Final results from the 16-year sumatriptan, naratriptan, and treximet pregnancy registry.

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.

First trimester paroxetine use and the prevalence of congenital, specifically cardiac, defects: a meta-analysis of epidemiological studies.

Background: Several studies have evaluated maternal first trimester paroxetine use and the prevalence of congenital defects, particularly cardiac defects. To synthesize current epidemiologic information, a meta-analysis was conducted.

Methods: A systematic literature search was conducted for original research published from January 1, 1992, through September 30, 2008.

Paroxetine in the first trimester and the prevalence of congenital malformations.

Purpose: To refine a preliminary analysis identifying a possibly increased prevalence of malformations among infants born to women exposed to paroxetine in the first trimester.

Methods: This study used data from UnitedHealthcare, a large U.S.

The utility of the general practice research database to examine selected congenital heart defects: a validation study.

Objective: The purpose of this research was (1) to validate that ventricular septal defect (VSD), tetralogy of Fallot (TOF), and coarctation of the aorta (COA) can be studied in the UK General practice research database (GPRD) and (2) to understand which of the available GPRD components (computerized medical records, questionnaires, and maternal/infant free text) provide maximal information about these heart defects.

Methods: Using a practitioner questionnaire, the positive predictive value (PPV) of the computerized medical record for VSD, TOF, and COA were determined. Both infant and maternal free text was examined.

Evaluation of the General Practice Research Database congenital heart defects prevalence: comparison to United Kingdom national systems.

Background: As part of an effort to validate the General Practice Research Database (GPRD) for future studies of medication use in pregnancy, this study examined whether the rates of all, and specific types of, congenital heart defects obtained from the GPRD are similar to those obtained from UK national systems.

Methods: The prevalence rates of heart defects for 2001-2003 were determined from the GPRD and compared with both the National Congenital Anomaly System (NCAS) and the European Concerted Action of Congenital Anomalies and Twins (EUROCAT). Rate ratios (RRs) and 95% CIs were calculated comparing the prevalence of all congenital heart defects as well as specific types of heart defects in the three data sources.

Headache, cerebrovascular symptoms, and stroke: the Atherosclerosis Risk in Communities Study.

Objective: To evaluate the occurrence of stroke/TIA symptoms and ischemic stroke events among those with a lifetime history of migraine or other headaches with some migraine features in a biracial cohort of older adults.

Methods: Participants were 12,750 African-American and white men and women from the Atherosclerosis Risk in Communities Study (1993 to 1995). The participants were queried about their lifetime headache history and characterized using modified International Headache Society diagnostic criteria.

The incidence of congestive heart failure associated with antidiabetic therapies.

Background: Increased risk for CHF in persons with type 2 diabetes is well established. Our objectives were to estimate the CHF risk associated with specific therapies for diabetes and to determine the differences in incidence rates of CHF associated with adding various antidiabetic agents.

Methods: Subjects were members of the Kaiser Permanente Northwest (KPNW) diabetes registry as of 1 January 1998, with no prior history of CHF (n = 8063).

The incidence of congestive heart failure in type 2 diabetes: an update.

Objective: The aims of this study were to update previous estimates of the congestive heart failure (CHF) incidence rate in patients with type 2 diabetes, compare it with an age- and sex-matched nondiabetic group, and describe risk factors for developing CHF in diabetic patients over 6 years of follow-up.

Research Design And Methods: We performed a retrospective cohort study of 8,231 patients with type 2 diabetes and 8,845 nondiabetic patients of similar age and sex who did not have CHF as of 1 January 1997, following them for up to 72 months to estimate the CHF incidence rate. In the diabetic cohort, we constructed a Cox regression model to identify risk factors for CHF development.

Lifetime prevalence of migraine and other headaches lasting 4 or more hours: the Atherosclerosis Risk in Communities (ARIC) study.

Objectives: To evaluate the lifetime prevalence of migraine and other headaches lasting 4 or more hours in a population-based study of older adults.

Background: Migraine and other headaches not fulfilling migraine criteria are common afflictions. Yet the health and social effects of these conditions have not been fully appreciated, particularly among older adults.

Menstrual patterns and risk of adult-onset diabetes mellitus.

We examined the association between menstrual patterns and risk of developing adult-onset diabetes in a prospective study of 668 white, college-educated women who completed menstrual diaries throughout their reproductive years. We calculated summary measures of cycle length and variability and bleeding duration for ages < or = 22, 23-27, 28-32, and 33-37 years. The analysis included 35,418 person-years of follow-up and 49 self-reported cases of diabetes (median age at diagnosis, 63 years).

Monitoring pregnancy outcomes following prenatal drug exposure through prospective pregnancy registries and passive surveillance: a pharmaceutical company commitment.

Objectives: Glaxo Wellcome (G.W.) becomes aware of prenatal exposures to its medications from as early as the clinical trial phase of development.

Monitoring birth outcomes in the Sumatriptan Pregnancy Registry.

Background: Health professionals often need to make medical management decisions by weighing potential risk versus benefit. Because 50% of pregnancies in the United States are unplanned, the likelihood for unintentional first-trimester exposure to medications is high and increases when women of childbearing potential (ages 15-44) are taking medications used to treat chronic or recurrent conditions, such as migraine. Prospective collection of pregnancy exposure and outcome data is one method for providing data to the medical community as a tool for making risk assessments.

Age at menopause and childbearing patterns in relation to mortality.

Several studies have reported increased mortality risk with early natural menopause. More recently, mortality risk was reported to be reduced among women who gave birth at age > or =40 years. The association between reproductive history and mortality was explored among 826 women in a prospective study involving 18,959 person-years of follow-up (from age 50 to 1990-1991) and 108 deaths.

Pregnancy and perinatal outcomes in migraineurs using sumatriptan: a prospective study.

Background: Sumatriptan is an acute treatment for migraine which is often used by women in their child-bearing years, and who become unexpectedly pregnant. Within the context of the post-marketing use of sumatriptan injection for the acute treatment of migraine, and in compliance with approved labeling, we wished to compare perinatal pregnancy outcomes in women who did and did not use the drug after conception.

Methods: Open-label, prospective study conducted in 12,339 migraineurs (including 9,861 women) whose demography and consumption pattern of sumatriptan injections were typical, and were predicted to include 150 pregnancies.

Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: a pharmaceutical company commitment.

Objective: Glaxo Wellcome becomes aware of prenatal exposures to its medications as early as the clinical trial phase of development. An international process for monitoring prenatal exposure to all Glaxo Wellcome medicines has been developed. For specific products there are prospective pregnancy registries.

Menstrual and reproductive risk factors for ischemic heart disease.

The role of hormones in ischemic heart disease is of considerable interest, but limited data are available pertaining to risk factors associated with endogenous hormones. We examined the association between menstrual and reproductive factors and ischemic heart disease in a cohort of 867 white, college-educated women who prospectively recorded menstrual cycle data for at least 5 years from their early 20s through their menopause. Ischemic heart disease history was obtained from a self-administered (N = 714) or proxy-administered (N = 153) questionnaire completed at a mean age of 73 years.

Greater incidence of electrocardiographic left ventricular hypertrophy in black men than in white men in Evans County, Georgia.

Population-based studies of black populations in the United States and Puerto Rico have reported higher prevalences of electrocardiographic left ventricular hypertrophy compared to white or lighter-skinned populations residing in the same areas. This study examines the incidence and correlates of electrocardiographic left ventricular hypertrophy in a population-based, biracial cohort of 435 white and 163 black men from the Evans County, Georgia, Heart Study, who were examined at entry in 1960 and reexamined in 1967. Only men over 35 years of age who were free of cardiovascular disease and had normal electrocardiograms at entry were eligible.