Randomized, double-blind, crossover study comparing DFN-11 injection (3 mg subcutaneous sumatriptan) with 6 mg subcutaneous sumatriptan for the treatment of rapidly-escalating attacks of episodic migraine
BACKGROUND: A 6-mg dose of SC sumatriptan is the most efficacious and fast-acting acute treatment for migraine, but a 3-mg dose of SC sumatriptan may improve tolerability while maintaining efficacy.
METHODS: This randomized, double-blind, crossover study compared the efficacy and tolerability of 3 mg subcutaneous (SC) sumatriptan (DFN-11) with 6 mg SC sumatriptan in 20 adults with rapidly-escalating migraine attacks. Eligible subjects were randomized (1:1) to treat 1 attack with DFN-11 and matching placebo autoinjector consecutively or 2 DFN-11 autoinjectors consecutively and a second attack similarly but with the alternative dose (3 mg or 6 mg).
RESULTS: The proportions of subjects who were pain-free at 60 min postdose, the primary endpoint, were similar following treatment with 3 mg SC sumatriptan and 6 mg SC sumatriptan (50% vs 52.6%, P = .87). The proportions of subjects experiencing pain relief (P ≥ .48); reductions in migraine pain intensity (P ≥ .78); and relief from nausea, photophobia, or phonophobia (P ≥ .88) with 3 mg SC sumatriptan and 6 mg SC sumatriptan were similar, as were the mean scores for satisfaction with treatment (M = 2.6 vs M = 2.4, P = .81) and the mean number of rescue medications used (M = .11 vs M = .26, P = .32). The most common adverse events with the 3- and 6-mg doses were triptan sensations - paresthesia, neck pain, flushing, and involuntary muscle contractions of the neck - and the incidence of adverse events with both doses was similar (32 events total: 3 mg, n = 14 [44%]; 6 mg, n = 18 [56%], P = .60). Triptan sensations affected 4 subjects with the 6-mg dose only, 1 subject with the 3-mg dose only, and 7 subjects with both sumatriptan doses. Chest pain affected 2 subjects (10%) treated with the 6-mg dose and no subjects (0%) treated with the 3-mg dose of DFN-11. There were no serious adverse events.
CONCLUSIONS: The 3-mg SC dose of sumatriptan in DFN-11 provided relief of migraine pain and associated symptoms comparable to a 6-mg SC dose of sumatriptan. Tolerability was similar with both study medications; DFN-11 treatment was associated with fewer triptan sensations than the 6-mg dose. DFN-11, with its 3-mg dose of sumatriptan, may be a clinically useful alternative to higher-dose autoinjectors.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2017 |
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| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
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| Enthalten in: |
The journal of headache and pain - 18(2017), 1 vom: 07. Dez., Seite 17 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Cady, Roger K [VerfasserIn] |
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| Links: |
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| Themen: |
8R78F6L9VO |
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| Anmerkungen: |
Date Completed 22.03.2017 Date Revised 17.03.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1186/s10194-016-0717-7 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM268761779 |
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| 100 | 1 | |a Cady, Roger K |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Randomized, double-blind, crossover study comparing DFN-11 injection (3 mg subcutaneous sumatriptan) with 6 mg subcutaneous sumatriptan for the treatment of rapidly-escalating attacks of episodic migraine |
| 264 | 1 | |c 2017 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
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| 500 | |a Date Completed 22.03.2017 | ||
| 500 | |a Date Revised 17.03.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: A 6-mg dose of SC sumatriptan is the most efficacious and fast-acting acute treatment for migraine, but a 3-mg dose of SC sumatriptan may improve tolerability while maintaining efficacy | ||
| 520 | |a METHODS: This randomized, double-blind, crossover study compared the efficacy and tolerability of 3 mg subcutaneous (SC) sumatriptan (DFN-11) with 6 mg SC sumatriptan in 20 adults with rapidly-escalating migraine attacks. Eligible subjects were randomized (1:1) to treat 1 attack with DFN-11 and matching placebo autoinjector consecutively or 2 DFN-11 autoinjectors consecutively and a second attack similarly but with the alternative dose (3 mg or 6 mg) | ||
| 520 | |a RESULTS: The proportions of subjects who were pain-free at 60 min postdose, the primary endpoint, were similar following treatment with 3 mg SC sumatriptan and 6 mg SC sumatriptan (50% vs 52.6%, P = .87). The proportions of subjects experiencing pain relief (P ≥ .48); reductions in migraine pain intensity (P ≥ .78); and relief from nausea, photophobia, or phonophobia (P ≥ .88) with 3 mg SC sumatriptan and 6 mg SC sumatriptan were similar, as were the mean scores for satisfaction with treatment (M = 2.6 vs M = 2.4, P = .81) and the mean number of rescue medications used (M = .11 vs M = .26, P = .32). The most common adverse events with the 3- and 6-mg doses were triptan sensations - paresthesia, neck pain, flushing, and involuntary muscle contractions of the neck - and the incidence of adverse events with both doses was similar (32 events total: 3 mg, n = 14 [44%]; 6 mg, n = 18 [56%], P = .60). Triptan sensations affected 4 subjects with the 6-mg dose only, 1 subject with the 3-mg dose only, and 7 subjects with both sumatriptan doses. Chest pain affected 2 subjects (10%) treated with the 6-mg dose and no subjects (0%) treated with the 3-mg dose of DFN-11. There were no serious adverse events | ||
| 520 | |a CONCLUSIONS: The 3-mg SC dose of sumatriptan in DFN-11 provided relief of migraine pain and associated symptoms comparable to a 6-mg SC dose of sumatriptan. Tolerability was similar with both study medications; DFN-11 treatment was associated with fewer triptan sensations than the 6-mg dose. DFN-11, with its 3-mg dose of sumatriptan, may be a clinically useful alternative to higher-dose autoinjectors | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Episodic | |
| 650 | 4 | |a Migraine | |
| 650 | 4 | |a Rapidly-escalating | |
| 650 | 4 | |a Subcutaneous | |
| 650 | 4 | |a Sumatriptan | |
| 650 | 4 | |a Treatment | |
| 650 | 7 | |a Serotonin 5-HT1 Receptor Agonists |2 NLM | |
| 650 | 7 | |a Sumatriptan |2 NLM | |
| 650 | 7 | |a 8R78F6L9VO |2 NLM | |
| 700 | 1 | |a Munjal, Sagar |e verfasserin |4 aut | |
| 700 | 1 | |a Cady, Ryan J |e verfasserin |4 aut | |
| 700 | 1 | |a Manley, Heather R |e verfasserin |4 aut | |
| 700 | 1 | |a Brand-Schieber, Elimor |e verfasserin |4 aut | |
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