scholarly journals What potential risk reduction could be achieved with evolocumab treatment? A simulation based on observational data from a cohort of users in 10 European countries

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.K Ray ◽  
I Bridges ◽  
E Bruckert ◽  
B Van Hout ◽  
M Sibartie ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Risk Reduction ◽  
Potential Risk ◽  
Real World ◽  
European Countries ◽  
Lipid Lowering ◽  
Funding Source ◽  
Lipid Lowering Therapy ◽  
Simulation Based

Abstract Background/Introduction The FOURIER trial enrolled very high-risk patients with a mean LDL-C of 2.5 mmol/L, and demonstrated that evolocumab reduced major cardiovascular events by 1.5% in absolute terms over 2.2 years. Further research may be conducted to understand the potential benefits of evolocumab in the real world. Purpose Predict/simulate baseline CV risk and assess potential risk reduction among a large European cohort of evolocumab users. Methods We used interim data from an observational study of patients initiating evolocumab across 10 European countries from August 2015 with follow-up through October 2019. Demographic and clinical characteristics, lipid-lowering therapy (LLT) and lipid values were collected from routine medical records (6 months prior to evolocumab initiation through 30 months post initiation). For each patient, we 1) predicted/simulated their 10-year CV risk using three different approaches: i) a prediction using REACH score, ii) a simulation based on FOURIER trial patients, iii) a simulation based on real-world FOURIER-like patients from a published obervational study; 2) calculated their absolute LDL-C reduction on evolocumab treatment; 3) simulated their relative risk reduction (RRR) by randomly sampling from the probability distribution of the rate ratio per 1 mmol/L from the key secondary endpoint in the FOURIER trial landmark analysis; 4) calculated their absolute risk reduction (ARR). Results Our analysis included 779 patients initiating evolocumab in clinical practice per local reimbursement criteria, with up to 18 months follow-up. Mean (SD) age was 62.7 (9.6) years and mean (SD) baseline LDL-C was 3.85 (1.39) mmol/L. Mean (SD) absolute LDL-C reduction on evolocumab was 2.1 (1.2) mmol/L. Predicted/simulated 10-year CV risk, RRR and ARR are presented in Table 1. Simulated probability distributions (based on FOURIER) for 10-year CV risk before and after evolocumab treatment are shown in Figure 1. Conclusion(s) This cohort of evolocumab users in clinical practice had an almost 2-fold higher baseline LDL-C than patients enrolled in FOURIER trial, which translated to higher baseline CV risk. For that reason, the estimated 10-year absolute benefit in this cohort was larger than expected based on FOURIER trial results. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Amgen

scholarly journals Potential cardiovascular risk reduction with evolocumab in the real world: a simulation in patients with a history of myocardial infarction from the HEYMANS register

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
K Ray ◽  
I Bridges ◽  
E Bruckert ◽  
P Perrone-Filardi ◽  
L Annemans ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Clinical Practice ◽  
Risk Reduction ◽  
Real World ◽  
Lipid Lowering ◽  
Number Needed To Treat ◽  
Lipid Lowering Therapy ◽  
Private Company ◽  
History Of

Abstract Background/Introduction FOURIER included 22,351 patients with a history of myocardial infarction (MI) and a median low-density lipoprotein cholesterol (LDL-C) of 2.4 mmol/L. Reducing LDL-C with evolocumab reduced the risk of major cardiovascular (CV) events by 1.3%, in absolute terms, over 2.2 years. Whether similar benefits might be observed in real-world evidence from evolocumab use is unknown. Purpose Simulate CV risk and assess the potential CV risk reduction among a large European cohort of evolocumab users with a history of MI. Methods We used interim data from HEYMANS, a register of patients initiating evolocumab in routine clinical practice across 12 European countries, from August 2015 with follow-up through July 2020. Demographic and clinical characteristics, lipid-lowering therapy (LLT), and lipid values were collected from routine medical records (6 months prior to evolocumab initiation through 30 months post initiation). Patients with a history of MI were considered and two sub-cohorts were created: recent MI (MI ≤1 year before evolocumab initiation) and remote MI (MI >1 year before evolocumab initiation). For each patient, we 1) simulated their CV risk using three different sources, correcting for age and LDL-C: i) the REACH equation, ii) FOURIER, iii) an observational study including FOURIER-like patients; 2) calculated their absolute LDL-C reduction on evolocumab; 3) simulated their relative risk reduction (RRR) by randomly sampling from the inverse probability distribution of the rate ratio per 1 mmol/L from the key secondary endpoint in the FOURIER landmark analysis; 4) calculated their absolute risk reduction (ARR) and number needed to treat (NNT) over 2 years (recent MI) or 10 years (remote MI). Results Our analysis included 90 recent MI and 489 remote MI patients initiating evolocumab in clinical practice per local reimbursement criteria, with up to 24 months follow-up. Median (inter-quartile range) age was 59 (53–67) and 61 (53–68) years in recent MI and remote MI patients, respectively. LDL-C before evolocumab was 3.8 (3.2–4.6) and 3.6 (3.0–4.5) mmol/L. Absolute LDL-C reduction on evolocumab was 2.2 (1.4–2.8) and 2.2 (1.6–2.8) mmol/L, meaning relative LDL-C reduction of 60% (44%-73%) and 62% (47%-72%), respectively. Predicted ARR with evolocumab was substantial, whether over 2 years (recent MI) or over 10 years (remote MI). See Table 1. Conclusions This cohort of evolocumab users in clinical practice had a higher baseline LDL-C and CV risk than patients enrolled in FOURIER. LDL-C reduction and RRR were very similar in recent MI and remote MI patients. However, patients with a recent MI had a higher short-term CV risk and therefore showed a larger ARR on evolocumab. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Amgen

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

European differences in characteristics, treatments and outcomes in patients with non-ST-elevation myocardial infarction – novel insights from four national real-world registries

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Edfors ◽  
T Jernberg ◽  
C Lewinter ◽  
J Eha ◽  
P Asser ◽  
...  
Keyword(s):  
Risk Factors ◽  
Myocardial Infarction ◽  
Real World ◽  
European Countries ◽  
High Rate ◽  
Lipid Lowering ◽  
Hospital Treatment ◽  
Funding Source ◽  
Term Survival ◽  
St Elevation

Abstract Background Large-scale collection of standardized variables in patients with myocardial infarction (MI) in national real-world registries are only available in a few European countries and there is lack of cross-country comparisons. Purpose To compare demography, risk factors, hospital treatment and short- and long-term survival in patients hospitalized for non-ST elevation MI (NSTEMI) in four different European countries. Methods NSTEMI patients hospitalized and enrolled in national MI registries; EMIR (Estonia), HUMIR (Hungary), NORMI (Norway (2013–2016)) and SWEDEHEART (Sweden) from 2014 to 2017 were included. Results In total 119,191 patients with NSTEMI were included. The mean age at admission ranged from 70 years (Hungary) to 75 years (Estonia). The proportion of women was 36% in Sweden and 44% in Estonia. In Norway 24% were smokers, as compared to 17% in Sweden. Patients in Hungary had a high rate of diabetes mellitus (37%) and antihypertensive treatment (84%) but a low rate of lipid lowering treatment (32%). The proportion of patients with prior MI ranged from 28% (Norway) to 37% (Sweden). The presence of previous peripheral artery disease ranged from 7% (Sweden) to 17% (Hungary). The absolute proportion of performed coronary angiographies (58% versus 75%) and percutaneous coronary interventions (38% versus 56%), differed most between Norway and Hungary. Dual antiplatelet therapy ranged from 60% (Estonia) to 81% (Hungary) and statins from 78% (Norway) to 89% (Hungary), at discharge. The crude mortality rates at 1 month and 1 year are listed in table 1. Conclusion Cross-comparison of four national European MI registries provide new insights in differences in risk factors, treatment and outcomes. Possible reasons for the observed differences, include differences in the underlying expected mortality in the populations, inclusion-criteria and coverage of the registries and variable definitions, that need to be further explored. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Estonian Research Council

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.

How many CCS- and ACS-patients might reach the newly recommended LDL-C-target <55mg/dl in clinical practice if guidelines were applied – an estimate from the DYSIS II study population

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A.K Gitt ◽  
M Horack ◽  
D Lautsch ◽  
R Zahn ◽  
J Ferrieres
Keyword(s):  
Clinical Practice ◽  
Real Life ◽  
Statin Treatment ◽  
Lipid Lowering ◽  
High Risk Population ◽  
High Dose ◽  
Funding Source ◽  
Pcsk9 Inhibitors ◽  
Target Values ◽  
Coronary Syndromes

Abstract Background The 2019 ESC guidelines for the management of dyslipidemia even further lowered the LDL-C-target values for the very high-risk population from &lt;70mg/dl to &lt;55mg/dl. Population based studies already had shown that the previous target was difficult to reach. It is yet unclear how many patients in clinical practice might be treated to the new target. Methods The Dyslipidemia International Study (DYSIS II) prospectively collected data of patients with chronic coronary syndromes (CCS) and acute coronary syndromes (ACS) (all on statins) in 18 countries in Europe, the Middle East, South- and East Asia to document patient characteristics, medication and a current lipid profile from 2012 to 2014 under real life conditions in physicians' offices and hospitals. We took these real-life lipid profiles and data on the kind/dose of used statins to estimate how treatment escalation such as changing statin treatment to a high dose (atorvastatin ≥40mg / rosuvastatin≥20mg), adding ezetimibe and adding a PCSK9-inhibitor might help to bring LDL-C-levels to the recommended &lt;55mg/dl target. Results A total of 7,865 patients were enrolled into DYSIS II, 6,794 had CCS and 1,071 ACS. Under the documented statin treatment in DYSIS only 12.7% of patients reached an LDL-C &lt;55mg/dl. Putting all patients on high dose statins in combination with ezetimibe, 64.1% would reach the target. If PCSK9-inhibitors would be used in the remaining patients not at goal a total of 94.0% would match the goal. Conclusion Our analysis indicates that in real life practice the use available lipid-lowering medications would substantially increase the percentage of CCS- and ACS-patients reaching the newly recommended 2019 ESC guideline LDL-C-target of &lt;55 mg/dl from less than 20% to more than 90% of the population. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): MSD

scholarly journals Is the use of two versus one long-acting bronchodilator by patients with COPD associated with a higher risk of acute coronary syndrome in real-world clinical practice?

2021 ◽  
Vol 8 (1) ◽  
pp. e000840
Author(s):  
Lianne Parkin ◽  
Sheila Williams ◽  
David Barson ◽  
Katrina Sharples ◽  
Simon Horsburgh ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Clinical Practice ◽  
Real World ◽  
Chronic Obstructive ◽  
Treatment Intensification ◽  
Cardiovascular Comorbidity ◽  
Coronary Syndrome ◽  
Long Acting ◽  
The Impact

BackgroundCardiovascular comorbidity is common among patients with chronic obstructive pulmonary disease (COPD) and there is concern that long-acting bronchodilators (long-acting muscarinic antagonists (LAMAs) and long-acting beta2 agonists (LABAs)) may further increase the risk of acute coronary events. Information about the impact of treatment intensification on acute coronary syndrome (ACS) risk in real-world settings is limited. We undertook a nationwide nested case–control study to estimate the risk of ACS in users of both a LAMA and a LABA relative to users of a LAMA.MethodsWe used routinely collected national health and pharmaceutical dispensing data to establish a cohort of patients aged >45 years who initiated long-acting bronchodilator therapy for COPD between 1 February 2006 and 30 December 2013. Fatal and non-fatal ACS events during follow-up were identified using hospital discharge and mortality records. For each case we used risk set sampling to randomly select up to 10 controls, matched by date of birth, sex, date of cohort entry (first LAMA and/or LABA dispensing), and COPD severity.ResultsFrom the cohort (n=83 417), we identified 5399 ACS cases during 281 292 person-years of follow-up. Compared with current use of LAMA therapy, current use of LAMA and LABA dual therapy was associated with a higher risk of ACS (OR 1.28 (95% CI 1.13 to 1.44)). The OR in an analysis restricted to fatal cases was 1.46 (95% CI 1.12 to 1.91).ConclusionIn real-world clinical practice, use of two versus one long-acting bronchodilator by people with COPD is associated with a higher risk of ACS.

Real-world use and accuracy of stress echocardiography: preliminary insights from the EVAREST study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
W Woodward ◽  
A McCourt ◽  
C Dockerill ◽  
L Ayres ◽  
D Augustine ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Stress Echocardiography ◽  
Significant Coronary Artery Disease ◽  
Phone Call ◽  
Funding Source ◽  
Private Company ◽  
Coronary Syndrome ◽  
Stress Echo ◽  
Cardiac Outcome

Abstract Background Stress echocardiography is a widely used, non-invasive imaging modality used to identify prognostically significant coronary artery disease. High levels of accuracy have been reported, however this is highly dependent on operator training and image quality. There are currently limited data available on the accuracy of stress echo in every day clinical practice. Purpose The EVAREST study links stress echo clinics in 30 NHS Hospital Trusts in England and therefore provides data to evaluate the performance and diagnostic accuracy of stress echo in “real-world” clinical practice. Methods Analysis was performed on the first 7415 patients recruited prospectively between 2015 and January 2020. Participants are included if they have undergone stress echo to investigate for ischaemic heart disease. Data is collected on medical history and stress echo performance. Participants are followed up for 12 months through health records and patient phone call, with all outcomes undergoing expert adjudication. A positive cardiac outcome is defined as initiation of anti-anginal medications, ≥70% stenosis on coronary angiography, revascularisation, confirmed acute coronary syndrome or cardiac-related death. Results Mean age of patients undergoing stress echo is 65±12.3 years and 56% are male. Average BMI is 28.9±5.6 kg/m2. 71.4% undergo dobutamine stress (DSE) and 28.4% exercise with &lt;1% having a pacemaker-mediated stress. Contrast was used in 71.4% of studies. Stress echos were interpreted at time of clinic visit as positive for inducible ischaemia in 18.2% of patients. One-year outcome data is currently available for 1892 participants. Sensitivity and specificity for clinician prediction of a positive cardiac outcome was 88.7% and 94.4%, respectively. Positive and negative predictive value of stress echo was 76.4% and 97.6%, respectively. Conclusion EVAREST provides unprecedented, large-scale information on the “real world” use and accuracy of stress echo across different healthcare settings in the UK, demonstrating performance consistent with best practice. Ongoing data collection will be used to evaluate sources of heterogeneity in the predictive accuracy of stress echo and identify optimal approaches to further improve performance. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Ultromics Ltd., Lantheus Ltd.

scholarly journals Lipoprotein(a) and Cardiovascular Outcomes after Revascularization of Carotid and Lower Limbs Arteries

Biomolecules ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 257
Author(s):  
Marat V. Ezhov ◽  
Narek A. Tmoyan ◽  
Olga I. Afanasieva ◽  
Marina I. Afanasieva ◽  
Sergei N. Pokrovsky
Keyword(s):  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Cardiovascular Outcomes ◽  
Lower Limbs ◽  
Lipid Lowering ◽  
Lipid Lowering Therapy ◽  
Cox Regression Analysis ◽  
Lipoprotein A ◽  
Secondary Endpoints

Background: Despite high-intensity lipid-lowering therapy, there is a residual risk of cardiovascular events that could be associated with lipoprotein(a) (Lp(a)). It has been shown that there is an association between elevated Lp(a) level and cardiovascular outcomes in patients with coronary heart disease. Data about the role of Lp(a) in the development of cardiovascular events after peripheral revascularization are scarce. Purpose: To evaluate the relationship of Lp(a) level with cardiovascular outcomes after revascularization of carotid and lower limbs arteries. Methods: The study included 258 patients (209 men, mean age 67 years) with severe carotid and/or lower extremity artery disease, who underwent successful elective peripheral revascularization. The primary endpoint was the composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. The secondary endpoint was the composite of primary endpoint and repeated revascularization. Results: For 36-month follow-up, 29 (11%) primary and 128 (50%) secondary endpoints were registered. There was a greater risk of primary (21 (8%) vs. 8 (3%); hazard ratio (HR), 3.0; 95% confidence interval (CI) 1.5–6.3; p < 0.01) and secondary endpoints (83 (32%) vs. 45 (17%), HR, 2.8; 95% CI 2.0–4.0; p < 0.01) in patients with elevated Lp(a) level (≥30 mg/dL) compared to patients with Lp(a) < 30 mg/dL. Multivariable-adjusted Cox regression analysis revealed that Lp(a) was independently associated with the incidence of cardiovascular outcomes. Conclusions: Patients with peripheral artery diseases have a high risk of cardiovascular events. Lp(a) level above 30 mg/dL is significantly and independently associated with cardiovascular events during 3-year follow-up after revascularization of carotid and lower limbs arteries.

scholarly journals Estimating the burden of hyperkalaemia in the UK in high-risk patient populations

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P McEwan ◽  
L Hoskin ◽  
K Badora ◽  
D Sugrue ◽  
G James ◽  
...  
Keyword(s):  
Clinical Practice ◽  
High Risk ◽  
Patient Outcomes ◽  
Real World ◽  
High Risk Patient ◽  
Incidence Rates ◽  
Funding Source ◽  
Eligible Population ◽  
Increased Risk ◽  
The Uk

Abstract Background Patients with chronic kidney disease (CKD), heart failure (HF), resistant hypertension (RHTN) and diabetes are at an increased risk of hyperkalaemia (HK) which can be potentially life-threatening, as a result of cardiac arrhythmias, cardiac arrest leading to sudden death. In these patients, renin-angiotensin-aldosterone system inhibitors (RAASi), are used to manage several cardiovascular and renal conditions, and are associated with an increased risk of HK. Assessing the burden of HK in real-world clinical practice may concentrate relevant care on those patients most in need, potentially improving patient outcomes and efficiency of the healthcare system. Purpose To assess the burden of HK in a real-world population of UK patients with at least one of: RHTN, Type I or II diabetes, CKD stage 3+, dialysis, HF, or in receipt of a prescription for RAASi. Methods Primary and secondary care data for this retrospective study were obtained from the UK Clinical Practice Research Datalink (CPRD) and linked Hospital Episode Statistics (HES). Eligible patients were identified using READ codes defining the relevant diagnosis, receipt of indication-specific medication, or, in the case of CKD, an estimated glomerular filtration rate (eGFR) ≤60 ml/min/1.73m2 within the study period (01 January 2008 to 30 June 2018) or in the five-year lookback period (2003–2007). The index date was defined as 01 January 2008 or first diagnosis of an eligible condition or RAASi prescription, whichever occurred latest. HK was defined as K+ ≥5.0 mmol/L; thresholds of ≥5.5 mmol/L and ≥6.0 mmol/L were explored as sensitivity analyses. Incidence rates of HK were calculated with 95% confidence intervals (CI). Results The total eligible population across all cohorts was 931,460 patients. RHTN was the most prevalent comorbidity (n=317,135; 34.0%) and dialysis the least prevalent (n=4,415; 0.5%). The majority of the eligible population were prescribed RAASi during follow-up (n=754,523; 81.0%). At a K+ threshold of ≥5.0 mmol/L, the dialysis cohort had the highest rate of HK (501.0 events per 1,000 patient-years), followed by HF (490.9), CKD (410.9), diabetes (355.0), RHTN (261.4) and the RAASi cohort (211.2) (Figure 1). This pattern was still observed at alternative threshold definitions of HK. Conclusion This large real-world study of UK patients demonstrates the burden of hyperkalaemia in high-risk patient populations from the UK. There is a need for effective prevention and treatment of HK, particularly in patients with CKD, dialysis or HF where increased incidence rates are observed which in turn will improve patient outcomes and healthcare resource usage. Figure 1. Rates of HK by condition Funding Acknowledgement Type of funding source: Private company. Main funding source(s): AstraZeneca

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