A narrative review of the importance of pharmacokinetics and drug-drug interactions of preventive therapies in migraine management.

OBJECTIVE: To review the pharmacokinetics of major classes of migraine preventives and the clinical implications of drug-drug interactions (DDIs) with the use of these therapies in migraine management. BACKGROUND: Preventive treatments for migraine are recommended for a large proportion of patients with frequent migraine attacks. These patients often exhibit a number of comorbidities, which may lead to the introduction of multiple concomitant therapies. Potential DDIs must be considered when using polytherapy to avoid increased risk of adverse events (AEs) or inadequate treatment of comorbid conditions. METHODS: A literature search was performed to identify pharmacokinetic properties and potential DDIs of beta-blockers, antiepileptic drugs, antidepressants, calcium channel blockers, gepants, and monoclonal antibody therapies targeting the calcitonin gene-related peptide pathway with medications that may be used for comorbid conditions. RESULTS: Most DDIs occur through alterations in cytochrome P450 isoenzyme activity and may be complicated by genetic polymorphism for metabolic enzymes. Additionally, drug metabolism may be altered by grapefruit juice ingestion and smoking. The use of migraine preventive therapies may exacerbate symptoms of comorbid conditions or increase the risk of AEs associated with comorbid conditions as a result of DDIs. CONCLUSIONS: DDIs are important to consider in patients with migraine who use multiple medications. The development of migraine-specific evidence-based preventive treatments allows for tailored clinical management that reduces the risk of DDIs and associated AEs in patients with comorbidities.

The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays.

The European Bioanalysis Forum, in collaboration with several key industry stakeholders, has recently led discussions that address international immunogenicity guidance documents, specifically the three tier approach for immunogenicity testing strategies, after more than 20 years of experience with biotherapeutics. As part of this, the strategy and methods used to assess drug tolerance across all immunogenicity assays are challenged, emphasizing that bioanalytical scientists need to consider the context-of-use of each assay. Here, recommendations for drug tolerance assessments, driven by strong scientific rationale and subject to reevaluation as needed, are provided. This includes carefully considering the drug and positive control concentrations considered to be appropriate and which tiers are most relevant for performing drug tolerance assessments.

Client characteristics and gender-specific correlates of testing HIV positive: a comparison of standalone center versus mobile outreach HIV testing and counseling in Botswana.

Using data from Botswana's largest HIV testing and counseling (HTC) provider, Tebelopele, we evaluate populations served and gender-specific correlates of testing HIV-positive among clients of two programs: standalone centers and outreach testing. Client records from January to June 2007 (n = 47,890) were evaluated by HTC program and gender. Bivariate and multivariate analyses were performed to identify demographic, testing, and risk-behavior variables associated with testing HIV-positive. Compared to outreach testing, standalone centers served proportionally more clients who were young, well-educated, unmarried, and HIV-infected; outreach testing reached an older, less-educated population. Age, educational attainment, marital status, couples testing, testing because of illness or discordant relationship, and nonuse of condoms (among young clients only) were consistently associated with testing HIV-positive, by HTC program and gender. Our evaluation suggests that Tebelopele standalone and outreach HTC programs serve different populations, and identifies strategies to reduce HIV infection risk and to improve uptake of HTC by HIV-infected, undiagnosed Batswana.

Data harmonization process for creating the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Atlas.

In 2009, the CDC National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) initiated the online, interactive NCHHSTP Atlas. The goal of the Atlas is to strengthen the capacity to monitor the diseases overseen by NCHHSTP and to illustrate demographic, spatial, and temporal variation in disease patterns. The Atlas includes HIV, AIDS, viral hepatitis, sexually transmitted disease, and tuberculosis surveillance data, and aims to provide a single point of access to meet the analytical and data dissemination needs of NCHHSTP. To accomplish this goal, an NCHHSTP-wide Data Harmonization Workgroup reviewed surveillance data collected by each division to harmonize the data across diseases, allowing one to query data and generate comparable maps and tables via the same user interface. Although we were not able to harmonize all data elements, data standardization is necessary and work continues toward that goal.