Sumatriptan - Medication and Pregnancy KB

Sumatriptan

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Ephross (Control exposed to Naratriptan), 2014	Worlwide 1996 - 2012	Women were eligible for enrollment by their health care provider if they were pregnant, exposed to sumatriptan, naratriptan, or the sumatriptan/naproxen sodium combination product at any time during pregnancy (beginning from the first day of the last menstrual period)	Pregnant women exposed to sumatriptan at any time during pregnancy (beginning from the first day of the last menstrual period).	exposed to other treatment, sick Pregnant women exposed to naratriptan at any time during pregnancy (beginning from the first day of the last menstrual period).	626 / 57	PV registry of GlaxoSmithKline. Exposure to sumatriptan and naratriptan provided and considered as separate subgroups.
Kallen, 2001	Sweden 1995 - 1999	Almost all births (approximately 1% are missing).	Women who had reported the use of Sumatriptan in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) All deliveries in Sweden as registered in the Medical Birth Registry.	658 / -9	Exposed group of the whole study: use of drugs for migraine.
Källén (Controls exposed to ergots), 2011	Sweden 1995 - 2008	All deliveries in Sweden (1 211 670 women) recorded in the Medical Birth Register with data from antenatal care.	Infants born to women who had used Sumatriptan 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).	2257 / 527	Exposed groups of the whole study: drugs for migraine (ergots or triptans).
Källén (Controls unexposed, disease free), 2011	Sweden 1995 - 2008	All deliveries in Sweden (1 211 670 women) recorded in the Medical Birth Register with data from antenatal care.	Infants born to women who had used Sumatriptan 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.	2257 / 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)
Nezvalová-Henriksen (Control unexposed, disease free), 2013	Norway 2004 - 2007	All singleton deliveries (after the 12th gestational week) without chromosomal abnormalities during the study period.	Sumatriptan prescription redemption during pregnancy ('anytime' or 'during the first trimester' or 'during the second trimester' or 'during the third trimester'). (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Pregnant women did not redeem triptans during the study period (the population comparison group).	575 / 178565	Other triptans also studied.
Nezvalová-Henriksen (Control unexposed, sick), 2013	Norway 2004 - 2007	All singleton deliveries (after the 12th gestational week) without chromosomal abnormalities during the study period.	Sumatriptan prescription redemption during pregnancy ('anytime' or 'during the first trimester' or 'during the second trimester' or 'during the third trimester'). (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Triptan prescription redemption between 7 and 1 month prior to pregnancy only.	575 / 1095	Other triptans also studied.
O'Quinn, 1999	USA Not specified	Patients could be male or female, could have migraine with or without aura, and were at least 18 years of age. Ergotamine-containing drugs could not be prescribed for 24 h before or after use of sumatriptan.	Pregnant women exposed to sumatriptan after conception.	unexposed, sick Pregnant women exposed to sumatriptan only prior to conception.	76 / 92	Open-label, prospective study conducted by Glaxo Wellcome Research Institute.
Olesen (Control unexposed, disease free), 2000	Denmark 1991 - 1996	Women who filled prescriptions during pregnancy in North Jutland County (approximately 10% of the total Danish population).	Women who filled at least one prescription for sumatriptan during pregnancy.	unexposed, disease free Healthy women, who in this context are defined as women who did not redeem any prescriptions during pregnancy,	34 / 15995
Olesen (Control unexposed, sick), 2000	Denmark 1991 - 1996	Women who filled prescriptions during pregnancy in North Jutland County (approximately 10% of the total Danish population).	Women who filled at least one prescription for sumatriptan during pregnancy.	unexposed, sick Migraine controls, who were women who redeemed at least one prescription for sumatriptan or ergotamine 52 to 12 weeks prior to conception, but not during pregnancy.	34 / 89	(Table 2: Control group: Migraine patients who did not redeem prescriptions for antimigraine drugs 3 months prior to or during pregnancy.)
Shuhaiber (Control exposed to other treatments), 1998	Canada, USA	Pregnant women who voluntarily contacted a teratogen information service (TIS)	Pregnant women who used sumatriptan during pregnancy.	exposed to other treatment, sick Disease-matched controls (pregnant women contacting Motherisk who had migraine headache and used other drugs such as acetaminophen, nonsteroidal anti-inflammatory drugs, and narcotic analgesics).	96 / 96	A total of 96 women who were exposed to sumatriptan during pregnancy were followed up prospectively by the four participating centers: 91 in Toronto, 3 in Philadelphia, 1 in London, and 1 in Farmington. Mosterrik => main center.
Shuhaiber (Control unexposed, disease free), 1998	Canada, USA	Pregnant women who voluntarily contacted a teratogen information service (TIS)	Pregnant women who used sumatriptan during pregnancy.	unexposed, disease free Nonteratogen controls (pregnant women who contacted Motherisk requesting counseling about medications known to be safe in the human fetus).	96 / 96	A total of 96 women who were exposed to sumatriptan during pregnancy were followed up prospectively by the four participating centers: 91 in Toronto, 3 in Philadelphia, 1 in London, and 1 in Farmington. Mosterrik => main center.
Spielmann (Control mainly exposed other treatments, sick), 2017	Germany 1999 - 2014	Cohort of pregnant women enrolled by the German Embryotox system for risk assessment related to pregnancy.	Pregnant women with Sumatriptan 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.	253 / 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.
Spielmann (Control unexposed, disease free), 2017	Germany 1999 - 2014	Cohort of pregnant women enrolled by the German Embryotox system for risk assessment related to pregnancy.	Pregnant women with Sumatriptan 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.	253 / 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.
Yusuf (Control exposed to Naratriptan), 2018	The United States 1996 - 2012	Women with a diagnosis of migraine (International Classification of Diseases, Ninth Revision, diagnosis codes 346.xx) or prescription claims for migraine‐specific acute medications (triptans or ergotamine‐derivatives).	Pregnant women with migraine exposed to Sumatriptan during pregnancy using an insurance administrative claims database.	exposed to other treatment, sick Pregnant women with migraine exposed to Naratriptan during pregnancy using an insurance administrative claims database.	4519 / 230	This study was funded by Amgen and was conceived and conducted by Amgen employees.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk
De Jonge, 2013	The Netherlands 1998 - 2008	All malformed foetuses and children (live births, stillbirths, spontaneous abortions and terminations of pregnancy) excluding chromosomal and genetic disorders.	From the IADB, a population-based prescription database that contains prescription data from approximately 55 community pharmacies in The Netherlands, we selected the population controls. The IADB covers an estimated population of 500,000 individuals, which is considered representative of the general population.	3212 / 29223	'All types of births are included in the registry: live births, stillbirths, spontaneous abortions and terminations of pregnancy.' Other drugs studied: 'Drugs acting on nervous system and Drugs considered to be safe'.

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