Treatment of venous thromboembolism with rivaroxaban in relation to body weight

Abstract

The pharmacokinetics of oral rivaroxaban are highly predictable and only affected to a limited extent by bodyweight; therefore, dose adjustments for bodyweight are not required. However, this raises concerns among physicians for potential under- or overdosing. This substudy of the randomised EINSTEIN DVT and EINSTEIN PE trials, which compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy, aimed to determine the incidence of major bleeding in patients with a low bodyweight and recurrent venous thromboembolism (VTE) in patients with a high bodyweight during rivaroxaban or enoxaparin/VKA therapy. More than 8,000 patients with objectively diagnosed deep-vein thrombosis or pulmonary embolism were included. Adjusted hazard ratios for recurrent VTE and bleeding were calculated using the Cox proportional hazards model. Analyses were performed for both the first 21 days of treatment and the whole treatment period. For rivaroxaban recipients, there was no association between bodyweight or body mass index (BMI) and risk of recurrent VTE (ptrend=0.87 and 0.62, respectively), major bleeding (ptrend=0.24 and 0.36, respectively) or clinically relevant bleeding (ptrend=0.17 and 0.63, respectively). Major bleeding events were numerically lower in rivaroxaban patients across all bodyweight and BMI categories. Hazard ratios for rivaroxaban vs enoxaparin/VKA were similar in all bodyweight and BMI categories, both during the first 21 days and the whole treatment period. The fixed-dose rivaroxaban regimen is not associated with an increased risk of major bleeding or recurrent VTE in patients with either a low or high bodyweight. A high BMI was not associated with an increased risk of recurrent VTE during anticoagulation.

Rivaroxaban versus nadroparin for preventing deep venous thrombosis after total hip arthroplasty following femoral neck fractures: A retrospective comparative study

“… 4 – 6 Notably, the curative effect of rivaroxaban for preventing DVT has been well documented. 3 , 12 …”

“…In recent years, through a large number of clinical and experimental observations, these three major factors were proven reliable. 12 , 28 , 29 The risk of lower extremity venous thrombosis increases significantly after initial THA. 3 , 11 , 30 The following factors contribute to this result.…”

“… 3 , 11 , 30 The following factors contribute to this result. 12 , 30 , 31 First, the lower limb needs to be braced within a certain period of time, whereas joint flexion, limb compression, and prolonged bed rest after surgery reduce the venous blood flow velocity. Second, activation of endogenous coagulation factors induced by surgery results in hypercoagulability.…”

“… 11 In addition, rivaroxaban is associated with dose-dependent inhibition of factor Xa activity, and maximum inhibition of this activity failed to vary significantly between initial and steady-state administration. 12 , 13 Elderly patients with osteoporosis undergoing initial THA following femoral neck fractures have reported very low rates of complications (DVT and/or PE) while on rivaroxaban therapy. 14 , 15 However, nadroparin was not evaluated in these studies.…”

Anticoagulation Resumption After Intracerebral Hemorrhage

“…Given the significantly lower risk of ICH in AF patients [ 61 ], the role of NOACs in these patients could be promising. In patients at high risk of DVT and PE, NOACs may also be an alternative to warfarin [ 70 – 75 ].…”