TY - JOUR
T1 - Sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura
T2 - A randomized study
AU - Silberstein, Stephen
AU - McDonald, Susan A.
AU - Goldstein, Jerome
AU - Aurora, Sheena
AU - Lener, Shelly E.
AU - White, Jonathan
AU - Runken, Michael C.
AU - Saiers, Jane
AU - Derosier, Frederick
AU - Lipton, Richard B.
N1 - Funding Information:
This work was supported by GlaxoSmithKline. Acknowledgments
PY - 2014/4
Y1 - 2014/4
N2 - Objective: Probable migraine is a common, disabling migraine subtype fulfilling all but one of the diagnostic criteria for migraine. This study was conducted to evaluate the efficacy and tolerability of sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura. Methods: Patients treated a headache of probable migraine without aura when pain was moderate or severe with sumatriptan/naproxen sodium (n 222 intent-to-treat (ITT)) or placebo (n 221 ITT/complete case analysisa) in this randomized, double-blind, parallel-group study. Results: Sumatriptan/naproxen sodium was more effective than placebo with respect to the co-primary efficacy endpoints two-hour pain-free response (29% sumatriptan/naproxen sodium vs 11% placebo, p<0.001) and two- to 24-hour sustained pain-free response (24% sumatriptan/naproxen sodium vs 9% placebo, p<0.001). Sumatriptan/naproxen sodium was significantly more effective than placebo with respect to the secondary efficacy endpoints of pain-free response four hours postdose (p<0.001), pain-free response maintained one to two hours postdose (p 0.034) and two to four hours postdose (p<0.001), headache relief four hours postdose (p<0.001), headache relief maintained two to four hours postdose (p 0.015), sustained headache relief two through 24 hours postdose (p 0.002), and rescue medication use (p<0.001); but not productivity scores. The most common adverse events were dizziness (4% sumatriptan/ naproxen sodium,<1% placebo), dry mouth (2% sumatriptan/naproxen sodium, <1% placebo), and nausea (2% sumatriptan/naproxen sodium, <1% placebo). Conclusion: Sumatriptan/naproxen sodium is effective in the acute treatment of probable migraine as demonstrated by higher rates of freedom from pain and restoration of function.
AB - Objective: Probable migraine is a common, disabling migraine subtype fulfilling all but one of the diagnostic criteria for migraine. This study was conducted to evaluate the efficacy and tolerability of sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura. Methods: Patients treated a headache of probable migraine without aura when pain was moderate or severe with sumatriptan/naproxen sodium (n 222 intent-to-treat (ITT)) or placebo (n 221 ITT/complete case analysisa) in this randomized, double-blind, parallel-group study. Results: Sumatriptan/naproxen sodium was more effective than placebo with respect to the co-primary efficacy endpoints two-hour pain-free response (29% sumatriptan/naproxen sodium vs 11% placebo, p<0.001) and two- to 24-hour sustained pain-free response (24% sumatriptan/naproxen sodium vs 9% placebo, p<0.001). Sumatriptan/naproxen sodium was significantly more effective than placebo with respect to the secondary efficacy endpoints of pain-free response four hours postdose (p<0.001), pain-free response maintained one to two hours postdose (p 0.034) and two to four hours postdose (p<0.001), headache relief four hours postdose (p<0.001), headache relief maintained two to four hours postdose (p 0.015), sustained headache relief two through 24 hours postdose (p 0.002), and rescue medication use (p<0.001); but not productivity scores. The most common adverse events were dizziness (4% sumatriptan/ naproxen sodium,<1% placebo), dry mouth (2% sumatriptan/naproxen sodium, <1% placebo), and nausea (2% sumatriptan/naproxen sodium, <1% placebo). Conclusion: Sumatriptan/naproxen sodium is effective in the acute treatment of probable migraine as demonstrated by higher rates of freedom from pain and restoration of function.
KW - Migraine
KW - clinical trial
KW - headache
KW - probable migraine
KW - sumatriptan/naproxen sodium
UR - http://www.scopus.com/inward/record.url?scp=84896466080&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84896466080&partnerID=8YFLogxK
U2 - 10.1177/0333102413508242
DO - 10.1177/0333102413508242
M3 - Article
C2 - 24108307
AN - SCOPUS:84896466080
SN - 0333-1024
VL - 34
SP - 268
EP - 279
JO - Cephalalgia
JF - Cephalalgia
IS - 4
ER -