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Meta-Analysis
. 2012 Feb 15;2012(2):CD008615.
doi: 10.1002/14651858.CD008615.pub2.

Sumatriptan (oral route of administration) for acute migraine attacks in adults

Affiliations
Meta-Analysis

Sumatriptan (oral route of administration) for acute migraine attacks in adults

Christopher J Derry et al. Cochrane Database Syst Rev. .

Abstract

Background: Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an abortive medication for migraine attacks, belonging to the triptan family.

Objectives: To determine the efficacy and tolerability of oral sumatriptan compared to placebo and other active interventions in the treatment of acute migraine attacks in adults.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, online databases, and reference lists for studies through 13 October 2011.

Selection criteria: We included randomised, double-blind, placebo- and/or active-controlled studies using oral sumatriptan to treat a migraine headache episode, with at least 10 participants per treatment arm.

Data collection and analysis: Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment.

Main results: Sixty-one studies (37,250 participants) compared oral sumatriptan with placebo or an active comparator. Most of the data were for the 50 mg and 100 mg doses. Sumatriptan surpassed placebo for all efficacy outcomes. For sumatriptan 50 mg versus placebo the NNTs were 6.1, 7.5, and 4.0 for pain-free at two hours and headache relief at one and two hours, respectively. NNTs for sustained pain-free and sustained headache relief during the 24 hours postdose were 9.5 and 6.0, respectively. For sumatriptan 100 mg versus placebo the NNTs were 4.7, 6.8, 3.5, 6.5, and 5.2, respectively, for the same outcomes. Results for the 25 mg dose were similar to the 50 mg dose, while sumatriptan 100 mg was significantly better than 50 mg for pain-free and headache relief at two hours, and for sustained pain-free during 24 hours. Treating early, during the mild pain phase, gave significantly better NNTs for pain-free at two hours and sustained pain-free during 24 hours than did treating established attacks with moderate or severe pain intensity.Relief of associated symptoms, including nausea, photophobia, and phonophobia, was greater with sumatriptan than with placebo, and use of rescue medication was lower with sumatriptan than with placebo. For the most part, adverse events were transient and mild and were more common with the sumatriptan than with placebo, with a clear dose response relationship (25 mg to 100 mg).Sumatriptan was compared directly with a number of active treatments, including other triptans, paracetamol (acetaminophen), acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), and ergotamine combinations.

Authors' conclusions: Oral sumatriptan is effective as an abortive treatment for migraine attacks, relieving pain, nausea, photophobia, phonophobia, and functional disability, but is associated with increased adverse events.

PubMed Disclaimer

Conflict of interest statement

RAM and SD have received research support from charities, government, and industry sources at various times. RAM has consulted for various pharmaceutical companies, including GlaxoSmithKline, the manufacturers of sumatriptan. RAM has received lecture fees from pharmaceutical companies related to analgesics and other healthcare interventions. CD has no interests to declare. GlaxoSmithKline were not in any way involved in conducting this review.

Figures

1
1
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
2
2
Forest plot of comparison: 4 Oral sumatriptan 50 mg versus placebo, outcome: 4.1 Pain‐free at 2 h.
3
3
Forest plot of comparison: 4 Oral sumatriptan 50 mg versus placebo, outcome: 4.4 Headache relief at 2 h.
4
4
Forest plot of comparison: 4 Oral sumatriptan 50 mg versus placebo, outcome: 4.5 24 h sustained pain‐free.
5
5
Forest plot of comparison: 4 Oral sumatriptan 50 mg versus placebo, outcome: 4.11 Any adverse event within 24 h.
6
6
Consistency of response: proportion of participants treated with sumatriptan 100 mg achieving headache relief at 2 hours over successive attacks
7
7
Consistency of response: proportion of participants treated with sumatriptan 25 mg or 50 mg experiencing any adverse events within 24 hours over successive attacks (data from Gallagher 2000)
8
8
L'Abbé plot showing results for sumatriptan 50 mg versus placebo for headache relief at 2 hours. Each circle represents a different study; size of circle is proportional to size of study; diagonal is line of equivalence
9
9
L'Abbé plot showing results for sumatriptan 50 mg versus placebo for pain‐free at 2 hours. Each circle represents a different study; size of circle is proportional to size of study; diagonal is line of equivalence
10
10
L'Abbé plot showing results for sumatriptan 50 mg versus placebo for sustained pain‐free during 24 hours. Each circle represents a different study; size of circle is proportional to size of study; diagonal is line of equivalence
1.1
1.1. Analysis
Comparison 1 Oral sumatriptan 25 mg versus placebo, Outcome 1 Pain‐free at 2 h.
1.2
1.2. Analysis
Comparison 1 Oral sumatriptan 25 mg versus placebo, Outcome 2 Headache relief at 1 h.
1.3
1.3. Analysis
Comparison 1 Oral sumatriptan 25 mg versus placebo, Outcome 3 Headache relief at 2 h.
1.4
1.4. Analysis
Comparison 1 Oral sumatriptan 25 mg versus placebo, Outcome 4 Use of rescue medication.
1.5
1.5. Analysis
Comparison 1 Oral sumatriptan 25 mg versus placebo, Outcome 5 Relief of associated symptoms.
1.6
1.6. Analysis
Comparison 1 Oral sumatriptan 25 mg versus placebo, Outcome 6 Relief of functional disability at 2 h.
1.7
1.7. Analysis
Comparison 1 Oral sumatriptan 25 mg versus placebo, Outcome 7 Any adverse event within 24 h.
1.8
1.8. Analysis
Comparison 1 Oral sumatriptan 25 mg versus placebo, Outcome 8 Individual adverse events.
1.9
1.9. Analysis
Comparison 1 Oral sumatriptan 25 mg versus placebo, Outcome 9 Any adverse event withdrawal.
1.10
1.10. Analysis
Comparison 1 Oral sumatriptan 25 mg versus placebo, Outcome 10 Headache relief at 2 h ‐ effect of quality score.
2.1
2.1. Analysis
Comparison 2 Oral sumatriptan 25 mg versus rizatriptan 5 mg, Outcome 1 Pain free at 2 h.
2.2
2.2. Analysis
Comparison 2 Oral sumatriptan 25 mg versus rizatriptan 5 mg, Outcome 2 Headache relief at 1 h.
2.3
2.3. Analysis
Comparison 2 Oral sumatriptan 25 mg versus rizatriptan 5 mg, Outcome 3 Headache relief at 2 h.
2.4
2.4. Analysis
Comparison 2 Oral sumatriptan 25 mg versus rizatriptan 5 mg, Outcome 4 Use of rescue medication.
2.5
2.5. Analysis
Comparison 2 Oral sumatriptan 25 mg versus rizatriptan 5 mg, Outcome 5 Any adverse event within 24 h.
2.6
2.6. Analysis
Comparison 2 Oral sumatriptan 25 mg versus rizatriptan 5 mg, Outcome 6 Individual adverse events.
3.1
3.1. Analysis
Comparison 3 Oral sumatriptan 25 mg versus rizatriptan 10 mg, Outcome 1 Pain‐free at 2 h.
3.2
3.2. Analysis
Comparison 3 Oral sumatriptan 25 mg versus rizatriptan 10 mg, Outcome 2 Headache relief at 1 h.
3.3
3.3. Analysis
Comparison 3 Oral sumatriptan 25 mg versus rizatriptan 10 mg, Outcome 3 Headache relief at 2 h.
3.4
3.4. Analysis
Comparison 3 Oral sumatriptan 25 mg versus rizatriptan 10 mg, Outcome 4 Use of rescue medication.
3.5
3.5. Analysis
Comparison 3 Oral sumatriptan 25 mg versus rizatriptan 10 mg, Outcome 5 Any adverse event within 24 h.
3.6
3.6. Analysis
Comparison 3 Oral sumatriptan 25 mg versus rizatriptan 10 mg, Outcome 6 Individual adverse events.
4.1
4.1. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 1 Pain‐free at 2 h.
4.2
4.2. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 2 Pain free at 1 h.
4.3
4.3. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 3 Headache relief at 1 h.
4.4
4.4. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 4 Headache relief at 2 h.
4.5
4.5. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 5 24 h sustained pain‐free.
4.6
4.6. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 6 24 h sustained headache relief.
4.7
4.7. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 7 Use of rescue medication.
4.8
4.8. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 8 Relief of associated symptoms in participants with moderate or severe baseline pain intensity.
4.9
4.9. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 9 Relief of associated symptoms in participants with mild baseline pain intensity.
4.10
4.10. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 10 Relief of functional disability at 2 h.
4.11
4.11. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 11 Any adverse event within 24 h.
4.12
4.12. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 12 Individual adverse events.
4.13
4.13. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 13 Any adverse event withdrawal.
4.14
4.14. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 14 Pain free at 2 h ‐ effect of quality score.
4.15
4.15. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 15 Headache relief at 1 h ‐ effect of quality score.
4.16
4.16. Analysis
Comparison 4 Oral sumatriptan 50 mg versus placebo, Outcome 16 Headache relief at 2 h ‐ effect of quality score.
5.1
5.1. Analysis
Comparison 5 Oral sumatriptan 50 mg versus effervescent ASA 1000 mg, Outcome 1 Pain‐free at 2 h.
5.2
5.2. Analysis
Comparison 5 Oral sumatriptan 50 mg versus effervescent ASA 1000 mg, Outcome 2 Pain‐free at 1 h.
5.3
5.3. Analysis
Comparison 5 Oral sumatriptan 50 mg versus effervescent ASA 1000 mg, Outcome 3 Headache relief at 1 h.
5.4
5.4. Analysis
Comparison 5 Oral sumatriptan 50 mg versus effervescent ASA 1000 mg, Outcome 4 Headache relief at 2 h.
5.5
5.5. Analysis
Comparison 5 Oral sumatriptan 50 mg versus effervescent ASA 1000 mg, Outcome 5 Any adverse event within 24 h.
6.1
6.1. Analysis
Comparison 6 Oral sumatriptan 50 mg versus zolmitriptan 2.5 mg, Outcome 1 Headache relief at 1 h.
6.2
6.2. Analysis
Comparison 6 Oral sumatriptan 50 mg versus zolmitriptan 2.5 mg, Outcome 2 Headache relief at 2 h.
6.3
6.3. Analysis
Comparison 6 Oral sumatriptan 50 mg versus zolmitriptan 2.5 mg, Outcome 3 Any adverse event within 24 h.
7.1
7.1. Analysis
Comparison 7 Oral sumatriptan 50 mg versus zolmitriptan 5 mg, Outcome 1 Headache relief at 1 h.
7.2
7.2. Analysis
Comparison 7 Oral sumatriptan 50 mg versus zolmitriptan 5 mg, Outcome 2 Headache relief at 2 h.
7.3
7.3. Analysis
Comparison 7 Oral sumatriptan 50 mg versus zolmitriptan 5 mg, Outcome 3 Any adverse event within 24 h.
8.1
8.1. Analysis
Comparison 8 Oral sumatriptan 50 mg versus rizatriptan 5 mg, Outcome 1 Pain‐free at 2 h.
8.2
8.2. Analysis
Comparison 8 Oral sumatriptan 50 mg versus rizatriptan 5 mg, Outcome 2 Headache relief at 1 h.
8.3
8.3. Analysis
Comparison 8 Oral sumatriptan 50 mg versus rizatriptan 5 mg, Outcome 3 Headache relief at 2 h.
8.4
8.4. Analysis
Comparison 8 Oral sumatriptan 50 mg versus rizatriptan 5 mg, Outcome 4 Use of rescue medication.
8.5
8.5. Analysis
Comparison 8 Oral sumatriptan 50 mg versus rizatriptan 5 mg, Outcome 5 Any adverse event within 24 h.
9.1
9.1. Analysis
Comparison 9 Oral sumatriptan 50 mg versus rizatriptan 10 mg, Outcome 1 Pain‐free at 2 h.
9.2
9.2. Analysis
Comparison 9 Oral sumatriptan 50 mg versus rizatriptan 10 mg, Outcome 2 Headache relief at 1 h.
9.3
9.3. Analysis
Comparison 9 Oral sumatriptan 50 mg versus rizatriptan 10 mg, Outcome 3 Headache relief at 2 h.
9.4
9.4. Analysis
Comparison 9 Oral sumatriptan 50 mg versus rizatriptan 10 mg, Outcome 4 Use of rescue medication.
9.5
9.5. Analysis
Comparison 9 Oral sumatriptan 50 mg versus rizatriptan 10 mg, Outcome 5 Any adverse event within 24 h.
10.1
10.1. Analysis
Comparison 10 Oral sumatriptan 50 mg versus eletriptan 40 mg, Outcome 1 Pain‐free at 2 h.
10.2
10.2. Analysis
Comparison 10 Oral sumatriptan 50 mg versus eletriptan 40 mg, Outcome 2 Headache relief at 1 h.
10.3
10.3. Analysis
Comparison 10 Oral sumatriptan 50 mg versus eletriptan 40 mg, Outcome 3 Headache relief at 2 h.
10.4
10.4. Analysis
Comparison 10 Oral sumatriptan 50 mg versus eletriptan 40 mg, Outcome 4 Relief of associated symptoms.
10.5
10.5. Analysis
Comparison 10 Oral sumatriptan 50 mg versus eletriptan 40 mg, Outcome 5 Relief of functional disability at 2 h.
11.1
11.1. Analysis
Comparison 11 Oral sumatriptan 50 mg versus eletriptan 80 mg, Outcome 1 Pain‐free at 2 h.
11.2
11.2. Analysis
Comparison 11 Oral sumatriptan 50 mg versus eletriptan 80 mg, Outcome 2 Headache relief at 1 h.
11.3
11.3. Analysis
Comparison 11 Oral sumatriptan 50 mg versus eletriptan 80 mg, Outcome 3 Headache relief at 2 h.
11.4
11.4. Analysis
Comparison 11 Oral sumatriptan 50 mg versus eletriptan 80 mg, Outcome 4 Relief of associated symptoms.
11.5
11.5. Analysis
Comparison 11 Oral sumatriptan 50 mg versus eletriptan 80 mg, Outcome 5 Relief of functional disability at 2 h.
12.1
12.1. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 1 Pain‐free at 2 h.
12.2
12.2. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 2 Pain‐free at 1 h.
12.3
12.3. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 3 Headache relief at 1 h.
12.4
12.4. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 4 Headache relief at 2 h.
12.5
12.5. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 5 24 h sustained pain free.
12.6
12.6. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 6 24 h sustained headache relief.
12.7
12.7. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 7 Use of rescue medication.
12.8
12.8. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 8 Relief of associated symptoms in participants with moderate or severe baseline pain intensity.
12.9
12.9. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 9 Relief of associated symptoms in participants with mild baseline pain intensity.
12.10
12.10. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 10 Relief of functional disability at 2 h.
12.11
12.11. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 11 Any adverse event within 24 h.
12.12
12.12. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 12 Individual adverse events.
12.13
12.13. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 13 Any adverse event withdrawal.
12.14
12.14. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 14 Headache relief at 2 h ‐ effect of formulation.
12.15
12.15. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 15 Pain‐free at 2 h ‐ effect of quality score.
12.16
12.16. Analysis
Comparison 12 Oral sumatriptan 100 mg versus placebo, Outcome 16 Headache relief at 2 h ‐ effect of quality score.
13.1
13.1. Analysis
Comparison 13 Oral sumatriptan 100 mg versus eletriptan 40 mg, Outcome 1 Pain‐free at 2 h.
13.2
13.2. Analysis
Comparison 13 Oral sumatriptan 100 mg versus eletriptan 40 mg, Outcome 2 Pain‐free at 1 h.
13.3
13.3. Analysis
Comparison 13 Oral sumatriptan 100 mg versus eletriptan 40 mg, Outcome 3 Headache relief at 1 h.
13.4
13.4. Analysis
Comparison 13 Oral sumatriptan 100 mg versus eletriptan 40 mg, Outcome 4 Headache relief at 2 h.
13.5
13.5. Analysis
Comparison 13 Oral sumatriptan 100 mg versus eletriptan 40 mg, Outcome 5 24 h sustained headache relief.
13.6
13.6. Analysis
Comparison 13 Oral sumatriptan 100 mg versus eletriptan 40 mg, Outcome 6 Use of rescue medication.
13.7
13.7. Analysis
Comparison 13 Oral sumatriptan 100 mg versus eletriptan 40 mg, Outcome 7 Relief of associated symptoms.
13.8
13.8. Analysis
Comparison 13 Oral sumatriptan 100 mg versus eletriptan 40 mg, Outcome 8 Relief of functional disability at 2 h.
14.1
14.1. Analysis
Comparison 14 Oral sumatriptan 100 mg versus eletriptan 80 mg, Outcome 1 Pain‐free at 2 h.
14.2
14.2. Analysis
Comparison 14 Oral sumatriptan 100 mg versus eletriptan 80 mg, Outcome 2 Pain‐free at 1 h.
14.3
14.3. Analysis
Comparison 14 Oral sumatriptan 100 mg versus eletriptan 80 mg, Outcome 3 Headache relief at 1 h.
14.4
14.4. Analysis
Comparison 14 Oral sumatriptan 100 mg versus eletriptan 80 mg, Outcome 4 Headache relief at 2 h.
14.5
14.5. Analysis
Comparison 14 Oral sumatriptan 100 mg versus eletriptan 80 mg, Outcome 5 Relief of associated symptoms.
14.6
14.6. Analysis
Comparison 14 Oral sumatriptan 100 mg versus eletriptan 80 mg, Outcome 6 Relief of functional disability at 2 h.
15.1
15.1. Analysis
Comparison 15 Oral sumatriptan 100 mg versus rizatriptan 10 mg, Outcome 1 Pain‐free at 2 h.
15.2
15.2. Analysis
Comparison 15 Oral sumatriptan 100 mg versus rizatriptan 10 mg, Outcome 2 Headache relief at 1 h.
15.3
15.3. Analysis
Comparison 15 Oral sumatriptan 100 mg versus rizatriptan 10 mg, Outcome 3 Any adverse event within 24 h.
16.1
16.1. Analysis
Comparison 16 Oral sumatriptan 100 mg versus almotriptan 12.5 mg, Outcome 1 Pain‐free at 2 h.
16.2
16.2. Analysis
Comparison 16 Oral sumatriptan 100 mg versus almotriptan 12.5 mg, Outcome 2 24 h sustained pain‐free.
17.1
17.1. Analysis
Comparison 17 Oral sumatriptan 100 mg versus paracetamol 1000 mg + metoclopramide 10 mg, Outcome 1 Headache relief at 2 hours.
17.2
17.2. Analysis
Comparison 17 Oral sumatriptan 100 mg versus paracetamol 1000 mg + metoclopramide 10 mg, Outcome 2 Relief of associated symptoms.
17.3
17.3. Analysis
Comparison 17 Oral sumatriptan 100 mg versus paracetamol 1000 mg + metoclopramide 10 mg, Outcome 3 Use of rescue medication.
17.4
17.4. Analysis
Comparison 17 Oral sumatriptan 100 mg versus paracetamol 1000 mg + metoclopramide 10 mg, Outcome 4 Any adverse event within 24 h.
18.1
18.1. Analysis
Comparison 18 Oral sumatriptan 100 mg versus acetylsalicylic acid 900 mg + metoclopramide 10 mg, Outcome 1 Pain‐free at 2 hours.
18.2
18.2. Analysis
Comparison 18 Oral sumatriptan 100 mg versus acetylsalicylic acid 900 mg + metoclopramide 10 mg, Outcome 2 Headache relief at 2 hours.
18.3
18.3. Analysis
Comparison 18 Oral sumatriptan 100 mg versus acetylsalicylic acid 900 mg + metoclopramide 10 mg, Outcome 3 Relief of associated symptoms.
18.4
18.4. Analysis
Comparison 18 Oral sumatriptan 100 mg versus acetylsalicylic acid 900 mg + metoclopramide 10 mg, Outcome 4 Any adverse event within 24 hours.
19.1
19.1. Analysis
Comparison 19 Oral sumatriptan 200 mg versus placebo, Outcome 1 Headache relief at 2 h.
19.2
19.2. Analysis
Comparison 19 Oral sumatriptan 200 mg versus placebo, Outcome 2 Any adverse event withdrawal.
19.3
19.3. Analysis
Comparison 19 Oral sumatriptan 200 mg versus placebo, Outcome 3 Individual adverse events.
20.1
20.1. Analysis
Comparison 20 Oral sumatriptan 300 mg versus placebo, Outcome 1 Headache relief at 2 h.
20.2
20.2. Analysis
Comparison 20 Oral sumatriptan 300 mg versus placebo, Outcome 2 Individual adverse events.

Update of

References

References to studies included in this review

160‐104 {unpublished data only}
    1. A multicentre, double‐blind, placebo controlled, parallel group study of two dose levels of oral eletriptan and two dose levels of oral sumatriptan given for the acute treatment of migraine. Pfizer clinical trial report 1998.
Banerjee 1992 {published data only}
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Brandes 2007 {published data only}
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Carpay 2004 {published data only}
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Cutler 1995 {published data only}
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Dahlof 1991 {published data only}
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Dahlof 2009 {published data only}
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Diener 2004a {published data only}
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DKSMSG 1999 {published data only}
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Dodick 2002 {published data only}
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Dowson 2002 {published data only}
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    1. Dowson AJ, Massiou H, LaÍnez JM, Cabarrocas X. Almotriptan is an effective and well‐tolerated treatment for migraine pain: results of a randomized, double‐blind, placebo‐controlled clinical trial. Cephalalgia 2002;22(6):453‐61. [PUBMED: 12133045] - PubMed
Ensink 1991 {published data only}
    1. Ensink FB, Sumatriptan International Study Group. Subcutaneous sumatriptan in the acute treatment of migraine. Journal of Neurology 1991;238 Suppl 1:S66‐9. [PUBMED: 1646291] - PubMed
Freitag 2001 {published data only}
    1. Freitag FG, Cady R, DiSerio F, Elkind A, Gallagher RM, Goldstein J, et al. Comparative study of a combination of isometheptene mucate, dichloralphenazone with acetaminophen and sumatriptan succinate in the treatment of migraine. Headache 2001;41(4):391‐8. [DOI: 10.1046/j.1526-4610.2001.111006391.x] - DOI - PubMed
Gallagher 2000 {published data only}
    1. Gallagher RM, Dennish G, Spierings EL, Chitra R. A comparative trial of zolmitriptan and sumatriptan for the acute oral treatment of migraine. Headache 2000;40(2):119‐28. [DOI: 10.1046/j.1526-4610.2000.00017.x] - DOI - PubMed
Geraud 2000 {published data only}
    1. Geraud G, Olesen J, Pfaffenrath V, Tfelt‐Hansen P, Zupping R, Diener HC, et al. Comparison of the efficacy of zolmitriptan and sumatriptan: issues in migraine trial design. Cephalalgia 2000;20(1):30‐8. [PUBMED: 10817444] - PubMed
GL/MIG/001/92 {unpublished data only}
    1. A double‐blind, general practice study to compare GR43175 with paracetamol and metoclopramide in the acute treatment of migraine (Original protocol). www.gsk‐clinicalstudyregister.com/ 1992.
GL/MIG/001A/92 {unpublished data only}
    1. A double‐blind, general practice study to compare GR43175 with paracetamol and metoclopramide in the acute treatment of migraine (Amended protocol). www.gsk‐clinicalstudyregister.com/ 1992.
GL/MIG/002 {unpublished data only}
    1. A double‐blind general practice study to compare sumatriptan with Migraleve in the acute treatment of migraine (Original protocol). www.gsk‐clinicalstudyregister.com/ 1990.
GL/MIG/002A {unpublished data only}
    1. A double‐blind general practice study to compare sumatriptan with Migraleve in the acute treatment of migraine (Amended protocol). www.gsk‐clinicalstudyregister.com/ 1991.
GL/MIG/009 {unpublished data only}
    1. A double blind study to compare acute sumatriptan with Migril in the treatment of migraine. www.gsk‐clinicalstudyregister.com/ 1991.
Goadsby 1991 {published data only}
    1. Goadsby PJ, Zagami AS, Donnan GA, Symington G, Anthony M, Bladin PF, et al. Oral sumatriptan in acute migraine. Lancet 1991;338(8770):782‐3. [DOI: 10.1016/0140-6736(91)90666-D] - DOI - PubMed
Goadsby 2000 {published data only}
    1. Goadsby PJ, Ferrari MD, Olesen J, Stovner LJ, Senard JM, Jackson NC, et al. Eletriptan Steering Committee. Eletriptan in acute migraine: a double‐blind, placebo‐controlled comparison to sumatriptan. Neurology 2000;54(1):156‐63. - PubMed
Goldstein 1998 {published data only}
    1. Goldstein J, Ryan R, Jiang K, Getson A, Norman B, Block GA, et al. Rizatriptan Protocol 046 Study Group. Crossover comparison of rizatriptan 5 mg and 10 mg versus sumatriptan 25 mg and 50 mg in migraine. Headache 1998;38(10):737‐47. [DOI: 10.1046/j.1526-4610.1998.3810737.x] - DOI - PubMed
Goldstein 2005 {published data only}
    1. Goldstein J, Silberstein SD, Saper JR, Elkind AH, Smith TR, Gallagher RM, et al. Acetaminophen, aspirin, and caffeine versus sumatriptan succinate in the early treatment of migraine: results from the ASSET trial. Headache 2005;45(8):973‐82. [DOI: 10.1111/j.1526-4610.2005.05177.x] - DOI - PubMed
Gruffyd‐Jones 2001 {published data only}
    1. Gruffyd‐Jones K, Kies B, Middleton A, Mulder LJ, Røsjø Ø, Millson DS. Zolmitriptan versus sumatriptan for the acute oral treatment of migraine: a randomized, double‐blind, international study. European Journal of Neurology 2001;8(3):237‐45. - PubMed
Havanka 2000 {published data only}
    1. Havanka H, Dahlöf C, Pop PH, Diener HC, Winter P, Whitehouse H, et al. Naratriptan S2WB2004 Study Group. Efficacy of naratriptan tablets in the acute treatment of migraine: a dose‐ranging study. Clinical Therapeutics 2000;22(8):970‐80. [DOI: 10.1016/S0149-2918(00)80068-5] - DOI - PubMed
Ishkanian 2007 {published data only}
    1. Ishkanian G, Blumenthal H, Webster CJ, Richardson MS, Ames M. Efficacy of sumatriptan tablets in migraineurs self‐described or physician‐diagnosed as having sinus headache: a randomized, double‐blind, placebo‐controlled study. Clinical Therapeutics 2007;29(1):99‐109. [DOI: 10.1016/j.clinthera.2007.01.012] - DOI - PubMed
Jelinski 2006 {published data only}
    1. Jelinski SE, Becker WJ, Christie SN, Ahmad FE, Pryse‐Phillips W, Simpson SD. Pain free efficacy of sumatriptan in the early treatment of migraine. Canadian Journal of Neurological Sciences 2006;33(1):73‐9. [http://cjns.metapress.com/openurl.asp?genre=article&issn=0317‐1671&a... - PubMed
    1. SUM40291. A randomized, double‐blind, placebo‐controlled, parallel‐group, single‐attack evaluation of sumatriptan 50 mg and 100 mg versus placebo during a migraine headache at the first sign of pain. www.gsk‐clinicalstudyregister.com/ 2001.
Kaniecki 2006 {published data only}
    1. Kaniecki R, Ruoff G, Smith T, Barrett PS, Ames MH, Byrd S, et al. Prevalence of migraine and response to sumatriptan in patients self‐reporting tension/stress headache. Current Medical Research and Opinion 2006;22(8):1535‐44. [DOI: 10.1185/030079906X118685] - DOI - PubMed
Kolodny 2004 {published data only}
    1. Kolodny A, Polis A, Battisti WP, Johnson‐Pratt L, Skobieranda F, Rizatriptan Protocol 052 Study Group. Comparison of rizatriptan 5 mg and 10 mg tablets and sumatriptan 25 mg and 50 mg tablets. Cephalalgia 2004;24(7):540‐6. - PubMed
Kudrow 2005 {published data only}
    1. Kudrow D, Thomas HM, Ruoff G, Ishkanian G, Sands G, Le VH, et al. Valdecoxib for treatment of a single, acute, moderate to severe migraine headache. Headache 2005;45(9):1151‐62. [DOI: 10.1111/j.1526-4610.2005.00238.x] - DOI - PubMed
Latere 1991 {published data only}
    1. The Multinational Oral Sumatriptan and Cafergot Comparative Study Group. A randomized, double‐blind comparison of sumatriptan and Cafergot in the acute treatment of migraine. European Neurology 1991;31(5):314‐22. - PubMed
Lines 2001 {published data only}
    1. Lines CR, Vandormael K, Malbecq W. A comparison of visual analog scale and categorical ratings of headache pain in a randomized controlled clinical trial with migraine patients. Pain 2001;93(2):185‐90. [DOI: 10.1016/S0304-3959(01)00315-3] - DOI - PubMed
Lipton 2000 {published data only}
    1. Lipton RB, Stewart WF, Cady R, Hall C, O'Quinn S, Kuhn T, et al. 2000 Wolfe Award. Sumatriptan for the range of headaches in migraine sufferers: results of the Spectrum Study. Headache 2000;40(10):783‐91. [DOI: 10.1111/j.1526-4610.2000.00143.x] - DOI - PubMed
Mathew 2003 {published data only}
    1. Mathew NT, Schoenen J, Winner P, Muirhead N, Sikes CR. Comparative efficacy of eletriptan 40 mg versus sumatriptan 100 mg. Headache 2003;43(3):214‐22. [DOI: 10.1046/j.1526-4610.2003.03044.x] - DOI - PubMed
Myllyla 1998 {published data only}
    1. Myllylä VV, Havanka H, Herrala L, Kangasniemi P, Rautakorpi I, Turkka J, et al. Tolfenamic acid rapid release versus sumatriptan in the acute treatment of migraine: comparable effect in a double‐blind, randomized, controlled, parallel‐group study. Headache 1998;38(3):201‐7. [DOI: 10.1046/j.1526-4610.1998.3803201.x] - DOI - PubMed
Nappi 1994 {published data only}
    1. Nappi G, Sicuteri F, Byrne M, Roncolato M, Zerbini O. Oral sumatriptan compared with placebo in the acute treatment of migraine. Journal of Neurology 1994;241(3):138‐44. - PubMed
Nett 2003 {published data only}
    1. Landy S, Savani N, Shackelford S, Loftus J, Jones M. Efficacy and tolerability of sumatriptan tablets administered during the mild‐pain phase of menstrually associated migraine. International Journal of Clinical Practice 2004;58(10):913‐9. [DOI: 10.1111/j.1368-5031.2004.00295.x] - DOI - PubMed
    1. Nett R, Landy S, Shackelford S, Richardson MS, Ames M, Lener M. Pain‐free efficacy after treatment with sumatriptan in the mild pain phase of menstrually associated migraine. Journal of Obstetrics and Gynecology 2003;102(4):835‐42. - PubMed
Patten 1991 {published data only}
    1. Patten JP. Clinical experience with oral sumatriptan: a placebo‐controlled, dose‐ranging study. Oral Sumatriptan Dose‐defining Study Group. Journal of Neurology 1991;238 Suppl 1:S62‐5. - PubMed
Pfaffenrath 1998 {published data only}
    1. Pfaffenrath V, Cunin G, Sjonell G, Prendergast S. Efficacy and safety of sumatriptan tablets (25 mg, 50 mg, and 100 mg) in the acute treatment of migraine: defining the optimum doses of oral sumatriptan. Headache 1998;38(3):184‐90. [DOI: 10.1046/j.1526-4610.1998.3803184.x] - DOI - PubMed
Pini 1995 {published data only}
    1. Pini LA, Sternieri E, Fabbri L, Zerbini O, Bamfi F, The Oral Sumatriptan Italian Study Group. High efficacy and low frequency of headache recurrence after oral sumatriptan. Journal of International Medical Research 1995;23(2):96‐105. - PubMed
Pini 1999 {published data only}
    1. Pini LA, Fabbri L, Cavazzuti L, The Sumatriptan 50 mg Italian Study Group. Efficacy and safety of sumatriptan 50 mg in patients not responding to standard care, in the treatment of mild to moderate migraine. International Journal of Clinical Pharmacology Research 1999;19(2):57‐64. - PubMed
Sandrini 2002 {published data only}
    1. Sandrini G, Färkkilä M, Burgess G, Forster E, Haughie S, Eletriptan Steering Committee. Eletriptan vs sumatriptan: a double‐blind, placebo‐controlled, multiple migraine attack study. Neurology 2002;59(8):1210‐7. - PubMed
Sandrini 2007 {published data only}
    1. Sandrini G, Cerbo R, Bene E, Ferrari A, Genco S, Grazioli I, et al. Efficacy of dosing and re‐dosing of two oral fixed combinations of indomethacin, prochlorperazine and caffeine compared with oral sumatriptan in the acute treatment of multiple migraine attacks: a double‐blind, double‐dummy, randomised, parallel group, multicentre study. International Journal of Clinical Practice 2007;61(8):1256‐69. [DOI: 10.1111/j.1742-1241.2007.01458.x] - DOI - PMC - PubMed
Sargent 1995 {published data only}
    1. Sargent J, Kirchner JR, Davis R, Kirkhart B. Oral sumatriptan is effective and well tolerated for the acute treatment of migraine: results of a multicenter study. Neurology 1995;45(8 Suppl 7):S10‐4. - PubMed
Savani 1999 {published data only}
    1. Savani N, Brautaset NJ, Reunanen M, Szirmai I, Ashford EA, Hassani H, et al. Sumatriptan Tablets S2CM07 Study Group. A double‐blind placebo‐controlled study assessing the efficacy and tolerability of 50 mg sumatriptan tablets in the acute treatment of migraine. International Journal of Clinical Practice. Supplement 1999;105:7‐15. - PubMed
Schulman 2003 {published data only}
    1. Schulman EA, Dermott KF. Sumatriptan plus metoclopramide in triptan‐nonresponsive migraineurs. Headache 2003;43(7):729‐33. [DOI: 10.1046/j.1526-4610.2003.03130.x] - DOI - PubMed
Sheftell 2005 {published data only}
    1. Sheftell FD, Dahlöf CG, Brandes JL, Agosti R, Jones MW, Barrett PS. Two replicate randomized, double‐blind, placebo‐controlled trials of the time to onset of pain relief in the acute treatment of migraine with a fast‐disintegrating/rapid‐release formulation of sumatriptan tablets. Clinical Therapeutics 2005;27(4):407‐17. - PubMed
Smith 2005 {published data only}
    1. Smith TR, Sunshine A, Stark SR, Littlefield DE, Spruill SE, Alexander WJ. Sumatriptan and naproxen sodium for the acute treatment of migraine. Headache 2005;45(8):983‐91. [DOI: 10.1111/j.1526-4610.2005.05178.x] - DOI - PubMed
Spierings 2001 {published data only}
    1. Spierings EL, Gomez‐Mancilla B, Grosz DE, Rowland CR, Whaley FS, Jirgens KJ. Oral almotriptan vs. oral sumatriptan in the abortive treatment of migraine: a double‐blind, randomized, parallel‐group, optimum‐dose comparison. Archives of Neurology 2001;58(6):944‐50. - PubMed
Tfelt‐Hansen 1995 {published data only}
    1. Tfelt‐Hansen P, Henry P, Mulder LJ, Scheldewaert RG, Schoenen J, Chazot G. The combination of oral lysine‐acetylsalicylate and metoclopramide compared with oral sumatriptan in the treatment of migraine attacks. A randomized, double‐blind, placebo‐controlled clinical trial. Ugeskrift for Laeger 1996;158(45):6435‐9. - PubMed
    1. Tfelt‐Hansen P, Henry P, Mulder LJ, Scheldewaert RG, Schoenen J, Chazot G. The effectiveness of combined oral lysine acetylsalicylate and metoclopramide compared with oral sumatriptan for migraine. Lancet 1995;346(8980):923‐6. - PubMed
Tfelt‐Hansen 1998 {published data only}
    1. Tfelt‐Hansen P, Teall J, Rodriguez F, Giacovazzo M, Paz J, Malbecq W, et al. Rizatriptan 030 Study Group. Oral rizatriptan versus oral sumatriptan: a direct comparative study in the acute treatment of migraine. Headache 1998;38(10):748‐55. [DOI: 10.1046/j.1526-4610.1998.3810748.x] - DOI - PubMed
Tfelt‐Hansen 2006 {published data only}
    1. Tfelt‐Hansen P, Bach FW, Daugaard D, Tsiropoulos I, Riddersholm B. Treatment with sumatriptan 50 mg in the mild phase of migraine attacks in patients with infrequent attacks: a randomised, double‐blind, placebo‐controlled study. Journal of Headache and Pain 2006;7(6):389‐94. [DOI: 10.1007/s10194-006-0333-z] - DOI - PMC - PubMed
Thomson 1992 {published data only}
    1. The Oral Sumatriptan and Aspirin plus Metoclopramide Comparative Study Group. A study to compare oral sumatriptan with oral aspirin plus oral metoclopramide in the acute treatment of migraine. European Neurology 1992;32(3):177‐84. - PubMed
Visser 1996 {published data only}
    1. Visser WH, Terwindt GM, Reines SA, Jiang K, Lines CR, Ferrari MD. Rizatriptan vs sumatriptan in the acute treatment of migraine. A placebo‐controlled, dose‐ranging study. Dutch/US Rizatriptan Study Group. Archives of Neurology 1996;53(11):1132‐7. - PubMed
Winner 2003 {published data only}
    1. Winner P, Mannix LK, Putnam DG, McNeal S, Kwong J, O'Quinn S, et al. Pain‐free results with sumatriptan taken at the first sign of migraine pain: 2 randomized, double‐blind, placebo‐controlled studies. Mayo Clinic Proceedings 2003;78(10):1214‐22. - PubMed

References to studies excluded from this review

Cady 1994 {published data only}
    1. Cady RK, Rubino J, Crummett D, Littlejohn TW 3rd. Oral sumatriptan in the treatment of recurrent headache. Archives of Family Medicine 1994;3(9):766‐72. - PubMed
Cady 2000 {published data only}
    1. Cady RK, Lipton RB, Hall C, Stewart WF, O'Quinn S, Gutterman D. Treatment of mild headache in disabled migraine sufferers: results of the Spectrum Study. Headache 2000;40(10):792‐7. - PubMed
Centonze 1995 {published data only}
    1. Centonze V, Polito MB, Bari M, Fabbri L, Cassiano MA, Bassi A, et al. Evaluation of the efficacy of oral sumatriptan in the management of migraine attacks. Clinical results [Italian]. La Clinica Terapeutica 1995;146(11):721‐8. - PubMed
Colman 2001 {published data only}
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Dowson 2000 {published data only}
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Dowson 2005 {published data only}
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Ferrari 1994 {published data only}
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Gobel 2000 {published data only}
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Landy 2004 (Study 1) {published data only}
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Midelfart 1994 {published data only}
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Padma 1998 {published data only}
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Rapoport 1995 {published data only}
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Rederich 1995 {published data only}
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Salonen 1999 {published data only}
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Savani 2001 {published data only}
    1. Savani N, Pfaffenrath V, Rice L, Boswell D, Black L, Jones M. Sumatriptan SUMB4007 Study Group. Efficacy, tolerability, and patient satisfaction with 50‐ and 100‐mg sumatriptan tablets in those initially dissatisfied with the efficacy of 50‐mg sumatriptan tablets. Clinical Therapeutics 2001;23(2):260‐71. [DOI: 10.1016/S0149-2918(01)80008-4] - DOI - PubMed
Scott 1996 {published data only}
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Sramek 1999 {published data only}
    1. Sramek JJ, Hussey EK, Clements B, Cutler NR. Oral sumatriptan pharmacokinetics in the migraine state. Clinical Drug Investigation 1999;17(2):137‐44.
SUMA4014 {unpublished data only}
    1. A double‐blind, placebo‐controlled, parallel group study to evaluate the efficacy of a second sumatriptan succinate tablet (25 or 50 mg) in the acute treatment of migraine. www.gsk‐clinicalstudyregister.com/ 1998.
Tepper 2006 {published data only}
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Tfelt‐Hansen 2000 {published data only}
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Wells 2001 {published data only}
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