Ulrich Laufs1, Andreas L Birkenfeld2,3, Uwe Fraass4, Bernd Hohenstein5, Carsten Siegert4, Jens Klotsche6, Elisabeth Steinhagen-Thiessen7, David Pittrow8,9, Stefan Dexl4, Sunnhild Salmen4, Volker J J Schettler10, Klaus G Parhofer11. 1. Klinik und Poliklinik Für Kardiologie, Universitätsklinikum, Leipzig, Germany. ulrich.laufs@medizin.uni-leipzig.de. 2. Innere Medizin IV - Diabetologie, Endokrinologie Und Nephrologie Am Universitätsklinikum, Tübingen, Germany. 3. Institut Für Diabetesforschung und Metabolische Erkankungen (IDM) des Helmholtz Zentrums München, Partner des Deutschen Zentrums Für Diabetesforschung (DZD E.V.), Munich, Germany. 4. Amgen GmbH, Muenchen, Germany. 5. Nephrologisches Zentrum Villingen-Schwenningen, Göttingen, Germany. 6. Deutsches Rheumaforschungszentrum, Berlin, Germany. 7. Department of Endocrinology and Metabolism, Charité Universitätsmedizin Berlin, Berlin, Germany. 8. Medizinische Fakultät, Technische Universität, Dresden, Germany. 9. Innovationszentrum Real-World Evidence, GWT-TUD GmbH, Dresden, Germany. 10. Nephrologisches Zentrum Göttingen GbR, Göttingen, Germany. 11. Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, Munich, Germany.
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.
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.
Authors: Daniel Steffens; Peter Bramlage; Julia Müller; Cornelia Dorn; W Dieter Paar; Celine Scheeff; Mario Kasner; U Rauch-Kröhnert Journal: Open Heart Date: 2021-05
Authors: David Nanchen; David Carballo; Stefan Bilz; Hans Rickli; Konstantinos C Koskinas; François Mach; Christian Mueller; Carmela Crljenica; Mariagrazia Rossi; Nina Reichert; Isabella Sudano Journal: Adv Ther Date: 2021-11-18 Impact factor: 3.845