Table 2.

Summary of Landmark Clinical Trials of Rivaroxaban According to BMI of Patients

Reference	Study Design*	Study Population		Distribution of Patients by BMI (kg/m2) and No. (%) of Patients			Treatment	Treatment Duration	Follow-Up	Outcome
Freidman et al.24	R, DB	12 355 patients with total hip or knee arthroplasty	BMI < 25 n = 3008 (24.3)	BMI 25–29 n = 4916 (39.8)	BMI 30–39 n = 3986 (32.3)	BMI ≥ 40 n = 445 (3.6)	Riv 10 mg PO daily or Enox 40 mg SC daily or Enox 30 mg SC bid	31–39 or 10–14 days	30–35 days	No significant differences in VTE or major bleeding in relation to BMI
Di Nisio et al.25	OL, R	8282 patients† with deep vein thrombosis or pulmonary embolism	BMI < 25 n = 2481 (30.0)	BMI ≥ 25 to < 30 n = 3258 (39.3)	BMI ≥ 30 to < 35 n = 1630 (19.7)	BMI ≥ 35 n = 861 (10.4)	Riv 15 mg bid × 21 days, then 20 mg daily or dose-adjusted Enox (according to body weight), followed by VKA, with target INR of 2–3	Median 182 days	30 days	No association between body weight or BMI and VTE or major bleeding
Patel et al.26	R, DB	14 264 patients‡ with atrial fibrillation	BMI ≤ 25 n = 3445 (24.2)	BMI 25 to ≤ 35 n = 8826 (61.9)		BMI > 35 n = 1891 (13.3)	Riv 20 mg daily (15 mg daily if CrCl 30–49 mL/min) or dose- adjusted warfarin, with target INR of 2–3	Median 590 days	Median 707 days	No association between body weight or BMI and risk of stroke or systemic embolism or bleeding events

BMI = body mass index, Enox = enoxaparin, INR = international normalized ratio, NS = nonsignificant, Riv = rivaroxaban, VKA = vitamin K antagonist, VTE = venous thromboembolism.

^*Abbreviations used for aspects of study design: DB = double-blind, OL = open label, R = randomized.

^†BMI was missing for 52 patients (0.6% of the sample): 1 patient did not provide informed consent, 10 patients did not report body weight, and 41 patients did not report height.

^‡BMI data were taken from Figure 3 in the ROCKET AF supplementary appendix, which did not account for all patients.