Efficacy and safety comparison of rapid-acting insulin aspart and regular human insulin in the treatment of type 1 and type 2 diabetes mellitus: a systematic review.

ABSTRACT

BACKGROUND: Insulin aspart (IAsp) is one of the three rapid-acting insulin analogues (RAAs) registered for the treatment of diabetes. However, there is an ongoing debate concerning the efficacy and safety of RAAs. For this reason, a systematic review-based study was performed to compare clinical outcomes of treatment with IAsp and regular human insulin (RHI) as well as biphasic insulin aspart and premixed human insulin in type 1 and type 2 diabetes (T1DM, T2DM) patients. METHODS: Relevant articles were identified by a systematic search through the electronic medical databases (MEDLINE, EMBASE, CENTRAL) up to July 2009. RESULTS: A total of 28 trials fulfilled the inclusion criteria, including 17 studies of T1DM, 10 of T2DM and one study of both. For T1DM, pooled data for HbA(1c) (13 studies) demonstrated lower levels with IAsp than with RHI (WMD=-0.11%; 95% CI -0.16 to -0.06). In addition, meta-analysis revealed statistically significant differences in favour of IAsp for postprandial glucose (PPG) after breakfast, lunch and dinner, but not for fasting glucose (FG). The Diabetes Treatment Satisfaction Questionnaire evaluating treatment flexibility showed IAsp benefits compared with RHI (WMD=0.31; 95% CI 0.15 to 0.47). Safety analyses (three studies) showed a significant reduction in nocturnal hypoglycaemia risk with IAsp (RR=0.67; 95% CI 0.54 to 0.83), and no difference in severe hypoglycaemias and a slight increase in any hypoglycaemic episodes with RAAs (RR=1.06; 95% CI 1.01 to 1.10). For T2DM, a meta-analysis of nine studies revealed no significant differences between IAsp and RHI in HbA(1c) (WMD=-0.04%; 95% CI -0.10 to 0.03), whereas PPG was significantly lower in the IAsp group (WMD=-1.18 mmol/L; 95% CI -1.88 to -0.47). No studies of treatment satisfaction or quality of life were identified. CONCLUSION: Analyses based on a systematic review showed that treatment with IAsp in T1DM patients resulted in moderately better metabolic control and treatment satisfaction than RHI. In T2DM patients, meta-analysis showed improvement in PPG, but not in any other outcomes.