Use of Lipid-Lowering Therapies Over 2 Years

Key Takeaway

• The Gould study demonstrated only modest intensifications of LLTs and improvement in LDL-C levels over 2 years in patients with ASCVD.
  • In patients with LDL-C ≥70mg/dL or receiving PCSK9i, only 17.1% patients had LLT intensification.
  • About 1 in 3 patients achieved LDL-C level <70 mg/dL, and 1 in 10 patients achieved an LDLC level <55mg/dL.

Why This Matters

• Compliance to guideline recommended use of LLTs in ASCVD and evidence on LDL-C level attainment is limited.
• Gould study tracks LDL-C treatment patterns over time in patients with clinical ASCVD.

Study Design

Prospective, multicenter, observational, gould registry study across us  (N = 5,006)

Inclusion Criteria:

• Age ≥18 years, established ASCVD*, and receiving some type of stable LLT for ≥4 weeks

Exclusion Criteria:

1. No informed consent,
2. Participating/planningparticipation in an interventional clinical study involving any investigational medical device or drug treatment,
3. Life expectancy of <12 months, (4)Pregnant/breastfeeding/planning a pregnancy

Study Cohort:

• Cohort 1: Receiving PCSK9i
• Cohort 2: Not receiving PCSK9i, LDL-C ≥100 mg/dL
• Cohort 3: Not receiving PCSK9i, LDL-C 70-99 mg/dL
• Primary outcome: Change in LLT over 2 years
• Secondary outcomes: (1) Performance of a blood test measuring LDL-C andother lipid values, (2) Timing of lipid measurement, LDL-C and other lipid values, and (3) Responses to the physician and patient surveys

Key Results

• 5,006 patients† (mean age = 67.8 years), from 119 centers in US (Cohort 1: 554, Cohort 2: 1,801, Cohort 3: 2,651)
• Of these, 4,257 patients completed 2 years of follow-up (Cohort 1: 512 and Cohorts 2 and 3: 3,745)

LLT Intensification

17.1% patients (855/5,006) hadsome type of LLT intensification^‡

Cohort 1: 12.5% patients

• Statin intensified: 1.3%, statin added:3.6%, ezetimibe added: 4.0%, PCSK9i added: 1.8%

Cohort 2: 22.4% patients

• Statin intensified: 6.4%, statin added:4.7%, ezetimibe added: 6.8%, PCSK9i added: 6.3%

Cohort 3: 14.4% patients

• Statin intensified: 6.3%, statin added:2.0%, ezetimibe added: 4.5%, PCSK9i added: 2.2%

Improvement in LDL-C Levels

88.5% patients (3,768/4,257) had lipidsmeasured at least once in 2 years

Median LDL-C levels at 2 years:

• Cohort 1: Stable from 68 mg/dL to67 mg/dL, P <0.77
• Cohort 2: Decreased from120 mg/dL to 95 mg/dL, P <0.001
• Cohort 3: Decreased from82 mg/dL to 77 mg/dL, P <0.001

Goal LDL-C <70 mg/dL (% patients):Cohort 1 = 52.4%, Cohort 2 = 21.0%, and Cohort 3 = 33.9%

Goal LDL-C <55 mg/dL (% patients):Cohort 1= 39.9%, Cohort 2 = 10%, and Cohort 3 = 11.9%*

*ASCVD defined as any 1 of the following: history of myocardial infarction, coronary artery disease, coronary or other arterialrevascularization, ischemic stroke or transient ischemic attack, carotid artery stenosis, or documented peripheral arterialdisease secondary to atherosclerosis. ^† 80.5% had coronary artery disease, 31.7% had myocardial infarction and 33.9% had type 2 diabetes. ^‡ At 2 years 83.7% were receiving statin, 43.6% were receiving a high-intensity statin, 14.3% were receiving ezetimibe, and 13.5% were receiving PCSK9i.

MAT-KW-2200110/v2/Jan 2024