The Experts below are selected from a list of 324 Experts worldwide ranked by ideXlab platform
Alexander G.g. Turpie - One of the best experts on this subject based on the ideXlab platform.
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SR123781A: A New Once-Daily Synthetic Oligosaccharide Anticoagulant for Thromboprophylaxis After Total Hip Replacement Surgery: The DRIVE (Dose Ranging Study in Elective Total Hip Replacement Surgery) Study
Journal of the American College of Cardiology, 2008Co-Authors: Michael R. Lassen, Ola E. Dahl, Patrick Mismetti, Dirk Zielske, Alexander G.g. TurpieAbstract:Objectives This Study assessed the dose response of SR123781A for the prevention of venous thromboembolism (VTE) in patients undergoing total hip replacement (THR) surgery. Background Despite VTE preventive measures, residual VTE complications still occur after THR. SR123781A, a synthetic oligosaccharide with a mixed profile of anti-factor Xa and IIa activities, could be an alternative to current treatments. Methods In this double-blind Study, 1,023 patients undergoing THR were randomly assigned to 1 of 5 daily doses of SR123781A or to a calibrator arm of enoxaparin 40 mg. Treatment was continued for 10 days or until bilateral venography was performed after a minimum of 5 days. Results A significant dose-response effect for VTE was observed for SR123781A (p Conclusions The model based on these dose-finding Study results suggests that SR123781A doses ranging from 1.5 to 2.5 mg show a reasonable risk-to-benefit ratio for VTE prevention after major orthopedic surgery. (Dose Ranging Study in Elective Total Hip Replacement Surgery [DRIVE]; NCT00338897 )
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bay 59 7939 an oral direct factor xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement a phase ii dose ranging Study
Journal of Thrombosis and Haemostasis, 2005Co-Authors: Alexander G.g. Turpie, Frank Misselwitz, William D Fisher, Kenneth A Bauer, Louis M Kwong, M W Irwin, Peter Kalebo, Michael GentAbstract:Summary. Background: BAY 59-7939, a novel, oral, direct factor Xa inhibitor, is in clinical development for the prevention of venous thromboembolism (VTE), a frequent complication following orthopaedic surgery. Methods: In a multicenter, parallel-group, double-blind, double-dummy Study, 621 patients undergoing elective total knee replacement were randomly assigned to oral BAY 59-7939 (2.5, 5, 10, 20, and 30 mg b.i.d., initiated 6–8 h postsurgery), or subcutaneous enoxaparin (30 mg b.i.d., initiated 12–24 h postsurgery). Treatment was continued until mandatory bilateral venography 5–9 days after surgery. The primary efficacy endpoint was a composite of any deep vein thrombosis (proximal and/or distal), confirmed non-fatal pulmonary embolism and all-cause mortality during treatment. The primary safety endpoint was major, postoperative bleeding during treatment. Results: Of the 613 patients treated, 366 (59.7%) were evaluable for the primary efficacy analysis. The primary efficacy endpoint occurred in 31.7%, 40.4%, 23.3%, 35.1%, and 25.4% of patients receiving 2.5, 5, 10, 20 and 30 mg b.i.d. doses of BAY 59-7939, respectively (test for trend, P = 0.29), compared with 44.3% in the enoxaparin group. The frequency of major, postoperative bleeding increased with increasing doses of BAY 59-7939 (test for trend, P = 0.0007), with no significant difference between any dose group compared with enoxaparin. Bleeding endpoints were lower for the 2.5–10 mg b.i.d. doses compared with higher doses of BAY 59-7939. Conclusions: Oral administration of 2.5–10 mg b.i.d. of BAY 59-7939, early in the postoperative period, showed potential efficacy and an acceptable safety profile, similar to enoxaparin, for the prevention of VTE in patients undergoing elective total knee replacement.
Michael Gent - One of the best experts on this subject based on the ideXlab platform.
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bay 59 7939 an oral direct factor xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement a phase ii dose ranging Study
Journal of Thrombosis and Haemostasis, 2005Co-Authors: Alexander G.g. Turpie, Frank Misselwitz, William D Fisher, Kenneth A Bauer, Louis M Kwong, M W Irwin, Peter Kalebo, Michael GentAbstract:Summary. Background: BAY 59-7939, a novel, oral, direct factor Xa inhibitor, is in clinical development for the prevention of venous thromboembolism (VTE), a frequent complication following orthopaedic surgery. Methods: In a multicenter, parallel-group, double-blind, double-dummy Study, 621 patients undergoing elective total knee replacement were randomly assigned to oral BAY 59-7939 (2.5, 5, 10, 20, and 30 mg b.i.d., initiated 6–8 h postsurgery), or subcutaneous enoxaparin (30 mg b.i.d., initiated 12–24 h postsurgery). Treatment was continued until mandatory bilateral venography 5–9 days after surgery. The primary efficacy endpoint was a composite of any deep vein thrombosis (proximal and/or distal), confirmed non-fatal pulmonary embolism and all-cause mortality during treatment. The primary safety endpoint was major, postoperative bleeding during treatment. Results: Of the 613 patients treated, 366 (59.7%) were evaluable for the primary efficacy analysis. The primary efficacy endpoint occurred in 31.7%, 40.4%, 23.3%, 35.1%, and 25.4% of patients receiving 2.5, 5, 10, 20 and 30 mg b.i.d. doses of BAY 59-7939, respectively (test for trend, P = 0.29), compared with 44.3% in the enoxaparin group. The frequency of major, postoperative bleeding increased with increasing doses of BAY 59-7939 (test for trend, P = 0.0007), with no significant difference between any dose group compared with enoxaparin. Bleeding endpoints were lower for the 2.5–10 mg b.i.d. doses compared with higher doses of BAY 59-7939. Conclusions: Oral administration of 2.5–10 mg b.i.d. of BAY 59-7939, early in the postoperative period, showed potential efficacy and an acceptable safety profile, similar to enoxaparin, for the prevention of VTE in patients undergoing elective total knee replacement.
Naomi Schlesinger - One of the best experts on this subject based on the ideXlab platform.
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Canakinumab for the treatment of acute flares in difficult‐to‐treat gouty arthritis: Results of a multicenter, phase II, dose‐ranging Study
Arthritis & Rheumatism, 2010Co-Authors: Alexander So, Marc De Meulemeester, Andrey Pikhlak, A. Eftal Yücel, Dominik Richard, Valda Murphy, Udayasankar Arulmani, Peter Sallstig, Naomi SchlesingerAbstract:Objective To assess the efficacy and tolerability of canakinumab, a fully human anti–interleukin-1β monoclonal antibody, for the treatment of acute gouty arthritis. Methods In this 8-week, single-blind, double-dummy, Dose-Ranging Study, patients with acute gouty arthritis whose disease was refractory to or who had contraindications to nonsteroidal antiinflammatory drugs and/or colchicine were randomized to receive a single subcutaneous dose of canakinumab (10, 25, 50, 90, or 150 mg; n = 143) or an intramuscular dose of triamcinolone acetonide (40 mg; n = 57). Patients assessed pain using a 100-mm visual analog scale. Results Seventy-two hours after treatment, a statistically significant dose response was observed for canakinumab. All canakinumab doses were associated with numerically less pain than triamcinolone acetonide; thus, a dose with equivalent efficacy to triamcinolone acetonide 72 hours after treatment could not be determined. The reduction from baseline in pain intensity with canakinumab 150 mg was greater than with triamcinolone acetonide 24, 48, and 72 hours after treatment (differences of −11.5 mm [P = 0.04], −18.2 mm [P = 0.002], and −19.2 mm [P < 0.001], respectively), and 4, 5, and 7 days after treatment (all P < 0.05). Canakinumab significantly reduced the risk of recurrent flares versus triamcinolone acetonide (P ≤ 0.01 for all doses) (relative risk reduction 94% for canakinumab 150 mg versus triamcinolone acetonide). The overall incidence of adverse events was similar for canakinumab (41%) and triamcinolone acetonide (42%); most were mild or moderate in severity. Conclusion Our findings indicate that canakinumab 150 mg provides rapid and sustained pain relief in patients with acute gouty arthritis, and significantly reduces the risk of recurrent flares compared with triamcinolone acetonide.
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Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: Results of a multicenter, phase II, Dose-Ranging Study
Arthritis and Rheumatism, 2010Co-Authors: Alexander So, Marc De Meulemeester, Andrey Pikhlak, A. Eftal Yücel, Dominik Richard, Valda Murphy, Udayasankar Arulmani, Peter Sallstig, Naomi SchlesingerAbstract:To assess the efficacy and tolerability of canakinumab, a fully human anti-interleukin-1β monoclonal antibody, for the treatment of acute gouty arthritis.
Frank Misselwitz - One of the best experts on this subject based on the ideXlab platform.
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A Dose-Ranging Study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein–DVT Dose-Ranging Study
Blood, 2008Co-Authors: Harry R. Büller, Anthonie W. A. Lensing, Martin H. Prins, Giancarlo Agnelli, Alexander T. Cohen, Alexander Gallus, Frank Misselwitz, Gary E. Raskob, Sebastian Schellong, Annelise SegersAbstract:We performed a randomized Dose-Ranging Study, double-blind for rivaroxaban doses and open-label for the comparator (low-molecular-weight heparin followed by vitamin K antagonists) to assess the optimal dose of rivaroxaban for the treatment of deep vein thrombosis. A total of 543 patients with acute deep-venous thrombosis received rivaroxaban 20, 30, or 40 mg once daily or comparator. Treatment lasted for 84 days. The primary efficacy outcome was the 3-month incidence of the composite of symptomatic venous thromboembolic complications and asymptomatic deterioration in thrombotic burden as assessed by comparison of ultrasound and perfusion lung scanning at day 84 with baseline. The main safety outcome was the composite of major bleeding and clinically relevant nonmajor bleeding. A total of 449 (83%) of the 543 patients could be included in the per-protocol population. The primary efficacy outcome occurred in 6.1%, 5.4%, and 6.6% of the rivaroxaban 20-, 30-, and 40-mg treatment groups, respectively, and in 9.9% of those receiving standard therapy. The main safety outcome occurred in 5.9%, 6.0%, and 2.2% of the rivaroxaban 20-, 30-, and 40-mg treatment groups, respectively, and in 8.8% of those receiving standard therapy. These results with simple fixed-dose oral regimens justify phase 3 evaluations ([www.ClinicalTrials.gov][1] no.[NCT00395772][2]). [1]: http://www.ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00395772&atom=%2Fbloodjournal%2F112%2F6%2F2242.atom
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bay 59 7939 an oral direct factor xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement a phase ii dose ranging Study
Journal of Thrombosis and Haemostasis, 2005Co-Authors: Alexander G.g. Turpie, Frank Misselwitz, William D Fisher, Kenneth A Bauer, Louis M Kwong, M W Irwin, Peter Kalebo, Michael GentAbstract:Summary. Background: BAY 59-7939, a novel, oral, direct factor Xa inhibitor, is in clinical development for the prevention of venous thromboembolism (VTE), a frequent complication following orthopaedic surgery. Methods: In a multicenter, parallel-group, double-blind, double-dummy Study, 621 patients undergoing elective total knee replacement were randomly assigned to oral BAY 59-7939 (2.5, 5, 10, 20, and 30 mg b.i.d., initiated 6–8 h postsurgery), or subcutaneous enoxaparin (30 mg b.i.d., initiated 12–24 h postsurgery). Treatment was continued until mandatory bilateral venography 5–9 days after surgery. The primary efficacy endpoint was a composite of any deep vein thrombosis (proximal and/or distal), confirmed non-fatal pulmonary embolism and all-cause mortality during treatment. The primary safety endpoint was major, postoperative bleeding during treatment. Results: Of the 613 patients treated, 366 (59.7%) were evaluable for the primary efficacy analysis. The primary efficacy endpoint occurred in 31.7%, 40.4%, 23.3%, 35.1%, and 25.4% of patients receiving 2.5, 5, 10, 20 and 30 mg b.i.d. doses of BAY 59-7939, respectively (test for trend, P = 0.29), compared with 44.3% in the enoxaparin group. The frequency of major, postoperative bleeding increased with increasing doses of BAY 59-7939 (test for trend, P = 0.0007), with no significant difference between any dose group compared with enoxaparin. Bleeding endpoints were lower for the 2.5–10 mg b.i.d. doses compared with higher doses of BAY 59-7939. Conclusions: Oral administration of 2.5–10 mg b.i.d. of BAY 59-7939, early in the postoperative period, showed potential efficacy and an acceptable safety profile, similar to enoxaparin, for the prevention of VTE in patients undergoing elective total knee replacement.
Alexander So - One of the best experts on this subject based on the ideXlab platform.
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Canakinumab for the treatment of acute flares in difficult‐to‐treat gouty arthritis: Results of a multicenter, phase II, dose‐ranging Study
Arthritis & Rheumatism, 2010Co-Authors: Alexander So, Marc De Meulemeester, Andrey Pikhlak, A. Eftal Yücel, Dominik Richard, Valda Murphy, Udayasankar Arulmani, Peter Sallstig, Naomi SchlesingerAbstract:Objective To assess the efficacy and tolerability of canakinumab, a fully human anti–interleukin-1β monoclonal antibody, for the treatment of acute gouty arthritis. Methods In this 8-week, single-blind, double-dummy, Dose-Ranging Study, patients with acute gouty arthritis whose disease was refractory to or who had contraindications to nonsteroidal antiinflammatory drugs and/or colchicine were randomized to receive a single subcutaneous dose of canakinumab (10, 25, 50, 90, or 150 mg; n = 143) or an intramuscular dose of triamcinolone acetonide (40 mg; n = 57). Patients assessed pain using a 100-mm visual analog scale. Results Seventy-two hours after treatment, a statistically significant dose response was observed for canakinumab. All canakinumab doses were associated with numerically less pain than triamcinolone acetonide; thus, a dose with equivalent efficacy to triamcinolone acetonide 72 hours after treatment could not be determined. The reduction from baseline in pain intensity with canakinumab 150 mg was greater than with triamcinolone acetonide 24, 48, and 72 hours after treatment (differences of −11.5 mm [P = 0.04], −18.2 mm [P = 0.002], and −19.2 mm [P < 0.001], respectively), and 4, 5, and 7 days after treatment (all P < 0.05). Canakinumab significantly reduced the risk of recurrent flares versus triamcinolone acetonide (P ≤ 0.01 for all doses) (relative risk reduction 94% for canakinumab 150 mg versus triamcinolone acetonide). The overall incidence of adverse events was similar for canakinumab (41%) and triamcinolone acetonide (42%); most were mild or moderate in severity. Conclusion Our findings indicate that canakinumab 150 mg provides rapid and sustained pain relief in patients with acute gouty arthritis, and significantly reduces the risk of recurrent flares compared with triamcinolone acetonide.
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Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: Results of a multicenter, phase II, Dose-Ranging Study
Arthritis and Rheumatism, 2010Co-Authors: Alexander So, Marc De Meulemeester, Andrey Pikhlak, A. Eftal Yücel, Dominik Richard, Valda Murphy, Udayasankar Arulmani, Peter Sallstig, Naomi SchlesingerAbstract:To assess the efficacy and tolerability of canakinumab, a fully human anti-interleukin-1β monoclonal antibody, for the treatment of acute gouty arthritis.
