Endpoints in diabetes cardiovascular outcome trials

The three-component major adverse cardiac events (MACE) endpoint, often used to assess cardiovascular safety, includes a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.2,3 Hospital admission for heart failure is another cardiovascular endpoint of interest. F...

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Published inThe Lancet (British edition) Vol. 391; no. 10138; p. 2412
Main Authors Patel, Tejas, Tesfaldet, Bereket, Chowdhury, Iffat, Kettermann, Anna, Smith, James P, Pucino, Frank, Almario, Eileen E Navarro
Format Journal Article
LanguageEnglish
Published England Elsevier Ltd 16.06.2018
Elsevier Limited
Subjects
Cardiovascular Diseases - mortality
Clinical Trials as Topic
Diabetes mellitus
Endpoint Determination
Heart attacks
Heart failure
Heart Failure - epidemiology
Hospitalization - statistics & numerical data
Humans
Hypoglycemic Agents - adverse effects
Myocardial infarction
Myocardial Infarction - epidemiology
Odds Ratio
Patient admissions
Proportional Hazards Models
Scholarships & fellowships
Stroke - epidemiology
United States > US
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Summary:The three-component major adverse cardiac events (MACE) endpoint, often used to assess cardiovascular safety, includes a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.2,3 Hospital admission for heart failure is another cardiovascular endpoint of interest. Furthermore, another limitation was that we excluded trials that used methods related to the collection and recording of adverse events that precluded direct comparisons with adjudicated MACE or hospital admission for heart failure events.6,7,12,14,15 In conclusion, MedDRA query-derived endpoints could have a role in the assessment of cardiovascular safety. Additional research is needed to identify factors related to trial conduct (eg, prespecified endpoint definitions, adverse event assessment, collection, and reporting, and training of investigators) that are essential for assuring reliable results when using MedDRA queries to characterise the effects of drugs on cardiovascular outcomes.
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ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(18)31184-X