Key result
PCSK9 inhibitors are linked to ~52% of patients achieving LDL-C <70 mg/dL versus eligible non-receivers.
Why the study?
The clinical characteristics and baseline lipid profiles of patients with very high cardiovascular risk eligible for PCSK9 inhibitor treatment, including those receiving and not receiving PCSK9i, were not well characterized.
What are the baseline characteristics and lipid levels of very high CV risk patients receiving versus not receiving eligible PCSK9 inhibitor treatment?
Observational (n=1,659)
Yes
What are the baseline characteristics and lipid levels of very high CV risk patients receiving versus not receiving eligible PCSK9 inhibitor treatment?
In real-world practice, PCSK9 inhibitors are preferentially prescribed to patients with statin intolerance and higher baseline LDL-C, resulting in better lipid control compared to eligible non-receivers.
AIM: The PERI-DYS study aims to characterize two groups of patients with dyslipidaemia at very high CV risk: PCSK9i receivers and patients qualifying for but not receiving PCSK9i. METHODS: This is an observational study by office-based and clinic-based physicians, mainly cardiologists and other internists in Germany, with data extracted from patient charts. CLINICALTRIALS: gov identifier NCT03110432. RESULTS: A total of 1659 patients were enrolled across 70 sites. The majority of patients (91.0%) were reported as having mixed dyslipidaemia or non-familial or heterozygous familial hypercholesterolemia. At enrolment, 794 (47.9%) of patients were PCSK9i receivers (of these 65.9% ongoing, and 34.1% newly treated within 30 days before their baseline visit). Among PCSK9i receivers, the majority had evolocumab 140 mg (n = 632, 38.1% of total). PCSK9i receivers compared to non-receivers were about 2 years younger and had a lower proportion of males. In terms of comorbidities, they had (statistically significantly) more often CAD, and less often PAD, diabetes mellitus, arterial hypertension and chronic renal disease. The calculated untreated median LDL-C was 187 mg/dl (IQR 127; 270) in ongoing PCSK9i receivers, 212 mg/dl (IQR 132; 277) in newly treated PCSK9i receivers, and 179 mg/dl (IQR 129; 257) in non-receivers. Physician-reported statin intolerance was much more common in the two PCSK9i receiver groups as compared to non-receivers (67.3% versus 15.3%). Consequently, patients in the PCSK9i groups received fewer concomitant statins. Mean total cholesterol (143 vs. 172 mg/dl) and LDL-C (69 vs. 99 mg/dl) were considerably lower in ongoing PCSK9i receivers compared to non-receivers. CONCLUSIONS: PCSK9i receivers are characterized by higher baseline LDL-C and a higher portion of statin intolerance compared to those qualified for but not-receiving PCSK9i treatment. On-treatment, LDL-C was lower in PCSK9i receivers. Ongoing follow-up will determine the prognostic importance of these findings.
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Laufs et al. (2022) conducted an observational in Dyslipidaemia at very high cardiovascular risk (n=1,659). PCSK9 inhibitors vs. Eligible non-receivers was evaluated on LDL-C goal achievement of < 70 mg/dl (p=<0.001). Ongoing PCSK9 inhibitor receivers achieved an LDL-C goal of <70 mg/dl significantly more often than eligible non-receivers (51.9% vs 19.4%), and had a higher prevalence of statin intolerance (67.3% vs 15.3%).
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