Novel Insights into the Management of Patients with Very High Cardiovascular Risk Eligible for PCSK9 Inhibitor Treatment: Baseline Findings from the PERI-DYS Study
Authors: Laufs Ulrich , Birkenfeld Andreas L. , Fraass Uwe , Hohenstein Bernd , Siegert Carsten , Klotsche Jens , Steinhagen-Thiessen Elisabeth , Pittrow David , Dexl Stefan , Salmen Sunnhild , Schettler Volker J. J. , Parhofer Klaus G. ,   Collaborators in the PERI-DYS Study, Noé Sebastian , Spengler Ulrike , Fendler Franz-Rudolf , Bäumer Anselm , Schön Norbert , Unger Tilman , Taggeselle Jens , Schwittay Andreas , Janseen Ulf , Menzel Frank , Axthelm Christoph , Wilke Andreas , Spens Antje , Al-Zoebi Ayham , Schettler Volker J.J. , Schwarz Toralf , Jansen Armin , Hohenstein Bernd , Stadelmann Alexander , Eberhand Karin , Borucki Katrin , Steinhagen-Thiessen Elisabeth , Schlitt Axel , Knittel Markus , Koschker Ann-Cathrin , Mann Alexander , Ebert Hans-Holger , Tekiyeh Mohsen , Gebauer Katrin , Spitthöver Ralf , Beigel Andrea , Laufs Ulrich , Sinning David , Jahnke Norbert , Wild Beate , Gysan Detlef , Ruef Johannes , Weißbrodt Matthias , Birkenfeld Andreas , Killat Holger , Bischoff Steffen , Beckermann Johannes , Wittig Ina , Gerth Jens , Salbach Peter , Raddatz Dirk , Ries Wolfgang , Hanefeld Markolf , Haas Johannes , Simon-Wager Ilka , Zugck Christian , Twisselmann Thomas , Neumann Volker , Brode Markus , Ringel Jens , Schulze Beate , Rothe Hansjörg , Oettler Wolfram , Stöckl Alexander , Meyer Sven , Keßler Sebastian , Meesters Rüdiger , Brandt Michael , Stach-Jablonski Ksenija , Amann Berthold 
Published: September 2022

Abstract

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.