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Results of European post-marketing surveillance of bosentan in pulmonary hypertension.
Eur Respir J. 2007 Aug; 30(2):338-44.ER

Abstract

After the approval of bosentan for the treatment of pulmonary arterial hypertension (PAH), European authorities required the introduction of a post-marketing surveillance system (PMS) to obtain further data on its safety profile. A novel, prospective, internet-based PMS was designed, which solicited reports on elevated aminotransferases, medical reasons for bosentan discontinuation and other serious adverse events requiring hospitalisation. Data captured included demographics, PAH aetiology, baseline functional status and concomitant PAH-specific medications. Safety signals captured included death, hospitalisation, serious adverse events, unexpected adverse events and elevated aminotransferases. Within 30 months, 4,994 patients were included, representing 79% of patients receiving bosentan in Europe. In total, 4,623 patients were naïve to treatment; of these, 352 had elevated aminotransferases, corresponding to a crude incidence of 7.6% and an annual rate of 10.1%. Bosentan was discontinued due to elevated aminotransferases in 150 (3.2%) bosentan-naïve patients. Safety results were consistent across subgroups and aetiologies. The novel post-marketing surveillance captured targeted safety data ("potential safety signals") from the majority of patients and confirmed that the incidence and severity of elevated aminotransferase levels in clinical practice was similar to that reported in clinical trials. These data complement those from randomised controlled clinical trials and provide important additional information on the safety profile of bosentan.

Authors+Show Affiliations

Dept of Respiratory Medicine, Antoine Béclère Hospital, Clamart, France. marc.humbert@abc.ap-hop-paris.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

17504794

Citation

Humbert, M, et al. "Results of European Post-marketing Surveillance of Bosentan in Pulmonary Hypertension." The European Respiratory Journal, vol. 30, no. 2, 2007, pp. 338-44.
Humbert M, Segal ES, Kiely DG, et al. Results of European post-marketing surveillance of bosentan in pulmonary hypertension. Eur Respir J. 2007;30(2):338-44.
Humbert, M., Segal, E. S., Kiely, D. G., Carlsen, J., Schwierin, B., & Hoeper, M. M. (2007). Results of European post-marketing surveillance of bosentan in pulmonary hypertension. The European Respiratory Journal, 30(2), 338-44.
Humbert M, et al. Results of European Post-marketing Surveillance of Bosentan in Pulmonary Hypertension. Eur Respir J. 2007;30(2):338-44. PubMed PMID: 17504794.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Results of European post-marketing surveillance of bosentan in pulmonary hypertension. AU - Humbert,M, AU - Segal,E S, AU - Kiely,D G, AU - Carlsen,J, AU - Schwierin,B, AU - Hoeper,M M, Y1 - 2007/05/15/ PY - 2007/5/17/pubmed PY - 2007/10/20/medline PY - 2007/5/17/entrez SP - 338 EP - 44 JF - The European respiratory journal JO - Eur. Respir. J. VL - 30 IS - 2 N2 - After the approval of bosentan for the treatment of pulmonary arterial hypertension (PAH), European authorities required the introduction of a post-marketing surveillance system (PMS) to obtain further data on its safety profile. A novel, prospective, internet-based PMS was designed, which solicited reports on elevated aminotransferases, medical reasons for bosentan discontinuation and other serious adverse events requiring hospitalisation. Data captured included demographics, PAH aetiology, baseline functional status and concomitant PAH-specific medications. Safety signals captured included death, hospitalisation, serious adverse events, unexpected adverse events and elevated aminotransferases. Within 30 months, 4,994 patients were included, representing 79% of patients receiving bosentan in Europe. In total, 4,623 patients were naïve to treatment; of these, 352 had elevated aminotransferases, corresponding to a crude incidence of 7.6% and an annual rate of 10.1%. Bosentan was discontinued due to elevated aminotransferases in 150 (3.2%) bosentan-naïve patients. Safety results were consistent across subgroups and aetiologies. The novel post-marketing surveillance captured targeted safety data ("potential safety signals") from the majority of patients and confirmed that the incidence and severity of elevated aminotransferase levels in clinical practice was similar to that reported in clinical trials. These data complement those from randomised controlled clinical trials and provide important additional information on the safety profile of bosentan. SN - 0903-1936 UR - https://www.unboundmedicine.com/medline/citation/17504794/Results_of_European_post_marketing_surveillance_of_bosentan_in_pulmonary_hypertension_ L2 - http://erj.ersjournals.com/cgi/pmidlookup?view=long&pmid=17504794 DB - PRIME DP - Unbound Medicine ER -