Objective: To assess the burden of hypoglycemia in patients with diabetes mellitus (DM) in Spain, including epidemiological data and information relating to healthcare resource utilization (HRU) and costs, and patients' quality of life (QoL).
Methods: A systematic literature review (SLR) was conducted to identify studies that included original information on epidemiology, HRU and costs, and/or QoL associated with hypoglycemia in patients with DM in Spain, published in either Spanish or English, between January 2007 and April 2017.
Results: Fifteen articles, involving 14 studies, were identified in the SLR and included in the analysis. The estimated rate of severe hypoglycemia (SH) events per patient per year ranged from 0.90 to 1.50 in patients with type 1 DM (T1DM) and from 0.30 to 0.63 in patients with type 2 DM (T2DM). The data on HRU differed extensively between studies, making it difficult to draw a conclusion. Total costs per SH event ranged from €409.97 in patients with T1DM to €713.10 in patients with DM. Work absence was reported in 11.80-18% of the working patients. Further, patients who experienced hypoglycemic events expressed a higher fear and had a poorer QoL than those who did not report these events.
Conclusion: Although the data included in the SLR were difficult to synthesize due to heterogeneity of the study designs and patient characteristics in the 14 studies, our search identified a high burden associated with hypoglycemic events in terms of HRU and costs, and patients' QoL. Further research is recommended to reach a consensus on hypoglycemia definition and study design to provide robust evidence on the burden of hypoglycemia and to accurately weigh the impact of this acute complication in Spain.
Funding: Eli Lilly and Company.
Keywords: Diabetes mellitus; Hypoglycemia; Observational studies; Spain; Systematic literature review.