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

Abstract

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.

Efficacy and safety of 1,000mg effervescent aspirin: individual patient data meta-analysis of three trials in migraine headache and migraine accompanying symptoms

“…In Table 1, the design and the characteristics of the three studies [12][13][14] are summarised. The individual patient data of these placebo-controlled, double-blind, randomised clinical trials con- ducted in adult patients between 1998 and 2002 were transferred into a new database and an efficacy and safety analysis according to a predefined statistical analysis plan (SAP) was performed.…”

“…Aspirin (acetylsalicylic acid, ASA) has been investigated in different oral and injectable formulations and in co-administration with antiemetic drugs that increase gastric motility to facilitate the absorption of ASA and thus enhance its efficacy [10,11]. An effervescent highly buffered formulation of 500 mg aspirin (eASA) with an acid neutralization capacity of 15 mEq that promotes stomach motility and enhances the onset of the analgesic effect, has been shown to be effective without antiemetics at a dose of 1,000 mg (2 x 500 mg) for the treatment of acute migraine headache and migraine accompanying symptoms [11][12][13][14].…”

Sumatriptan (Oral Route of Administration) for Acute Migraine Attacks in Adults

“…• Sumatriptan 50 mg versus placebo (160-104;Bussone 2000;Dahlof 2009;Diener 2004a;Diener 2004b;Goldstein 1998;Goldstein 2005;Ishkanian 2007;Jelinski 2006;Kolodny 2004;Kudrow 2005;Lines 2001;Nett 2003;Pfaffenrath 1998;Pini 1999;Sandrini 2002;Sargent 1995;Savani 1999;Sheftell 2005 • Sumatriptan 50 mg versus tonabersat 20 mg (Dahlof 2009). …”

“…• Sumatriptan 50 mg versus effervescent acetylsalicylic acid (ASA) 1000 mg (Diener 2004a;Diener 2004b). …”

“…Sumatriptan 50 mg verus placebo-Four studies (2079 participants) provided data for the use of rescue medication up to 24 hours after initial dosing, in participants with moderate or severe baseline pain intensity (Diener 2004a;Ishkanian 2007;). …”