Predictors of premature discontinuation of treatment in multiple disease states

Eric Nantz1, Hong Liu-Seifert², Vladimir Skljarevski²

¹Department of Statistics, Western Michigan University, Kalamazoo, MI, USA; ²Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

Background: Premature discontinuation of treatment impacts outcomes of clinical practice. The traditional perception has been patient discontinuation is mainly driven by unwanted side effects. Systematic analysis of data from clinical trials across several disease states was performed to identify predictors of premature discontinuation during clinical interventions.

Methods: A post hoc analysis was conducted on 22 randomized, double-blind, placebo-controlled clinical trials for treatment of fibromyalgia, diabetic peripheral neuropathic pain, major depressive disorder, and generalized anxiety disorder. Analyses were conducted on pooled data within each disease state.

Results: Lack of early therapeutic response was a significant predictor of patient discontinuation in each disease state. Visit-wise changes in therapeutic response and severity of adverse events were also significant risk factors, with change in therapeutic response having a higher significance level in three disease states. Patients who discontinued due to adverse events had similar therapeutic responses as patients completing treatment.

Conclusion: Contrary to the conventional belief that premature treatment discontinuation is primarily related to adverse events, our findings suggest lack of therapeutic response also plays a significant role in patient attrition. This research highlights the importance of systematic monitoring of therapeutic response in clinical practice as a measure to prevent patients’ discontinuation from pharmacological treatments.

Keywords: attrition, depression, generalized anxiety disorder, fibromyalgia, therapeutic response, adverse event