Table 3.
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.