| Objectives: The objective of this trial was to find the efficacy and safety of VTE prophylaxis with Rivaroxaban (BAY 59-7939, 10 mg once daily administered for 5 weeks) in patients aged 18 years or above undergoing elective THR.Methodology: Prospective, randomized, double-blind, double-dummy, active comparator controlled, multi-center study. Subjects were screened for study eligibility and randomized at 11 centers in China to treatment with either Rivaroxaban 10mg od (164 subjects) or enoxaparin 40 mg od (161 subjects). Test group (Rivaroxaban): The first Rivaroxaban tablet was taken on the day of surgery (Day 1), at least 6-8 h after wound closure. Rivaroxaban was administered once daily every 24±2 h up to Day 35±4 (the day prior to venography). All subjects in the Rivaroxaban treatment group additionally received enoxaparin placebo sc injections once daily in the evening, starting on Day 0 (day before surgery) and ending on Day 12±2 (last dose). Enoxaparin placebo was provided as 0.4 mL pre-filled syringe. Reference group (Enoxaparin) : The first enoxaparin injection was administered in the evening of the day before surgery (Day 0) until Day 12±2.Additionally, all subjects in the enoxaparin group received Rivaroxaban placebo tablets. The first Rivaroxaban placebo tablet was taken on the day of surgery (Day 1), at least 6-8 h after wound closure. Rivaroxaban placebo was administered once daily every 24±2 h up to Day 35±4 (the day prior to venography). By comparison the efficacy and safety variables, we got the efficacy and safety measurements of the Rivaroxaban.Number of patients: (planned and actual analysised) : A total of 325 subjects were randomized at 11 centers in China. 316 subjects were treated with study drug (safety population); of these, 243 were valid for the modified intent to treat (MITT) analysis, 228 were valid for the per protocol (PP) analysis.Result of efficacy: A 5-week Rivaroxaban 10 mg od treatment regimen was both clinically effective and statistically superior to a 2-week SC enoxaparin 40 mg od treatment regimen in the prevention of VTE in subjects undergoing elective total hip replacement, even in the subpopulation from China. Rivaroxaban met the pre-specified primary and secondary efficacy objectives. The results detected in the subpopulation from China are fully consistent with the results in the total study population. Result of safety: Of the 325 randomized subjects, 316 were exposed to study drug Rivaroxaban: 160, enoxaparin: 156 and included in the safety population. Generally, the safety results indicated a comparable safety profile of Rivaroxaban to enoxaparin despite different treatment durations between the 2 treatment groups resulting in a longer exposure to study medication for the Rivaroxaban 10 mg od treated subjects.Conclusions: Rivaroxaban was both clinically effective and statistically superior to enoxaparin .Because of the size of the subpopulation from China, the statistical approach as specified for the total population was not applicable and the analyses performed in need to be interpreted with caution. The study results in the Chinese population were consistent with the results obtained in the total study population. The clinical benefit of Rivaroxaban (as demonstrated in the total study population) was accompanied by a favorable safety profile in both the total study population and the subpopulation from China. The Rivaroxaban safety profile in the subpopulation from China was comparable to that of enoxaparin. The efficacy and safety results of this descriptive analysis of the subpopulation from China support the beneficial use of Rivaroxaban in the prevention of VTE for Chinese subjects undergoing elective total hip replacement. This is the first Evidence Based Medicine research (EBM) focused on the VTE prophylaxis following total hip replacement in China.
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