SNFGE SNFGE
 
Thématique :
- Intestin/Nutrition/Troubles fonctionnels
Originalité :
Très original
Solidité :
Intermédiaire
Doit faire évoluer notre pratique :
Pas encore
 
 
Nom du veilleur :
Docteur Pauline JOUET
Coup de coeur :
 
 
Gastroenterology
  2017/11  
 
  2017 Nov;153(5):1240-1250.e2.  
  doi: 10.1053/j.gastro.2017.07.035.  
 
  Efficacy and Safety of Relamorelin in Diabetics With Symptoms of Gastroparesis: A Randomized, Placebo-Controlled Study.  
 
  Camilleri M, McCallum RW, Tack J, Spence SC, Gottesdiener K, Fiedorek FT  
  https://www.ncbi.nlm.nih.gov/pubmed/28760384  
 
 

Abstract

BACKGROUND & AIMS:

Gastroparesis is a complication of diabetes with few treatment options. Relamorelin (also referred to as RM-131) is a selective, prokinetic agonist of ghrelin. We aimed to evaluate the efficacy of relamorelin on symptoms and gastric emptying (GE) in a 12-week, phase 2B study of diabetic patients with moderate to severe gastroparesis symptoms (DG).

METHODS:

We performed a study of 393 patients with DG (37.7% male; 9.9% with type 1 diabetes; median age, 58.2 years [range 20-76]; median body mass index, 31.4 kg/m2 [range, 18.2-60.1]; HbA1c level, 7.6%, [range, 5.2-11.0]). All participants had 13C-spirulina GE breath test T1/2 values of 79 minutes or more (with 89.8% delayed relative to 90th %ile of normal, 85.75 minutes), recent vomiting, and gastroparesis cardinal symptom index-daily diary scores of 2.6 or more. Patients were randomly assigned to groups given placebo (n=104) or relamorelin (10 μg [n=98], 30 μg [n=109], or 100 μg [n=82] twice daily) for 12 weeks, following a 2-week, single-blind, placebo run-in period. Patient-reported outcomes were determined from DG Symptom Severity daily e-diaries, in which patients recorded vomiting frequency and symptom scores (nausea, abdominal pain, postprandial fullness, and bloating) on a 0-10 scale. Endpoints were change from baseline in vomiting frequency, composite DG Symptom Severity score, GE, and safety. We performed longitudinal, mixed-effects model analysis using repeated measures, with baseline and baseline-by-week interaction values as covariates.

RESULTS:

Patients given relamorelin had a 75% reduction in vomiting frequency compared with baseline, but this difference was not significant compared with the placebo group. All 4 symptoms of DG (composite or individual symptoms) were significantly reduced over the 12-week study period in all 3 relamorelin dose groups compared with the placebo group (all P < .05, based on longitudinal analysis over 12 weeks). Relamorelin significantly accelerated GE from baseline compared with placebo (by 12%, P < .05 for the 10 μg and 30 μg groups; P = .051 for the 100 μg group). Dose-related worsening of glycemic control was noted in 14.5% of patients who received relamorelin; some required insulin or other diabetes drug dosage adjustments.

CONCLUSIONS:

In a phase 2B randomized trial of patients with moderate to severe DG, relamorelin significantly reduced core symptoms of DG and overall composite score compared with placebo, accelerated GE, and was generally safe and well tolerated. ClinicalTrials.gov Identifier: NCT02357420.

 

 
Question posée
 
Quel est l’effet de la relamoreline, un agoniste de la grehline, sur les symptômes de gastroparésie chez les patients ayant une gastroparésie diabétique ?
 
Question posée
 
Dans cette étude randomisée de phase 2B portant sur 393 patients ayant une gastroparésie diabétique ( type 1 : 9,9% ), la prise de relamoreline à 10, 30 ou 100 microgrammes matin et soir en sous-cutanée pendant 12 semaines en comparaison au placebo n’avait pas d’efficacité sur l’objectif principal qui était le nombre de vomissements (réduction de 75% sous relamoreline vs 70% sous placebo) mais améliorait significativement les 4 symptômes de gastroparésie (nausées, douleurs abdominales, plénitude gastrique, ballonnement) au prix d’une dégradation du contrôle glycémique dans 14,5% des cas sous relamoreline.
 
Commentaires

Des résultats très encourageants pour la prise en charge des symptômes de gastroparésie diabétique pour lesquels les traitements médicamenteux sont souvent insuffisants. A suivre !!

 
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