Insulin aspart : an evidence-based medicine review.

This paper provides a review and evaluation of the published evidence relating to the efficacy, safety and ease of administration of the rapid-acting insulin analogue insulin aspart in comparison with human insulin (HI) in diabetes mellitus in the following categories: (a) in adults, (b) in children, and (c) in continuous subcutaneous insulin infusion (CSII). A search for publications on insulin aspart was conducted for the following databases: Cochrane, BIOSIS, EMBASE-DP and MEDLINE. Publications were examined for relevance by two independent assessors and were graded using a system developed by the Oxford Centre for Evidence-Based Medicine. Overall, the evidence comparing insulin aspart with HI was of high quality, with all three categories graded as grade A evidence. Studies showed strong evidence for better glycaemic control, without an increased risk of hypoglycaemia, together with evidence supporting improved convenience and flexibility in administration of insulin aspart compared with regular HI in adult diabetic patients. Evidence from three trials in adults with type 1 diabetes showed a lower incidence of major nocturnal hypoglycaemia with insulin aspart versus regular HI. Published evidence also confirmed the more rapid action of insulin aspart versus HI, and a comparable efficacy and safety profile for both insulin types in type 1 paediatric patients. There was also strong evidence that insulin aspart is well tolerated and efficacious for CSII/pump use. Insulin aspart better mimics the physiological response to meals than regular HI, and may offer advantages in terms of glycaemic control and reduction of hypoglycaemia combined with flexibility and convenience of administration. Overall, there is a good body of evidence to support the efficacy, tolerability and ease of administration of insulin aspart in patients with type 1 and type 2 diabetes.