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Minerva Pneumologica 2010 June;49(2):83-91

Copyright © 2010 EDIZIONI MINERVA MEDICA

language: English

Tolerance and safety of Trypsone®: prospective follow-up in alpha-1 antitrypsin deficient subjects with pulmonary emphysema

Vidal R. 1, Barros-Tizón J. C. 2, Gáldiz J. B. 3, García-Talavera I. 4, Nuñez L. 5, Bustamante A. 6, Rodríguez J. L. 7, Casas F. 8, Blanco I. 9, Camprubí S. 5

1 Department of Pneumology, CIBERES, Vall d’Hebron Universitary Hospital, Barcelona, Spain 2 Department of Pneumology, Xeral Cies Universitary Hospital, Vigo, Spain 3 Department of Pneumology, Hospital de Cruces, Cruces/Barakaldo, Spain 4 Department of Pneumology, Nuestra Señora de Candelaria Universitary Hospital, Santa Cruz de Tenerife, Spain 5 Clinical Trials Department, Instituto Grifols, S.A., Barcelona, Spain 6 Department of Pneumology, Sierrallana Hospital, Torrelavega, Spain 7 Department of Pneumology, San Carlos Hospital Madrid, Spain 8 Department of Pneumology San Cecilio Universitary Hospital, Granada, Spain 9 Department of Pneumology Valle del Nalón Hospital, Langreo, Spain


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AIM: In the perspective of postmarketing surveillance of human alpha-1 antitrypsin (AAT) products for intravenous administration, clinical studies following long-term augmentation therapy in significant cohorts of AAT-deficient subjects are needed. The main objective of this study was to assess tolerance of Trypsone®, a lyophilized and sterile preparation of AAT highly purified from human plasma, as chronic replacement therapy in AAT-deficient subjects with associated pulmonary emphysema. Furthermore, the safety of the study drug was evaluated as a secondary objective.
METHODS: This was a multicenter, prospective, non-controlled, observational clinical study with 23 individuals. Tolerance to the drug exposure was assessed by monitoring vital signs and considering adverse events (AEs) which took place during the AAT infusions. For safety evaluation, all AEs occurring to any participating subject were considered; from the first study drug exposure to the end of the prospective period of observation, regardless whether the event occurred during the infusions.
RESULTS: No clinically significant changes of vital signs were reported as AEs during the administration of the study drug. Only one, among 555 infusions, had an AE possibly related to the study drug. This AE consisted in a vasovagal reaction with arterial hypotension and dizziness which was classified as non-serious, of moderate intensity and expected. Regarding other AEs not occurring during the infusions, a total of 5 serious AEs were reported in 4 subjects but none of them were related to the study drug.
CONCLUSION: Trypsone® represents a viable and safe treatment option for augmentation therapy with in AAT deficient individuals.

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