Acetaminophen, aspirin, and caffeine in combination versus ibuprofen for acute migraine

Results from a multicenter, double-blind, randomized, parallel-group, single-dose, placebo-controlled study

Jerome Goldstein, Stephen D. Silberstein, Joel R. Saper, Robert E. Ryan, Richard B. Lipton

Research output: Contribution to journalArticle

76 Citations (Scopus)

Abstract

Objective. - Compare the effectiveness of a combination analgesic containing acetaminophen, aspirin, and caffeine to that of ibuprofen in the treatment of migraine. Methods. - Multicenter, double-blind, randomized, parallel-group, placebo-controlled, single-dose study. A total of 1555 migraineurs were included in the analysis. No patients were excluded solely because of severity of symptoms or degree of disability. A single 2-tablet dose for each of the 3 treatment groups: a combination product containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg per tablet (AAC); ibuprofen 200 mg per tablet (IB); or matching placebo. The primary efficacy endpoint was the weighted sum of pain relief (PAR) scores at 2 hours postdose (TOTPAR2) and an important secondary endpoint was the time to onset of meaningful relief. Results. - There were 669 patients in the AAC group, 666 patients in the IB group, and 220 patients in the placebo group. The 3 treatment groups had similar demographic profiles, migraine histories, and baseline symptom profiles. While both active treatments were significantly better than placebo in relieving the pain and associated symptoms of migraine, AAC was superior to IB for TOTPAR2, as well as for PAR, time to onset of meaningful PAR, pain intensity reduction, headache response, and pain free. The mean TOTPAR2 scores for AAC, IB, and placebo were 2.7, 2.4, and 2.0, respectively (AAC vs. IB, P < .03). The median time to meaningful PAR for AAC was 20 minutes earlier than that of IB (P < .036). Conclusion. - AAC and IB are safe, cost-effective treatments for migraine; AAC provides significantly superior efficacy and speed of onset compared with IB.

Original languageEnglish (US)
Pages (from-to)444-453
Number of pages10
JournalHeadache
Volume46
Issue number3
DOIs
StatePublished - Mar 2006

Fingerprint

Ibuprofen
Migraine Disorders
Placebos
Pain
Tablets
Therapeutics
Acetaminophen
Caffeine
Health Care Costs
Aspirin
Headache
Analgesics
acetaminophen, aspirin, caffeine drug combination
Demography

Keywords

  • Acetaminophen
  • Aspirin
  • Caffeine
  • Ibuprofen
  • Migraine

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

Cite this

Acetaminophen, aspirin, and caffeine in combination versus ibuprofen for acute migraine : Results from a multicenter, double-blind, randomized, parallel-group, single-dose, placebo-controlled study. / Goldstein, Jerome; Silberstein, Stephen D.; Saper, Joel R.; Ryan, Robert E.; Lipton, Richard B.

In: Headache, Vol. 46, No. 3, 03.2006, p. 444-453.

Research output: Contribution to journalArticle

@article{bb23d866f2d44110a924cd7dd5d67a34,
title = "Acetaminophen, aspirin, and caffeine in combination versus ibuprofen for acute migraine: Results from a multicenter, double-blind, randomized, parallel-group, single-dose, placebo-controlled study",
abstract = "Objective. - Compare the effectiveness of a combination analgesic containing acetaminophen, aspirin, and caffeine to that of ibuprofen in the treatment of migraine. Methods. - Multicenter, double-blind, randomized, parallel-group, placebo-controlled, single-dose study. A total of 1555 migraineurs were included in the analysis. No patients were excluded solely because of severity of symptoms or degree of disability. A single 2-tablet dose for each of the 3 treatment groups: a combination product containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg per tablet (AAC); ibuprofen 200 mg per tablet (IB); or matching placebo. The primary efficacy endpoint was the weighted sum of pain relief (PAR) scores at 2 hours postdose (TOTPAR2) and an important secondary endpoint was the time to onset of meaningful relief. Results. - There were 669 patients in the AAC group, 666 patients in the IB group, and 220 patients in the placebo group. The 3 treatment groups had similar demographic profiles, migraine histories, and baseline symptom profiles. While both active treatments were significantly better than placebo in relieving the pain and associated symptoms of migraine, AAC was superior to IB for TOTPAR2, as well as for PAR, time to onset of meaningful PAR, pain intensity reduction, headache response, and pain free. The mean TOTPAR2 scores for AAC, IB, and placebo were 2.7, 2.4, and 2.0, respectively (AAC vs. IB, P < .03). The median time to meaningful PAR for AAC was 20 minutes earlier than that of IB (P < .036). Conclusion. - AAC and IB are safe, cost-effective treatments for migraine; AAC provides significantly superior efficacy and speed of onset compared with IB.",
keywords = "Acetaminophen, Aspirin, Caffeine, Ibuprofen, Migraine",
author = "Jerome Goldstein and Silberstein, {Stephen D.} and Saper, {Joel R.} and Ryan, {Robert E.} and Lipton, {Richard B.}",
year = "2006",
month = "3",
doi = "10.1111/j.1526-4610.2006.00376.x",
language = "English (US)",
volume = "46",
pages = "444--453",
journal = "Headache",
issn = "0017-8748",
publisher = "Wiley-Blackwell",
number = "3",

}

TY - JOUR

T1 - Acetaminophen, aspirin, and caffeine in combination versus ibuprofen for acute migraine

T2 - Results from a multicenter, double-blind, randomized, parallel-group, single-dose, placebo-controlled study

AU - Goldstein, Jerome

AU - Silberstein, Stephen D.

AU - Saper, Joel R.

AU - Ryan, Robert E.

AU - Lipton, Richard B.

PY - 2006/3

Y1 - 2006/3

N2 - Objective. - Compare the effectiveness of a combination analgesic containing acetaminophen, aspirin, and caffeine to that of ibuprofen in the treatment of migraine. Methods. - Multicenter, double-blind, randomized, parallel-group, placebo-controlled, single-dose study. A total of 1555 migraineurs were included in the analysis. No patients were excluded solely because of severity of symptoms or degree of disability. A single 2-tablet dose for each of the 3 treatment groups: a combination product containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg per tablet (AAC); ibuprofen 200 mg per tablet (IB); or matching placebo. The primary efficacy endpoint was the weighted sum of pain relief (PAR) scores at 2 hours postdose (TOTPAR2) and an important secondary endpoint was the time to onset of meaningful relief. Results. - There were 669 patients in the AAC group, 666 patients in the IB group, and 220 patients in the placebo group. The 3 treatment groups had similar demographic profiles, migraine histories, and baseline symptom profiles. While both active treatments were significantly better than placebo in relieving the pain and associated symptoms of migraine, AAC was superior to IB for TOTPAR2, as well as for PAR, time to onset of meaningful PAR, pain intensity reduction, headache response, and pain free. The mean TOTPAR2 scores for AAC, IB, and placebo were 2.7, 2.4, and 2.0, respectively (AAC vs. IB, P < .03). The median time to meaningful PAR for AAC was 20 minutes earlier than that of IB (P < .036). Conclusion. - AAC and IB are safe, cost-effective treatments for migraine; AAC provides significantly superior efficacy and speed of onset compared with IB.

AB - Objective. - Compare the effectiveness of a combination analgesic containing acetaminophen, aspirin, and caffeine to that of ibuprofen in the treatment of migraine. Methods. - Multicenter, double-blind, randomized, parallel-group, placebo-controlled, single-dose study. A total of 1555 migraineurs were included in the analysis. No patients were excluded solely because of severity of symptoms or degree of disability. A single 2-tablet dose for each of the 3 treatment groups: a combination product containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg per tablet (AAC); ibuprofen 200 mg per tablet (IB); or matching placebo. The primary efficacy endpoint was the weighted sum of pain relief (PAR) scores at 2 hours postdose (TOTPAR2) and an important secondary endpoint was the time to onset of meaningful relief. Results. - There were 669 patients in the AAC group, 666 patients in the IB group, and 220 patients in the placebo group. The 3 treatment groups had similar demographic profiles, migraine histories, and baseline symptom profiles. While both active treatments were significantly better than placebo in relieving the pain and associated symptoms of migraine, AAC was superior to IB for TOTPAR2, as well as for PAR, time to onset of meaningful PAR, pain intensity reduction, headache response, and pain free. The mean TOTPAR2 scores for AAC, IB, and placebo were 2.7, 2.4, and 2.0, respectively (AAC vs. IB, P < .03). The median time to meaningful PAR for AAC was 20 minutes earlier than that of IB (P < .036). Conclusion. - AAC and IB are safe, cost-effective treatments for migraine; AAC provides significantly superior efficacy and speed of onset compared with IB.

KW - Acetaminophen

KW - Aspirin

KW - Caffeine

KW - Ibuprofen

KW - Migraine

UR - http://www.scopus.com/inward/record.url?scp=33645057181&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33645057181&partnerID=8YFLogxK

U2 - 10.1111/j.1526-4610.2006.00376.x

DO - 10.1111/j.1526-4610.2006.00376.x

M3 - Article

VL - 46

SP - 444

EP - 453

JO - Headache

JF - Headache

SN - 0017-8748

IS - 3

ER -