Efficacy and tolerability of a new powdered formulation of diclofenac potassium for oral solution for the acute treatment of migraine: Results from the International Migraine Pain Assessment Clinical Trial (IMPACT)

Lipton, Richard B.; Grosberg, Brian M.; Singer, Richard P.; Pearlman, Starr H.; Sorrentino, James V.; Quiring, John; Saper, Joel R.

doi:10.1177/0333102410367523

Cited by 49 publications

(72 citation statements)

References 27 publications

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“…32 For the four co-primary endpoints for this trial, a significantly higher percentage of patients who received diclofenac potassium for oral solution experienced no nausea, photophobia, or phonophobia at 2 h than did those who received placebo (all p < 0.002). 32 Significant improvements in pain intensity were observed 30 min after treatment with diclofenac potassium for oral solution (p = 0.013), and the improvements were maintained for the duration of the study period (24 h; p < 0.001). 32 A recent Cochrane systematic review of clinical trials of diclofenac potassium for acute migraine provided summary outcomes versus placebo (Table 4).…”

Section: Registration Trialsmentioning

confidence: 85%

“…31 In the second trial, a large, double-blind, placebocontrolled, US study, 690 patients with migraine with or without aura were randomized and received treatment with diclofenac potassium for oral solution or placebo for the acute treatment of a single moderate or severe migraine attack. 32 Significantly more patients were pain free at 2 h with diclofenac potassium for oral solution compared with placebo (25.1% versus 10.1%; p < 0.001). 32 For the four co-primary endpoints for this trial, a significantly higher percentage of patients who received diclofenac potassium for oral solution experienced no nausea, photophobia, or phonophobia at 2 h than did those who received placebo (all p < 0.002).…”

Section: Registration Trialsmentioning

confidence: 93%

“…32 Significantly more patients were pain free at 2 h with diclofenac potassium for oral solution compared with placebo (25.1% versus 10.1%; p < 0.001). 32 For the four co-primary endpoints for this trial, a significantly higher percentage of patients who received diclofenac potassium for oral solution experienced no nausea, photophobia, or phonophobia at 2 h than did those who received placebo (all p < 0.002). 32 Significant improvements in pain intensity were observed 30 min after treatment with diclofenac potassium for oral solution (p = 0.013), and the improvements were maintained for the duration of the study period (24 h; p < 0.001).…”

Section: Registration Trialsmentioning

confidence: 93%

“…26,28 Clinical studies of diclofenac for the acute treatment of a migraine attack The efficacy and safety of diclofenac potassium in the acute treatment of a migraine attack has been evaluated in 4 placebo-or active-controlled studies, including 2 studies that used different formulations 29,30 and 2 registration studies of diclofenac potassium for oral solution. 31,32 Diclofenac potassium sugar-coated tablets were evaluated in 144 patients with migraine with or without aura. 29 Headache pain at 2 h was significantly decreased with diclofenac potassium compared with placebo (difference in mm on VAS: 50 mg, −17.0; 100 mg, −18.6; p < 0.001 for both).…”

Section: Pharmacokinetics Of Diclofenacmentioning

confidence: 99%

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Diclofenac potassium for oral solution (CAMBIA^®) in the acute management of a migraine attack: clinical evidence and practical experience

Joshi

Rapoport

2017

Ther Adv Neurol Disord

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Abstract:Migraine headache affects about 12% of Western populations and is the third most common disease worldwide (sixth in terms of disability). In 1993, triptans were introduced in the United States as a new treatment for managing migraine attacks, but their use is limited by lack of response and safety concerns in some patients. Treatment options for patients with migraine who fail or cannot tolerate triptans include switching to another medication or adding an adjunctive medication. Desirable characteristics reported by patients for acute treatment of migraine attacks include complete pain relief, fast onset of action, and no pain recurrence. Diclofenac is a nonsteroidal anti-inflammatory medication that has been established as effective for acute treatment of migraine by the American Headache Society based on available evidence. Diclofenac potassium for oral solution is rapidly absorbed, achieving maximal plasma concentrations in 15 min, which coincides with a rapid onset of effect. In a comparison of diclofenac potassium for oral solution with diclofenac potassium tablets, the solution achieved a significant reduction in headache intensity beginning at 15 min compared with 60 min for the tablet. Across randomized clinical trials, approximately 25% of patients were pain free 2 h after administration of diclofenac oral solution and the effects were maintained over a 24-h period. Diclofenac potassium for oral solution is well tolerated; the most common adverse events are dizziness and gastrointestinal complaints, with incidences similar to placebo. No serious adverse events have been reported in clinical trials of diclofenac potassium for oral solution in the acute treatment of migraine. Diclofenac oral solution may offer rapid and sustained pain relief for patients who do not achieve pain resolution with other medications. In addition, patients who experience central sensitization with allodynia may benefit from the cyclooxygenase-blocking activity of diclofenac, which is needed in this advanced phase of migraine.

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Section: Registration Trialsmentioning

confidence: 85%

Section: Registration Trialsmentioning

confidence: 93%

Section: Registration Trialsmentioning

confidence: 93%

Section: Pharmacokinetics Of Diclofenacmentioning

confidence: 99%

See 2 more Smart Citations

Diclofenac potassium for oral solution (CAMBIA^®) in the acute management of a migraine attack: clinical evidence and practical experience

Joshi

Rapoport

2017

Ther Adv Neurol Disord

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“…Intravenous (IV) ketorolac can be used for emergency management of migraine. NSAID's needs to us be used with caution in patients with renal toxicity [26][27][28][29]. Characterized of different NSAID's are summarized in Table 3.…”

Section: Nsaidsmentioning

confidence: 99%

A Complete Review of Migraine

Ommurugan

Priya

Bairy

2017

Asian J Pharm Clin Res

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Migraine characterized by recurrent headaches present with aura or without aura. Various treatment modalities ranging from 5-hydroxytryptamine 1B/1D agonists, non-steroidal anti-inflammatory drugs to steroids are available for acute treatment of migraine. Prophylaxis for chronic cases is usually with β blockers, calcium channel blockers, and antiepileptics. Even many nutraceutical preparations are helpful in migraine including riboflavin, vitamin b12. This review focuses on the newer agents available for treatment of migraine with some sight into their clinical trials.

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

Derry

Rabbie²,

Moore

2012

Cochrane Database of Systematic Reviews

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Background Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers choose not to, or are unable to, seek professional help and rely on over-the-counter (OTC) analgesics. Diclofenac is an established analgesic, and new formulations using the potassium or epolamine salts, which can be dissolved in water, have been developed for rapid absorption, which may be beneficial in acute migraine. Co-therapy with an antiemetic should help to reduce the nausea and vomiting commonly associated with migraine. Objectives To determine the efficacy and tolerability of diclofenac, 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 the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Relief Database, ClinicalTrials.gov, and reference lists for studies through 27 September 2011. Selection criteria We included randomised, double-blind, placebo- and/or active-controlled studies using self administered diclofenac 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. We used numbers of participants achieving each outcome to calculate relative risk (or ‘risk ratio’) and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment. Main results Five studies (1356 participants) compared oral diclofenac with placebo, and one also compared it with sumatriptan; none combined diclofenac with a self administered antiemetic. Four studies treated attacks with single doses of medication, and two allowed an optional second dose for inadequate response. Only two studies, with three active treatment arms, provided data for pooled analysis of primary outcomes. For single doses of diclofenac potassium 50 mg versus placebo (two studies), the NNTs were 6.2, 8.9, and 9.5 for pain-free at two hours, headache relief at two hours, and pain-free responses at 24 hours, respectively. Associated symptoms of nausea, photophobia and phonophobia, and functional disability were reduced within two hours, and similar numbers of participants experienced adverse events, which were mostly mild and transient. There were insufficient data to evaluate other doses of oral diclofenac, or to compare different formulations or different dosing regimens; only one study compared oral diclofenac with an active comparator (oral sumatriptan 100 mg). Authors’ conclusions Oral diclofenac potassium 50 mg is an effective treatment for acute migraine, providing relief from pain and associated symptoms, although only a minority of patients experience pain-free responses. Adverse events are mostly mild and transient and occur at the same rate as with placebo.

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Efficacy and tolerability of a new powdered formulation of diclofenac potassium for oral solution for the acute treatment of migraine: Results from the International Migraine Pain Assessment Clinical Trial (IMPACT)

Cited by 49 publications

References 27 publications

Diclofenac potassium for oral solution (CAMBIA^®) in the acute management of a migraine attack: clinical evidence and practical experience

Diclofenac potassium for oral solution (CAMBIA^®) in the acute management of a migraine attack: clinical evidence and practical experience

A Complete Review of Migraine

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

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Efficacy and tolerability of a new powdered formulation of diclofenac potassium for oral solution for the acute treatment of migraine: Results from the International Migraine Pain Assessment Clinical Trial (IMPACT)

Cited by 49 publications

References 27 publications

Diclofenac potassium for oral solution (CAMBIA®) in the acute management of a migraine attack: clinical evidence and practical experience

Diclofenac potassium for oral solution (CAMBIA®) in the acute management of a migraine attack: clinical evidence and practical experience

A Complete Review of Migraine

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

Contact Info

Product

Resources

About

Diclofenac potassium for oral solution (CAMBIA^®) in the acute management of a migraine attack: clinical evidence and practical experience

Diclofenac potassium for oral solution (CAMBIA^®) in the acute management of a migraine attack: clinical evidence and practical experience