Pharmacoepidemiology

Medications are an important part of medical treatment in all stages of kidney disease. Some medications are used to slow progression of chronic kidney disease (CKD), whereas other medications—particularly those indicated for people with end-stage kidney disease—are used to address complications of disease, including changes in biochemistry.

Unfortunately, nephrology is a medical specialty relatively short on evidence from randomized clinical trials. When evidence from trials exists, it may merely show that a medication alters blood chemistry or another surrogate outcome, leaving open the question of whether the medication improves survival or reduces the risk of cardiovascular hospitalization.

Pharmacoepidemiology can help us fill this gap by providing evidence of effectiveness and safety of medication use in clinical practice, in addition to data about medication use itself. CDRG has extensive experience with pharmacoepidemiologic studies of CKD, addressing both long-standing and emerging therapies:

• Apixaban
• Cinacalcet
• Erythropoiesis-stimulating agents
• Intravenous iron
• Phosphate binders
• Vitamin D analogs

Our studies have spanned the range from descriptive studies of medication use to comparative effectiveness studies of competing treatments. Much work draws upon Medicare and Medicaid claims data, from which both physician-administered medications in the clinical setting and oral medications in the home setting can be ascertained. Notably, comparative effectiveness research requires sophisticated methodology to address all the challenges posed by retrospective data analysis, including confounding by indication. CDRG has experience with numerous analytic techniques, including propensity score matching, inverse probability of treatment weighting, and marginal structural modeling.

CDRG can also assist with post-market studies of claims data, including those mandated by regulatory authorities such as the US Food and Drug Administration. These studies require precise protocols and validated algorithms, such as those for identifying clinical events in databases populated with diagnosis and procedure codes.

Whether your company is in the pre-approval or post-approval phase of drug and market development, CDRG can offer expert analysis and insight.

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