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Table 5 Pharmacodynamic measures - Regimen B: 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 8 (F)

Day 18 (F+R)

Day 8-Day 1

Day 18-Day 8

Day 18-Day 1

HR (bpm)

58

66

62

5 (2 to 9)

-1 (-4 to 3)

4 (2 to 7)

PEP (ms)

105

97

98

-7 (-22 to 7)

3 (-9 to 17)

-5 (-19 to 20)

QS2 (ms)

434

431

445

-4 (-18 to 9)

4 (-7 to 13)

2 (-13 to 16)

dZ/dt (Ω/s)

1.81

1.94

1.82

0.06 (-0.07 to 0.19)

-0.08 (-0.37 to 0.07)

-0.03 (-0.30 to 0.16)

CO (L/min)

9.7

9.7

10.3

0.7 (-0.9 to 2.0)

-0.5 (-1.7 to 0.6)

0.3 (-1.7 to 2.1)

TPR (dyn.s.cm-5)

657

668

709

-18 (-198 to 70)

28 (-80 to 100)

-36 (-186 to 105)

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 8 (F)

Day 18 (F+R)

Day 8-Day 1

Day 1

Day 8 (F)

Day 18 (F+R)

Day 8-Day 1

HR (bpm)

62

72

72

9 (5 to 11)

51

62

60

7 (3 to 10)

PEP (ms)

122

117

116

-4 (-14 to 2)

87

84

85

0 (-7 to 6)

QS2 (ms)

459

440

445

-14 (-27 to 4)

424

408

410

-13 (-22 to -3)

dZ/dt (Ω/s)

2.05

2.10

2.20

0.01 (-0.15 to 0.21)

1.53

1.64

1.60

0.03 (-0.13 to 0.17)

CO (L/min)

9.8

11.8

11.8

1.7 (0.6 to 2.6)

8.4

8.2

8.0

0.5 (-0.5 to 1.4)

TPR (dyn.s.cm-5)

870

882

865

-49 (-160 to 80)

655

561

556

-96 (-188 to -24)

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 8 (F)

Day 18 (F+R)

Day 18-Day 8

 

Day 8 (F)

Day 18 (F+R)

Day 18-Day 8

HR (bpm)

 

16

14

-2 (-6 to 2)

 

-2

-3

-1 (-2 to 1)

PEP (ms)

 

25

21

3 (-19 to 4)

 

-26

-25

0 (-4 to 4)

QS2 (ms)

 

13

15

4 (-7 to 13)

 

-47

-37

8 (-1 to 15)

dZ/dt (Ω/s)

 

0.32

0.28

0.05 (-0.16 to 0.17)

 

-0.29

-0.37

-0.05 (-0.27 to 0.15)

CO (L/min)

 

2.9

3.3

0.0 (-1.0 to 1.5)

 

-0.6

-0.6

-0.4 (-1.3 to 0.6)

TPR (dyn.s.cm-5)

 

61

66

-18 (-95 to 73)

 

-221

-224

-42 (-107 to 35)

  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), formoterol alone (F; Day 8) and formoterol plus roflumilast (F+R; 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