OBJECTIVES: To analyze the clinical effectiveness, resource utilization, labor productivity losses and associated costs of the prescription of citicoline (Somazina^®) for the treatment of ischemic stroke and traumatic brain injury (TBI) in Spain. Clinical Effectiveness was determined by patients’ quality of life (Barthel index and Mini-Mental State Examination, MMSE).

METHODS: This is an observational and retrospective case-control study based on the electronic medical records from the BIG-PAC^® database, which collects data from 1.8 million individuals in Spain. The case cohort included patients who initiated treatment with citicoline after suffering a stroke or TBI between 01/01/2016 and 31/12/2018. The follow-up period was 18 months from the index date (date of stroke or TBI diagnosis). Demographic and clinical characteristics, including basic activities of daily living, along with healthcare resource use and costs (€, 2020) were analyzed. All statistical results were performed using SPSSWIN version 23.

RESULTS: The study considered 5,144 patients with stroke (mean age: 73.3 years; males: 58.2%) and 779 with TBI (mean age: 37.7 years; males: 75.5%). The stroke cohort consisted of 4,525 (88%) untreated with citicoline and 619 (12%) treated. Of these, the mean cost per patient was €3,454 vs. €4,393, p<0.001 for case/control patients, respectively. The stroke case cohort showed an improvement in cognitive function (MMSE; diff: 2.5 vs. 1.1 points; p<0.001) compared to the control. The TBI cohort consisted of 535 (68.7%) untreated with citicoline and 244 (31.3%) treated. Of these, the mean cost per patient was €3,793 vs. €5,007, p<0.001 for case/control patients, respectively. The TBI case cohort showed a slight improvement in cognitive function (MMSE; diff: 2.3 vs. 1.5 points; p<0.001) over the control cohort.

CONCLUSIONS: The use of citicoline was associated with improved cognitive function in patients with a first episode of stroke or TBI, resulting in lower costs from the societal perspective.