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Sitaxsentan Improves 6MW in Patients with Pulmonary Arterial Hypertension (PAH) Related to Connective-Tissue Diseases (CTD) FREE TO VIEW

Vallerie V. McLaughlin, MD*; Nicholas Hill, MD; Victor Tapson, MD; Adaani Frost, MD; David Langleben, MD; Ron Oudiz, MD; Shelley Shapiro, MD; Ivan Robbins, MD; Robyn J. Barst, MD
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University of Michigan Hospital, Ann Arbor, MI


Chest. 2004;126(4_MeetingAbstracts):759S. doi:10.1378/chest.126.4_MeetingAbstracts.759S-a
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PURPOSE:  PAH related to CTD is progressive and difficult to manage. The multicenter, randomized, placebo (PBO) controlled bosentan BREATHE-1 PAH trial reported a trend towards a 6MW treatment effect in the CTD subgroup (47 of the 213 patients in BREATHE-1 had PAH related to CTD). However, this was due to deterioration in the PBO group rather than an improvement in the bosentan treatment group. Sitaxsentan (SITAX) is a selective (6500:1) once daily oral endothelin A receptor antagonist in clinical development for the treatment of PAH.

METHODS:  The Sitaxsentan to Relieve Impaired Exercise trial (STRIDE-1) was a multicenter, randomized, double-blind, placebo-controlled, 12 week trial evaluating SITAX 100mg, 300 mg, and PBO in 178 patients with PAH. A post hoc analysis was performed to evaluate the effect of SITAX in the intent-to-treat CTD subgroup (42 of the 178 patients had PAH related to CTD). Due to similar treatment effects in total ITT population, the SITAX 100mg and 300mg groups were pooled.

RESULTS:  All CTD patients were NYHA class II or III at baseline (BL). BL 6MW distance was 356 meters. 6MW treatment effect was 58m (p= 0.0274), due to both an increase in 6MW in the SITAX group from BL (+20m; p=0.0327) and a decrease in 6MW in the PBO group from BL (-38m). 8/33 (24%) SITAX patients improved by one NYHA functional class on SITAX compared with 1/9 (11%) PBO patients. SITAX was well tolerated. No patients experienced LFT abnormalities and no patients discontinued due to adverse events.

CONCLUSION:  SITAX improves 6MW and NYHA functional class in PAH related to CTD.

CLINICAL IMPLICATIONS:  SITAX improves 6MW and NYHA functional class in PAH related to CTD.

DISCLOSURE:  V.V. McLaughlin, Encysive

Tuesday, October 26, 2004

12:30 PM- 2:00 PM




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