Acute Treatment of Migraine Attacks: Efficacy and Safety of A Nonsteroidal Anti-Inflammatory Drug, Diclofenac-Potassium, in Comparison To Oral Sumatriptan and Placebo

Bussone, G.; Grazzi, Licia; D’Amico, Domenico; Manzoni, Cristina; Granella, Franco; Cortelli, Pietro; Pierangeli, Giulia; Canal, N.; Colombo, Bruno; Frediani, Fabio; Maltempo, C.; Peruzzi, Elena; Edson, Kathryn; Ezzet, N.; Huels, Jasper

doi:10.1046/j.1468-2982.1999.019004232.x

Cited by 89 publications

(22 citation statements)

References 21 publications

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“…Enterocoated diclofenac 50 mg had marginal efficacy [64] whereas the more rapidly absorbed potassium salt or the sodium salt softgel formulation were superior at doses of 50 mg and 100 mg in several trials [94,95,96,97]. In one placebo-controlled trial, diclofenac K was as effective as caffeine plus ergotamine [96].…”

Section: Results Of Randomized Controlled Trialsmentioning

confidence: 99%

“…In one placebo-controlled trial, diclofenac K was as effective as caffeine plus ergotamine [96]. There was no increase in efficacy with 100 mg diclofenac compared to 50 mg [94,95] but adding 100 mg caffeine enhanced the efficacy of 100 mg diclofenac softgel but also caused more side effects [97]. Diclofenac sodium was found as effective as oral sumatriptan 100 mg in one study and had less adverse effects [97].…”

Section: Results Of Randomized Controlled Trialsmentioning

confidence: 99%

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NSAIDs in the Acute Treatment of Migraine: A Review of Clinical and Experimental Data

Párdutz

Schoenen

2010

Pharmaceuticals

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Migraine is a common disabling neurological disorder with a serious socio-economical burden. By blocking cyclooxygenase nonsteroidal anti-inflammatory drugs (NSAIDs) decrease the synthesis of prostaglandins, which are involved in the pathophysiology of migraine headaches. Despite the introduction more than a decade ago of a new class of migraine-specific drugs with superior efficacy, the triptans, NSAIDs remain the most commonly used therapies for the migraine attack. This is in part due to their wide availability as over-the-counter drugs and their pharmaco-economic advantages, but also to a favorable efficacy/side effect profile at least in attacks of mild and moderate intensity. We summarize here both the experimental data showing that NSAIDs are able to influence several pathophysiological facets of the migraine headache and the clinical studies providing evidence for the therapeutic efficacy of various subclasses of NSAIDs in migraine therapy. Taken together these data indicate that there are several targets for NSAIDs in migraine pathophysiology and that on the spectrum of clinical potency acetaminophen is at the lower end while ibuprofen is among the most effective drugs. Acetaminophen and aspirin excluded, comparative trials between the other NSAIDs are missing. Since evidence-based criteria are scarce, the selection of an NSAID should take into account proof and degree of efficacy, rapid GI absorption, gastric ulcer risk and previous experience of each individual patient. If selected and prescribed wisely, NSAIDs are precious, safe and cost-efficient drugs for the treatment of migraine attacks.

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Section: Results Of Randomized Controlled Trialsmentioning

confidence: 99%

Section: Results Of Randomized Controlled Trialsmentioning

confidence: 99%

NSAIDs in the Acute Treatment of Migraine: A Review of Clinical and Experimental Data

Párdutz

Schoenen

2010

Pharmaceuticals

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“…Diclofenac potassium immediate-release tablets were also evaluated in patients with acute migraine headaches. The rapid and effective analgesia reported for diclofenac in studies in other acute pain conditions and the potent anti-inflammatory activity of diclofenac were considered to be potentially beneficial in preventing neurogenic inflammation, one of the major causes underlying migraine attacks [ 146 , 147 ]. In clinical studies, diclofenac potassium immediate-release tablets were reported to be effective in relieving migraine pain and provided significant pain relief 1 – 2 h following initial dosing [ 147 , 148 ].…”

Section: Oral Preparations Of Diclofenac Potassiummentioning

confidence: 99%

“…The rapid and effective analgesia reported for diclofenac in studies in other acute pain conditions and the potent anti-inflammatory activity of diclofenac were considered to be potentially beneficial in preventing neurogenic inflammation, one of the major causes underlying migraine attacks [ 146 , 147 ]. In clinical studies, diclofenac potassium immediate-release tablets were reported to be effective in relieving migraine pain and provided significant pain relief 1 – 2 h following initial dosing [ 147 , 148 ]. In one study, diclofenac potassium immediate-release tablets appeared to be as efficacious as, but better tolerated than, the serotonin agonist sumatriptan, a first-line agent commonly prescribed for the relief of migraine headache [ 147 ].…”

Section: Oral Preparations Of Diclofenac Potassiummentioning

confidence: 99%

Advances in NSAID Development: Evolution of Diclofenac Products Using Pharmaceutical Technology

Altman¹,

Bosch

Brune

et al. 2015

Drugs

377

193

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Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) of the phenylacetic acid class with anti-inflammatory, analgesic, and antipyretic properties. Contrary to the action of many traditional NSAIDs, diclofenac inhibits cyclooxygenase (COX)-2 enzyme with greater potency than it does COX-1. Similar to other NSAIDs, diclofenac is associated with serious dose-dependent gastrointestinal, cardiovascular, and renal adverse effects. Since its introduction in 1973, a number of different diclofenac-containing drug products have been developed with the goal of improving efficacy, tolerability, and patient convenience. Delayed- and extended-release forms of diclofenac sodium were initially developed with the goal of improving the safety profile of diclofenac and providing convenient, once-daily dosing for the treatment of patients with chronic pain. New drug products consisting of diclofenac potassium salt were associated with faster absorption and rapid onset of pain relief. These include diclofenac potassium immediate-release tablets, diclofenac potassium liquid-filled soft gel capsules, and diclofenac potassium powder for oral solution. The advent of topical formulations of diclofenac enabled local treatment of pain and inflammation while minimizing systemic absorption of diclofenac. SoluMatrix diclofenac, consisting of submicron particles of diclofenac free acid and a proprietary combination of excipients, was developed to provide analgesic efficacy at reduced doses associated with lower systemic absorption. This review illustrates how pharmaceutical technology has been used to modify the pharmacokinetic properties of diclofenac, leading to the creation of novel drug products with improved clinical utility.

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“…Another interesting aspect is that regarding headache response triptans have so far failed to show a clear superiority over analgesics such as ASA [6, 18], ketoprofen [19], diclofenac-K [20]or tolfenamic acid [21]. With the exception of the above-mentioned trials [10, 11], however, triptans were more effective than analgesics or NSAIDs for the parameter ‘pain free after 2 h’.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of 1,000 mg Effervescent Acetylsalicylic Acid and Sumatriptan in Treating Associated Migraine Symptoms

Eikermann

Gessner

et al. 2004

Eur Neurol

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Recently a new effervescent acetylsalicylic acid (ASA) tablet with high buffering capacity has been developed. In this double-blind, 3-arm, multicenter, parallel-group study, 433 patients were treated either with 1,000 mg effervescent ASA or 50 mg encapsulated sumatriptan or placebo. The primary endpoint was the percentage of patients with complete remission of the 3 accompanying symptoms nausea, photophobia and phonophobia within 2 h after intake of the study drug. 43.8% of patients treated with ASA, 43.7% of patients treated with sumatriptan and 30.9% of patients treated with placebo showed complete remission of all 3 accompanying symptoms (p < 0.05 for ASA and sumatriptan vs. placebo). Both active treatments were superior to placebo regarding the individual symptoms photophobia and phonophobia, but not for nausea. The percentage of patients with reduction in headache severity from moderate or severe to mild or no pain (secondary objective) was 49.3% for ASA, 48.8% for sumatriptan and 32.9% for placebo. All active treatments were superior to placebo (p < 0.05). 25.3, 24.4 and 14.5% of patients treated with ASA, sumatriptan or placebo were pain free at 2 h. Drug-related adverse events were reported in 3.9, 4.7 and 6.7% of patients treated with placebo, ASA or sumatriptan. The study showed that administration of effervescent ASA leads to remission of the migraine symptoms nausea, photophobia and phonophobia, reduces migraine headache and is comparable to sumatriptan.

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Acute Treatment of Migraine Attacks: Efficacy and Safety of A Nonsteroidal Anti-Inflammatory Drug, Diclofenac-Potassium, in Comparison To Oral Sumatriptan and Placebo

Cited by 89 publications

References 21 publications

NSAIDs in the Acute Treatment of Migraine: A Review of Clinical and Experimental Data

NSAIDs in the Acute Treatment of Migraine: A Review of Clinical and Experimental Data

Advances in NSAID Development: Evolution of Diclofenac Products Using Pharmaceutical Technology

Efficacy of 1,000 mg Effervescent Acetylsalicylic Acid and Sumatriptan in Treating Associated Migraine Symptoms

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