The Experts below are selected from a list of 441 Experts worldwide ranked by ideXlab platform
Shintaro Tachibana - One of the best experts on this subject based on the ideXlab platform.
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safety and efficacy of edoxaban an oral factor xa inhibitor versus Enoxaparin for thromboprophylaxis after total knee arthroplasty the stars e 3 trial
Thrombosis Research, 2014Co-Authors: Takeshi Fuji, Tetsuya Kimura, Kenji Abe, Satoru Fujita, Yohko Kawai, Chingjen Wang, Mashio Nakamura, Kei Ibusuki, Hitoshi Ushida, Shintaro TachibanaAbstract:Abstract Introduction This phase 3 trial compared the safety and efficacy of edoxaban, an oral direct factor Xa inhibitor, with Enoxaparin Sodium (Enoxaparin) for thromboprophylaxis after total knee arthroplasty (TKA) in patients in Japan and Taiwan. Materials and methods In this randomized, double-blind, double-dummy study, patients received oral edoxaban 30mg once daily beginning 6 to 24hours postsurgery or Enoxaparin 2000IU (equivalent to 20mg) subcutaneously twice daily beginning 24 to 36hours postsurgery for 11 to 14days. The primary efficacy endpoint was the composite of symptomatic pulmonary embolism and symptomatic and asymptomatic deep vein thrombosis. Safety endpoints included the incidence of major bleeding, clinically relevant non-major (CRNM) bleeding, major bleeding or CRNM bleeding, all bleeding events, adverse events, and adverse drug reactions. Results Of 716 patients enrolled, 360 and 356 were randomized to receive edoxaban or Enoxaparin, respectively. The primary efficacy outcome occurred in 22/299 (7.4%) and 41/295 (13.9%) patients in the edoxaban and Enoxaparin groups, respectively (relative risk reduction=46.8%), indicating non-inferiority ( P P =0.010) of edoxaban versus Enoxaparin. In the edoxaban and Enoxaparin groups, major bleeding occurred in 4/354 (1.1%) versus 1/349 (0.3%) patients ( P =0.373); major or CRNM bleeding occurred in 22/354 (6.2%) versus 13/349 (3.7%) patients ( P =0.129), respectively. Conclusions Edoxaban 30mg once daily was more effective for thromboprophylaxis than subcutaneous Enoxaparin 2000IU twice daily following TKA and demonstrated a similar incidence of bleeding events.
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safety and efficacy of edoxaban an oral factor xa inhibitor versus Enoxaparin for thromboprophylaxis after total knee arthroplasty the stars e 3 trial
Thrombosis Research, 2014Co-Authors: Takeshi Fuji, Tetsuya Kimura, Kenji Abe, Satoru Fujita, Yohko Kawai, Chingjen Wang, Mashio Nakamura, Kei Ibusuki, Hitoshi Ushida, Shintaro TachibanaAbstract:Abstract Introduction This phase 3 trial compared the safety and efficacy of edoxaban, an oral direct factor Xa inhibitor, with Enoxaparin Sodium (Enoxaparin) for thromboprophylaxis after total knee arthroplasty (TKA) in patients in Japan and Taiwan. Materials and methods In this randomized, double-blind, double-dummy study, patients received oral edoxaban 30 mg once daily beginning 6 to 24 hours postsurgery or Enoxaparin 2000 IU (equivalent to 20 mg) subcutaneously twice daily beginning 24 to 36 hours postsurgery for 11 to 14 days. The primary efficacy endpoint was the composite of symptomatic pulmonary embolism and symptomatic and asymptomatic deep vein thrombosis. Safety endpoints included the incidence of major bleeding, clinically relevant non-major (CRNM) bleeding, major bleeding or CRNM bleeding, all bleeding events, adverse events, and adverse drug reactions. Results Of 716 patients enrolled, 360 and 356 were randomized to receive edoxaban or Enoxaparin, respectively. The primary efficacy outcome occurred in 22/299 (7.4%) and 41/295 (13.9%) patients in the edoxaban and Enoxaparin groups, respectively (relative risk reduction = 46.8%), indicating non-inferiority (P Conclusions Edoxaban 30 mg once daily was more effective for thromboprophylaxis than subcutaneous Enoxaparin 2000 IU twice daily following TKA and demonstrated a similar incidence of bleeding events.
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Safety and efficacy of edoxaban in patients undergoing hip fracture surgery
Thrombosis research, 2014Co-Authors: Takeshi Fuji, Tetsuya Kimura, Kenji Abe, Satoru Fujita, Yohko Kawai, Mashio Nakamura, Yuichi Kiuchi, Shintaro TachibanaAbstract:Abstract Introduction Edoxaban is an oral, direct, once-daily factor Xa inhibitor. This study evaluated the safety and efficacy of edoxaban compared to subcutaneous Enoxaparin in Japanese patients undergoing hip fracture surgery. Materials and methods In this multicenter, randomized, open-label, active-comparator, phase 3 trial, 92 patients were randomized 2:1 to receive edoxaban 30 mg once daily (n = 62) or Enoxaparin Sodium (Enoxaparin) 2000 IU (equivalent to 20 mg) twice daily (n = 30) for 11 to 14 days. The primary endpoints were the incidence of major or clinically relevant non-major (CRNM) bleeding and incidence of any bleeding events (major, CRNM, or minor bleeding). Secondary efficacy endpoints included the incidence of thromboembolic events, venous thromboembolism-related deaths, and all-cause deaths. Additional adverse events were recorded throughout the study. Results In the edoxaban and Enoxaparin treatment groups, the incidence of major or CRNM bleeding was 3.4% and 6.9%, respectively, while any bleeding event occurred in 25.4% and 17.2% of patients, respectively. The incidence of thromboembolic events was 6.5% in the edoxaban group and 3.7% in the Enoxaparin group. All events were asymptomatic deep vein thrombosis. The incidence of adverse events was 72.9% and 82.8% in the edoxaban and Enoxaparin groups, respectively. Conclusions Compared to subcutaneous Enoxaparin 2000 IU twice daily, oral edoxaban 30 mg once daily demonstrated similar safety and efficacy in the prevention of thromboembolic events in Japanese patients undergoing hip fracture surgery. Clinical trials registration number: NCT01181141.
Gary E Raskob - One of the best experts on this subject based on the ideXlab platform.
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a cost effectiveness analysis of fondaparinux Sodium compared with Enoxaparin Sodium as prophylaxis against venous thromboembolism use in patients undergoing major orthopaedic surgery
PharmacoEconomics, 2004Co-Authors: Sean D Sullivan, Gerry Oster, Bruce L Davidson, Susan R Kahn, James E Muntz, Gary E RaskobAbstract:Objective: To determine the cost effectiveness of fondaparinux Sodium compared with Enoxaparin Sodium for prophylaxis against venous thromboembolism in patients undergoing major orthopaedic surgery.
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a cost effectiveness analysis of fondaparinux Sodium compared with Enoxaparin Sodium as prophylaxis against venous thromboembolism use in patients undergoing major orthopaedic surgery
PharmacoEconomics, 2004Co-Authors: Sean D Sullivan, Gerry Oster, Bruce L Davidson, Susan R Kahn, James E Muntz, Gary E RaskobAbstract:Objective: To determine the cost effectiveness of fondaparinux Sodium compared with Enoxaparin Sodium for prophylaxis against venous thromboembolism in patients undergoing major orthopaedic surgery. Methods: Using a cohort simulation model, two primary analyses were conducted from the perspective of the US healthcare payer. Probabilities for a trial-based analysis were obtained from patients participating in the fondaparinux clinical trial programme supplemented with data from published literature. Probabilities for a label-based analysis were estimated for a hypothetical cohort of US patients receiving either fondaparinux or Enoxaparin as recommended by US FDA-approved labelling. Resource use and costs were obtained from large US healthcare databases. Outcome measures were rates of symptomatic thromboembolic events and healthcare costs. Costs were in 2003 values. Results: In the trial-based analysis, fondaparinux was estimated to prevent 15.1 symptomatic venous thromboembolic events (per 1000 patients) at 3 months for patients undergoing major orthopaedic surgery compared with Enoxaparin. The cost savings (per patient) of using fondaparinux over Enoxaparin are $US61 at 30 days, $US89 at 3 months, and $US155 at 5 years. In the label-based analysis, fondaparinux was estimated to prevent 17.8 venous thromboembolic events (per 1000 patients) at 3 months compared with Enoxaparin, producing savings per patient of $US25 at discharge, $US112 over 1 month, $US141 over 3 months and $US234 over 5 years. Results remain robust to clinically plausible variation in input parameters and assumptions. Conclusions: Our model suggests that fondaparinux, when compared with the current standard regimen of Enoxaparin for prophylaxis of venous thromboembolism in major orthopaedic surgery, improves outcomes and is cost saving from a US healthcare-payer perspective over the broad range of assumptions evaluated.
Gerry Oster - One of the best experts on this subject based on the ideXlab platform.
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a cost effectiveness analysis of fondaparinux Sodium compared with Enoxaparin Sodium as prophylaxis against venous thromboembolism use in patients undergoing major orthopaedic surgery
PharmacoEconomics, 2004Co-Authors: Sean D Sullivan, Gerry Oster, Bruce L Davidson, Susan R Kahn, James E Muntz, Gary E RaskobAbstract:Objective: To determine the cost effectiveness of fondaparinux Sodium compared with Enoxaparin Sodium for prophylaxis against venous thromboembolism in patients undergoing major orthopaedic surgery. Methods: Using a cohort simulation model, two primary analyses were conducted from the perspective of the US healthcare payer. Probabilities for a trial-based analysis were obtained from patients participating in the fondaparinux clinical trial programme supplemented with data from published literature. Probabilities for a label-based analysis were estimated for a hypothetical cohort of US patients receiving either fondaparinux or Enoxaparin as recommended by US FDA-approved labelling. Resource use and costs were obtained from large US healthcare databases. Outcome measures were rates of symptomatic thromboembolic events and healthcare costs. Costs were in 2003 values. Results: In the trial-based analysis, fondaparinux was estimated to prevent 15.1 symptomatic venous thromboembolic events (per 1000 patients) at 3 months for patients undergoing major orthopaedic surgery compared with Enoxaparin. The cost savings (per patient) of using fondaparinux over Enoxaparin are $US61 at 30 days, $US89 at 3 months, and $US155 at 5 years. In the label-based analysis, fondaparinux was estimated to prevent 17.8 venous thromboembolic events (per 1000 patients) at 3 months compared with Enoxaparin, producing savings per patient of $US25 at discharge, $US112 over 1 month, $US141 over 3 months and $US234 over 5 years. Results remain robust to clinically plausible variation in input parameters and assumptions. Conclusions: Our model suggests that fondaparinux, when compared with the current standard regimen of Enoxaparin for prophylaxis of venous thromboembolism in major orthopaedic surgery, improves outcomes and is cost saving from a US healthcare-payer perspective over the broad range of assumptions evaluated.
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a cost effectiveness analysis of fondaparinux Sodium compared with Enoxaparin Sodium as prophylaxis against venous thromboembolism use in patients undergoing major orthopaedic surgery
PharmacoEconomics, 2004Co-Authors: Sean D Sullivan, Gerry Oster, Bruce L Davidson, Susan R Kahn, James E Muntz, Gary E RaskobAbstract:Objective: To determine the cost effectiveness of fondaparinux Sodium compared with Enoxaparin Sodium for prophylaxis against venous thromboembolism in patients undergoing major orthopaedic surgery.
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cost effectiveness of Enoxaparin vs low dose warfarin in the prevention of deep vein thrombosis after total hip replacement surgery
JAMA Internal Medicine, 1995Co-Authors: Joseph Menzin, Graham A Colditz, Meredith M Regan, Randel E Richner, Gerry OsterAbstract:Background: Enoxaparin Sodium, a low-molecular-weight heparin, was recently approved for use in the United States to prevent deep-vein thrombosis after total hip replacement surgery. Its cost-effectiveness relative to prophylaxis with low-dose warfarin Sodium is unknown. Methods: A decision-analytic model was developed to compare two strategies of prophylaxis for deep-vein thrombosis with a strategy of not using prophylaxis in a hypothetical cohort of 10 000 patients undergoing total hip replacement surgery. For each of these strategies, we estimated the expected number of cases of confirmed deep-vein thrombosis or pulmonary embolism, the expected number of thromboembolic deaths, and the expected costs of venous thromboembolic care, including prophylaxis, diagnosis, and treatment. Data were drawn primarily from the published literature. Results: Compared with no prophylaxis, the use of low-dose warfarin would be expected to reduce the number of cases of confirmed deep-vein thrombosis from about 1000 (per 10 000 patients) to 420 and the number of thromboembolic deaths from about 250 to 110. Expected costs of care related to deep-vein thrombosis also would be reduced from approximately $530 to $330 per patient. Prophylaxis with Enoxaparin would be expected to reduce further the number of cases of confirmed deep-vein thrombosis and the number of thromboembolic deaths (to 250 and 70, respectively) but increase costs of care by approximately $50 per patient. The cost-effectiveness of Enoxaparin (relative to low-dose warfarin) is estimated to be approximately $12 000 per death averted. Conclusion: Although Enoxaparin is more costly than low-dose warfarin, its cost-effectiveness in total hip replacement compares favorably with that of other generally accepted medical interventions. (Arch Intern Med. 1995;155:757-764)
Takeshi Fuji - One of the best experts on this subject based on the ideXlab platform.
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safety and efficacy of edoxaban an oral factor xa inhibitor versus Enoxaparin for thromboprophylaxis after total knee arthroplasty the stars e 3 trial
Thrombosis Research, 2014Co-Authors: Takeshi Fuji, Tetsuya Kimura, Kenji Abe, Satoru Fujita, Yohko Kawai, Chingjen Wang, Mashio Nakamura, Kei Ibusuki, Hitoshi Ushida, Shintaro TachibanaAbstract:Abstract Introduction This phase 3 trial compared the safety and efficacy of edoxaban, an oral direct factor Xa inhibitor, with Enoxaparin Sodium (Enoxaparin) for thromboprophylaxis after total knee arthroplasty (TKA) in patients in Japan and Taiwan. Materials and methods In this randomized, double-blind, double-dummy study, patients received oral edoxaban 30mg once daily beginning 6 to 24hours postsurgery or Enoxaparin 2000IU (equivalent to 20mg) subcutaneously twice daily beginning 24 to 36hours postsurgery for 11 to 14days. The primary efficacy endpoint was the composite of symptomatic pulmonary embolism and symptomatic and asymptomatic deep vein thrombosis. Safety endpoints included the incidence of major bleeding, clinically relevant non-major (CRNM) bleeding, major bleeding or CRNM bleeding, all bleeding events, adverse events, and adverse drug reactions. Results Of 716 patients enrolled, 360 and 356 were randomized to receive edoxaban or Enoxaparin, respectively. The primary efficacy outcome occurred in 22/299 (7.4%) and 41/295 (13.9%) patients in the edoxaban and Enoxaparin groups, respectively (relative risk reduction=46.8%), indicating non-inferiority ( P P =0.010) of edoxaban versus Enoxaparin. In the edoxaban and Enoxaparin groups, major bleeding occurred in 4/354 (1.1%) versus 1/349 (0.3%) patients ( P =0.373); major or CRNM bleeding occurred in 22/354 (6.2%) versus 13/349 (3.7%) patients ( P =0.129), respectively. Conclusions Edoxaban 30mg once daily was more effective for thromboprophylaxis than subcutaneous Enoxaparin 2000IU twice daily following TKA and demonstrated a similar incidence of bleeding events.
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safety and efficacy of edoxaban an oral factor xa inhibitor versus Enoxaparin for thromboprophylaxis after total knee arthroplasty the stars e 3 trial
Thrombosis Research, 2014Co-Authors: Takeshi Fuji, Tetsuya Kimura, Kenji Abe, Satoru Fujita, Yohko Kawai, Chingjen Wang, Mashio Nakamura, Kei Ibusuki, Hitoshi Ushida, Shintaro TachibanaAbstract:Abstract Introduction This phase 3 trial compared the safety and efficacy of edoxaban, an oral direct factor Xa inhibitor, with Enoxaparin Sodium (Enoxaparin) for thromboprophylaxis after total knee arthroplasty (TKA) in patients in Japan and Taiwan. Materials and methods In this randomized, double-blind, double-dummy study, patients received oral edoxaban 30 mg once daily beginning 6 to 24 hours postsurgery or Enoxaparin 2000 IU (equivalent to 20 mg) subcutaneously twice daily beginning 24 to 36 hours postsurgery for 11 to 14 days. The primary efficacy endpoint was the composite of symptomatic pulmonary embolism and symptomatic and asymptomatic deep vein thrombosis. Safety endpoints included the incidence of major bleeding, clinically relevant non-major (CRNM) bleeding, major bleeding or CRNM bleeding, all bleeding events, adverse events, and adverse drug reactions. Results Of 716 patients enrolled, 360 and 356 were randomized to receive edoxaban or Enoxaparin, respectively. The primary efficacy outcome occurred in 22/299 (7.4%) and 41/295 (13.9%) patients in the edoxaban and Enoxaparin groups, respectively (relative risk reduction = 46.8%), indicating non-inferiority (P Conclusions Edoxaban 30 mg once daily was more effective for thromboprophylaxis than subcutaneous Enoxaparin 2000 IU twice daily following TKA and demonstrated a similar incidence of bleeding events.
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Safety and efficacy of edoxaban in patients undergoing hip fracture surgery
Thrombosis research, 2014Co-Authors: Takeshi Fuji, Tetsuya Kimura, Kenji Abe, Satoru Fujita, Yohko Kawai, Mashio Nakamura, Yuichi Kiuchi, Shintaro TachibanaAbstract:Abstract Introduction Edoxaban is an oral, direct, once-daily factor Xa inhibitor. This study evaluated the safety and efficacy of edoxaban compared to subcutaneous Enoxaparin in Japanese patients undergoing hip fracture surgery. Materials and methods In this multicenter, randomized, open-label, active-comparator, phase 3 trial, 92 patients were randomized 2:1 to receive edoxaban 30 mg once daily (n = 62) or Enoxaparin Sodium (Enoxaparin) 2000 IU (equivalent to 20 mg) twice daily (n = 30) for 11 to 14 days. The primary endpoints were the incidence of major or clinically relevant non-major (CRNM) bleeding and incidence of any bleeding events (major, CRNM, or minor bleeding). Secondary efficacy endpoints included the incidence of thromboembolic events, venous thromboembolism-related deaths, and all-cause deaths. Additional adverse events were recorded throughout the study. Results In the edoxaban and Enoxaparin treatment groups, the incidence of major or CRNM bleeding was 3.4% and 6.9%, respectively, while any bleeding event occurred in 25.4% and 17.2% of patients, respectively. The incidence of thromboembolic events was 6.5% in the edoxaban group and 3.7% in the Enoxaparin group. All events were asymptomatic deep vein thrombosis. The incidence of adverse events was 72.9% and 82.8% in the edoxaban and Enoxaparin groups, respectively. Conclusions Compared to subcutaneous Enoxaparin 2000 IU twice daily, oral edoxaban 30 mg once daily demonstrated similar safety and efficacy in the prevention of thromboembolic events in Japanese patients undergoing hip fracture surgery. Clinical trials registration number: NCT01181141.
Sean D Sullivan - One of the best experts on this subject based on the ideXlab platform.
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a cost effectiveness analysis of fondaparinux Sodium compared with Enoxaparin Sodium as prophylaxis against venous thromboembolism use in patients undergoing major orthopaedic surgery
PharmacoEconomics, 2004Co-Authors: Sean D Sullivan, Gerry Oster, Bruce L Davidson, Susan R Kahn, James E Muntz, Gary E RaskobAbstract:Objective: To determine the cost effectiveness of fondaparinux Sodium compared with Enoxaparin Sodium for prophylaxis against venous thromboembolism in patients undergoing major orthopaedic surgery.
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a cost effectiveness analysis of fondaparinux Sodium compared with Enoxaparin Sodium as prophylaxis against venous thromboembolism use in patients undergoing major orthopaedic surgery
PharmacoEconomics, 2004Co-Authors: Sean D Sullivan, Gerry Oster, Bruce L Davidson, Susan R Kahn, James E Muntz, Gary E RaskobAbstract:Objective: To determine the cost effectiveness of fondaparinux Sodium compared with Enoxaparin Sodium for prophylaxis against venous thromboembolism in patients undergoing major orthopaedic surgery. Methods: Using a cohort simulation model, two primary analyses were conducted from the perspective of the US healthcare payer. Probabilities for a trial-based analysis were obtained from patients participating in the fondaparinux clinical trial programme supplemented with data from published literature. Probabilities for a label-based analysis were estimated for a hypothetical cohort of US patients receiving either fondaparinux or Enoxaparin as recommended by US FDA-approved labelling. Resource use and costs were obtained from large US healthcare databases. Outcome measures were rates of symptomatic thromboembolic events and healthcare costs. Costs were in 2003 values. Results: In the trial-based analysis, fondaparinux was estimated to prevent 15.1 symptomatic venous thromboembolic events (per 1000 patients) at 3 months for patients undergoing major orthopaedic surgery compared with Enoxaparin. The cost savings (per patient) of using fondaparinux over Enoxaparin are $US61 at 30 days, $US89 at 3 months, and $US155 at 5 years. In the label-based analysis, fondaparinux was estimated to prevent 17.8 venous thromboembolic events (per 1000 patients) at 3 months compared with Enoxaparin, producing savings per patient of $US25 at discharge, $US112 over 1 month, $US141 over 3 months and $US234 over 5 years. Results remain robust to clinically plausible variation in input parameters and assumptions. Conclusions: Our model suggests that fondaparinux, when compared with the current standard regimen of Enoxaparin for prophylaxis of venous thromboembolism in major orthopaedic surgery, improves outcomes and is cost saving from a US healthcare-payer perspective over the broad range of assumptions evaluated.