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Table 4 Pharmacodynamic measures - Regimen A: treatment medians and treatment contrasts

From: No relevant cardiac, pharmacokinetic or safety interactions between roflumilast and inhaled formoterol in healthy subjects: an open-label, randomised, actively controlled study

Untransformed pre-dose morning values

 

Median

Point estimate (95% CI)

Variable

Day 1

Day 11 (R)

Day 18 (R+F)

Day 11-Day 1

Day 18-Day 11

Day 18-Day 1

HR (bpm)

59

63

61

3 (-5 to 8)

1 (-1 to 6)

5 (-2 to 10)

PEP (ms)

106

94

95

-3 (-17 to 10)

-4 (-13 to 6)

-8 (-19 to 6)

QS2 (ms)

435

423

430

-10 (-21 to 2)

-1 (-14 to 12)

-12 (-23 to 4)

dZ/dt (Ω/s)

1.82

1.67

1.77

-0.06 (-0.29 to 0.16)

0.03 (-0.08 to 0.12)

-0.05 (-0.26 to 0.15)

CO (L/min)

10.4

9.1

10.4

-0.6 (-1.7 to 0.5)

0.1 (-1.0 to 1.7)

-0.3 (-1.0 to 0.6)

TPR (dyn.s.cm-5)

755

838

706

14 (-98 to 121)

-12 (-121 to 85)

-4 (-93 to 84)

Untransformed post-dose maximum and minimum values

 

d max (U)

d min (U)

 

Median

Point estimate (95% CI)

Median

Point estimate (95% CI)

Variable

Day 1

Day 11 (R)

Day 18 (R+F)

Day 11-Day 1

Day 1

Day 11 (R)

Day 18 (R+F)

Day 11-Day 1

HR (bpm)

62

64

70

3 (-4 to 6)

52

54

61

4 (1 to 7)

PEP (ms)

119

121

114

3 (-7 to 11)

86

86

81

0 (-9 to 13)

QS2 (ms)

457

454

432

-1 (-11 to 11)

416

410

399

-9 (-21 to 8)

dZ/dt (Ω/s)

2.09

1.93

2.06

-0.05 (-0.25 to 0.15)

1.59

1.56

1.62

0.03 (-0.18 to 0.20)

CO (L/min)

10.3

10.6

11.7

0.2 (-1.1 to 1.4)

7.6

8.3

8.8

-0.4 (-1.2 to 0.4)

TPR (dyn.s.cm-5)

1013

934

877

47 (-124 to 178)

762

733

603

-18 (-96 to 43)

Day 1-matched post-dose maximum and minimum values

 

d max (δ)

d min (δ)

 

Median

Point estimate (95% CI)

Median

Point estimate (95% CI)

Variable

 

Day 11 (R)

Day 18 (R+F)

Day 18-Day 11

 

Day 11 (R)

Day 18 (R+F)

Day 18-Day 11

HR (bpm)

 

9

14

5 (-1 to 11)

 

-4

0

5 (1 to 9)

PEP (ms)

 

25

19

-8 (-19 to 4)

 

-27

-30

-2 (-11 to 10)

QS2 (ms)

 

19

4

-15 (-31 to -8)

 

-34

-47

-14 (-29 to 1)

dZ/dt (Ω/s)

 

0.28

0.32

0.08 (-0.07 to 0.22)

 

-0.10

-0.26

0.05 (-0.12 to 0.21)

CO (L/min)

 

1.6

2.6

0.8 (-0.7 to 2.3)

 

-1.7

-1.2

0.3 (-0.6 to 1.8)

TPR (dyn.s.cm-5)

 

126

108

-42 (-179 to 77)

 

-128

-168

-42 (-131 to 43)

  1. CO, cardiac output; dmax, post-dose maximum values; dmin, post-dose minimum values; dZ/dt, rate of change of the transthoracic impedance; HR, heart rate; PEP, pre-ejection period; QS2, total electromechanic systole; TPR, total peripheral resistance.
  2. Medians for baseline (Day 1), roflumilast alone (R; Day 11) and roflumilast plus formoterol (R+F; Day 18) with the corresponding point and 95% confidence interval (CI) estimates for untransformed (U) morning pre-dose values, untransformed post-dose maximum and minimum values (dmax and dmin), and Day 1-matched (δ) post-dose maximum and minimum values.
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BMC Clinical Pharmacology

ISSN: 1472-6904