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• W4239337761 abstract "The debate whether anticoagulant prophylaxis for pregnancy complications should be applied in women with a history of hereditary thrombophilia and (recurrent) pregnancy loss remains ongoing. In the February issue, Brenner and colleagues presented the results of the LIVE‐ENOX study, in which the outcome of subsequent pregnancies in women with thrombophilia and a heterogeneous history of pregnancy losses who were treated with 40 or 80 mg s.c. once daily enoxaparin was investigated [1Brenner B. Hoffman R. Carp H. Dulitzky M. Younis J. for the LIVE‐ENOX InvestigatorsEfficacy and safety of two doses of enoxaparin in women with thrombophilia and recurrent pregnancy loss: the LIVE‐ENOX study.J Thromb Haemost. 2005; 3: 227-32Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar]. The authors conclude that enoxaparin in either dose results in a favorable outcome in the majority of patients. Moreover, in the same issue, Gris and Marès argued that the LIVE‐ENOX study has greatly contributed to the insight of the effect of low‐molecular‐weight heparin (LMWH) in women with thrombophilia [2Gris J.C. Mares P. The long and winding road … towards LMWH for pregnancy loss.J Thromb Haemost. 2005; 3: 224-9Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar]. However, the key problem is that this study has not compared enoxaparin treatment with the current standard, i.e. no treatment. I am in agreement with Lindqvist and Merlo, who listed a large number of methodological weaknesses of the LIVE‐ENOX study, to such an extent that they conclude that this paper is an ‘inappropriate source of reference’ [3Lindqvist P.G. Merlo J. Low molecular weight heparin for repeated pregnancy loss ‐ is it based on solid evidence.J Thromb Haemost. 2005; 3: 221-3Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar]. Many of these comments have been previously published [4Middeldorp S. Antithrombotic prophylaxis for women with thrombophilia and pregnancy complications – No.J Thromb Haemost. 2003; 1: 2073-4Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar, 5DiNisio M. Peters L.W. Middeldorp S. Anticoagulants for the treatment of recurrent pregnancy loss in women without antiphospholipid syndrome.Cochrane Database Syst Rev. 2005; Crossref Google Scholar]. There are three additional points that I would like to raise. First, the reporting of the LIVE‐ENOX study lacks transparency, which debilitates adequate judgment of both internal and external validity of the results. For instance, the randomization method and concealment of allocation was unclear, which is an important quality item that is likely to overestimate the benefits of randomized controlled trials (RCTs) [6Egger M. Juni P. Bartlett C. Holenstein F. Sterne J. How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study.Health Technol Assess. 2003; 7: 1-76Crossref PubMed Google Scholar]. The participant flow was not stated but from the given numbers, the conclusion can be drawn that an adequate intention‐to‐treat analysis was not performed. The quality of follow‐up with respect to the safety outcomes cannot be judged, and the number of skin reactions of 3% is much lower than that would be expected based on published experience [7Bank I. Libourel E.J. Middeldorp S. van der Meer J. Buller HR. High rate of skin complications due to low‐molecular‐weight heparins in pregnant women.J Thromb Haemost. 2003; 1: 859-61Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar]. The Journal of Thrombosis and Haemostasis should reinforce authors to follow the CONSORT Statement for reporting of clinical trials [8Ioannidis J.P. Evans S.J. Gotzsche P.C. O'Neill R.T. Altman D.G. Schulz K. Moher D. Better reporting of harms in randomized trials: an extension of the CONSORT statement.Ann Intern Med. 2004; 141: 781-8Crossref PubMed Google Scholar]. Secondly, the claim with respect to safety in the LIVE‐ENOX study should be interpreted with caution. RCTs are usually powered to demonstrate efficacy, and not to evaluate the risks of harm of a given intervention. For instance, with the sample size in the LIVE‐ENOX study in which no side effects were observed, this point estimate of 0% has an upper limit of the 95% confidence interval of 4%. It is likely that when larger numbers of women are exposed to anticoagulant drugs in the future, a substantial number of women will experience bleeding, in particular, during delivery. Finally and most notably, in the 21st century we should refrain from performing invalid, uncontrolled studies. Although I do agree with the difficulties Gris and Marès list when performing drug intervention trials in pregnancy, I disagree with the statement that it will be difficult to convince women with an unfavorable previous outcome to receive a placebo during a next pregnancy. The fact that fetuses are legally recorded as babies from the sixth month of gestation does underscore our duty to protect these babies and their mothers for treatment options that have not been fully evaluated. When everyone follows good clinical practice guidelines for evaluating the indication for drug treatment in pregnant women, patients would not be questioning those colleagues who try to perform adequately designed trials. Performing a placebo‐controlled study is feasible. It takes approximately 100 patients per study arm to demonstrate a clinically relevant 20% absolute risk reduction of subsequent pregnancy loss by any anticoagulant treatment when compared with placebo, assuming a live birth rate in the untreated group of 50%–60%. Publishing uncontrolled studies like the LIVE‐ENOX study makes the lives of current investigators a lot harder, and will likely slow down recruitment rates. It is my genuine opinion that, in particular for pregnant women and their babies, it is of utmost importance that efficacy of any drug intervention should be clearly demonstrated before it is being implemented. At present we do lack this information." @default.
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• W4239337761 date "2005-04-01" @default.
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• W4239337761 title "The use of LMWH in pregnancies at risk: new evidence or perception?" @default.
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• W4239337761 doi "https://doi.org/10.1111/j.1538-7836.2005.01288.x" @default.
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