The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid and diabetes trials

Heinz Drexel; Giuseppe M C Rosano; Basil S Lewis; Kurt Huber; Alexander Vonbank; Jörn F Dopheide; Arthur Mader; Alexander Niessner; Gianluigi Savarese; Sven Wassmann; Stefan Agewall

doi:10.1093/ehjcvp/pvz029

The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid and diabetes trials

Eur Heart J Cardiovasc Pharmacother. 2020 Apr 1;6(2):97-103. doi: 10.1093/ehjcvp/pvz029.

Authors

Heinz Drexel^{1

2

3

4}, Giuseppe M C Rosano⁵, Basil S Lewis⁶, Kurt Huber^{7

8}, Alexander Vonbank^{1

3

9}, Jörn F Dopheide², Arthur Mader^{1

3

9}, Alexander Niessner¹⁰, Gianluigi Savarese¹¹, Sven Wassmann^{12

13}, Stefan Agewall^{14

15}

Affiliations

¹ Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT), Academic Teaching Hospital Feldkirch, Carinagasse 47, 6800 Feldkirch, Austria.
² Division of Angiology, Swiss Cardiovascular Center, Freiburgstrasse 18, University Hospital Bern, 3010 Bern, Switzerland.
³ Doctorate Studies Medical Science, Private University of the Principality of Liechtenstein, Dorfstrasse 24, 9495 Triesen, Principality of Liechtenstein.
⁴ Drexel University College of Medicine, 2900 W Queen Ln, Philadelphia, PA 19129, USA.
⁵ Department of Medical Sciences, IRCCS San Raffaele Hospital, Via della Pisana 235, 00163 Rome, Italy.
⁶ Technion-Israel Institute of Technology, Ruth and Bruce Rappaport School of Medicine, Efron St 1, Bat Galim, 3525433 Haifa, Israel.
⁷ 3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, Montleartstraße 37, 1160 Vienna, Austria.
⁸ Medical School, Cardiology, Sigmund Freud University, Campus Prater, Freudplatz 1, 1020 Vienna, Austria.
⁹ Department of Medicine I, Academic Teaching Hospital Feldkirch, Carinagasse 47, 6800 Feldkirch, Austria.
¹⁰ Department of Internal Medicine II, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.
¹¹ Cardiology Unit, Department of Medicine, Karolinska Institute, Solnavägen 1, 171 77 Solna, Sweden.
¹² Cardiology Practice Pasing, Institutstraße 14, 81241 Munich, Germany.
¹³ Medical Faculty, Clinical Medicine, University of the Saarland, Kirrberger Straße, 66421 Homburg, Germany.
¹⁴ Department of Cardiology, Oslo University Hospital Ulleval, Kirkeveien 166, 0450 Oslo, Norway.
¹⁵ Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Søsterhjemmet, Kirkeveien 166, 0450 Oslo, Norway.

PMID: 31298686
DOI: 10.1093/ehjcvp/pvz029

Abstract

Randomized clinical trials (RCTs) are important and the Gold Standard for drugs in modern cardiovascular (CV) therapy. The cornerstone of RCTs is the recording of hard clinical endpoints instead of surrogates. It is important to select an appropriate endpoint. Efficacy endpoints must be clinically relevant and can be hierarchically divided. A very interesting innovation in endpoint acquisition is the total event paradigm.

Keywords: Cardiovascular disease; Cardiovascular pharmacotherapy; Diabetes; Endpoints; Randomized clinical trial.

Publication types

Review

MeSH terms

Biomarkers / blood
Blood Glucose / drug effects*
Blood Glucose / metabolism
Cardiovascular Diseases / diagnosis
Cardiovascular Diseases / mortality
Cardiovascular Diseases / prevention & control*
Diabetes Mellitus / blood
Diabetes Mellitus / diagnosis
Diabetes Mellitus / drug therapy*
Diabetes Mellitus / mortality
Dyslipidemias / blood
Dyslipidemias / diagnosis
Dyslipidemias / drug therapy*
Dyslipidemias / mortality
Endpoint Determination*
Humans
Hypoglycemic Agents / adverse effects
Hypoglycemic Agents / therapeutic use*
Hypolipidemic Agents / adverse effects
Hypolipidemic Agents / therapeutic use*
Lipids / blood*
Randomized Controlled Trials as Topic / methods*
Research Design*
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome

Substances

Biomarkers
Blood Glucose
Hypoglycemic Agents
Hypolipidemic Agents
Lipids