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. 2009 Aug 6;5:607–619. doi: 10.2147/vhrm.s4713

Table 3.

PAH studies reporting effect of bosentan

First author Name Year N= Groups Comparator Design Effect vs comparator P-value
Channick28 Study 351 2001 32 IPAH; SSc Placebo DB R 6MWD +76 m p < 0.05
Rubin29 BREATHE-1 2002 213 IPAH; CTD Placebo DB R 6MWD +35 m (250 mg) p < 0.01
Barst13 BREATHE-3 2003 19 Baseline OL mPAP −8 mmHg
PVR –300 dynes/s/cm5
Humbert30 BREATHE-2 2004 33 IPAH; CTD Placebo R PVR −188 dynes/s/cm5 ns
Sitbon12 BREATHE-4 2004 16 HIV Baseline OL 6MWD +91 m p < 0.001
Wilkins31 SERAPH 2005 26 IPAH; CTD Sildenafil R 6MWD −16 m ns
Barst32 STRIDE-2 2006 185 IPAH; CTD; CHD Sitaxentan OL R 6MWD +1.5 m ns
Galiè14 BREATHE-5 2006 54 CHD Placebo DB R PVRI −472 dynes/s/cm5 p < 0.05
6MWD +53 m p < 0.01
Mathai33 2006 25 IPAH; SSc Baseline OL 6MWD +52 m ns
Denton34 TRUST 2007 53 CTD Baseline OL 12 patients improved FC
Akagi35 2008 8 IPAH Baseline OL mPAP −13 mmHg p < 0.05
Galiè36 EARLY 2008 185 IPAH; CHD; CTD; HIV Placebo DB R 6MWD +19 m ns
PVR −197 dynes/s/cm5 p < 0.0001
Jaïs15 BENEFIT 2008 99 CTEPH Placebo DB R PVR −193 dynes/s/cm5 p < 0.0001
6MWD +2 m ns

Abbreviations: IPAH, idiopathic pulmonary artery hypertension; SSc, scleroderma-associated pulmonary arterial hypertension; CTD, connective tissue disease associatedi pulmonary artery hypertension; HIV, human immunodeficiency virus associated pulmonary artery hypertension; CHD, congenital heart disease associated pulmonary artery hypertension; CTEPH, chronic thromboembolic pulmonary hypertension; DB, double blinded; R, randomized; OL, open label, 6MWD, six-minute walk distance; mPAP, mean pulmonary artery pressure; PVR, pulmonary vascular resistance; FC, functional class.