GOULD Registry Details Subpar Levels of Intensifying Lipid-Lowering Therapies in ASCVD Patients

Data from an analysis of the GOULD Registry details the sluggish rates of treatment intensification among patients with suboptimal LDL-C levels in the US.

A look at treatment patterns from July 2016-July 2018, results of the analysis suggest fewer than 20% of patients had lipid-lowering therapy intensification after 2 years of treatment, despite more than 50% remaining at an LDL-C above goal.

“Among the patients who had an LDL-C level remeasured during 2 years of follow-up, approximately 1 in 3 achieved an LDL-C level less than 70 mg/dL, and 1 in 10 achieved an LDL-C level less than 55mg/dL. New efforts to facilitate more intensification of LLT are necessary to optimize lipids in this ASCVD population,” wrote investigators.

A prospective, observational registry, GOULD was created with an interest in better understanding trends in guideline-directed use of lipid-lowering therapies in patients with ASCVD. Enrolling more than 5000 patients, GOULD placed patients into one of 3 cohorts for analysis. The first group included those receiving a PCSK9 inhibitor, the second was made up of patients not receiving a PCKS9 inhibitor with an LDL-C of 100 mg/dL or more, and those not receiving a PCSK9 inhibitor and an LDL-C of 70-99 mg/dL.

The primary outcome of interest for the study was change in lipid-lowering therapies over 2 years. Investigators noted this outcome included intimation or discontinuation of statin therapy, ezetimibe, or PCSK9 inhibitor, increasing or decreasing dosage of a statin or PCSK9 inhibitor, switching to a different statin or PCSK9 inhibitor.

The 5006-patient cohort had a mean age of 67.8 (SD, 9.9) years, 39.7% were women, and 86.1% were White individuals. Of these 5006, 554 were already on a PCSK9 inhibitor, 1801 had an LDL-C at or above 100 mg/dL, and 2651 had an LDL-C of 70-99 mg/dL. At 2 years, only 885 had lipid-lowering therapy intensification.

Among those with LDL-C levels of 100 mg/dL or more and 70-99 mg/dL, lipid-lowering therapy intensification occurred in 22.4% and 14.4%, respectively. Further analysis indicated statins were intensified in 6.4% and 6.3%, ezetimibe was added in 6.8% and 4.5%, and PCKS9 inhibitors were added in 6.3% and 2.2%, respectively. Among those in the cohort already taking PCSK9 inhibitors, 91.7% were still taking a PCSK9 inhibitor at 2 years.

During the 2 years of follow-up, 3768 (88.5%) of the study cohort underwent lipid panel measurements at least once. This included 96.1% of patients already taking a PCSK9 inhibitor, 85.9% of the group with an LDL-C level at or above 100 mg/dL, and 88.6% of the group with an LDL-C between 70-99 mg/dL. Based on these measurements, investigators determined the levels of LDL-C fell from medians of 120 (IQR, 108-141) mg/dL to 95 (IQR, 73-118) mg/dL in the cohort with LDL-C levels of 100 mg/dL or more, 82 (IQR, 75-89) to 77 (IQR, 65-90) mg/dL in the cohort with LDL-C levels of 70-99 mg/dL, and 67 (IQR, 42-104) mg/dL to 67 (IQR, 42-96) mg/dL in the PCSK9 inhibitor cohort.

When assessing those who achieved an LDL-C of less than 70 mg/dL at 2 years, results indicated this level was achieved by 21.0% and 33.9% of those in in the groups with LDL-C levels of 100 mg/dL or more and 70-99 mg/dL, respectively. In comparison, 52.4% of the cohort already taking PCSK9 inhibitors achieved an LDL-C of 70 mg/dL or less.

Multiple factors were associated with lipid-lowering therapy intensification and achieving LDL-C target at 2 years. Factors associated with increased likelihood of both these included being treated at a teaching vs non-teaching hospital, presence of lipid protocols, and receiving care from a cardiologist vs an internal or family medicine practitioner.

This study, “Use of Lipid-Lowering Therapies Over 2 Years in GOULD, a Registry of Patients With Atherosclerotic Cardiovascular Disease in the US,” was published in JAMA Cardiology.