J. Alexander Cole

Purpose: Reports from the GlaxoSmithKline Bupropion Pregnancy Registry suggested an increase in cardiovascular defects following exposure to bupropion during pregnancy. We conducted a study of congenital malformations among infants born to women exposed to bupropion during their first trimester.Methods: The study used data from UnitedHealthcare between January 1995 and September 2004. We calculated the prevalence of all congenital malformations and cardiovascular malformations associated with bupropion exposure in the estimated first trimester (1213 infants), compared with (1) other antidepressant exposure in the first trimester (4743 infants) and (2) bupropion exposure outside the first trimester (1049 infants). Malformation cases were confirmed through medical record abstraction. We calculated adjusted odds ratios (AORs) using the GEE form of logistic regression.Results: For all congenital malformations, the prevalence associated with bupropion first trimester was 23.1 per 1000 infants. The AORs were 0.95 (95%CI 0.62–1.45) and 1.00 (95%CI 0.57–1.73) in comparison to other antidepressants (prevalence 23.2 per 1000) and bupropion outside the first trimester (prevalence 21.9 per 1000), respectively. For cardiovascular malformations, the prevalence associated with bupropion first trimester was 10.7 per 1000 infants. The AORs were 0.97 (95%CI 0.52–1.80) and 1.07 (95%CI 0.48–2.40) in comparison to other antidepressants (prevalence 10.8 per 1000) and bupropion outside the first trimester (prevalence 9.5 per 1000), respectively.Conclusions: Results do not support a hypothesis of a teratogenic effect of first trimester bupropion exposure. The prevalence of malformations associated with bupropion exposure in the first trimester was not increased relative to the comparison groups. Copyright © 2006 John Wiley & Sons, Ltd.

Study Objective. To measure the association among prescription copayment, drug adherence, and subsequent health outcomes among patients with chronic heart failure (CHF).Design. Retrospective cohort study.Data Source. Database of a large, national health insurance plan.Patients. Patients with CHF receiving commercial and Medicare supplemental benefits.Measurements and Main Results. We estimated adherence to therapy with β‐blockers or angiotensin‐converting enzyme (ACE) inhibitors in 2002 by using the medication possession ratio, an estimate of the proportion of days a patient was exposed to a drug while taking a drug regimen. For 2003, we measured the annualized total cost of health care and identified hospitalizations with a diagnostic code for CHF. We used a two‐stage regression approach to model the association among copayment, adherence, and patient outcomes. For patients taking ACE inhibitors, a $10 increase in copayment was associated with a 2.6% decrease in the medication possession ratio (95% confidence interval [CI] 2.0–3.1%). This change in adherence was associated with a predicted 0.8% decrease in medical costs (95% CI‐4.2–2.5%) but a predicted 6.1% increase in the risk of hospitalization for CHF (95% CI 0.5–12.0%). Among patients taking β‐blockers, a $10 increase in copayment was associated with a 1.8% decrease in the medication possession ratio (95% CI 1.4–2.2%). This change in adherence was associated with a predicted 2.8% decrease in medical costs (95% CI −5.9–0.1%) and a predicted 8.7% increase in the risk of hospitalization for CHF (95% CI 3.8–13.8%).Conclusion. Among patients with CHF, higher drug copayments were associated with poorer adherence. The change was relatively small and did not affect predicted total health care costs, but it was sufficient to increase the predicted risk of hospitalization for CHF.