| Popis: |
The PREDICTIVE project was an international multicentric, open observation study evaluating the safety and efficiency of insulin detemir in clinical practice. 1,695 type 1 or 2 diabetes mellitus (DM) patients were enrolled in the study in the Czech Republic. The patients were treated by insulin detemir for the period of 26 weeks in accordance with the standard scheme implemented by the treating doctor. The primary objective of the study was to monitor the incidence of serious adverse events including severe hypoglycaemias. The secondary objective of the study (the number of adverse events, the incidence of all and nocturnal hypoglycaemic episodes, the variability of fasting glycaemia, the change in HbA1c at the end of the study, the change in the patients' weight) focused on the safety and efficiency of diabetes treatment.Insulin detemir therapy resulted in a statistically significant decrease in all nocturnal episodes (from 26.8 to 10.4 episodes/patient/year in type 1 DM; from 9.2 to 2.6 in persons with type 2 DM), in severe nocturnal episodes (from 2.5 to 0.1 episode/patient/year in type 1 DM, and from 0.6 to 0 in type 2 DM), and also in hypoglycaemic nocturnal episodes (from 7.2 to 1.8 episode/patient/year in type 1 DM and from 1.7 to 0.3 in type 2 DM) as compared with the period preceding the therapy. In addition, detemir therapy resulted in a statistically significant improvement of diabetes compensation characterised by a decrease in the average HbAlc from 7.6% to 6.7% in type 1 DM patients, and from 7.9% to 7.0% in type 2 DM patients. Average fasting glycaemia recorded a significant decrease by 2.4 mmol/l in type 1 DM patients, and by 2.3 mmol/l in type 2 DM patients. Also the variability of fasting glycaemia recorded a significant decrease at the end of the study in both patient groups. No major change in weight was recorded in the course of the study in persons with type 1 DM, while a significant decrease in weight was recorded for type 2 DM patients.The results of the study PREDICTIVE confirmed the data from randomised studies on the safety and efficiency of insulin detemir treatment in the conditions of standard clinical practice in the Czech Republic. |
