The association between antiepileptic drug and HMG-CoA reductase inhibitor co-medication and cholesterol management in patients with epilepsy.

PURPOSE: Pharmacokinetic interactions have been demonstrated in enzyme-inducing antiepileptic drugs (EIAEDs) and statins; however, their clinical significance is not well established. The purpose of this study was to evaluate the association of EIAEDs and non-enzyme-inducing antiepileptic drugs (NEIAEDs) on statin dose adjustments and low-density lipoprotein (LDL) cholesterol levels in patients with epilepsy. METHODS: Retrospective insurance claims from 2000 to 2006 from the Ingenix Impact (formerly Integrated Health Care Information Services) database were analyzed. Two cohorts were compared, EIAEDs+statin and NEIAEDs+statin: 1118 patients were analyzed (58% men; 66% aged >55 years); 506 (45%) initiated with an EIAED. Outcomes assessed included statin dose adjustments and, for a subset of subjects, risk of mean LDL >100mg/dL during the 12-month follow-up period. Descriptive statistics were calculated and regression models estimated. RESULTS: Among the EIAED group, 72% initiated with phenytoin; among the NEIAED group, 57% initiated with gabapentin. For the EIAED group, the risk of upward statin dose adjustments was significantly greater (odds ratio=1.36; P=0.04) compared with the NEIAED group; similarly, the risk of having mean LDL >100mg/dL was significantly greater (odds ratio=41.22; P=0.005) and increased during the follow-up period (+26.6mg/dL; P=0.001) for the EIAED group. DISCUSSION: This study suggests that concomitant use of EIAEDs and statins may be associated with reduced clinical effectiveness of statins. Patients with epilepsy who use EIAEDs and statins concomitantly may require greater vigilance for optimal cholesterol management.

Comparing outcomes in patients with persistent asthma: a registry of two therapeutic alternatives.

OBJECTIVE: Clinical trials have demonstrated improved efficacy of fluticasone propionate/salmeterol (100/50 mcg) in a single device (FSC) compared with montelukast (10 mg) (MON). This study was designed to assess asthma control, asthma-related quality of life, asthma-related emergency department (ED) visit/hospitalization, treatment-related satisfaction, and productivity losses in patients newly started on FSC or MON. RESEARCH DESIGN AND METHODS: Patients who were newly prescribed FSC or MON during a regularly scheduled office visit were enrolled in a prospective observational study by nearly 500 physicians from eight managed care plans. Patient survey data were collected at baseline and at months 1, 3, 6, and 12, to measure study outcomes. ED visits/inpatient stays were reported from commercial claims data. Multivariate analyses assessed 12-month outcomes, controlling for several baseline patient characteristics. RESULTS: A total of 1414 patients >or= 15 years old were enrolled in the registry (FSC, n = 1061; MON, n = 353), 90% of which completed a 12-month survey. FSC patients had significantly greater improvement in both asthma control and quality of life, and reported significantly higher satisfaction with their medication (p = 0.003) and fewer days at work/school with asthma symptoms (p = 0.04) than MON. Other parameters of productivity losses such as missed work/school days due to asthma were not significantly different between the two groups. FSC use was also significantly associated with a lower risk of an asthma-related ED visit/hospitalization compared with MON (odds ratio = 0.35, 95% confidence interval: 0.15-0.92). CONCLUSION: In a 12-month office-based observational study, patients age 15 and older with persistent asthma, newly started on FSC, improved in symptom, quality of life, treatment, and utilization-related outcomes compared with patients newly started on MON. These results should be interpreted in light of the inherent limitations of non-randomized, uncontrolled studies.