scholarly journals A real-world assessment of treatment patterns in patients with atherosclerotic cardiovascular disease with hypercholesterolemia: a retrospective database analysis in Germany

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
I Gouni-Berthold ◽  
D Seshagiri ◽  
R Studer ◽  
S Klebs ◽  
A Achouba ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Real World ◽  
Treatment Patterns ◽  
Lipid Lowering ◽  
Atherosclerotic Cardiovascular Disease ◽  
Pcsk9 Inhibitors ◽  
Private Company ◽  
General Physician ◽  
Statin Monotherapy ◽  
The Mean

Abstract Background The European Society of Cardiology (ESC) guidelines suggest that greater absolute reduction in low-density lipoprotein cholesterol (LDL-C) leads to greater cardiovascular risk reduction. Several lipid-lowering treatments (LLTs) are available in Germany; however, the research on treatment patterns and LDL-C outcomes among patients (pts) receiving LLTs in real-world setting is limited. Purpose To characterize the pts characteristics, treatment patterns and LDL-C outcomes of pts with atherosclerotic cardiovascular disease (ASCVD) with hypercholesterolemia (ASCVD-H) in Germany. Methods This is a descriptive, non-interventional, retrospective cohort study of ASCVD-H pts identified from general physician (GP) practices available in the electronic medical record (EMR) database Disease Analyzer (January 1992-June 2020) in Germany. ASCVD-H pts were included if they had a recorded diagnosis, were prescribed LLTs or had LDL-C levels of ≥55 mg/dL anytime within 6 months before and 3 months after the index date (ID), as per the data recorded by the participating physician. The first encounter of ASCVD after hypercholesterolemia during the identification period (1/07/2015–30/06/2019) was considered as the ID. Persistence was measured as the duration (in days) with allowed gap of 60 days and adherence as proportion of days covered (PDC) within 12 and 24 months after ID. Results We included 147,905 pts with ASCVD-H (57.2% male; mean age: 70.6 yrs; ≥75 yrs-old: 43.3%; mean BMI: 29.0 kg/m2). Coronary artery disease was the most common index diagnosis (73.2%), followed by cerebrovascular disease (31.7%) and peripheral vascular disease (21.5%). Hypertension (83.5%) and diabetes (27.6%) were the most common comorbidities among these pts. At ID, statin monotherapy (58.6%) was the most commonly prescribed LLT, with simvastatin being the most common drug (36.4%). The use of PCSK9 inhibitors, ezetimibe and fibrates was very limited (<1%; Table 1). Of note, LDL-C measurements (6 months prior and 3 months post index) were available for 50.7% of pts. In pts with uncontrolled LDL-C (≥55 mg/dL), 47.9% were receiving statin monotherapy (28.6% were on simvastatin), whereas there was no LLT prescribed in 48.0% of pts. The mean (SD) persistence and adherence to statins monotherapy within 24 months follow-up was 522 (260) days and 0.721 (0.345), respectively, with 60% of pts being adherent (PDC ≥0.80) to statins monotherapy. Conclusions Pts with ASCVD-H in Germany treated by GPs are elderly pts with multiple cardiovascular comorbidities. LDL-C was measured in nearly half of the pts, and almost all had LDL-C ≥55 mg/dL at ID. Findings indicate low prescription of LLTs in GP setting, particularly non-statin LLTs. The mean adherence (PDC) to statin monotherapy was 72% within the 24-month after ID. Data suggest the need for newer therapies with potential to control LDL-C levels. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Novartis Pharma AG, Basel, Switzerland.

scholarly journals Treatment patterns in patients with Familial hypercholesterolemia: evidence from real-world studies in Germany and the UK

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
I Gouni-Berthold ◽  
D Seshagiri ◽  
R Studer ◽  
A Durand ◽  
S Klebs ◽  
...  
Keyword(s):  
Familial Hypercholesterolemia ◽  
Real World ◽  
Treatment Patterns ◽  
Lipid Lowering ◽  
Clinical Practice Research Datalink ◽  
Private Company ◽  
Statin Monotherapy ◽  
The Mean ◽  
The Uk

Abstract Background Familial hypercholesterolemia (FH) includes a spectrum of disease as per the number and effect of mutations in specific proteins involved in low-density lipoprotein cholesterol (LDL-C) metabolism, together with other genetic factors. Elevated LDL-C levels have been strongly associated with risk of cardiovascular and coronary heart disease, with up to 10-fold risk in patients (pts) with FH than without FH. The aim of lipid-lowering treatments (LLTs) is to reduce the LDL-C levels, although there is limited research describing treatment patterns and LDL-C outcomes in FH pts in routine care. Purpose To characterize the treatment patterns and LDL-C outcomes of FH pts in the real-world setting in Germany (GER) and the UK. Methods We conducted two descriptive, non-interventional and retrospective cohort studies. Pts in GER were identified from General Physician (GP) and Cardiology practices available in electronic medical records database Disease Analyzer (January 1992-June 2020). Pts in the UK were identified from the Clinical Practice Research Datalink linked to the Hospital Episode Statistics admitted pts care and Office of National Statistics datasets. Pts were included if they had diagnosis of FH (index date [ID]) and data available within 6-month before and 3-month after the ID. The first diagnosis of FH in the identification period (GER, 1/07/2015–30/06/2019; UK, 01/01/2010–31/05/2018) was considered the ID. Persistence and adherence to the recorded LLT at ID was analyzed for pts with at least 12 months and 24 months of follow-up. Persistence was measured as the duration (in days) with allowed gap of 60 days and adherence as proportion of days covered (PDC). Results Analysis included 2,105 FH pts from GER and 9,846 from the UK. Data are presented as GER/UK. The mean (SD) age of pts was 60 (15)/52 (14) years, and 60%/61% were females. Hypertension (53%/27%) and depression (31%/38%) were the common comorbidities. At ID, statin monotherapy (29%/68%) was the most commonly prescribed LLT. The use of ezetimibe, fibrates and PCSK9 inhibitors was very low in both countries (Table 1). Of note, LDL-C measurements at ID (−6m/+3m) were available for 31%/73% of pts. In pts with uncontrolled LDL-C (≥55 mg/dL), 34%/64% were receiving statin monotherapy, whereas there was no use of LLT in 62%/29% of pts. During the 24 months follow-up, the mean (SD) persistence and PDC to statins monotherapy was 471 (264)/489 (289) days and 0.65 (0.36)/0.69 (0.46), respectively, with 50%/70% of pts being adherent (PDC ≥0.80). Conclusions In our study, in GER, the rate of LDL-C measurements was low. In both GER and UK, almost all measured patients had LDL-C ≥55mg/dL at ID. Findings indicate low prescriptions of LLTs in GP setting, particularly non-statin LLTs in both countries. The mean adherence (PDC) in GER and the UK was 65% and 69%, respectively within 24 months after ID. Improved LDL-C monitoring and new therapies with potential to lower LDL-C are warranted. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Novartis Pharma AG, Basel, Switzerland

scholarly journals Real-world use of PCSK9 inhibitors: A single-center experience

2018 ◽  
Vol 47 (1) ◽  
pp. 265-270 ◽  
Author(s):  
Sinan Sarsam ◽  
Abeer Berry ◽  
George Degheim ◽  
Robby Singh ◽  
Marcel Zughaib
Keyword(s):  
Cardiovascular Disease ◽  
Lipid Profile ◽  
Real World ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Lipoprotein Cholesterol ◽  
Atherosclerotic Cardiovascular Disease ◽  
Pcsk9 Inhibitors ◽  
Pcsk9 Inhibitor ◽  
The Impact

Objective Hyperlipidemia is an important risk factor for atherosclerotic cardiovascular disease. Many patients are intolerant to or have limited benefit from statins. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been approved for treating hyperlipidemia in these patients. We sought to investigate the impact of these medications in a real-world cardiology practice. Methods This was a retrospective study of 17 patients with either heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease with low-density lipoprotein cholesterol (LDL-C) levels above the treatment target despite maximally tolerated statins. Baseline lipid profile was compared with a repeat lipid profile obtained 4 to 6 weeks after initiating treatment with a PCSK9 inhibitor. Results The average duration of PCSK9 inhibitor treatment was 10.7 months. Lipid profile comparison showed that total cholesterol decreased from 243 ± 72 to 148 ± 39 (mg/dL) (39% reduction), triglycerides decreased from 185 ± 86 to 149 ± 62 (mg/dL) (19.5% reduction), high-density lipoprotein cholesterol increased from 56 ± 20 to 62 ± 26 (mg/dL) (10.7% increase), and LDL-C decreased from 154 ± 30 to 57 ± 32 (mg/dL) (63% reduction) from baseline. Conclusions PCSK9 inhibitors as add-on therapy to maximally tolerated statins resulted in an approximately 63% reduction in LDL-C.

scholarly journals Potential use of PCSK9 inhibitors as a secondary preventative measure for cardiovascular disease following acute coronary syndrome: a UK real-world study

2019 ◽  
Vol 95 (1120) ◽  
pp. 61-66 ◽  
Author(s):  
Ahmed Farouk Mohamed Elamin ◽  
Ciaran Grafton-Clarke ◽  
Kai Wen Chen ◽  
Toba Obafemi ◽  
Ahai Luvai ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Statin Therapy ◽  
Real World ◽  
Density Lipoprotein ◽  
Lipid Lowering ◽  
Lipid Lowering Therapy ◽  
Pcsk9 Inhibitors ◽  
Lipid Management ◽  
Coronary Syndrome ◽  
Potential Use

BackgroundProprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are a major development in the prevention of cardiovascular disease (CVD) and is one of the most significant discoveries since the development of statin therapy. Administration of two human monoclonal antibodies to PCSK9 (alirocumab and evolocumab) can significantly reduce low-density lipoprotein cholesterol (LDL-c) concentrations, thus improving lipid management. Accordingly, guidelines on the specific indications for alirocumab and evolocumab usage have been released. This multicentre study aimed to estimate the proportion of patients treated for an acute myocardial infarction (MI) who could be considered for PCSK9 inhibitors under the current National Institute for Health and Care Excellence (NICE) lipid targets criteria.MethodsThe records of 596 patients in two large hospitals in Liverpool, UK were analysed. Information was collected on lipid profiles during and after admission, lipid-lowering therapy and previous CVD.ResultsAt least 2.2% of patients were eligible for PCSK9 inhibitors post-MI under the current NICE guidance. Additionally, 29% of patients failed to achieve LDL-c concentrations <2.0 mmol/L despite maximum statin therapy and failed to meet eligibility for PCSK9 inhibitors as per the NICE criteria. This cohort represents a group of patients ‘in limbo’, in which statin therapy alone is not sufficient to reduce LDL-c.ConclusionsPCSK9 inhibitors are expensive and so their use must be highly selective. At present, in a real-world setting with ezetimibe underprescribing, ~2% of patients are eligible and a further 30% are deprived of benefit and improved outcomes by lack of optimisation and/or potential use of PCSK9 inhibitors.

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 &lt;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 &lt;1.4mmol/L during follow-up. Among pts receiving background statins ± ezetimibe at evolocumab initiation, 67% (710/1053) achieved at least one LDL-C &lt;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 &gt;50% reduction in LDL-C, only ∼50% pts achieved an LDL-C &lt;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

Abstract 338: Patterns of Lipid Lowering Medication Use among Patients with Atherosclerotic Cardiovascular Disease

2015 ◽  
Vol 8 (suppl_2) ◽  
Author(s):  
Peter P Toth ◽  
Xuehua Ke ◽  
Zhenxiang Zhao ◽  
Nicole Bonine ◽  
Mark J Cziraky ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Health Plan ◽  
High Intensity ◽  
Index Date ◽  
Prescribing Patterns ◽  
Lipid Lowering ◽  
Dose Titration ◽  
Atherosclerotic Cardiovascular Disease ◽  
Statin Monotherapy

Background: The 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines for the treatment of hypercholesterolemia marked a departure from previously established guidelines in regards to pharmacologic therapy. This study identified patients with atherosclerotic cardiovascular disease (ASCVD) using the new guidelines, and examined their patterns of lipid lowering medication (LLM) use in a real-world environment. Methods: This retrospective cohort study utilized claims data from the HealthCore Integrated Research Database (HIRD SM ). Newly diagnosed ASCVD patients aged ≥18 years were identified between 1/1/2007 and 11/30/2012 (index date=first ASCVD diagnosis date). Patients had both ≥ 12 months pre- and post- index health plan enrollment and no LLM use at baseline. Index LLM was identified based on earliest fill of LLM within 6 months after the index date. Index LLM dose titration, discontinuation, switch, and augmentation were examined among monotherapy initiators only. Descriptive statistics were used to examine patterns of LLM use at 12 and 36 months follow-up among all patients and those with ≥36 months post-index health plan enrollment respectively. Results: The study identified 128,017 ASCVD patients with a mean age of 59 years, 43.1% (55,136 of 128,017) female, and 48.8% (62,493 of 128,017) with ≥36 months follow-up. Within 6 months after the index date, 7.8% (9,929 of 128,017) initiated high-intensity statin monotherapy; 27.8% (35,634 of 128,017) moderate/low-intensity statin monotherapy; 1.6% (2,024 of 128,017) non-statin monotherapy; 1.4% (1,770 of 128,017) combination therapy; and 61.4% (78,660 of 128,017) had no fills for any LLM. Among monotherapy initiators over 12 and 36 months follow-up, 8.8% (4,180 of 47,587) and 12.4% (2,635 of 21,198) had up-titration of index LLM, 54.5% (25,938 of 47,587) and 77.8% (16,488 of 21,198) discontinued index LLM, 9.6% (4,579 of 47,587) and 13.9% (2,935 of 21,198) switched their index LLM, and 3.0% (1,403 of 47,587) and 2.8% (586 of 21,198) augmented index LLM. Among all patients over 12 and 36 months follow-up, 41.4% (53,049 of 128,017) and 49.7% (31,057 of 62,493) had statins, 10.6% (13,522 of 128,017) and 13.0% (8,134 of 62,493) had high-intensity statins, 5.8% (7,361of 128,017) and 12.8% (7,989 of 62,493) had ≥2 types of statins, 4.9% (6,253 of 128,017) and 9.3% (5,798 of 62,493) had both statins and non-statin LLMs, and 56.9% (72,897 of 128,017) and 47.9% (29,923 of 62,493) had no LLM. Conclusions: Few patients initiated a high-intensity statin within 6 months of ASCVD diagnosis and at 12 months and 36 months follow-up. Our findings suggest that treatment for ASCVD patients was not optimal in relation to the recent ACC/AHA guideline recommendations and significant modifications in prescribing patterns should be made towards use of high-intensity statins to improve treatment outcomes.

scholarly journals Intensified lipid-lowering treatment with alirocumab in patients with coronary heart disease

Open Heart ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. e001572
Author(s):  
Daniel Steffens ◽  
Peter Bramlage ◽  
Julia Müller ◽  
Cornelia Dorn ◽  
W Dieter Paar ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Coronary Heart Disease ◽  
Heart Disease ◽  
Real World ◽  
Familial Hypercholesterolaemia ◽  
Phase Iii ◽  
Lipid Lowering ◽  
Atherosclerotic Cardiovascular Disease ◽  
Statin Intolerance ◽  
Real World Setting

BackgroundAtherosclerotic cardiovascular disease is the leading cause of death and disability in the Western world.ObjectiveTo characterise adults with confirmed coronary heart disease (CHD) and primary heterozygous familial or non-familial hypercholesterolaemia or mixed dyslipidaemia who received alirocumab in a real-world setting.MethodsThis open, prospective, multicentre, non-interventional study, conducted in Germany, enroled patients with confirmed CHD who were treated with alirocumab according to its summary of product characteristics. Prescription was at the physician’s discretion and independent of study participation. Patients were followed for 12 weeks after alirocumab initiation.ResultsIn total, 245 patients (mean age 62.2 years; 34.0% female) were documented at 90 sites. Overall, 47.7% had familial hypercholesterolaemia, 48.9% non-familial hypercholesterolaemia and 43.8% mixed dyslipidaemia; 74.6% had hypertension and 29.2% diabetes mellitus. The most common lipid-lowering therapy in the 12 months preceding alirocumab was a statin, often in combination with ezetimibe (73.5%). Statin contraindications were documented for 46.2% patients and statin intolerance for 63.8%. The mean low-density lipoprotein cholesterol (LDL-C)-level prior to alirocumab was 150.5±51.6 mg/dL. Alirocumab prescription was in compliance with German national recommendations and/or European guidelines. The most common starting dose was 75 mg every other week. Overall, 57% patients reached target LDL-C levels (<70 mg/dL) after 12 weeks of treatment. Alirocumab was generally well tolerated.ConclusionIn a real-world setting in Germany, alirocumab was prescribed for patients with atherosclerotic cardiovascular disease who had high baseline LDL-C levels with or without statin intolerance. Efficacy and safety were consistent with findings observed in the ODYSSEY Phase III programme.

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