Topiramate use during pregnancy and major congenital malformations in multiple populations.

BACKGROUND: We measured birth prevalence of major congenital malformations (MCMs) after topiramate use during pregnancy to screen for a possible signal of increased risk. METHODS: Using four healthcare databases, we identified three cohorts of pregnant women: cohort 1, used topiramate during the first trimester; cohort 2, used topiramate or another antiepileptic drug previously but not during pregnancy; and cohort 3, were pregnant and did not use topiramate but had indications for use individually matched to those of users. Cohort 1 was compared with cohorts 2 and 3. MCMs were a code for any major congenital malformation dated within 30 days of the delivery date on the mother's claims or within 365 days after infant birth date, excluding a genetic or syndromic basis, and with procedure or healthcare usage consistent with the MCM diagnosis code in the 365 days after infant birth. RESULTS: Of the 10 specific common MCMs evaluated, 1 (conotruncal heart defects) had a prevalence ratio greater than 1.5 for both primary comparisons, and 4 (ventricular septal defect, atrial septal defect, hypospadias, coarctation of the aorta) had a prevalence ratio greater than 1.5 for one of the two comparisons. Following screening of organ systems with elevated MCMs, the prevalence ratio was greater than 1.5 for patent ductus arteriosus in both comparisons and for obstructive genitourinary defects in one comparison. CONCLUSION: To evaluate a large number of MCMs across many pregnancies, we used crude methods for detecting potential signals. Therefore, these results should be seen as potential signals, not causal.

Comparison of direct and indirect costs of abnormal uterine bleeding treatment with global endometrial ablation and hysterectomy.

AIM: The objective was to compare abnormal uterine bleeding (AUB) direct healthcare costs and indirect work absence or short-term disability costs associated with treatment with second-generation global endometrial ablation (GEA) or hysterectomy. METHODS: Women aged 30-55 years with AUB who underwent GEA or hysterectomy during 2006-2010 were identified in the Truven Health MarketScan(®) Commercial and Health and Productivity Management databases. RESULTS & CONCLUSION: Two-thirds (66.3%) of the 61,602 study patients underwent GEA compared with hysterectomy (33.7%). Hysterectomy patients had higher treatment costs (US$12,147 vs 5837; p < 0.001), higher annual absenteeism costs (US$7543 vs 5621; p < 0.001), were four-times more likely to have a short-term disability claim (84 vs 21%; p < 0.001) and had higher per-patient short-term disability costs (US$5744 vs 1361; p < 0.001). Overall hysterectomy costs were approximately twice those of GEA.

Retrospective database analysis of clinical outcomes and costs for treatment of abnormal uterine bleeding among women enrolled in US Medicaid programs.

BACKGROUND: Women with abnormal uterine bleeding (AUB) may be treated surgically with hysterectomy or global endometrial ablation (GEA), an outpatient procedure. We compared the costs and clinical outcomes of these surgical procedures for AUB among women in Medicaid programs. METHODS: The Truven Health MarketScan(®) Medicaid Multi-State Database was used to identify Medicaid women aged 30-55 years with AUB who newly initiated GEA or hysterectomy (index event) during 2006-2010. Patients were required to have 12 months of continuous enrollment pre-index and post-index. Baseline characteristics were assessed in the pre-index period; health care utilization and costs (2011 USD), treatment complications, and reinterventions were assessed in the post-index period. RESULTS: Of 1,880 women who met the study criteria (mean age 40.7 years), 53.4% were Caucasian, 33.1% were African-American, and 2.3% were Hispanic; many (42.8%) received their Medicaid eligibility due to disability. Similar proportions received GEA (50.9%) or hysterectomy (49.1%). At baseline, both groups also had similar Deyo-Charlson Comorbidity scores (0.65), and use of antibiotics (69.4%), nonsteroidal anti-inflammatory drugs (56.3%), and oral contraceptives (5.3%). More hysterectomy patients than GEA patients had a treatment-related complication (52% versus 36%, respectively, P<0.001). Initial treatment costs were higher for hysterectomy ($11,270) than for GEA ($3,958, P<0.001); monthly gynecology-related costs in the remainder of the year were not significantly different for hysterectomy ($63) and GEA ($16, P=0.11). CONCLUSION: Hysterectomy was nearly three times more costly than GEA for initial treatment of AUB, and associated with more treatment-related complications. These results may be informative in the context of new federal mandates for Medicaid expansion, which are likely to focus on cost savings through use of outpatient treatments such as GEA.

Topiramate use in pregnancy and the birth prevalence of oral clefts.

PURPOSE: First marketed in the USA in 1996, topiramate (TPM) is an antiepileptic drug later approved for migraine prophylaxis, and in 2012 for weight loss in combination with phentermine. Some studies indicate an elevated prevalence of oral cleft (OC) in infants exposed to TPM in utero. We evaluated the association between TPM use in early pregnancy and the risk of OC. METHODS: This retrospective cohort study used 1997-2011 automated data from four sources: HealthCore and OptumInsight (commercial insurance claims), Truven Health (Medicaid claims), and Kaiser Permanente Northern California Region (electronic medical records). We compared the prevalence of OCs in infants of women exposed to TPM in the first trimester (TPM cohort) with the prevalence in infants of women formerly exposed to TPM or other antiepileptic drugs (formerly exposed [FE] cohort) and infants of women with similar medical profiles (SMPs) to the TPM cohort that were not exposed to TPM (SMP cohort). To control for confounding, we used stratification and standardization for individual variables and propensity score deciles. RESULTS: The birth prevalence of OCs was 0.36% (7/1945) in the TPM cohort, 0.14% (20/13 512) in the FE cohort, and 0.07% (9/13 614) in the SMP cohort. Standardized by site, the prevalence ratio (PR) for TPM versus FE was 2.5 (95% CI: 1.0-6.0) and for TPM versus SMP was 5.4 (95% CI: 2.0-14.6). Adjustment for covariates one at a time or by propensity score yielded similar results. CONCLUSION: Consistent with other recent epidemiologic research, first-trimester TPM exposure was associated with an elevated birth prevalence of OC.