A Double‐blind, Placebo‐controlled, Multicenter, Prospective, Randomized Study of Beraprost Sodium Treatment for Cats with Chronic Kidney Disease

Abstract

BackgroundChronic 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/ObjectivesTo evaluate the efficacy and safety of BPS in the treatment of cats with CKD, as compared to placebo.AnimalsSeventy‐four client‐owned cats with naturally occurring CKD.MethodsDouble‐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).ResultsThe 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 ImportanceBeraprost sodium treatment was well tolerated and safe in cats with CKD. BPS inhibited the reduction in renal filtration function as measured by sCr increase.

Prostacyclin analog beraprost sodium efficacy in primary glomerular disease or nephrosclerosis: Analysis of the Japanese subgroup in CASSIOPEIR study

“…In CKD cats, the mechanism of tubulointerstitial fibrosis is similar to that in humans, confirming its usefulness as a model of human CKD [ 13 ]. BPS significantly inhibited the increase in serum creatinine (SCr) levels in a randomized controlled trial in cats [ 14 ].…”

Combination therapy with beraprost sodium and aspirin for acute ischemic stroke: a single-center retrospective study

“…21 Additionally, the renoprotective effect of BPS has also been shown in other animal models of CKD, which further explained the possible mechanism of BPS. 22,24,25 BPS improved renal function by inhibiting inflammatory factor expression, apoptosis in renal microvascular endothelial and tubular epithelial cells, and tubulointerstitial fibrosis. 26,27 Koyama et al.…”

The Multicomponent, Multitarget Therapy SUC in Cats with Chronic Kidney Disease: A Multicenter, Prospective, Observational, Nonrandomized Cohort Study

“…The results of the current study showed that the multicomponent, multitarget combination SUC is noninferior to the commonly used ACEI benazepril for the treatment of cats with CKD of mild to moderate severity, with similar effects on laboratory parameters indicative of disease progression. Review of the current literature showed that most tested drugs are noninferior compared to benazepril [21][22][23][24][42][43][44][45] (Table 4). Some of the indicated studies included a placebo group to confirm effectivity of their study drug [22,23,42,45,46].…”

“…Review of the current literature showed that most tested drugs are noninferior compared to benazepril [21][22][23][24][42][43][44][45] (Table 4). Some of the indicated studies included a placebo group to confirm effectivity of their study drug [22,23,42,45,46]. Mizutani et al [22] and Takenaka et al [45] showed an increase in serum creatinine within the treatment time of 180 days in the placebo group, showing the progressive course of the disease.…”

“…Some of the indicated studies included a placebo group to confirm effectivity of their study drug [22,23,42,45,46]. Mizutani et al [22] and Takenaka et al [45] showed an increase in serum creatinine within the treatment time of 180 days in the placebo group, showing the progressive course of the disease. In the present study, a placebo group was not included due to ethical constraints and because it is widely accepted that renal function in affected cats decreases over time with increasing serum creatinine levels.…”