Forum Πρωτοβάθμιας Φροντίδας Υγείας
ΠΦΥ -Εκπαίδευση => Αποσπάσματα από τον έντυπο & ηλεκτρονικό τύπο => Μήνυμα ξεκίνησε από: Argirios Argiriou στις 23 Δεκεμβρίου 2015, 15:27:47
-
Alain Joffe, MD, MPH, FAAP reviewing Libman IM et al. JAMA 2015 Dec 1.
In a 6-month trial, the addition of metformin to standard insulin regimens was not associated with lower HbA1C levels.
A growing proportion of adolescents with type 1 diabetes mellitus (T1DM) are overweight or obese. Metformin appears to have some benefit in overweight/obese adults with T1DM, but data for adolescents are lacking.
Investigators from 26 sites randomized 140 adolescents (mean age, 15.3 years; age range, 12–19.6 years; 66% female; 74% white) with presumed autoimmune T1DM (age <10 years at diagnosis or presence of diabetes-related autoantibodies) to receive 2000 mg metformin daily or placebo. Insulin doses were adjusted according to the clinical judgment of treating clinicians. The primary study outcome was change in HbA1C levels (8.8% at baseline in both groups).
At 13 weeks, the metformin group had a 0.2% decrease in HbA1C compared with a 0.1% increase in the placebo group (P=0.02), but at 26 weeks, each group showed a 0.2% increase. In secondary outcomes metformin-treated adolescents had significantly better results in reduced daily insulin dose (−0.1 vs. 0.0 U/kg/day), weight gain (0 vs. 2 kg), ≥5% loss of body weight (17% vs. 7%, P=0.09), and ≥10% reduction in body-mass index Z score (24% vs. 7%). Seventy percent of the metformin group reported gastrointestinal adverse effects compared with 35% in the placebo group.
Comment
Adding metformin did not improve glycemic control in these overweight/obese patients with T1DM, although the authors note that because clinicians were free to adjust insulin doses as they saw fit, the ability to detect changes in HbA1C levels between groups may have been limited. Because the clinical importance of the secondary outcomes that favored metformin is uncertain, these findings do not support adding metformin to the insulin regimens of overweight/obese adolescents with T1DM.
Editor Disclosures at Time of Publication
Disclosures for Alain Joffe, MD, MPH, FAAP at time of publication
Grant / Research support: Consolidated Health Plans
Editorial boards Adolescent Medicine: State of the Art Reviews; JAMA Pediatrics; Neinstein’s Textbook of Adolescent and Young Adult Health Care, Associate Editor
Citation(s):
Libman IM et al. Effect of metformin added to insulin on glycemic control among overweight/obese adolescents with type 1 diabetes: A randomized clinical trial. JAMA 2015 Dec 1; 314:2241. (http://dx.doi.org/10.1001/jama.2015.16174)
http://www.jwatch.org/na39771/2015/12/03/metformin-use-overweight-obese-adolescents-with-type-1?query=topic_diabetes&jwd=000100032085&jspc=GP