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. 2016 Apr 20;2016(4):CD008541. doi: 10.1002/14651858.CD008541.pub3
Study ID Treatment Any AE SAE AE withdrawal Other withdrawal
Brandes 2007 Study 1 (1) suma/naprox 85/500 mg, n = 370
(2) suma 85 mg, n = 365
(3) naprox 500 mg, n = 361
(4) placebo, n = 365
≤ 24 h:
(1) 100/370
(2) 89/365
(3) 48/361
(4) 45/365
No SAE with combination, naproxen alone, or placebo in either study. 1 person admitted to hospital with palpitations following sumatriptan 85 mg 1 person in (2) with palpitations Exclusions ‐ took medication but no evaluable data:
(1) 6
(2) 4
(3) 5
(4) 5
Brandes 2007 Study 2 (1) suma/naprox 85/500 mg, n = 367
(2) suma 85 mg, n = 370
(3) naprox 500 mg, n = 371
(4) placebo, n = 387
≤ 24 h:
(1) 97/367
(2) 105/370
(3) 52/371
(4) 39/387
No SAE None Exclusions ‐ took medication but no evaluable data:
(1) 5
(2) 8
(3) 7
(4) 5
Calhoun 2014 (1) suma/naprox 85/500 mg, n = 43
(2) placebo n = 43 No data No data No data No data
Lipton 2009 Study 1 (1) suma/naprox 85/500 mg, n = 447 (1693 attacks)
(2) placebo, n = 123 (424 attacks)
≤ 72 h:
Study 1, 1st attack:
(1) 57/447
(2) 15/123
All attacks:
(1) 153/1693
(2) 28/424
7 SAE across both studies, but judged not related to study medication, and occurred > 72 h after taking study medication. No details of groups (1) 8 (3 chest discomfort)
(2) 0
All judged related to study medication; mild/mod severity
People lost to follow‐up or withdrawn for any attack:
(1) < 6%
(2) < 8%
Lipton 2009 Study 2 (1) suma/naprox 85/500 mg, n = 458 (1678 attacks)
(2) placebo, n = 107 (422 attacks)
≤ 72 h:
1st attack:
(1) 85/458
(2) 15/107
All attacks:
(1) 219/1678
(2) 36/422
(1) 6 (3 chest discomfort, 3 nausea)
(2) 1 (nausea)
All judged related to study medication; mild/mod severity
People lost to follow‐up or withdrawn for any attack:
(1) < 6%
(2) < 7%
Mannix 2009 Study 1 (1) suma/naprox 85/500 mg, n = 152
(2) placebo, n = 160
≤ 48 h (possibly 24 h)
AEs consistent with known profile of 2 drugs
Drug‐related AE frequency < 1%
None None Excluded from efficacy analysis:
(1) 1
(2) 0
Mannix 2009 Study 2 (1) suma/naprox 85/500 mg, n = 151
(2) placebo, n = 160
≤ 48 h (possibly 24 h)
AEs consistent with known profile of 2 drugs
Drug‐related AE frequency < 5%
None None Excluded from efficacy analysis:
(1) 0
(2) 1
Mathew 2009 Study 1 (1) suma/naprox 85/500 mg, n = 144
(2) placebo, n = 144
Assume AE reported for safety population within 24 h
(1) 16/144
(2) 6/144 None reported 1 AE withdrawal following placebo 5 people in (1) and (2) took medication, but not included in ITT. Unclear, but probably had no post‐baseline efficacy data
Mathew 2009 Study 2 (1) suma/naprox 85/500 mg, n = 139
(2) placebo, n = 139
Assume AE reported for safety population within 24 h
(1) 13/139
(2) 7/139
None reported None 2 people in (1) and (2) took medication, but not included in ITT. Unclear, but probably had no post‐baseline efficacy data
Silberstein 2008 Study 1 (1) suma/naprox 85/500 mg, n = 283
(2) placebo, n = 297
AE reported for safety population during study period (up to 1 week)
(1) 31/283
(2) 21/297 None None 3 people in (1) and 1 in (2) took medication but had no post‐baseline efficacy data
Silberstein 2008 Study 2 (1) suma/naprox 85/500 mg, n = 278
(2) placebo, n = 264
AE reported for safety population during study period (up to 1 week)
(1) 39/278
(2) 24/264
None None 2 people in (1) and 5 in (2) took medication but had no post‐baseline efficacy data
Smith 2005 (1) suma/naprox 50/500 mg, n = 251
(2) suma 50 mg, n = 229
(3) naprox 500 mg, n = 250
(4) placebo, n = 241
AE reported for safety population up to 72 h
(1) 58/251
(2) 55/242
(3) 43/250
(4) 36/242
None None None reported
TRX109011/13 2010 (1) suma/naprox 85/500 mg, n = 317
(2) BCM, n = 392
(3) placebo, n = 320
AE for safety population reported within 72 h:
(1) 36/406
(2) 21/392
(3) 28/405
(1) 2 (breast cancer diagnosis, chest pain, and hypertension)
(2) 0
(3) 1 (intestinal mass and viral meningitis)
None considered related to study medication
(1) 3, (2) 0, (3) 1 4 in total; pregnancy (2), breast cancer diagnosis (1), and use of prohibited medication (1)
AE: adverse event; BCM: barbiturate‐containing medication; h: hour; naprox: naproxen; ITT: intention to treat; SAE: serious adverse event; suma: sumatriptan; suma/naprox: sumatriptan plus naproxen.