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Are adverse drug reaction patterns different between romiplostim and eltrombopag? 2009-2013 French PharmacoVigilance assessment.

• アブストラクト	BACKGROUND: Romiplostim and eltrombopag, the two marketed thrombopoietin receptor agonists (TPO-RAs), have distinct binding sites and might have distinct pharmacodynamic mechanisms. The aim of this study was to compare their adverse drug reaction (ADR) patterns. METHODS: We selected in the French PharmacoVigilance Database all ADRs associated with TPO-RAs from TPO-RA marketing until the 31st of December 2013. Medical charts were reviewed. We conducted disproportionality analyses comparing romiplostim exposure in the reports of a given ADR pattern (thrombosis, neurological, cutaneous, gastrointestinal or hematological) to romiplostim exposure in all other TPO-RA-related ADR reports. Reporting Odds Ratios (RORs) were adjusted for age and gender. We also compared the number of reports of a given ADR pattern per million daily defined doses (DDDs) dispensed in France during the study period. RESULTS: We described 45 reports (53 ADRs) with romiplostim and 26 reports (37 ADRs) with eltrombopag. There were 19 venous thromboses. At least one other risk factor was present in 83.3% of the cases. Ten (55.6%) patients had been splenectomized previously. There were eight arterial thromboses. Another risk factor was noticed in all cases. There was no signal for an excess risk of thrombosis with romiplostim versus eltrombopag (ROR: 1.45, 95% CI [0.48-4.45]). There was a signal for a higher risk of gastrointestinal ADRs with eltrombopag (ROR: 30.28, 95% CI [3.23-383.86]) and of hematological ADRs with romiplostim (ROR: 14.36, 95% CI [1.73-119.08]). Dispensing data-adjusted comparisons led to similar results. CONCLUSIONS: This study suggests different ADR patterns between romiplostim and eltrombopag.
  ジャーナル名	European journal of internal medicine
  投稿日	2014/9/23
  投稿者	Moulis, Guillaume; Bagheri, Haleh; Sailler, Laurent; Jonville-Bera, Annie-Pierre; Weber, Emmanuelle; Guy, Claire; Petitpain, Nadine; Laroche, Marie-Laure; Favreliere, Sylvie; Bene, Johana; Baldin, Bernadette; Villeval-Federici, Laure; Tebacher-Alt, Martine; Bres, Virginie; Veyrac, Gwenaelle; Grandvuillemin, Aurelie; Mauprivez, Cedric; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis
  組織名	Laboratoire de Pharmacologie Medicale et Clinique, Universite Paul Sabatier,;Faculte de Medecine, 37 Allees Jules-Guesde, 31000 Toulouse, France; Equipe de;Pharmacoepidemiologie de l'INSERM U 1027, Faculte de Medecine, 37 Allees;Jules-Guesde, 31000 Toulouse, France; Service de Medecine Interne, Centre;Hospitalier Universitaire de Toulouse, Place du Dr Baylac, TSA 40031, 31059;Toulouse Cedex 9, France. Electronic address: guillaume.moulis@univ-tlse3.fr.;Jules-Guesde, 31000 Toulouse, France; Service de Pharmacologie Clinique, Centre;Midi-Pyrenees de Pharmacovigilance, de Pharmacoepidemiologie et d'Informations;sur le Medicament, Centre Hospitalier Universitaire de Toulouse, Faculte de;Medecine, 37 Allees Jules-Guesde, 31000 Toulouse, France.;Equipe de Pharmacoepidemiologie de l'INSERM U 1027, Faculte de Medecine, 37;Allees Jules-Guesde, 31000 Toulouse, France; Service de Medecine Interne, Centre;Toulouse Cedex 9, France.;Service de Pharmacologie Clinique, Centre Regional de Pharmacovigilance, Centre;Hospitalier Universitaire de Tours, 2 bd Tonnelle, 37044 Tours Cedex 9, France.;Service de Medecine Interne, Hopital Nord, Centre Hospitalier Universitaire de;Saint-Etienne, 42055 Saint-Etienne Cedex 02, France.;Centre Regional de Pharmacovigilance et de Renseignements sur le Medicament,;Hopital Nord, Centre Hospitalier Universitaire de Saint-Etienne, 42055;Saint-Etienne Cedex 02, France.;Service de Pharmacologie Clinique, Centre Regional de Pharmacovigilance de;Lorraine, Centre Hospitalier Universitaire de Nancy, 29 Avenue du;Marechal-de-Lattre-de-Tassigny, 54035 Nancy Cedex, France.;Service de Pharmacologie, Toxicologie et Pharmacovigilance, Centre Regional de;Pharmacovigilance, de Pharmacoepidemiologie et d'Information sur les Medicaments,;Centre Hospitalier Universitaire de Limoges, 2 Avenue Martin-Luther-King, 87042;Limoges Cedex, France.;Centre Regional de Pharmacovigilance, Centre Hospitalier Universitaire de;Poitiers, BP 577, 86021 Poitiers Cedex, France.;Centre Regional de Pharmacovigilance, Centre Hospitalier Universitaire de Lille,;1 Place de Verdun, 59045 Lille Cedex, France.;Centre Regional de Pharmacovigilance, Centre Hospitalier Universitaire de Nice, 4;Avenue Reine Victoria, BP 1179, 06003 Nice Cedex 1, France.;Service de Medecine Interne, Clinique Adassa, 13 Place de Haguenau, 67000;Strasbourg, France.;Strasbourg, 1 Place de l'Hopital, BP 426, 67091 Strasbourg Cedex, France.;Departement de Pharmacologie Medicale et Toxicologie, Centre Regional de;Pharmacovigilance de Languedoc-Roussillon, Centre Hospitalier Universitaire de;Montpellier, 371 Avenue du Doyen-Gaston-Giraud, 34295 Montpellier Cedex 5,;France.;Service de Pharmacologie Clinique, UF de Pharmacovigilance, Institut de Biologie,;Centre Hospitalier Universitaire de Nantes, 9 Quai Moncousu, 44093 Nantes Cedex;01, France.;Centre Regional de Pharmacovigilance de Bourgogne, EA 4184, Centre Hospitalier;Universitaire de Dijon, 14 rue Paul-Gaffarel, BP 77908, 21079 Dijon Cedex,;Centre Regional de Pharmacovigilance de Paris-Cochin, Assistance Publique -;Hopitaux de Paris, 27 rue du Faubourg-Saint-Jacques, 75014 Paris, France.
  Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/25242516/

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