Use of Patient Health Records to Quantify Drug-Related Pro-arrhythmic Risk.
Cell Rep Med
; 1(5): 100076, 2020 08 25.
Article
in En
| MEDLINE
| ID: mdl-33205069
ABSTRACT
There is an increasing expectation that computational approaches may supplement existing human decision-making. Frontloading of models for cardiac safety prediction is no exception to this trend, and ongoing regulatory initiatives propose use of high-throughput in vitro data combined with computational models for calculating proarrhythmic risk. Evaluation of these models requires robust assessment of the outcomes. Using FDA Adverse Event Reporting System reports and electronic healthcare claims data from the Truven-MarketScan US claims database, we quantify the incidence rate of arrhythmia in patients and how this changes depending on patient characteristics. First, we propose that such datasets are a complementary resource for determining relative drug risk and assessing the performance of cardiac safety models for regulatory use. Second, the results suggest important determinants for appropriate stratification of patients and evaluation of additional drug risk in prescribing and clinical support algorithms and for precision health.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Arrhythmias, Cardiac
/
Pharmaceutical Preparations
Type of study:
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Adult
/
Animals
/
Female
/
Humans
/
Male
Language:
En
Journal:
Cell Rep Med
Year:
2020
Document type:
Article
Affiliation country:
Reino Unido