| pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
|---|
| thrombosis prevention | fondaparinux | abdominal surgery | versus placebo or control No demonstrated result for efficacy fondaparinux inferior to placebo (on top intermittent pneumatic comp.) in terms of Major bleeding in APOLLO (Turpie), 2007 (abdominal surgery patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| APOLLO (Turpie), 2007 | fondaparinux vs placebo (on top intermittent pneumatic comp.) | DVT 0.31 [0.14; 0.73] VTE 0.31 [0.14; 0.73] | Major bleeding 10.24 [1.31; 79.73] | Death 0.51 [0.05; 5.63] PE NaN [NaN; NaN] proximal DVT 0.14 [0.02; 1.14] Symptomatic venous thromboembolism 1.01 [0.06; 16.18] |
| Trial | Treatments | Patients | Method |
|---|
| APOLLO (Turpie), 2007 | fondaparinux 2.5 mg s.c. for 5-9 days, starting 6-8 h postoperatively + intermittent pneumatic compression (n=650) vs. placebo s.c. for 5-9 days, starting 6-8 h postoperatively + intermittent pneumatic compression (n=659) | Patients aged at least 40 years undergoing abdominal surgery | double blind Parallel groups Sample size: 650/659 Primary endpoint: venous thromboembolism up to day 10 FU duration: 10 days |
|
| thrombosis prevention | fondaparinux | abdominal surgery | versus Low molecular weight heparin No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PEGASUS, 2005 | fondaparinux vs enoxaparin | | | Death 0.75 [0.38; 1.45] Major bleeding 1.39 [0.91; 2.13] PE 1.66 [0.40; 6.95] DVT 0.72 [0.49; 1.06] proximal DVT 1.00 [0.29; 3.45] Nonfatal pulmonary embolism ∞ [NaN; ∞] VTE 0.75 [0.52; 1.09] Fatal pulmonary embolism 1.00 [0.20; 4.94] Symptomatic venous thromboembolism 1.20 [0.37; 3.92] Symptomatic deep-vein thrombosis 1.00 [0.14; 7.08] |
| Trial | Treatments | Patients | Method |
|---|
| PEGASUS, 2005 | once-daily subcutaneous injections of fondaparinux 2·5 mg started 6 h after surgery for 5–9 days (n=1465) vs. once-daily subcutaneous injections of dalteparin 5000 units for 5–9 days (2500 units each, given 2 h before surgery and 12 h after the preoperative administration) (n=1462) | patients undergoing major abdominal surgery | double blind Parallel groups Sample size: 1465/1462 Primary endpoint: venous thromboembolism FU duration: 10 days (30 days) |
|
| thrombosis prevention | fondaparinux | hip surgery | versus Low molecular weight heparin No demonstrated result for efficacy fondaparinux inferior to enoxaparin in terms of Symptomatic venous thromboembolism in PENTATHLON (Turpie), 2002 (hip surgery patients) fondaparinux inferior to enoxaparin in terms of Symptomatic deep-vein thrombosis in PENTATHLON (Turpie), 2002 (hip surgery patients) | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PENTHIFRA (Eriksson), 2001 | fondaparinux vs enoxaparin | DVT 0.42 [0.31; 0.57] proximal DVT 0.21 [0.09; 0.51] VTE 0.44 [0.32; 0.59] | | Death 0.70 [0.33; 1.49] Major bleeding 0.96 [0.51; 1.82] PE 2.20 [0.45; 10.87] Nonfatal pulmonary embolism 1.01 [0.06; 16.13] Fatal pulmonary embolism 1.01 [0.14; 7.16] Symptomatic venous thromboembolism 1.01 [0.25; 4.03] Symptomatic deep-vein thrombosis 1.01 [0.06; 16.13] | | PENTATHLON (Turpie), 2002 | fondaparinux vs enoxaparin | DVT 0.69 [0.48; 1.00] | Symptomatic venous thromboembolism 10.02 [1.28; 78.13] Symptomatic deep-vein thrombosis 10.02 [1.28; 78.13] | Death 3.00 [0.31; 28.82] Major bleeding 1.82 [0.88; 3.78] PE 5.01 [0.59; 42.81] proximal DVT 1.42 [0.64; 3.19] Nonfatal pulmonary embolism ∞ [NaN; ∞] VTE 0.74 [0.51; 1.05] Fatal pulmonary embolism 0.00 [0.00; NaN] | | EPHESUS (Lassen), 2002 | fondaparinux vs enoxaparin | DVT 0.44 [0.30; 0.64] proximal DVT 0.26 [0.11; 0.64] VTE 0.44 [0.30; 0.64] | | Death 0.00 [0.00; NaN] Major bleeding 1.51 [0.96; 2.35] PE 0.99 [0.14; 7.05] Nonfatal pulmonary embolism 0.66 [0.11; 3.96] Fatal pulmonary embolism NaN [NaN; NaN] Symptomatic venous thromboembolism 1.66 [0.40; 6.92] Symptomatic deep-vein thrombosis 2.98 [0.31; 28.65] | | Turpie, 2001 | fondaparinux vs enoxaparin | | | |
| Trial | Treatments | Patients | Method |
|---|
| PENTHIFRA (Eriksson), 2001 | fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery (n=831) vs. enoxaprin 40mg once daily (n=840) | hip fracture surgery | double blind Parallel groups Sample size: 831/840 Primary endpoint: venous thromboembolism FU duration: 11 days | | PENTATHLON (Turpie), 2002 | fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery (n=1138) vs. enoxaparin 30mg twice daily (North america recommendation) (n=1137) | elective hip replacement surgery | double blind Parallel groups Sample size: 1138/1137 Primary endpoint: venous thromboembolism FU duration: 11 days | | EPHESUS (Lassen), 2002 | fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery (n=1155) vs. enoxaprin 40mg once daily (n=1154) | elective hip replacement surgery | double blind Parallel groups Sample size: 1155/1154 Primary endpoint: venous thromboembolism FU duration: 11 days (6 weeks) | | Turpie, 2001 | pentasaccharide Org31540/SR90107A subcutaneous once daily at doses 0.75 mg, 1.5 mg, 3.0 mg, 6.0 mg, and 8.0 mg (n=673) vs. enoxaparin 30mg once daily subcutaneous (n=260) dose-ranging study | patients undergoing total hip replacement | double blind Parallel groups Sample size: 673/260 Primary endpoint: venous thromboembolism FU duration: >15 days dose finding study |
|
| thrombosis prevention | fondaparinux | knee surgery | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DRI4757 | fondaparinux vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| DRI4757 | fondaparinux subcutaneously at 0.75, 1.5, 2.5, and 3.0 mg for at least 10 calendar days, (with a maximum of 14 days) (n=345) vs. placebo (n=87) | Japanese patients undergoing elective total knee replacement surgery | double blind Parallel groups Sample size: 345/87 Primary endpoint: VTE FU duration: 14 days dose response study |
|
| thrombosis prevention | fondaparinux | knee surgery | versus Low molecular weight heparin No demonstrated result for efficacy fondaparinux inferior to enoxaparin in terms of Major bleeding in PENTAMAKS (Bauer), 2001 (knee surgery patients) | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| PENTAMAKS (Bauer), 2001 | fondaparinux vs enoxaparin | DVT 0.46 [0.33; 0.63] proximal DVT 0.45 [0.21; 0.99] VTE 0.45 [0.33; 0.62] | Major bleeding 11.00 [1.43; 84.90] | Death 0.67 [0.11; 3.97] PE 0.25 [0.03; 2.23] Nonfatal pulmonary embolism 0.25 [0.03; 2.23] Fatal pulmonary embolism NaN [NaN; NaN] Symptomatic venous thromboembolism 0.43 [0.11; 1.65] Symptomatic deep-vein thrombosis 0.75 [0.17; 3.33] | | L8635 | fondaparinux vs enoxaparin | | | Major bleeding NaN [NaN; NaN] VTE 0.78 [0.05; 11.67] |
| Trial | Treatments | Patients | Method |
|---|
| PENTAMAKS (Bauer), 2001 | fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery (n=517) vs. enoxaparin 30mg twice daily (North america recommendation) (n=517) | elective major knee surgery | double blind Parallel groups Sample size: 517/517 Primary endpoint: venous thromboembolism FU duration: 11 days | | L8635 | Fondaparinux 2.5mg once daily subcutaneously for 7 days (n=28) vs. enoxaparin 40mg once daily SC for 7 days (n=23) | Taiwanese patients undergoing elective knee replacement | open, blind assessment Parallel groups Sample size: 28/23 Primary endpoint: VTE events FU duration: 10 days |
|
| thrombosis prevention | fondaparinux | medical patients | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ARTEMIS (Cohen), 2006 | fondaparinux vs placebo | | | All-cause death during follow-up 0.00 [0.00; NaN] Major bleeding during follow-up 0.97 [0.06; 15.52] Symptomatic pulmonary embolism during follow-up 0.00 [0.00; NaN] Symptomatic deep vein thrombosis during follow-up NaN [NaN; NaN] |
| Trial | Treatments | Patients | Method |
|---|
| ARTEMIS (Cohen), 2006 | Fondaparinux 2.5 mg once daily for 6–14 days (n=425) vs. placebo
(n=414)
| High-risk medical patients
| double blind Parallel groups Sample size: 425/414 Primary endpoint: venous thromboembolism FU duration: 6-15 days
|
|
| thrombosis prevention | fondaparinux | orthopaedic surgery | versus Low molecular weight heparin No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| L8541 | fondaparinux vs enoxaparin | | | Major bleeding 0.92 [0.41; 2.07] DVT 0.25 [0.03; 2.22] |
| Trial | Treatments | Patients | Method |
|---|
| L8541 | fondaparinux 2.5mg subcutaneous once-daily for 7+/-2 days (n=119) vs. enoxaparin 40mg s.c. once-daily (n=118) | chinese patients undergoing major orthopaedic surgery of the lower limbs | single-blind Parallel groups Sample size: 119/118 Primary endpoint: overall deep vein thrombosis FU duration: 9 days (49d) |
|
