Rofecoxib in the Acute Treatment of Migraine: A Randomized Controlled Clinical Trial

Saper, Joel R.; Dahlöf, Carl; So, Yuen T.; Tfelt‐Hansen, Peer; Malbecq, William; Loeys, Tom; Barraclough, Eleathea; Klipfel, Meghan; Visser, Hester; Reines, Scott A.; Yuen, Eric

doi:10.1111/j.1526-4610.2006.00334.x

Cited by 30 publications

(32 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The results seen with GW406381 are comparable to those described for other COX‐2 inhibitors in the treatment of migraine [12,13,25,26]. For example, headache relief at 2 h post‐dose was reported by 54–62% of rofecoxib‐treated subjects [25,26] and 45–48% of valdecoxib‐treated subjects [13]. Whilst three‐arm studies may show a greater placebo response than two‐arm studies, the 35% response seen here is similar to the 30–34% placebo responses observed in the rofecoxib and valdecoxib studies [13,25,26], and also similar to the average placebo response of 30% used to power this study and seen in clinical trials of other analgesics in acute migraine [27].…”

Section: Discussionsupporting

confidence: 80%

“…The results seen with GW406381 are comparable to those described for other COX-2 inhibitors in the treatment of migraine [12,13,25,26]. For example, headache relief at 2 h post-dose was reported by 54-62% of rofecoxib-treated subjects [25,26] and 45-48% of valdecoxib-treated subjects [13].…”

Section: Discussionsupporting

confidence: 72%

“…The time course of the effect of GW406381 matches the known pharmacokinetic profile ( T max 1–2 h) [14]. Previous COX‐2 inhibitor studies have shown that headache relief is greater after multiple doses than after single doses to treat repeat headaches [25]. However, this study assessed the efficacy of just a single dose of GW406381 for one migraine headache.…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

A double‐blind, randomized, placebo‐controlled, single‐dose study of the cyclooxygenase‐2 inhibitor, GW406381, as a treatment for acute migraine

Wentz

Jimenez

Dixon

et al. 2008

Euro J of Neurology

View full text Add to dashboard Cite

The objective of the present study was to explore the clinical efficacy and tolerability of GW406381, a cyclooxygenase-2 (COX-2) inhibitor with relatively high CNS penetration, in acute migraine. This was a double-blind, single-dose study of GW406381 compared with placebo and naproxen sodium compared with placebo (protocol number CXA20008). Three hundred and thirty-seven subjects were randomized 1:1:1 to GW406381 (70 mg), naproxen sodium (825 mg), or placebo for the treatment of one migraine headache of moderate or severe intensity in a potential 8-week period. The primary end-point was the proportion of subjects with headache relief [reduction in headache severity score from pre-dose 2 (moderate) or 3 (severe) to 0 (no pain) or 1 (mild)] at 2 h post-dose for GW406381 compared with placebo. Significantly higher proportions of subjects treated with GW406381 (50%, P = 0.032) or naproxen sodium (56%, P = 0.005) than with placebo (35%) reported headache relief at 2 h post-dose. Additional significant benefits were observed on many secondary outcomes, including proportions of subjects pain-free, for both GW406381 and naproxen sodium treatment compared with placebo. Both active treatments were well tolerated. Single-dose GW406381 (70 mg) and naproxen sodium (825 mg) were effective and well tolerated in the treatment of acute migraine.

show abstract

Section: Discussionsupporting

confidence: 80%

Section: Discussionsupporting

confidence: 72%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

A double‐blind, randomized, placebo‐controlled, single‐dose study of the cyclooxygenase‐2 inhibitor, GW406381, as a treatment for acute migraine

Wentz

Jimenez

Dixon

et al. 2008

Euro J of Neurology

View full text Add to dashboard Cite

show abstract

“…Also the selective COX‐2 inhibitors have been investigated in clinical trials. Valdecoxib 20–40 mg and rofecoxib 25–50 mg, the latter one not available on the market any more, have shown efficacy in acute migraine treatment [27–30]. Table 1 presents an overview of analgesics with efficacy in acute migraine treatment.…”

Section: Drug Treatment Of Migraine Attacksmentioning

confidence: 99%

“…In placebo‐controlled trials, however, no consistent efficacy of this procedure in the acute treatment of migraine attacks [175] or in the prevention of recurrence could be proven [176–179]. Also by expert consensus and supported by open label studies, dihydroergotamine 2 mg (nasal spray or suppositories) is recommended for severe migraine attacks [29]. The intravenous application of metamizol was significantly superior to placebo but can cause severe arterial hypotension and allergic reactions [24,180].…”

Section: Specific Situationsmentioning

confidence: 99%

EFNS guideline on the drug treatment of migraine – revised report of an EFNS task force

Evers

Áfra²,

Frese

et al. 2009

Euro J of Neurology

694

556

View full text Add to dashboard Cite

Background: Migraine is one of the most frequent disabling neurological conditions with a major impact on the patientsÕ quality of life. Objectives: To give evidence-based or expert recommendations for the different drug treatment procedures in the particular migraine syndromes based on a literature search and the consensus of an expert panel. Methods: All available medical reference systems were screened for the range of clinical studies on migraine with and without aura and on migraine-like syndromes. The findings in these studies were evaluated according to the recommendations of the European Federation of Neurological Societies (EFNS) resulting in level A, B, or C recommendations and good practice points. Recommendations: For the acute treatment of migraine attacks, oral non-steroidal antiinflammatory drug (NSAID) and triptans are recommended. The administration should follow the concept of stratified treatment. Before intake of NSAID and triptans, oral metoclopramide or domperidone is recommended. In very severe attacks, intravenous acetylsalicylic acid or subcutaneous sumatriptan are drugs of first choice. Status migrainosus can be treated by cortoicosteroids, although this is not universally held to be helpful, or dihydroergotamine. For the prophylaxis of migraine, betablockers (propranolol and metoprolol) flunarizine, valproic acid, and topiramate are drugs of first choice. Drugs of second choice for migraine prophylaxis include amitriptyline, naproxen, petasites, and bisoprolol.

show abstract

Ibuprofen with or without an antiemetic for acute migraine headaches in adults

Rabbie¹,

Derry²,

Moore³

et al. 2010

Cochrane Database of Systematic Reviews

View full text Add to dashboard Cite

Background Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers do not seek professional help, relying instead on over-the-counter analgesics. Co-therapy with an antiemetic should help to reduce symptoms commonly associated with migraine headaches. Objectives To determine efficacy and tolerability of ibuprofen, alone or in combination with an antiemetic, compared to placebo and other active interventions in the treatment of acute migraine headaches in adults. Search methods We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies through 22 April 2010. Selection criteria We included randomised, double-blind, placebo- or active-controlled studies using self-administered ibuprofen to treat a migraine headache episode, with at least 10 participants per treatment arm. Data collection and analysis Two review authors independently assessed trial quality and extracted data. Numbers of participants achieving each outcome were used to calculate relative risk and number needed to treat (NNT) or harm (NNH) compared to placebo or other active treatment. Main results Nine studies (4373 participants, 5223 attacks) compared ibuprofen with placebo or other active comparators; none combined ibuprofen with a self-administered antiemetic. All studies treated attacks with single doses of medication. For ibuprofen 400 mg versus placebo, NNTs for 2-hour pain-free (26% versus 12% with placebo), 2-hour headache relief (57% versus 25%) and 24-hour sustained headache relief (45% versus 19%) were 7.2, 3.2 and 4.0, respectively. For ibuprofen 200 mg versus placebo, NNTs for 2-hour pain-free (20% versus 10%) and 2-hour headache relief (52% versus 37%) were 9.7 and 6.3, respectively. The higher dose was significantly better for 2-hour headache relief than the lower dose. Soluble formulations of ibuprofen 400 mg were better than standard tablets for 1-hour, but not 2-hour headache relief. Associated symptoms of nausea, vomiting, photophobia and phonophobia and functional disability were reduced within 2 hours, and fewer participants used rescue medication with ibuprofen compared with placebo. Similar numbers of participants experienced adverse events, which were mostly mild and transient. Ibuprofen 400 mg did not differ from rofecoxib 25 mg for 2-hour headache relief, 24-hour headache relief or use of rescue medication. Authors’ conclusions Ibuprofen is an effective treatment for acute migraine headaches, providing pain relief in about half of sufferers, but complete relief from pain and associated symptoms for only a minority. NNTs for all efficacy outcomes were better with 400 mg than 200 mg in comparisons with placebo, and soluble formulations provided more rapid relief. Adverse events were mostly mild and transient, occurring at the same rate as with placebo.

show abstract

Rofecoxib in the Acute Treatment of Migraine: A Randomized Controlled Clinical Trial

Abstract: Rofecoxib 25 and 50 mg and ibuprofen 400 mg were effective and generally well tolerated in the acute treatment of migraine.

Cited by 30 publications

References 20 publications

A double‐blind, randomized, placebo‐controlled, single‐dose study of the cyclooxygenase‐2 inhibitor, GW406381, as a treatment for acute migraine

A double‐blind, randomized, placebo‐controlled, single‐dose study of the cyclooxygenase‐2 inhibitor, GW406381, as a treatment for acute migraine

EFNS guideline on the drug treatment of migraine – revised report of an EFNS task force

Ibuprofen with or without an antiemetic for acute migraine headaches in adults

Contact Info

Product

Resources

About