pathology | Demonstrated benefit and harm | k | | | |
---|
acute coronary syndrome | versus UFH No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
FRAXIS (6days), 1998 | nadroparin vs UFH (on top of aspirin) | | | recurrent angina at 14 days 0.93 [0.76; 1.14] long term MI or death 1.10 [0.83; 1.44] death 1.06 [0.51; 2.18] all revascularisations 0.95 [0.67; 1.36] myocardial infarction 1.09 [0.66; 1.79] recurrent angina 0.84 [0.67; 1.06] death, myocardial infarction, or recurrent at 14 days 0.99 [0.83; 1.18] myocardial infarction or death 0.99 [0.63; 1.56] death at 30 days 1.18 [0.79; 1.77] myocardial infarction at 30 days 1.10 [0.79; 1.52] | FRAXIS (14 days), 1998 | nadroparin vs UFH (on top of aspirin) | | | recurrent angina at 14 days 1.11 [0.92; 1.35] long term MI or death 1.15 [0.87; 1.50] death 1.26 [0.70; 2.29] all revascularisations 0.95 [0.78; 1.14] myocardial infarction 0.98 [0.64; 1.49] recurrent angina 1.11 [0.92; 1.35] myocardial infarction or death 1.08 [0.74; 1.56] |
Trial | Treatments | Patients | Method |
---|
FRAXIS (6days), 1998 | nadroparin for 6 days (+aspirin) (n=1166) vs. unfractionated heparin for 6 days (+aspirin) (n=1151) | unstable angina or non-Q wave myocardial
infraction | Double blind Parallel groups Sample size: 1166/1151 Primary endpoint: death, MI, recurent or refractory angina FU duration: 14 days | FRAXIS (14 days), 1998 | nadroparin for 14 days
(n=1151) vs. unfractionated heparin for 14 days
(n=1151)
| unstable angina or non-Q wave myocardial
infraction
| double blind Sample size: 1151/1151 Primary endpoint: death, MI, recurent or refractory angina FU duration: 14 days
|
|
pulmonary embolism | versus unfractioned heparin No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
European multicentre study, 1991 | Nadroparin vs unfractionated heparin | | | Symptomatic venous thromboembolism at the end of treatment 0.77 [0.05; 12.00] | Prandoni sub-group, 1992 | Nadroparin vs unfractionated heparin | | | Symptomatic venous thromboembolism at the end of treatment 0.34 [0.04; 3.15] | Thery, 1992 | Nadroparin vs unfractionated heparin | | | Symptomatic venous thromboembolism at the end of treatment NaN [NaN; NaN] |
Trial | Treatments | Patients | Method |
---|
European multicentre study, 1991 | Nadroparin, 4750–6650 antifactor Xa IU twice daily, 10 days (n=61) vs. Unfractioned heparin: no bolus, infusion, 20 IU/kg per hour (n=47) | Symptomatic proximal DVT | open (blind assessment) Parallel groups Sample size: 61/47 Primary endpoint: Arnesen and Marder phlebographic scores FU duration: 3 mo | Prandoni sub-group, 1992 | Nadroparin, 4750–6650 antifactor Xa IU twice daily, 10 days (n=45) vs. Unfractioned heparin: bolus 100 IU/kg, infusion 35 000 IU/d (n=46) | Symptomatic proximal DVT sub group of a trial initially including patients with acute symptomatic VTE | open Parallel groups Sample size: 45/46 Primary endpoint: FU duration: 6 mo | Thery, 1992 | Nadroparin, 76 IU/kg twice daily, 14 days (n=35) vs. Unfractioned heparin: bolus 50 IU/kg, infusion 600 IU/kg per day (n=33) | patients with submassive pulmonary embolism | open Parallel groups Sample size: 35/33 Primary endpoint: pulmonary vascular obstruction FU duration: 14 d dose-finding study |
|
superficial thrombophlebitis | versus antithrombotics No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Titon (nadroparin 0.6ml vs naproxen), 1994 | nadroparin vs naproxene | | | | Vesalio, 2005 | nadroparin fixed-dose vs nadroparin weight-adjusted | | | | Titon (nadroparin 61.5 IU anti-Xa/kg vs naproxen), 1994 | nadroparin vs naproxene | | | |
Trial | Treatments | Patients | Method |
---|
Titon (nadroparin 0.6ml vs naproxen), 1994 | nadroparin (s.c. 0.6 ml for 6150 IU anti-Xa once daily)j (n=-9) vs. Naproxene (oral 500 mg once daily) (n=-9) | patients with ST | Sample size: -9/-9 Primary endpoint: FU duration: | Vesalio, 2005 | LMWH (nadroparin) body-weight adjusted (full dose for 10 days followed by half dose for 20 additional days)àĆ (n=-9) vs. nadroparin (2850 anti-Xa IU) for 30 days (n=-9) | patients with superficial vein thrombosis of the great saphenous vein with the thrombosis extending
up to 3 cm from the sapheno-femoral junction | Sample size: -9/-9 Primary endpoint: FU duration: | Titon (nadroparin 61.5 IU anti-Xa/kg vs naproxen), 1994 | nadroparin (s.c. 0.6 ml for 6150 IU anti-Xa once daily)j (n=-9) vs. Naproxene (oral 500 mg once daily) (n=-9) | patients with ST | Sample size: -9/-9 Primary endpoint: FU duration: |
|
thrombosis prevention | versus placebo or control No demonstrated result for efficacy | 9 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Fraisse, 2000 | Nadroparin vs placebo | | | All-cause death during follow-up 1.05 [0.41; 2.69] Major bleeding during follow-up 2.09 [0.54; 8.16] Symptomatic pulmonary embolism during follow-up NaN [NaN; NaN] DVT 0.55 [0.30; 1.00] Asymptomatic deep vein thrombosis during follow-up. 0.57 [0.30; 1.06] Symptomatic deep vein thrombosis during follow-up NaN [NaN; NaN] | Mahe, 2005 | Nadroparin vs placebo | | | All-cause death during follow-up 0.98 [0.78; 1.24] Major bleeding during follow-up 0.34 [0.04; 3.24] Symptomatic pulmonary embolism during follow-up 0.59 [0.27; 1.29] fatal PE 0.59 [0.27; 1.29] PE 0.59 [0.27; 1.29] | Balas [40] | nadroparin vs placebo | | | total bleeding 0.58 [0.17; 1.91] | Marassi [41] | nadroparin vs no treatment | | | total bleeding 0.00 [0.00; NaN] wound hematoma 0.00 [0.00; NaN] transfusin 1.15 [0.65; 2.04] | Nurmohamed, 1996 | nadroparin vs placebo | | | thromboembolic events (symptomatic or asymptomatic) 0.71 [0.48; 1.06] proxymal DVT 0.60 [0.30; 1.18] | KANT (7 days), 2008 | nadroparin vs control | asymptomatic proximal DVT, symptomatic VTE, all death 0.29 [0.12; 0.71] | | major or clinically relevant bleeding 3.01 [0.61; 14.88] | KANT (14 days), 2008 | nadroparin 14d vs control | asymptomatic proximal DVT, symptomatic VTE, all death 0.28 [0.10; 0.82] | | major or clinically relevant bleeding 1.49 [0.21; 10.51] | Kujath, 1993 | nadroparin vs control | VTE (symptomatic or asymptomatic) 0.29 [0.12; 0.69] | | PE NaN [NaN; NaN] | Bergmann, 1996 | nadroparin vs placebo | | | All-cause death during follow-up 0.98 [0.78; 1.24] |
Trial | Treatments | Patients | Method |
---|
Fraisse, 2000 | Nadroparin 3800–5700E once daily, Until no longer mechanical ventilation, <=21 days (n=109) vs. placebo (n=114) | Acute decompensated chronic obstructive pulmonary diseasewith mechanical ventilation | double blind Parallel groups Sample size: 109/114 Primary endpoint: FU duration: <=21 days | Mahe, 2005 | nadroparin 7500E once daily, Until hospital discharge, <=21 days (n=1230) vs. placebo (n=1244) | Congestive heart failure (NYHA III–IV), acute or respiratory disease, nonpulmonary sepsis, cancer | double blind Parallel groups Sample size: 1230/1244 Primary endpoint: FU duration: <=21 days | Balas [40] | Nadroparin 2850 anti-Xa units (n=94) vs. Placebo (n=95) | | Blind Sample size: 94/95 Primary endpoint: FU duration: | Marassi [41] | Nadroparin 2850 anti-Xa units (n=31) vs. No treatment (n=33) | | Open Sample size: 31/33 Primary endpoint: FU duration: | Nurmohamed, 1996 | Nadroparin, 7500 Institute Choay anti-Xa units per day subcutaneously 18-24 hours postoperatively plus compression for 10 days (n=241) vs. compression stockings + placebo (n=244) | Craniotomy or spinal surgery for tumor or injury, 18 years or older, without excess bleeding risk | Sample size: 241/244 Primary endpoint: FU duration: 56 days | KANT (7 days), 2008 | once-daily subcutaneous injection of LMWH (nadroparin, 3800 anti-Xa IU) for 7 days (n=657) vs. full-length graduated compression stocking for 7 days (n=660) 3 arms: elastic stockings for 7 days; nadroparin 0.4 ml sc once daily for 7 days; nadroparin 0.4 ml sc once daily for 14 days | patients undergoing knee arthroscopy | open (blinded assessment) Parallel groups Sample size: 657/660 Primary endpoint: prox DVT, VTE, death FU duration: 3 months | KANT (14 days), 2008 | once-daily subcutaneous injection of LMWH (nadroparin, 3800 anti-Xa IU) for 14 days (n=444) vs. full-length graduated compression stocking for 7 days (n=660) 3 arms: elastic stockings for 7 days; nadroparin 0.4 ml sc once daily for 7 days; nadroparin 0.4 ml sc once daily for 14 days
| patients undergoing knee arthroscopy
| open (blinded assessment) Parallel groups Sample size: 444/660 Primary endpoint: prox DVT, VTE, death FU duration: 3 months
| Kujath, 1993 | Nadroparin 2850 IU (n=126) vs. no prophylaxis (n=126) | patients with injuries of the lower limb immobilized by a plaster cast | open Parallel groups Sample size: 126/126 Primary endpoint: FU duration: 16 days | Bergmann, 1996 | nadroparin 7500 u anti-Xa once daily (n=-9) vs. placebo (n=-9) | hospitalized medical | Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: up to 21 |
|
thrombosis prevention | versus placebo or no treatment No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Yoo, 1997 | nadroparin vs no treatment | | | | Sourmelis, 1995 | nadroparin vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
Yoo, 1997 | nadroparin 41/kgx1 days 1-3, 62/kg x1 days 4-11+elastic stockings (n=50) vs. no treatment (n=50) | Elective hip | open Sample size: 50/50 Primary endpoint: FU duration: 10 days | Sourmelis, 1995 | nadroparin 3075x1 preop, 6150x1 post op (n=72) vs. Placebo (n=78) | Hip fracture | double blind Sample size: 72/78 Primary endpoint: FU duration: 10-12 days |
|
thrombosis prevention | versus No demonstrated result for efficacy | 6 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Kakkar and Murray, 1985 | nadroparin vs unfractionated heparin | asymptomatic DVT 0.36 [0.13; 0.99] | | death 0.83 [0.26; 2.69] clinical PE 0.00 [0.00; NaN] wound hematoma 0.79 [0.23; 2.65] symptomatic thromboembolism 0.00 [0.00; NaN] transfusion 1.14 [0.85; 1.53] | EFS, 1988 | nadroparin vs unfractionated heparin | symptomatic thromboembolism 0.27 [0.07; 0.95] | | death 0.89 [0.40; 2.01] total haemorrhage 0.99 [0.82; 1.19] clinical PE 0.20 [0.02; 2.07] asymptomatic DVT 0.63 [0.39; 1.01] wound hematoma 0.97 [0.37; 2.55] transfusion 1.01 [0.82; 1.25] | Dahan, 1989 | nadroparin vs unfractionated heparin | | | clinical PE NaN [NaN; NaN] asymptomatic DVT NaN [NaN; NaN] wound hematoma 0.00 [0.00; NaN] | | nadroparin vs unfractionated heparin | | | | | nadroparin vs unfractionated heparin | | | | NPHDO, 1998 | out of hospital Nadroparin vs standard prophylaxis | | | Death NaN [NaN; NaN] Major bleeding NaN [NaN; NaN] Minor bleeding ∞ [NaN; ∞] Pulmonary embolism NaN [NaN; NaN] Symptomatic venous thromboembolism 0.41 [0.04; 3.88] symptomatic deep vein thrombosis 0.30 [0.03; 2.88] |
Trial | Treatments | Patients | Method |
---|
Kakkar and Murray, 1985 | Nadroparin 2850 (n=200) vs. UFH 10 000 units (n=200) | General surgery | Blind Sample size: 200/200 Primary endpoint: FU duration: 10 days | EFS, 1988 | Nadroparin 2850 (n=968) vs. UFH 15 000 units (n=941) | Abdominal surgery | Open Sample size: 968/941 Primary endpoint: FU duration: 1 month | Dahan, 1989 | Nadroparin 2850 (n=46) vs. UFH 15 000 units (n=41) | Thoracic surgery | Open Sample size: 46/41 Primary endpoint: FU duration: | Barbui, 1990 | Nadroparin 2850 anti Xa units (n=171) vs. UFH 10 000 units (n=173) | General surgery | Open Sample size: 171/173 Primary endpoint: FU duration: | Eurin, 1994 | Nadroparin 2850 anti Xa units (n=241) vs. UFH 15 000 units (n=239) | Abdominopelvic surgery | Open Sample size: 241/239 Primary endpoint: FU duration: | NPHDO, 1998 | in hospital thromboprophylaxis followed by out of hospital Nadroparin weight-adjusted for a total duration of 37-38 days (n=173) vs. Nadroparin weight-adjusted for 16-17 days (n=173) | THR | Sample size: 173/173 Primary endpoint: FU duration: |
|
venous thrombosis | versus anticoagulant No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Lopez Beret, 2001 | extended nadroparin vs standard treatment | | | All-cause mortality 1.24 [0.52; 2.94] |
Trial | Treatments | Patients | Method |
---|
Lopez Beret, 2001 | Nadroparin 1.025 antiXa IU/10Kg
twice daily after aadroparin 1.025AXa IU/10Kg twice daily for 3 days. After 3 months, nadroparin was switched to once daily (n=-9) vs. acenocoumarol (target INR 2-3) for 3-6 months after nadroparin 1.025AXa IU/10Kg twice daily for 3 days (n=-9) | patients with known malignancy treated for symptomatic DVT of the lower limb | outcome assessment blinded Parallel groups Sample size: -9/-9 Primary endpoint: Death at 12 months FU duration: 12 months |
|
venous thrombosis | versus oral anticoagulant No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Lopaciuk, 1999 | Nadroparin vs acenocoumarol | | | VTE during follow-up after active anticoagulant treatment 2.53 [0.50; 12.71] VTE during active anticoagulant treatment 0.43 [0.11; 1.61] | Lopez-Beret, 2001 | Nadroparin vs acenocoumarol | | | VTE during follow-up after active anticoagulant treatment 0.50 [0.09; 2.65] VTE during active anticoagulant treatment 2.85 [0.80; 10.14] |
Trial | Treatments | Patients | Method |
---|
Lopaciuk, 1999 | LMWH, 85 UI/kg bid followed by Nadroparin 85 IU/kg qd (n=101) vs. LMWH, 85 UI/kg bid followed by Acenocoumarol target INR 2-3 (n=101) | patients with objective diagnosis of DVT by Venography | open Sample size: 101/101 Primary endpoint: none defined FU duration: 9 mo | Lopez-Beret, 2001 | LMWH, 1,025 IU/10 kg bid followed by Nadroparin 1,025 IU/10 kg bid (n=81) vs. LMWH, 1,025 IU/10 kg bid followed by Acenocoumarol target INR 2-3 (n=77) | patients with objective diagnosis of DVT by compression ultrasonography | open Sample size: 81/77 Primary endpoint: none defined FU duration: 6-9 mo |
|
venous thrombosis | versus No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Collaborative European Multicentre, 1991 | Nadroparin vs unfractionated heparin | | | all cause death 1.89 [0.18; 20.31] Recurrent thromboembolic event 2.83 [0.30; 26.52] Thrombus extension 0.47 [0.09; 2.49] Short term haemorrhage 1.89 [0.36; 9.95] | Prandoni et al , 1992 | Nadroparin vs unfractionated heparin | Thrombus extension 0.36 [0.13; 0.95] | | all cause death 0.50 [0.20; 1.27] Recurrent thromboembolic event 0.50 [0.20; 1.27] Short term haemorrhage 0.33 [0.04; 3.14] | Lopaciuk et al , 1992 | Nadroparin vs unfractionated heparin | | | all cause death 0.00 [0.00; NaN] Recurrent thromboembolic event 0.00 [0.00; NaN] Thrombus extension 0.84 [0.39; 1.83] Short term haemorrhage 0.00 [0.00; NaN] |
Trial | Treatments | Patients | Method |
---|
Collaborative European Multicentre, 1991 | Nadroparin Subcutaneous twice daily for 10 Days, 90 U/kg BID (n=70) vs. unfractionated heparin intravenous APPTx1.5-2 (n=66) | | Sample size: 70/66 Primary endpoint: FU duration: 12 Weeks | Prandoni et al , 1992 | Nadroparin Subcutaneous twice daily for >=0 Days, 90 U/kg BID (n=85) vs. unfractionated heparin intravenous APPTx1.5-2 (n=85) | | Sample size: 85/85 Primary endpoint: FU duration: 6 Months | Lopaciuk et al , 1992 | Nadroparin Subcutaneous twice daily for 10 Days, 92 U/kg BID (n=74) vs. unfractionated heparin subcutaneous twice daily APPTx1.5-2.5 (n=75) | | Sample size: 74/75 Primary endpoint: FU duration: 3 Months |
|
venous thrombosis | versus twice daily LMWH No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Charbonnier, 1998 | once daily nadroparin vs twice daily nadroparin | | | Mortality 0.73 [0.32; 1.69] Haemorraghic events 0.62 [0.29; 1.34] Recurrent thromboembolic events 0.57 [0.30; 1.11] |
Trial | Treatments | Patients | Method |
---|
Charbonnier, 1998 | Once daily nadroparin 20,500 (AXa IU/ml)continued for at least 5 days (n=316) vs. twice daily
nadroparin 10,250 (AXa IU/ml)continued for at least 5 days (n=335) | patients with acute symptomatic proximal DVT in popliteal vein or above
documented by venography | double blind Parallel groups Sample size: 316/335 Primary endpoint: FU duration: |
|