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Clinical utility of dabigatran in United Arab Emirates. A pharmacovigilance study
Abdulla Shehab1, Asim A Elnour, Adel Sadik
1Department of Internal Medicine, College of Medicine and Health Sciences, United Arab Emirates University, Al-Ain, United Arab Emirates. E-mail. a.shehab@uaeu.ac.ae.
Insights
Dabigatran shows clinical utility in the UAE, with a 23.7% bleeding rate, primarily melena. While a suitable warfarin alternative, plasma drug monitoring may be necessary for dabigatran use.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Medicine
Background:
- Direct oral anticoagulants (DOACs) like dabigatran offer alternatives to warfarin for stroke prevention.
- Limited data exists on dabigatran's real-world clinical utility in the United Arab Emirates (UAE).
Purpose of the Study:
- To assess the clinical utility and safety profile of dabigatran in a UAE population.
- To provide early data on bleeding events and patient outcomes associated with dabigatran use.
Main Methods:
- Retrospective cross-sectional study of 76 patients using dabigatran from September to December 2014.
- Analysis focused on the frequency of bleeding events across different dabigatran dosages (75, 110, 150 mg).
Main Results:
- The study cohort (mean age 67.9 years) primarily used dabigatran for atrial fibrillation.
- A bleeding rate of 23.7% was observed, with melena being the most frequent event (10.7%).
- Hospitalization rate was 67.1%, with a low dabigatran withdrawal rate (0.01%) and mortality rate (6.5%); no deaths were directly attributed to dabigatran.
Conclusions:
- Dabigatran presents a viable alternative to warfarin, eliminating the need for routine International Normalized Ratio (INR) monitoring.
- Consideration for plasma drug monitoring may be beneficial for optimizing dabigatran therapy.
Objectives:
To provide early data regarding clinical utility of dabigatran in Al-Ain, United Arab Emirates (UAE).
Methods:
This was an ethics approved retrospective cross sectional study. We retrieved a total of 76 patients who were using dabigatran from September to December 2014 in the Cardiology Clinic at Al-Ain Hospital, Al-Ain, UAE. The primary analysis was designed to test the frequency of bleeding events (rate) with dabigatran 75, 110, and 150 mg.
Results:
The mean age ± standard deviation of cohort was 67.9 ± 1.5 years (range; 29-98 years), composed of males (52.6%) with mean age of 66.3 ± 1.7 years, and females (47.4%) with mean age of 69.6 ± 1.1 years. The highest age group was those between 61-80 years (60.5%). Most comprised the age strata of ≤75 years (73.7%). The main indication for dabigatran use was atrial fibrillation. The rate of bleeding with dabigatran was 18/76 (23.7%), and melena was the leading cause of bleeding 8/76 (10.7%). The hospitalization rate was 67.1%, dabigatran withdrawal rate was 0.01%, and mortality rate was 6.5%. The cohort had exhibited incidences of minor bleeding with one fatal major bleeding, high co-morbidities, admission, and readmission, which was not directly linked to dabigatran. We did not identify any relation of death due to dabigatran.
Conclusion:
Dabigatran is a suitable alternative to warfarin obviating the need for repetitive international normalized ratio monitoring, however, it may need plasma drug monitoring.
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