Pilot investigations have suggested that a novel, long-acting, injectable, intra-muscular formulation of omeprazole (LA-OMEP) can induce acid suppression for up to 7 days following a single injection.
To investigate the pharmacodynamics and assess the clinical efficacy of the LA-OMEP formulation.
Part A) A pharmacodynamic study; Part B) A pilot clinical trial.
Part A) Six adult, Thoroughbred horses with percutaneous gastrotomy tubes were used. Intra-gastric pH was measured for continuous 23 hour periods (08.00 am - 07.00 am) for 8 consecutive days (days 0-7). A single 2.0 g dose of a 100 mg/mL, LA-OMEP formulation was administered at 08.00 am on day 1. Part B) Twenty-six horses with squamous or glandular gastric disease were enrolled based on routine gastroscopic evaluation. Once enrolled horses received 2.0 g of the 100 mg/mL LA-OMEP formulation by intra-muscular injection on days 0 and 7. Repeat gastroscopy was performed on day 14 (23 horses) or 16 (one horse).
Part A) The percentage of time pH was above 4 exceeded 66% for days 1-4 in all horses, and for days 1-7 in 4/6 horses studied. Part B) Healing was observed in 22/22 (100%: 95%CI 89 - 100%) horses with squamous disease, and 9/12 (75%: 95%CI 47 - 92%) horses with glandular disease. Improvement, by at least one grade, was observed in 22/22 (100%: 95%CI 89 - 100%) horses with squamous disease, and 12/12 (100%: 95%CI 81 - 100%) horses with glandular disease. Worsening of lesions was not observed. Lesion grade decreased over time for both the squamous (p<0.0001) and glandular mucosa (p = 0.0024).
Small sample sizes.
The results of the present study compare favourably with previous reports for the pharmacodynamics of omeprazole and clinical outcomes for trials reporting the response to oral omeprazole therapy. This article is protected by copyright. All rights reserved.