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Table 3 Effects of Lu AG09222 following VIP infusiona

From: The effect of Lu AG09222 on PACAP38- and VIP-induced vasodilation, heart rate increase, and headache in healthy subjects: an interventional, randomized, double-blind, parallel-group, placebo-controlled study

 

Placebo + saline + saline

n = 5

Placebo + PACAP38 + VIP

n = 10

Lu AG09222 + PACAP38 + VIP

n = 10

Superficial temporal artery diameter

 AUCSTA-VIP, mm × min, mean (SD)

4.06 (5.47)

22.7 (11.4)

16.5 (12.4)

  LS mean difference (SE) [95% CI]

 

18.1 (6.10) [4.68, 31.5]

‒6.49 (6.82) [‒20.9, 7.97]

  P-value

 

0.0128b

0.3555c

 CFISTA-60 min-VIP, mm, mean (SD)

0.047 (0.050)

0.188 (0.110)

0.144 (0.122)

  LS mean difference (SE) [95% CI]

  

‒0.045 (0.068) [‒0.188, 0.099]

  P-value

  

0.5173c

 maxSTA-VIP, mm, mean (SD)

0.071 (0.051)

0.405 (0.107)

0.274 (0.208)

  LS mean difference (SE) [95% CI]

  

‒0.124 (0.091) [‒0.316, 0.068]

  P-value

  

0.1894c

Radial artery diameter

 AUCRA-VIP, mm × min, mean (SD)

‒1.09 (4.34)

1.23 (6.49)

9.31 (6.24)

  LS mean difference (SE) [95% CI]

 

1.16 (3.69) [‒6.95, 9.28]

11.6 (2.83) [5.59, 17.6]

  P-value

 

0.7578b

 

 CFIRA-60 min-VIP, mm, mean (SD)

0.006 (0.045)

0.017 (0.066)

0.075 (0.052)

  LS mean difference (SE) [95% CI]

  

0.077 (0.030) [0.013, 0.141]

 maxRA-VIP, mm, mean (SD)

0.034 (0.23)

0.087 (0.097)

0.135 (0.062)

  LS mean difference (SE) [95% CI]

  

0.0773 (0.0403) [‒0.00811, 0.163]

Facial blood flow

 AUCFBF-VIP, flux × min, mean (SD)

‒1216 (4420)

11,919 (6959)

9827 (10,983)

  LS mean difference (SE) [95% CI]

 

12,865 (3129) [5977, 19,752]

‒3210 (4337) [‒12,400, 5985]

  P-value

 

0.0017b

0.4701c

 maxFBF-VIP, flux, mean (SD)

55.4 (31.0)

366 (169)

199 (99.8)

  LS mean difference (SE) [95% CI]

  

–214 (53.6) [–328, –100]

  P-value

  

0.0011c

Heart rate

 AUCHR-VIP, beats, mean (SD)

14.8 (524)

897 (560)

585 (568)

  LS mean difference (SE) [95% CI]

 

853 (295) [203, 1502]

–271 (215) [–728, 186]

  P-value

 

0.0147b

0.2265c

Headache intensity

 AUCHI-VIP 0-8 h, points, mean (SD)

35.9 (80.3)

104 (178)

88.4 (179)

  LS mean difference (SE) [95% CI]

  

-15.2 (82.2) [–189, 158]

  P-value

  

0.8554c

 maxHI-VIP, points, mean (SD)

0.400 (0.894)

1.10 (0.994)

0.800 (1.87)

  LS mean difference (SE) [95% CI]

  

-0.300 (0.690) [–1.76, 1.16]

  P-value

  

0.6692c

  1. AUC Area under the curve, AUCFBF-VIP AUC in change in facial blood flow from 0 to 120 min after start of infusion (SOI refers to start of infusion of PACAP38, VIP, or saline), AUCHI-VIP 0-8 h AUC for headache intensity from 0 to 8 h after SOI, AUCHR-VIP AUC in change in heart rate from 0 to 120 min after SOI, AUCRA-VIP AUC in change in RA diameter from 0 to 120 min after SOI, AUCSTA-VIP AUC of change in STA diameter from 0 to 120 min after SOI, CFI Change from SOI, CFIRA-60 min-VIP Change in RA diameter from 0 to 60 min after SOI, CFISTA-60 min-VIP Change in STA diameter from 0 to 60 min after SOI, CI Confidence interval, HR Heart rate, LS Least squares, maxFBF-VIP Maximum change in facial blood flow between 0 and 120 min after SOI, maxHI-VIP Peak headache score between 0 and 24 h after SOI, maxRA-VIP Maximum change in RA diameter between 0 and 120 min after SOI, maxSTA-VIP Maximum change in STA diameter between 0 and 120 min after SOI, PACAP38 Pituitary adenylate cyclase-activating polypeptide 38, RA Radial artery, SD Standard deviation, SE Standard error, STA Superficial temporal artery, VIP Vasoactive intestinal peptide
  2. aGroup-specific estimates are presented as mean (SD); all differences are expressed as least-squares mean differences (SE); note that least-squares mean differences may slightly differ from observed mean differences due to the adjustment for the baseline value
  3. bP-value vs. placebo + saline + saline was calculated for AUC values only (if no significant difference was detected between the two control groups [placebo + saline + saline and placebo + PACAP38 + VIP], then no further analysis was conducted to compare Lu AG09222 + PACAP38 + VIP and placebo + PACAP38 + VIP)
  4. cP-value vs. placebo + PACAP38 + VIP