Twelve-Month Tolerability and Safety of Sumatriptan--Naproxen Sodium for the Treatment of Acute Migraine

Winner, Paul; Cady, Roger K.; Ruoff, Gary E.; Frishberg, Benjamin M.; W. James Alexander; Ying Zhang; Kori, Shashidhar H.; Lener, Shelly E.
January 2007
Mayo Clinic Proceedings;Jan2007, Vol. 82 Issue 1, p61
Academic Journal
OBJECTIVES: To evaluate the long-term safety and tolerability of sumatriptan-naproxen sodium for the treatment of moderate to severe acute migraines and to assess the safety of administration of an optional second dose. PATIENTS AND METHODS: A 12-month, multicenter, open-label safety study was conducted In adults treated for migraine attacks of moderate to severe Intensity from April 14, 2004, to August 18, 2005. Safety evaluations Included adverse events and laboratory tests. RESULTS: Of 600 patients enrolled, 565 (94%) were treated for at least 1 migraine. Of treated patients, 414 (73%) and 362 (64%) completed 6 and 12 months of treatment, respectively. Of the. 24,485 attacks treated, 17,144 (70%) were treated with only 1 dose. On average, patients treated 5 migraine attacks per month, with a median of 6 days between attacks. The most common treatment-related adverse events were nausea, muscle tightness, and dizziness. Fourteen patients reported I or more serious adverse event with only 1 judged probably related to treatment. No deaths occurred. Eight percent of patients discontinued participation In the study because of adverse events or pregnancy. The rates of adverse events reported were no higher after treatment with 2 tablets (at least 2 hours apart) compared with 1 tablet. CONCLUSIONS: In this 12-month data set of more than 24,000 migraine attacks in 565 patIents, sumatriptan-naproxen sodium formulated In a single tablet was well tolerated when used episodically for the treatment of acute migraine. The adverse events did not differ from those expected for the Individual components alone, and no new or unexpected findings occurred.


Related Articles

  • sumatriptan.  // Royal Society of Medicine: Medicines;2002, p517 

    The article presents information on sumatriptan, a drug which is used to treat acute migraine attacks. Administration is oral as tablets, by injection, or as a nasal spray. Drugs of this class are used only with great caution in conditions predisposing to coronary artery disease. Sumatriptan is...

  • Sumatriptan.  // Reactions Weekly;10/25/2008, Issue 1225, p24 

    The article describes the case of a 50-year-old woman who developed ischaemic colitis after receiving intramuscular (IM) sumatriptan. She has a long-term history of migraine and had been taking oral sumatriptan for many years. She was brought to the hospital with abdominal pain, nausea, vomiting...

  • sumatriptan. Peters, Michael // BMA A-Z Family Medical Encyclopedia;2004, p721 

    An encyclopedia entry for "sumatriptan" is presented. It is a serotonin agonist drug used to relieve acute attacks of migraine and effective in treating cluster headaches. The drug is also used by people who have migraines that do not respond to analgesic drugs. Side effects of the drugs include...

  • Can Earlier Treatment of Episodic Migraine Improve a Patient's Well-Being? Dziedzic, Jessica // Neurology Reviews;Aug2007, Vol. 15 Issue 8, p52 

    The article focuses on the study concerning the effects of using triptan in treating migraine in Chicago, Illinois. The senior director at Merck & Co. Inc., Henry Hu, found out that the earlier a patient identified a migraine and took triptan, the shorter the time from headache onset to peak...

  • Rizatriptan.  // Reactions Weekly;12/5/2009, Issue 1281, p28 

    The article describes the case of a woman who developed acute-on-chronic ischaemic colitis while receiving treatment with rizatriptan for migraine. Before the presentation, she had experienced severe headaches and taken oral rizatriptan. She was diagnosed with rizatriptan induced...

  • Meeting Acute Migraine Treatment Needs through Novel Treatment Formulations Silberstein, Stephen D. // Neurotherapeutics;Apr2010, Vol. 7 Issue 2, p153 

    Summary: Migraineurs often do not use acute migraine-specific medications. Patient-reported satisfaction with triptans is modest. Patients are generally interested in obtaining more rapid and complete symptom relief. The role of trigeminal vascular activation may explain why some patients fail...

  • Drug Combo Better for Migraine Treatment.  // Primary Care Reports;May2007, Vol. 13 Issue 5, p2 

    The article discusses research on the efficacy of a combination of naprosyn and sumatriptan drugs from Pozen Pharmaceuticals/GlaxoSmithKline for the treatment of acute migraine. In studies conducted, patients with migraine were randomized to sumatriptan plus naproxen sodium, both drugs alone, or...

  • Sumatriptan.  // Reactions Weekly;11/24/2007, Issue 1179, p32 

    The article describes the case of a 50-year-old woman who, after receiving oral sumatriptan for migraine, had a myocardial infarction. On two previous occasions, the woman, who was a smoker, had received sumatriptan. Oral sumatriptan 100mg was given to her. She presented to hospital acutely with...

  • Sumatriptan.  // AHFS Consumer Medication Information;Apr2018, p1 

    Sumatriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes is accompanied by nausea or sensitivity to sound and light). Sumatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics