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在美国、加拿大和欧洲慢性高钾血症患者中,不同钾结合剂的适口性和偏好的随机、双盲、交叉评估:APPETIZE 研究。

Randomised, blinded, cross-over evaluation of the palatability of and preference for different potassium binders in participants with chronic hyperkalaemia in the USA, Canada and Europe: the APPETIZE study.

机构信息

Department of Renal Medicine, Centre for Nephrology, University College London, London, UK

Danish Kidney Association, Taastrup, Denmark.

出版信息

BMJ Open. 2024 Feb 21;14(2):e074954. doi: 10.1136/bmjopen-2023-074954.

Abstract

OBJECTIVES

Traditional potassium (K) binders for treating hyperkalaemia are unpalatable and poorly tolerated. Newer K binders are reportedly better tolerated; however, no published data describe their palatability, a determinant of long-term adherence. This study evaluated the palatability of and preference for three K binders: sodium and calcium polystyrene sulfonate (S/CPS), sodium zirconium cyclosilicate (SZC) and calcium patiromer sorbitex (patiromer).

DESIGN

Phase 4, randomised, participant-blinded, cross-over study. Participants were randomised to one of six taste sequences and, using a 'sip and spit' approach, tasted each K binder before completing a survey.

SETTING

17 centres across the USA, Canada and European Union.

PARTICIPANTS

144 participants with chronic kidney disease, hyperkalaemia and no recent use of K binders.

MAIN OUTCOME MEASURES

For the primary (USA) and key secondary (Canada and European Union) endpoints, participants rated palatability attributes (taste, texture, smell and mouthfeel) and willingness to take each K binder on a scale of 0-10 (rational evaluation). Feelings about each attribute, and the idea of taking the product once daily, were evaluated using a non-verbal, visual measure of emotional response. Finally, participants ranked the K binders according to palatability.

RESULTS

In each region, SZC and patiromer outperformed S/CPS on overall palatability (a composite of taste, texture, smell and mouthfeel), based on rational evaluation and emotional response. Taking the product once daily was more appealing for SZC and patiromer, creating greater receptivity than the idea of taking S/CPS. The emotional response to mouthfeel had the strongest influence on feelings about taking each product. In each region, a numerically greater proportion of participants ranked SZC as the most preferred K binder versus patiromer or S/CPS.

CONCLUSIONS

Preference for more palatable K binders such as SZC and patiromer may provide an opportunity to improve adherence to long-term treatment of hyperkalaemia.

TRIAL REGISTRATION NUMBER

NCT04566653.

摘要

目的

治疗高钾血症的传统钾(K)结合剂味道不佳且耐受性差。新型 K 结合剂据称具有更好的耐受性;然而,尚无关于其适口性的已发表数据,适口性是长期依从性的决定因素。本研究评估了三种 K 结合剂(钠和钙聚苯乙烯磺酸盐[S/CPS]、钠锆硅环硅酸酯[SZC]和钙帕替络尔山梨醇[patiromer])的适口性和偏好性。

设计

4 期、随机、参与者盲法、交叉研究。参与者按 6 种味觉序列之一随机分组,采用“抿一口吐掉”的方法品尝每种 K 结合剂,然后完成一项调查。

地点

美国、加拿大和欧盟的 17 个中心。

参与者

144 名患有慢性肾脏病、高钾血症且近期未使用 K 结合剂的患者。

主要观察指标

对于主要(美国)和关键次要(加拿大和欧盟)终点,参与者对适口性属性(味道、质地、气味和口感)以及服用每种 K 结合剂的意愿进行了 0-10 分(理性评估)的评分。使用非语言的视觉情感反应量表评估对每种属性的感受以及每天服用该产品的想法。最后,参与者根据适口性对 K 结合剂进行了排名。

结果

在每个地区,SZC 和 patiromer 在总体适口性(味道、质地、气味和口感的综合评价)方面均优于 S/CPS,基于理性评估和情感反应。每天服用 SZC 和 patiromer 更具吸引力,比服用 S/CPS 的想法更能引起接受。对口感的情感反应对服用每种产品的感受影响最大。在每个地区,与 patiromer 或 S/CPS 相比,更多的参与者将 SZC 列为最受欢迎的 K 结合剂。

结论

对更可口的 K 结合剂(如 SZC 和 patiromer)的偏好可能为提高高钾血症长期治疗的依从性提供机会。

试验注册编号

NCT04566653。

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