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• W2023116289 abstract "HomeCirculationVol. 116, No. 13Response to Letter Regarding Article, “Hormone Therapy and Venous Thromboembolism Among Postmenopausal Women: Impact of the Route of Estrogen Administration and Progestogens: The ESTHER Study” Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBResponse to Letter Regarding Article, “Hormone Therapy and Venous Thromboembolism Among Postmenopausal Women: Impact of the Route of Estrogen Administration and Progestogens: The ESTHER Study” Marianne Canonico, Emmanuel Oger, Geneviève Plu-Bureau and Pierre-Yves Scarabin Jacqueline Conard Guy Meyer Hervé Lévesque Nathalie Trillot Marie-Thérèse Barrellier Denis Wahl Joseph Emmerich Marianne CanonicoMarianne Canonico Inserm Unit 780, Cardiovascular Epidemiology Section, Villejuif, France Search for more papers by this author , Emmanuel OgerEmmanuel Oger Inserm Unit 780, Cardiovascular Epidemiology Section, Villejuif, France Search for more papers by this author , Geneviève Plu-BureauGeneviève Plu-Bureau Inserm Unit 780, Cardiovascular Epidemiology Section, Villejuif, France Search for more papers by this author and Pierre-Yves ScarabinPierre-Yves Scarabin Inserm Unit 780, Cardiovascular Epidemiology Section, Villejuif, France Search for more papers by this author Jacqueline ConardJacqueline Conard Université Paris 5 Réné Descartes, Service d’Hématologie Biologique, Hôpital Hôtel-Dieu, Paris, France Search for more papers by this author Guy MeyerGuy Meyer Université Paris-Descartes, Faculté de Médecine, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France Search for more papers by this author Hervé LévesqueHervé Lévesque Département de Médecine Interne, Centre Hôpitalier Universitaire Rouen, Rouen, France Search for more papers by this author Nathalie TrillotNathalie Trillot Institut d’Hématologie-Transfusion, Centre Hôpitalier Universitaire Régional, Lille, France Search for more papers by this author Marie-Thérèse BarrellierMarie-Thérèse Barrellier Service d’Explorations Fonctionnelles, CHU Côte de Nacre, Caen, France Search for more papers by this author Denis WahlDenis Wahl Unité de Médecine Interne Thrombose Maladies Vasculaires, CHU Nancy, Hôpital de Brabois, Vandoeuvre-Les-Nancy, France Search for more papers by this author Joseph EmmerichJoseph Emmerich Université Paris Descartes, Service de Médecine Vasculaire-HTA, Hôpital Européen Georges Pompidou, Paris, France Search for more papers by this author Originally published25 Sep 2007https://doi.org/10.1161/CIRCULATIONAHA.107.715607Circulation. 2007;116:e363We thank Drs Micheletti and Chevallier for their interest in our report.1 First, we believe that odds ratios (ORs) and 95% confidence intervals (CIs) estimated from logistic regressions provide adequate information about significance and the size and direction of the effect of norpregnane derivatives. Because elevation in venous thromboembolism (VTE) risk is substantial (OR: 4) and significantly different from 1 (with the 95% CI not crossing 1), our results suggest a thrombogenic effect of norpregnanes, and the probability value (P<0.006) indicates that the probability of the result being due to chance is very small.Second, only the main effects of the route of estrogen administration and type of progestogens were estimated with a joint model (Table 2 of the original article1). Stratified analyses by route of estrogen administration and type of progestogens have also been performed. Among transdermal estrogen users, women received estrogen alone (10 cases and 35 controls; OR: 0.8, 95% CI: 0.4 to 1.8 after adjustment for obesity, family history of VTE, and varicose veins) or combined with either micronized progesterone (13 cases and 63 controls; OR: 0.6, 95% CI: 0.3 to 1.2), pregnane derivatives (16 cases and 51 controls; OR: 0.8, 95% CI: 0.4 to 1.6), or norpregnane derivatives (28 cases and 31 controls; OR: 3.1, 95% CI: 1.7 to 5.9). Among oral estrogen users, women received estrogen alone (4 cases and 5 controls) or combined with either micronized progesterone (6 cases and no controls), pregnane derivatives (23 cases and 28 controls), norpregnane derivatives (12 cases and 6 controls), or nortestosterone derivatives (12 cases and 7 controls). There was no significant difference in VTE risk between any of the progestogen subgroups among current users of oral estrogen (overall OR: 4.5, 95% CI: 2.6 to 7.5).Third, to allow for adequate numbers of subjects within subgroups, stratified analysis by time of exposure used the median of the distribution (5 years) as a cutoff point. Unlike oral estrogens, there was no significant interaction between the time of exposure to either transdermal estrogens or norpregnane derivatives and VTE risk. Therefore, differences in exposure time to hormone therapy cannot explain our results.Finally, although our results may be clinically relevant, we acknowledge that interpretation of data may have been biased by the inclusion of women with hyperestrogenic symptoms who were prescribed norpregnane derivatives. This prescription bias was emphasized in the Discussion section. Regarding the absence of thrombogenic mechanism underlying our results, Micheletti and Chevallier quote an inconclusive small trial2 that failed to also show the well-known activation of blood coagulation among women using oral estrogens. In addition, relevant hemostatic tests such as plasma-activated protein C sensitivity were not included as end points in this trial. Because relevant data are lacking, we are presently investigating the impact of norpregnanes on hemostasis among users of hormone therapy in the Study of NorpregnAnes on Coagulation (SNAC study).DisclosuresDr Scarabin has received research grants from Inserm, Fondation pour la Recherche Médicale, Fondation de France, Aventis, Besins International, Sanofi, and Servier Institute. The remaining authors report no conflicts. References 1 Canonico M, Oger E, Plu-Bureau G, Conard J, Meyer G, Levesque H, Trillot N, Barrellier MT, Wahl D, Emmerich J, Scarabin PY; Estrogen and Thromboembolism Risk (ESTHER) Study Group. Hormone therapy and venous thromboembolism among postmenopausal women: impact of the route of estrogen administration and progestogens: the ESTHER study. Circulation. 2007; 115: 840–845.LinkGoogle Scholar2 Conard J, Denis C, Basdevant A, Guyenne TT, Thomas JL, Degrelle H, Ochsenbein E. Cardiovascular risk factors and combined estrogen-progestin replacement therapy: a placebo-controlled study with nomegestrol acetate and estradiol. Fertil Steril. 1995; 64: 957–962.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Lello S (2010) Nomegestrol Acetate, Drugs, 10.2165/11532130-000000000-00000, 70:5, (541-559), Online publication date: 1-Mar-2010. September 25, 2007Vol 116, Issue 13 Advertisement Article InformationMetrics https://doi.org/10.1161/CIRCULATIONAHA.107.715607 Originally publishedSeptember 25, 2007 PDF download Advertisement SubjectsEpidemiology" @default.
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