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Susan Sinclair - One of the best experts on this subject based on the ideXlab platform.
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final results from the 16 year sumatriptan Naratriptan and treximet pregnancy registry
Headache, 2014Co-Authors: Sara A Ephross, Susan SinclairAbstract:Objectives To monitor for a signal of major teratogenicity by determining the risk of all birth major defects following in utero exposure to sumatriptan, Naratriptan, and the sumatriptan/naproxen sodium combination product (tablets marketed in the United States as Treximet [GlaxoSmithKline, Research Triangle Park, NC, USA]), and to monitor for unusual patterns of defects that might suggest teratogenicity. Background The prevalence of migraine is highest in women of childbearing age. Coupled with the recurrent nature of migraine attacks and the high proportion of unplanned pregnancies, intentional and inadvertent exposure to anti-migraine drugs in pregnancy is likely. The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry captured data on women exposed to those drugs during pregnancy to monitor for evidence of major teratogenicity. Methods In this primarily prospective, observational study, health care professionals from anywhere in the world enrolled, on a voluntary basis, women exposed to sumatriptan, Naratriptan, or the sumatriptan/naproxen sodium combination product during their pregnancies. Only pregnancies with unknown outcomes at the time of enrollment were included in the analysis. The proportion of infants or fetuses with major birth defects was calculated as the total number of infants/fetuses with major birth defects divided by the sum of the number of infants/fetuses with major birth defects + the number of live births without defects. The risk of major birth defects was further stratified by earliest trimester of pregnancy exposure. Results The registry enrolled 680 evaluable exposed pregnant women, which resulted in 689 infants and fetuses (outcomes). Of these outcomes, 626 were exposed to sumatriptan, 57 were exposed to Naratriptan (seven were exposed to both sumatriptan and Naratriptan), and six were exposed to the sumatriptan/naproxen sodium combination product. Twenty outcomes with major birth defects were reported among 528 outcomes exposed in the first trimester to sumatriptan. The estimated risk of major birth defects following first-trimester sumatriptan exposure is 4.2% (20/478 [95% confidence interval [CI] 2.6%–6.5%]). Among 52 first-trimester exposures to Naratriptan, major birth defects were reported in one outcome, an infant with exposure to both sumatriptan and Naratriptan [birth defect risk of 2.2% (1/46 [95% CI 0.1%–13.0%]). No major defects were reported among the five outcomes with first-trimester exposure to the sumatriptan/naproxen sodium combination products. Conclusions The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry detected no signal of teratogenicity associated with major birth defects for sumatriptan. This finding is consistent with results from other observational studies using a variety of control groups. Enrollment in the registry was insufficient to permit definitive conclusions of the risks associated with Naratriptan or sumatriptan/naproxen sodium tablets, or to assess the risk of individual birth defects in any of the products studied. Low enrollment and high rates of loss to follow up within the registry over an extended period of time led the registry's scientific advisory committee to conclude that continuation of the registry beyond its 16 years would offer little additional power to rule out more moderate increases in the risk of birth defects. Data from the other ongoing surveillance sources constitute an important element of post-marketing surveillance of these medications. The lack of a signal of major teratogenicity with sumatriptan across these several sources of data is encouraging.
Habib Hassani - One of the best experts on this subject based on the ideXlab platform.
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Efficacy of Naratriptan tablets in the acute treatment of migraine: A dose-ranging study
Clinical Therapeutics, 2000Co-Authors: Hannele Havanka, Paul Winter, Helen Whitehouse, Carl Dahlöf, Hans-christoph Diener, Habib HassaniAbstract:Abstract Objective This study sought to compare the efficacy of several doses of Naratriptan tablets with that of sumatriptan tablets and placebo in the acute treatment of a single migraine attack. Methods This was a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study. Patients received either Naratriptan tablets (1, 2.5, 5, 7.5, or 10 mg), sumatriptan tablets (100 mg), or placebo. Results A total of 643 patients took part in the study. Two hours after dosing, headache relief was reported by significantly more patients treated with any dose of Naratriptan (52%–69%) or sumatriptan (60%) than with placebo (31%) ( P P
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Tolerability and Efficacy of Naratriptan Tablets in the Acute Treatment of Migraine Attacks for 1 Year
Cephalalgia, 2000Co-Authors: J Heywood, P Winter, Mam Bomhof, A Pradalier, L Thaventhiran, Habib HassaniAbstract:Objective and design: This open‐label study was conducted to evaluate the tolerability and efficacy of the 5HT1 agonist Naratriptan with repeated use in the acute treatment of migraine attacks for ...
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Early clinical experience with subcutaneous Naratriptan in the acute treatment of migraine: a dose-ranging study.
European Journal of Neurology, 1998Co-Authors: Carl Dahlöf, Habib Hassani, Jean Schoenen, Leon Hogenhuis, Jes Olesen, Henri Petit, Jacques Ribbat, Diane Boswell, Eliane Fuseau, Paul WinterAbstract:Naratriptan is a novel, potent agonist at the 5HT1B/1D receptor. A total of 335 migraine patients were treated in this randomized, double-blind, placebo-controlled, dose-ranging, in-clinic study, to evaluate the efficacy, safety and tolerability of five doses of subcutaneous (sc) Naratriptan (0.5, 1, 2.5, 5 or 10 mg) in comparison with sc sumatriptan (6 mg) and placebo in the acute treatment of a moderate/severe migraine attack. Headache relief [reduction of headache severity from moderate or severe (grade 2/3) to mild or none (grade 1/0)] at 1 and 2 h after each dose, was reported by a statistically significantly higher proportion of patients for all doses of sc Naratriptan and sc sumatriptan (6 mg) than for placebo. The percentages of patients with headache relief at 2 h post-dose were: Naratriptan (0.5 mg) 65%, (1 mg) 75%, (2.5 mg) 83%, (5 mg) 94% and (10 mg) 91%; sumatriptan (6 mg) 89%; placebo 41%, (P < 0.005). The earliest report of a statistically significant difference compared with placebo for the times assessed was with sc Naratriptan (10 mg) at 10 min post-dose (P = 0.023). The percentages of patients reporting adverse events were dose-related; sc Naratriptan (0.5 mg) 33%, (1 mg) 29%, (2.5 mg) 43%, (5 mg) 59% and (10 mg) 71%; sc sumatriptan 53%; placebo 22%. There were no clinically significant changes in electrocardiogram (ECG), vital signs or laboratory parameters. Systemic exposure increased proportionally to the dose, the absorption of sc Naratriptan was rapid (tmax = 10 min) and the half-life was 5 h. In conclusion, sc Naratriptan was an effective and well-tolerated acute treatment for migraine. Copyright 1998 Lippincott Williams & Wilkins
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Tolerability and efficacy of Naratriptan tablets with long‐term treatment (6 months)
Cephalalgia, 1998Co-Authors: Mam Bomhof, P Winter, H. Enahoro, J Heywood, A Pradalier, Habib HassaniAbstract:This open-label study was conducted to examine the long-term tolerability and efficacy of the novel 5HT1 agonist Naratriptan tablets 2.5 mg used to treat all migraine attacks for 6 months. Patients...
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tolerability and efficacy of Naratriptan tablets with long term treatment 6 months
Cephalalgia, 1998Co-Authors: Mam Bomhof, P Winter, H. Enahoro, J Heywood, A Pradalier, Habib HassaniAbstract:This open-label study was conducted to examine the long-term tolerability and efficacy of the novel 5HT1 agonist Naratriptan tablets 2.5 mg used to treat all migraine attacks for 6 months. Patients...
Sara A Ephross - One of the best experts on this subject based on the ideXlab platform.
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final results from the 16 year sumatriptan Naratriptan and treximet pregnancy registry
Headache, 2014Co-Authors: Sara A Ephross, Susan SinclairAbstract:Objectives To monitor for a signal of major teratogenicity by determining the risk of all birth major defects following in utero exposure to sumatriptan, Naratriptan, and the sumatriptan/naproxen sodium combination product (tablets marketed in the United States as Treximet [GlaxoSmithKline, Research Triangle Park, NC, USA]), and to monitor for unusual patterns of defects that might suggest teratogenicity. Background The prevalence of migraine is highest in women of childbearing age. Coupled with the recurrent nature of migraine attacks and the high proportion of unplanned pregnancies, intentional and inadvertent exposure to anti-migraine drugs in pregnancy is likely. The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry captured data on women exposed to those drugs during pregnancy to monitor for evidence of major teratogenicity. Methods In this primarily prospective, observational study, health care professionals from anywhere in the world enrolled, on a voluntary basis, women exposed to sumatriptan, Naratriptan, or the sumatriptan/naproxen sodium combination product during their pregnancies. Only pregnancies with unknown outcomes at the time of enrollment were included in the analysis. The proportion of infants or fetuses with major birth defects was calculated as the total number of infants/fetuses with major birth defects divided by the sum of the number of infants/fetuses with major birth defects + the number of live births without defects. The risk of major birth defects was further stratified by earliest trimester of pregnancy exposure. Results The registry enrolled 680 evaluable exposed pregnant women, which resulted in 689 infants and fetuses (outcomes). Of these outcomes, 626 were exposed to sumatriptan, 57 were exposed to Naratriptan (seven were exposed to both sumatriptan and Naratriptan), and six were exposed to the sumatriptan/naproxen sodium combination product. Twenty outcomes with major birth defects were reported among 528 outcomes exposed in the first trimester to sumatriptan. The estimated risk of major birth defects following first-trimester sumatriptan exposure is 4.2% (20/478 [95% confidence interval [CI] 2.6%–6.5%]). Among 52 first-trimester exposures to Naratriptan, major birth defects were reported in one outcome, an infant with exposure to both sumatriptan and Naratriptan [birth defect risk of 2.2% (1/46 [95% CI 0.1%–13.0%]). No major defects were reported among the five outcomes with first-trimester exposure to the sumatriptan/naproxen sodium combination products. Conclusions The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry detected no signal of teratogenicity associated with major birth defects for sumatriptan. This finding is consistent with results from other observational studies using a variety of control groups. Enrollment in the registry was insufficient to permit definitive conclusions of the risks associated with Naratriptan or sumatriptan/naproxen sodium tablets, or to assess the risk of individual birth defects in any of the products studied. Low enrollment and high rates of loss to follow up within the registry over an extended period of time led the registry's scientific advisory committee to conclude that continuation of the registry beyond its 16 years would offer little additional power to rule out more moderate increases in the risk of birth defects. Data from the other ongoing surveillance sources constitute an important element of post-marketing surveillance of these medications. The lack of a signal of major teratogenicity with sumatriptan across these several sources of data is encouraging.
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Final Results From the 16‐Year Sumatriptan, Naratriptan, and Treximet Pregnancy Registry
Headache: The Journal of Head and Face Pain, 2014Co-Authors: Sara A Ephross, Susan M. SinclairAbstract:Objectives To monitor for a signal of major teratogenicity by determining the risk of all birth major defects following in utero exposure to sumatriptan, Naratriptan, and the sumatriptan/naproxen sodium combination product (tablets marketed in the United States as Treximet [GlaxoSmithKline, Research Triangle Park, NC, USA]), and to monitor for unusual patterns of defects that might suggest teratogenicity. Background The prevalence of migraine is highest in women of childbearing age. Coupled with the recurrent nature of migraine attacks and the high proportion of unplanned pregnancies, intentional and inadvertent exposure to anti-migraine drugs in pregnancy is likely. The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry captured data on women exposed to those drugs during pregnancy to monitor for evidence of major teratogenicity. Methods In this primarily prospective, observational study, health care professionals from anywhere in the world enrolled, on a voluntary basis, women exposed to sumatriptan, Naratriptan, or the sumatriptan/naproxen sodium combination product during their pregnancies. Only pregnancies with unknown outcomes at the time of enrollment were included in the analysis. The proportion of infants or fetuses with major birth defects was calculated as the total number of infants/fetuses with major birth defects divided by the sum of the number of infants/fetuses with major birth defects + the number of live births without defects. The risk of major birth defects was further stratified by earliest trimester of pregnancy exposure. Results The registry enrolled 680 evaluable exposed pregnant women, which resulted in 689 infants and fetuses (outcomes). Of these outcomes, 626 were exposed to sumatriptan, 57 were exposed to Naratriptan (seven were exposed to both sumatriptan and Naratriptan), and six were exposed to the sumatriptan/naproxen sodium combination product. Twenty outcomes with major birth defects were reported among 528 outcomes exposed in the first trimester to sumatriptan. The estimated risk of major birth defects following first-trimester sumatriptan exposure is 4.2% (20/478 [95% confidence interval [CI] 2.6%–6.5%]). Among 52 first-trimester exposures to Naratriptan, major birth defects were reported in one outcome, an infant with exposure to both sumatriptan and Naratriptan [birth defect risk of 2.2% (1/46 [95% CI 0.1%–13.0%]). No major defects were reported among the five outcomes with first-trimester exposure to the sumatriptan/naproxen sodium combination products. Conclusions The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry detected no signal of teratogenicity associated with major birth defects for sumatriptan. This finding is consistent with results from other observational studies using a variety of control groups. Enrollment in the registry was insufficient to permit definitive conclusions of the risks associated with Naratriptan or sumatriptan/naproxen sodium tablets, or to assess the risk of individual birth defects in any of the products studied. Low enrollment and high rates of loss to follow up within the registry over an extended period of time led the registry's scientific advisory committee to conclude that continuation of the registry beyond its 16 years would offer little additional power to rule out more moderate increases in the risk of birth defects. Data from the other ongoing surveillance sources constitute an important element of post-marketing surveillance of these medications. The lack of a signal of major teratogenicity with sumatriptan across these several sources of data is encouraging.
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the safety of sumatriptan and Naratriptan in pregnancy what have we learned
Headache, 2009Co-Authors: Marianne Cunnington, Sara A Ephross, Paige ChurchillAbstract:Objectives.— To monitor for a signal of major teratogenicity by determining the risk of all major defects following in utero exposure to sumatriptan and Naratriptan. To monitor for unusual patterns of birth defects that might suggest teratogenicity. Background.— The prevalence of migraine is highest in women of childbearing age. Coupled with the recurrent nature of migraine attacks and the high proportion of unplanned pregnancies, intentional and inadvertent exposure to these drugs in pregnancy is likely. The Sumatriptan and Naratriptan Pregnancy Registry captures data on women exposed to those drugs during pregnancy to monitor for evidence of major teratogenicity. Methods.— Healthcare professionals from anywhere in the world can enroll, on a voluntary basis, women exposed to sumatriptan or Naratriptan during their pregnancies in this primarily prospective, observational study. Only pregnancies with unknown outcomes at the time of enrollment were included in the analysis. The percentage of infants or fetuses with major birth defects was calculated as the total number of infants/fetuses with major birth defects divided by the sum of the number of infants/fetuses with major birth defects + the number of live births without defects. The risk of major birth defects was further stratified by earliest trimester of pregnancy exposure. Results.— Data are available on pregnancy outcomes from 599 exposed women. Among 479 first-trimester exposures to sumatriptan, 20 outcomes with major birth defects were reported (4.6%, 95% confidence interval [CI] 2.9-7.2%). The risk of major birth defects following exposure to sumatriptan during any trimester was 4.7% (95% CI 3.1-7.0%). No distinctive pattern of major birth defects among exposed infants was noted. There were 50 first-trimester exposures to Naratriptan with 1 reported birth defect in a fetus with exposure to both sumatriptan and Naratriptan. Conclusions.— The risk of all major birth defects following first-trimester exposure to sumatriptan was 4.6% (95% CI 2.9-7.2%). This coupled with a consistent failure of additional epidemiological studies to observe a signal for major teratogenicity gives a level of reassurance concerning the safety of sumatriptan in pregnancy. There are too few data on Naratriptan to draw definitive conclusions, and the sample size for sumatriptan remains too small to detect any but very large increases in specific birth defects.
Mam Bomhof - One of the best experts on this subject based on the ideXlab platform.
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Tolerability and Efficacy of Naratriptan Tablets in the Acute Treatment of Migraine Attacks for 1 Year
Cephalalgia, 2000Co-Authors: J Heywood, P Winter, Mam Bomhof, A Pradalier, L Thaventhiran, Habib HassaniAbstract:Objective and design: This open‐label study was conducted to evaluate the tolerability and efficacy of the 5HT1 agonist Naratriptan with repeated use in the acute treatment of migraine attacks for ...
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Tolerability and efficacy of Naratriptan tablets with long‐term treatment (6 months)
Cephalalgia, 1998Co-Authors: Mam Bomhof, P Winter, H. Enahoro, J Heywood, A Pradalier, Habib HassaniAbstract:This open-label study was conducted to examine the long-term tolerability and efficacy of the novel 5HT1 agonist Naratriptan tablets 2.5 mg used to treat all migraine attacks for 6 months. Patients...
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tolerability and efficacy of Naratriptan tablets with long term treatment 6 months
Cephalalgia, 1998Co-Authors: Mam Bomhof, P Winter, H. Enahoro, J Heywood, A Pradalier, Habib HassaniAbstract:This open-label study was conducted to examine the long-term tolerability and efficacy of the novel 5HT1 agonist Naratriptan tablets 2.5 mg used to treat all migraine attacks for 6 months. Patients...
Lawrence C Newman - One of the best experts on this subject based on the ideXlab platform.
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Naratriptan as short term prophylaxis of menstrually associated migraine a randomized double blind placebo controlled study
Headache, 2001Co-Authors: Lawrence C Newman, Lisa K Mannix, Steve Landy, Stephen D Silberstein, Richard B Lipton, D Pait G Putnam, C Watson, M Jobsis, Alice S BatenhorstAbstract:Objective.—To determine the efficacy of Naratriptan 1-mg and 2.5-mg tablets twice daily compared with placebo as short-term prophylaxis of menstrually associated migraine. Background.—Approximately 60% of women with migraine report headaches associated with their menstrual cycles. Results from an open-label study suggest that short-term administration of sumatriptan is useful in the prophylaxis of menstrually associated migraine. Methods.—A randomized, double-blind, three-arm, parallel-group, placebo-controlled study was conducted in women aged 18 years or older with a history of migraine with or without aura, as defined by the International Headache Society, of at least 6 months. Two dose strengths of Naratriptan (1 mg, 2.5 mg) or identical-appearing placebo tablets (1:1:1) were administered twice daily for 5 days starting 2 days prior to the expected onset of menses across four perimenstrual periods. End points included the number of menstrually associated migraines, total migraine days, peak headache severity, lost work/activity time, migraine-related quality of life, and incidence of adverse events. Results.—Overall, the intent-to-treat population comprised 206 women (Naratriptan 1 mg, n = 70; Naratriptan 2.5 mg, n = 70, and placebo, n = 66); 171 women treated four perimenstrual periods. Significantly more perimenstrual periods per subject treated with Naratriptan, 1 mg, were headache-free compared with placebo (50% versus 25%, P = .003). Naratriptan, 1 mg, significantly reduced the number of menstrually associated migraines (2.0 versus 4.0, P < .05) and menstrually associated migraine days (4.2 versus 7.0, P < .01) compared with placebo. More patients treated with Naratriptan, 1 mg, were headache-free across all treated perimenstrual periods compared with placebo (23% versus 8%). No difference in headache severity was observed in breakthrough headaches. The incidence and severity of adverse events was similar across treatment groups. Naratriptan, 2.5 mg, was not statistically superior to placebo for any measure. Conclusions.—Naratriptan, 1 mg, with tolerability similar to placebo, is an effective, short-term, prophylactic treatment for menstrually associated migraine.
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Naratriptan as short-term prophylaxis of menstrually associated migraine: a randomized, double-blind, placebo-controlled study.
Headache: The Journal of Head and Face Pain, 2001Co-Authors: Lawrence C Newman, Lisa K Mannix, Steve Landy, Stephen D Silberstein, Richard B Lipton, C Watson, M Jobsis, Alice S Batenhorst, D.g. Pait Putnam, Stephen O'quinnAbstract:Objective.—To determine the efficacy of Naratriptan 1-mg and 2.5-mg tablets twice daily compared with placebo as short-term prophylaxis of menstrually associated migraine. Background.—Approximately 60% of women with migraine report headaches associated with their menstrual cycles. Results from an open-label study suggest that short-term administration of sumatriptan is useful in the prophylaxis of menstrually associated migraine. Methods.—A randomized, double-blind, three-arm, parallel-group, placebo-controlled study was conducted in women aged 18 years or older with a history of migraine with or without aura, as defined by the International Headache Society, of at least 6 months. Two dose strengths of Naratriptan (1 mg, 2.5 mg) or identical-appearing placebo tablets (1:1:1) were administered twice daily for 5 days starting 2 days prior to the expected onset of menses across four perimenstrual periods. End points included the number of menstrually associated migraines, total migraine days, peak headache severity, lost work/activity time, migraine-related quality of life, and incidence of adverse events. Results.—Overall, the intent-to-treat population comprised 206 women (Naratriptan 1 mg, n = 70; Naratriptan 2.5 mg, n = 70, and placebo, n = 66); 171 women treated four perimenstrual periods. Significantly more perimenstrual periods per subject treated with Naratriptan, 1 mg, were headache-free compared with placebo (50% versus 25%, P = .003). Naratriptan, 1 mg, significantly reduced the number of menstrually associated migraines (2.0 versus 4.0, P
