Efficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy.

Hdl Handle:
http://hdl.handle.net/10147/82443
Title:
Efficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy.
Authors:
Ní Ainle, Fionnuala; Wong, Audris; Appleby, Niamh; Byrne, Brigitte; Regan, Carmen; Hassan, Tayyaba; Milner, Marie; Sullivan, Ann O; White, Barry; O'Donnell, James
Affiliation:
National Centre for Hereditary Coagulation Disorders, St James's Hospital, Ireland. jodonne@tcd.ie
Citation:
Efficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy. 2008, 19 (7):689-92 Blood Coagul. Fibrinolysis
Journal:
Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis
Issue Date:
Oct-2008
URI:
http://hdl.handle.net/10147/82443
DOI:
10.1097/MBC.0b013e32830b14ef
PubMed ID:
18832911
Abstract:
Low molecular weight heparin (LMWH) is widely regarded as the anticoagulant treatment of choice for the prevention and treatment of venous thromboembolism during pregnancy. However, previous studies have demonstrated that the pharmacokinetic profiles of LMWH vary significantly with increasing gestation. Consequently, it remains unclear whether LMWH regimens recommended for use in nonpregnant individuals can be safely extrapolated to pregnant women. The aims of this study were to assess the safety and the efficacy of tinzaparin sodium (Innohep) administered only once daily during pregnancy. A systematic retrospective review identified a cohort of 37 high-risk pregnancies which had been managed using tinzaparin 175 IU/kg once daily. In 26 cases, the index pregnancy had been complicated by development of an acute venous thromboembolism (17 deep vein thrombosis and nine pulmonary embolism). For each individual, case notes were examined and data extracted using a predetermined questionnaire. No episodes of recurrent venous thromboembolism were identified amongst this cohort of pregnancies managed using once daily LMWH administration. However, two unusual thrombotic complications were observed, including a parietal infarct in one patient, and a postpartum cerebral venous thrombosis in another. Once daily tinzaparin was well tolerated, with no cases of heparin-induced thrombocytopaenia, symptomatic osteoporosis, or foetal malformations. Tinzaparin dose modification based upon peak anti-Xa levels occurred in 45% of the cases examined. The present study is the largest study to have examined the clinical efficacy of once daily LMWH for use in pregnant women at high risk of venous thromboembolism. Our data support the safety and efficacy of antenatal tinzaparin at a dose of 175 IU/kg. In order to determine whether this once daily regimen provides equivalent (or indeed greater) thromboprophylaxis to twice daily LMWH regimens during pregnancy will require highly powered direct comparative studies.
Language:
en
MeSH:
Adult; Cohort Studies; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Fibrinolytic Agents; Heparin, Low-Molecular-Weight; Humans; Pregnancy; Pregnancy Complications, Hematologic; Pregnancy Outcome; Pregnancy, High-Risk; Retrospective Studies; Venous Thromboembolism; Young Adult
ISSN:
0957-5235

Full metadata record

DC FieldValue Language
dc.contributor.authorNí Ainle, Fionnuala-
dc.contributor.authorWong, Audris-
dc.contributor.authorAppleby, Niamh-
dc.contributor.authorByrne, Brigitte-
dc.contributor.authorRegan, Carmen-
dc.contributor.authorHassan, Tayyaba-
dc.contributor.authorMilner, Marie-
dc.contributor.authorSullivan, Ann O-
dc.contributor.authorWhite, Barry-
dc.contributor.authorO'Donnell, James-
dc.date.accessioned2009-09-24T10:02:05Z-
dc.date.available2009-09-24T10:02:05Z-
dc.date.issued2008-10-
dc.identifier.citationEfficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy. 2008, 19 (7):689-92 Blood Coagul. Fibrinolysisen
dc.identifier.issn0957-5235-
dc.identifier.pmid18832911-
dc.identifier.doi10.1097/MBC.0b013e32830b14ef-
dc.identifier.urihttp://hdl.handle.net/10147/82443-
dc.description.abstractLow molecular weight heparin (LMWH) is widely regarded as the anticoagulant treatment of choice for the prevention and treatment of venous thromboembolism during pregnancy. However, previous studies have demonstrated that the pharmacokinetic profiles of LMWH vary significantly with increasing gestation. Consequently, it remains unclear whether LMWH regimens recommended for use in nonpregnant individuals can be safely extrapolated to pregnant women. The aims of this study were to assess the safety and the efficacy of tinzaparin sodium (Innohep) administered only once daily during pregnancy. A systematic retrospective review identified a cohort of 37 high-risk pregnancies which had been managed using tinzaparin 175 IU/kg once daily. In 26 cases, the index pregnancy had been complicated by development of an acute venous thromboembolism (17 deep vein thrombosis and nine pulmonary embolism). For each individual, case notes were examined and data extracted using a predetermined questionnaire. No episodes of recurrent venous thromboembolism were identified amongst this cohort of pregnancies managed using once daily LMWH administration. However, two unusual thrombotic complications were observed, including a parietal infarct in one patient, and a postpartum cerebral venous thrombosis in another. Once daily tinzaparin was well tolerated, with no cases of heparin-induced thrombocytopaenia, symptomatic osteoporosis, or foetal malformations. Tinzaparin dose modification based upon peak anti-Xa levels occurred in 45% of the cases examined. The present study is the largest study to have examined the clinical efficacy of once daily LMWH for use in pregnant women at high risk of venous thromboembolism. Our data support the safety and efficacy of antenatal tinzaparin at a dose of 175 IU/kg. In order to determine whether this once daily regimen provides equivalent (or indeed greater) thromboprophylaxis to twice daily LMWH regimens during pregnancy will require highly powered direct comparative studies.-
dc.language.isoenen
dc.subject.meshAdult-
dc.subject.meshCohort Studies-
dc.subject.meshDose-Response Relationship, Drug-
dc.subject.meshDrug Administration Schedule-
dc.subject.meshFemale-
dc.subject.meshFibrinolytic Agents-
dc.subject.meshHeparin, Low-Molecular-Weight-
dc.subject.meshHumans-
dc.subject.meshPregnancy-
dc.subject.meshPregnancy Complications, Hematologic-
dc.subject.meshPregnancy Outcome-
dc.subject.meshPregnancy, High-Risk-
dc.subject.meshRetrospective Studies-
dc.subject.meshVenous Thromboembolism-
dc.subject.meshYoung Adult-
dc.titleEfficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy.en
dc.contributor.departmentNational Centre for Hereditary Coagulation Disorders, St James's Hospital, Ireland. jodonne@tcd.ieen
dc.identifier.journalBlood coagulation & fibrinolysis : an international journal in haemostasis and thrombosisen

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