LLT and LDLC Over 2 years in CKD and ASCVD From the Gould Registry

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.

MAT-KW-2300055/V1/FEB2023