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Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life.
Headache. 2009 Jul; 49(7):971-82.H

Abstract

OBJECTIVE

To evaluate efficacy and tolerability of a single, fixed-dose tablet of sumatriptan 85 mg/naproxen sodium 500 mg (sumatriptan/naproxen sodium) vs placebo in migraineurs who had discontinued treatment with a short-acting triptan because of poor response or intolerance.

BACKGROUND

Triptan monotherapy is ineffective or poorly tolerated in 1 of 3 migraineurs and in 2 of 5 migraine attacks. In April, 2008, the Food and Drug Administration approved the combination therapy sumatriptan/naproxen sodium, developed specifically to target multiple migraine mechanisms. This combination product offers an alternative migraine therapy for patients who have reported poor response or intolerance to short-acting triptans.

METHODS

Two replicate, randomized, multicenter, double-blind, placebo-controlled, 2-attack crossover trials evaluated migraineurs who had discontinued a short-acting triptan in the past year because of poor response or intolerance. Patients were instructed to treat within 1 hour and while pain was mild.

RESULTS

Patients (n = 144 study 1; n = 139 study 2) had discontinued an average of 3.3 triptans before study entry. Sumatriptan/naproxen sodium was superior (P < .001) to placebo for 2- through 24-hour sustained pain-free response (primary end point) (study 1, 26% vs 8%; study 2, 31% vs 8%) and pain-free response 2 hours post dose (key secondary end point) (study 1, 40% vs 17%; study 2, 44% vs 14%). A similar pattern of results was observed for other end points that evaluated acute (2- or 4-hour), intermediate (8-hour), or 2- through 24-hour sustained response for migraine (ie, pain and associated symptoms), photophobia, phonophobia, or nausea (with the exception of nausea 2 and 4 hours post dose). The percentage of patients with at least 1 adverse event (regardless of causality) was 11% with sumatriptan/naproxen sodium compared with 4% with placebo in study 1 and 9% with sumatriptan/naproxen sodium compared with 5% with placebo in study 2. Only 1 adverse event in 1 study was reported in > or =2% of patients after treatment with sumatriptan/naproxen sodium and reported more frequently with sumatriptan/naproxen than placebo: chest discomfort was reported in 2% of subjects in study 1, and no events met this threshold in study 2. No serious adverse events attributed to study medication were reported in either study.

CONCLUSION

In migraineurs who reported poor response to a short-acting triptan, sumatriptan/naproxen sodium was generally well tolerated and significantly more effective than placebo in conferring initial, intermediate, and sustained efficacy for pain and migraine-associated symptoms of photophobia and phonophobia.

Authors+Show Affiliations

Houston Headache Clinic, Houston, 1213 Hermann Drive, Suite 820, Houston, TX 77004, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19486178

Citation

Mathew, Ninan T., et al. "Fixed-dose Sumatriptan and Naproxen in Poor Responders to Triptans With a Short Half-life." Headache, vol. 49, no. 7, 2009, pp. 971-82.
Mathew NT, Landy S, Stark S, et al. Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache. 2009;49(7):971-82.
Mathew, N. T., Landy, S., Stark, S., Tietjen, G. E., Derosier, F. J., White, J., Lener, S. E., & Bukenya, D. (2009). Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache, 49(7), 971-82. https://doi.org/10.1111/j.1526-4610.2009.01458.x
Mathew NT, et al. Fixed-dose Sumatriptan and Naproxen in Poor Responders to Triptans With a Short Half-life. Headache. 2009;49(7):971-82. PubMed PMID: 19486178.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. AU - Mathew,Ninan T, AU - Landy,Stephen, AU - Stark,Stuart, AU - Tietjen,Gretchen E, AU - Derosier,Frederick J, AU - White,Jonathan, AU - Lener,Shelly E, AU - Bukenya,Deo, Y1 - 2009/05/27/ PY - 2009/6/3/entrez PY - 2009/6/3/pubmed PY - 2009/10/9/medline SP - 971 EP - 82 JF - Headache JO - Headache VL - 49 IS - 7 N2 - OBJECTIVE: To evaluate efficacy and tolerability of a single, fixed-dose tablet of sumatriptan 85 mg/naproxen sodium 500 mg (sumatriptan/naproxen sodium) vs placebo in migraineurs who had discontinued treatment with a short-acting triptan because of poor response or intolerance. BACKGROUND: Triptan monotherapy is ineffective or poorly tolerated in 1 of 3 migraineurs and in 2 of 5 migraine attacks. In April, 2008, the Food and Drug Administration approved the combination therapy sumatriptan/naproxen sodium, developed specifically to target multiple migraine mechanisms. This combination product offers an alternative migraine therapy for patients who have reported poor response or intolerance to short-acting triptans. METHODS: Two replicate, randomized, multicenter, double-blind, placebo-controlled, 2-attack crossover trials evaluated migraineurs who had discontinued a short-acting triptan in the past year because of poor response or intolerance. Patients were instructed to treat within 1 hour and while pain was mild. RESULTS: Patients (n = 144 study 1; n = 139 study 2) had discontinued an average of 3.3 triptans before study entry. Sumatriptan/naproxen sodium was superior (P < .001) to placebo for 2- through 24-hour sustained pain-free response (primary end point) (study 1, 26% vs 8%; study 2, 31% vs 8%) and pain-free response 2 hours post dose (key secondary end point) (study 1, 40% vs 17%; study 2, 44% vs 14%). A similar pattern of results was observed for other end points that evaluated acute (2- or 4-hour), intermediate (8-hour), or 2- through 24-hour sustained response for migraine (ie, pain and associated symptoms), photophobia, phonophobia, or nausea (with the exception of nausea 2 and 4 hours post dose). The percentage of patients with at least 1 adverse event (regardless of causality) was 11% with sumatriptan/naproxen sodium compared with 4% with placebo in study 1 and 9% with sumatriptan/naproxen sodium compared with 5% with placebo in study 2. Only 1 adverse event in 1 study was reported in > or =2% of patients after treatment with sumatriptan/naproxen sodium and reported more frequently with sumatriptan/naproxen than placebo: chest discomfort was reported in 2% of subjects in study 1, and no events met this threshold in study 2. No serious adverse events attributed to study medication were reported in either study. CONCLUSION: In migraineurs who reported poor response to a short-acting triptan, sumatriptan/naproxen sodium was generally well tolerated and significantly more effective than placebo in conferring initial, intermediate, and sustained efficacy for pain and migraine-associated symptoms of photophobia and phonophobia. SN - 1526-4610 UR - https://www.unboundmedicine.com/medline/citation/19486178/Fixed_dose_sumatriptan_and_naproxen_in_poor_responders_to_triptans_with_a_short_half_life_ L2 - https://doi.org/10.1111/j.1526-4610.2009.01458.x DB - PRIME DP - Unbound Medicine ER -