Twelve-month tolerability and safety of sumatriptan-naproxen sodium for the treatment of acute migraine.
OBJECTIVE
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.


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 1 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.
Winner
Paul
P
Palm Beach Headache Center, 4631 N Congress Ave, Suite 200, West Palm Beach, FL 33407, USA. eneuro@aol.com
Cady
Roger K
RK
Ruoff
Gary E
GE
Frishberg
Benjamin M
BM
Alexander
W James
WJ
Zhang
Ying
Y
Kori
Shashidhar H
SH
Lener
Shelly E
SE
D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D009288:Naproxen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018170:Sumatriptan / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016312:Treatment Refusal; D014662:Vasoconstrictor Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D014662:Vasoconstrictor Agents; D009288:Naproxen; D018170:Sumatriptan