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

Pfizer36 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

Sitaxentan sodiumDRUG

Sitaxentan sodium 100 mg / day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation

Participants still receiving Thelin with evidence of receipt of another PAH-related therapy (eg. bosentan, sildenafil) not previously received during the study period. Mean time in months to therapy augmentation.

Time frame: Day 1 to Month 6

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching

Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period.

Time frame: Day 1 to Month 6

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation

Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated.

Time frame: Day 1 to Month 6

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration

Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy.

Time frame: Day 1 to Month 6

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed

Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first.

Time frame: Day 1 to Month 6

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage

Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits.

Time frame: Day 1 to Month 6

Data from ClinicalTrials.gov

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Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications

Use of PAH-related medications other than Thelin described by class of agent received.

Time frame: Day 1 to Month 6

Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension

Class I: no limitation of usual (usl) physical activity (PA); PA does not increase(d) (incr) dyspnea (dys), fatigue (ftg), chest pain (CP), or syncope (syn); Class II: mild limitation of usl PA; no discomfort at rest, but normal PA causes incr dys, ftg, CP, or presyncope (presyn); Class III: marked limitation of PA; no discomfort at rest but \< ordinary activity causes incr dys, ftg, CP, or presyn; Class IV: unable to perform any PA at rest; may have signs of right ventricular failure; sys and/or ftg at rest and symptoms are incr by almost any PA.