Resumen de Effects of Gevokizumab on Glycemia and Inflammatory Markers in Type 2 Diabetes

Claudia Cavelti-Weder, Andrea Babians-Brunner, Cornelia Keller, Marc A Stahel, Malaika Kurz-Levin, Hany Zayed, Alan M Solinger, Thomas Mandrup-Poulsen, Charles A. Dinarello, Marc Y Donath

• DAFNE (Dose Adjustment For Normal Eating), a structured education program in flexible insulin therapy, has been widely adopted in the U.K. after validation in a randomized trial. To determine benefits in routine practice, we collected biomedical and psychological data from all participants attending during a 12-month period. HbA^sub 1c^, weight, self-reported hypoglycemia awareness, severe hypoglycemia frequency, PAID (Problem Areas In Diabetes), HADS (Hospital Anxiety and Depression Scale), and EuroQol Group 5-Dimension Self-Report Questionnaire scores were recorded prior to DAFNE and after 1 year. Complete baseline and follow-up HbA^sub 1c^ data were available for 639 (54.9%) of 1,163 attendees. HbA^sub 1c^ fell from 8.51 ± 1.41 (mean ± SD) to 8.24 ± 1.29% (difference 0.27 [95% CI 0.16-0.38]; P < 0.001), with a greater mean fall of 0.44% from baseline HbA^sub 1c^ >8.5%. Severe hypoglycemia rate fell from 1.7 ± 8.5 to 0.6 ± 3.7 episodes per person per year (1.1 [0.7-1.4]) and hypoglycemia recognition improved in 43% of those reporting unawareness. Baseline psychological distress was evident, with a PAID score of 25.2 and HADS scores of 5.3 (anxiety) and 4.8 (depression), falling to 16.7 (8.5 [6.6-10.4]), 4.6 (0.7 [0.4-1.0]), and 4.2 (0.6 [0.3-0.8]), respectively (all P < 0.001 at 1 year). Clinically relevant anxiety and depression (HADS ?8) fell from 24.4 to 18.0% and 20.9 to 15.5%, respectively. A structured education program delivered in routine clinical practice not only improves HbA^sub 1c^ while reducing severe hypoglycemia rate and restoring hypoglycemia awareness but also reduces psychological distress and improves perceived well-being.