Table 3.

Summary of dabigatran etexilate phase III studies

Trial	Anticoagulation indication	Dabigatran etexilate dosing	Control dosing	Participant age, mean (years)	Participant CLcr, mean (ml min−1)	Primary outcome analysis (vs. control)	Bleeding analysis (vs. control)
RE-MODEL[12]	VTE prophylaxis post-KJR	150 mg or 220 mg daily	Enoxaparin 40 mg daily	68	?	VTE and all-cause mortality: non-inferior for both doses	Major bleeding: no significant difference for both doses
							Minor bleeding: analysis not given
RE-NOVATE[13]	VTE prophylaxis post-HJR	150 mg or 220 mg daily	Enoxaparin 40 mg daily	64	89	VTE and all-cause mortality: non-inferior for both doses	Major bleeding: no significant difference for both doses
							Minor bleeding: analysis not given
RE-MOBILIZE[14]	VTE prophylaxis post-KJR	150 mg or 220 mg daily	Enoxaparin 30 mg twice daily	66	83	VTE and all-cause mortality: inferior for both doses	Major bleeding: no significant difference for both doses
							Minor bleeding: analysis not given
RE-NOVATE II[22]	VTE prophylaxis post-HJR	220 mg daily	Enoxaparin 40 mg daily	62	97	VTE and all-cause mortality: non-inferior	Major bleeding: no significant difference
							Any bleeding: no significant difference
RE-LY[10, 15, 20]	AF	150 or 110 mg twice daily	Warfarin (INR 2–3)	71	73	Stroke or systemic embolism: non-inferior for both doses, superior for 150 mg twice daily	Major bleeding: superior for 110 mg no significant difference for 150 mg
							Any bleeding: superior for both doses
RE-COVER[16]	Acute VTE treatment	150 mg twice daily	Warfarin (INR 2–3)	55	105	VTE and all-cause mortality: non-inferior	Major bleeding: no significant difference
							Any bleeding: Superior

AF, atrial fibrillation; CL_cr, creatinine clearance; HJR, hip joint replacement; KJR, knee joint replacement; VTE, venous thromboembolism.