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Equine veterinary journal2017; 49(6); 795-801; doi: 10.1111/evj.12688

Preliminary investigations into a novel, long-acting, injectable, intramuscular formulation of omeprazole in the horse.

Abstract: Pilot investigations have suggested that a novel, long-acting, injectable i.m. formulation of omeprazole (LA-OMEP) can induce acid suppression for up to 7 days following a single injection. Objective: To investigate the pharmacodynamics and assess the clinical efficacy of the LA-OMEP formulation. Methods: Part A comprised a pharmacodynamic study. Part B consisted of a pilot clinical trial. Methods: Part A enrolled six adult Thoroughbred horses with percutaneous gastrotomy tubes. Intragastric pH was measured for continuous 23-h periods (08.00-07.00 h) for eight consecutive days (days 0-7). A single 2.0-g dose of a 100 mg/mL LA-OMEP formulation was administered at 08.00 h on day 1. In Part B, 26 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 i.m. injection on days 0 and 7. Repeat gastroscopy was performed on days 14 (23 horses) or 16 (one horse). Results: In Part A, the percentage of time during which pH was above 4 exceeded 66% for days 1-4 in all horses and days 1-7 in four of the six horses studied. In Part B, healing was observed in all 22 (100%, 95% confidence interval [CI] 89-100%) horses with squamous disease and in nine of 12 (75%, 95% CI 47-92%) horses with glandular disease. Improvement, by at least one grade, was observed in all 22 (100%, 95% CI 89-100%) horses with squamous disease and in all 12 (100%, 95% CI 81-100%) horses with glandular disease. No worsening of lesions was observed. Lesion grade decreased over time in both the squamous (P<0.0001) and glandular (P = 0.0024) mucosa. Conclusions: Small sample sizes. Conclusions: The results of the present study compare favourably with previous reports on the pharmacodynamics of omeprazole and the clinical outcomes of trials reporting response to oral omeprazole therapy.
Publication Date: 2017-05-17 PubMed ID: 28397996DOI: 10.1111/evj.12688Google Scholar: Lookup
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  • Clinical Trial
  • Journal Article

Summary

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This research investigates a newly developed long-lasting injectable form of omeprazole in horses, showing that it was effective in suppressing stomach acid for up to a week from a single injection and aiding in the healing of gastric disease.

Objectives and Methodology

  • The research aimed to understand the pharmacodynamics (how the drug works in the body) and the clinical efficiency of a new long-acting, injectable omeprazole formulation (LA-OMEP).
  • The study was conducted in two parts: Part A, the pharmacodynamic study, and Part B, a small-scale clinical trial.
  • In Part A, six adult Thoroughbreds with gastrotomy tubes were enrolled. For eight consecutive days, their intragastric pH was continuously monitored except for one hour daily. Each horse was given a single dose of LA-OMEP on day 1.
  • In Part B, 26 horses diagnosed with either squamous or glandular gastric disease were enrolled based on routine gastroscopy. They were administered the LA-OMEP by injection on days 0 and 7, and their conditions were reevaluated through gastroscopy on days 14 (for 23 horses) or 16 (for one horse).

Findings

  • The results from Part A showed successful acid suppression. The stomach pH was above 4 (a measure of low acidity) for more than 66% of the time during days 1-4 in all six horses, and for days 1-7 in four of those six.
  • In Part B, healing was observed in all enrolled horses. Of the horses with squamous gastric disease, 100% showed healing, and of those with glandular disease, 75% displayed healing. Every horse with either type of gastric disease showed at least one grade of improvement, and no horse saw a worsening of lesions.
  • Over time, the severity (grade) of the disease in both squamous and glandular mucosa (the stomach lining) decreased significantly. This suggests that LA-OMEP was effective in promoting healing and reducing gastric disease severity.

Conclusion

  • The study sample size was small, which might limit the breadth of conclusions that could be drawn from the results.
  • Despite this, the findings provided promising evidence regarding the efficacy of LA-OMEP in suppressing acid and treating gastric disease. The drug’s performance was comparable, if not superior, to effects noted in previous similar studies involving oral omeprazole therapy.

Cite This Article

APA
Sykes BW, Kathawala K, Song Y, Garg S, Page SW, Underwood C, Mills PC. (2017). Preliminary investigations into a novel, long-acting, injectable, intramuscular formulation of omeprazole in the horse. Equine Vet J, 49(6), 795-801. https://doi.org/10.1111/evj.12688

Publication

ISSN: 2042-3306
NlmUniqueID: 0173320
Country: United States
Language: English
Volume: 49
Issue: 6
Pages: 795-801

Researcher Affiliations

Sykes, B W
  • School of Veterinary Science, University of Queensland, Gatton, Queensland, Australia.
  • Luoda Pharma Pty Ltd, Caringbah, New South Wales, Australia.
Kathawala, K
  • Centre for Pharmaceutical Innovation and Development, University of South Australia, Adelaide, South Australia, Australia.
Song, Y
  • Centre for Pharmaceutical Innovation and Development, University of South Australia, Adelaide, South Australia, Australia.
Garg, S
  • Centre for Pharmaceutical Innovation and Development, University of South Australia, Adelaide, South Australia, Australia.
Page, S W
  • Luoda Pharma Pty Ltd, Caringbah, New South Wales, Australia.
Underwood, C
  • School of Veterinary Science, University of Queensland, Gatton, Queensland, Australia.
Mills, P C
  • School of Veterinary Science, University of Queensland, Gatton, Queensland, Australia.

MeSH Terms

  • Animals
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / pharmacology
  • Delayed-Action Preparations
  • Dosage Forms
  • Female
  • Gastric Acidity Determination
  • Horse Diseases / drug therapy
  • Horses
  • Injections, Intramuscular
  • Male
  • Omeprazole / administration & dosage
  • Omeprazole / pharmacology
  • Stomach Ulcer / drug therapy
  • Stomach Ulcer / veterinary

Citations

This article has been cited 11 times.
  1. Ferlini Agne G, May BE, Lovett A, Simon O, Steel C, Santos L, Guedes do Carmo L, Barbosa B, Werner LC, Daros RR, Somogyi AA, Sykes B, Franklin S. Horse Grimace Scale Does Not Detect Pain in Horses with Equine Gastric Ulcer Syndrome.. Animals (Basel) 2023 May 12;13(10).
    doi: 10.3390/ani13101623pubmed: 37238054google scholar: lookup
  2. Vokes J, Lovett A, Sykes B. Equine Gastric Ulcer Syndrome: An Update on Current Knowledge.. Animals (Basel) 2023 Apr 5;13(7).
    doi: 10.3390/ani13071261pubmed: 37048517google scholar: lookup
  3. Song Y, Day CM, Afinjuomo F, Tan JE, Page SW, Garg S. Advanced Strategies of Drug Delivery via Oral, Topical, and Parenteral Administration Routes: Where Do Equine Medications Stand?. Pharmaceutics 2023 Jan 4;15(1).
    doi: 10.3390/pharmaceutics15010186pubmed: 36678815google scholar: lookup
  4. Pratt SL, Bowen M, Hallowell GH, Shipman E, Bailey J, Redpath A. Does lesion type or severity predict outcome of therapy for horses with equine glandular gastric disease? - A retrospective study.. Vet Med Sci 2023 Jan;9(1):150-157.
    doi: 10.1002/vms3.1034pubmed: 36495212google scholar: lookup
  5. Odunayo A, Galyon G, Price J, Hecht S, Tolbert MK. Evaluation of a long-acting injectable formulation of omeprazole in healthy dogs.. J Vet Intern Med 2022 Jul;36(4):1416-1421.
    doi: 10.1111/jvim.16440pubmed: 35546514google scholar: lookup
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    doi: 10.1002/vms3.807pubmed: 35412651google scholar: lookup
  7. Gough S, Hallowell G, Rendle D. Evaluation of the treatment of equine glandular gastric disease with either long-acting-injectable or oral omeprazole.. Vet Med Sci 2022 Mar;8(2):561-567.
    doi: 10.1002/vms3.728pubmed: 35167731google scholar: lookup
  8. Hewetson M, Tallon R. Equine Squamous Gastric Disease: Prevalence, Impact and Management.. Vet Med (Auckl) 2021;12:381-399.
    doi: 10.2147/VMRR.S235258pubmed: 35004264google scholar: lookup
  9. Jansson A, Harris P, Davey SL, Luthersson N, Ragnarsson S, Ringmark S. Straw as an Alternative to Grass Forage in Horses-Effects on Post-Prandial Metabolic Profile, Energy Intake, Behaviour and Gastric Ulceration.. Animals (Basel) 2021 Jul 24;11(8).
    doi: 10.3390/ani11082197pubmed: 34438656google scholar: lookup
  10. Gough S, Hallowell G, Rendle D. A study investigating the treatment of equine squamous gastric disease with long-acting injectable or oral omeprazole.. Vet Med Sci 2020 May;6(2):235-241.
    doi: 10.1002/vms3.220pubmed: 31945806google scholar: lookup
  11. Banse HE, Andrews FM. Equine glandular gastric disease: prevalence, impact and management strategies.. Vet Med (Auckl) 2019;10:69-76.
    doi: 10.2147/VMRR.S174427pubmed: 31406687google scholar: lookup