Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)

NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)

The objectives of this study are to develop research methods and corresponding materials for a study of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings; to pilot test these methods at three study centers in Europe; and to refine and finalize research methods and corresponding materials for possible use in a follow-on, full-scale examination of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings.

At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.

Inclusion Criteria:

• Idiopathic PAH, or PAH secondary to connective tissue disease
• Receipt of Thelin for treatment of PAH
• 6 months of follow-up (except in the event of death) subsequent to initial receipt of Thelin
• Minimum of one clinic visit documented in the medical record during the 6-month period subsequent to initial receipt of Thelin

Exclusion Criteria:

• Participation in any investigational study of Thelin or any other medication for the treatment of PAH during the period beginning 6 months prior to initial receipt of Thelin and ending 6 months subsequent to such receipt
• Receipt of Thelin prior to January 11, 2005 (i.e., the date following the last day on which patients could be enrolled in double-blind treatment in STRIDE-1, STRIDE-2, and/or STRIDE-6); or
• Known contraindications to Thelin therapy (i.e., known hypersensitivity to sitaxsentan or any of its excipients; mild-to-severe hepatic impairment [Child-Pugh Class A-C]; elevated aminotransferases prior to initiation of treatment, defined as aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >3 times upper limit of normal [ULN]; concomitant use of cyclosporin A; lactation)