Appropriateness of dabigatran dosing in patients with nonvalvular atrial fibrillation (NVAF): A retrospective study conducted in a tertiary care university hospital in the eastern province of Saudi Arabia

Abstract

BackgroundEstablishment of thromboembolism prevention remains a challenge despite the widespread consensus that thromboprophylaxis safely reduces patient morbidity and mortality. Dabigatran is a nonvitamin K antagonist oral anticoagulant (NOAC) which reduces the risk of thromboembolism. Proper dosing is important to achieve the maximum prophylactic benefit with a maintained safety profile.ObjectiveTo evaluate the appropriateness of dabigatran dosing for stroke and systemic embolism prevention in patients with nonvalvular atrial fibrillation (NVAF).MethodsThis is a retrospective cohort study of adults with NVAF. The data were collected from the electronic filing system of the hospital. Patients receiving dabigatran therapy were divided into two treatment groups according to the dose of dabigatran received. The indications for dabigatran as an oral direct anticoagulant, including age, risk of bleeding, creatinine clearance (CrCl), were collected. Appropriateness of dose reduction included any of the following factors: HAS-BLED score >2 points, age ≥75 years, or CrCl of 30–50 mL/min. The two groups were evaluated according to dose appropriateness.ResultsDabigatran dose of 110 mg was found to be inappropriately low in a large number of patients (31.3%). Multivariate regression analysis showed significant association of age and dose appropriateness (p < 0.001).ConclusionThis study revealed inappropriate prescription of reduced doses of dabigatran in a large number of patients. Age was identified as the main driving factor for underdosing. Physicians’ and pharmacists’ awareness regarding this type of high-risk medication should be improved to ensure appropriate and safe use of this commonly used drug.

The patient pathway in cardiovascular care: A position paper from the International Pharmacists for Anticoagulation Care Taskforce (iPACT)

“…Some studies have even demonstrated that a proportion as high as 30% of patients were receiving a dose of dabigatran inappropriately low, after taking into account creatinine clearance, age, and bleeding risk …”

“…34 Some studies have even demonstrated that a proportion as high as 30% of patients were receiving a dose of dabigatran inappropriately low, after taking into account creatinine clearance, age, and bleeding risk. 86 The predictors for dose reduction, other than dabigatran treatment, include advanced age, high CHA 2 DS 2 -VASc score, and high HAS-BLED score. 87 The role of the hospital pharmacist in medicines optimization goes obviously beyond OAC and studies undertaken in Brazil have shown that even in venous thromboembolism prevention, there is wide room for improvement as around 40% of hospitalized patients were found to receive inappropriate treatment.…”

Patient-guided modifications of oral anticoagulant drug intake during Ramadan fasting: a multicenter cross-sectional study

“…The fear for bleeding complications is a likely cause for this finding. Other studies also reported inappropriate prescription of DOAC in Saudi Arabia, including under-dosing or non-approved indications [ 13 , 15 , 22 , 23 ]. This finding points to the importance of ensuring an approval-conform intake of OAC medication in general.…”

“…Warfarin and DOAC are nationally approved in Saudi Arabia. Patient information leaflets were evaluated for the recommended intake regimen of all five anticoagulants (warfarin: QD only, dabigatran: BID only, apixaban: BID only, rivaroxaban: QD only, and edoxaban: QD only) [13][14][15].…”

Better survival in morbidly obese patients with atrial fibrillation treated with non-vitamin K-dependent oral anticoagulants

“…When compared to warfarin, NOACs have significantly fewer drug–drug and food–drug interactions. NOACs also have the advantage of fixed dosing criteria, predictable pharmacokinetics and dynamic profile, less bleeding risk, and no need for monitoring [ 1 , 3 , 4 ]. However, NOACs have dose adjustments in renal-impaired patients since the kidney entirely clears them.…”