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Table 2 Effects of Lu AG09222 following PACAP38 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-PACAP38, mm × min, mean (SD)

‒0.49 (5.03)

38.6 (13.0)

2.01 (3.96)

  LS mean difference (SE) [95% CI]

 

37.3 (6.46) [23.1, 51.5]

‒35.4 (4.32) [‒44.6, ‒26.3]

  P-value

 

0.0001b

 < 0.0001c

 CFISTA-60 min-PACAP38, mm, mean (SD)

‒0.006 (0.043)

0.336 (0.116)

0.015 (0.043)

  LS mean difference (SE) [95% CI]

  

‒0.313 (0.041) [‒0.399, ‒0.227]

  P-value

  

 < 0.0001c

 maxSTA-PACAP38, mm, mean (SD)

0.046 (0.026)

0.410 (0.112)

0.060 (0.036)

  LS mean difference (SE) [95% CI]

  

‒0.340 (0.036) [‒0.416, ‒0.264]

  P-value

  

 < 0.0001c

Radial artery diameter

 AUCRA-PACAP38, mm × min, mean (SD)

2.79 (7.41)

2.01 (6.78)

6.26 (10.5)

  LS mean difference (SE) [95% CI]

 

‒3.82 (3.27) [‒11.0, 3.38]

3.12 (4.67) [‒6.79, 13.0]

  P-value

 

0.2676b

 

 CFIRA-60 min-PACAP38, mm, mean (SD)

0.021 (0.066)

0.047 (0.102)

0.056 (0.123)

  LS mean difference (SE) [95% CI]

  

0.0003 (0.060) [‒0.127, 0.127]

 maxRA-PACAP38, mm, mean (SD)

0.062 (0.066)

0.098 (0.102)

0.108 (0.112)

  LS mean difference (SE) [95% CI]

  

‒0.013 (0.054) [‒0.127, 0.101]

Facial blood flow

 AUCFBF-PACAP38, flux × min, mean (SD)

‒2755 (6572)

63,907 (16,516)

2113 (8197)

  LS mean difference (SE) [95% CI]

 

64,321 (7158) [48,567, 80,075]

‒60,200 (5808) [‒72,500, ‒47,900]

  P-value

 

 < 0.0001b

 < 0.0001c

 maxFBF-PACAP38, flux, mean (SD)

36.6 (46.2)

665 (190)

126 (162)

  LS mean difference (SE) [95% CI]

  

‒505 (72.1) [‒658, ‒352]

  P-value

  

 < 0.0001c

Heart rate

 AUCHR-PACAP38, beats, mean (SD)

262 (282)

2792 (1001)

290 (337)

  LS mean difference (SE) [95% CI]

  

‒2520 (359) [‒3280, ‒1750]

  P-value

  

 < 0.0001c

Headache intensity

 AUCHI-PACAP38 0-8 h, points, mean (SD)

169 (204)

762 (725)

156 (324)

  LS mean difference (SE) [95% CI]

  

‒606 (252) [‒1140, ‒74.1]

  P-value

  

0.0279c

 maxHI-PACAP38, points, mean (SD)

2.00 (1.87)

2.60 (2.07)

1.00 (1.76)

  LS mean difference (SE) [95% CI]

  

‒1.60 (0.775) [‒3.23, 0.034]

  P-value

  

0.0544c

  1. AUC Area under the curve, AUCFBF-PACAP38 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-PACAP38 0-8 h AUC for headache intensity from 0 to 8 h after SOI, AUCHR-PACAP38 AUC in change in heart rate from 0 to 120 min after SOI, AUCRA-PACAP38 AUC in change in RA diameter from 0 to 120 min after SOI, AUCSTA-PACAP38 AUC of change in STA diameter from 0 to 120 min after SOI, CFI Change from SOI, CFIRA-60 min-PACAP38 Change in RA diameter from 0 to 60 min after SOI, CFISTA-60 min-PACAP38 Change in STA diameter from 0 to 60 min after SOI, CI Confidence interval, HR Heart rate, LS Least squares, maxFBF-PACAP38 Maximum change in facial blood flow between 0 and 120 min after SOI; maxHI-PACAP38 Peak headache score between 0 and 24 h after SOI, maxRA-PACAP38 Maximum change in RA diameter between 0 and 120 min after SOI; maxSTA-PACAP38 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 LS 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
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The Journal of Headache and Pain

ISSN: 1129-2377

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