Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium

Vincent T. Martin, Jeanne Ballard, Michael Peter Diamond, Lisa K. Mannix, Frederick J. Derosier, Shelly E. Lener, Alok Krishen, Susan A. McDonald

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background: Dysmenorrhea and menstrual migraine may share a common pathogenic pathway. Both appear to be mediated, in part, by an excess of prostaglandin production that occurs during menstruation. Methods: Data were pooled from two replicate randomized controlled trials of 621 adult menstrual migraineurs with dysmenorrhea who treated migraine with sumatriptan-naproxen or placebo. Along with headache symptoms, nonpain menstrual symptoms (bloating, fatigue, and irritability) and menstrual pain symptoms (abdominal and back pain) were recorded at the time periods of 30 minutes and 1, 2, 4, and 4-24 hours. Relief of menstrual symptoms was compared using a Cochran-Mantel-Haenszel test. Logistic regression was used to determine the odds of a headache response with increasing numbers of moderate to severe dymenorrheic symptoms. Results: Sumatriptan-naproxen was superior to placebo for relief of tiredness, irritability, and abdominal pain at the time periods of 2, 4, and 4-24 hours (p≤0.023); back pain at the time periods of 4 and 4-24 hours (p≤0.023); and bloating at 4-24 hours endpoint (p=0.01). The odds ratios (ORs) of attaining migraine pain freedom for 2 hours and for sustained 2-24 hours decreased as moderate to severe dysmenorrhea symptoms increased with sumatriptan-naproxen versus placebo. Conclusions: Treatment with sumatriptan-naproxen may provide relief of menstrual symptoms and migraine in female migraineurs with dysmenorrhea. The presence of moderate to severe dysmenorrhea symptoms is associated with decreased response rates for menstrual migraine, suggesting that the co-occurrence of these disorders may negatively impact the results of migraine-abortive therapy.

Original languageEnglish (US)
Pages (from-to)389-396
Number of pages8
JournalJournal of Women's Health
Volume23
Issue number5
DOIs
StatePublished - May 1 2014

Fingerprint

Dysmenorrhea
Naproxen
Migraine Disorders
Tablets
Placebos
Back Pain
Abdominal Pain
Headache
Menstruation
Prostaglandins
Fatigue
sumatriptan-naproxen
Randomized Controlled Trials
Logistic Models
Odds Ratio
Pain
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium. / Martin, Vincent T.; Ballard, Jeanne; Diamond, Michael Peter; Mannix, Lisa K.; Derosier, Frederick J.; Lener, Shelly E.; Krishen, Alok; McDonald, Susan A.

In: Journal of Women's Health, Vol. 23, No. 5, 01.05.2014, p. 389-396.

Research output: Contribution to journalArticle

Martin, VT, Ballard, J, Diamond, MP, Mannix, LK, Derosier, FJ, Lener, SE, Krishen, A & McDonald, SA 2014, 'Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium', Journal of Women's Health, vol. 23, no. 5, pp. 389-396. https://doi.org/10.1089/jwh.2013.4577
Martin, Vincent T. ; Ballard, Jeanne ; Diamond, Michael Peter ; Mannix, Lisa K. ; Derosier, Frederick J. ; Lener, Shelly E. ; Krishen, Alok ; McDonald, Susan A. / Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium. In: Journal of Women's Health. 2014 ; Vol. 23, No. 5. pp. 389-396.
@article{6490967bc82c4b8c8f13159d6ae094c4,
title = "Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium",
abstract = "Background: Dysmenorrhea and menstrual migraine may share a common pathogenic pathway. Both appear to be mediated, in part, by an excess of prostaglandin production that occurs during menstruation. Methods: Data were pooled from two replicate randomized controlled trials of 621 adult menstrual migraineurs with dysmenorrhea who treated migraine with sumatriptan-naproxen or placebo. Along with headache symptoms, nonpain menstrual symptoms (bloating, fatigue, and irritability) and menstrual pain symptoms (abdominal and back pain) were recorded at the time periods of 30 minutes and 1, 2, 4, and 4-24 hours. Relief of menstrual symptoms was compared using a Cochran-Mantel-Haenszel test. Logistic regression was used to determine the odds of a headache response with increasing numbers of moderate to severe dymenorrheic symptoms. Results: Sumatriptan-naproxen was superior to placebo for relief of tiredness, irritability, and abdominal pain at the time periods of 2, 4, and 4-24 hours (p≤0.023); back pain at the time periods of 4 and 4-24 hours (p≤0.023); and bloating at 4-24 hours endpoint (p=0.01). The odds ratios (ORs) of attaining migraine pain freedom for 2 hours and for sustained 2-24 hours decreased as moderate to severe dysmenorrhea symptoms increased with sumatriptan-naproxen versus placebo. Conclusions: Treatment with sumatriptan-naproxen may provide relief of menstrual symptoms and migraine in female migraineurs with dysmenorrhea. The presence of moderate to severe dysmenorrhea symptoms is associated with decreased response rates for menstrual migraine, suggesting that the co-occurrence of these disorders may negatively impact the results of migraine-abortive therapy.",
author = "Martin, {Vincent T.} and Jeanne Ballard and Diamond, {Michael Peter} and Mannix, {Lisa K.} and Derosier, {Frederick J.} and Lener, {Shelly E.} and Alok Krishen and McDonald, {Susan A.}",
year = "2014",
month = "5",
day = "1",
doi = "10.1089/jwh.2013.4577",
language = "English (US)",
volume = "23",
pages = "389--396",
journal = "Journal of Women's Health",
issn = "1540-9996",
publisher = "Mary Ann Liebert Inc.",
number = "5",

}

TY - JOUR

T1 - Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium

AU - Martin, Vincent T.

AU - Ballard, Jeanne

AU - Diamond, Michael Peter

AU - Mannix, Lisa K.

AU - Derosier, Frederick J.

AU - Lener, Shelly E.

AU - Krishen, Alok

AU - McDonald, Susan A.

PY - 2014/5/1

Y1 - 2014/5/1

N2 - Background: Dysmenorrhea and menstrual migraine may share a common pathogenic pathway. Both appear to be mediated, in part, by an excess of prostaglandin production that occurs during menstruation. Methods: Data were pooled from two replicate randomized controlled trials of 621 adult menstrual migraineurs with dysmenorrhea who treated migraine with sumatriptan-naproxen or placebo. Along with headache symptoms, nonpain menstrual symptoms (bloating, fatigue, and irritability) and menstrual pain symptoms (abdominal and back pain) were recorded at the time periods of 30 minutes and 1, 2, 4, and 4-24 hours. Relief of menstrual symptoms was compared using a Cochran-Mantel-Haenszel test. Logistic regression was used to determine the odds of a headache response with increasing numbers of moderate to severe dymenorrheic symptoms. Results: Sumatriptan-naproxen was superior to placebo for relief of tiredness, irritability, and abdominal pain at the time periods of 2, 4, and 4-24 hours (p≤0.023); back pain at the time periods of 4 and 4-24 hours (p≤0.023); and bloating at 4-24 hours endpoint (p=0.01). The odds ratios (ORs) of attaining migraine pain freedom for 2 hours and for sustained 2-24 hours decreased as moderate to severe dysmenorrhea symptoms increased with sumatriptan-naproxen versus placebo. Conclusions: Treatment with sumatriptan-naproxen may provide relief of menstrual symptoms and migraine in female migraineurs with dysmenorrhea. The presence of moderate to severe dysmenorrhea symptoms is associated with decreased response rates for menstrual migraine, suggesting that the co-occurrence of these disorders may negatively impact the results of migraine-abortive therapy.

AB - Background: Dysmenorrhea and menstrual migraine may share a common pathogenic pathway. Both appear to be mediated, in part, by an excess of prostaglandin production that occurs during menstruation. Methods: Data were pooled from two replicate randomized controlled trials of 621 adult menstrual migraineurs with dysmenorrhea who treated migraine with sumatriptan-naproxen or placebo. Along with headache symptoms, nonpain menstrual symptoms (bloating, fatigue, and irritability) and menstrual pain symptoms (abdominal and back pain) were recorded at the time periods of 30 minutes and 1, 2, 4, and 4-24 hours. Relief of menstrual symptoms was compared using a Cochran-Mantel-Haenszel test. Logistic regression was used to determine the odds of a headache response with increasing numbers of moderate to severe dymenorrheic symptoms. Results: Sumatriptan-naproxen was superior to placebo for relief of tiredness, irritability, and abdominal pain at the time periods of 2, 4, and 4-24 hours (p≤0.023); back pain at the time periods of 4 and 4-24 hours (p≤0.023); and bloating at 4-24 hours endpoint (p=0.01). The odds ratios (ORs) of attaining migraine pain freedom for 2 hours and for sustained 2-24 hours decreased as moderate to severe dysmenorrhea symptoms increased with sumatriptan-naproxen versus placebo. Conclusions: Treatment with sumatriptan-naproxen may provide relief of menstrual symptoms and migraine in female migraineurs with dysmenorrhea. The presence of moderate to severe dysmenorrhea symptoms is associated with decreased response rates for menstrual migraine, suggesting that the co-occurrence of these disorders may negatively impact the results of migraine-abortive therapy.

UR - http://www.scopus.com/inward/record.url?scp=84899923208&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84899923208&partnerID=8YFLogxK

U2 - 10.1089/jwh.2013.4577

DO - 10.1089/jwh.2013.4577

M3 - Article

C2 - 24579886

AN - SCOPUS:84899923208

VL - 23

SP - 389

EP - 396

JO - Journal of Women's Health

JF - Journal of Women's Health

SN - 1540-9996

IS - 5

ER -