Clinical trial NCT02770131: Chart Review of Repatha® in Subjects With Hyperlipidaemia
Official title: Observational Serial Chart Review of Repatha® Use in European Subjects With Hyperlipidaemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolaemia
Keywords: hypercholesterolaemia
lipid-lowering therapies
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-05-12
Enrollment: 1986
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population comprises patients from European countries, who have received Repatha® as part of routine clinical management of their hyperlipidaemia, between August 2015 and June 2021.

Brief summary: Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.


Eligibility criteria: Inclusion Criteria:

Adults (\>18 years) Provided informed consent Initiated on Repatha® at physician's discretion, after 1st August 2015 Received at least one dose of Repatha®

Exclusion Criteria:

Enrolled in an interventional study of PCSK9 inhibitor within 12 weeks prior to initiation of Repatha® Received commercially available PCSK9 inhibitor within 12 weeks prior to initiation of Repatha®

Primary outcomes:
measure: Description of clinical characteristics of subjects initiated on Repatha®
timeFrame: Study day 1
Secondary outcomes:
measure: Describe LDL-C and other cholesterol values over time
timeFrame: Up to 26 weeks prior to the first dose of Repatha®, up to 30 months post first dose of Repatha®
measure: Describe Repatha® dose over time
timeFrame: From the first dose of Repatha® up to 30 months post first dose
measure: Describe use of other lipid-modifying therapies
timeFrame: From the first dose of Repatha® up to 30 months post first dose
measure: Describe Physician visits
timeFrame: From the first dose of Repatha® up to 30 months post first dose
measure: Describe hospitalizations
timeFrame: From the first dose of Repatha® up to 30 months post first dose
measure: Describe Repatha® dose frequency over time
timeFrame: From the first dose of Repatha® up to 30 months post first dose
measure: Describe Repatha® administrative device use over time
timeFrame: From the first dose of Repatha® up to 30 months post first dose
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Klagenfurt
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Villach
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: La Louvière
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Kostenets
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Ceske Budejovice
country: Czechia
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Liberec
country: Czechia
facility: Research Site
city: Olomouc
country: Czechia
facility: Research Site
city: Plzen
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Praha 5
country: Czechia
facility: Research Site
city: Usti nad Labem
country: Czechia
facility: Research Site
city: Zlin
country: Czechia
facility: Research Site
city: Aachen
country: Germany
facility: Research Site
city: Bad Reichenhall
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bielefeld
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Borsdorf
country: Germany
facility: Research Site
city: Detmold
country: Germany
facility: Research Site
city: Garbsen
country: Germany
facility: Research Site
city: Germering
country: Germany
facility: Research Site
city: Göttingen
country: Germany
facility: Research Site
city: Halberstadt
country: Germany
facility: Research Site
city: Halle (Saale)
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Langenhagen
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Markleeberg
country: Germany
facility: Research Site
city: Muenchen
country: Germany
facility: Research Site
city: Mönchengladbach
country: Germany
facility: Research Site
city: Mühldorf
country: Germany
facility: Research Site
city: Mülheim an der Ruhr
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Neuwied
country: Germany
facility: Research Site
city: Nürnberg
country: Germany
facility: Research Site
city: Oschatz
country: Germany
facility: Research Site
city: Pirna
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Rotenburg
country: Germany
facility: Research Site
city: Viersen-Dülken
country: Germany
facility: Research Site
city: Villingen-Schwenningen
country: Germany
facility: Research Site
city: Zwickau
country: Germany
facility: Research Site
city: Alexandroupoli
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Piraeus
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Acerra
country: Italy
facility: Research Site
city: Arzignano
country: Italy
facility: Research Site
city: Asti
country: Italy
facility: Research Site
city: Bassano Del Grappa (VI)
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Brindisi
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Cinisello Balsamo (MI)
country: Italy
facility: Research Site
city: Cona FE
country: Italy
facility: Research Site
city: Cosenza
country: Italy
facility: Research Site
city: Foggia
country: Italy
facility: Research Site
city: Lido Di Camaiore LU
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research Site
city: Mestre (VE)
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Pescara
country: Italy
facility: Research Site
city: Reggio Calabria
country: Italy
facility: Research Site
city: Rivoli
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Salerno
country: Italy
facility: Research Site
city: Seriate
country: Italy
facility: Research Site
city: Sesto San Giovanni (MI)
country: Italy
facility: Research Site
city: Taranto
country: Italy
facility: Research Site
city: Torrette Di Ancona
country: Italy
facility: Research Site
city: Treviglio (BG)
country: Italy
facility: Research Site
city: Trieste
country: Italy
facility: Research Site
city: Almada
country: Portugal
facility: Research Site
city: Carnaxide
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Faro
country: Portugal
facility: Research Site
city: Matosinhos
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Brezno
country: Slovakia
facility: Research Site
city: Handlova
country: Slovakia
facility: Research Site
city: Komarno
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Martin
country: Slovakia
facility: Research Site
city: Martin
country: Slovakia
facility: Research Site
city: Moldava nad Bodvou
country: Slovakia
facility: Research Site
city: Myjava
country: Slovakia
facility: Research Site
city: Namestovo
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Nove Mesto nad Vahom
country: Slovakia
facility: Research Site
city: Nove Zamky
country: Slovakia
facility: Research Site
city: Poprad
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Roznava
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Cadiz
country: Spain
facility: Research Site
state: Andalucía
city: Huelva
country: Spain
facility: Research Site
state: Andalucía
city: Jaen
country: Spain
facility: Research Site
state: Andalucía
city: Malaga
country: Spain
facility: Research Site
state: Andalucía
city: Sevilla
country: Spain
facility: Research Site
state: Andalucía
city: Sevilla
country: Spain
facility: Research Site
state: Andalucía
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: Badalona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Reus
country: Spain
facility: Research Site
state: Cataluña
city: Sabadell
country: Spain
facility: Research Site
state: Cataluña
city: Ferrol
country: Spain
facility: Research Site
state: Galicia
city: Lugo
country: Spain
facility: Research Site
state: Galicia
city: Alcala de Henares
country: Spain
facility: Research Site
state: Madrid
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Geneva 14
country: Switzerland
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: Winterthur
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Ray KK, Dhalwani N, Sibartie M, Bridges I, Ebenbichler C, Perrone-Filardi P, Villa G, Vogt A, Bruckert E. Low-density lipoprotein cholesterol levels exceed the recommended European threshold for PCSK9i initiation: lessons from the HEYMANS study. Eur Heart J Qual Care Clin Outcomes. 2022 Jun 6;8(4):447-460. doi: 10.1093/ehjqcco/qcac009.
citation: Blaha V, Margoczy R, Petrov I, Postadzhiyan A, Raslova K, Rosolova H, Bridges I, Dhalwani NN, Zachlederova M, Ray KK. Evolocumab is Initiated in Central and Eastern Europe at Much Higher LDL-C Levels Than Recommended in Guidelines: Results from the Observational HEYMANS Study. J Cardiovasc Pharmacol Ther. 2023 Jan-Dec;28:10742484231172847. doi: 10.1177/10742484231172847.
citation: Blanco Echevarria A, Garcia Diaz JD, Caixas A, Plana Gil N, Rico Corral MA, Bridges I, Dhalwani N, Gatell Menchen S, Ray KK. Long-term treatment persistence and maintained reduction of LDL-cholesterol levels with evolocumab over 30 months: Results from the Spanish cohort of the European prospective HEYMANS study. Clin Investig Arterioscler. 2023 Nov-Dec;35(6):263-271. doi: 10.1016/j.arteri.2023.04.004. Epub 2023 May 24. English, Spanish.
citation: Ebenbichler C, Drexel H, Hanusch U, Toplak H, Dhalwani NN, Bridges I, Hoelzl R, Hemetsberger M, Ray KK. Evolocumab effectiveness in the real-world setting: Austrian data from the pan-European observational HEYMANS study. Wien Klin Wochenschr. 2024 Feb;136(3-4):77-86. doi: 10.1007/s00508-023-02245-w. Epub 2023 Jul 31.
citation: Sudano I, Krahenbuhl S, Mach F, Anstett A, Dhalwani N, Bridges I, Sibartie M, Ray KK. Evolocumab use in clinical practice in Switzerland: final data of the observational HEYMANS cohort study. Ther Adv Cardiovasc Dis. 2024 Jan-Dec;18:17539447231213288. doi: 10.1177/17539447231213288.
citation: Lehrke M, Vogt A, Schettler V, Girndt M, Fraass U, Tabbert-Zitzler A, Bridges I, Dhalwani NN, Ray KK. Evolocumab-Based LDL-C Management in High and Very High Cardiovascular Risk Patients in German Clinical Practice: The HEYMANS Study. Adv Ther. 2024 Mar;41(3):1184-1200. doi: 10.1007/s12325-023-02757-x. Epub 2024 Jan 30.
citation: Vlachopoulos C, Massia D, Kochiadakis G, Kolovou G, Patsilinakos S, Bridges I, Sibartie M, Dhalwani NN, Liberopoulos E, Ray KK. Evolocumab use in Greece is associated with early and sustainable reductions in low-density cholesterol (LDL-C) and high persistence to therapy: Results from the Greek cohort analysis of the observational HEYMANS study. Hellenic J Cardiol. 2023 Nov-Dec;74:74-76. doi: 10.1016/j.hjc.2023.09.003. Epub 2023 Sep 18. No abstract available.