Dose Titration of Pregabalin in Patients with Painful Diabetic Peripheral Neuropathy: Simulation Based on Observational Study Patients Enriched with Data from Randomized Studies

Pregabalin is approved in the United States and Europe for treatment of neuropathic pain (NeP) associated with diabetic peripheral neuropathy (pDPN). A microsimulation platform was used to integrate actual patient data from randomized placebo-controlled clinical trials with data from a large observational study in Germany, with the goal of evaluating the effects of pregabalin dose changes on therapeutic response for NeP associated with pDPN. Upward dose titration was associated with significantly better treatment outcomes. Tolerability did not appear to be a significant influence on treatment response patterns or the decision not to titrate dose. Simulations of patients with pDPN who were inadequately titrated suggested that they may have achieved improved treatment outcomes with titration.