PMID- 20435272
OWN - NLM
STAT- MEDLINE
DCOM- 20100723
LR  - 20200928
IS  - 1878-7398 (Electronic)
IS  - 1550-8579 (Linking)
VI  - 7
IP  - 2
DP  - 2010 Apr
TI  - Safety and tolerability of frovatriptan in the acute treatment of migraine and 
      prevention of menstrual migraine: Results of a new analysis of data from five 
      previously published studies.
PG  - 88-108
LID - 10.1016/j.genm.2010.04.006 [doi]
AB  - BACKGROUND: Triptans are a recommended first-line treatment for moderate to 
      severe migraine. OBJECTIVE: Using clinical trial data, we evaluated the safety 
      and tolerability of frovatriptan as acute treatment (AT) and as short-term 
      preventive (STP) therapy for menstrual migraine (MM). METHODS: Data from 2 Phase 
      III AT trials (AT1: randomized, placebo controlled, 1 attack; AT2: 12-months, 
      noncomparative, open label) and 3 Phase IIIb STP trials in MM (MMP1 and MMP2: 
      randomized, placebo controlled, double blind, 3 perimenstrual periods; MMP3: open 
      label, noncomparative, 12 perimenstrual periods) were analyzed. In AT1, patients 
      treated each attack with frovatriptan 2.5 mg, sumatriptan 100 mg, or placebo. In 
      AT2, they used frovatriptan 2.5 mg. In MMP1 and MMP2, women administered 
      frovatriptan 2.5 mg for 6 days during the perimenstrual period, taking a loading 
      dose of 2 or 4 tablets on day 1, followed by once-daily or BID frovatriptan 2.5 
      mg, respectively; in MMP3, they used BID frovatriptan 2.5 mg. In AT1, which was 
      previously published in part, group differences in adverse events (AEs) were 
      analyzed using the Fisher exact test, and response rates were compared using 
      logistic regression. Post hoc analyses of sustained pain-free status with no AEs 
      (SNAE) and sustained pain response with no AEs (SPRNAE) were performed using a 
      2-sample test for equality of proportions without continuity correction. For AT2 
      and the STP studies, data were summarized using descriptive statistics. Results 
      of individual safety analyses for the STP studies were previously reported; the 
      present report includes new results from a pooled analysis of MMP1 and MMP2 and a 
      new analysis of MMP3 in which AEs were coded using Medical Dictionary for 
      Regulatory Activities version 8.0. RESULTS: AT1 included 1206 patients in the 
      safety group; AT2 included 496. In the STP studies, safety data were collected 
      for 1487 women. In AT1 and AT2, 85.6% and 88.3%, respectively, of enrolled 
      patients were women. Overall, AEs were generally mild to moderate (AT studies: 
      82.3%-90.0%; STP studies: 78.9%89.5%). In AT1, 27.3% (131/480) of frovatriptan 
      patients, 33.4% (161/482) of sumatriptan patients, and 14.8% (36/244) of placebo 
      patients experienced an AE considered possibly or probably related to treatment 
      (P < 0.001 for either drug vs placebo).There were no significant differences 
      between frovatriptan and sumatriptan in SNAE at 4 to 24 hours or in SPRNAE at 2 
      to 24 hours or at 4 to 24 hours. In randomized, controlled STP trials for MM, AEs 
      were reported by 57.8% (166/287, BID) and 63.4% (210/331, once daily) of 
      frovatriptan users versus 62.8% (216/344) of placebo recipients. There were no 
      consistent differences in AEs reported by patients with potential cardiovascular 
      risk or in AEs related to the use of estrogencontaining contraceptives (ECCs). 
      CONCLUSIONS: In randomized controlled trials and 12-month open-label studies, 
      frovatriptan was well tolerated in these women during AT and STP therapy for MM. 
      Subgroup analyses provide preliminary evidence of tolerability in women using 
      ECCs and in women with comorbidities that do not contraindicate triptan use but 
      may be suggestive of cardiovascular risk.
CI  - 2010 Excerpta Medica Inc. All rights reserved.
FAU - MacGregor, E Anne
AU  - MacGregor EA
AD  - The City of London Migraine Clinic, London, United Kingdom. 
      anne.macgregor@migraineclinic.org.uk
FAU - Pawsey, Stephen P
AU  - Pawsey SP
FAU - Campbell, John C
AU  - Campbell JC
FAU - Hu, Xiaojun
AU  - Hu X
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Gend Med
JT  - Gender medicine
JID - 101225178
RN  - 0 (Carbazoles)
RN  - 0 (Serotonin Receptor Agonists)
RN  - 0 (Tryptamines)
RN  - 8R78F6L9VO (Sumatriptan)
RN  - H82Q2D5WA7 (frovatriptan)
SB  - IM
MH  - Acute Disease
MH  - *Carbazoles/adverse effects/therapeutic use
MH  - Cardiovascular Diseases/etiology
MH  - Clinical Trials, Phase III as Topic
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Logistic Models
MH  - Male
MH  - *Menstruation Disturbances/drug therapy/prevention & control
MH  - *Migraine Disorders/drug therapy/prevention & control
MH  - Multicenter Studies as Topic
MH  - Randomized Controlled Trials as Topic
MH  - Research Design
MH  - *Safety
MH  - *Serotonin Receptor Agonists/adverse effects/therapeutic use
MH  - Sumatriptan/therapeutic use
MH  - Treatment Outcome
MH  - *Tryptamines/adverse effects/therapeutic use
EDAT- 2010/05/04 06:00
MHDA- 2010/07/24 06:00
CRDT- 2010/05/04 06:00
PHST- 2010/03/26 00:00 [accepted]
PHST- 2010/05/04 06:00 [entrez]
PHST- 2010/05/04 06:00 [pubmed]
PHST- 2010/07/24 06:00 [medline]
AID - S1550-8579(10)00042-2 [pii]
AID - 10.1016/j.genm.2010.04.006 [doi]
PST - ppublish
SO  - Gend Med. 2010 Apr;7(2):88-108. doi: 10.1016/j.genm.2010.04.006.