Summary
Compared to rapid-acting human insulin (regular insulin), insulin glulisine has a stronger effect on postprandial blood glucose levels, which, if elevated, is associated with the development of cardiovascular complications. The aim of this database analysis was therefore to compare the incidence of cardiovascular events in type 2 diabetics treated with either insulin glulisine or regular insulin for at least 3.5 years. Data from 952 glulisine users (age: 61 ± 11 years) and 11,157 regular insulin users (age: 65 ± 11 years) from outpatient practices throughout Germany were available for analysis (Disease Analyzer, November 2004 to March 2010). The hazard ratios (HR; Cox regression) for the risk of developing a cardiovascular event within 3.5 years were adjusted for the potential influencing factors of age, sex, duration of diabetes, microvascular complications, concomitant antidiabetic medication (basal insulin, oral antidiabetics), hypertension, hyperlipidemia, depression, care by a diabetologist, health insurance, and the treating physician's practice location. Overall, the risk of cardiovascular events was 20% lower (p<0.05) in the glulisine group than with regular insulin. A significantly reduced risk of coronary heart disease (HR; 95% CI: 0.78; 0.62-0.99) and an indication of a lower risk of myocardial infarction (HR; 95% CI: 0.66; 0.43-1.02) were observed. Since this is a retrospective database analysis, the results should be confirmed in a randomized controlled trial.

Incidence of cardiovascular events in insulin-treated patients with type 2 diabetes under real-life conditions
Insulin glulisine has a higher efficacy in reducing postprandial glucose excursions than rapid human insulin (regular insulin). This is of importance because the postprandial glucose level is a critical component of diabetes related cardiovascular complications in type 2 diabetes. Therefore the objective of the current database analysis was to compare the incidence of cardiovascular outcomes in type 2 diabetes patients treated with insulin glulisine or regular human insulin for at least 3.5 years. There were 952 insulin glulisine (age: 61 ± 11 years) and 11,157 regular human insulin patients (65 ± 11 years) available with first-time prescriptions from open care practices from all parts of Germany (Disease Analyzer; 11/2004 till 03/2010). The hazard ratios (HR, Cox regression) for the risk to develop a cardiovascular event within 3.5 years were adjusted for age, sex, diabetes duration, microvascular complications, hypoglycemic co-medication (basal insulins, oral antidiabetics), hypertension, hyperlipidemia, depression, diabetologist care, type of health insurance and physician`s residency. Insulin glulisine was associated with a reduced incidence (- 20%) of cardiovascular outcomes compared to human regular insulin (p < 0.05). A significant risk reduction could be shown for coronary artery disease (HR; 95% CI: 0.78; 0.62-0.99). Furthermore, there was an indication for a lower risk for incident myocardial infarction, which did not reach statistical significance (HR; 95% CI: 0.66; 0.43-1.02). Due to the fact that the results were derived from a retrospective database analysis they should be confirmed by a prospective randomized controlled trial.

keywords
Diabetes mellitus, insulin glulisine, regular human insulin, cardiovascular complications, insulin glulisine, regular human insulin, cardiovascular complications