Table 2

Adjusted mean differences from PBO (95% CI), safety analysis (intent-to-treat population)

Change from baseline maximum heart rate (bpm) (0–4 h)
 Day 1 (PBO, n=20; FF/VI 400/25 μg, n=40)1.4 (–3.1 to 5.9)
 Day 14 (PBO, n=16; FF/VI 400/25 μg, n=39)1.9 (–3.4 to 7.3)
 Day 28 (PBO, n=16; FF/VI 400/25 μg, n=39)3.2 (–2.5 to 8.8)
Change from baseline in weighted mean systolic blood pressure (mm Hg) (0–4 h)
 Day 1 (PBO, n=20; FF/VI 400/25 μg, n=40)–0.1 (–5.4 to 5.3)
 Day 14 (PBO, n=16; FF/VI 400/25 μg, n=39)–2.2 (–7.9 to 3.4)
 Day 28 (PBO, n=16; FF/VI 400/25 μg, n=39)0.3 (–6.2 to 6.8)
Change from baseline in maximum systolic blood pressure (mm Hg) (0–4 h)
 Day 1 (PBO, n=20; FF/VI 400/25 μg, n=40)–1.0 (–7.4 to 5.5)
 Day 14 (PBO, n=16; FF/VI 400/25 μg, n=39)–2.9 (–9.0 to 3.3)
 Day 28 (PBO, n=16; FF/VI 400/25 μg, n=39)0.9 (–5.9 to 7.8)
Change from baseline in weighted mean diastolic blood pressure (mm Hg) (0–4 h)
 Day 1 (PBO, n=20; FF/VI 400/25 μg, n=40)–2.1 (–4.6 to 0.4)
 Day 14 (PBO, n=16; FF/VI 400/25 μg, n=39)–3.6 (−6.7 to −0.5)
 Day 28 (PBO, n=16; FF/VI 400/25 μg, n=39)–1.4 (–5.1 to 2.4)
Change from baseline in minimum diastolic blood pressure (mm Hg) (0–4 h)
 Day 1 (PBO, n=20; FF/VI 400/25 μg, n=40)–2.3 (−5.2 to 0.6)
 Day 14 (PBO, n=16; FF/VI 400/25 μg, n=39)–5.2 (−8.8 to −1.6)
 Day 28 (PBO, n=16; FF/VI 400/25 μg, n=39)–2.7 (–7.4 to 1.9)
  • Population sizes for each day and each time point relate to the number of patients with analysable data at the given time point.

  • bpm, beats per minute; FF, fluticasone furoate; PBO, placebo; VI, vilanterol.