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Drugs
Published in: Drugs 12/2013

01-08-2013 | Adis Drug Evaluation

Sumatriptan/Naproxen Sodium: A Review of Its Use in Adult Patients with Migraine

Author: Lily P. H. Yang

Published in: Drugs | Issue 12/2013

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Abstract

A fixed-dose combination of sumatriptan/naproxen sodium (Treximet®) has been approved in the US for the acute treatment of migraine in adults. In two randomized trials, sumatriptan/naproxen sodium demonstrated significantly better efficacy than sumatriptan alone, naproxen sodium alone, or placebo as late-intervention therapy for a single migraine episode in adults, as assessed by co-primary efficacy endpoints evaluating pain and other migraine-related symptoms, as well as health-related quality of life (HR-QOL) endpoints. In four other randomized trials, the drug combination was also effective as early intervention in adults with migraine (including those with menstrual migraine and dysmenorrhoea, or those with poor response or intolerance to triptan therapy) according to various pain-related primary efficacy and HR-QOL endpoints. Data from longer-term, non-randomized studies support these findings, and the drug combination appears to be beneficial in patients with migraine and cutaneous allodynia. In clinical trials, sumatriptan/naproxen sodium was generally well tolerated, with an overall tolerability profile similar to that of sumatriptan. The most common adverse events were in line with those expected for sumatriptan and naproxen sodium. Current data indicate that sumatriptan/naproxen sodium is a useful option in the treatment of adult migraine.
Literature
1.
Stovner L, Hagen K, Jensen R, et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007;27(3):193–210.PubMedCrossRef
2.
Leonardi M, Steiner TJ, Scher AT, et al. The global burden of migraine: measuring disability in headache disorders with WHO’s Classification of Functioning, Disability and Health (ICF). J Headache Pain. 2005;6(6):429–40.PubMedCrossRef
3.
Tfelt-Hansen P, Olesen J. Taking the negative view of current migraine treatments: the unmet needs. CNS Drugs. 2012;26(5):375–82.PubMedCrossRef
4.
Diamond S, Bigal ME, Silberstein S, et al. Patterns of diagnosis and acute and preventive treatment for migraine in the United States: results from the American Migraine Prevalence and Prevention study. Headache. 2007;47(3):355–63.PubMed
5.
Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343–9.PubMedCrossRef
6.
Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology [published erratum appears in Neurology. 2000;56(1):142]. Neurology. 2000;55(6):754–62.PubMedCrossRef
7.
Snow V, Weiss K, Wall EM, et al. Pharmacologic management of acute attacks of migraine and prevention of migraine headache. Ann Intern Med. 2002;137(10):840–9.PubMedCrossRef
8.
Evers S, Afra J, Frese A, et al. EFNS guideline on the drug treatment of migraine: revised report of an EFNS task force. Eur J Neurol. 2009;16(9):968–81.PubMedCrossRef
9.
10.
11.
Tfelt-Hansen P, De Vries P, Saxena PR. Triptans in migraine: a comparative review of pharmacology, pharmacokinetics and efficacy. Drugs. 2000;60(6):1259–87.PubMedCrossRef
12.
Rao P, Knaus EE. Evolution of nonsteroidal anti-inflammatory drugs (NSAIDs): cyclooxygenase (COX) inhibition and beyond. J Pharm Pharm Sci. 2008;11(2):81s–110s.PubMed
13.
Khoury CK, Couch JR. Sumatriptan-naproxen fixed combination for acute treatment of migraine: a critical appraisal. Drug Des Devel Ther. 2010;4:9–17.PubMedCrossRef
14.
Vause CV, Durham PL. Identification of cytokines and signaling proteins differentially regulated by sumatriptan/naproxen. Headache. 2012;52(1):80–9.PubMedCrossRef
15.
De Felice M, Edelmayer R, Kasasbeh A, et al. Chronic exposure to sumatriptan, but not to sumatriptan plus naproxen, induces latent sensitization and increased excitability of dural afferents [abstract no. PS1-59]. Cephalalgia. 2011;31(1 Suppl):45.
16.
Derry CJ, Derry S, Moore RA. Sumatriptan (oral route of administration) for acute migraine attacks in adults. Cochrane Database Syst Rev. 2012;2:CD008615.
17.
Suthisisang CC, Poolsup N, Suksomboon N, et al. Meta-analysis of the efficacy and safety of naproxen sodium in the acute treatment of migraine. Headache. 2012;50(5):808–18.CrossRef
18.
Krymchantowski AV. Naproxen sodium decreases migraine recurrence when administered with sumatriptan. Arq Neuropsiquiatr. 2000;58(2B):428–30.
19.
Smith TR, Sunshine A, Stark SR, et al. Sumatriptan and naproxen sodium for the acute treatment of migraine. Headache. 2005;45(8):983–91.PubMedCrossRef
20.
Haberer LJ, Walls CM, Lener SE, et al. Distinct pharmacokinetic profile and safety of a fixed-dose tablet of sumatriptan and naproxen sodium for the acute treatment of migraine. Headache. 2010;50(3):357–73.PubMedCrossRef
21.
White WB, Derosier FJ, Thompson AH, et al. Evaluation of the migraine treatment sumatriptan/naproxen sodium on blood pressure following long-term administration. J Clin Hypertens. 2011;13(12):910–6.CrossRef
22.
Edwards KR, Rosenthal BL, Farmer KU, et al. Evaluation of sumatriptan-naproxen in the treatment of acute migraine: a placebo-controlled, double-blind, cross-over study assessing cognitive function. Headache. 2013;53(4):656–64.PubMedCrossRef
23.
Srinivasu P, Rambhau D, Rao BR, et al. Lack of pharmacokinetic interaction between sumatriptan and naproxen. J Clin Pharmacol. 2000;40(1):99–104.PubMedCrossRef
24.
Todd PA, Clissold SP. Naproxen: a reappraisal of its pharmacology, and therapeutic use in rheumatic diseases and pain states. Drugs. 1990;40(1):91–137.PubMedCrossRef
25.
Brandes JL, Kudrow D, Stark SR, et al. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007;297(13):1443–54.PubMedCrossRef
26.
Silberstein SD, Mannix LK, Goldstein J, et al. Multimechanistic (sumatriptan-naproxen) early intervention for the acute treatment of migraine [published erratum appears in Neurology. 2009;72(15):1369]. Neurology. 2008;71(2):114–21.PubMedCrossRef
27.
Mannix LK, Martin VT, Cady RK, et al. Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials. Obstet Gynecol. 2009;114(1):106–13.PubMed
28.
Lipton RB, Dodick DW, Adelman JU, et al. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled, crossover study. Cephalalgia. 2009;29(8):826–36.PubMedCrossRef
29.
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.PubMedCrossRef
30.
Smith T, Blumenthal H, Diamond M, et al. Sumatriptan/naproxen sodium for migraine: efficacy, health related quality of life, and satisfaction outcomes. Headache. 2007;47(5):683–92.PubMedCrossRef
31.
Cady R, Banks J, Nett RB, et al. Multi-center comparison of response to a single tablet of sumatriptan 85 mg and naproxen 500 mg vs usual therapy treating multiple migraine attacks as measured by the completeness of response survey. Headache. 2011;51(6):961–70.PubMedCrossRef
32.
Landy S, Hoagland R, Hoagland NA. Sumatriptan-naproxen migraine efficacy in allodynic patients: early intervention. Headache. 2012;52(1):133–9.PubMedCrossRef
33.
Landy S, DeRossett SE, Rapoport A, et al. Two double-blind, multicenter, randomized, placebo-controlled, single-dose studies of sumatriptan/naproxen sodium in the acute treatment of migraine: function, productivity, and satisfaction outcomes. MedGenMed. 2007;9(2):53.PubMed
34.
Landy S, White J, Lener SE, et al. Fixed-dose sumatriptan/naproxen sodium compared with each monotherapy utilizing the novel composite endpoint of sustained pain-free/no adverse events. Ther Adv Neurol Disord. 2009;2(3):135–41.PubMedCrossRef
35.
Lener S, Richard N, McDonald S, et al. Prior acute treatment of migraine is not a predictive factor of sumatriptan/naproxen sodium (SumaRT/Nap) response or superiority over the components [abstract no. PO32]. Cephalalgia. 2009;29(1 Suppl):23–4.
36.
Derosier F, Thompson AH, Richard N. Exploration of the relationship between presence or absence of aura to response and tolerability after treatment with sumatriptan 85 mg formulated with RT technology/naproxen sodium 500 mg (SumaRT/Nap) for the early intervention treatment of migraine [abstract no. PO258]. Cephalalgia. 2009;29(1 Suppl):112–3.
37.
Winner PK, Brandes JL, Thompson AH, et al. Evaluation of the relationship body mass index (BMI) to response and tolerability after treatment with sumatriptan 85 mg formulated with RT technology/naproxen sodium 500 mg (SumaRT/Nap) for the early intervention treatment of migraine [abstract no. PO38]. Cephalalgia. 2009;29(1 Suppl):26.
38.
Lener S, Palchinsky J, Richard N, et al. Does gender affect efficacy and tolerability of SumaRT/Nap during the early intervention treatment of migraine? [abstract no. P06.247]. In: Proceedings of the 62nd annual meeting of the American Academy of Neurology; 10–17 Apr 2010; Toronto.
39.
Taylor FR, Heiring JO, Messina E, et al. Sumatriptan/naproxen sodium as early intervention for migraine: effects on functional ability, productivity, and satisfaction in 2 randomized controlled trials. J Clin Outcomes Manage. 2007;14(4):195–204.
40.
Cady RK, Diamond ML, Diamond MP, et al. Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes. Headache. 2011;51(5):664–73.PubMedCrossRef
41.
Lipton RB, McDonald SA, Richard NE, et al. Evaluation of consistency of adverse events after treatment of multiple attacks with a fixed-dose single tablet of sumatriptan and naproxen sodium (SumaRT/Nap) [abstract no. PO35]. Cephalalgia. 2009;29(1 Suppl):25.
42.
Winner P, Cady RK, Ruoff GE, et al. Twelve-month tolerability and safety of sumatriptan-naproxen sodium for the treatment of acute migraine. Mayo Clin Proc. 2007;82(1):61–8.PubMed
43.
Cady RJ, Shade CL, Cady RK. Advances in drug development for acute migraine. Drugs. 2012;72(17):2187–205.PubMedCrossRef
44.
Loder E. Fixed drug combinations for the acute treatment of migraine: place in therapy. CNS Drugs. 2005;19(9):769–84.PubMedCrossRef
45.
Straube A, Aicher B, Fiebich BL, et al. Combined analgesics in (headache) pain therapy: shotgun approach or precise multi-target therapeutics? BMC Neurol. 2011;11:43.
46.
Matchar DB, McCrory DC, Gray RN. Toward evidence-based management of migraine. JAMA. 2000;284(20):2640–1.PubMedCrossRef
47.
Lipton RB, Stewart WF, Stone AM, et al. Stratified care vs step care strategies for migraine: the disability in strategies of care (DISC) study: a randomized trial. JAMA. 2000;284(20):2599–605.PubMedCrossRef
48.
Houghton LA, Fowler P, Keene ON, et al. Effect of sumatriptan, a new selective 5HT1-like agonist, on liquid gastric emptying in man. Aliment Pharmacol Ther. 1992;6(6):685–91.PubMedCrossRef
49.
Moro E, Crema F, De Ponti F, et al. Triptans and gastric accommodation: pharmacological and therapeutic aspects. Dig Liver Dis. 2004;36(1):85–92.PubMedCrossRef
50.
Rani PU, Naidu MUR, Rao TRK, et al. Sumatriptan delays paracetamol absorption in migraine patients. Clin Drug Invest. 1996;11(5):300–4.CrossRef
51.
Runken MC, Landy S, Silberstein S, et al. Impact of early versus late intervention on productivity and clinical disability in migraineurs [abstract no. E045]. Cephalalgia. 2007;27(6):702.
52.
53.
54.
Dodick D, Lipton RB, Martin V, et al. Consensus statement: cardiovascular safety profile of triptans (5-HT agonists) in the acute treatment of migraine. Headache. 2004;44(5):414–25.PubMedCrossRef
55.
Trelle S, Reichenbach S, Wandel S, et al. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ. 2011;342:c7086.PubMedCrossRef
56.
Antman EM, Bennett JS, Daugherty A, et al. Use of nonsteroidal antiinflammatory drugs: an update for clinicians: a scientific statement from the American Heart Association. Circulation. 2007;115(12):1634–42.PubMedCrossRef
57.
Dodick D, Sandrini G, Williams P. Use of the sustained pain-free plus no adverse events endpoint in clinical trials of triptans in acute migraine. CNS Drugs. 2007;21(1):73–82.PubMedCrossRef
58.
Runken MC, Goodwin B, Shah M, et al. Differences in pharmacotherapy utilization for patients initiating a fixed-dose tablet of sumatriptan and naproxen sodium vs oral triptan therapy in the treatment of acute migraine [abstract no. PO-37]. Headache. 2010;50(Suppl s1):19.
59.
60.
61.
Tfelt-Hansen P. Clinical pharmacology of current and future drugs for the acute treatment of migraine: a review and an update. Curr Clin Pharmacol. 2012;7(1):66–72.PubMedCrossRef
62.
Blumenfeld A, Gennings C, Cady R. Pharmacological synergy: the next frontier on therapeutic advancement for migraine. Headache. 2012;52(4):636–47.PubMedCrossRef
63.
Moore RA, Derry CJ, Derry S, et al. A conservative method of testing whether combination analgesics produce additive or synergistic effects using evidence from acute pain and migraine. Eur J Pain. 2012;16(4):585–91.PubMedCrossRef
64.
Derosier F, Sheftell F, Silberstein S, et al. Sumatriptan-naproxen and butalbital: a double-blind, placebo-controlled crossover study. Headache. 2012;52(4):530–43.PubMedCrossRef
65.
Tfelt-Hansen PC, Diener HC. Why should American headache and migraine patients still be treated with butalbital-containing medicine? Headache. 2012;52(4):672–4.PubMedCrossRef
66.
McLean W, Boucher EA, Brennan M, et al. Is there an indication for the use of barbiturate-containing analgesic agents in the treatment of pain? Guidelines for their safe use and withdrawal management. Canadian Pharmacists Association. Can J Clin Pharmacol. 2000;7(4):191–7.PubMed
67.
68.
Rolan PE. Drug interactions with triptans: which are clinically significant? CNS Drugs. 2012;26(11):949–57.PubMedCrossRef
69.
Sclar DA, Robison LM, Castillo LV, et al. Concomitant use of triptan, and SSRI or SNRI after the US Food and Drug Administration alert on serotonin syndrome. Headache. 2012;52(2):198–203.PubMedCrossRef
70.
Evans RW, Tepper SJ, Shapiro RE, et al. The FDA alert on serotonin syndrome with use of triptans combined with selective serotonin reuptake inhibitors or selective serotonin-norepinephrine reuptake inhibitors: American Headache Society position paper. Headache. 2010;50(6):1089–99.PubMedCrossRef
Metadata
Title
Sumatriptan/Naproxen Sodium: A Review of Its Use in Adult Patients with Migraine
Author
Lily P. H. Yang
Publication date
01-08-2013
Publisher
Springer International Publishing
Published in
Drugs / Issue 12/2013
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-013-0099-y

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