The Effects of Ulcershield , a Novel Omeprazole …

1 Ulcer Score Description 0 Intact mucosal epithelium (can have reddening and/or hyperkeratosis) 1 Small single or small multifocal ulcers 2 Large single or large multifocal ulcers 3 Extensive, often coalescing ulcers with areas of apparent deep ulceration. Table 1. EGUS scoring system (Andrews et al. 1999) Figure 1: Placement of nasogastric tube and pH probe for continuous monitoring of intra-gastric pH and intermittent sampling of gastric contents in two horses. Figure 2: Continuous pH measurements on Day 1 (A) and Day 5 (B) after Ulcershield administration. Note the time the pH is > in B. Mean median hourly gastric pH Day 5 Time of collection08:00:0009:00:0010:00:0011:00: 0012:00:0013:00:0014:00:0015:00:0016:00: 0017:00:0018:00:00 Gastric pH123456789 UlcershieldOmoguardD a y - 1 Figure 3: Mean hourly 24 hour pH in horses treated with Ulcershield or omoguard on day 5 compared to Day -1.

2 Figure 4: Summed gastric squamous ulcer scores in horses after 1 and 5 days of Ulcershield and Omoguard Treatment. The Ef fects of Ulcershield , a Novel Omeprazole Paste, on Gastric Ulcer Scores and Gastric Juice pH Sharanne L. Raidal1, Frank M. Andrews2, Gareth D. Trope1 1 School of Animal and Veterinary Sciences, Veterinary Clinical Centre, Charles Sturt University, Agriculture Ave., Locked Bag 588, Wagga Wagga NSW, Australia; 2 Equine Health Studies Program Dept. of Vet. Clin. Sci., School of Veterinary Medicine, Louisiana State University, Baton Rouge, LA., USA. Introduction Equine Gastric Ulcer Syndrome (EGUS) is common and prevalence ranges from 60 to 90%. Ulcers occur in the nonglandular (squamous) and glandular stomach due to its lack of resistance due to the erosive Effects of gastric acids (hydrochloric, volatile fatty and bile acids).

3 Horses with this condition perform poorly which makes it a significant economical problem within the horse industry. Omeprazole , a potent antiulcer medication, is highly effective in treating and preventing stomach ulcers by increasing stomach pH setting up a permissive environment for healing. Ulcershield , a Novel formulation of Omeprazole paste, is a potent antiulcer medication and promotes healing of stomach ulcers in horses. The purpose of this study was to test the Effects of Ulcershield (Randlab Pty Ltd, Chipping Norton, NSW, Australia) on gastric ulcer scores and gastric juice pH in stall-confined Thoroughbred and Standardbred horses. Materials and Methods Twelve healthy Thoroughbred and Standardbred horses (7 geldings and 5 females), aged 3 to 8 years ( years, mean SD), weighing 365-548 kg ( kg) with no abnormalities on physical examination, haematology or serum biochemistry were included in the study.

4 Horses were acclimatised to box stalls (Day -7) for at least 1 week before treatment, and were fed pelleted feed (1 kg, twice daily; Coprice, Leeton NSW) and oaten hay ( - 2% bwt) divided twice daily). Horses were turned out into a dirt yard for a least 1 hour daily. Water was supplied ad lib, and horses were monitored daily for clinical signs or adverse events. The study was performed as a masked, randomized, 2-period, 2-treatment, 2 sequence cross-over design, so that all horses received the two formulations of Omeprazole ( mg/kg, orally, Q24h) from Days 0 to 5, 6 daily doses. Horses were stratified based on EGUS scorea (Table 1) assigned by a single masked investigator (GT) after endoscopic evaluation of lesser curvature, greater curvature and fundus, prior to the acclimation period (Day -7).

5 The horses were then blocked in pairs and randomly assigned to receive Ulcershield ( mg/kg, PO, Q24h) or Omoguard at the same dose each day at 8am. After conclusion of Period 1, horses were returned to paddocks and commenced Period 2 of the trial, receiving the reciprocal product, after a minimum 14 day wash out. Gastroscopy was performed, and gastric pH determined, on the day prior to starting treatment (Day -1) and again on Day 5, after the sixth daily Omeprazole dose (Day 5). In addition, continuous gastric pH determination was performed for 10 hours following Omeprazole administration (Day 0) using a modified antimony pH electrode coupled to a data logger. The probe was sited within a nasogastric tube and placed in the most ventral portion of the stomach; aspiration of gastric content was attempted every 30 to 60 minutes to confirm gastric fluid pH (Fig 1&2).

6 Results Confinement and dietary modification were associated with decreased gastric pH compared to data obtained prior to beginning the study, when horses were on pasture and fed supplementary lucerne hay. Gastric pH significantly (P= ) increased after treatment with either Ulcershield or Omoguard and there was no difference attributable to treatment (P= ) (Fig. 3). On Day 5, gastric fluid pH was significantly (P< ) increased after Ulcershield or Omoguard treatment with a significant (P= ) treatment effect at 8:00 am, 24 hours after the 4th treatment. The horses, when moved to box stalls and undergoing dietary changes, showed significantly increased gastric ulcer scores when compared to pre-tr ial findings (P= ). However, by Day 5, after the 6th daily dose, Ulcershield or Omoguard treatments both resulted in significantly lower gastric ulcer scores, and were not significantly (P= ) different between one another (Fig 4).

7 Based on the comparison of area under the time - gastric pH curve for 10 hours following administration of Ulcershield or Omoguard on Day 5, we can conclude that these products were bioequivalent at the 5% significance level (Fig 2). Conclusion Confinement and dietary modification were associated with lower stomach pH and increased gastric ulcer scores. Ulcershield was safe and no adverse responses were seen in the treated horses. Ulcershield and Omoguard treatments resulted in equivalent increases in gastric pH and gastric fluid pH profiles. Ulcershield showed an equivalent and beneficial effect on gastric squamous mucosal ulceration, when compared to Omoguard . Ulcershield is pharmacodynamically bioequivalent to Omoguard the registered product and shows beneficial Effects in treatment of gastric ulcers in horses.

8 AAndrews FM, et al. Equine Vet J. 1999. Ulcershield is a registered trademark of Randlab Pty LTD. Ulcershield APVMA #81799/104073. Omoguard is a registered trademark of Ceva Animal Health. 012345678 Pre-trialDay -1 USDay 5 USDay -1 OGDay 5 OGSummed gastric squamous ulcer score A B Email: Phone: (61-2) 9728 3505 RANDLABV eterinary MedicinesDr Michael Robinson Global TEchnical 0451 481 050 SuPPorT:John Dalton nSW/acT 0404 221 776 Andrew Grant 0426 407 117 Alex Macpherson 0421 829 101 Angelo PiazzettacoMMErcial 0416 776 991