Efficacy and Safety of Two Different Enoxaparin Doses for Thromboprophylaxis in Non-Critically Ill Patients: A Randomized Controlled Trial

Document Type : Research article

Authors

1 Department of Infectious and Tropical diseases, Loghman-Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

2 Student Research Committee, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

3 Student Research Committee, Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

4 Clinical Pharmacy Resident, Student Research Committee, Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

5 Student research committee, Department of Clinical Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran

6 Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

10.22037/ijpr.2021.115743.15498

Abstract

Aims: Recently, a few studies based on anti-factor Xa activity levels have propounded doubtful and sub-prophylactic levels by the usual dose of enoxaparin in surgical and critically ill patients. In this study, we assessed two doses of enoxaparin in non-critically ill adult patients.
Methods: Patients were randomly assigned to receive daily 60mg or 40mg enoxaparin as intervention and control groups, respectively. Anti-factor Xa activity was measured based on the peak steady-state levels. The level of 0.2 to 0.4 IU/mL was considered as a prophylactic goal. All individuals were followed for bleeding or thromboembolic events during admission.
Results: Twenty-nine and 31 cases were included in the intervention and control groups, respectively. The mean levels of anti-factor Xa were 0.29±0.13 IU/mL in the control group and 0.44±0.19 IU/mL in the intervention group. More patients in the control group had an optimal level of anti-factor Xa compared to the patients in the intervention group (62.1% vs 29%). No adverse outcome was detected in each group.
Conclusion: Enoxaparin dose of 60mg daily provide anti-factor Xa level higher than desired in most patients. In non-critically ill patients, the dose of 40mg is the proper dose for thromboprophylaxis.
The trial was retrospectively registered on 05/18/2020 at the Iranian Registry on Clinical Trials (IRCT20130917014693N11).

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