Valdecoxib for Treatment of a Single, Acute, Moderate to Severe Migraine Headache

Kudrow, David; Thomas, Hallie; Ruoff, Gary; Ishkanian, Gary; Sands, George H.; Le, Vu; Brown, Mark T.

doi:10.1111/j.1526-4610.2005.00238.x

Cited by 21 publications

(26 citation statements)

References 25 publications

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“…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%

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

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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.

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Section: Discussionsupporting

confidence: 72%

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

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“…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%

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

669

544

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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.

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“…Another large RCDBT has compared two doses of valdecoxib (20 and 40 mg) with placebo and sumatriptan 50 mg doses. This showed that valdecoxib was better than placebo and similar to sumatriptan, but with fewer side effects [108]. A small open-label study [109], comparing the effect of yet another COX 2 inhibitor, celecoxib 400 mg, with that of a classic NSAID (Naproxen 550 mg) for a single migraine attack, found similar efficacy for the two drugs, but significantly fewer in the celecoxib group reported epigastric pain.…”

Section: Drugs Influencing the Prostanoid Systemmentioning

confidence: 99%

New drugs for migraine

2009

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After the triptans, a calcitonin gene-related peptide blocker (telcagepant) is the first acute medicine that has been developed primarily for treatment of acute migraine. Otherwise, the new drugs have been developed first for other purposes, like anticonvulsants, antihypertensives and antidepressants used for migraine prophylaxis. For acute attacks, a new way to administer a traditional drug like dihydroergotamine is under way, and documentation of efficacy in migraine has been gained for some commonly used painkillers and anti-inflammatory drugs, and for some herbal extracts. Based on insights into the basic pathophysiological mechanisms of the disorder, some drugs have been developed which seem promising in early phase II studies (NOS inhibitors and 5HT1F-receptor agonists). In the future, development and enhancements of existing medicines must be accompanied by increased efforts to develop truly new migraine drugs based on knowledge of the pathophysiology if one wishes to reduce substantially the great burden migraine poses on patients and society.

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Valdecoxib for Treatment of a Single, Acute, Moderate to Severe Migraine Headache

Abstract: A single 40-mg dose of valdecoxib is effective and well tolerated in treatment of migraine headache pain and associated symptoms.

Cited by 21 publications

References 25 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

New drugs for migraine

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