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A Double-blind, Placebo-controlled, Multicenter, Prospective, Randomized Study of Beraprost Sodium Treatment for Cats
M Takenaka1, A Iio2, R Sato3
1Animal Clinical Research Foundation, Kurayoshi, Tottori, Japan.
Insights
Beraprost sodium (BPS) is safe and effective for treating cats with chronic kidney disease (CKD). BPS treatment inhibited the decline in renal filtration function, unlike placebo.
Area of Science:
- Veterinary Medicine
- Nephrology
Background:
- Chronic kidney disease (CKD) is a prevalent, progressive, and irreversible condition in felines.
- The therapeutic potential of beraprost sodium (BPS) in feline CKD remains uninvestigated.
Purpose of the Study:
- To assess the efficacy and safety of beraprost sodium (BPS) compared to placebo in treating cats diagnosed with chronic kidney disease (CKD).
Main Methods:
- A prospective, randomized, double-blind, placebo-controlled, multicenter trial involving 74 cats with naturally occurring CKD.
- Cats received either BPS (55 μg/cat) or a placebo orally every 12 hours for 180 days.
- Primary endpoints included changes in serum creatinine (sCr), serum phosphorus-to-calcium ratio, and urine specific gravity (USG).
Main Results:
- Serum creatinine levels increased significantly in the placebo group (2.8 ± 0.7 to 3.2 ± 1.3 mg/dL) but remained stable in the BPS group (2.4 ± 0.7 to 2.5 ± 0.7 mg/dL).
- The serum phosphorus-to-calcium ratio also significantly increased in the placebo group (0.46 ± 0.10 to 0.52 ± 0.21 mg/dL), with no significant change in the BPS group (0.50 ± 0.08 to 0.51 ± 0.11 mg/dL).
- No significant changes in USG were observed in either group. Vomiting was the only treatment-related adverse event, occurring in one cat in the placebo group. No other clinically significant changes were noted in bloodwork.
Conclusions:
- Beraprost sodium (BPS) demonstrated a favorable safety profile and was well-tolerated in cats with chronic kidney disease (CKD).
- BPS effectively inhibited the decline in renal filtration function, as indicated by stable serum creatinine levels.
- These findings suggest BPS as a potential therapeutic agent for managing feline CKD.
Background:
Chronic kidney disease (CKD) is a common progressive and irreversible disease in cats. The efficacy and safety of beraprost sodium (BPS) in cats with CKD have not been evaluated.
Hypothesis/Objectives:
To evaluate the efficacy and safety of BPS in the treatment of cats with CKD, as compared to placebo.
Animals:
Seventy-four client-owned cats with naturally occurring CKD.
Methods:
Double-blind, placebo-controlled, multicenter, prospective, randomized trial. The cats received BPS (55 μg/cat) or a placebo PO q12 h for 180 days. The primary endpoint was prospectively defined as a change in the serum creatinine (sCr), serum phosphorus-to-calcium ratio or urine specific gravity (USG).
Results:
The sCr increased significantly (P = 0.0030) in the placebo group (mean ± SD: 2.8 ± 0.7 to 3.2 ± 1.3 mg/dL) but not in the BPS group (2.4 ± 0.7 to 2.5 ± 0.7 mg/dL). The difference between the groups at day 180 was significant (0.8 mg/dL, 95% CI: 0.2 to 1.3 mg/dL, P = 0.0071). The serum phosphorus-to-calcium ratio was significantly (P = 0.0037) increased in the placebo group (0.46 ± 0.10 to 0.52 ± 0.21 mg/dL) but not in the BPS group (0.50 ± 0.08 to 0.51 ± 0.11 mg/dL). There was no significant change in the USG in either group. An adverse event judged as being treatment-related included vomiting that occurred in 1 case in the placebo group. No clinically relevant change was observed in the CBC and other blood chemistry tests.
Conclusions And Clinical Importance:
Beraprost sodium treatment was well tolerated and safe in cats with CKD. BPS inhibited the reduction in renal filtration function as measured by sCr increase.
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