Off-label dose direct oral anticoagulants and clinical outcomes in Asian patients with atrial fibrillation: A new evidence of Asian dose.
Int J Cardiol
; 371: 184-190, 2023 Jan 15.
Article
em En
| MEDLINE
| ID: mdl-36208678
ABSTRACT
AIM:
This study aimed to evaluate the label compliance of DOACs in the Chinese AF population and explore the relationship between inappropriate DOACs dosage and clinical results. METHODS ANDRESULTS:
This is a retrospective multicenter cohort study conducted in 14 centers in China. According to the China Food and Drug Administration(CFDA) label and the recommendations of international guidelines, we divided patients into on-label dosage and off-label dosage. We then compared the clinical results after propensity score matching. We collect demographic information through the hospital information system and obtain clinical events through follow-up of patients or their families. Clinical results include major, minor, total bleeding, thrombosis, and all-cause death. 4191 patients with non-valvular AF (NVAF) were included, and approximately 55.6% and 1.7% of AF patients received off-label underdose and off-label overdose of DOACs, respectively. Compared with the on-label dose, DOACs with off-label underdose were associated with a significantly reduced risk of major bleeding (P = 0.004, OR = 0.23,95% CI 0.08-0.69) and all-cause death (P<0.001, OR = 0.49,95% CI 0.33-0.73). However, there was no significant difference in thrombotic events (P = 0.865 OR = 1.06,95% CI 0.54-2.07) and minor bleeding (P = 0.465, OR = 1.10,95% CI 0.85-1.43) risk.CONCLUSIONS:
About 57.3% of Asian AF patients received an off-label dose of DOACs in daily practice. Off-label underdose DOACs were associated with significantly lower risks of major bleeding, all-cause death, and similar risks of minor bleeding, thrombotic events compared with on-label dose DOACs. Further prospective randomized trials are needed to determine the optimal dose of DOACs in Asian patients with AF at high bleeding risk.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
1_ASSA2030
/
2_ODS3
/
6_ODS3_enfermedades_notrasmisibles
Base de dados:
MEDLINE
Assunto principal:
Fibrilação Atrial
/
Acidente Vascular Cerebral
Tipo de estudo:
Clinical_trials
/
Guideline
/
Observational_studies
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Int J Cardiol
Ano de publicação:
2023
Tipo de documento:
Article