Insulin Detemir izboljša glikemično urejenost in ima nevtralen učinek na telesno maso v slovenski kohorti raziskave Predictive - klinične izkušnje v Sloveniji
Insulin Detemir improves glycemic control and is weight neutral in the Slovenian cohort of the Predictive study - clinical experience in Slovenija

slovenian

2008

volume 77, issue 10

Agonists   Body Weight   Cohort Studies   Diabetes Mellitus, Insulin-Dependent   Diabetes Mellitus, Non-Insulin-Dependent   Hemoglobin A, Glycosylated   Hypoglycemia   Insulin   Therapeutic Use   therapy

Slovensko zdravniško društvo
(Obvezni izvod spletne publikacije)

Background The PREDICTIVET study is a large, multinational, multi-centre, observational study assessing the safety and efficacy of insulin detemir in everyday clinical practice. Patients and methods The Slovenian cohort included303 patients, with 268 (78 Type 1, 181 Type 2) patients eligible for the final analysis. The analysis was performed 12 weeks after switching the patients to insulin detemir, and evaluated: characteristics of the antidiabetic therapy (ATh; including OAD and number of daily injections), safety (total, severe and nocturnal hypoglycaemic events), efficacy (HbA1c andFBG levels, FBG variability), and effect on body weight. Results As for theATh, the main shift was observed from premix regimens to more complex insulin regimens, and from OAD regimens to insulin therapy. Statistically significant reductions of total, severe and nocturnal hypoglycaemic events were observed in both groups (Type 1: from 4.4 %, 0.38 % and 1.11 % at the baseline to 1.8 %, 0.01 % and 0.24 % at the end; Type 2: from 2.3 %, 0.2 % and0.89 % at the baseline to 0.7 %, 0.03 % and 0.2 % at the end, respectively;all p values < 0.001). Statistically significant reductions of HbA1c and FBG levels were also observed (Type 1: HbA1c from 8.11 % to 7.63 %, FBG from 8.9 mmol/L to 7.4 mmol/L; Type 2: HbA1c from 8.72 % to 8.06 %, FBG from 9.4 mmol/L to 8.0 mmol/L; all p values < 0.001). FBG variability (as measured by the average standard deviation) decreased from 2.33 mmol/L and 1.58 mmol/L to 1.86 mmol/L and 1.32 mmol/L in Type 1 and Type 2, respectively;both p values < 0.05). An overall trend toward weight loss was noted at week 12 (Type 1: -0.3 kg, NS; Type 2: -0.4 kg, p < 0.05). ConclusionsThe Slovenian cohort data thus support the short-term safety and efficacy of insulin detemir in daily clinical practice. These results are consistent with the findings of controlled clinical trials, includin

16.09.2009