Efficacy and safety of once daily oral administration of sodium-glucose cotransporter-2 inhibitor velagliflozin compared with twice daily insulin injection in diabetic cats

IF 2.1 2区农林科学 Q1 VETERINARY SCIENCES

Journal of Veterinary Internal Medicine Pub Date : 2024-06-17 DOI:10.1111/jvim.17124

Stijn J. M. Niessen, Hans S. Kooistra, Yaiza Forcada, Charlotte R. Bjørnvad, Balazs Albrecht, Franziska Roessner, Esther Herberich, Carla Kroh

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Abstract

Background

Options for treatment of diabetes mellitus in cats are limited to insulin injections and monitoring for hypoglycemia.

Hypothesis

Once daily sodium-glucose cotransporter-2 inhibitor velagliflozin PO is noninferior to insulin injections.

Animals

Client-owned diabetic cats (127 safety; 116 efficacy assessment).

Methods

Prospective, randomized (1 mg/kg velagliflozin), positive controlled (titrated Caninsulin), open label, noninferiority field trial, comparing number of cats with treatment success in ≥1 clinical variable and ≥1 glycemic variable (margin Δ: 15%) on Day 45; secondary endpoints included glycemic and clinical assessments during 91 days.

Results

On Day 45, 29/54 (54%) velagliflozin-treated cats and 26/62 (42%) Caninsulin-treated cats showed treatment success, demonstrating noninferiority (difference −11.8%; upper 1-sided 97.5% confidence interval, −∞ to 6.3%). By Day 91, quality of life (QoL), polyuria, and polydipsia had improved in 81%, 54% and 61% (velagliflozin); on blood glucose (BG) curves, mean BG was <252 mg/dL in 42/54 (78%; velagliflozin) and 37/62 (60%; Caninsulin); minimum BG was <162 mg/dL in 41/54 (76%; velagliflozin) and 41/62 (66%; Caninsulin); serum fructosamine was <450 μmol/L in 41/54 (76%; velagliflozin) and 38/62 (61%; Caninsulin). Velagliflozin's most frequent adverse events were loose feces/diarrhea (n = 23/61, 38%), positive urine culture (n = 19/61, 31%), and nonclinical hypoglycemia (BG <63 mg/dL; n = 8/61, 13%); Caninsulin's: clinical and nonclinical hypoglycemia (n = 35/66, 53%), positive urine culture (n = 18/66, 27%), and loose feces/diarrhea (n = 10/66, 15%). Diabetic ketoacidosis occurred in 4/61 (7%; velagliflozin) and 0/66 (Caninsulin).

Conclusions and Clinical Importance

Once daily oral administration of velagliflozin was noninferior to insulin injections, showed good QoL and glycemia without clinical hypoglycemia.

Abstract Image

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糖尿病猫每天口服一次钠-葡萄糖共转运体-2抑制剂velagliflozin与每天注射两次胰岛素的疗效和安全性比较。

背景：治疗猫糖尿病的方法仅限于注射胰岛素和监测低血糖：每天一次的钠-葡萄糖共转运体-2抑制剂velagliflozin PO不劣于胰岛素注射：动物：客户饲养的糖尿病猫（127只安全性评估；116只疗效评估）：前瞻性、随机（1 mg/kg velagliflozin）、阳性对照（滴定卡尼胰岛素）、开放标签、非劣效性现场试验，比较第 45 天在≥1 个临床变量和≥1 个血糖变量（差值Δ：15%）方面治疗成功的猫的数量；次要终点包括 91 天内的血糖和临床评估：在第 45 天，29/54（54%）只接受过 velagliflozin 治疗的猫和 26/62（42%）只接受过 Caninsulin 治疗的猫都取得了治疗成功，显示出非劣效性（差异为 -11.8%；单侧 97.5% 置信区间上限为 -∞ 至 6.3%）。到第 91 天，81%、54% 和 61%（velagliflozin）的患者生活质量（QoL）、多尿和多饮得到改善；在血糖（BG）曲线上，平均血糖为结论，具有临床重要性：每日口服一次velagliflozin并不比注射胰岛素效果差，显示出良好的QoL和血糖水平，且无临床低血糖。

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来源期刊

Journal of Veterinary Internal Medicine 农林科学-兽医学

CiteScore

4.50

自引率

11.50%

发文量

243

审稿时长

22 weeks

期刊介绍： The mission of the Journal of Veterinary Internal Medicine is to advance veterinary medical knowledge and improve the lives of animals by publication of authoritative scientific articles of animal diseases.