neurocognitive evaluation was performed before TAVI, at discharge and at 3-month follow-up. Results Of the 117 patients enrolled, 96 underwent a postprocedural MRI; SCIL were observed in 76% of patients, distributed in all vascular territories, with a median number of 2 lesions, median diameter 4.5 mm, and median total volume 140 mm3. Independent predictors of SCIL occurrence were a higher baseline ARWMC score and the use of self-expanding or mechanically-expanded bioprostheses. Among 47 patients who underwent follow-up MRI, only 26.7% of postprocedural SCIL evolved into a gliotic scar. SCIL occurrence was associated with a more pronounced transient neurocognitive decline early after TAVI and with a lower recovery at follow-up. Conclusions SCIL occur in the vast majority of patients undergoing TAVR and are predicted by a more diffuse white matter damage at baseline and by the use of non-balloon-expandable prostheses. Although most SCIL disappear within months, their occurrence has a limited but significant impact on neurocognitive function. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): unrestricted grants from Edwards Lifesciences SA, Nyon, Switzerland, and from Medtronic Italia SpA, Milan, Italy

Benefits of tafamidis in patients with advanced transthyretin amyloid cardiomyopathy

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Rapezzi ◽  
A.V Kristen ◽  
B Gundapaneni ◽  
M.B Sultan ◽  
M Hanna
Keyword(s):  
Disease Severity ◽  
Nyha Class ◽  
Funding Source ◽  
Class Iii ◽  
Private Company ◽  
Risk Of Death ◽  
6Mwt Distance ◽  
All Cause Mortality ◽  
Amyloid Cardiomyopathy

Abstract Background In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT), tafamidis was shown to be an effective treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Further assessment of the efficacy of tafamidis in patients with more advanced ATTR-CM would aid treatment decisions. Purpose To characterize the benefits of tafamidis in patients with advanced ATTR-CM. Methods In ATTR-ACT, ATTR-CM patients were randomized to tafamidis (n=264) or placebo (n=177) for 30 months. Efficacy outcomes included all-cause mortality and frequency of cardiovascular (CV)-related hospitalisations. Key secondary endpoints were change from baseline to Month 30 in 6MWT distance and KCCQ-OS score. Efficacy assessments in NYHA Class III patients at baseline (n=141) were a pre-specified analysis. In a post-hoc analysis, mortality and CV-related hospitalizations were assessed in all patients grouped into quartiles of increasing disease severity based on 6MWT distance at baseline. Longer-term all-cause mortality (as of 1 Aug 2019) was assessed in NYHA Class III patients utilizing data from ATTR-ACT patients who enrolled in a long-term, extension study (LTE) and continued treatment with higher dose tafamidis (n=55; median treatment duration 51.6 months); or, if previously treated with placebo, started tafamidis treatment (placebo/tafamidis; n=63 [50.1 months]). Results In advanced ATTR-CM patients (NYHA Class III), tafamidis reduced the risk of death (HR [95% CI] 0.837, [0.541, 1.295], P=0.4253), and the decline in 6MWT distance (LS mean [SE], 31.6 (22.1) m; P=0.1526) and KCCQ-OS score (LS mean [SE], 13.1 (5.0); P=0.0090), vs placebo. Paradoxically, there was a higher frequency of CV-related hospitalizations with tafamidis (RR [95% CI] vs placebo, 1.411 [1.048, 1.900]). In all patients by 6MWT quartile, CV-related hospitalizations/year with tafamidis and placebo increased with disease severity, with the exception that placebo-treated patients in the highest severity quartile had fewer CV-related hospitalisations (0.73) than those in the third quartile (0.92). Mortality with tafamidis and placebo increased, and was greater with placebo, in every quartile (Figure). Survival (NYHA Class III patients in ATTR-ACT and LTE) was improved with high dose tafamidis with longer term follow-up (HR vs placebo/tafamidis [95% CI], 0.6569 [0.4175, 1.0336]; P=0.0692). Conclusions These analyses, including longer-term follow-up, demonstrate that patients with advanced ATTR-CM benefit from tafamidis. The decrease in CV-related hospitalisations in more severe patients treated with placebo suggests that the comparatively greater hospitalisation frequency in NYHA Class III patients treated with tafamidis is a consequence of their lower mortality rate. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was sponsored by Pfizer

scholarly journals RNAi inhibition of angiopoietin-like protein 3 (ANGPTL3) with ARO-ANG3 mimics the lipid and lipoprotein profile of familial combined hypolipidemia

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G.F Watts ◽  
C Schwabe ◽  
R Scott ◽  
P Gladding ◽  
D Sullivan ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dose Response ◽  
Minimal Change ◽  
Funding Source ◽  
Private Company ◽  
Good Tolerability ◽  
Duration Of Action ◽  
Mixed Dyslipidemia ◽  
Genetic Deficiency

Abstract Background Elevated LDL-C and triglyceride rich lipoproteins (TRLs) are independent risk factors for cardiovascular disease (CVD). Genetic deficiency of angiopoietin-like protein 3 (ANGPTL3) is associated with reduced circulating levels of LDL-C, triglycerides (TGs), VLDL-C, HDL-C and reduced CVD risk, with no described adverse phenotype. ARO-ANG3 is a RNA interference drug designed to silence expression of ANGPTL3. Single doses of ARO-ANG3 have been shown to reduce ANGPTL3, TGs, VLDL-C and LDL-C in healthy volunteers (HVs, AHA 2019). We report the effects of multiple doses of ARO-ANG3 in HVs with a focus on the duration of action. Methods ARO-ANG3 was administered subcutaneously to HVs on days 1 and 29 at doses of 100, 200 or 300 mg (n=4 per group). Measured parameters included ANGPTL3, LDL-C, TGs, VLDL-C and HDL-C. Follow up is ongoing. Results All HVs have received both doses and follow-up is currently through week 16 (12 weeks after second dose). Mean nadir for ANGPTL3 levels occurred 2 weeks after the second dose (−83–93%) with minimal change for 200 and 300 mg but 16% recovery for 100 mg at week 16. Mean TGs and VLDL-C reached nadir earlier (3 wks, −61–65%) without apparent dose response and minimal change for any dose at wk 16. LDL-C nadir occurred 4–6 wks after the second dose (−45–54%), again with minimal evidence for dose response or change through wk 16. HDL-C was reduced 14–37% at wk 16. ARO-ANG3 was well tolerated without serious or severe adverse events or dropouts related to drug. The most common adverse events have been headache and upper respiratory infections. Conclusions Genetic deficiency of ANGPTL3 is a cause of familial combined hypolipemia and is associated with a decreased risk of CVD. Using RNAi to selectively suppress ANGPTL3 production reproduces these genetic effects with a duration of at least 12 weeks following a second dose and with good tolerability over 16 wks. ANGPTL3 inhibition results in lowering of LDL-C and TRLs which may confer protection against CVD in patients with atherogenic mixed dyslipidemia. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Arrowhead Pharmaceuticals

Low-density lipoprotein cholesterol goal attainment and treatment patterns in a cohort of >143,000 patients with atherosclerotic cardiovascular disease in Ontario, Canada

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Fairbairn ◽  
P Oh ◽  
R Goeree ◽  
R.M Rogoza ◽  
M Packalen ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Goal Attainment ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Data Repository ◽  
Funding Source ◽  
Atherosclerotic Cardiovascular Disease ◽  
Low Density ◽  
Low Density Lipoprotein Cholesterol

Abstract Background/Introduction Limited real-world data are available on attainment of low-density lipoprotein cholesterol (LDL-C) treatment goals in patients with atherosclerotic cardiovascular disease (ASCVD) in Canada. Purpose A retrospective observational study was conducted to describe types of ASCVD events/procedures, time between events and use of lipid lowering treatment (LLT) in patients who did not achieve LDL-C goal. Methods Patients in Ontario ≥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 (<2.0 mmol/L or 50% reduction from index LDL-C) and analysed by LLT and by index event type. Results Overall, 28% of 143,302 patients ≥65 years on LLT failed to attain LDL-C goal at follow up (Figure). The proportion of patients failing to achieve LDL-C goal decreased from 35% to 22% over the 11-year study period. Mean time between index and follow up LDL-C (based on lowest score >2 weeks and up to 1 year after index LDL-C) was 203±97 days. When analysed by low-, moderate- or high-intensity statin, 57%, 30%, and 22% of patients failed to achieve LDL-C goal at follow up, respectively. Conclusions In this study, more than 1 in 4 patients with ASCVD in Ontario failed to achieve guideline recommended LDL-C goal despite treatment. In particular, ∼1 in 3 patients with cerebral and peripheral arterial disease were not at goal. An opportunity exists to better manage these high risk ASCVD patients with further statin intensification and additional LLTs 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 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Amgen Canada Inc.

Relationship between country income, socioeconomic factors and control of cardiovascular disease risk factors in patients with type 2 Diabetes: insights from the global DISCOVER registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Malik ◽  
H Chen ◽  
A Cooper ◽  
M Gomes ◽  
V Hejjaji ◽  
...  
Keyword(s):  
Risk Factors ◽  
Type 2 Diabetes ◽  
Optimal Control ◽  
Risk Factor ◽  
Socioeconomic Factors ◽  
Funding Source ◽  
Risk Factor Control ◽  
Cv Disease

Abstract Background In patients with type 2 diabetes (T2D), optimal management of cardiovascular (CV) risk factors is critical for primary prevention of CV disease. Purpose To describe the association of country income and patient socioeconomic factors with risk factor control in patients with T2D. Methods DISCOVER is a 37-country, prospective, observational study of 15,983 patients with T2D enrolled between January 2016 and December 2018 at initiation of 2nd-line glucose-lowering therapy and followed for 3 years. In patients without known CV disease with sub-optimally controlled risk factors at baseline, we examined achievement of risk factor control (HbA1c <7%, BP <140/90 mmHg, appropriate statin) at the 3 year follow-up. Countries were stratified by gross national income (GNI)/capita, per World Bank report. We explored variability across countries in risk factor control achievement using hierarchical logistic regression models and examined the association of country- and patient-level economic factors with risk factor control. Results Among 9,613 patients with T2D but without CV disease (mean age 57.2 years, 47.9% women), 83.1%, 37.5%, and 66.3% did not have optimal control of glucose, BP, and statins, respectively, at baseline. Of these, 40.8%, 55.5%, and 28.6% achieved optimal control at 3 years of follow-up. There was substantial variability in achievement of risk factor control across countries (Figure) but no association of country GNI/capita on achievement of risk factor control (Table). Insurance status, which differed substantially by GNI group, was strongly associated with glycemic control, with no insurance and public insurance associated with lower odds of patients achieving HbA1c <7%. Conclusions In a global cohort of patients with T2D, a substantial proportion do not achieve risk factor control even after 3 years of follow-up. The variability across countries in risk factor control is not explained by the GNI/capita of the country. Proportion of patients at goal Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The DISCOVER study is funded by AstraZeneca

Baseline characteristics and follow-up outcomes in routine clinical practice patients categorised by renal function in the ETNA-AF-Europe registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R De Caterina ◽  
M Gwechenberger ◽  
A Bakhai ◽  
P Monteiro ◽  
P Kelly ◽  
...  
Keyword(s):  
Renal Function ◽  
Total Mortality ◽  
Haemorrhagic Stroke ◽  
Risk Scores ◽  
Funding Source ◽  
Private Company ◽  
Group I ◽  
Baseline Characteristics ◽  
Event Rates

Abstract Background Edoxaban is an oral factor Xa inhibitor anticoagulant with 50% renal clearance, and proven efficacy and safety in patients (pts) with atrial fibrillation (AF). The post-authorisation, observational, ETNA-AF-Europe registry (NCT02944019) assessed the risks and benefits of edoxaban in pts with AF from 10 European countries. Purpose Evaluate baseline characteristics and event rates in pts categorised by creatinine clearance (CrCl) at 1-year follow-up of the ETNA-AF-Europe registry. Methods In this analysis, pts were divided into three groups according to CrCl: ≤50 ml/min (I), 50–80 mL/min (II) and ≥80 mL/min (III) (calculated using Cockcroft-Gault). Outcomes were descriptively analysed. Results Pts with the lowest CrCl (Group I) were mostly females, and had a higher mean age, lower body weight, higher stroke and bleeding risk scores and were considered more frail than those with higher CrCl (Groups II and III) (Table). Group I experienced higher rates of stroke or SEE, major or CRNM bleeding, cardiovascular death, and had a higher total mortality (Figure). Rates of intracranial haemorrhage (ICH) and haemorrhagic stroke (intracerebral and subarachnoid haemorrhage) were low and similar in pts across the range of CrCl. Conclusions Those with lower CrCl had more comorbidities and higher event rates than those with higher CrCl, with the exception of ICH and haemorrhagic stroke. A steep rise in the proportion of pts perceived as frail and in overall mortality in the lowest renal function tertile, raises the question whether low renal function is a determinant or a correlate of mortality. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo Europe GmbH, Munich, Germany

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