Age but not sex is associated with efficacy and adverse events following administration of intravenous migraine medication: An analysis of a clinical trial database

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Abstract

Background Migraine prevalence is associated with both sex and age. Differences in efficacy of parenteral migraine medication administration based on the sex and age of the patient have not been explored in the published literature. Objective The objective was to determine whether sex and age are associated with short-term headache relief, sustained headache freedom, or adverse medication effects in data collected during 3 emergency department (ED)-based acute migraine comparative efficacy trials. Methods Data were combined from 3 studies in which patients who presented to an ED with acute migraine were randomized to one of the following intravenous medication regimens: (1) metoclopramide combined with diphenhydramine; (2) metoclopramide combined with diphenhydramine and dexamethasone; (3) metoclopramide alone; (4) ketorolac; or (5) valproate. In each of these studies, (1) short-term efficacy (patient description of the headache as "mild" or "none" 1 hour after medication administration); (2) sustained efficacy (patient description of the headache as "none" within 2 hours of medication administration and no headache recurrence for 24 hours post ED discharge); and (3) the frequency of any adverse medication effects within 24 hours of medication administration was determined. For each of the medication regimens studied, efficacy and adverse event rates were compared between men vs women and the older vs the younger half of patients. Multivariate logistic regression models were constructed in which sex and age were maintained in the model as well as variables representing each of the medication regimens patients received. Results A total of 884 patients were included in this analysis (140 men and 744 women). The median age was 35 years. After controlling for age and medication received, female sex was not associated with short-term efficacy (OR 0.98 [95% confidence interval (CI): 0.66, 1.46]), sustained efficacy (OR 0.72 [95%CI: 0.45, 1.15]), or adverse events (OR 1.14 [95%CI: 0.77, 1.71]). Age >36 years, however, was associated with short-term efficacy (OR 0.66 [95%CI: 0.49, 0.88]), sustained efficacy (OR 0.50 [95%CI: 0.34, 0.73]), and adverse events (OR 1.36 [95%CI: 1.02, 1.82]). Conclusion Sex was not associated with response to parenteral acute migraine medication. Age was associated with both efficacy and adverse events.

Original languageEnglish (US)
Pages (from-to)1342-1355
Number of pages14
JournalHeadache
Volume55
Issue number10
DOIs
StatePublished - Nov 1 2015

Fingerprint

Migraine Disorders
Intravenous Administration
Clinical Trials
Databases
Headache
Confidence Intervals
Metoclopramide
Hospital Emergency Service
Diphenhydramine
Logistic Models
Ketorolac
Valproic Acid
Dexamethasone
Recurrence

Keywords

  • age
  • emergency department
  • migraine
  • sex

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

@article{5f66032af2ca4ade96a29cc48658721c,
title = "Age but not sex is associated with efficacy and adverse events following administration of intravenous migraine medication: An analysis of a clinical trial database",
abstract = "Background Migraine prevalence is associated with both sex and age. Differences in efficacy of parenteral migraine medication administration based on the sex and age of the patient have not been explored in the published literature. Objective The objective was to determine whether sex and age are associated with short-term headache relief, sustained headache freedom, or adverse medication effects in data collected during 3 emergency department (ED)-based acute migraine comparative efficacy trials. Methods Data were combined from 3 studies in which patients who presented to an ED with acute migraine were randomized to one of the following intravenous medication regimens: (1) metoclopramide combined with diphenhydramine; (2) metoclopramide combined with diphenhydramine and dexamethasone; (3) metoclopramide alone; (4) ketorolac; or (5) valproate. In each of these studies, (1) short-term efficacy (patient description of the headache as {"}mild{"} or {"}none{"} 1 hour after medication administration); (2) sustained efficacy (patient description of the headache as {"}none{"} within 2 hours of medication administration and no headache recurrence for 24 hours post ED discharge); and (3) the frequency of any adverse medication effects within 24 hours of medication administration was determined. For each of the medication regimens studied, efficacy and adverse event rates were compared between men vs women and the older vs the younger half of patients. Multivariate logistic regression models were constructed in which sex and age were maintained in the model as well as variables representing each of the medication regimens patients received. Results A total of 884 patients were included in this analysis (140 men and 744 women). The median age was 35 years. After controlling for age and medication received, female sex was not associated with short-term efficacy (OR 0.98 [95{\%} confidence interval (CI): 0.66, 1.46]), sustained efficacy (OR 0.72 [95{\%}CI: 0.45, 1.15]), or adverse events (OR 1.14 [95{\%}CI: 0.77, 1.71]). Age >36 years, however, was associated with short-term efficacy (OR 0.66 [95{\%}CI: 0.49, 0.88]), sustained efficacy (OR 0.50 [95{\%}CI: 0.34, 0.73]), and adverse events (OR 1.36 [95{\%}CI: 1.02, 1.82]). Conclusion Sex was not associated with response to parenteral acute migraine medication. Age was associated with both efficacy and adverse events.",
keywords = "age, emergency department, migraine, sex",
author = "Friedman, {Benjamin W.} and Cisewski, {David H.} and Holden, {Lynne M.} and Bijur, {Polly E.} and Gallagher, {E. John}",
year = "2015",
month = "11",
day = "1",
doi = "10.1111/head.12697",
language = "English (US)",
volume = "55",
pages = "1342--1355",
journal = "Headache",
issn = "0017-8748",
publisher = "Wiley-Blackwell",
number = "10",

}

TY - JOUR

T1 - Age but not sex is associated with efficacy and adverse events following administration of intravenous migraine medication

T2 - An analysis of a clinical trial database

AU - Friedman, Benjamin W.

AU - Cisewski, David H.

AU - Holden, Lynne M.

AU - Bijur, Polly E.

AU - Gallagher, E. John

PY - 2015/11/1

Y1 - 2015/11/1

N2 - Background Migraine prevalence is associated with both sex and age. Differences in efficacy of parenteral migraine medication administration based on the sex and age of the patient have not been explored in the published literature. Objective The objective was to determine whether sex and age are associated with short-term headache relief, sustained headache freedom, or adverse medication effects in data collected during 3 emergency department (ED)-based acute migraine comparative efficacy trials. Methods Data were combined from 3 studies in which patients who presented to an ED with acute migraine were randomized to one of the following intravenous medication regimens: (1) metoclopramide combined with diphenhydramine; (2) metoclopramide combined with diphenhydramine and dexamethasone; (3) metoclopramide alone; (4) ketorolac; or (5) valproate. In each of these studies, (1) short-term efficacy (patient description of the headache as "mild" or "none" 1 hour after medication administration); (2) sustained efficacy (patient description of the headache as "none" within 2 hours of medication administration and no headache recurrence for 24 hours post ED discharge); and (3) the frequency of any adverse medication effects within 24 hours of medication administration was determined. For each of the medication regimens studied, efficacy and adverse event rates were compared between men vs women and the older vs the younger half of patients. Multivariate logistic regression models were constructed in which sex and age were maintained in the model as well as variables representing each of the medication regimens patients received. Results A total of 884 patients were included in this analysis (140 men and 744 women). The median age was 35 years. After controlling for age and medication received, female sex was not associated with short-term efficacy (OR 0.98 [95% confidence interval (CI): 0.66, 1.46]), sustained efficacy (OR 0.72 [95%CI: 0.45, 1.15]), or adverse events (OR 1.14 [95%CI: 0.77, 1.71]). Age >36 years, however, was associated with short-term efficacy (OR 0.66 [95%CI: 0.49, 0.88]), sustained efficacy (OR 0.50 [95%CI: 0.34, 0.73]), and adverse events (OR 1.36 [95%CI: 1.02, 1.82]). Conclusion Sex was not associated with response to parenteral acute migraine medication. Age was associated with both efficacy and adverse events.

AB - Background Migraine prevalence is associated with both sex and age. Differences in efficacy of parenteral migraine medication administration based on the sex and age of the patient have not been explored in the published literature. Objective The objective was to determine whether sex and age are associated with short-term headache relief, sustained headache freedom, or adverse medication effects in data collected during 3 emergency department (ED)-based acute migraine comparative efficacy trials. Methods Data were combined from 3 studies in which patients who presented to an ED with acute migraine were randomized to one of the following intravenous medication regimens: (1) metoclopramide combined with diphenhydramine; (2) metoclopramide combined with diphenhydramine and dexamethasone; (3) metoclopramide alone; (4) ketorolac; or (5) valproate. In each of these studies, (1) short-term efficacy (patient description of the headache as "mild" or "none" 1 hour after medication administration); (2) sustained efficacy (patient description of the headache as "none" within 2 hours of medication administration and no headache recurrence for 24 hours post ED discharge); and (3) the frequency of any adverse medication effects within 24 hours of medication administration was determined. For each of the medication regimens studied, efficacy and adverse event rates were compared between men vs women and the older vs the younger half of patients. Multivariate logistic regression models were constructed in which sex and age were maintained in the model as well as variables representing each of the medication regimens patients received. Results A total of 884 patients were included in this analysis (140 men and 744 women). The median age was 35 years. After controlling for age and medication received, female sex was not associated with short-term efficacy (OR 0.98 [95% confidence interval (CI): 0.66, 1.46]), sustained efficacy (OR 0.72 [95%CI: 0.45, 1.15]), or adverse events (OR 1.14 [95%CI: 0.77, 1.71]). Age >36 years, however, was associated with short-term efficacy (OR 0.66 [95%CI: 0.49, 0.88]), sustained efficacy (OR 0.50 [95%CI: 0.34, 0.73]), and adverse events (OR 1.36 [95%CI: 1.02, 1.82]). Conclusion Sex was not associated with response to parenteral acute migraine medication. Age was associated with both efficacy and adverse events.

KW - age

KW - emergency department

KW - migraine

KW - sex

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U2 - 10.1111/head.12697

DO - 10.1111/head.12697

M3 - Article

C2 - 26486928

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VL - 55

SP - 1342

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JO - Headache

JF - Headache

SN - 0017-8748

IS - 10

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