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• W1877454703 abstract "9See also Roeters van Lennep JE, Meijer E, Klumper FJ, Middeldorp JM, Bloemenkamp KW, Middeldorp S. Prophylaxis with low‐dose low‐molecular‐weight‐heparin during pregnancy and postpartum: is it effective? J Thromb Haemost 2011; : 473–80; Roeters van Lennep JE, Meijer E, Klumper FJCM, Middeldorp JM, Bloemenkamp KWM, Middeldorp S. Low‐molecular‐weight‐heparin and pregnancy, when the dose does it: a nephrologist’s opinion: reply to a rebuttal. This issue, pp 2129–30. See also Roeters van Lennep JE, Meijer E, Klumper FJ, Middeldorp JM, Bloemenkamp KW, Middeldorp S. Prophylaxis with low‐dose low‐molecular‐weight‐heparin during pregnancy and postpartum: is it effective? J Thromb Haemost 2011; : 473–80; Roeters van Lennep JE, Meijer E, Klumper FJCM, Middeldorp JM, Bloemenkamp KWM, Middeldorp S. Low‐molecular‐weight‐heparin and pregnancy, when the dose does it: a nephrologist’s opinion: reply to a rebuttal. This issue, pp 2129–30. In a recent paper on prophylaxis with low‐dose low‐molecular‐weight‐heparin (LMWH) during pregnancy and postpartum, the authors raised concern on its effectiveness. They conclude that ‘although prophylaxis with low‐dose LMWH during pregnancy and postpartum proved to be safe, the risk of pregnancy‐related venous thromboembolism (VTE) is considerable in women with high risk of VTE, … and VTE prophylaxis with low‐dose LMWH may not be sufficiently effective in these women’ [1Roeters van Lennep J.E. Meijer E. Klumper F.J. Middeldorp J.M. Bloemenkamp K.W. Middeldorp S. Prophylaxis with low‐dose low‐molecular‐weight‐heparin during pregnancy and postpartum: is it effective?.J Thromb Haemost. 2011; 9: 473-80Abstract Full Text Full Text PDF PubMed Scopus (77) Google Scholar]. A similar conclusion has been reached in recent systematic review and meta‐analysis on heparin treatment in antiphospholipid syndrome (APS) with recurrent pregnancy loss. However, in this case thrombophrophylaxis for APS had pregnancy success rate as primary outcome with VTE as secondary outcomes. Indeed, the authors concluded that, unlike unfractionated heparin (UFH), the combination of LMWH and aspirin did not confer a significant benefit in live births [2Ziakas P.D. Pavlou M. Voulgarelis M. Heparin treatment in antiphospholipid syndrome with recurrent pregnancy loss: a systematic review and meta‐analysis.Obstet Gynecol. 2010; 115: 1256-62Crossref PubMed Scopus (145) Google Scholar]. However, we believe that, in general, achievement of adequate target levels should be documented before any assessment on LMWH effectiveness can be made. As the assumption that standard LMWH dosages that are efficacious outside pregnancy have the same efficacy during pregnancy has yet to be proven, this may be difficult to do. Unlike UFH, LMWH have a different pharmacokinetic profile during pregnancy as compared with non‐pregnant individuals, with significant variations between trimesters of pregnancy [3Sephton V. Farquharson R.G. Topping J. Quenby S.M. Cowan C. Back D.J. Toh C.H. A longitudinal study of maternal dose response to low molecular weight heparin in pregnancy.Obstet Gynecol. 2003; 101: 1307-11Crossref PubMed Scopus (80) Google Scholar, 4Ensom M.H. Stephenson M.D. Pharmacokinetics of low molecular weight heparin and unfractionated heparin in pregnancy.J Soc Gynecol Investig. 2004; 11: 377-83Crossref PubMed Scopus (34) Google Scholar, 5Fox N.S. Laughon S.K. Bender S.D. Saltzman D.H. Rebarber A. Anti‐factor Xa plasma levels in pregnant women receiving low molecular weight heparin thromboprophylaxis.Obstet Gynecol. 2008; 112: 884-9Crossref PubMed Scopus (45) Google Scholar, 6Friedrich E. Hameed A.B. Fluctuations in anti‐factor Xa levels with therapeutic enoxaparin anticoagulation in pregnancy.J Perinatol. 2010; 30: 253-7Crossref PubMed Scopus (56) Google Scholar]. This depends on the fact that body mass index (BMI) and renal glomerular filtration rate (GFR) play a key role in modulating LMWH pharmacokinetics. While UFH molecules bind to heparin‐binding proteins, antithrombin, endothelial cells and macrophages in a molecule length‐dependent way, making its metabolism difficult to predict, LMWH are structurally inadequate for protein binding and therefore have a more consistent dose‐response relationship, a longer plasma half‐life and a dose‐independent mechanism of renal clearance. We have previously shown the impact of different GFR and BMI on peak activity of anti‐Xa following injection of different dosages of LMWH (Fig. 1). In non‐pregnant individuals, we found a significant inverse relationship between creatinine clearance and plasma anti‐Xa activity, with a risk of achieving target anticoagulation significantly increased with higher LMWH doses (by 77‐fold every 0.1 mL increase of dose) and reduced by increased values in creatinine clearance (OR = 0.90; 95% CI: 0.82–0.99). The number of patients below target at least once at any time was 62/68 (91%), 39/68 (57%) at least once at 4 and 12 h post‐dose, and 23/68 (34%) at least once at 4 h post‐dose. The risk of having ant‐Xa levels below the target was significantly increased in patients with higher BMI (OR = 1.17; 95% CI: 1.006–1.367) and creatinine clearance [7Stratta P. Karvela E. Canavese C. Quaglia M. Lazzarich E. Fenoglio R. Pergolini P. Bellomo G. Cena T. Magnani C. Structure‐activity relationships of low molecular weight heparins expose to the risk of achieving inappropriate targets in patients with renal failure.Curr Med Chem. 2009; 16: 3028-40Crossref PubMed Scopus (8) Google Scholar] and doses below the standard prophylactic dose of 0.4 mL day−1, though not at a level of statistical significance, (OR = 4.54; 95% CI: 0.76–27.10). Therefore it is plausible that pregnancy‐related alterations in GFR and BMI have an impact on LWMH pharmacokinetics. It is well known that, paralleling the increases in blood volume and cardiac output, both renal plasma flow and GFR progressively progressively increase during the first trimester and are 50–60% higher than in the non‐pregnant state at term, resulting in a superimposable elevations in creatinine clearance, with a consequent reduction in urea and serum creatinine by 40%. As a consequence, a lower activity of standard doses of LMW heparin as compared to the non‐pregnant population was demonstrated both with regimen of thromboprophylaxis, when targeted plasma anti‐factor Xa level was reached in only 59% of cases and it was sub‐prophylactic in 26% of these [5Fox N.S. Laughon S.K. Bender S.D. Saltzman D.H. Rebarber A. Anti‐factor Xa plasma levels in pregnant women receiving low molecular weight heparin thromboprophylaxis.Obstet Gynecol. 2008; 112: 884-9Crossref PubMed Scopus (45) Google Scholar] and of anticoagulation, when trough and 8 h post‐dose anti‐factor Xa activity levels were sub‐therapeutic in a substantial number of patients receiving a b.i.d. regimen of therapeutic LMWH [6Friedrich E. Hameed A.B. Fluctuations in anti‐factor Xa levels with therapeutic enoxaparin anticoagulation in pregnancy.J Perinatol. 2010; 30: 253-7Crossref PubMed Scopus (56) Google Scholar]. Monitoring anti‐Xa activity has been recommended in special populations receiving prophylactic treatment to avoid the risk of underdosing when using standard fixed doses [8Lim W. Using low molecular weight heparin in special patient populations.J Thromb Thrombolysis. 2010; 29: 233-40Crossref PubMed Scopus (56) Google Scholar]. On the other hand, it is true that systematic anti‐Xa level monitoring for pregnant patients on LMWH can increase costs, but the cost/benefit balance of this very peculiar setting may still favour its use. In conclusion, as LMWH may offer clinical and practical advantages as compared with UFH, it would be useful to perform prospective large population studies including anti‐Xa activity measuring during pregnancy. It is still plausible that LMWH may also be efficacacious in the setting of pregnancy, provided that it is used at the appropriate dose, which attains target levels of anti‐Xa activity. The authors state that they have no conflict of interest." @default.
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