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Hepatitis sitaxsentan

Liver Fulminant hepatic failure during treatment with sitaxsentan has been reported in a patient whose liver function tests had been normal less than a month before [86 ]. [Pg.329]

Observational studies STRIDE-2X is the 1-year open extension study of the 18 week STRIDE-2 (Sitaxsentan To Relieve ImpaireD Exercise) investigation that followed patients taking sitaxsentan or bosentan for pulmonary artery hypertension [87 ]. As well as efficacy measures, the researchers included time to withdrawal because of adverse events and time to rises in hepatic aminotransferases in the outcome measures. For the analysis population, the risk of raised aminotransferases to more than 3 times the upper limit of normal at 1 year was 6% with sitaxsentan 100 mg/day and 14% with bosentan. The cumulative risk of withdrawal at 1 year with raised aminotransferases was 3% with sitaxsentan 100 mg/day and 9% with bosentan. Other adverse events were peripheral edema, nasopharyngitis, dyspnea, and cough, consistent with previous trials in pulmonary artery hypertension. The overall withdrawal rates at 1 year were 15% with sitaxsentan 100 mg/ day and 30% with bosentan. Sitaxsentan therefore seems to have similar efficacy to bosentan and from this evidence may have the advantage of causing fewer hepatic adverse events in longer-term treatment (but see below). [Pg.423]

Liver In addition to the trial evidence, case studies of sitaxsentan and hepatic dysfunction have been reported. Liver damage associated with sitaxsentan progressed... [Pg.423]

Sitaxsentan was withdrawn from the worldwide market in December 2010 (SEDA-35) on accoxmt of hepatic damage that did not resolve on withdrawal of the drug but eventually proved fatal. A double-blind randomised controlled trial PO -] was conducted prior to the withdrawal to assess the efficacy and safety of lower dose range of sitaxsentan (50 or 100 mg) compared to placebo. Most adverse events documented by the authors including headaches, peripheral oedema, dizziness, nausea, extremity pain were said to be mild/moderate. Increased liver transaminases greater than three times of the upper limit was reported for one patient in each treatment arm, but reversed back to normal on discontinuation of the drug. [Pg.285]

Liver A case of a 61-year-old female who developed acute severe hepatitis following a 16-week therapy of sitaxsentan at 100 mg daily has been reported [31 ]. Despite withdrawal of therapy, her liver tests failed to improve after 6 weeks of follow-up. She however showed clinical and biochemical improvement when a high dose of corticosteroid was administered. The authors thus opined that an immxme-mediated mechanism as opposed to an inhibition of the bile salt transport is the pathway through which sitaxsentan causes hepatotoxicity. [Pg.285]

Chin M, Levy RD, Yoshida EM, Byrne MF. Sitaxsentan-induced acute severe hepatitis treated with glucocorticoid therapy. Can Respir J 2012 19 el-2. [Pg.288]


See other pages where Hepatitis sitaxsentan is mentioned: [Pg.215]    [Pg.835]   
See also in sourсe #XX -- [ Pg.423 ]




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