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A comprehensive safety profile of tafamidis in patients with transthyretin amyloid polyneuropathy.
Huber, Peter; Flynn, Alison; Sultan, Marla B; Li, Huihua; Rill, Denise; Ebede, Ben; Gundapaneni, Balarama; Schwartz, Jeffrey H.
Afiliação
  • Huber P; Pfizer Inc. , Collegeville , PA , USA.
  • Flynn A; Pfizer Inc. , Collegeville , PA , USA.
  • Sultan MB; Pfizer Inc. , New York , NY , USA.
  • Li H; Pfizer Inc. , Collegeville , PA , USA.
  • Rill D; Pfizer Inc. , Collegeville , PA , USA.
  • Ebede B; Pfizer Inc. , Collegeville , PA , USA.
  • Gundapaneni B; Pfizer Inc. , Groton , CT , USA.
  • Schwartz JH; Pfizer Inc. , New York , NY , USA.
Amyloid ; 26(4): 203-209, 2019 Dec.
Article em En | MEDLINE | ID: mdl-31353964
Background: Tafamidis is approved in over 40 countries to delay neurologic progression in patients with transthyretin amyloid polyneuropathy (ATTR-PN). A comprehensive, integrated analysis of safety data from interventional, observational and surveillance studies of tafamidis in ATTR-PN patients was conducted. Methods: Safety data from all sponsored, completed, or ongoing, Phase 2/3 studies of tafamidis in ATTR-PN patients as of 3 January 2017 were pooled. Also assessed were safety data from the ongoing Transthyretin Amyloidosis Outcomes Survey (THAOS) as of 3 January 2017 and post-marketing surveillance reports as of 31 March 2017. Results: There were 137 patients in Phase 2/3 studies (mean duration of tafamidis exposure, 44.2 months), with 134 (97.8%) experiencing ≥1 treatment-emergent adverse event (TEAE) and 46 (33.6%) ≥1 treatment-emergent serious adverse event (TESAE). The most common TEAEs were diarrhoea (26.3%), urinary tract infection (UTI; 25.5%) and influenza (21.2%). In THAOS, 661 subjects had tafamidis exposure (mean duration, 27.6 months), with 250 (37.8%) experiencing ≥1 TEAE and 96 (14.5%) ≥1 TESAE. The most common TEAE was UTI (6.1%). Post-marketing surveillance reports generally reflected the known safety profile of tafamidis. Conclusions: This analysis did not reveal any significant new safety findings; tafamidis was generally safe and well tolerated in ATTR-PN patients. ClinicalTrials.gov: NCT00409175, NCT00791492, NCT00630864, NCT01435655, NCT00925002, and NCT00628745.
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Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Polineuropatias / Benzoxazóis / Neuropatias Amiloides Familiares / Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Tipo de estudo: Observational_studies Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Amyloid Assunto da revista: BIOQUIMICA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Polineuropatias / Benzoxazóis / Neuropatias Amiloides Familiares / Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Tipo de estudo: Observational_studies Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Amyloid Assunto da revista: BIOQUIMICA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos