Plasma concentrations and therapeutic effects of budesonide in dogs with inflammatory bowel disease

Marco Pietra Department of Veterinary Medical Sciences, College of Veterinary Medicine, Alma Mater Studiorum–Università di Bologna, Ozzano dell'Emilia, Bologna, 40064 Italy.

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Federico Fracassi Department of Veterinary Medical Sciences, College of Veterinary Medicine, Alma Mater Studiorum–Università di Bologna, Ozzano dell'Emilia, Bologna, 40064 Italy.

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Alessia Diana Department of Veterinary Medical Sciences, College of Veterinary Medicine, Alma Mater Studiorum–Università di Bologna, Ozzano dell'Emilia, Bologna, 40064 Italy.

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Teresa Gazzotti Department of Veterinary Medical Sciences, College of Veterinary Medicine, Alma Mater Studiorum–Università di Bologna, Ozzano dell'Emilia, Bologna, 40064 Italy.

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Giuliano Bettini Department of Veterinary Medical Sciences, College of Veterinary Medicine, Alma Mater Studiorum–Università di Bologna, Ozzano dell'Emilia, Bologna, 40064 Italy.

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Angelo Peli Department of Veterinary Medical Sciences, College of Veterinary Medicine, Alma Mater Studiorum–Università di Bologna, Ozzano dell'Emilia, Bologna, 40064 Italy.

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Maria Morini Department of Veterinary Medical Sciences, College of Veterinary Medicine, Alma Mater Studiorum–Università di Bologna, Ozzano dell'Emilia, Bologna, 40064 Italy.

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Giampiero Pagliuca Department of Veterinary Medical Sciences, College of Veterinary Medicine, Alma Mater Studiorum–Università di Bologna, Ozzano dell'Emilia, Bologna, 40064 Italy.

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Paola Roncada Department of Veterinary Medical Sciences, College of Veterinary Medicine, Alma Mater Studiorum–Università di Bologna, Ozzano dell'Emilia, Bologna, 40064 Italy.

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Abstract

Objective—To evaluate the pharmacokinetics and clinical efficacy of budesonide in dogs with inflammatory bowel disease (IBD).

Animals—11 dogs (mean ± SD age, 5.7 ± 3.9 years; various breeds and body weights) with moderate or severe IBD.

Procedures—Each dog received a controlled-release formulation of budesonide (3 mg/m2, PO, q 24 h) for 30 days (first day of administration was day 1). The concentration of budesonide and its metabolite (16-α-hydroxyprednisolone) was measured via liquid chromatography–tandem mass spectrometry in plasma and urine samples obtained on days 1 and 8 of treatment. On those days, plasma samples were obtained before the daily budesonide administration and 0.5, 1, 2, 4, and 7 hours after drug administration, whereas urine samples were obtained after collection of the last blood sample. A clinical evaluation was performed on the dogs before onset of drug administration and on days 20 and 30 after start of drug administration.

Results—The highest plasma concentration of budesonide and 16-α-hydroxyprednisolone on day 1 was detected at 1 hour and at 2 hours after drug administration, respectively. After standardization on the basis of specific gravity, the ratio between urinary concentrations of budesonide and 16-α-hydroxyprednisolone was 0.006 and 0.012 on days 1 and 8, respectively. The clinical response was adequate in 8 of 11 dogs.

Conclusions and Clinical Relevance—Budesonide was rapidly absorbed and metabolized in dogs with IBD. The drug gradually accumulated, and there was an adequate therapeutic response and no adverse effects.

Abstract

Objective—To evaluate the pharmacokinetics and clinical efficacy of budesonide in dogs with inflammatory bowel disease (IBD).

Animals—11 dogs (mean ± SD age, 5.7 ± 3.9 years; various breeds and body weights) with moderate or severe IBD.

Procedures—Each dog received a controlled-release formulation of budesonide (3 mg/m2, PO, q 24 h) for 30 days (first day of administration was day 1). The concentration of budesonide and its metabolite (16-α-hydroxyprednisolone) was measured via liquid chromatography–tandem mass spectrometry in plasma and urine samples obtained on days 1 and 8 of treatment. On those days, plasma samples were obtained before the daily budesonide administration and 0.5, 1, 2, 4, and 7 hours after drug administration, whereas urine samples were obtained after collection of the last blood sample. A clinical evaluation was performed on the dogs before onset of drug administration and on days 20 and 30 after start of drug administration.

Results—The highest plasma concentration of budesonide and 16-α-hydroxyprednisolone on day 1 was detected at 1 hour and at 2 hours after drug administration, respectively. After standardization on the basis of specific gravity, the ratio between urinary concentrations of budesonide and 16-α-hydroxyprednisolone was 0.006 and 0.012 on days 1 and 8, respectively. The clinical response was adequate in 8 of 11 dogs.

Conclusions and Clinical Relevance—Budesonide was rapidly absorbed and metabolized in dogs with IBD. The drug gradually accumulated, and there was an adequate therapeutic response and no adverse effects.

Contributor Notes

Presented as a poster at the 20th European College of Veterinary Internal Medicine–Companion Animals Congress, Toulouse, France, September 2010.

Address correspondence to Dr. Pietra (marco.pietra@unibo.it).
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