Sumatriptan-Naproxen for Acute Treatment of Migraine

Brandes, Jan Lewis; Kudrow, David; Stark, Stuart R.; O’Carroll, C. Phillip; Adelman, James U.; O’Donnell, Francis; Alexander, W. James; Spruill, Susan E.; Barrett, Pamela S.; Lener, Shelly E.

doi:10.1001/jama.297.13.1443

Cited by 236 publications

(254 citation statements)

References 36 publications

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“…500 mg showed benefit of the combination compared with either monotherapy, with a well-tolerated adverse event profile (55).…”

Section: Management Of Aggravating Factorsmentioning

confidence: 97%

Primary Headache Disorders: Focus on Migraine

Bahra

2011

Reviews in Pain

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k e y w o r d s migraine, aura, headache, primary headache disorders, disabling tension-type headache, medication overuse headache s u m m a r y p o i n t s• Migraine is the most common disabling headache disorder.• Most patients with disabling tension-type headache are likely to have migraine and accordingly respond to treatments efficacious in migraine.• Individuals are genetically predisposed to experiencing recurrent migraine.• Evidence supports migraine to be a primarily neural and not vascular mediated disorder.• 1-2% of the population have chronic daily headache associated with acute-relief medication overuse; the majority are migraineurs.• The presence of acute-relief medication overuse renders preventative medication less adequately efficacious.unipolar depression. The only painful disorder with greater disability than migraine is osteoarthritis, which is the 4 th most disabling in women and 6 th in men. The one year prevalence rate of migraine with or without aura in the UK is 7.6% in men and 18.3% in women (3). The prevalence varies by age and gender. Before puberty it is higher in boys than girls. The prevalence increases more rapidly in girls than boys into adolescence. Thereafter the prevalence increases in both sexes to peak at 40, and then declines (4). About one third of individuals will experience migraine with aura. Four to five percent of the population suffer from daily headache (5-7), and between 30 and 50% of these have a clinical syndrome which is consistent with migraine. One to two percent of the population have daily headache associated with medication overuse (6,8). Clinical characteristicsThere are a number of aspects to the migraine attack: the premonitory phase, headache, aura and recovery (9) (Table 1).

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“…500 mg showed benefit of the combination compared with either monotherapy, with a well-tolerated adverse event profile (55).…”

Section: Management Of Aggravating Factorsmentioning

confidence: 97%

Primary Headache Disorders: Focus on Migraine

Bahra

2011

Reviews in Pain

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“…A combination of sumatriptan-naproxen as a single tablet for acute migraine, was superior to monotherapy with each component drug alone or placebo, in terms of pain-free outcome from 2 to 24 hours, with an adverse effects profile no worse than sumatriptan alone (Brandes et al, 2007 Level II).…”

Section: Chaptermentioning

confidence: 99%

Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non‐inferiority trial

Cohen

Smit

Andrianopoulos³

et al. 2017

Medical Journal of Australia

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Objectives: This study aimed to assess analgesia provided by acupuncture, alone or in combination with pharmacotherapy, to patients presenting to emergency departments with acute low back pain, migraine or ankle sprain. Design: A pragmatic, multicentre, randomised, assessor‐blinded, equivalence and non‐inferiority trial of analgesia, comparing acupuncture alone, acupuncture plus pharmacotherapy, and pharmacotherapy alone for alleviating pain in the emergency department. Setting, participants: Patients presenting to emergency departments in one of four tertiary hospitals in Melbourne with acute low back pain, migraine, or ankle sprain, and with a pain score on a 10‐point verbal numerical rating scale (VNRS) of at least 4. Main outcome measures: The primary outcome measure was pain at one hour (T1). Clinically relevant pain relief was defined as achieving a VNRS score below 4, and statistically relevant pain relief as a reduction in VNRS score of greater than 2 units. Results: 1964 patients were assessed between January 2010 and December 2011; 528 patients with acute low back pain (270 patients), migraine (92) or ankle sprain (166) were randomised to acupuncture alone (177 patients), acupuncture plus pharmacotherapy (178) or pharmacotherapy alone (173). Equivalence and non‐inferiority of treatment groups was found overall and for the low back pain and ankle sprain groups in both intention‐to‐treat and per protocol (PP) analyses, except in the PP equivalence testing of the ankle sprain group. 15.6% of patients had clinically relevant pain relief and 36.9% had statistically relevant pain relief at T1; there were no between‐group differences. Conclusion: The effectiveness of acupuncture in providing acute analgesia for patients with back pain and ankle sprain was comparable with that of pharmacotherapy. Acupuncture is a safe and acceptable form of analgesia, but none of the examined therapies provided optimal acute analgesia. More effective options are needed. Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12609000989246.

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“…The methods and results of the studies are fully described elsewhere [Brandes et al 2007]. The protocols for the studies were approved by ethics committees or institutional review boards for all study sites.…”

Section: Methodsmentioning

confidence: 99%

Fixed-dose sumatriptan/naproxen sodium compared with each monotherapy utilizing the novel composite endpoint of sustained pain-free/no adverse events

Landy¹,

White

Lener

et al. 2009

Ther Adv Neurol Disord

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A novel composite endpoint, sustained pain-free/no adverse events, was recently proposed as a more rigorous means of capturing in a single measure the attributes of migraine pharmacotherapy that patients consider most important: rapid and sustained pain-free response with no side-effects. Using pooled data from two replicate randomized, double-blind, parallel-group, placebo-controlled studies, this post hoc analysis compared the fixed-dose combination tablet sumatriptan/naproxen sodium (n ¼ 726) with sumatriptan monotherapy (n ¼ 723), naproxen sodium monotherapy (n ¼ 720), and placebo (n ¼ 742) with respect to sustained pain-free/no adverse events and closely related composite measures. Sustained painfree/no adverse events was defined as having both a sustained pain-free response from 2 through 24 hours post-dose with no use of rescue medication and having no adverse events within up to 5 days after dosing with study medication. The percentage of patients with sustained pain-free/no adverse events was 16% with sumatriptan/naproxen sodium compared with 11%, 9% and 7% for sumatriptan, naproxen sodium and placebo, respectively (p50.01 sumatriptan/naproxen sodium versus each other treatment). Sumatriptan/naproxen sodium was also significantly more effective than sumatriptan, naproxen sodium, and placebo for other composite endpoints including the percentages of patients with (1) sustained pain-free/no adverse events within 1 day; (2) sustained pain-free/no drug-related adverse events within up to 5 days; (3) sustained pain-free/no drug-related adverse events within 1 day; (4) sustained pain relief/no adverse events within up to 5 days; and (5) sustained pain relief/no adverse events within 1 day. The results demonstrate the superiority of sumatriptan/naproxen sodium to sumatriptan monotherapy, naproxen sodium monotherapy and placebo with respect to the rigorous and clinically relevant endpoint of sustained pain-free/no adverse events and reinforce the usefulness of utilizing this new composite endpoint.

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Sumatriptan-Naproxen for Acute Treatment of Migraine

Abstract: clinicaltrials.gov Identifiers: NCT00434083 (study 1); NCT00433732 (study 2).

Cited by 236 publications

References 36 publications

Primary Headache Disorders: Focus on Migraine

Primary Headache Disorders: Focus on Migraine

Acupuncture for analgesia in the emergency department: a multicentre, randomised, equivalence and non‐inferiority trial

Fixed-dose sumatriptan/naproxen sodium compared with each monotherapy utilizing the novel composite endpoint of sustained pain-free/no adverse events

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