Cholesterol Goal Attainment Research Articles

Low-density lipoprotein cholesterol goal attainment with "inclisiran first" versus usual care in patients with atherosclerotic cardiovascular disease

Abstract Background Rapid and sustained attainment of guideline-recommended low-density lipoprotein cholesterol (LDL-C) goals is critical for patients with atherosclerotic cardiovascular disease (ASCVD). In VICTORION-INITIATE, inclisiran administered twice-yearly by a healthcare professional earlier in the treatment pathway allowed more patients with ASCVD to achieve and sustain LDL-C goals vs current usual care (UC). Purpose To evaluate cumulative LDL-C exposure in the overall population and LDL-C goal attainment and safety in subgroups of participants (type of ASCVD, timing of ASCVD event, and history of statin intolerance) who received an "inclisiran first" implementation strategy (IF; adding inclisiran immediately on failure to achieve LDL-C <70 mg/dL [1.8 mmol/L] with maximally tolerated statins) compared with UC. Methods VICTORION-INITIATE was a 330-day, prospective, pragmatically designed trial that randomised participants 1:1 (stratified by insurance status) to IF (open-label inclisiran 284 mg at Days 0, 90 and 270 plus UC) or UC alone (lipid management directed by treating physician’s discretion). The study took place at 45 sites across 20 states in the USA. Treating physicians had access to LDL-C measurements and were encouraged to intensify treatment per clinical practice guidelines. This prespecified subgroup analysis evaluated LDL-C goal attainment by timing of the most recent ASCVD event (<1 year/≥1 year prior to consent), ASCVD subtype (coronary heart disease [CHD], peripheral arterial disease [PAD], and cerebrovascular disease [CVD]) and statin intolerance status. Cumulative LDL-C exposure over time in the overall population and safety by subgroup were also evaluated. Results Of 450 patients randomised to IF or UC, 11.1% and 84.2% had an ASCVD event <1 year or ≥1 year prior to consent, respectively; 91.8%, 18.2% and 14.7% had a history of CHD, CVD or PAD, and 25.8% were statin intolerant. Cumulative exposure to LDL-C to Day 330 was lower in patients treated with IF vs UC (mean time-adjusted LDL-C: 42.4 mg/dL vs 90.7 mg/dL, Figure). Significantly more patients who received IF achieved LDL-C goals of <70 mg/dL and <55 mg/dL at Day 330 vs UC, irrespective of subgroup (Table). Across subgroups, the incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs were similar between IF and UC (IF: 52.6−71.2%, UC: 46.2−66.0% and IF: 10.7−28.3%, UC: 11.4−22.2%, respectively). Conclusions Participants with ASCVD and LDL-C >70 mg/dL who received IF had lower cumulative LDL-C exposure over the study period than those treated with UC. IF resulted in rapid and sustained achievement of LDL-C goals regardless of ASCVD subtype, event timing and statin intolerance. The safety profile of IF was consistent across the subgroups analysed.

Lipid-lowering therapy with Inclisiran in the real-world setting: initial data from a national health care service

Abstract Introduction Inclisiran, a first-in-class siRNA enabling long-term inhibition of PCSK9 synthesis, demonstrates good safety and efficacy profile in randomized clinical trials. Challenges for real-life use of inclisiran include limited access to therapy, injections by medical staff, lack of cardiovascular outcome data, and concern from adverse effects considering the novel mechanism and long-term activity. Real-life data on the potential to attain lipid-goals and reduce treatment gaps is lacking. We investigated the implementation of inclisiran in real-world clinical setting in Israel. Methods Data from a nationwide healthcare organization on patients initiating inclisiran therapy during the period of 3/2022-11/2023. Patients’ characteristics, efficacy, use of combination lipid-lowering therapies, and attainment of low-density lipoprotein cholesterol (LDL-C) goals, were evaluated. Results Inclisiran was initiated by 503 patients (57% women; mean age 66±11 years). Atherosclerotic cardiovascular disease was present in 54%, and peak historical LDL-C levels >190 mg/dL documented in 64%. Prior exposure to PCSK9 monoclonal antibodies was evident in 28%. Follow-up lipid profile >2 months after filling first prescription, was available in 397 patients (347 with ≥2 injections). In patients treated by inclisiran only (n=254), median LDL-C reduction from peak historical levels was 57% (IQR, 48%-67%), and from pre-injection levels 40% (19%-54%). In those with concomitant oral lipid-lowering therapies (n=143), median LDL-C reduction from peak levels was 66% (IQR, 55%-73%), and from pre-injection levels 46% (23%-59%) (Figure). LDL-C <70 mg/dL was attained by 39% and LDL-C <55 mg/dL by 21.9%. Of those treated with concomitant statin therapy, 38% attained LDL-C <55 mg/dL. Overall, 6.5% did not persist with inclisiran therapy after initial injection. Conclusions In real-life practice, inclisiran showed good efficacy with positive short-term adherence. However, attainment rates of lipid-goals were suboptimal due to limited use of combination lipid-lowering therapy and high-rates of severe hypercholesterolemia in our patient population cohort.Waterfall Plot of LDL-C (%) Reduction

Contemporary LDL-cholesterol management in male and female patients at high-cardiovascular risk: results from the European observational SANTORINI study

Abstract Background Middle aged women have a faster increase in atherosclerotic cardiovascular disease (ASCVD) events than men over time. Undertreatment with guideline-recommended therapy in women may be one of the drivers for this burden. Purpose To compare high- or very high-risk male and female patients regarding contemporary 1-year low-density lipoprotein cholesterol (LDL-C) goal attainment, lipid-lowering therapy (LLT) intensity, and major adverse cardiovascular event (MACE) rate. Methods SANTORINI is an observational, prospective study that enrolled high- and very high-cardiovascular risk patients between March 2020 and Feb 2021, across 623 sites and 14 countries in Europe from primary & secondary care settings, with a further 1-year prospective follow-up. We included all patients with an LDL-C measurement at baseline and 1-year follow up (1yFU) for the current analysis. LDL-C goal attainment was defined separately for high and very-high risk categories according to 2019 ESC/EAS guidelines. Results Overall, 5197 males with a mean age of 65 years, and 2013 females with a mean age 66 years were included. At baseline, male patients had higher prevalence of pre-existing ASCVD (81.6% vs. 63.5%), and a lower prevalence of familial hypercholesterolaemia (8.7% vs. 17.2%) than female patients (Table 1). The proportion of patients reaching LDL-C goal improved from baseline to 1yFU, but was greater in males (22.9% and 33.3%, respectively) than females (16.9% and 24.6%, respectively). Similarly, the proportion of patients receiving no LLT decreased from baseline to 1yFU for both sexes, however, more females than males received no LLT at 1yFU (male: 20.7% to 2.7%; female: 23.9% to 3.9%). High intensity statin use increased for both sexes but was higher for males (22.2% to 27.3%) than for females (15.5% to 19.5%) at 1yFU. By contrast, PCSK9i use at baseline and 1yFU was lower for males (6.6% to 9.3%) than for females (9.8% to 13.4%). Nevertheless, the use of combination LLT at 1yFU was lower among females than males (male: 27.8% to 42.2%; female: 26.7% to 40.2%). During follow-up, MACE-4 was higher in males (5.31/100 patient years [PY]; 95% confidence interval [CI]: 4.68–5.95) than in females (3.63/100PY; 95% CI: 2.79–4.47). Similar results were observed for MACE-3 (Table 2). Conclusions Despite similar guideline recommendations, use of combination LLT and high intensity statin therapy was lower in female patients at high or very high cardiovascular risk than in male patients over one year of follow-up. Accordingly, female patients had lower LDL-C goal attainment both at baseline and at one-year. Nevertheless, due to intrinsic risk factors, female patients had lower rates of MACE-4 and MACE-3 than male patients.

Use of combination therapy is associated with improved LDL cholesterol management: 1-year follow-up results from the European observational SANTORINI study.

To assess whether implementation of the 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) dyslipidaemia guidelines observed between 2020 and 2021 improved between 2021 and 2022 in the SANTORINI study. Patients with high or very high cardiovascular (CV) risk were recruited across 14 European countries from March 2020 to February 2021, with 1-year prospective follow-up until May 2022. Lipid-lowering therapy (LLT) and 2019 ESC/EAS risk-based low-density lipoprotein (LDL) cholesterol (LDL-C) goal attainment (defined as <1.4 mmol/L for patients at very high CV risk and <1.8 mmol/L for patients at high CV risk) at 1-year follow-up were compared with baseline. Of 9559 patients enrolled, 9136 (2626 high risk and 6504 very high risk) had any available follow-up data, and 7210 (2033 high risk and 5173 very high risk) had baseline and follow-up LDL-C data. Lipid-lowering therapy was escalated in one-third of patients and unchanged in two-thirds. Monotherapy and combination therapy usage rose from 53.6 and 25.6% to 57.1 and 37.9%, respectively. Mean LDL-C levels decreased from 2.4 to 2.0 mmol/L. Goal attainment improved from 21.2 to 30.9%, largely driven by LLT use among those not on LLT at baseline. Goal attainment was greater with combination therapy compared with monotherapy at follow-up (39.4 vs. 25.5%). Lipid-lowering therapy use and achievement of risk-based lipid goals increased over 1-year follow-up particularly when combination LLT was used. Nonetheless, most patients remained above goal; hence, strategies are needed to improve the implementation of combination LLT.

Impact of team-based health information technology to improve low-density lipoprotein cholesterol goal attainment after acute coronary syndrome hospital discharge: a single-center experience

Abstract Objectives The reduction in circulating low-density lipoprotein cholesterol (LDL-C) is the primary aim of lipid-lowering therapies as a method of atherosclerotic cardiovascular disease risk reduction. Although guidelines recommended strictly control of low-density lipoprotein cholesterol (LDL-C) below 70 mg/dL by high-intensity statin therapy in patients with acute coronary syndrome (ACS), the LDL-C target goal is not often attained. Health information technology (HIT) with information integration, decision making algorithm, is being applied on chronic illness care. Purpose We aimed to perform a qualitative review of the impact of HIT interventions on lipid management and LDL-C goal attainment in patients after ACS hospital discharge. Method Consecutive ACS patients with dyslipidemia (LDL-C &amp;gt;100 mg/dL) at discharge between January 2018 and December 2021 in a tertiary medical center were retrospectively reviewed. The LDL-C &amp;lt;70 mg/dL is defined as target. The team-based approach quality improvement program that consisted of patient education and high-intensity statin initiation before discharge, outpatient clinics with periodic laboratory follow-up, titration of lipid-lowering agents, and system-level interventions that involve database monitoring and outreach by centralized care teams, was introduced in October 2018. Electronical medical records including the medications, laboratory data at discharge and within 1 year were compared, before and after initiation of HIT system. Result A total 2248 ACS patients were included. The LDL-C &amp;lt;70 mg/dL attainment rate (36.52%, 53.57%, 59.22%, 62.18% in 2018, 2019, 2020, and 2021) and medium serum LDL-C level (80.5 mg/dL, 68 mg/dL, 65 mg/dL, 64 mg/dL in 2018, 2019, 2020, and 2021) significantly improved within 6 months after initiation of the team-based integrated intervention with assisted by HIT (2018 as the reference, all p&amp;lt;0.001). The LDL-C goal attainment rate at 12-month kept increasing gradually (53.80%, 61.82%, 64.21%, in 2019, 2020, 2021, p= 0.019). Most of the population initiated with moderate-intensity statin in 2018 (76.24%, 20.92%, 10.95%, 6.41% in 2018, 2019, 2020, and 2021), then switched to a high-intensity statin after initiation of the program (0.57%, 63.67%, 72.41%, 84.44% in 2018, 2019, 2020, and 2021) (2018 as the reference, all p&amp;lt;0.001), while the adverse event rates including hepatotoxicity and rhabdomyolysis remained similarly low. Conclusion Our results confirmed that multifaceted intervention with HIT assisted multidisciplinary approach could substantially improve LDL-C goal attainment in post-ACS patients. There was a direct relationship between high-intensity statins and LDL-C goal attainment, without significant increase of adverse events.LDL-C goal attainment rate and levelLower lipid treatment and adverse event

Low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol in type 1 diabetes and type 2 diabetes: Lipid goal attainment in a large German-Austrian diabetes registry.

To assess the implementation of the 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guideline recommendations for lipid-lowering therapies among more than 30 000 patients with type 1 diabetes (T1D) and type 2 diabetes (T2D) in a German and Austrian registry from 2020 to 2022. Registry data from 2020 and 2021 of 32 170 adult patients (8314 patients with T1D and 23 856 with T2D) were stratified according to the 2019 ESC/EAS risk categories, and guideline-based low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) goal attainment was analysed. In patients with T1D (median age 38.35 [20.51-57.13] years), overall statin use was 19.3%, ezetimibe use was 2.2% and the use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors or fibrates was less than 1%. In patients with T2D (median age 68.76 [58.86-78.39] years), 45.7% received statins, 3.4% received ezetimibe, and fibrates and PCSK9 inhibitors were used by 1% and 0.1%, respectively. Among patients with T1D, 6.16% reached their risk-based recommended LDL-C goal of less than 55 mg/dL (very high risk), 10.97% of less than 70 mg/dL (high risk), and 69.50% of less than 100 mg/dL (moderate risk), respectively. In patients with T2D, 11.81% reached their risk-based goal of LDL-C less than 55 mg/dL, 16.25% of less than 70 mg/dL, and 51.33% of less than 100 mg/dL. Non-HDL-C goals were reached more often, with 15.3%, 25.52% and 91.61% in patients with T1D and 18.56%, 17.96% and 82.30% in patients with T2D for very high, high and moderate risk, respectively. Approximately 2 years after publication of the guidelines, LDL-C and non-HDL-C goal attainment was rarely achieved in patients with T1D and T2D with a high or very high cardiovascular risk.

Optimal implementation of the 2019 ESC/EAS dyslipidaemia guidelines in patients with and without atherosclerotic cardiovascular disease across Europe: a simulation based on the DA VINCI study.

The impact of the stepwise implementation of the 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) treatment algorithm on low-density lipoprotein cholesterol (LDL-C) goal attainment was simulated in patients from the DA VINCI study. Monte Carlo simulation was used to evaluate treatment optimisation scenarios, based on a patient's risk category: statin intensification (step 1), addition of ezetimibe (step 2), and addition of a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor (step 3). Residual cardiovascular risk and predicted relative and absolute risk reduction (RRR and ARR) in cardiovascular events were assessed. In DA VINCI, 2482 patients did not achieve their 2019 ESC/EAS LDL-C goals and were included in the simulation. In patients without atherosclerotic cardiovascular disease (ASCVD) (n=962), 27.0% (n=259) and 57.0% (n=548) are likely to achieve their LDL-C goals at step 1 and step 2, respectively. Of those at very high risk without ASCVD (n=74), 88.1% (n=65) are likely to achieve their LDL-C goals at step 3. In patients with ASCVD (n=1520), 12.0% (n=183), 42.1% (n=641) and 93.2% (n=1416) are likely to achieve their LDL-C goals at steps 1, 2 and 3, respectively. In patients with and without ASCVD, treatment optimisation may result in mean simulated RRR of 24.0% and 17.7%, respectively, and ARR of 8.1% and 2.6%, respectively. Most patients at high cardiovascular risk are unlikely to achieve LDL-C goals through statin optimisation and ezetimibe, and will require a PCSK9 inhibitor, leading to greater reduction in cardiovascular risk. Amgen.

Real-World Attainment of Low-Density Lipoprotein Cholesterol Goals in Patients at High Risk of Cardiovascular Disease Treated with High-Intensity Statins: The TERESA Study.

Despite steady improvements in cardiovascular disease (CVD) prevention, a scarce proportion of patients achieve the recommended LDL-C goals, even under high-intensity lipid-lowering therapy (LLT). Our study aimed to evaluate the attainment rate of LDL-C targets recommended by the 2019 European guidelines, and to characterize potential factors associated with LDL-C goal achievement and change patterns in LLT. We conducted a retrospective, observational study on patients treated with high-intensity atorvastatin or rosuvastatin ± ezetimibe at cardiology and internal medicine clinics across Spain. It included 1570 evaluable patients (median age: 62 years; established CVD: 77.5% [myocardial infarction: 34.3%]; and 85.8% at very high cardiovascular risk). Rosuvastatin ± ezetimibe was the LLT in 52.2% of patients, and atorvastatin ± ezetimibe in 47.8%. LLT had been modified in 36.8% of patients (side effects: 10%), being the most common switch from atorvastatin- to rosuvastatin-based treatment (77.2%). The risk-based LDL-C goal attainment rate was 31.1%, with 78.2% high-risk and 71.7% very high-risk patients not achieving the recommended LDL-C targets. Established CVD and familial hypercholesterolemia were significantly associated with the non-achievement of LDL-C goals. Although having limitations, this study shows that the guideline-recommended LDL-C goal attainment rate is still suboptimal despite using high-intensity statin therapy in a real-world setting in Spain.

How Did the Updated 2019 European Society of Cardiology/European Atherosclerosis Society Risk Categorization for Patients with Diabetes Affect the Risk Perception and Lipid Goals? A Simulated Analysis of Real-life Data from EPHESUS Study.

The recent 2019 European Society of Cardiology/European Atherosclerosis Society practice guidelines introduced a new risk categorization for patients with diabetes. We aimed to compare the implications of the 2016 and 2019 European Society of Cardiology/European Atherosclerosis Society guidelines with regard to the lipid-lowering treatment use, low-density lipoprotein cholesterol goal attainment rates, and the estimated proportion of patients who would be at goal in an ideal setting. Patients with diabetes were classified into 4 risk categories according to 2019 European Society of Cardiology/European Atherosclerosis Society dyslipidemia guidelines from the database of EPHESUS (cross-sectional, observational, countrywide registry of cardiology outpatient clinics) study. The use of lipid-lowering treatment and low-density lipoprotein cholesterol goal attainment rates were then compared according to previous and new guidelines. This analysis included a total of 873 diabetic adults. Half of the study population (53.8%) were on lipid-lowering treatment and almost one-fifth (19.1%) were on high-intensity statins. While low-density lipoprotein cholesterol goal was achieved in 19.5% and 7.5% of patients, 87.4% and 69.6% would be on target if their lipid-lowering treatment was intensified according to 2016 and 2019 European Society of Cardiology/European Atherosclerosis Society lipid guidelines, respectively. The new target <55 mg/dL could only be achieved in 2.2% and 8.1% of very high-risk primary prevention and secondary prevention patients, respectively. The control of dyslipidemia was extremely poor among patients with diabetes. The use of lipid-lowering treatment was not at the desired level, and high-intensity lipid-lowering treatment use was even lower. Our simulation model showed that the high-dose statin plus ezetimibe therapy would improve goal attainment; however, it would not be possible to get goals with this treatment in more than one-third of the patients.

1075 USE OF LIPID-LOWERING COMBINATION THERAPIES IN SANTORINI STUDY: EVIDENCE FROM ITALIAN COHORT

Abstract The SANTORINI registry is an observational study that aims to evaluate the management of patients with high and very high cardiovascular (CV) risk in clinical practice, collecting data at enrolment and after 12 months. Italy participated in this study with 1531 patients at very high risk and 446 at high risk. The scope of the present analysis was to investigate low-density lipoprotein cholesterol (LDL-C) goal attainment in patients who do not qualify for PCSK9 inhibitors (PCSK9i) (according to Italian reimbursement regulations) in Italian cohort, with focus on patients in secondary prevention. The current indications for PCKS9i charged to the National Health System in Italy in secondary prevention, are for patients aged ≤ 80 years with LDL-c levels ≥ 70 mg/dl in at least three detections despite therapy for at least 6 months with high intensity statin at the highest tolerated dose and ezetimibe or after a single LDL-C detection for recent myocardial infarction or multiple cardiovascular events or with demonstrated intolerance to statins and/or ezetimibe. At enrolment, a total of 509 (33.2%) of 1531 patients at very-high risk had an LDL-C level of less than 70 mg/dl. Of them, about half do not reach the LDL-C target. In particular, 34.4% takes statin monotherapy, and 50.3% of them do not reach the target. Even patients taking high-intensity statins as monotherapy reach the target in only 47.9% of cases, leaving more than half of patients with LDL-C levels between 55 and 70 mg/dl. Regarding combination therapy, statin and ezetimibe, patients taking this combination account for 26.9%, of these those taking the combination of moderate-intensity statin and ezetimibe reach the target in 56.7% of cases while those taking high-intensity statins and ezetimibe reach the target in 51.4% of cases. Our findings show that there is a proportion of patients with LDL-C below 70 mg/dl who do not qualify for PCSK9i who are not at target for LDL-C levels despite maximal therapy with statins and ezetimibe.

Low-density lipoprotein cholesterol goal attainment in patients with clinical evidence of familial hypercholesterolemia and elevated Lp(a)

BackgroundAlthough potent lipid-lowering therapies are available, patients commonly fall short of recommended low-density lipoprotein cholesterol (LDL-C) levels. The aim of this study was to examine the relationship between familial hypercholesterolemia (FH) and elevated lipoprotein(a) [Lp(a)] and LDL-C goal attainment, as well as the prevalence and severity of coronary artery disease (CAD). Moreover, we characterized patients failing to meet recommended LDL-C goals.MethodsWe performed a cross-sectional analysis in a cohort of patients undergoing cardiac catheterization. Clinical FH was determined by the Dutch Clinical Lipid Network Score, and Lp(a) ≥ 50 mg/dL (≈ 107 nmol/L) was considered elevated.ResultsA total of 838 participants were included. Overall, the prevalence of CAD was 72%, and 62% received lipid-lowering treatment. The prevalence of clinical FH (probable and definite FH) was 4%, and 19% had elevated Lp(a) levels. With 35%, LDL-C goal attainment was generally poor. Among the participants with clinical FH, none reached their LDL-C target. Among patients with elevated Lp(a), LDL-C target achievement was only 28%. The prevalence and severity of CAD were higher in participants with clinical FH (86% prevalence) and elevated Lp(a) (80% prevalence).ConclusionMost participants failed to meet their individual LDL-C goals according to the ESC 2016 and 2019 guidelines. In particular, high-risk patients with clinical FH or elevated Lp(a) rarely met their target for LDL-C. The identification of these patients and more intense treatment approaches are crucial for the improvement of CAD primary and secondary prevention.

Low-density lipoprotein cholesterol goal attainment in Germany: Results from the DA VINCI study

Background and aimsCardiovascular mortality is high in Germany. For patients with high or very high cardiovascular risk, the European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines recommend intensive lipid lowering therapy (LLT). This study aimed to assess dyslipidaemia management and achievement of the ESC/EAS guideline-recommended low-density lipoprotein cholesterol (LDL-C) goals. MethodsThis European 18-country, cross-sectional, observational DA VINCI study (EUPAS22075) collected data during a single visit between June 2017 and November 2018 and included LLT in the preceding 12 months and the patients' most recent LDL-C measurement. Achievement of the risk-based 2016 and 2019 ESC/EAS LDL-C goals while receiving stabilized LLT was assessed. Data from the German cohort are presented here. ResultsSeven German sites enrolled a total of 421 primary and secondary prevention patients, 327 were receiving stabilized LLT at the time of LDL-C measurement, i.e. statin monotherapy of high (16%; n = 53), moderate (49%; n = 160) or low (7%; n = 24) intensity, ezetimibe combination (18%; n = 58), proprotein convertase subtilisin/kexin type 9 antibody combination (3%; n = 9), and other LLT (7%; n = 23). The 2016 and 2019 risk-based LDL-C goals were attained by 46% (n = 149) and 28% (n = 92) of patients, respectively. ConclusionsThere is a large gap between ESC/EAS recommendations and LDL-C goal achievement in routine clinical practice in high and very high-risk patients in Germany. Low-to-moderate-intensity statin monotherapy was the most frequently used LLT; use of high-intensity statins and combination therapy was limited. In addition to optimizing statin intensity, combination with non-statin LLT may be needed in most of these patients.

Number of lipid-lowering medications and attainment of lipid goals in familial hypercholesterolemia patients: Data from the Latvian registry

Background and Aims : Attainment of low-density lipoprotein cholesterol (LDL-C) goals remains a challenge in patients with heterozygous familial hypercholesterolemia (FH). Combinations of lipid lowering medications (LLM) are commonly required. National registries play a crucial role to monitor quality of care in FH patients. We aimed to provide contemporary data on the number of used LLM, achieved lipid levels and attainment of LDL-C goals in FH patients from the Latvian Registry of FH (LRFH).

Intensity of lipid-lowering therapy, adherence and LDL-cholesterol goal attainment in patients with coronary heart disease

Background and Aims : To examine patterns of lipid-lowering therapy (LLT) use, and persistence and adherence among coronary heart disease (CHD) patients and their association with lipoprotein cholesterol (LDL-C) goal attainment.

Intensity of and Adherence to Lipid-Lowering Therapy as Predictors of Major Adverse Cardiovascular Outcomes in Patients With Coronary Heart Disease.

Background The effectiveness of lipid-lowering therapy (LLT) is affected by both intensity and adherence. This study evaluated the associations of LLT intensity, adherence, and the combination of these 2 aspects of LLT management with the risk of major adverse cardiovascular events (MACE) in people with coronary heart disease. Methods and Results This is an observational study of all adults who suffered a myocardial infarction or had coronary revascularization during 2012 to 2018 and initiated LLT in Stockholm, Sweden. Study exposures were LLT adherence (proportion of days covered), LLT intensity (expected reduction of low-density lipoprotein cholesterol), and the combined measure of adherence and intensity. At each LLT fill, adherence and intensity during the previous 12 months were calculated. The primary outcomes were MACE (nonfatal myocardial infarction or stroke and death); secondary outcomes were low-density lipoprotein cholesterol goal attainment and individual components of MACE. We studied 20 490 patients aged 68±11 years, 75% men, mean follow-up 2.6±1.1 years. Every 10% increase in 1-year adherence, intensity, or adherence-adjusted intensity was associated with a lower risk of MACE (hazard ratio [HR], 0.94 [95% CI, 0.93-0.96]; HR, 0.92 [95% CI, 0.88-0.96]; and HR, 0.91 [95% CI, 0.89-0.94], respectively) and higher odds of attaining low-density lipoprotein cholesterol goals (odds ratio [OR],1.12 [95% CI, 1.10-1.15]; OR, 1.42 [95% CI, 1.34-1.51], and OR, 1.16 [95% CI, 1.19-1.24], respectively). Among patients with good adherence (≥80%), the risk of MACE was similar with low-moderate and high-intensity LLT despite differences in the low-density lipoprotein cholesterol goal attainment with the treatment intensities. Discontinuation ≥1 year increased the risk markedly (HR,1.66 [95% CI, 1.23-2.22]). Conclusions In routine care, good adherence to LLT was associated with the greatest benefit for patients with coronary heart disease. Strategies that improve adherence and use of intensive therapies could substantially reduce cardiovascular risk.

Attainment of low-density lipoprotein cholesterol goals in statin treated patients: Real-world evidence from Australia.

Little is known about the attainment of low-density lipoprotein cholesterol (LDL-C) targets in patients treated with statins in Australian primary healthcare setting that are at increased risk of cardiovascular disease. A retrospective cohort study was conducted using data from electronic medical records of patients treated by general practitioners across Australia. LDL-C target attainment was defined as LDL-C levels ≤ 2 mmol/L for all risk groups, in line with Australian guidelines. Multivariable logistic regression was used to identify the factors associated with LDL-C target attainment. Overall, 61,407 patients were included in the analysis. The mean age was 65 years (± standard deviation [SD] 12.1); 52.0% were males.. Overall, the median LDL-C level was 2.3 mmol/L (IQR = 1.8 - 2.8) and 36.0% of the study population met therapeutic targets. Increased likelihood to achieve LDL-C targets was observed in patients diagnosed with type 2 diabetes (OR 2.07, 95% CI 1.92 - 2.24), stroke (OR = 1.58, 95% CI 1.39 - 1.79, P < 0.001) or chronic heart disease (OR = 1.67, 95% CI 1.55 - 1.81, P < 0.001). Patients diagnosed with dyslipidemia (OR = 0.59, 95% CI 0.55 - 0.64, P < 0.001), hypertension (OR = 0.91, 95% CI 0.83 - 1.00, P < 0.05) and current smokers (OR = 0.71, 95% CI 0.71 - 1.00, P < 0.05), were less likely to attain LDL-C targets, regardless of the type, intensity and length of use of the prescribed statin. Longer duration and higher intensity statin were associated with more patients achieving targeted LDL-C goal, however nearly two thirds of Australians still failed to achieve targeted outcome even after 24 months of statin therapy.

Lipid-lowering treatment intensity, persistence, adherence and goal attainment in patients with coronary heart disease

BackgroundTo examine patterns of lipid-lowering therapy (LLT) use, and persistence and adherence among patients with coronary heart disease and their associations with lipoprotein cholesterol (LDL-C) goal attainment. MethodsObservational study among 26,768 patients who had suffered a myocardial infarction or had been revascularized in Stockholm during 2012 to 2018, and followed up through 2019. Outcomes included initiation of LLT, discontinuation, re-initiation, adherence to treatment and LDL-C goal attainment according to the European dyslipidaemia guidelines from 2011 and 2016 (mainly LDL-C <1.8 mmol/L). Results82% of patients commenced or continued LLT within 90 days after discharge. Of those, 71% were dispensed an LLT prescription within 30 days (62% of them for high-intensity LLT). High-intensity LLT prescribing increased over time, from 12% in 2012 to 78% in 2018. During a median follow-up of 3 (IQR 2-5) years 73% continued to fill prescriptions for a statin, 26.3% temporarily or permanently discontinued, and 0.5% changed to non-statin LLT. Only 1.3% discontinued statin treatment permanently. Throughout observation, about 80% of patients showed good statin adherence (proportion of days covered ≥80%). LDL-C target attainment was 52% the first year and <50% during subsequent years. LDL-C goal attainment was highest among patients receiving high-intensity statin treatment and showing good treatment adherence. ConclusionIn secondary prevention for patients with established coronary heart disease, the proportion of LDL-C target attainment was low throughout the time period of the study, despite increasing use of high-intensity LLT and good treatment persistence and adherence.

Attainment of low-density lipoprotein cholesterol goals in patients treated with combination therapy: A retrospective cohort study in primary care

The attainment of low-density lipoprotein cholesterol (LDL-C) therapeutic goals in real-world settings among patients receiving combination lipid-lowering therapy (LLT, statins plus non-statins) is not well characterised. To evaluate LDL-C levels and LDL-C goal attainment in patients treated with combination LLT in real-world primary care settings. A retrospective cohort study of patients treated with combination LLT. Data were drawn from general practitioner electronic medical records across Australia from 2013 to 2019. The on-treatment goal for LDL-C was < 2 mmol/L (77 mg/dL), as per Australian guidelines. The cohort analysed included 9,173 individuals treated with combination LLT. The mean age was 65.8 years (standard deviation [SD] 11.5), 60.1% were males, and 56.7% had at least one cardiovascular risk factor. The median on-treatment LDL-C was 2.1 mmol/L (IQR 1.6-2.8), and overall 45.4% of the cohort met LDL-C goals, with individuals on fixed-dose combination of statins plus ezetimibe having the highest rates of achievement (49.8%). In multivariable logistic regression analyses, factors associated with LDL-C goal achievement were male sex (odds ratio [OR] 1.4, 95% confidence interval [CI] 1.3-1.6, p < 0.001), aged >80 years (OR 4.2, 95% CI 1.5 - 6.6, p=0.006), and a history of T2DM (OR 1.7; 95% CI 1.5-1.9, p < 0.001) or coronary heart disease (OR 1.4, 95% CI 1.2 - 1.6, p < 0.001). More than half of Australians on combination LLT did not achieve LDL-C goals. Urgent measures are needed to address this gap in clinical practice to minimise negative health outcomes.

Risk stratification and low-density lipoprotein cholesterol goal attainment rates in patients with very high-risk or extreme high-risk atherosclerotic cardiovascular diseases regarding three guidelines

Objective: To explore the differences of risk stratification of very high-risk or extreme high-risk atherosclerotic cardiovascular diseases (ASCVD) and the attainment rates of low-density lipoprotein cholesterol (LDL-C) management targets evaluated by three different criteria, and the causal attributions of these differences. Methods: Patients with ASCVD were consecutively enrolled from January 1 to December 31 in 2019, and were evaluated for very high-risk or extreme high-risk and LDL-C goal attainment rates with 2018 American guideline on the management of blood cholesterol (2018AG), 2019 China Cholesterol Education Program (CCEP) Expert Advice for the management of dyslipidemias (2019EA) and 2020 Chinese expert consensus on lipid management of very high-risk ASCVD patients(2020EC), respectively. The causal attributions of the differences in attainment rates were analyzed as well. Results: A total of 1 864 ASCVD patients were included in this study. According to 2018AG, 2019EA and 2020EC, the proportions of the patients with very high-risk or extreme high-risk were 59.4%, 90.7%, and 65.6%, respectively. The absolute LDL-C target attainment rates were 37.2%, 15.7%, and 13.7%, respectively, the differences between each two rates were statistically significant (all P<0.001). As to the differences in attainment rates between 2020EC and 2018AG, 61.5% were due to the different LDL-C goal attainment values and 38.5% were caused by the different risk stratifications, while for the differences between 2020EC and 2019EA attainment rates, different LDL-C goal attainment values were responsible for 13.2%, and different risk stratifications were responsible for 86.8% of the differences. Conclusions: There are significant differences in the proportions and LDL-C attainment rates among the three different criteria for very high-risk or extreme high-risk ASCVD. 2020EC showed a moderate proportion of patients with extreme high-risk, and had the lowest LDL-C attainment rate. The differences between 2020EC and 2018AG are mainly due to the LDL-C target values, and the differences between 2020EC and 2019EA are mainly caused by the risk stratifications.

Lipid treatment status and goal attainment among patients with atherosclerotic cardiovascular disease in the United States: A 2019 update

ObjectiveTo update the prevalence of atherosclerotic cardiovascular disease (ASCVD) in the United States (US) and re-evaluate lipid-lowering therapies (LLT) utilization and low-density lipoprotein cholesterol (LDL-C) goal attainment among ASCVD patients after proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have become available using data from 2019. MethodsASCVD patients with at least 1 valid LDL-C measurement from the 2019 Truven MarketScan Research Database were included and stratified into hierarchical cardiovascular risk groups. The number of patients in each group was extrapolated to approximate national figures based on national demographic and ASCVD prevalence numbers. Descriptive statistics on demographic and clinical characteristics, treatment status and LDL-C for each hierarchical category were reported. ResultsThe overall prevalence of ASCVD in the US in 2019 was 24.0 million, approximately 10% of the total US population above 21 years old. We found heavy comorbidity burden among ASCVD patients and 31.2% were at very high risk for recurrent events. The majority of ASCVD patients were not at guideline-recommended LDL-C goal. Although there was a significant increase in the use of LLTs (especially of high-intensity statins) in 2019 compared to 2014, overall LLT utilization remained low, with only 3.8% of ASCVD patients on ezetimibe, less than 1% on PCSK9 inhibitors and over 40% on no LLTs. We also found higher utilization of LLTs among patients who were at goal of < 70 or < 55 mg/dL vs. those not at goal. ConclusionDespite an increase in high-intensity statins use since 2014, there was still an underutilization of LLTs in spite of evidence of their efficacy in LDL-C lowering and ability to reduce the risk of coronary heart disease. Increased awareness of guidelines by healthcare providers and urgency to treat ASCVD is needed in order to improve LLT utilization and help more patients reach the LDL-C goal.