Table 1 Summarized Characteristics of Included Randomized Controlled Trials.

From: Incidence and risk of respiratory tract infection associated with specific drug therapy in pulmonary arterial hypertension: a systematic review

Source

Groups

Baseline therapy

N

Mean Age (y)

Female (%)

WHO FC (%)

Duration (weeks)

Etiology (%)

Outcome Measures

PCA vs. Placebo

McLaughlin et al., 2006 (STEP)14

INH Iloprost

ERA

35

51.0

79.4

II (2)

12

IPAH (55),

RTI

III (94)

APAH (45)

Placebo

32

49.0

78.8

IV (4)

 

Hoeper et al., 2006 (COMBI)15

INH Iloprost

ERA

19

48.0

21.1

III (100)

12

IPAH (100)

RTI

Placebo

21

56.0

23.8

McLaughlin et al., 2010 (TRIUMPH)16

INH Treprostinil

ERA, or PDE5

115

55.0

80.9

III (98)

12

IPAH (56),

RTI, SRTI

IV (2)

APAH (33)

Placebo

120

52.0

81.7

 

Others (11)

Tapson et al., 2012 (FREEDOM-C)17

Oral Treprostinil

ERA, PDE5, or both

174

51.0

85.1

II (21)

16

IPAH (66),

RTI, SRTI

III (76)

APAH (34)

Placebo

176

50.0

79.5

IV (3)

 

Tapson et al., 2013 (FREEDOM-C2)18

Oral Treprostinil

ERA, PDE5i, or both

157

51.5

75.8

II (26)

16

IPAH (66),

RTI, SRTI

Placebo

153

50.4

79.7

III (73)

APAH (34)

Jing et al., 2013 (FREEDOM-M)19

Oral Treprostinil

Conventional therapy

151

37.8

72.0

II (33)

12

IPAH (75),

RTI, SRTI

Placebo

77

42.5

75.0

III (66)

APAH (25)

Hiremath et al., 2010 (TRUST)4

IV Treprostinil

Conventional therapy

30

30.0

63.3

III (100)

12

IPAH

SRTI

Placebo

14

36.0

57.1

ERA vs. Placebo

Rubin et al., 2002 (BREATHE-1)11

Bosentan

Conventional therapy

144

48.7

79.2

III (92)

16

IPAH (70),

SRTI

Placebo

69

47.2

78.3

IV (8)

APAH (30)

Humbert et al., 2004 (BREATHE-2)20

Bosentan

PCA

22

45.0

77.3

III (76)

16

IPAH (82),

RTI, SRTI

Placebo

11

47.0

54.5

IV (24)

APAH (18)

Corte et al., 2014 (BPHIT)21

Bosentan

Conventional therapy

40

66.4

32.5

II (7)

16

FIIP-PH

SRTI

III (43)

−100

Placebo

20

66.9

25

IV (50)

 

McLaughlin et al., 2015 (COMPASS-2)22

Bosentan

PDE5

159

52.9

78.6

I (42)

16

IPAH (68), APAH (32)

RTI, SRTI

II (58)

Placebo

174

54.7

73.1

IV (<1)

ARTEMIS-PH23

Ambrisentan

Conventional therapy

25

68.0

20

NA

56

IPF-PH

RTI, SRTI

Placebo

15

68.0

33.3

−100

AMBER I24

Ambrisentan

Conventional therapy

17

63.0

47.1

NA

16

CTEPH

RTI, SRTI

Placebo

16

59.0

62.5

−100

Pulido et al., 2013 (SERAPHIN)5

Macitentan

PCA, PDE5, or no

492

45.1

77.4

II (52)

24

IPAH (56)

RTI, SRTI

III (46)

APAH (44)

Placebo

249

46.7

73.9

IV (2)

 

PDE5 vs. Placebo

Galiè et al., 2005 (SUPER-1)12

Sildenafil

Conventional therapy

207

48.7

73.4

II (39)

12

IPAH (63)

SRTI

Placebo

70

49.0

81

III (58)

APAH (27)

Simonneau et al., 2008 (PACES)25

Sildenafil

PCA

134

47.8

82.1

II (25)

16

IPAH (79)

RTI, SRTI

III (66)

APAH (21)

Placebo

131

47.5

77.4

IV (6)

 

Galiè et al., 2009 (PHIRST)6

Tadalafil

ERA, or no

323

53.5

78

II (35)

16

IPAH (63)

RTI

Placebo

82

55.0

79.3

III (63)

APAH (37)

Barst et al., 2011 (PHIRST-1b)13

Tadalafil

ERA

74

50.0

80

II (31)

16

IPAH (65)

RTI

Placebo

37

51.7

78

III (67)

APAH (35)

sGC vs. Placebo

Ghofrani et al., 2013 (CHEST-1)26

Riociguat

Conventional therapy

173

59.0

68

II (31)

16

NA

RTI, SRTI

III (64)

Placebo

88

59.0

61

IV (4)

Ghofrani et al., 2013 (PATENT-1)7

Riociguat

PCA, ERA, or no

317

50.0

79.5

II (45)

12

IPAH (60)

RTI, SRTI

III (52)

APAH (40)

Placebo

126

50.7

77.8

IV (1)

 

Galiè et al., 2015 (PATENT PLUS)27

Riociguat

PDE5

12

58.0

50

II (56)

12

IPAH (50)

RTI, SRTI

Placebo

6

61.0

50

III (33)

APAH (50)

Selective prostacyclin receptor agonist vs. Placebo

Simonneau et al., 201228

Selexipag

ERA, or PDE5

33

54.8

81.8

II (40)

17

IPAH (81)

SRTI

Placebo

10

53.8

80

III (60)

APAH (19)

Sitbon et al., 2015 (GRIPHON)8

Selexipag

ERA, PDE5, both, or no

575

48.2

79.6

II (46)

71

IPAH (61)

RTI, SRTI

III (53)

APAH (39)

Placebo

577

47.9

80.1

IV (1)

 

ERA vs. PDE5 vs. ERA+PDE5

Galiè et al., 2015 (AMBITION)29

Ambrisentan

Conventional therapy

152

53.9

79

II (31)

24

IPAH (59), APAH (41)

RTI, SRTI

Tadalafil

151

54.5

83

III (69)

Ambrisentan + Tadalafil

302

54.5

74

 
  1. PCAs: prostanoids; ERAs: Endothelin receptor antagonists; PDE5s: Phosphodiesterase-5 inhibitors; sGCs: soluble guanylate cyclase simulators; PAH: pulmonary arterial hypertension; IPAH: idiopathic pulmonary arterial hypertension (includes familial or hereditary hypertension, or PAH due to drug or toxins and anorexigens); APAH: associated pulmonary arterial hypertension(includes PAH due to connective tissue disease, congenital heart disease, human immunodeficiency virus infection, and portal hypertension); CTEPH: chronic thromboembolic pulmonary hypertension; FIIP-PH: pulmonary hypertension associated with fibrotic idiopathic interstitial pneumonia; IPF-PH: pulmonary hypertension associated with idiopathic pulmonary fibrosis; WHO FC: World Health Organization functional class; NA: not available; N: number of patients; RTI: respiratory tract infection; SRTI: serious respiratory tract infection.
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