Abstract | OBJECTIVE: DATA SOURCES: STUDY SELECTION AND DATA EXTRACTION: Due to the limited number of articles on sitaxsentan, all studies captured in the search results were evaluated. DATA SYNTHESIS: Four studies of sitaxsentan in humans with PAH have been published to date. An uncontrolled open-label study and a randomized placebo-controlled study (STRIDE-1; Sitaxsentan to Relieve Impaired Exercise-1) showed sitaxsentan to improve exercise tolerance in patients with PAH, as evidenced by significant increases in the distance walked in 6 minutes. Significant hepatotoxicity developed in patients receiving sitaxsentan 300 mg. The benefits of sitaxsentan with respect to exercise tolerance and hemodynamics were sustained in a one year extension of the placebo-controlled study. The results of a multicenter, randomized, placebo-controlled trial of 2 doses of sitaxsentan with an open-label bosentan arm (STRIDE-2) suggested that only the 100 mg dose provided superior benefit in exercise tolerance and improvement in functional class. Treatment-related adverse effects were similar for all groups. CONCLUSIONS:
Sitaxsentan appears to be superior to placebo in improving exercise tolerance in patients with PAH but may produce therapeutic outcomes similar to those of bosentan, a comparator agent. The optimal dose of sitaxsentan appears to be 100 mg once daily. Information about the use of sitaxsentan in a greater number of patients with PAH for longer periods is necessary to further define its place in the treatment of PAH.
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Authors | Eric T Wittbrodt, Amina Abubakar |
Journal | The Annals of pharmacotherapy
(Ann Pharmacother)
Vol. 41
Issue 1
Pg. 100-5
(Jan 2007)
ISSN: 1542-6270 [Electronic] United States |
PMID | 17164394
(Publication Type: Journal Article, Review)
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Chemical References |
- Endothelin Receptor Antagonists
- Isoxazoles
- Receptors, Endothelin
- Thiophenes
- sitaxsentan
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Topics |
- Animals
- Endothelin Receptor Antagonists
- Humans
- Hypertension, Pulmonary
(drug therapy, epidemiology, metabolism)
- Isoxazoles
(pharmacology, therapeutic use)
- Receptors, Endothelin
(metabolism)
- Thiophenes
(pharmacology, therapeutic use)
- Treatment Outcome
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