MILOS: Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia

Sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04579367

Collaborator

(none)

5,000

Enrollment

127

Locations

43.5

Anticipated Duration (Months)

39.4

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to describe in the real-world setting patient characteristics and outcomes of patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia using bempedoic acid and/or its fixed-dose combination with ezetimibe in managing plasma levels of low-density lipoprotein cholesterol (LDL-C).

Secondary objectives are to document and evaluate as applicable:

Assessment of the cardiovascular risk of patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe using different risk scores (e.g. Systematic Coronary Risk Estimation (SCORE) system, SMART score for Very High Risk patients and Framingham risk score for High Risk patients. The scores will be re-calculated during the analysis and used as an analytical tool only).
Changes in low-density lipoprotein cholesterol (LDL-C) levels prior to treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe compared to 1 year follow-up and subsequent data collection points, if applicable.
Characterize plasma levels of other potentially ASCVD-modifying cholesterol fragments, namely, LDL-C, total cholesterol (TC), apolipoprotein B (apoB), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, triglycerides (TGs) and lipoprotein A (Lp[a]) compared to 1 year follow-up and subsequent data collection points, if applicable.
Changes in the levels of inflammatory marker hsCRP compared to 1 year follow-up and subsequent data collection points, if applicable.
Adverse Drug Reactions associated to bempedoic acid and/or its fixed-dose combination with ezetimibe.
Changes in uric acid levels compared to 1 year follow-up and subsequent data collection points, if applicable.
Relevant CV events:
Myocardial infarction
Unstable angina
Coronary artery bypass graft surgery (CABG)
Percutaneous transluminal coronary angioplasty (PTCA)
Stroke
Transient ischemic attack (TIA)
Acute peripheral arterial occlusion
All-cause death
Cardiovascular (CV)-death
Adverse effects associated with lipid-modifying treatment (LMT)
Laboratory abnormalities
Muscle-associated symptoms
New onset and/or worsening diabetes
Changes in the patients´ glycemic status over time
Site characteristics (sites and practitioners) caring for patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe.
Use of LMTs prior or concomitantly to receiving bempedoic acid and/or its fixed-dose combination with ezetimibe (therapies including combination treatments).
Bempedoic acid and/or its fixed-dose combination with ezetimibe treatment parameters such as treatment duration by therapy, dosage, prescription intervals, permanent discontinuations, switches and reasons for these, (concomitant medication, additional therapy/interventions).
Healthcare resource use especially consultation visits with specialist, nurse time and hospitalizations as well as patient-reported outcome using EQ-5D-5L and PAM-13.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia Mixed Dyslipidemia	Drug: Bempedoic acid and/or its fixed-dose combination with ezetimibe

Detailed Description

This non-interventional study will be conducted to characterize the risks and benefits of bempedoic acid and/or its fixed-dose combination with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of low-density lipoprotein cholesterol) as well as safety (clinical events associated with the treatment modalities). Real world evidence will be collected in 5000 participants, treated by specialized as well as non-specialized physicians in hospitals and office based centers.

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Non-interventional Study on the Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia (MILOS)

Actual Study Start Date :

Jan 15, 2021

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Bempedoic acid and/or fixed-dose combination with ezetimibe Participants with primary hypercholesterolemia or mixed dyslipidemia who received bempedoic acid and/or its fixed-dose combination with ezetimibe.	Drug: Bempedoic acid and/or its fixed-dose combination with ezetimibe This is a non-interventional study. No study medication will be provided to the patients. Medication will be prescribed by the treating physician in line with the clinical practice.

Arm

Intervention/Treatment

Bempedoic acid and/or fixed-dose combination with ezetimibe

Participants with primary hypercholesterolemia or mixed dyslipidemia who received bempedoic acid and/or its fixed-dose combination with ezetimibe.

Drug: Bempedoic acid and/or its fixed-dose combination with ezetimibe

This is a non-interventional study. No study medication will be provided to the patients. Medication will be prescribed by the treating physician in line with the clinical practice.

Outcome Measures

Primary Outcome Measures

Summary of patient characteristics in patients with primary hypercholesterolemia or mixed dyslipidemia following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe [Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)]

Secondary Outcome Measures

Overview of the cardiovascular risk of patients with primary hypercholesterolemia or mixed dyslipidemia following treatment with bempedoic acid/ and/or its fixed-dose combination with ezetimibe [Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)]
Cardiovascular risk scores will be assessed using the Systematic Coronary Risk Estimation (SCORE) system, Second manifestations of arterial disease (SMART) and Framingham risk scores. The SMART risk score will estimate 10-year risk for very high-risk participants based on clinical patient characteristics. The gender-specific Framingham risk score will be used to estimate 10-year cardiovascular risk for high-risk participants.
Summary of changes in plasma low-density lipoprotein cholesterol levels following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia [Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)]
Summary in changes in plasma levels of atherosclerotic cardiovascular disease-modifying cholesterol fragments following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe [Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)]
Plasma levels of total cholesterol (TC), apolipoprotein B (apoB), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs) and lipoprotein a (Lp[a]) will be assessed.
Summary of changes in plasma inflammatory marker hsCRP levels following treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia [Baseline (date of signed informed consent) up to 1 year minimum or 2 year maximum follow up (depending on the availability of bempedoic acid in countries)]
Inflammatory status was assessed using high-sensitive C-reactive protein.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Written informed consent to participate
At least 18 years of age
Participants suffering from documented primary hypercholesterolemia or mixed dyslipidemia treated or intended to be treated with bempedoic acid and/or its fixed dose combination with ezetimibe at the discretion of the physician are appropriate for participation in the observation.
No contraindications exist according to the SmPC of bempedoic acid and/or its fixed-dose combination with ezetimibe
No concurrent participation in an interventional study (simultaneous participation in other non-interventional study is possible)
Life expectancy > 1 year

Exclusion Criteria:

As this is a non-interventional study, no explicit exclusion criteria are defined. The prescribing behavior will not be influenced. Only patients will be included where the decision has been made by the treating physician to treat the patients either with bempedoic acid and/or its fixed-dose combination with ezetimibe.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	MVZ Helios Aue	Aue	Germany	08280
2	Kardiologische Praxis Enders	Bad Elster	Germany	08645
3	Kardiologische Praxis	Bad Homburg	Germany	61348
4	Universitätsklinikum Freiburg - Universitäts-Herzzentrum	Bad Krozingen	Germany	79189
5	Praxis am Landratspark	Bad Segeberg	Germany	23795
6	CIMS Studienzentrum Bamberg GmbH Drs. Kirschner/Haas/Ritzel	Bamberg	Germany	96049
7	Kardiologische Praxis	Bechhofen	Germany	66894
8	Praxis Rankestraße	Berlin	Germany	10789
9	Herzpraxis Berlin MVZ	Berlin	Germany	12165
10	Charité - Universitätsmedizin Berlin	Berlin	Germany	12203
11	Dres. Seeger & Partner	Berlin	Germany	12627
12	Diabetespraxis Dr. Braun	Berlin	Germany	13187
13	Lipidambulanz Charite	Berlin	Germany	13353
14	Praxiszentrum Biedenkopf	Biedenkopf	Germany	35216
15	Praxis Dr. A. Biedermann	Blankenhain	Germany	99444
16	MVZ für Innere Medizin	Bonn	Germany	53173
17	Kardiologie im Friedrichspalast Bruchsal	Bruchsal	Germany	76646
18	Studiengesellschaft Könemann und Steinmann GbR	Bunde	Germany	32257
19	MediClin Reha-Zentrum Spreewald	Burg	Germany	03096
20	MVZ am Küchwald	Chemnitz	Germany	09113
21	Kardiologische Praxis Stellmach	Chemnitz	Germany	09126
22	MVZ Polymed	Chemnitz	Germany	09130
23	Praxis Dr. Menzel	Dessau	Germany	06846
24	Klinikum Lippe GmbH	Detmold	Germany	32756
25	Kardiologische Gemeinschaftspraxis	Dortmund	Germany	44137
26	Cardiologicum Dresden/Pirna	Dresden	Germany	01277
27	Dres. Günther/Kolschmann	Dresden	Germany	01307
28	Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden	Dresden	Germany	01307
29	Universitätsklinikum Carl Gustav Carus	Dresden	Germany	01307
30	DZDM Diabeteszentrum Duisburg Mitte	Duisburg	Germany	47051
31	Nierenzentrum Düren	Düren	Germany	52351
32	Universitätsklinikum Düsseldorf	Düsseldorf	Germany	40225
33	Praxis Dilltal	Ehringshausen	Germany	35630
34	Praxis Dipl. -Med. Petra Herrmann	Eisenach	Germany	99817
35	Kardiologische Praxis	Elsterwerda	Germany	04910
36	Gemeinschaftspraxis ISP Erlangen	Erlangen	Germany	91052
37	Hausarztzentrum am Germaniaplatz	Essen	Germany	45355
38	DIAKO Flensburg	Flensburg	Germany	24939
39	Praxis für Nieren und Hochdruck-Krankheiten	Flensburg	Germany	24941
40	MVZ Altstadt-Carree Fulda	Fulda	Germany	36037
41	Praxis Dr. Langel	Gera	Germany	07551
42	Universitätsmedizin Greifswald	Greifswald	Germany	17475
43	Praxis Dr. Müller	Gräfenhainichen	Germany	06773
44	Praxis für Gefäßmedizin	Görlitz	Germany	02827
45	Universitätsmedizin Göttingen	Göttingen	Germany	37075
46	Evangelisches Krankenhaus Hagen-Haspe	Hagen	Germany	58135
47	Praxis	Hainburg	Germany	63512
48	Cardiologicum Hamburg - Praxis Wandsbek	Hamburg	Germany	22041
49	Diabetes Zentrum Wandsbeck	Hamburg	Germany	22041
50	MVZ Prof. Mathey, Prof. Schofer	Hamburg	Germany	22527
51	Kardiologie am Tibarg	Hamburg	Germany	22549
52	Kardiologie List	Hannover	Germany	30177
53	Kardiologische Praxis	Haßloch	Germany	67454
54	Kardiologische Schwerpunktpraxis	Heidelberg	Germany	69115
55	Universitätsklinikum Heidelberg	Heidelberg	Germany	69120
56	Praxis Heik/Wedig	Heiligenstadt	Germany	37308
57	KARDIO-IN Kardiologische Gemeinschaftspraxis	Ingolstadt	Germany	85049
58	Kardiologische Praxis	Kaiserslautern	Germany	67655
59	SRH Klinikum Karlsbad-Langensteinbach	Karlsbad	Germany	76307
60	B. Braun Ambulantes Herzzentrum Kassel	Kassel	Germany	34121
61	Praxis Dr. Heiner Müller	Katzhütte	Germany	98746
62	Nephrologie Kiel	Kiel	Germany	24106
63	Gemeinschaftsklinikum Mittelrhein	Koblenz	Germany	56068
64	Studienzentrum der Inneren Medizin I & II am Klinikum Konstanz	Konstanz	Germany	78464
65	Kardiologie Dr. med. E. Persicke / Dr. med. O. Scheuermann	Kornwestheim	Germany	70806
66	Kardiologische Praxis Kyritz	Kyritz	Germany	16866
67	Zentrum für klinische Forschung	Köln	Germany	51069
68	IKAPP	Köln	Germany	51105
69	Universitätsklinikum Leipzig	Leipzig	Germany	04103
70	Kardiologische Praxis Boudriot	Leipzig	Germany	04129
71	MVZ Stoffwechselmedizin Leipzig	Leipzig	Germany	04317
72	Praxis Dr. I.Simon-Wagner	Lichtenfels	Germany	96215
73	St. Vincenz Krankenhaus	Limburg	Germany	65549
74	Gemeinschaftspraxis Dr. Jens Biesenbaum und Dr. Uwe Gerbaulet	Lohne	Germany	32584
75	Cardio Centrum Ludwigsburg-Bietigheim	Ludwigsburg	Germany	71634
76	Kardiologische Praxisklinik Ludwigshafen	Ludwigshafen	Germany	67071
77	Universität zu Lübeck	Luebeck	Germany	23538
78	Kardiologische Praxis Tamm/Hoh	Lutherstadt Wittenberg	Germany	06886
79	Institut für Präventive Medizin & Klinische Forschung GbR	Magdeburg	Germany	39110
80	Cardiopraxis Mainz	Mainz	Germany	55122
81	Katholisches Klinikum Mainz	Mainz	Germany	55131
82	Universitätsklinikum Mainz	Mainz	Germany	55131
83	ZE:RO Praxen	Mannheim	Germany	68165
84	UMM Mannheim	Mannheim	Germany	68167
85	Kardiologische Praxis	Markkleeberg	Germany	04416
86	Praxis Ben-Chur	Meiningen	Germany	98617
87	Praxis Haj-Yehia	Moers	Germany	47441
88	Gemeinschaftspraxis Dr. Prohaska/Dr. Schulte	Mühldorf	Germany	84453
89	Kardiologie Mühldorf am Inn	Mühldorf	Germany	84453
90	Herzquartier Mülheim	Mülheim an der Ruhr	Germany	45468
91	Kardiologie Neuhausen-Nymphenburg	München	Germany	80634
92	Dres. Wauer/Windstetter	München	Germany	80799
93	Praxis Kiepenkerl	Münster	Germany	48143
94	Zentrum für Kardiologie an der Raphaelsklinik Münster	Münster	Germany	48143
95	Praxis für Innere Medizin Münster	Münster	Germany	48149
96	Universitätsklinikum Münster	Münster	Germany	48149
97	Internistische Praxisgemeinschaft	Neu Isenburg	Germany	63263
98	Hausarztpraxis	Oer-Erkenschwick	Germany	45739
99	St. Vincenz-Krankenhaus GmbH	Paderborn	Germany	33098
100	Kardiologische Praxis Papenburg - Site 6071	Papenburg	Germany	26871
101	Kardiologische Praxis Papenburg - Site 6072	Papenburg	Germany	26871
102	Gemeinschaftspraxis Dres. med. Karl-Heinz Göttl - Omar Adjan	Passau	Germany	94032
103	Hausärztlich-Kardiologisches MVZ "Am Felsenkeller" GmbH	Pirna	Germany	01796
104	VieSante Herzmedizin Potsdam	Potsdam	Germany	14469
105	Kardiologische Gemeinschaftspraxis	Potsdam	Germany	14471
106	Allgemeinmedizinisch Internistische Praxis Dr. H. Borgmann	Radebeul	Germany	01445
107	Gemeinschaftspraxis Herz Riesa	Riesa	Germany	01587
108	Universitätsmedizin Rostock	Rostock	Germany	18057
109	MVZ Schwerin West GmbH	Schwerin	Germany	19057
110	Facharztpraxis für Kardiologie und Innere Medizin	Schwäbisch Hall	Germany	74523
111	Klinik Singen	Singen	Germany	78224
112	MEDINOS Klinik Sonneberg	Sonneberg	Germany	96515
113	Kardiologische Praxis im Steiner Thor	Straubing	Germany	94315
114	Praxis Dr Knöbel u. Partner	Straubing	Germany	94315
115	Praxis Dr. Michael Rother	Strausberg	Germany	15344
116	Diabetologische Schwerpunktpraxis	Trier	Germany	54292
117	Krankenhaus der Barmherzigen Brüder Trier	Trier	Germany	54292
118	Studienzentrum der Herzklinik Ulm GbR	Ulm	Germany	89077
119	Praxis Dr. Hansen	Unterwellenborn	Germany	07333
120	Herzzentrum Saar	Völklingen	Germany	66333
121	GRN Weinheim	Weinheim	Germany	69469
122	Kardiologische Praxis Al-Zoebi	Wermsdorf	Germany	04779
123	Internistische Gemeinschaftspraxis Dr. med. Schreckenberg, Dr. med. Vorderstraße	Weyhe	Germany	28844
124	Kardiologische Fachpraxis	Wolmirstedt	Germany	39326
125	Zentrum für Nieren- und Hochdrucklerkrankungen Hofaue	Wuppertal	Germany	42103
126	Universitätsklinikum Würzburg	Würzburg	Germany	97080
127	Gemeinschaftspraxis am Angerbrunnen	Zwiesel	Germany	94227