Two-thirds of ASCVD patients in the US do not reach LDL-c <70 mg/dL after 2 years on LLT
This prospective registry study in the US showed that only 17.1% of patients with ASCVD on LLT had their therapy intensified over the next 2 years. Only 31.7% of patients achieved LDL-c levels <70mg/dL at 2 years.
Use of Lipid-Lowering Therapies Over 2 Years in GOULD, a Registry of Patients With Atherosclerotic Cardiovascular Disease in the USLiterature - Cannon CP, de Lemos JA, Rosenson RS et al. - JAMA Cardiol. 2021 Jun 16. doi: 10.1001/jamacardio.2021.1810.
Introduction and methods
The ACC/AHA guidelines on the management of blood cholesterol recommend intensive statin therapy and adding nonstatin therapy if LDL-c levels are ≥70mg/dL [1]. The ESC guidelines on the management of dyslipidemia recommend an even lower treatment goal of ≥55mg/dL and at least 50% reduction in LDL-c level from baseline in patients at very high CV risk [2]. There is limited data on LDL-c level attainment in clinical practice following these guidelines. This study tracked LDL-c treatment patterns over 2 years in patients with clinical ASCVD.
The Getting to an Improved Understanding of Low Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) study is a prospective observational registry study in the US. The study was conducted at 119 participating centers evenly distributed across the US. A total of 5006 patients (≥18 years old) with established ASCVD and receiving any lipid-lowering therapy (LLT) were enrolled into 1 of 3 cohorts: 1) Patients currently receiving a PCSK9i; 2) not receiving a PCSK9i and LDL-c ≥100 mg/dL; or 3) not receiving a PCSK9i and LDL-c of 70 to 99 mg/dL. Mean age was 67.9 (SD: 9.9) years, 39.7% were women, 86.1% were white. Enrolled patients were asked about their perceptions and attitudes toward LLT twice a year in structured questionnaires via telephone interviews. At each participating center, a physician filled out structured questionnaire at baseline, and at 1 and 2 years about perceptions and patterns of LLT use. The primary outcome was change in LLT over 2 years.
Main results
- After 2 years follow-up, 17.1% of patients (855 of 5006) had received LLT intensification.
- In the cohort with LDL-c ≥100 mg/dL, 22.4% of patients had received LLT intensification at 2 years: statin dosage was intensified in 6.4%, a statin was initiated in 4.7%, ezetimibe was added in 6.8% and a PCSK9i was added in 6.3% of patients.
- 14.4% of patients had received LLT intensification at 2 years in the cohort with LDL-c levels between 70 and 99 mg/dL: statin dosage was intensified in 6.3%, a statin was initiated in 2.0%, ezetimibe was added in 4.5% and a PCSK9i was added in 2.2% of patients.
- In the group of patients receiving PCSK9i and with LDL-c >70 mg/dL at baseline, 16.4% of patients had received LLT intensification at 2 years.
- Median LDL-c levels decreased from 120 (IQR 108-141) mg/dL at baseline to 95 (IQR 73-118) mg/dL at 2 years in the cohort with LDL-c ≥100 mg/dL (P<0.001). In the cohort with LDL-c levels between 70 and 99 mg/dL, Median LDL-c levels decreased from 82 (IQR 75-89) mg/dL to 77 (IQR 65-90) mg/dL (P<0.001). Median LDL-c levels remained stable in those receiving PCSK9i (68 [IQR 43-104] mg/dL at baseline and 67 [IQR 42-96] mg/dL at 2 years [P=0.77]).
- Across all patients, 31.7% of patients achieved LDL-c levels<70 mg/dL at 2 years. LDL-c levels <70 mg/dL at 2 years were achieved by 21.0%, 33.9%, and 52.4% of patients in the cohort with LDL-c levels ≥100 mg/dL, the cohort with LDL-c levels of 70 to 99 mg/dL, and the cohort with patients receiving PCSK9i, respectively. Among patients receiving a PCSK9i, 46% of patients on PCSK9i monotherapy and 64% of patients on PCSK9i plus another LLT achieved LDL-c levels <70 mg/dL at 2 years.
- The ESC guidelines recommend a lower treatment goal of ≥55mg/dL. After 2 years follow-up, this goal was achieved by 14.7% of all enrolled patients, 10% in the cohort with LDL-C levels ≥100mg/dL, 11.9% in the cohort with LDL-C levels of 70 to 99 mg/dL, and 39.9% in the cohort with patients receiving PCSK9i. Among patients receiving a PCSK9i, 33% of patients on PCSK9i monotherapy and 50% of patients on PCSK9i plus another LLT achieved LDL-c levels <55 mg/dL at 2 years.
Conclusion
This prospective observational registry study in the US showed that 17.1% of patients with ASCVD on LLT who had LDL-c ≥70mg/dL or were taking a PCSK9i at baseline had their therapy intensified over the next 2 years. Only 31.7% of all enrolled patients achieved LDL-c levels<70mg/dL at 2 years and 14.7% of patients reached LDL-c levels <55mg/dL.
The authors state that ‘with two-thirds of the patients still at or above the recommended LDL-c threshold of 70 mg/dL at 2 years, further intensive efforts are needed to achieve optimal LDL-c management in patients with ASCVD.’
References
1. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73(24):e285-e350. doi:10.1016/j.jacc.2018.11.003
2. Mach F, Baigent C, Catapano AL, et al; ESC Scientific Document Group. 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020;41(1):111-188. doi:10.1093/eurheartj/ehz455