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Table 23Study characteristics table for KQ 3 (RCTs)

Study
Population (N)
Quality
Study Arms (N)Trial Duration (Weeks)Followup Assessments (Weeks)Outcome Measures
AMBRISENTAN
Individual Drug Studies
Galie, 2008106
ARIES-1 (US, Mexico, South America, Australia, and Europe)

PAH (N=201)

Good
124, 8, 12, 48
  • Mortality
  • 6MWD
  • Dyspnea
  • Functional class
  • Quality of life
  • Hospitalization
  • BNP
  • Adverse events
Galie, 2008106
ARIES-2 (Europe, Israel, and South America)

PAH (N=192)

Good
124, 8, 12, 48
  • Mortality
  • 6MWD
  • Dyspnea
  • Functional class
  • Quality of life
  • Hospitalization
  • BNP
  • Adverse events
BOSENTAN
Individual Drug Studies
Barst, 2010185
ASSET-1

SCD with PAH (N=14)

Fair
  • Bosentan 62.5 mg 2 times daily, then 125 mg 2 times daily (N=6)
  • Placebo (N=8)
1616
  • Mortality
  • 6MWD
  • RHC
Barst, 2010185
ASSET-2

PH (N=12)

Fair
  • Bosentan 62.5 mg 2 times daily, then 125 mg 2 times daily (N=5)
  • Placebo (N=7)
1616
  • Mortality
  • 6MWD
  • RHC
Channick, 200194

PPH or PH due to SCD (N=32)

Good
  • Bosentan 62.5 mg 2 times daily, then 125 mg 2 times daily (N=21)
  • Placebo (N=11)
124, 8, 12, 20, 28
  • 6MWD
  • Dyspnea
  • Functional class
  • Transplantation
  • RHC
  • Adverse events
Galie, 2006183
BREATHE-5
Eisenmenger syndrome (N=54)
Good
  • Bosentan 62.5 mg 2 times daily, then 125 mg 2 times daily (N=37)
  • Placebo (N=17)
44
  • 6MWD
  • Functional class
  • RHC
  • Adverse events
Galie, 2008184
EARLY
PAH (N=185)
Good
  • Bosentan 62.5 mg 2 times daily, then 125 mg 2 times daily (N=93)
  • Placebo (N=92)
2424
  • Mortalitya
  • 6MWDa
  • Dyspneaa
  • Functional classa
  • Quality of lifea
  • Hospitalizationa
  • RHCa
  • Adverse eventsa
Rubin, 2002182
BREATHE
PAH (N=213)
Good
  • Bosentan 62.5 mg 2 times daily, then 125 mg 2 times daily (N=74)
  • Bosentan 62.5 mg 2 times daily, then 250 mg 2 times daily (N=70)
  • Placebo (N=69)
124, 8, 16
  • Mortality
  • 6MWD
  • Dyspnea
  • Functional class
  • Hospitalization
  • Echocardiography
  • Adverse events
Direct Drug Comparison Studies
Wilkins, 2005156
SERAPH
PAH (N=26)
Good
  • Bosentan 62.5 mg 2 times daily, then 125 mg 2 times daily (N=12)
  • Sildenafil 50 mg 2 times daily, then 50 mg 3 times daily (N=14)
1616
  • Mortality
  • 6MWD
  • Quality of life
  • Right ventricular dysfunction
  • Echocardiography
  • BNP
Combination Drug Studies
Humbert, 2004186
BREATHE-2
PAH (N=33)
Good
1616
  • 6MWD
  • Dyspnea
  • Functional class
  • Hospitalization
  • RHC
  • Adverse events
EPOPROSTENOL
Individual Drug Studies
Badesch, 2000194
PH associated with SCD spectrum of disease (N=111)
Fair
  • Epoprostenol ≤2 ng/kg, then adjusted (N=56)
  • Conventional therapy only (N=55)
121, 6, 12
  • Mortality
  • 6MWD
  • Dyspnea
  • RHC
  • Adverse events
Barst, 199685
PPH (N=81)
Good
  • Epoprostenol 4 ng/kg, then adjusted (N=41)
  • Conventional therapy only (N=40)
121, 6, 12
  • Mortality
  • 6MWD
  • Quality of life
  • Transplantation
  • RHC
  • Adverse events
Rubin, 1990181
PPH (N=23)
Good
  • Intravenous epoprostenol 1–2 ng/kg per minute initially, then increased as tolerated (N=11)
  • Conventional therapy (N=12)
88
  • Mortality
  • 6MWD
  • RHC
  • Adverse events
ILOPROST
Individual Drug Studies
Olschewski, 2002190
Severe PAH or chronic thromboembolic PH (N=203)
Good
  • Aerosolized iloprost (N=101)
  • Placebo (N=102)
124, 8, 12
  • Mortality
  • 6MWD
  • Dyspnea
  • Functional class
  • Quality of life
  • Transplantation
  • Right ventricular dysfunction
  • RHC
  • Adverse events
Olschewski, 2010191
AIR
IPAH or other PH (N=63)
Fair
  • Aerosolized iloprost (N=30)
  • Conventional therapy only (N=33)
1212, 104
  • Mortality
  • 6MWD
  • Dyspnea
  • Functional class
  • Quality of life
  • RHC
  • Adverse events
Combination Drug Studies
Hoeper, 2006192
COMBI
IPAH (N=40)
Fair
126, 12
  • 6MWD
  • Adverse events
McLaughlin, 2006193
PAH (N=67)
Good
124, 8, 12
  • 6MWD
  • Dyspnea
  • Functional class
  • Hospitalization
  • RHC
  • Adverse events
SILDENAFIL
Individual Drug Studies
Barst, 2011188
STARTS-1
PAH (N=234)
Fair
1616, >156
  • Mortality
  • Functional class
  • Quality of life
  • RHC
  • Adverse events
Galie, 2005187
SUPER
PAH (N=277)
Good
124, 8, 12, 52, 156
  • Mortality
  • 6MWD
  • Dyspnea
  • Hospitalization
  • Adverse events
  • RHC
Combination Drug Studies
Simonneau, 2008189
PACES
PAH (N=267)
Good
164, 8, 12, 16
  • Mortality
  • Dyspnea
  • Quality of life
  • Hospitalization
  • Transplantation
  • Adverse events
TADALAFIL
Individual Drug Studies
Bharani, 200788
PAH (N=11)
Fair
  • Tadalafil 20 mg daily (N=11)
  • Placebo 20 mg daily (N=11)
44
  • 6MWDa
  • Dyspneaa
  • Functional classa
  • Echocardiographya
Galie, 2009196
PHIRST
PAH (N=405)
Good
164, 8, 12, 16
  • Mortality
  • 6MWD
  • Functional class
  • Hospitalization
  • RHC
  • Adverse events
Mukhopadhyay, 2011195
Eisenmenger syndrome (N=28)
Fair
66
TREPROSTINIL
Individual Drug Studies
Hiremath, 2010199
TRUST
PAH (N=44)
Fair
1212
  • Mortality
  • 6MWD
  • Dyspnea
  • Functional class
  • Adverse events
McLaughlin, 2003198
PPH (N=26)
Poor
88
  • 6MWDa
  • Dyspneaa
  • Adverse eventsa
Simonneau, 2002197
PAH (N=470)
Good
1212
  • Mortality
  • 6MWD
  • Dyspnea
  • Quality of life
  • Transplantation
  • Adverse events
Combination Drug Studies
McLaughlin, 2010131
TRIUMPH 1
Severe PAH (N=235)
Good
126, 12
  • Mortality
  • 6MWD
  • Dyspnea
  • Functional class
  • Quality of life
  • Hospitalization
  • Transplantation
  • BNP
  • Adverse events
VARDENAFIL
Individual Drug Studies
Jing, 2011200
EVALUATION
PAH (N=66)
Good
  • Vardenafil 5 mg daily, then 5 mg 2 times daily (N=44)
  • Placebo (N=22)
1212, 24
  • Mortality
  • 6MWD
  • Dyspnea
  • Functional class
  • Hospitalization
  • RHC
  • Adverse events

6MWD = 6 minute walk distance; IPAH = idiopathic PAH; mg = milligram; PAH = pulmonary arterial hypertension; PH = pulmonary hypertension; PPH = Primary pulmonary hypertension; RHC = right heart catheterization; SCD = scleroderma

a

Outcome not assessed at 12 or 16 weeks.

b

53 percent of patients received bosentan as background therapy.

Outcome not assessed at 12 or 16 weeks.

53 percent of patients received bosentan as background therapy.

From: Results

Cover of Pulmonary Arterial Hypertension: Screening, Management, and Treatment
Pulmonary Arterial Hypertension: Screening, Management, and Treatment [Internet].
Comparative Effectiveness Reviews, No. 117.
McCrory DC, Coeytaux RR, Schmit KM, et al.

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