LLT utilization and LDL-C levels over 2 years in patients with CKD and ASCVD: Findings from the GOULD registry

As per the GOULD registry, overall statin use was high in patients with chronic kidney disease (CKD) with modest increase in the use of high-intensity statin, ezetimibe, and proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) over a 2-year period. Majority of patients did not achieve an atheroprotective low‐density lipoprotein cholesterol (LDL-C) goal indicating key opportunity for improvement of quality of care and outcomes in the CKD population.

Key Takeaway

  • The GOULD registry is the first study to examine changes in statin use since the 2018 American Heart Association (AHA)/American College of Cardiology (ACC) guidelines were published.
  • Statin use was near or above 80% at all estimated glomerular filtration rates (eGFR), but without any significant change in these rates over 2 years
  • Overall, lipid lowering therapies (LLT) intensification over 2 years was seen in approximately 20% of patients
    • LLT intensification in the PCSK9i cohort was seen in only 12.5% of patients since their LDL‐C levels had more often achieved goal
  • This study highlights an opportunity for improvement in quality of care and outcomes in CKD patients considering that majority of patients did not achieve the atheroprotective LDL-C goal of <70mg/dL.

Why This Matters

  • Per the 2018 AHA/ACC/Multispecialty cholesterol guidelines, a high‐intensity statin with ezetimibe and/or PCSK9i is recommended for high‐risk atherosclerotic cardiovascular disease (ASCVD) patients with CKD and LDL‐C levels ≥70 mg/dL.
  • A meta-analysis of 13 studies of statin therapy has shown to reduce major cardiovascular events in patients with stage 3 and 4 CKD, with no significant benefits for patients with stage 5 CKD and for patients on dialysis
    • Overall, more patients with stage 4 and 5 CKD need to be evaluated through lipid lowering studies
  • This study evaluated changes in LLT usage and trends in LDL-C levels over 2 years in patients with ASCVD and CKD in the United States
    • One of the first studies to examine statin utilization since the publication of the 2018 ACC/AHA guidelines

Study Design

  • For details on the Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) registry please refer to GOULD.
  • Patients (N = 5,006) enrolled between 2016 and 2018 were categorized into 3 groups: (1) currently receiving a PCSK9i (n = 554), (2) LDL-C ≥100 mg/dL and not on PCSK9i (n = 1,801), and (3) LDL-C 70–99 mg/dL and not on PCSK9i (n = 2,651)
    • Patients were stratified by renal function based on the baseline eGFR data
  • Prospective information was obtained by reviewing medical records every 6 months for 2 years.

Key Results

  • In total 3,304 patients reported eGFR at baseline, 28.6% (n = 944) had an eGFR <60 ml/min/1.73 m2.
  • At 2 years, 2,870 patients had baseline eGFR, of which:
    • 2.1% (n = 61) had eGFR <30 ml/min/1.73 m2 (Stage 4–5 CKD) o 25.4% (n = 730) had eGFR 30 to <60 ml/min/1.73 m2 (Stage 3 CKD)
    • 56.5% (n = 1,623) had eGFR 60 to <90 ml/min/1.73 m2 (Stage 2 CKD)
    • 15.9% (n = 456) had eGFR ≥90 ml/min/1.73 m2

Changes in LLT usage from baseline to 2 years (by eGFR):

  • Statin use (any) remained consistent over 2 years while high intensity statin and statin/ezetimibe use showed modest increase over 2 years
  Baseline eGFR (ml / min / 1.73 m2)
<30 30 to <59 60 to <90 ≥90
Baseline (%) 2 Years (%) Baseline (%) 2 Years (%) Baseline (%) 2 Years (%) Baseline (%) 2 Years (%)
Any statins 88 79 83 80 85 83 84 85
High instensity statin 40 41 39 44 41 43 43 46
Ezetimibe + Statin 1 8 3 5 4 7 4 6

Intensification and de-escalation of LLT over 2 years:

  • Across cohorts, 19.0% (546/2,870) of patients had LLT intensification, while 9.8% (281/2,870) had de‐escalation of LLT.
  • Among the LDL‐C cohorts, 20.1% (496/2,469) had LLT intensification, while 8.3% (205/2,469) had de‐escalation of LLT.
  • Intensification of LLT was most frequently seen among LDL‐C ≥100 mg/dL cohort, while less among the PCSK9i cohort 
    • Rates of statin up-titration increased with deteriorating eGFR in the LDL‐C 70–99 mg/dL cohort
  • De‐escalation of LLT was most commonly seen among the PCSK9i cohort and less common among the LDL‐C 70–99 mg/dL cohort
    • Rates of statin discontinuation increased with worsening eGFR in the PCSK9i cohort
    • Statin down‐titration rates were highest in the LDL‐C 70–99 mg/dL cohort, with individuals having an eGFR <30 ml/min/1.73 m2

For additional details, please refer the source publication Shaik A, et al.

    Shaik A, Kosiborod M, de Lemos JA, Gao Q, Mues KE, Alam S, et al. Use of lipid‐lowering therapies in patients with chronic kidney disease and atherosclerotic cardiovascular disease: 2‐year results from Getting to an imprOved Understanding of Low‐Density lipoprotein cholesterol and dyslipidemia management (GOULD). Clin Cardiol. 2022;45(12):1303–1310. doi: 10.1002/clc.23923. PMID: 36124341.

MAT-KW-2300055/V1/FEB2023