医学
不利影响
内科学
转甲状腺素
临床试验
上市后监督
作者
Peter M. Huber,Alison Flynn,Marla B. Sultan,Huihua Li,Denise Rill,Ben Ebede,Balarama Gundapaneni,Jeffrey H. Schwartz
出处
期刊:Amyloid
[Informa]
日期:2019-07-27
卷期号:26 (4): 203-209
被引量:13
标识
DOI:10.1080/13506129.2019.1643714
摘要
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. Trial registration: ClinicalTrials.gov identifier: NCT00409175.Trial registration: ClinicalTrials.gov identifier: NCT00791492.Trial registration: ClinicalTrials.gov identifier: NCT00630864.Trial registration: ClinicalTrials.gov identifier: NCT01435655.Trial registration: ClinicalTrials.gov identifier: NCT00925002.Trial registration: ClinicalTrials.gov identifier: NCT00628745.
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