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Comment on: European Heart Journal global spotlight on European Medicines Agency evaluation of mavacamten.

Authors :
Spertus, John A.
Source :
European Heart Journal Open; Mar2024, Vol. 4 Issue 2, p1-1, 1p
Publication Year :
2024

Abstract

The document is a comment on the European Medicines Agency's evaluation of mavacamten for symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The author expresses concern about the EMA's interpretation of the benefits of mavacamten on patients' health status. They argue that the clinical trials reviewed by the EMA used the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure health status, and that a 5-point change in the KCCQ score is considered small but clinically important. The author believes that a larger proportion of patients experienced clinically important improvements in symptoms, function, and quality of life when treated with mavacamten. [Extracted from the article]

Subjects

Subjects :
HEART failure
HEART
CLINICAL trials

Details

Language :
English
Volume :
4
Issue :
2
Database :
Complementary Index
Journal :
European Heart Journal Open
Publication Type :
Academic Journal
Accession number :
177142397
Full Text :
https://doi.org/10.1093/ehjopen/oeae013