Naratriptan

Exposed non-exposed, cohort studies

Study Country
Study period
Study design
Data source Exposure definition Non-exposure definition Exposition period Sample size
(exposed/unexposed) Or (case / control)
Remarks Risk of bias
Ephross (Naratriptan versus Sumatriptan)
2014
Worlwide
1996 - 2012
prospective cohort
The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry Pregnant women exposed to naratriptan at any time during pregnancy (beginning from the first day of the last menstrual period). exposed to other treatment, sick
Pregnant women exposed to sumatriptan at any time during pregnancy (beginning from the first day of the last menstrual period).
1st trimester, during pregnancy (anytime or not specified) 57 / 626 PV registry of GlaxoSmithKline. Exposure to sumatriptan and naratriptan provided and considered as separate subgroups.
Shortly after the expected date of birth, registry personnel contacted the enrolling health care provider to obtain information focused on the use of sumatriptan, naratriptan, and/or the sumatriptan/naproxen sodium combination product and other headache medications during pregnancy.
Källén (control exposed to ergots)
2011
Sweden
1995 - 2008
population based cohort propective
The Swedish Medical Birth Register Infants born to women who had used Naratriptan during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Infants born to women who had used Ergots drugs for migraine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).
1st trimester 22 / 527 Exposed groups of the whole study: drugs for migraine (ergots or triptans).
Pregnant women who attend antenatal clinics in Sweden (which the vast majority do) are interviewed by a midwife and asked about drugs used since the pregnancy started. This interview is usually made before the end of the first trimester (usually between weeks 10 and 12 of pregnancy).
Källén (control unexposed, disease free)
2011
Sweden
1995 - 2008
population based cohort propective
The Swedish Medical Birth Register Infants born to women who had used Naratriptan during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Infants born to women who did not use drugs for migraine.
1st trimester 22 / 1229901 Exposed groups of the whole study: drugs for migraine (ergots or triptans). 1229901= Total number of infants (n=1233228) - Number of infants whose mother used drugs for migraine in 1st trimester (n=3327)
Pregnant women who attend antenatal clinics in Sweden (which the vast majority do) are interviewed by a midwife and asked about drugs used since the pregnancy started. This interview is usually made before the end of the first trimester (usually between weeks 10 and 12 of pregnancy).
Spielmann (Control mainly exposed other treatments, sick)
2017
Germany
1999 - 2014
prospective cohort
German Embryotox system Pregnant women with Naratriptan use for migraine disorder any time from conception to delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Pregnant women suffering from migraine disorder but not taking triptans between their last menstrual period and delivery.
during pregnancy (anytime or not specified) 42 / 475 The majority of exposed women took triptans in the first trimester (75.2%). Sumatriptan was the most frequently used triptan. Other triptans also studied.
All data are recorded using structured questionnaires via phone interview and/or as a written form.
Spielmann (Control unexposed, disease free)
2017
Germany
1999 - 2014
prospective cohort
German Embryotox system Pregnant women with Naratriptan use for migraine disorder any time from conception to delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Pregnant women without migraine disorder who were neither exposed to triptans nor to one of the following established teratogens or fetotoxicant.
during pregnancy (anytime or not specified) 42 / 1733 The majority of exposed women took triptans in the first trimester (75.2%). Sumatriptan was the most frequently used triptan. Other triptans also studied.
All data are recorded using structured questionnaires via phone interview and/or as a written form.
Yusuf (Control exposed to Sumatriptan)
2018
The United States
1996 - 2012
retrospective cohort (claims database)
The Truven Health Marketscan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits Databases Pregnant women with migraine exposed to Naratriptan during pregnancy using an insurance administrative claims database. exposed to other treatment, sick
Pregnant women with migraine exposed to Sumatriptan during pregnancy using an insurance administrative claims database.
1st trimester, 2nd and/or 3rd trimester 230 / 4519 This study was funded by Amgen and was conceived and conducted by Amgen employees.
Administrative claims data contained in the Truven Health Marketscan Com- mercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits Databases.

Case-control studies

Study Country
Study period
Study design
Data source Case Control Exposition Exposition period Sample size
(exposed/unexposed) Or (case / control)
Remarks Risk of bias

Risk of bias: : NA;   : low;   : moderate;   : serious;   : critical;   : unclear;  

Empty. There are no case-control studies available for this drug.

master protocol