GDC-0449 Vismodegib lacebo in patients undergoing THA

lacebo in patients undergoing THA . The incidence of bleeding was comparable between extended regimen rivaroxaban and short duration enoxaparin. Major bleeding events occurred in 0.1% of patients in both groups. Clinically relevant GDC-0449 Vismodegib nonmajor bleeding was recorded in 3.3% of the rivaroxaban group versus 2.7% of the enoxaparin group, haemorrhagic wound complications in 1.6% versus 1.7% of patients, and postoperative wound infections in 0.7% versus 0.5% of patients, respectively. Significantly fewer patients in the rivaroxaban group had symptomatic VTE than in the enoxaparin group during the active study period. In RECORD3, rivaroxaban prophylaxis was significantly more effective than the European enoxaparin regimen for prophylaxis in patients undergoing TKA, with a similar safety profile.
Rates ofmajor bleeding were similar in the rivaroxaban and enoxaparin groups, clinically relevant nonmajor bleeding occurred in 2.7% versus 2.3% of patients, haemorrhagic wound complications in 2.0% versus CYC202 1.9% of patients, and postoperative wound infections in 0.6% versus 0.9% of patients. There was a significant reduction in the number of symptomatic venous thromboembolic events in the rivaroxaban group. In RECORD4, rivaroxaban showed significantly better efficacy than the enoxaparin regimen commonly used in North America for short term prophylaxis after TKA . The rates of major bleeding were 0.7% versus 0.3%, respectively, clinically relevant nonmajor bleeding occurred in 2.6% versus 2.0% of patients, haemorrhagic wound complications in 1.4% versus 1.5% of patients, and postoperative wound infections in 0.
3% versus 0.2% of patients, respectively. The observed incidences of symptomatic VTE in those receiving rivaroxaban or enoxaparin were 0.7% versus 1.2%, respectively. In the four studies comparing rivaroxaban with enoxaparin, rivaroxaban demonstrated superior efficacy compared with enoxaparin. In addition, extended thromboprophylaxis with rivaroxaban was significantly more effective than shortterm enoxaparin plus placebo in the prevention of total, major and symptomatic VTE after THA. Furthermore, the incidence of treatment emergent major and clinically relevant nonmajor bleeding was low for rivaroxaban and enoxaparin. There was no evidence of compromised liver function or rebound cardiovascular events associated with rivaroxaban.
In a pooled analysis of the RECORD1, 2 and 3 studies , the prespecified primary efficacy outcome was 0.4% and 0.8%, respectively. The rates were 0.5% and 1.3%, respectively, at the end of the planned medication period. Rates of on treatment major bleeding were 0.2% for both drugs at 2 weeks, and 0.3% for rivaroxaban and 0.2% for enoxaparin at the end of the planned medication period. Rates of clinically relevant nonmajor bleeding were 2.6% for rivaroxaban and 2.3% for enoxaparin at 2 weeks, and 3.0% and 2.5%, respectively, at the end of the planned medication period. In a pooled analysis of all four RECORD studies, the primary efficacy endpoint was significantly reduced for the rivaroxaban regimens compared with enoxaparin regimens at day 12 2, in the planned treatment period, and in a post hoc analysis of the treatment and follow up period. Rates of treatmentemergent major bleeding were not significantly different between groups at any of the time points analysed. The composite of major and clinically relevant nonmajor bleeding did not differ at day 12 2, but was significantly higher for rivaroxaban in the planned medicatio

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